バイオシミラー市場 – 2035年までの世界予測

本調査レポートでは、バイオシミラー市場を、バイオシミラー市場別、医薬品クラス別（モノクローナル抗体（リツキシマブ、インフリキシマブ、アダリムマブ、トラスツズマブ、ペムブロリズマブ、デュピルマブ、ウステキヌマブ、リサンキズマブ、その他のモノクローナル抗体）、顆粒球コロニー刺激因子、インスリン、エリスロポエチン、遺伝子組換えヒト成長ホルモン、エタネルセプト、フォリトロピン、テリパラチド、インターフェロン、抗凝固薬、アフリベルセプト、GLP-1拮抗薬、その他の製品）、適応症別（腫瘍、炎症性および自己免疫疾患、慢性疾患、血液疾患、成長ホルモン欠乏症、感染症、2型糖尿病、肥満症、その他の適応症）、地域別（北米、欧州、アジア太平洋、ラテンアメリカ、中東、アフリカ）に分類しています。

本レポートは、バイオシミラー市場の成長に影響を与える主要な要因（促進要因、制約要因、課題、機会など）に関する詳細な情報を網羅しています。主要業界プレーヤーの詳細な分析により、事業概要、製品、ソリューション、主要戦略、提携、パートナーシップ、契約に関する洞察を提供しています。バイオシミラー市場に関連する新規承認／上市、提携、買収、および最近の動向についても解説しています。

The global biosimilars market is projected to reach USD 72.29 billion by 2035 from USD 35.04  billion in 2025, at a CAGR of 7.5% during the forecast period. The expansion of the biosimilars market has been predominantly fueled by heightened awareness and education regarding the safety, efficacy, and interchangeability of biosimilar products. Additionally, favorable insurance coverage and reimbursement structures implemented by both public and private payers have played a crucial role in this growth, alongside an increasing demand for cost-effective biologic therapies. Nonetheless, the market faces challenges from escalating complexities in the manufacturing processes and intensifying competition, leading to significant pricing pressures that may hinder further growth.

世界のバイオシミラー市場は、2025年の350.4億米ドルから2035年には722.9億米ドルに達し、予測期間中に7.5%の年平均成長率（CAGR）で成長すると予測されています。バイオシミラー市場の拡大は、主にバイオシミラー製品の安全性、有効性、互換性に関する意識の高まりと教育によって推進されてきました。さらに、費用対効果の高い生物学的療法に対する需要の高まりと並んで、公的および民間の保険支払者によって実施された有利な保険適用範囲と償還制度もこの成長に重要な役割を果たしてきました。しかしながら、市場は製造プロセスの複雑さの増大と競争の激化という課題に直面しており、さらなる成長を妨げる可能性のある大きな価格圧力につながっています。

The monoclonal antibodies segment is expected to grow at the highest CAGR during the study period.

Monoclonal antibodies (mAbs) such as infliximab, rituximab, adalimumab, trastuzumab, pembrolizumab, dupilumab, Ustekinumab, Risankizumab, and others are primarily utilized for the treatment of autoimmune disorders, various cancers, chronic illnesses, and select infectious diseases. The anticipated rise in patient demographics, coupled with increasing adoption rates and the impending patent expirations of several key biologics, is projected to drive demand in the mAb sector. These therapeutics are extensively employed in managing chronic and life-threatening conditions, notably cancer, rheumatoid arthritis, psoriasis, and inflammatory bowel disease, which are experiencing heightened global prevalence due to an aging populace and lifestyle-related risk factors. The emergence of biosimilars for these mAbs offers an opportunity to mitigate healthcare expenditures and improve access to essential therapies. With over 10-15 leading mAbs facing patent expirations within the next decade, competition is poised to intensify, piquing the interest of pharmaceutical companies in the mAb market. The affordability and extensive applicability of mAb biosimilars, particularly in oncology and autoimmune therapies, are likely to significantly contribute to future market growth.

The US is expected to grow at the highest CAGR in the global biosimilars market from 2025 to 2035.

The United States is projected to experience the highest compound annual growth rate (CAGR) in the global biosimilars market between 2025 and 2035. This rapid growth is largely driven by the expiration of patents on several blockbuster biologics and the increasingly favorable regulatory environment established by the Biologics Price Competition and Innovation Act (BPCIA). Over the next decade, the US is expected to see biosimilar entries for major biologics such as Keytruda (pembrolizumab), Stelara (ustekinumab), and Eylea (aflibercept), which are all multi-billion-dollar products. These launches will significantly expand the addressable market for biosimilars, particularly in oncology, immunology, and ophthalmology. Additionally, the growing payer and provider acceptance of biosimilars in the US healthcare system is accelerating uptake. For instance, biosimilars of adalimumab (Humira), the highest-selling biologic in the US for over a decade, began launching in 2023 with multiple entrants such as Amgen, Boehringer Ingelheim, and Sandoz. Early signs show that competitive pricing is starting to drive formulary access and payer adoption. Moreover, legislative and policy efforts, including Medicare reforms and price transparency regulations, are expected to further incentivize biosimilar use, leading to cost savings and greater market penetration. As more biosimilars gain interchangeable status, market dynamics are likely to mirror those seen in generics, thus supporting sustained growth in the US biosimilars sector over the next decade.

The primary interviews conducted for this report can be categorized as follows:

• By Respondent: Supply Side-70% and Demand Side-30%
• By Designation: Managers-45%, CXO and Directors-30%, and Executives-25%
• By Region: North America-40%, Europe-25%, the Asia Pacific-25%, Latin America-5%, and the Middle East & Africa-5%

List of Key Companies Profiled in the Report:

Sandoz Group AG  (Switzerland), Pfizer Inc. (US), Amgen Inc. (US), Celltrion, Inc. (South Korea), Biocon (India),  Dr. Reddy’s Laboratories Ltd. (India), Eli Lilly and Company (US), Teva Pharmaceutical Industries Ltd. (Israel), Fresenius Kabi AG (Germany), STADA Arzneimittel AG (Germany), Boehringer Ingelheim International GmbH (Germany), Samsung Biologics Co., Ltd. (South Korea), Amneal Pharmaceuticals LLC (US), Coherus BioSciences, Inc. (US), Bio-Thera Solutions, Ltd. (China), Aprogen Inc. (South Korea), Shanghai Henlius Biopharmaceuticals, Inc. (China).

Research Coverage:

This research report categorizes the biosimilars market by biosimilars market, by drug class [monoclonal antibodies (rituximab, infliximab, adalimumab, trastuzumab, Pembrolizumab, Dupilumab, Ustekinumab, Risankizumab, and other monoclonal antibodies), granulocyte colony-stimulating factor, insulin, erythropoietin, recombinant human growth hormone, etanercept, follitropin, teriparatide, interferons, anticoagulants, Aflibercept, GLP-1 antagonist, and other products), By indication (oncology, inflammatory and autoimmune diseases, chronic diseases, blood disorders, growth hormone deficiency, infectious diseases, type II diabetes, obesity, and other indications) and by region (North America, Europe, Asia Pacific, Latin America, Middle East, and Africa).

The scope of the report covers detailed information regarding the major factors, such as drivers, restraints, challenges, and opportunities, influencing the growth of the biosimilars market. A detailed analysis of the key industry players has been done to provide insights into their business overview, products, solutions, key strategies, collaborations, partnerships, and agreements. New approvals/launches, collaborations, acquisitions, and recent developments associated with the biosimilars market.

Key Benefits of Buying the Report:

The report will help market leaders and new entrants by providing them with the closest approximations of the revenue numbers for the overall biosimilars market and its subsegments. It will also help stakeholders better understand the competitive landscape and gain more insights to better position their businesses and make suitable go-to-market strategies. This report will enable stakeholders to understand the market’s pulse and provide them with information on the key market drivers, restraints, opportunities, and challenges.

The report provides insights on the following pointers:

• Analysis of key drivers (rising global demand for affordable alternatives to expensive biologic therapies, increasing number of biosimilar launches and approvals, Impending and ongoing patent expiry of blockbuster biologics, entry of emerging players with cost-efficient manufacturing capabilities), restraints (manufacturing complexities and high cost of biosimilars, intense competition, and pricing pressure among market players), opportunities (launch of GLP-1 biosimilars, increasing strategic partnerships and collaborations among biosimilar manufacturers, and growing focus on advanced R&D operating models), and Challenges (increased market competition between biosimilar manufacturers and originator biologic companies).
• Product Development/Innovation: Detailed insights on upcoming products, research and development activities, and new product approvals/launches in the biosimilars market.
• Market Development: Comprehensive information about lucrative markets; the report analyses the market across varied regions.
• Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the biosimilars market.
• Competitive Assessment: In-depth assessment of market shares, growth strategies, and product offerings of leading players. A detailed analysis of the key industry players has been done to provide insights into their key strategies, product launches/ approvals, pipeline analysis, acquisitions, partnerships, agreements, collaborations, other recent developments, investment and funding activities, brand/product comparative analysis, and vendor valuation and financial metrics of the biosimilars market.

Table of Contents

1               INTRODUCTION              34

1.1           STUDY OBJECTIVES       34

1.2           MARKET DEFINITION   34

1.3           STUDY SCOPE   35

1.3.1        MARKET SEGMENTATION & REGIONAL SCOPE 35

1.3.2        INCLUSIONS & EXCLUSIONS       36

1.3.3        YEARS CONSIDERED      36

1.3.4        CURRENCY CONSIDERED            36

1.4           STAKEHOLDERS               37

1.5           SUMMARY OF CHANGES               37

2               RESEARCH METHODOLOGY       39

2.1           RESEARCH DATA              39

2.1.1        SECONDARY DATA          40

2.1.1.1    Objectives of secondary research       40

2.1.1.2    Key data from secondary sources       41

2.1.2        PRIMARY DATA 41

2.1.2.1    Breakdown of primaries      42

2.1.2.2    Key objective of primary research      42

2.2           MARKET ESTIMATION  43

2.2.1        GLOBAL MARKET ESTIMATION 43

2.2.1.1    Company revenue analysis (bottom-up approach)         43

2.2.1.1.1 Revenue share analysis of Sandoz Group AG  44

2.2.1.2    MnM repository analysis     45

2.2.1.3    Primary interviews                45

2.2.2        INSIGHTS FROM PRIMARY EXPERTS        46

2.2.3        SEGMENTAL MARKET SIZE ESTIMATION (TOP-DOWN APPROACH)       46

2.3           MARKET GROWTH RATE PROJECTIONS                47

2.4           DATA TRIANGULATION                50

2.5           STUDY ASSUMPTIONS  51

2.6           RESEARCH LIMITATIONS             51

2.7           RISK ANALYSIS  52

3               EXECUTIVE SUMMARY  53

4               PREMIUM INSIGHTS       57

4.1           BIOSIMILARS MARKET OVERVIEW           57

4.2           NORTH AMERICA: BIOSIMILARS MARKET, BY DRUG CLASS AND COUNTRY   58

4.3           BIOSIMILARS MARKET: GEOGRAPHIC GROWTH OPPORTUNITIES              59

4.4           BIOSIMILARS MARKET: EMERGING VS. DEVELOPED MARKETS,

2025 VS. 2035 (USD MILLION)      59

5               MARKET OVERVIEW       60

5.1           INTRODUCTION              60

5.2           MARKET DYNAMICS       60

5.2.1        DRIVERS               61

5.2.1.1    Rising global demand for affordable alternatives to expensive biologic therapies 61

5.2.1.2    Increasing number of biosimilar launches and approvals                 62

5.2.1.3    Impending and ongoing patent expiry of blockbuster biologics                 65

5.2.1.4    Entry of emerging players with cost-efficient

manufacturing capabilities 66

5.2.2        RESTRAINTS      67

5.2.2.1    Manufacturing complexities and high cost of biosimilars                 67

5.2.2.2    Intense competition and pricing pressure among market players                 67

5.2.3        OPPORTUNITIES              68

5.2.3.1    Launch of GLP-1 biosimilars             68

5.2.3.2    Increasing strategic partnerships and collaborations among biosimilar manufacturers    68

5.2.3.3    Growing focus on advanced R&D operating models      69

5.2.4        CHALLENGES    69

5.2.4.1    Increased market competition between biosimilar manufacturers and originator biologic companies     69

5.3           TECHNOLOGY ANALYSIS             70

5.3.1        KEY TECHNOLOGIES     70

5.3.1.1    Advanced bioprocessing & manufacturing technologies                 70

5.3.1.2    Analytical & characterization techniques          70

5.3.2        COMPLEMENTARY TECHNOLOGIES       71

5.3.2.1    AI & ML 71

5.3.2.2    Lab automation & robotics 71

5.3.3        ADJACENT TECHNOLOGIES       71

5.3.3.1    Microbial fermentation        71

5.3.3.2    3D bioprinting & high-density cell culture       72

5.4           TRENDS/DISRUPTIONS IMPACTING CUSTOMERS’ BUSINESSES       72

5.5           VALUE CHAIN ANALYSIS               74

5.6           ECOSYSTEM ANALYSIS  75

5.6.1        ROLE IN ECOSYSTEM     76

5.7           PATENT ANALYSIS          77

5.7.1        LIST OF KEY PATENTS   78

5.8           PIPELINE ANALYSIS        80

5.8.1        BIOSIMILAR PRODUCTS IN CLINICAL PIPELINE 80

5.8.2        LIST OF KEY BIOLOGICS TO GO OFF-PATENT    83

5.9           REGULATORY ANALYSIS               84

5.9.1        REGULATORY BODIES, GOVERNMENT AGENCIES,

AND OTHER ORGANIZATIONS  84

5.9.2        REGULATORY FRAMEWORK       86

5.10         REIMBURSEMENT SCENARIO ANALYSIS                 88

5.11         PRICING ANALYSIS          91

5.11.1      AVERAGE SELLING PRICE TREND OF BIOSIMILAR PRODUCTS, BY KEY PLAYER, 2022–2024  91

5.11.2      AVERAGE SELLING PRICE TREND OF BIOSIMILAR PRODUCTS, BY REGION, 2022–2024           93

5.12         KEY CONFERENCES & EVENTS, 2025–2026              95

5.13         PORTER’S FIVE FORCES ANALYSIS           96

5.13.1      THREAT OF NEW ENTRANTS      97

5.13.2      THREAT OF SUBSTITUTES          97

5.13.3      BARGAINING POWER OF SUPPLIERS       97

5.13.4      BARGAINING POWER OF BUYERS             97

5.13.5      INTENSITY OF COMPETITIVE RIVALRY 98

5.14         KEY STAKEHOLDERS & BUYING CRITERIA            98

5.14.1      KEY STAKEHOLDERS IN BUYING PROCESS           98

5.14.2      KEY BUYING CRITERIA  99

5.15         INVESTMENT & FUNDING SCENARIO     101

5.16         IMPACT OF AI/GEN AI ON BIOSIMILARS MARKET                 102

5.17         IMPACT OF 2025 US TARIFF ON BIOSIMILARS MARKET                 103

5.17.1      INTRODUCTION              103

5.17.2      KEY TARIFF RATES          103

5.17.3      PRICE IMPACT ANALYSIS             104

5.17.4      IMPACT ON COUNTRY/REGION                105

5.17.4.1  North America      105

5.17.4.1.1                US           105

5.17.4.2  Europe   105

5.17.4.3  Asia Pacific            106

5.17.5      IMPACT ON UPSTREAM MANUFACTURING INDUSTRIES                 106

6               BIOSIMILARS MARKET, BY DRUG CLASS                107

6.1           INTRODUCTION              108

6.2           MONOCLONAL ANTIBODIES     109

6.2.1        RITUXIMAB        112

6.2.1.1    Rising incidences of autoimmune diseases and cancer to

boost segment growth          112

6.2.2        INFLIXIMAB       115

6.2.2.1    Loss of patent exclusivity to fuel adoption for treating

autoimmune diseases           115

6.2.3        ADALIMUMAB  118

6.2.3.1    Cost-effectiveness and improved patient access to support

segment growth    118

6.2.4        TRASTUZUMAB                 121

6.2.4.1    Rising incidence of breast cancer to spur market growth                 121

6.2.5        PEMBROLIZUMAB           124

6.2.5.1    Expansion of immunotherapy in oncology to propel segment growth    124

6.2.6        DUPILUMAB      126

6.2.6.1    High cost of originator therapy and ongoing label expansions to increase demand for affordable biosimilars      126

6.2.7        USTEKINUMAB 129

6.2.7.1    High annual treatment costs of original drug to augment

segment growth    129

6.2.8        RISANKIZUMAB 132

6.2.8.1    Increased biologic-naïve patient growth and high demand for targeted immunotherapies to fuel adoption     132

6.2.9        OTHER MONOCLONAL ANTIBODIES     135

6.3           GRANULOCYTE COLONY-STIMULATING FACTOR                 138

6.3.1        RISING GLOBAL CANCER BURDEN AND INCREASING INVESTMENTS BY PHARMA COMPANIES TO PROPEL MARKET GROWTH             138

6.4           INSULIN               142

6.4.1        HIGH PREVALENCE OF DIABETES TO BOOST MARKET GROWTH             142

6.5           ERYTHROPOIETIN          145

6.5.1        RISING INCIDENCE OF BLOOD DISEASES TO AUGMENT MARKET GROWTH          145

6.6           RECOMBINANT HUMAN GROWTH HORMONE   149

6.6.1        RISING INCIDENCE OF CACHEXIA AND LIVER DISEASES TO FUEL

MARKET GROWTH          149

6.7           ETANERCEPT    152

6.7.1        RISING INCIDENCE OF AUTOIMMUNE DISEASES TO DRIVE APPROVAL AND COMMERCIALIZATION OF ETANERCEPT BIOSIMILARS        152

6.8           FOLLITROPIN   154

6.8.1        POPULARITY OF FOLLITROPIN IN INFERTILITY TREATMENT TO

SPUR MARKET GROWTH               154

6.9           TERIPARATIDE 157

6.9.1        INCREASING INCIDENCE OF OSTEOPOROSIS TO BOOST MARKET DEMAND          157

6.10         INTERFERONS  160

6.10.1      GROWING PREVALENCE OF INFECTIOUS DISEASES TO SUPPORT

MARKET GROWTH          160

6.11         ANTICOAGULANTS         163

6.11.1      RISING PREVALENCE OF CARDIOVASCULAR DISEASES TO FUEL

MARKET GROWTH          163

6.12         AFLIBERCEPT    166

6.12.1      HIGH COST OF ORIGINATOR DRUG AND INCREASED PREVALENCE OF AGE-RELATED EYE DISEASES TO DRIVE SEGMENT            166

6.13         GLP-1 ANTAGONIST       169

6.13.1      HIGH PREVALENCE OF DIABETES AND OBESITY TO AID MARKET GROWTH          169

6.14         OTHER DRUG CLASSES 172

7               BIOSIMILARS MARKET, BY INDICATION                176

7.1           INTRODUCTION              177

7.2           ONCOLOGY        177

7.2.1        HIGH PREVALENCE OF CANCER TO DRIVE MARKET                 177

7.3           INFLAMMATORY & AUTOIMMUNE DISEASES     181

7.3.1        RISING LIFE EXPECTANCY AND GROWING GERIATRIC POPULATION TO AUGMENT MARKET GROWTH               181

7.4           CHRONIC DISEASES       184

7.4.1        HIGH BURDEN OF CARDIOVASCULAR DISEASES TO FUEL

UPTAKE OF BIOSIMILARS            184

7.5           BLOOD DISORDERS        187

7.5.1        INCREASING INCIDENCE OF BLOOD DISORDERS TO BOOST

BIOSIMILAR DEMAND   187

7.6           GROWTH HORMONE DEFICIENCY           190

7.6.1        INCREASING CASES OF GROWTH HORMONE DEFICIENCY AMONG ADULTS TO INCREASE DEMAND FOR BIOSIMILARS     190

7.7           INFECTIOUS DISEASES 193

7.7.1        HIGH POPULATION DENSITY AND INDUSTRIALIZATION OF FOOD PRODUCTION TO DRIVE PREVALENCE IN EMERGING ECONOMIES             193

7.8           TYPE II DIABETES            196

7.8.1        COST-EFFECTIVENESS AND HIGH EFFICACY TO DRIVE BIOSIMILAR

ADOPTION FOR DIABETES          196

7.9           OBESITY              199

7.9.1        INCREASING SEDENTARY LIFESTYLE AMONG ADULTS TO

PROPEL MARKET GROWTH         199

7.10         OTHER INDICATIONS   202

8               BIOSIMILARS MARKET, BY REGION         206

8.1           INTRODUCTION              207

8.2           EUROPE               207

8.2.1        MACROECONOMIC OUTLOOK FOR EUROPE      208

8.2.2        GERMANY           213

8.2.2.1    Acceptance of biosimilars by physicians over originator products to propel market growth      213

8.2.3        UK          216

8.2.3.1    Rising prevalence of life-threatening diseases to fuel demand for low-priced biosimilars         216

8.2.4        FRANCE                219

8.2.4.1    Increased government R&D investments for biosimilar drugs to augment market growth      219

8.2.5        ITALY    222

8.2.5.1    Favorable government regulations and reimbursement policies to propel market growth           222

8.2.6        SPAIN    225

8.2.6.1    Favorable patient incentives and high healthcare R&D expenditure to promote biosimilar use              225

8.2.7        REST OF EUROPE             228

8.3           ASIA PACIFIC     231

8.3.1        MACROECONOMIC OUTLOOK FOR ASIA PACIFIC                 231

8.3.2        JAPAN   235

8.3.2.1    High demand for affordable biologics and recent patent expiries of blockbuster biologics to drive market            235

8.3.3        CHINA  238

8.3.3.1    Increasing investments in pharmaceutical R&D and innovation to augment market growth      238

8.3.4        INDIA    241

8.3.4.1    Need for government healthcare expenditure reduction to propel adoption of biosimilars        241

8.3.5        SOUTH KOREA  244

8.3.5.1    Favourable government incentives to promote biosimilar use in clinical practice     244

8.3.6        AUSTRALIA         247

8.3.6.1    Launch of biosimilar-switching programs in healthcare settings to aid market adoption         247

8.3.7        REST OF ASIA PACIFIC   250

8.4           NORTH AMERICA             253

8.4.1        MACROECONOMIC OUTLOOK FOR NORTH AMERICA                 253

8.4.2        US           258

8.4.2.1    US to dominate North American biosimilars market

during forecast period          258

8.4.3        CANADA               262

8.4.3.1    Favorable government initiatives to drive growth in biopharma research and manufacturing facilities                262

8.5           LATIN AMERICA                265

8.5.1        MACROECONOMIC OUTLOOK FOR LATIN AMERICA                 265

8.5.2        BRAZIL 269

8.5.2.1    Increased government pharmaceutical R&D investments for biosimilars to aid market growth        269

8.5.3        MEXICO                272

8.5.3.1    Well-developed regulatory landscape and high demand for chronic disease treatment to fuel biosimilar uptake        272

8.5.4        REST OF LATIN AMERICA             275

8.6           MIDDLE EAST   277

8.6.1        MACROECONOMIC OUTLOOK FOR MIDDLE EAST                 277

8.6.2        GCC COUNTRIES              281

8.6.2.1    Focus on local pharmaceutical R&D to augment market growth                 281

8.6.3        REST OF MIDDLE EAST 283

8.7           AFRICA 285

8.7.1        INCREASED CANCER BURDEN AND NEED FOR AFFORDABLE ALTERNATIVES TO HIGH-COST BIOLOGICS TO BOOST ADOPTION         285

8.7.2        MACROECONOMIC OUTLOOK FOR AFRICA        285

9               COMPETITIVE LANDSCAPE         288

9.1           INTRODUCTION              288

9.2           KEY PLAYER STRATEGIES/RIGHT TO WIN            288

9.2.1        OVERVIEW OF STRATEGIES ADOPTED BY KEY PLAYERS IN

BIOSIMILARS MARKET, 2022−2024            288

9.3           REVENUE ANALYSIS, 2020–2024  290

9.4           MARKET SHARE ANALYSIS, 2024                 291

9.5           COMPANY EVALUATION MATRIX: KEY PLAYERS, 2024                 293

9.5.1        STARS   293

9.5.2        EMERGING LEADERS     293

9.5.3        PERVASIVE PLAYERS      293

9.5.4        PARTICIPANTS 293

9.5.5        COMPETITIVE BENCHMARKING: KEY PLAYERS, 2024                 295

9.5.5.1    Company footprint               295

9.5.5.2    Region footprint   296

9.5.5.3    Drug class footprint              297

9.5.5.4    Indication footprint              298

9.6           COMPANY EVALUATION MATRIX: STARTUPS/SMES, 2024        299

9.6.1        PROGRESSIVE COMPANIES         299

9.6.2        RESPONSIVE COMPANIES            299

9.6.3        DYNAMIC COMPANIES  299

9.6.4        STARTING BLOCKS         299

9.6.5        COMPETITIVE BENCHMARKING: STARTUPS/SMES, 2024                 301

9.6.5.1    Detailed list of key startups/SMEs    301

9.6.5.2    Competitive benchmarking of key startups/SMEs          302

9.7           COMPANY VALUATION & FINANCIAL METRICS 303

9.7.1        FINANCIAL METRICS      303

9.7.2        COMPANY VALUATION 303

9.8           BRAND/PRODUCT COMPARISON             304

9.9           COMPETITIVE SCENARIO             305

9.9.1        PRODUCT LAUNCHES AND APPROVALS               305

9.9.2        DEALS  306

9.9.3        EXPANSIONS     306

10            COMPANY PROFILES      308

10.1         KEY PLAYERS     308

10.1.1      SANDOZ GROUP AG       308

10.1.1.1  Business overview 308

10.1.1.2  Products offered   309

10.1.1.3  Recent developments           310

10.1.1.3.1                Product launches and approvals         310

10.1.1.3.2                Deals      311

10.1.1.3.3                Expansions             311

10.1.1.3.4                Other developments             312

10.1.1.4  MnM view              312

10.1.1.4.1                Key strengths        312

10.1.1.4.2                Strategic choices   312

10.1.1.4.3                Weaknesses & competitive threats     312

10.1.2      PFIZER INC.        313

10.1.2.1  Business overview 313

10.1.2.2  Products offered   314

10.1.2.3  Recent developments           315

10.1.2.3.1                Product approvals 315

10.1.2.3.2                Deals      316

10.1.2.4  MnM view              316

10.1.2.4.1                Key strengths        316

10.1.2.4.2                Strategic choices   316

10.1.2.4.3                Weaknesses & competitive threats     317

10.1.3      AMGEN INC.       318

10.1.3.1  Business overview 318

10.1.3.2  Products offered   319

10.1.3.3  Products in pipeline             320

10.1.3.4  Recent developments           320

10.1.3.4.1                Product launches and approvals         320

10.1.3.4.2                Deals      321

10.1.3.4.3                Expansions             321

10.1.3.5  MnM view              321

10.1.3.5.1                Key strengths        321

10.1.3.5.2                Strategic choices   322

10.1.3.5.3                Weaknesses & competitive threats     322

10.1.4      CELLTRION INC.               323

10.1.4.1  Business overview 323

10.1.4.2  Products offered   324

10.1.4.3  Recent developments           325

10.1.4.3.1                Product launches and approvals         325

10.1.4.3.2                Deals      326

10.1.4.4  MnM view              326

10.1.4.4.1                Key strengths        326

10.1.4.4.2                Strategic choices   327

10.1.4.4.3                Weaknesses & competitive threats     327

10.1.5      BIOCON               328

10.1.5.1  Business overview 328

10.1.5.2  Products offered   329

10.1.5.3  Recent developments           331

10.1.5.3.1                Product approvals 331

10.1.5.3.2                Deals      331

10.1.5.3.3                Other developments             332

10.1.5.4  MnM view              332

10.1.5.4.1                Key strengths        332

10.1.5.4.2                Strategic choices   332

10.1.5.4.3                Weaknesses & competitive threats     332

10.1.6      DR. REDDY’S LABORATORIES LTD.          333

10.1.6.1  Business overview 333

10.1.6.2  Products offered   334

10.1.6.3  Recent developments           335

10.1.6.3.1                Product launches  335

10.1.6.3.2                Deals      335

10.1.6.3.3                Other developments             336

10.1.7      ELI LILLY AND COMPANY            337

10.1.7.1  Business overview 337

10.1.7.2  Products offered   338

10.1.7.3  Recent developments           339

10.1.7.3.1                Product launches  339

10.1.7.3.2                Deals      339

10.1.7.3.3                Expansions             339

10.1.8      TEVA PHARMACEUTICAL INDUSTRIES LTD.       340

10.1.8.1  Business overview 340

10.1.8.2  Products offered   341

10.1.8.3  Recent developments           341

10.1.8.3.1                Product launches and approvals         341

10.1.8.3.2                Deals      342

10.1.8.3.3                Other developments             342

10.1.9      FRESENIUS KABI AG        343

10.1.9.1  Business overview 343

10.1.9.2  Products offered   344

10.1.9.3  Recent developments           345

10.1.9.3.1                Product launches and approvals         345

10.1.9.3.2                Deals      346

10.1.10   STADA ARZNEIMITTEL AG           347

10.1.10.1                 Business overview 347

10.1.10.2                 Products offered   348

10.1.10.3                 Recent developments           349

10.1.10.3.1             Product launches  349

10.1.10.3.2             Deals      349

10.1.10.3.3             Expansions             350

10.1.10.3.4             Other developments             350

10.1.11   BOEHRINGER INGELHEIM INTERNATIONAL GMBH                 351

10.1.11.1                 Business overview 351

10.1.11.2                 Products offered   352

10.1.11.3                 Recent developments           353

10.1.11.3.1             Product approvals 353

10.1.11.3.2             Deals      353

10.1.11.3.3             Expansions             353

10.1.12   SAMSUNG BIOLOGICS   354

10.1.12.1                 Business overview 354

10.1.12.2                 Products offered   355

10.1.12.3                 Recent developments           357

10.1.12.3.1             Product approvals 357

10.1.12.3.2             Deals      358

10.1.12.3.3             Expansions             358

10.1.13   AMNEAL PHARMACEUTICALS LLC           359

10.1.13.1                 Business overview 359

10.1.13.2                 Products offered   360

10.1.13.3                 Recent developments           360

10.1.13.3.1             Product approvals 360

10.1.13.3.2             Deals      360

10.1.13.3.3             Other developments             361

10.1.14   COHERUS BIOSCIENCES               362

10.1.14.1                 Business overview 362

10.1.14.2                 Products offered   363

10.1.14.3                 Recent developments           363

10.1.14.3.1             Deals      363

10.1.14.3.2             Other developments             363

10.1.15   BIO THERA SOLUTIONS                364

10.1.15.1                 Business overview 364

10.1.15.2                 Products offered   365

10.1.15.3                 Recent developments           365

10.1.15.3.1             Product approvals 365

10.1.15.3.2             Deals      366

10.1.16   APROGEN            367

10.1.16.1                 Business overview 367

10.1.16.2                 Products offered   367

10.1.16.3                 Recent developments           367

10.1.16.3.1             Product approvals 367

10.1.16.4                 Products in pipeline             368

10.1.17   SHANGHAI HENLINUS BIOTECH, INC.    369

10.1.17.1                 Business overview 369

10.1.17.2                 Products offered   370

10.1.17.3                 Products in pipeline             370

10.1.17.4                 Recent developments           370

10.1.17.4.1             Product approvals 370

10.1.17.4.2             Deals      371

10.1.17.4.3             Other developments             371

10.2         OTHER PLAYERS              372

10.2.1      ALVOTECH         372

10.2.2      AMEGA BIOTECH             373

10.2.3      BIOCAD                374

10.2.4      PROBIOMED S.A. DE C.V.              375

10.2.5      FUJIFILM KYOWA KIRIN BIOLOGICS CO., LTD.   375

10.2.6      POLPHARMA BIOLOGICS GROUP             376

10.2.7      NEUCLONE         377

10.2.8      XENTRIA              378

10.2.9      YL BIOLOGICS  379

10.2.10   KASHIV BIOSCIENCES, LLC          380

10.2.11   NANOGEN PHARMACEUTICAL BIOTECHNOLOGY JSC                 381

10.2.12   SYNERMORE BIOLOGICS (SUZHOU) CO., LTD.   382

10.2.13   CURATEQ BIOLOGICS PVT. LTD.              383

11            APPENDIX           384

11.1         DISCUSSION GUIDE        384

11.2         KNOWLEDGESTORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL                388

11.3         CUSTOMIZATION OPTIONS        390

11.4         RELATED REPORTS         390

11.5         AUTHOR DETAILS           391

LIST OF TABLES

TABLE 1                BIOSIMILARS MARKET: INCLUSIONS & EXCLUSIONS      36

TABLE 2                IMPACT ANALYSIS OF SUPPLY- AND DEMAND-SIDE FACTORS  48

TABLE 3                BIOSIMILARS MARKET: RISK ANALYSIS  52

TABLE 4                BIOSIMILARS MARKET: IMPACT ANALYSIS OF MARKET DYNAMICS       61

TABLE 5                LIST OF KEY BIOSIMILARS APPROVED BY MAJOR PLAYERS, 2023–2025          63

TABLE 6                LIST OF IMPENDING AND ONGOING PATENT EXPIRIES OF BLOCKBUSTER BIOLOGICS, 2023–2035          65

TABLE 7                COMPARISON AMONG DIFFERENT DRUG TYPES, INVESTMENTS, APPROVAL TIMES, AND NUMBER OF PATIENTS IN STUDIES  67

TABLE 8                BIOSIMILARS MARKET: ROLE IN ECOSYSTEM                 76

TABLE 9                BIOSIMILARS MARKET: NUMBER OF PATENTS FILED

(APPLIED/GRANTED), 2014–2024                77

TABLE 10              BIOSIMILARS MARKET: INDICATIVE LIST OF KEY PATENTS, 2024          78

TABLE 11              BIOSIMILARS MARKET: PRODUCTS IN CLINICAL PIPELINE             80

TABLE 12              BIOSIMILARS MARKET: LIST OF KEY BIOLOGICS TO GO OFF-PATENT, 2025–2035 83

TABLE 13              NORTH AMERICA: REGULATORY BODIES, GOVERNMENT AGENCIES,

AND OTHER ORGANIZATIONS  84

TABLE 14              EUROPE: REGULATORY BODIES, GOVERNMENT AGENCIES,

AND OTHER ORGANIZATIONS  84

TABLE 15              ASIA PACIFIC: REGULATORY BODIES, GOVERNMENT AGENCIES,

AND OTHER ORGANIZATIONS  85

TABLE 16              REST OF THE WORLD: REGULATORY BODIES, GOVERNMENT AGENCIES,

AND OTHER ORGANIZATIONS  85

TABLE 17              BIOSIMILARS MARKET: COUNTRY/REGION-WISE REGULATORY FRAMEWORK            86

TABLE 18              US: REIMBURSEMENT SCENARIO FOR RECENTLY LAUNCHED BIOSIMILARS,

2024–2025              89

TABLE 19              US: REIMBURSEMENT CODES FOR BIOSIMILAR PRODUCTS         90

TABLE 20              AVERAGE SELLING PRICE TREND OF BIOSIMILAR PRODUCTS, BY KEY PLAYER, 2022–2024 (USD)                 92

TABLE 21              AVERAGE SELLING PRICE TREND OF BIOSIMILAR PRODUCTS, BY REGION,

2022–2024 (USD)                93

TABLE 22              BIOSIMILARS MARKET: DETAILED LIST OF KEY CONFERENCES & EVENTS,

JANUARY 2025–DECEMBER 2026 95

TABLE 23              BIOSIMILARS MARKET: PORTER’S FIVE FORCES                 97

TABLE 24              INFLUENCE OF KEY STAKEHOLDERS ON BUYING PROCESS, BY DRUG CLASS (%) 98

TABLE 25              KEY BUYING CRITERIA FOR BIOSIMILAR PRODUCTS, BY END USER            100

TABLE 26              US ADJUSTED RECIPROCAL TARIFF RATES                 103

TABLE 27              BIOSIMILARS MARKET, BY DRUG CLASS, 2023–2035 (USD MILLION)       108

TABLE 28              BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,

2023–2035 (USD MILLION)            109

TABLE 29              BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY REGION,

2023–2035 (USD MILLION)            110

TABLE 30              NORTH AMERICA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES,

BY COUNTRY, 2023–2035 (USD MILLION)               110

TABLE 31              EUROPE: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY COUNTRY, 2023–2035 (USD MILLION)            111

TABLE 32              ASIA PACIFIC: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES,

BY COUNTRY, 2023–2035 (USD MILLION)               111

TABLE 33              LATIN AMERICA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES,

BY COUNTRY, 2023–2035 (USD MILLION)               112

TABLE 34              MIDDLE EAST: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY REGION, 2023–2035 (USD MILLION)            112

TABLE 35              RITUXIMAB MARKET, BY REGION, 2023–2035 (USD MILLION) 113

TABLE 36              NORTH AMERICA: RITUXIMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     113

TABLE 37              EUROPE: RITUXIMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)            114

TABLE 38              ASIA PACIFIC: RITUXIMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     114

TABLE 39              LATIN AMERICA: RITUXIMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     115

TABLE 40              MIDDLE EAST: RITUXIMAB MARKET, BY REGION, 2023–2035 (USD MILLION)          115

TABLE 41              INFLIXIMAB MARKET, BY REGION, 2023–2035 (USD MILLION) 116

TABLE 42              NORTH AMERICA: INFLIXIMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     116

TABLE 43              EUROPE: INFLIXIMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)            116

TABLE 44              ASIA PACIFIC: INFLIXIMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     117

TABLE 45              LATIN AMERICA: INFLIXIMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     117

TABLE 46              MIDDLE EAST: INFLIXIMAB MARKET, BY REGION, 2023–2035 (USD MILLION)          117

TABLE 47              ADALIMUMAB MARKET, BY REGION, 2023–2035 (USD MILLION) 118

TABLE 48              NORTH AMERICA: ADALIMUMAB MARKET, BY COUNTRY,

2023–2035 (USD MILLION)            119

TABLE 49             EUROPE: ADALIMUMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)            119

TABLE 50              ASIA PACIFIC: ADALIMUMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     120

TABLE 51              LATIN AMERICA: ADALIMUMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     120

TABLE 52              MIDDLE EAST: ADALIMUMAB MARKET, BY REGION, 2023–2035 (USD MILLION)          120

TABLE 53              TRASTUZUMAB MARKET, BY REGION, 2023–2035 (USD MILLION) 121

TABLE 54              NORTH AMERICA: TRASTUZUMAB MARKET, BY COUNTRY,

2023–2035 (USD MILLION)            122

TABLE 55              EUROPE: TRASTUZUMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     122

TABLE 56              ASIA PACIFIC: TRASTUZUMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     123

TABLE 57              LATIN AMERICA: TRASTUZUMAB MARKET, BY COUNTRY,

2023–2035 (USD MILLION)            123

TABLE 58              MIDDLE EAST: TRASTUZUMAB MARKET, BY REGION, 2023–2035 (USD MILLION)          123

TABLE 59              PEMBROLIZUMAB MARKET, BY REGION, 2023–2035 (USD MILLION)       124

TABLE 60              NORTH AMERICA: PEMBROLIZUMAB MARKET, BY COUNTRY,

2023–2035 (USD MILLION)            124

TABLE 61              EUROPE: PEMBROLIZUMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     125

TABLE 62              ASIA PACIFIC: PEMBROLIZUMAB MARKET, BY COUNTRY,

2023–2035 (USD MILLION)            125

TABLE 63              LATIN AMERICA: PEMBROLIZUMAB MARKET, BY COUNTRY,

2023–2035 (USD MILLION)            126

TABLE 64              MIDDLE EAST: PEMBROLIZUMAB MARKET, BY REGION,

2023–2035 (USD MILLION)            126

TABLE 65              DUPILUMAB MARKET, BY REGION, 2023–2035 (USD MILLION) 127

TABLE 66              NORTH AMERICA: DUPILUMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     127

TABLE 67              EUROPE: DUPILUMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)            128

TABLE 68              ASIA PACIFIC: DUPILUMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     128

TABLE 69              LATIN AMERICA: DUPILUMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     129

TABLE 70              MIDDLE EAST: DUPILUMAB MARKET, BY REGION, 2023–2035 (USD MILLION)          129

TABLE 71              USTEKINUMAB MARKET, BY REGION, 2023–2035 (USD MILLION) 130

TABLE 72              NORTH AMERICA: USTEKINUMAB MARKET, BY COUNTRY,

2023–2035 (USD MILLION)            130

TABLE 73              EUROPE: USTEKINUMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     131

TABLE 74              ASIA PACIFIC: USTEKINUMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     131

TABLE 75              LATIN AMERICA: USTEKINUMAB MARKET, BY COUNTRY,

2023–2035 (USD MILLION)            132

TABLE 76              MIDDLE EAST: USTEKINUMAB MARKET, BY REGION, 2023–2035 (USD MILLION)          132

TABLE 77              RISANKIZUMAB MARKET, BY REGION, 2023–2035 (USD MILLION) 133

TABLE 78              NORTH AMERICA: RISANKIZUMAB MARKET, BY COUNTRY,

2023–2035 (USD MILLION)            133

TABLE 79              EUROPE: RISANKIZUMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     133

TABLE 80              ASIA PACIFIC: RISANKIZUMAB MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     134

TABLE 81              LATIN AMERICA: RISANKIZUMAB MARKET, BY COUNTRY,

2023–2035 (USD MILLION)            134

TABLE 82              MIDDLE EAST: RISANKIZUMAB MARKET, BY REGION, 2023–2035 (USD MILLION)          134

TABLE 83              OTHER MONOCLONAL ANTIBODIES MARKET, BY REGION,

2023–2035 (USD MILLION)            136

TABLE 84              NORTH AMERICA: OTHER MONOCLONAL ANTIBODIES MARKET, BY COUNTRY, 2023–2035 (USD MILLION)                 136

TABLE 85              EUROPE: OTHER MONOCLONAL ANTIBODIES MARKET, BY COUNTRY,

2023–2035 (USD MILLION)            137

TABLE 86              ASIA PACIFIC: OTHER MONOCLONAL ANTIBODIES MARKET, BY COUNTRY,

2023–2035 (USD MILLION)            137

TABLE 87              LATIN AMERICA: OTHER MONOCLONAL ANTIBODIES MARKET, BY COUNTRY,

2023–2035 (USD MILLION)            138

TABLE 88              MIDDLE EAST: OTHER MONOCLONAL ANTIBODIES MARKET, BY REGION,

2023–2035 (USD MILLION)            138

TABLE 89              LIST OF APPROVED BIOSIMILARS FOR GRANULOCYTE COLONY-

STIMULATING FACTOR (G-CSF)                139

TABLE 90              BIOSIMILARS MARKET FOR GRANULOCYTE COLONY-STIMULATING FACTOR,

BY REGION, 2023–2035 (USD MILLION)   140

TABLE 91              NORTH AMERICA: BIOSIMILARS MARKET FOR GRANULOCYTE COLONY-STIMULATING FACTOR, BY COUNTRY, 2023–2035 (USD MILLION)     140

TABLE 92              EUROPE: BIOSIMILARS MARKET FOR GRANULOCYTE COLONY-STIMULATING FACTOR, BY COUNTRY, 2023–2035 (USD MILLION)     141

TABLE 93              ASIA PACIFIC: BIOSIMILARS MARKET FOR GRANULOCYTE COLONY-STIMULATING FACTOR, BY COUNTRY, 2023–2035 (USD MILLION)     141

TABLE 94              LATIN AMERICA: BIOSIMILARS MARKET FOR GRANULOCYTE COLONY-STIMULATING FACTOR, BY COUNTRY, 2023–2035 (USD MILLION)     142

TABLE 95              MIDDLE EAST: BIOSIMILARS MARKET FOR GRANULOCYTE COLONY-STIMULATING FACTOR, BY REGION, 2023–2035 (USD MILLION)            142

TABLE 96              BIOSIMILARS MARKET FOR INSULIN, BY REGION, 2023–2035 (USD MILLION)          143

TABLE 97              NORTH AMERICA: BIOSIMILARS MARKET FOR INSULIN, BY COUNTRY,

2023–2035 (USD MILLION)            143

TABLE 98              EUROPE: BIOSIMILARS MARKET FOR INSULIN, BY COUNTRY,

2023–2035 (USD MILLION)            144

TABLE 99              ASIA PACIFIC: BIOSIMILARS MARKET FOR INSULIN, BY COUNTRY,

2023–2035 (USD MILLION)            144

TABLE 100            LATIN AMERICA: BIOSIMILARS MARKET FOR INSULIN, BY COUNTRY,

2023–2035 (USD MILLION)            145

TABLE 101            MIDDLE EAST: BIOSIMILARS MARKET FOR INSULIN, BY REGION,

2023–2035 (USD MILLION)            145

TABLE 102            LIST OF APPROVED BIOSIMILARS FOR ERYTHROPOIETIN          146

TABLE 103            BIOSIMILARS MARKET FOR ERYTHROPOIETIN, BY REGION,

2023–2035 (USD MILLION)            146

TABLE 104            NORTH AMERICA: BIOSIMILARS MARKET FOR ERYTHROPOIETIN, BY COUNTRY, 2023–2035 (USD MILLION)                 147

TABLE 105            EUROPE: BIOSIMILARS MARKET FOR ERYTHROPOIETIN, BY COUNTRY,

2023–2035 (USD MILLION)            147

TABLE 106            ASIA PACIFIC: BIOSIMILARS MARKET FOR ERYTHROPOIETIN, BY COUNTRY,

2023–2035 (USD MILLION)            148

TABLE 107            LATIN AMERICA: BIOSIMILARS MARKET FOR ERYTHROPOIETIN, BY COUNTRY, 2023–2035 (USD MILLION)                 148

TABLE 108            MIDDLE EAST: BIOSIMILARS MARKET FOR ERYTHROPOIETIN, BY REGION,

2023–2035 (USD MILLION)            148

TABLE 109            BIOSIMILARS MARKET FOR RECOMBINANT HUMAN GROWTH HORMONE,

BY REGION, 2023–2035 (USD MILLION)   149

TABLE 110            NORTH AMERICA: BIOSIMILARS MARKET FOR RECOMBINANT HUMAN GROWTH HORMONE, BY COUNTRY, 2023–2035 (USD MILLION)            150

TABLE 111            EUROPE: BIOSIMILARS MARKET FOR RECOMBINANT HUMAN GROWTH HORMONE, BY COUNTRY, 2023–2035 (USD MILLION)            150

TABLE 112            ASIA PACIFIC: BIOSIMILARS MARKET FOR RECOMBINANT HUMAN GROWTH HORMONE, BY COUNTRY, 2023–2035 (USD MILLION)            151

TABLE 113            LATIN AMERICA: BIOSIMILARS MARKET FOR RECOMBINANT HUMAN GROWTH HORMONE, BY COUNTRY, 2023–2035 (USD MILLION)            151

TABLE 114            MIDDLE EAST: BIOSIMILARS MARKET FOR RECOMBINANT HUMAN GROWTH HORMONE, BY REGION, 2023–2035 (USD MILLION)            151

TABLE 115            BIOSIMILARS MARKET FOR ETANERCEPT, BY REGION, 2023–2035 (USD MILLION)          152

TABLE 116            NORTH AMERICA: BIOSIMILARS MARKET FOR ETANERCEPT, BY COUNTRY,

2023–2035 (USD MILLION)            152

TABLE 117            EUROPE: BIOSIMILARS MARKET FOR ETANERCEPT, BY COUNTRY,

2023–2035 (USD MILLION)            153

TABLE 118            ASIA PACIFIC: BIOSIMILARS MARKET FOR ETANERCEPT, BY COUNTRY,

2023–2035 (USD MILLION)            153

TABLE 119            LATIN AMERICA: BIOSIMILARS MARKET FOR ETANERCEPT, BY COUNTRY,

2023–2035 (USD MILLION)            154

TABLE 120            MIDDLE EAST: BIOSIMILARS MARKET FOR ETANERCEPT, BY REGION,

2023–2035 (USD MILLION)            154

TABLE 121            BIOSIMILARS MARKET FOR FOLLITROPIN, BY REGION, 2023–2035 (USD MILLION)          155

TABLE 122            NORTH AMERICA: BIOSIMILARS MARKET FOR FOLLITROPIN, BY COUNTRY,

2023–2035 (USD MILLION)            155

TABLE 123            EUROPE: BIOSIMILARS MARKET FOR FOLLITROPIN, BY COUNTRY,

2023–2035 (USD MILLION)            156

TABLE 124            ASIA PACIFIC: BIOSIMILARS MARKET FOR FOLLITROPIN, BY COUNTRY,

2023–2035 (USD MILLION)            156

TABLE 125            LATIN AMERICA: BIOSIMILARS MARKET FOR FOLLITROPIN, BY COUNTRY,

2023–2035 (USD MILLION)            157

TABLE 126            MIDDLE EAST: BIOSIMILARS MARKET FOR FOLLITROPIN, BY REGION,

2023–2035 (USD MILLION)            157

TABLE 127            BIOSIMILARS MARKET FOR TERIPARATIDE, BY REGION,

2023–2035 (USD MILLION)            158

TABLE 128            NORTH AMERICA: BIOSIMILARS MARKET FOR TERIPARATIDE, BY COUNTRY,

2023–2035 (USD MILLION)            158

TABLE 129            EUROPE: BIOSIMILARS MARKET FOR TERIPARATIDE, BY COUNTRY,

2023–2035 (USD MILLION)            159

TABLE 130            ASIA PACIFIC: BIOSIMILARS MARKET FOR TERIPARATIDE, BY COUNTRY,

2023–2035 (USD MILLION)            159

TABLE 131            LATIN AMERICA: BIOSIMILARS MARKET FOR TERIPARATIDE, BY COUNTRY,

2023–2035 (USD MILLION)            160

TABLE 132            MIDDLE EAST: BIOSIMILARS MARKET FOR TERIPARATIDE, BY REGION,

2023–2035 (USD MILLION)            160

TABLE 133            BIOSIMILARS MARKET FOR INTERFERONS, BY REGION,

2023–2035 (USD MILLION)            161

TABLE 134            NORTH AMERICA: BIOSIMILARS MARKET FOR INTERFERONS, BY COUNTRY,

2023–2035 (USD MILLION)            161

TABLE 135            EUROPE: BIOSIMILARS MARKET FOR INTERFERONS, BY COUNTRY,

2023–2035 (USD MILLION)            162

TABLE 136            ASIA PACIFIC: BIOSIMILARS MARKET FOR INTERFERONS, BY COUNTRY,

2023–2035 (USD MILLION)            162

TABLE 137            LATIN AMERICA: BIOSIMILARS MARKET FOR INTERFERONS, BY COUNTRY,

2023–2035 (USD MILLION)            163

TABLE 138            MIDDLE EAST: BIOSIMILARS MARKET FOR INTERFERONS, BY REGION,

2023–2035 (USD MILLION)            163

TABLE 139            BIOSIMILARS MARKET FOR ANTICOAGULANTS, BY REGION,

2023–2035 (USD MILLION)            164

TABLE 140            NORTH AMERICA: BIOSIMILARS MARKET FOR ANTICOAGULANTS, BY COUNTRY, 2023–2035 (USD MILLION)                 164

TABLE 141            EUROPE: BIOSIMILARS MARKET FOR ANTICOAGULANTS, BY COUNTRY,

2023–2035 (USD MILLION)            165

TABLE 142            ASIA PACIFIC: BIOSIMILARS MARKET FOR ANTICOAGULANTS, BY COUNTRY,

2023–2035 (USD MILLION)            165

TABLE 143            LATIN AMERICA: BIOSIMILARS MARKET FOR ANTICOAGULANTS, BY COUNTRY, 2023–2035 (USD MILLION)                 166

TABLE 144            MIDDLE EAST: BIOSIMILARS MARKET FOR ANTICOAGULANTS, BY REGION,

2023–2035 (USD MILLION)            166

TABLE 145            BIOSIMILARS MARKET FOR AFLIBERCEPT, BY REGION, 2023–2035 (USD MILLION)          167

TABLE 146            NORTH AMERICA: BIOSIMILARS MARKET FOR AFLIBERCEPT, BY COUNTRY,

2023–2035 (USD MILLION)            167

TABLE 147            EUROPE: BIOSIMILARS MARKET FOR AFLIBERCEPT, BY COUNTRY,

2023–2035 (USD MILLION)            168

TABLE 148            ASIA PACIFIC: BIOSIMILARS MARKET FOR AFLIBERCEPT, BY COUNTRY,

2023–2035 (USD MILLION)            168

TABLE 149            LATIN AMERICA: BIOSIMILARS MARKET FOR AFLIBERCEPT, BY COUNTRY,

2023–2035 (USD MILLION)            169

TABLE 150            MIDDLE EAST: BIOSIMILARS MARKET FOR AFLIBERCEPT, BY REGION,

2023–2035 (USD MILLION)            169

TABLE 151          BIOSIMILARS MARKET FOR GLP-1 ANTAGONIST, BY REGION,

2023–2035 (USD MILLION)            170

TABLE 152            NORTH AMERICA: BIOSIMILARS MARKET FOR GLP-1 ANTAGONIST, BY COUNTRY, 2023–2035 (USD MILLION)                 170

TABLE 153            EUROPE: BIOSIMILARS MARKET FOR GLP-1 ANTAGONIST, BY COUNTRY,

2023–2035 (USD MILLION)            171

TABLE 154            ASIA PACIFIC: BIOSIMILARS MARKET FOR GLP-1 ANTAGONIST, BY COUNTRY, 2023–2035 (USD MILLION)                 171

TABLE 155            LATIN AMERICA: BIOSIMILARS MARKET FOR GLP-1 ANTAGONIST, BY COUNTRY, 2023–2035 (USD MILLION)                 172

TABLE 156            MIDDLE EAST: BIOSIMILARS MARKET FOR GLP-1 ANTAGONIST, BY REGION,

2023–2035 (USD MILLION)            172

TABLE 157            BIOSIMILARS MARKET FOR OTHER DRUG CLASSES, BY REGION,

2023–2035 (USD MILLION)            173

TABLE 158            NORTH AMERICA: BIOSIMILARS MARKET FOR OTHER DRUG CLASSES,

BY COUNTRY, 2023–2035 (USD MILLION)               173

TABLE 159            EUROPE: BIOSIMILARS MARKET FOR OTHER DRUG CLASSES, BY COUNTRY,

2023–2035 (USD MILLION)            174

TABLE 160            ASIA PACIFIC: BIOSIMILARS MARKET FOR OTHER DRUG CLASSES, BY COUNTRY, 2023–2035 (USD MILLION)                 174

TABLE 161            LATIN AMERICA: BIOSIMILARS MARKET FOR OTHER DRUG CLASSES, BY COUNTRY, 2023–2035 (USD MILLION)                 175

TABLE 162            MIDDLE EAST: BIOSIMILARS MARKET FOR OTHER DRUG CLASSES, BY REGION, 2023–2035 (USD MILLION)                 175

TABLE 163            BIOSIMILARS MARKET, BY INDICATION, 2023–2035 (USD MILLION)       177

TABLE 164            BIOSIMILARS MARKET FOR ONCOLOGY, BY REGION, 2023–2035 (USD MILLION)          178

TABLE 165            NORTH AMERICA: BIOSIMILARS MARKET FOR ONCOLOGY, BY COUNTRY,

2023–2035 (USD MILLION)            179

TABLE 166            EUROPE: BIOSIMILARS MARKET FOR ONCOLOGY, BY COUNTRY,

2023–2035 (USD MILLION)            179

TABLE 167            ASIA PACIFIC: BIOSIMILARS MARKET FOR ONCOLOGY, BY COUNTRY,

2023–2035 (USD MILLION)            180

TABLE 168            LATIN AMERICA: BIOSIMILARS MARKET FOR ONCOLOGY, BY COUNTRY,

2023–2035 (USD MILLION)            180

TABLE 169            MIDDLE EAST: BIOSIMILARS MARKET FOR ONCOLOGY, BY REGION,

2023–2035 (USD MILLION)            181

TABLE 170            BIOSIMILARS MARKET FOR INFLAMMATORY & AUTOIMMUNE DISEASES,

BY REGION, 2023–2035 (USD MILLION)   182

TABLE 171            NORTH AMERICA: BIOSIMILARS MARKET FOR INFLAMMATORY & AUTOIMMUNE DISEASES, BY COUNTRY, 2023–2035 (USD MILLION)            182

TABLE 172            EUROPE: BIOSIMILARS MARKET FOR INFLAMMATORY & AUTOIMMUNE DISEASES, BY COUNTRY, 2023–2035 (USD MILLION)            183

TABLE 173            ASIA PACIFIC: BIOSIMILARS MARKET FOR INFLAMMATORY & AUTOIMMUNE DISEASES, BY COUNTRY, 2023–2035 (USD MILLION)            183

TABLE 174            LATIN AMERICA: BIOSIMILARS MARKET FOR INFLAMMATORY & AUTOIMMUNE DISEASES, BY COUNTRY, 2023–2035 (USD MILLION)            184

TABLE 175            MIDDLE EAST: BIOSIMILARS MARKET FOR INFLAMMATORY & AUTOIMMUNE DISEASES, BY REGION, 2023–2035 (USD MILLION)       184

TABLE 176            BIOSIMILARS MARKET FOR CHRONIC DISEASES, BY REGION,

2023–2035 (USD MILLION)            185

TABLE 177            NORTH AMERICA: BIOSIMILARS MARKET FOR CHRONIC DISEASES, BY COUNTRY, 2023–2035 (USD MILLION)                 185

TABLE 178            EUROPE: BIOSIMILARS MARKET FOR CHRONIC DISEASES, BY COUNTRY,

2023–2035 (USD MILLION)            186

TABLE 179            ASIA PACIFIC: BIOSIMILARS MARKET FOR CHRONIC DISEASES, BY COUNTRY, 2023–2035 (USD MILLION)                 186

TABLE 180            LATIN AMERICA: BIOSIMILARS MARKET FOR CHRONIC DISEASES, BY COUNTRY, 2023–2035 (USD MILLION)                 187

TABLE 181            MIDDLE EAST: BIOSIMILARS MARKET FOR CHRONIC DISEASES, BY REGION,

2023–2035 (USD MILLION)            187

TABLE 182            BIOSIMILARS MARKET FOR BLOOD DISORDERS, BY REGION,

2023–2035 (USD MILLION)            188

TABLE 183            NORTH AMERICA: BIOSIMILARS MARKET FOR BLOOD DISORDERS, BY COUNTRY, 2023–2035 (USD MILLION)                 188

TABLE 184            EUROPE: BIOSIMILARS MARKET FOR BLOOD DISORDERS, BY COUNTRY,

2023–2035 (USD MILLION)            189

TABLE 185            ASIA PACIFIC: BIOSIMILARS MARKET FOR BLOOD DISORDERS, BY COUNTRY, 2023–2035 (USD MILLION)                 189

TABLE 186            LATIN AMERICA: BIOSIMILARS MARKET FOR BLOOD DISORDERS, BY COUNTRY, 2023–2035 (USD MILLION)                 190

TABLE 187            MIDDLE EAST: BIOSIMILARS MARKET FOR BLOOD DISORDERS, BY REGION,

2023–2035 (USD MILLION)            190

TABLE 188            BIOSIMILARS MARKET FOR GROWTH HORMONE DEFICIENCY, BY REGION,

2023–2035 (USD MILLION)            191

TABLE 189            NORTH AMERICA: BIOSIMILARS MARKET FOR GROWTH HORMONE DEFICIENCY,

BY COUNTRY, 2023–2035 (USD MILLION)               191

TABLE 190            EUROPE: BIOSIMILARS MARKET FOR GROWTH HORMONE DEFICIENCY,

BY COUNTRY, 2023–2035 (USD MILLION)               192

TABLE 191            ASIA PACIFIC: BIOSIMILARS MARKET FOR GROWTH HORMONE DEFICIENCY,

BY COUNTRY, 2023–2035 (USD MILLION)               192

TABLE 192            LATIN AMERICA: BIOSIMILARS MARKET FOR GROWTH HORMONE DEFICIENCY,

BY COUNTRY, 2023–2035 (USD MILLION)               193

TABLE 193            MIDDLE EAST: BIOSIMILARS MARKET FOR GROWTH HORMONE DEFICIENCY,

BY REGION, 2023–2035 (USD MILLION)   193

TABLE 194            BIOSIMILARS MARKET FOR INFECTIOUS DISEASES, BY REGION,

2023–2035 (USD MILLION)            194

TABLE 195            NORTH AMERICA: BIOSIMILARS MARKET FOR INFECTIOUS DISEASES,

BY COUNTRY, 2023–2035 (USD MILLION)               194

TABLE 196            EUROPE: BIOSIMILARS MARKET FOR INFECTIOUS DISEASES, BY COUNTRY,

2023–2035 (USD MILLION)            195

TABLE 197            ASIA PACIFIC: BIOSIMILARS MARKET FOR INFECTIOUS DISEASES, BY COUNTRY, 2023–2035 (USD MILLION)                 195

TABLE 198            LATIN AMERICA: BIOSIMILARS MARKET FOR INFECTIOUS DISEASES, BY COUNTRY, 2023–2035 (USD MILLION)                 196

TABLE 199            MIDDLE EAST: BIOSIMILARS MARKET FOR INFECTIOUS DISEASES, BY REGION, 2023–2035 (USD MILLION)                 196

TABLE 200            BIOSIMILARS MARKET FOR TYPE II DIABETES, BY REGION,

2023–2035 (USD MILLION)            197

TABLE 201            NORTH AMERICA: BIOSIMILARS MARKET FOR TYPE II DIABETES, BY COUNTRY, 2023–2035 (USD MILLION)                 197

TABLE 202            EUROPE: BIOSIMILARS MARKET FOR TYPE II DIABETES, BY COUNTRY,

2023–2035 (USD MILLION)            198

TABLE 203            ASIA PACIFIC: BIOSIMILARS MARKET FOR TYPE II DIABETES, BY COUNTRY,

2023–2035 (USD MILLION)            198

TABLE 204            LATIN AMERICA: BIOSIMILARS MARKET FOR TYPE II DIABETES, BY COUNTRY, 2023–2035 (USD MILLION)                 199

TABLE 205            MIDDLE EAST: BIOSIMILARS MARKET FOR TYPE II DIABETES, BY REGION,

2023–2035 (USD MILLION)            199

TABLE 206            BIOSIMILARS MARKET FOR OBESITY, BY REGION, 2023–2035 (USD MILLION)          200

TABLE 207            NORTH AMERICA: BIOSIMILARS MARKET FOR OBESITY, BY COUNTRY,

2023–2035 (USD MILLION)            200

TABLE 208            EUROPE: BIOSIMILARS MARKET FOR OBESITY, BY COUNTRY,

2023–2035 (USD MILLION)            201

TABLE 209            ASIA PACIFIC: BIOSIMILARS MARKET FOR OBESITY, BY COUNTRY,

2023–2035 (USD MILLION)            201

TABLE 210            LATIN AMERICA: BIOSIMILARS MARKET FOR OBESITY, BY COUNTRY,

2023–2035 (USD MILLION)            202

TABLE 211            MIDDLE EAST: BIOSIMILARS MARKET FOR OBESITY, BY REGION,

2023–2035 (USD MILLION)            202

TABLE 212            BIOSIMILARS MARKET FOR OTHER INDICATIONS, BY REGION,

2023–2035 (USD MILLION)            203

TABLE 213            NORTH AMERICA: BIOSIMILARS MARKET FOR OTHER INDICATIONS, BY COUNTRY, 2023–2035 (USD MILLION)                 203

TABLE 214            EUROPE: BIOSIMILARS MARKET FOR OTHER INDICATIONS, BY COUNTRY,

2023–2035 (USD MILLION)            204

TABLE 215            ASIA PACIFIC: BIOSIMILARS MARKET FOR OTHER INDICATIONS, BY COUNTRY, 2023–2035 (USD MILLION)                 204

TABLE 216            LATIN AMERICA: BIOSIMILARS MARKET FOR OTHER INDICATIONS, BY COUNTRY, 2023–2035 (USD MILLION)                 205

TABLE 217            MIDDLE EAST: BIOSIMILARS MARKET FOR OTHER INDICATIONS, BY REGION, 2023–2035 (USD MILLION)                 205

TABLE 218            BIOSIMILARS MARKET, BY REGION, 2023–2035 (USD MILLION) 207

TABLE 219            EUROPE: KEY MACROINDICATORS          208

TABLE 220            EUROPE: LIST OF APPROVED BIOSIMILARS, 2022–2025              210

TABLE 221            EUROPE: BIOSIMILARS MARKET, BY COUNTRY, 2023–2035 (USD MILLION)            211

TABLE 222            EUROPE: BIOSIMILARS MARKET, BY DRUG CLASS, 2023–2035 (USD MILLION)              211

TABLE 223            EUROPE: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,

2023–2035 (USD MILLION)            212

TABLE 224            EUROPE: BIOSIMILARS MARKET, BY INDICATION, 2023–2035 (USD MILLION)                212

TABLE 225            GERMANY: BIOSIMILARS MARKET, BY DRUG CLASS, 2023–2035 (USD MILLION)              214

TABLE 226            GERMANY: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2023–2035 (USD MILLION)            215

TABLE 227            GERMANY: BIOSIMILARS MARKET, BY INDICATION, 2023–2035 (USD MILLION)                215

TABLE 228            UK: LIST OF APPROVED BIOSIMILARS, 2022–2025                 216

TABLE 229            UK: BIOSIMILARS MARKET, BY DRUG CLASS, 2023–2035 (USD MILLION)            217

TABLE 230            UK: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,

2023–2035 (USD MILLION)            218

TABLE 231            UK: BIOSIMILARS MARKET, BY INDICATION, 2023–2035 (USD MILLION)            218

TABLE 232            FRANCE: BIOSIMILARS MARKET, BY DRUG CLASS, 2023–2035 (USD MILLION)              220

TABLE 233            FRANCE: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,

2023–2035 (USD MILLION)            221

TABLE 234            FRANCE: BIOSIMILARS MARKET, BY INDICATION, 2023–2035 (USD MILLION)                221

TABLE 235            ITALY: BIOSIMILARS MARKET, BY DRUG CLASS, 2023–2035 (USD MILLION)            223

TABLE 236            ITALY: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,

2023–2035 (USD MILLION)            224

TABLE 237            ITALY: BIOSIMILARS MARKET, BY INDICATION, 2023–2035 (USD MILLION)            224

TABLE 238            SPAIN: BIOSIMILARS MARKET, BY DRUG CLASS, 2023–2035 (USD MILLION)            226

TABLE 239            SPAIN: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,

2023–2035 (USD MILLION)            227

TABLE 240            SPAIN: BIOSIMILARS MARKET, BY INDICATION, 2023–2035 (USD MILLION)            227

TABLE 241            REST OF EUROPE: BIOSIMILARS MARKET, BY DRUG CLASS,

2023–2035 (USD MILLION)            229

TABLE 242            REST OF EUROPE: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES,

BY TYPE, 2023–2035 (USD MILLION)         230

TABLE 243            REST OF EUROPE: BIOSIMILARS MARKET, BY INDICATION,

2023–2035 (USD MILLION)            230

TABLE 244            ASIA PACIFIC: KEY MACROINDICATORS                 232

TABLE 245            ASIA PACIFIC: BIOSIMILARS MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     232

TABLE 246            ASIA PACIFIC: BIOSIMILARS MARKET, BY DRUG CLASS, 2023–2035 (USD MILLION)              233

TABLE 247            ASIA PACIFIC: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2023–2035 (USD MILLION)            234

TABLE 248            ASIA PACIFIC: BIOSIMILARS MARKET, BY INDICATION, 2023–2035 (USD MILLION)                234

TABLE 249            JAPAN: LIST OF APPROVED BIOSIMILARS, 2022–2025        236

TABLE 250            JAPAN: BIOSIMILARS MARKET, BY DRUG CLASS, 2023–2035 (USD MILLION)            236

TABLE 251            JAPAN: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,

2023–2035 (USD MILLION)            237

TABLE 252            JAPAN: BIOSIMILARS MARKET, BY INDICATION, 2023–2035 (USD MILLION)            237

TABLE 253            CHINA: BIOSIMILARS MARKET, BY DRUG CLASS, 2023–2035 (USD MILLION)            239

TABLE 254            CHINA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,

2023–2035 (USD MILLION)            240

TABLE 255            CHINA: BIOSIMILARS MARKET, BY INDICATION, 2023–2025 (USD MILLION)            240

TABLE 256            INDIA: BIOSIMILARS APPROVED AND MARKETED, 2022–2025    241

TABLE 257            INDIA: BIOSIMILARS MARKET, BY DRUG CLASS, 2023–2035 (USD MILLION)            242

TABLE 258            INDIA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,

2023–2035 (USD MILLION)            243

TABLE 259            INDIA: BIOSIMILARS MARKET, BY INDICATION, 2023–2035 (USD MILLION)            243

TABLE 260            SOUTH KOREA: LIST OF APPROVED BIOSIMILARS, 2022–2025                 244

TABLE 261            SOUTH KOREA: BIOSIMILARS MARKET, BY DRUG CLASS,

2023–2035 (USD MILLION)            245

TABLE 262            SOUTH KOREA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2023–2035 (USD MILLION)            246

TABLE 263            SOUTH KOREA: BIOSIMILARS MARKET, BY INDICATION,

2023–2035 (USD MILLION)            246

TABLE 264            AUSTRALIA: LIST OF APPROVED BIOSIMILARS, 2022–2025              247

TABLE 265            AUSTRALIA: BIOSIMILARS MARKET, BY DRUG CLASS, 2023–2035 (USD MILLION)              248

TABLE 266            AUSTRALIA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2023–2035 (USD MILLION)            249

TABLE 267            AUSTRALIA: BIOSIMILARS MARKET, BY INDICATION, 2023–2035 (USD MILLION)                249

TABLE 268            NEW ZEALAND: LIST OF APPROVED BIOSIMILARS, 2022–2025                 250

TABLE 269            MALAYSIA: LIST OF APPROVED BIOSIMILARS, 2022–2025              250

TABLE 270            REST OF ASIA PACIFIC: BIOSIMILARS MARKET, BY DRUG CLASS,

2023–2035 (USD MILLION)            251

TABLE 271            REST OF ASIA PACIFIC: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES,

BY TYPE, 2023–2035 (USD MILLION)         252

TABLE 272            REST OF ASIA PACIFIC: BIOSIMILARS MARKET, BY INDICATION,

2023–2035 (USD MILLION)            252

TABLE 273            NORTH AMERICA: KEY MACROINDICATORS                 254

TABLE 274            NORTH AMERICA: BIOSIMILARS MARKET, BY COUNTRY,

2023–2035 (USD MILLION)            255

TABLE 275            NORTH AMERICA: BIOSIMILARS MARKET, BY DRUG CLASS,

2023–2035 (USD MILLION)            256

TABLE 276            NORTH AMERICA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES,

BY TYPE, 2023–2035 (USD MILLION)         257

TABLE 277            NORTH AMERICA: BIOSIMILARS MARKET, BY INDICATION,

2023–2035 (USD MILLION)            257

TABLE 278            US: LIST OF APPROVED BIOSIMILARS, 2022–2025                 258

TABLE 279            US: BIOSIMILARS MARKET, BY DRUG CLASS, 2023–2035 (USD MILLION)            260

TABLE 280            US: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,

2023–2035 (USD MILLION)            261

TABLE 281            US: BIOSIMILARS MARKET, BY INDICATION, 2023–2035 (USD MILLION)            261

TABLE 282            CANADA: LIST OF APPROVED BIOSIMILARS, 2022–2025              262

TABLE 283            CANADA: BIOSIMILARS MARKET, BY DRUG CLASS, 2023–2035 (USD MILLION)              263

TABLE 284            CANADA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,

2023–2035 (USD MILLION)            264

TABLE 285            CANADA: BIOSIMILARS MARKET, BY INDICATION, 2023–2035 (USD MILLION)                264

TABLE 286            LATIN AMERICA: KEY MACROINDICATORS                 266

TABLE 287            LATIN AMERICA: BIOSIMILARS MARKET, BY COUNTRY, 2023–2035 (USD MILLION)     266

TABLE 288            LATIN AMERICA: BIOSIMILARS MARKET, BY DRUG CLASS,

2023–2035 (USD MILLION)            267

TABLE 289            LATIN AMERICA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2023–2035 (USD MILLION)            268

TABLE 290            LATIN AMERICA: BIOSIMILARS MARKET, BY INDICATION,

2023–2035 (USD MILLION)            268

TABLE 291          BRAZIL: BIOSIMILARS MARKET, BY DRUG CLASS, 2023–2035 (USD MILLION)            270

TABLE 292            BRAZIL: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,

2023–2035 (USD MILLION)            271

TABLE 293          BRAZIL: BIOSIMILARS MARKET, BY INDICATION, 2023–2035 (USD MILLION)            271

TABLE 294            MEXICO: BIOSIMILARS MARKET, BY DRUG CLASS, 2023–2035 (USD MILLION)              273

TABLE 295            MEXICO: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,

2023–2035 (USD MILLION)            274

TABLE 296            MEXICO: BIOSIMILARS MARKET, BY INDICATION, 2023–2035 (USD MILLION)                274

TABLE 297            REST OF LATIN AMERICA: BIOSIMILARS MARKET, BY DRUG CLASS,

2023–2035 (USD MILLION)            275

TABLE 298            REST OF LATIN AMERICA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2023–2035 (USD MILLION) 276

TABLE 299            REST OF LATIN AMERICA: BIOSIMILARS MARKET, BY INDICATION,

2023–2035 (USD MILLION)            276

TABLE 300            MIDDLE EAST: KEY MACROINDICATORS                 278

TABLE 301            MIDDLE EAST: BIOSIMILARS MARKET, BY REGION, 2023–2035 (USD MILLION)          278

TABLE 302            MIDDLE EAST: BIOSIMILARS MARKET, BY DRUG CLASS,

2023–2035 (USD MILLION)            279

TABLE 303            MIDDLE EAST: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2023–2035 (USD MILLION)            280

TABLE 304            MIDDLE EAST: BIOSIMILARS MARKET, BY INDICATION, 2023–2035 (USD MILLION)                280

TABLE 305            GCC COUNTRIES: BIOSIMILARS MARKET, BY DRUG CLASS,

2023–2035 (USD MILLION)            281

TABLE 306            GCC COUNTRIES: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2023–2035 (USD MILLION)            282

TABLE 307            GCC COUNTRIES: BIOSIMILARS MARKET, BY INDICATION,

2023–2035 (USD MILLION)            282

TABLE 308            REST OF MIDDLE EAST: BIOSIMILARS MARKET, BY DRUG CLASS,

2023–2035 (USD MILLION)            283

TABLE 309            REST OF MIDDLE EAST: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES,

BY TYPE, 2023–2035 (USD MILLION)         284

TABLE 310            REST OF MIDDLE EAST: BIOSIMILARS MARKET, BY INDICATION,

2023–2035 (USD MILLION)            284

TABLE 311            AFRICA: KEY MACROINDICATORS            286

TABLE 312          AFRICA: BIOSIMILARS MARKET, BY DRUG CLASS, 2023–2035 (USD MILLION)            286

TABLE 313            AFRICA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,

2023–2035 (USD MILLION)            287

TABLE 314          AFRICA: BIOSIMILARS MARKET, BY INDICATION, 2023–2035 (USD MILLION)            287

TABLE 315            OVERVIEW OF MAJOR STRATEGIES DEPLOYED BY KEY PLAYERS IN

BIOSIMILARS MARKET, 2022–2024              288

TABLE 316            BIOSIMILARS MARKET: DEGREE OF COMPETITION 292

TABLE 317            BIOSIMILARS MARKET: REGION FOOTPRINT                 296

TABLE 318            BIOSIMILARS MARKET: DRUG CLASS FOOTPRINT       297

TABLE 319            BIOSIMILARS MARKET: INDICATION FOOTPRINT       298

TABLE 320            BIOSIMILARS MARKET: DETAILED LIST OF KEY STARTUPS/SME PLAYERS             301

TABLE 321            BIOSIMILARS MARKET: COMPETITIVE BENCHMARKING OF

KEY STARTUPS/SME PLAYERS, 2024         302

TABLE 322            BIOSIMILARS MARKET: PRODUCT APPROVALS AND LAUNCHES,

JANUARY 2022–APRIL 2025            305

TABLE 323            BIOSIMILARS MARKET: DEALS, JANUARY 2022–APRIL 2025           306

TABLE 324            BIOSIMILARS MARKET: EXPANSIONS, JANUARY 2022– APRIL 2025               306

TABLE 325            SANDOZ GROUP AG: COMPANY OVERVIEW                 308

TABLE 326            SANDOZ GROUP AG: PRODUCTS OFFERED                 309

TABLE 327            SANDOZ GROUP AG: PRODUCT LAUNCHES AND APPROVALS,

JANUARY 2022–APRIL 2025            310

TABLE 328            SANDOZ GROUP AG: DEALS, JANUARY 2022–APRIL 2025           311

TABLE 329            SANDOZ GROUP AG: EXPANSIONS, JANUARY 2022–APRIL 2025                311

TABLE 330            SANDOZ GROUP AG: OTHER DEVELOPMENTS, JANUARY 2022–APRIL 2025            312

TABLE 331            PFIZER INC.: COMPANY OVERVIEW         313

TABLE 332            PFIZER INC.: PRODUCTS OFFERED          314

TABLE 333            PFIZER INC.: PRODUCT APPROVALS, JANUARY 2022–APRIL 2025                315

TABLE 334            PFIZER INC.: DEALS, JANUARY 2022–APRIL 2025                 316

TABLE 335            AMGEN INC.: COMPANY OVERVIEW        318

TABLE 336            AMGEN INC.: PRODUCTS OFFERED         319

TABLE 337            AMGEN INC.: PRODUCTS IN PIPELINE   320

TABLE 338            AMGEN INC.: PRODUCT LAUNCHES AND APPROVALS, JANUARY 2022–APRIL 2025 320

TABLE 339            AMGEN INC.: DEALS, JANUARY 2022–APRIL 2025                 321

TABLE 340            AMGEN INC.: EXPANSIONS, JANUARY 2022–APRIL 2025           321

TABLE 341            CELLTRION INC.: COMPANY OVERVIEW                 323

TABLE 342            CELLTRION INC.: PRODUCTS OFFERED                 324

TABLE 343            CELLTRION INC.: PRODUCT LAUNCHES AND APPROVALS,

JANUARY 2022–APRIL 2025            325

TABLE 344            CELLTRION INC.: DEALS, JANUARY 2022–APRIL 2025        326

TABLE 345            BIOCON: COMPANY OVERVIEW                328

TABLE 346            BIOCON: PRODUCTS OFFERED 329

TABLE 347            BIOCON: PRODUCT APPROVALS, JANUARY 2022–APRIL 2025                331

TABLE 348            BIOCON: DEALS, JANUARY 2022–APRIL 2025                 331

TABLE 349            BIOCON: OTHER DEVELOPMENTS, JANUARY 2022–APRIL 2025                332

TABLE 350            DR. REDDY’S LABORATORIES LTD.: COMPANY OVERVIEW          333

TABLE 351            DR. REDDY’S LABORATORIES LTD.: PRODUCTS OFFERED             334

TABLE 352            DR. REDDY’S LABORATORIES LTD.: PRODUCT LAUNCHES,

JANUARY 2022–APRIL 2025            335

TABLE 353            DR. REDDY’S LABORATORIES LTD.: DEALS, JANUARY 2022–APRIL 2025            335

TABLE 354            DR. REDDY’S LABORATORIES LTD.: OTHER DEVELOPMENTS,

JANUARY 2022–APRIL 2025            336

TABLE 355            ELI LILLY AND COMPANY: COMPANY OVERVIEW          337

TABLE 356            ELI LILLY AND COMPANY: PRODUCTS OFFERED                 338

TABLE 357            ELI LILLY AND COMPANY: PRODUCT LAUNCHES, JANUARY 2022–APRIL 2025   339

TABLE 358            ELI LILLY AND COMPANY: DEALS, JANUARY 2022–APRIL 2025                339

TABLE 359            ELI LILLY AND COMPANY: EXPANSIONS, JANUARY 2022–APRIL 2025            339

TABLE 360            TEVA PHARMACEUTICAL INDUSTRIES LTD.: COMPANY OVERVIEW   340

TABLE 361            TEVA PHARMACEUTICAL INDUSTRIES LTD.: PRODUCTS OFFERED    341

TABLE 362            TEVA PHARMACEUTICAL INDUSTRIES LTD.: PRODUCT LAUNCHES AND

APPROVALS, JANUARY 2022–APRIL 2025 341

TABLE 363            TEVA PHARMACEUTICAL INDUSTRIES LTD.: DEALS, JANUARY 2022–APRIL 2025             342

TABLE 364            TEVA PHARMACEUTICAL INDUSTRIES LTD.: OTHER DEVELOPMENTS,

JANUARY 2022–APRIL 2025            342

TABLE 365            FRESENIUS KABI AG: COMPANY OVERVIEW                 343

TABLE 366            FRESENIUS KABI AG: PRODUCTS OFFERED                 344

TABLE 367            FRESENIUS KABI AG: PRODUCT LAUNCHES AND APPROVALS,

JANUARY 2022–APRIL 2025            345

TABLE 368            FRESENIUS KABI AG: DEALS, JANUARY 2022–APRIL 2025           346

TABLE 369            STADA ARZEIMITTEL AG: COMPANY OVERVIEW                 347

TABLE 370            STADA ARZEIMITTEL AG: PRODUCTS OFFERED                 348

TABLE 371          STADA ARZEIMITTEL AG: PRODUCT LAUNCHES, JANUARY 2022–APRIL 2025            349

TABLE 372            STADA ARZEIMITTEL AG: DEALS, JANUARY 2022–APRIL 2025                349

TABLE 373            STADA ARZEIMITTEL AG: EXPANSIONS, JANUARY 2022–APRIL 2025            350

TABLE 374            STADA ARZEIMITTEL AG: OTHER DEVELOPMENTS, JANUARY 2022–APRIL 2025       350

TABLE 375            BOEHRINGER INGELHEIM INTERNATIONAL GMBH: COMPANY OVERVIEW    351

TABLE 376            BOEHRINGER INGELHEIM INTERNATIONAL GMBH: PRODUCTS OFFERED     352

TABLE 377            BOEHRINGER INGELHEIM INTERNATIONAL GMBH: PRODUCT APPROVALS, JANUARY 2022–APRIL 2025                 353

TABLE 378            BOEHRINGER INGELHEIM INTERNATIONAL GMBH:

DEALS, JANUARY 2022–APRIL 2025             353

TABLE 379            BOEHRINGER INGELHEIM INTERNATIONAL GMBH:

EXPANSIONS, JANUARY 2022–APRIL 2025                353

TABLE 380            SAMSUNG BIOLOGICS: COMPANY OVERVIEW                 354

TABLE 381            SAMSUNG BIOLOGICS: PRODUCTS OFFERED                 355

TABLE 382            SAMSUNG BIOLOGICS: PRODUCT APPROVALS, JANUARY 2022–APRIL 2025            357

TABLE 383            SAMSUNG BIOLOGICS: DEALS, JANUARY 2022–APRIL 2025           358

TABLE 384            SAMSUNG BIOLOGICS: EXPANSIONS, JANUARY 2022–APRIL 2025                358

TABLE 385            AMNEAL PHARMACEUTICALS LLC: COMPANY OVERVIEW          359

TABLE 386            AMNEAL PHARMACEUTICALS LLC: PRODUCTS OFFERED             360

TABLE 387            AMNEAL PHARMACEUTICALS LLC: PRODUCT APPROVALS,

JANUARY 2022–APRIL 2025            360

TABLE 388            AMNEAL PHARMACEUTICALS LLC: DEALS, JANUARY 2022–APRIL 2025            360

TABLE 389            AMNEAL PHARMACEUTICALS LLC: OTHER DEVELOPMENTS,

JANUARY 2022–APRIL 2025            361

TABLE 390            COHERUS BIOSCIENCES: COMPANY OVERVIEW                 362

TABLE 391            COHERUS BIOSCIENCES: PRODUCTS OFFERED                 363

TABLE 392            COHERUS BIOSCIENCES: DEALS, JANUARY 2022–APRIL 2025           363

TABLE 393            COHERUS BIOSCIENCES: OTHER DEVELOPMENTS, JANUARY 2022–APRIL 2025       363

TABLE 394            BIO THERA SOLUTIONS: COMPANY OVERVIEW                 364

TABLE 395            BIO THERA SOLUTIONS: PRODUCTS OFFERED                 365

TABLE 396          BIO THERA SOLUTIONS: PRODUCT APPROVALS, JANUARY 2022–APRIL 2025            365

TABLE 397            BIO THERA SOLUTIONS: DEALS, JANUARY 2022–APRIL 2025           366

TABLE 398            APROGEN: COMPANY OVERVIEW             367

TABLE 399            APROGEN: PRODUCTS OFFERED              367

TABLE 400            APROGEN: PRODUCT APPROVALS, JANUARY 2022–APRIL 2025                367

TABLE 401            APROGEN: PRODUCTS IN PIPELINE        368

TABLE 402            SHANGHAI HENLINUS BIOTECH, INC.: COMPANY OVERVIEW   369

TABLE 403            SHANGHAI HENLINUS BIOTECH, INC.: PRODUCTS OFFERED    370

TABLE 404            SHANGHAI HENLINUS BIOTECH, INC.: PRODUCTS IN PIPELINE               370

TABLE 405            SHANGHAI HENLINUS BIOTECH, INC.: PRODUCT APPROVALS,

JANUARY 2022–APRIL 2025            370

TABLE 406            SHANGHAI HENLINUS BIOTECH, INC.: DEALS, JANUARY 2022–APRIL 2025            371

TABLE 407            SHANGHAI HENLINUS BIOTECH, INC.: OTHER DEVELOPMENTS,

JANUARY 2022–APRIL 2025            371

TABLE 408            ALVOTECH: COMPANY OVERVIEW          372

TABLE 409            AMGEGA BIOTECH: COMPANY OVERVIEW                 373

TABLE 410            BIOCAD: COMPANY OVERVIEW 374

TABLE 411            PROBIOMED S.A. DE C.V.: COMPANY OVERVIEW                 375

TABLE 412            FUJIFILM KYOWA KIRIN BIOLOGICS CO., LTD.: COMPANY OVERVIEW   375

TABLE 413            POLPHARMA BIOLOGICS GROUP: COMPANY OVERVIEW          376

TABLE 414            NEUCLONE: COMPANY OVERVIEW         377

TABLE 415            XENTRIA: COMPANY OVERVIEW               378

TABLE 416            YL BIOLOGICS: COMPANY OVERVIEW   379

TABLE 417            KASHIV BIOSCIENCES, LLC: COMPANY OVERVIEW          380

TABLE 418            NANOGEN PHARMACEUTICAL BIOTECHNOLOGY JSC: COMPANY OVERVIEW   381

TABLE 419            SYNERMORE BIOLOGICS (SUZHOU) CO., LTD.: COMPANY OVERVIEW   382

TABLE 420            CURATEQ BIOLOGICS PVT. LTD.: COMPANY OVERVIEW          383

LIST OF FIGURES

FIGURE 1              BIOSIMILARS MARKET SEGMENTATION & REGIONAL SCOPE            35

FIGURE 2              BIOSIMILARS MARKET: YEARS CONSIDERED                 36

FIGURE 3              BIOSIMILARS MARKET: RESEARCH DESIGN                 39

FIGURE 4              BIOSIMILARS MARKET: KEY DATA FROM SECONDARY SOURCES  41

FIGURE 5              BIOSIMILARS MARKET: BREAKDOWN OF PRIMARIES (SUPPLY- AND

DEMAND-SIDE PARTICIPANTS) 42

FIGURE 6              BIOSIMILARS MARKET SIZE ESTIMATION (SUPPLY-SIDE ANALYSIS), 2024  43

FIGURE 7              COMPANY REVENUE ANALYSIS-BASED ESTIMATION:

BOTTOM-UP APPROACH (2024)                 44

FIGURE 8              REVENUE SHARE ANALYSIS OF SANDOZ GROUP AG (2024)              44

FIGURE 9              BIOSIMILARS MARKET SIZE VALIDATION FROM PRIMARY EXPERTS          46

FIGURE 10            BIOSIMILARS MARKET: TOP-DOWN APPROACH                 47

FIGURE 11            BIOSIMILARS MARKET: CAGR PROJECTIONS                 48

FIGURE 12            BIOSIMILARS MARKET: DATA TRIANGULATION                 50

FIGURE 13            BIOSIMILARS MARKET, BY DRUG CLASS, 2025 VS. 2035 (USD MILLION)       53

FIGURE 14            BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,

2025 VS. 2035 (USD MILLION)      54

FIGURE 15            BIOSIMILARS MARKET, BY INDICATION, 2025 VS. 2035 (USD MILLION)       55

FIGURE 16            REGIONAL SNAPSHOT OF BIOSIMILARS MARKET               56

FIGURE 17            INCREASING INVESTMENTS IN BIOSIMILAR RESEARCH AND GROWING DEMAND FOR COST-EFFECTIVE TREATMENT OPTIONS TO DRIVE MARKET          57

FIGURE 18            US AND MONOCLONAL ANTIBODIES ARE EXPECTED TO ACCOUNT FOR

LARGEST MARKET SHARE IN 2025             58

FIGURE 19            REST OF EUROPE TO REGISTER HIGHEST CAGR FROM 2025 TO 2035          59

FIGURE 20            EMERGING MARKETS TO REGISTER HIGHER GROWTH RATES

DURING STUDY PERIOD               59

FIGURE 21            BIOSIMILARS MARKET: DRIVERS, RESTRAINTS, OPPORTUNITIES,

AND CHALLENGES          60

FIGURE 22            BIOSIMILARS MARKET: TRENDS/DISRUPTIONS IMPACTING

CUSTOMERS’ BUSINESSES           73

FIGURE 23            BIOSIMILARS MARKET: VALUE CHAIN ANALYSIS                 74

FIGURE 24            BIOSIMILARS MARKET: ECOSYSTEM ANALYSIS                 76

FIGURE 25            BIOSIMILARS MARKET: PATENT PUBLICATION TRENDS, JURISDICTION,

AND TOP APPLICANT ANALYSIS (JANUARY 2014–DECEMBER 2024)      78

FIGURE 26            AVERAGE SELLING PRICE TREND OF BIOSIMILAR PRODUCTS, 2022–2024 (USD)             93

FIGURE 27            AVERAGE SELLING PRICE TREND OF BIOSIMILAR PRODUCTS,

BY REGION, 2022–2024 (USD)      94

FIGURE 28            BIOSIMILARS MARKET: PORTER’S FIVE FORCES ANALYSIS            96

FIGURE 29            INFLUENCE OF KEY STAKEHOLDERS ON BUYING PROCESS, BY DRUG CLASS         98

FIGURE 30            KEY BUYING CRITERIA FOR BIOSIMILAR PRODUCTS, BY END USER            99

FIGURE 31            BIOSIMILARS MARKET: INVESTMENT & FUNDING SCENARIO, 2023–2025 101

FIGURE 32            BIOSIMILARS MARKET: IMPACT OF AI/GEN AI                 102

FIGURE 33            EUROPE: BIOSIMILARS MARKET SNAPSHOT                 209

FIGURE 34            NORTH AMERICA: BIOSIMILARS MARKET SNAPSHOT          255

FIGURE 35            REVENUE ANALYSIS OF KEY PLAYERS IN BIOSIMILARS MARKET,

2020–2024 (USD MILLION)            290

FIGURE 36            MARKET SHARE ANALYSIS OF KEY PLAYERS IN BIOSIMILARS MARKET (2024)      291

FIGURE 37            BIOSIMILARS MARKET: COMPANY EVALUATION MATRIX (KEY PLAYERS), 2024         294

FIGURE 38            BIOSIMILARS MARKET: COMPANY FOOTPRINT                 295

FIGURE 39            BIOSIMILARS MARKET: COMPANY EVALUATION MATRIX (STARTUPS/SMES), 2024 300

FIGURE 40            EV/EBITDA OF KEY VENDORS   303

FIGURE 41            YEAR-TO-DATE (YTD) PRICE TOTAL RETURN AND 5-YEAR STOCK

BETA OF KEY VENDORS                303

FIGURE 42            BIOSIMILARS MARKET: BRAND/PRODUCT COMPARATIVE ANALYSIS            304

FIGURE 43            SANDOZ GROUP AG: COMPANY SNAPSHOT                 309

FIGURE 44            PFIZER INC.: COMPANY SNAPSHOT         314

FIGURE 45            AMGEN INC.: COMPANY SNAPSHOT       319

FIGURE 46            CELLTRION INC.: COMPANY SNAPSHOT                 324

FIGURE 47            BIOCON: COMPANY SNAPSHOT                329

FIGURE 48            DR. REDDY’S LABORATORIES LTD.: COMPANY SNAPSHOT          334

FIGURE 49            ELI LILLY AND COMPANY: COMPANY SNAPSHOT          338

FIGURE 50            TEVA PHARMACEUTICAL INDUSTRIES LTD.: COMPANY SNAPSHOT   340

FIGURE 51            FRESENIUS KABI AG: COMPANY SNAPSHOT                 344

FIGURE 52            STADA ARZEIMITTEL AG: COMPANY SNAPSHOT                 348

FIGURE 53            BOEHRINGER INGELHEIM INTERNATIONAL GMBH: COMPANY SNAPSHOT   352

FIGURE 54            SAMSUNG BIOLOGICS: COMPANY SNAPSHOT                 355

FIGURE 55            AMNEAL PHARMACEUTICALS LLC: COMPANY SNAPSHOT          359

FIGURE 56            COHERUS BIOSCIENCES: COMPANY SNAPSHOT                 362

FIGURE 57            BIO THERA SOLUTIONS: COMPANY SNAPSHOT                 364

FIGURE 58            SHANGHAI HENLINUS BIOTECH, INC.: COMPANY SNAPSHOT   369

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