バイオシミラー市場

出版:MarketsandMarkets

Biosimilars Market by Product (Monoclonal antibodies (infliximab, rituximab, trastuzumab), Insulin, Interferon, Etanercept, Glucagon, Calcitonin), Indication (Oncology, Chronic Disease, Blood Disorder, Autoimmune Disease), Region – Global Forecast to 2026

出版 MarketsandMarkets
出版年月 2021年10月
ページ数 224
図表数 183
種別 英文調査報告書

レポート目次  お問合せ

バイオシミラー市場 製品[モノクローナル抗体(インフリキシマブ、リツキシマブ、トラスツズマブ)、インスリン、インターフェロン、エタネルセプト、グルカゴン、カルシトニン]、適応症(腫瘍学、慢性疾患、血液疾患、自己免疫疾患)、地域別

The global biosimilars market is projected to reach USD 44.7 billion by 2026 from USD 15.6 billion in 2021, at a CAGR of 23.5% during the forecast period of 2021 to 2026. Market growth is largely driven by the rising incidence of chronic diseases and increasing demand of biosimilars for their cost-effectiveness. Regulatory approvals and other regulations favouring biosimilars adoption in different countries is also a major driving factor in the biosimilars market. However, the complexities in the development and manufacturing of biosimilars and resistance from reference biologic manufacturers is expected to restrain the growth of this market during the forecast period.

“The monoclonal antibodies productsegment accounted for the highest growth rate in the biosimilarsmarket, byproduct, during the forecast period”
In 2020, the monoclonal antibodies product segment accounted for the largest share (27.5%) of the biosimilars market, mainly due to the low prices of biosimilar monoclonal antibodies compared to the reference drugs and their wide use in the treatment of cancer, autoimmune disorders, and osteoporosis. They are also used in indications such as rheumatoid arthritis, multiple sclerosis, and macular degeneration. The growth of the fastest-growing segment was attributed to the rising incidence of cancer cases and chronic diseases and growth in the geriatric population.

“Oncologysegment accounted for the largest share of the indication segment”
Based on the indication, the biosimilars market is segmented into oncology, inflammatory and autoimmune diseases, chronic diseases, blood disorders, growth hormone deficiency, infectious diseases, and other indications (infertility, hypoglycemia, myocardial infarction, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases). Oncology is the largest segment in this market owing to the availability of biosimilars at a lower price than innovative biologics and a large number of cancer patients. The availability of biosimilars in the field of oncology has lowered prices and made cancer treatment more affordable and accessible. Also, due to the high incidence and prevalence of cancer, healthcare systems across the globe are focusing on reducing the burden of cancer by adopting cost effective treatment options. In this scenario, biosimilar drugs might witness widespread adoption in major markets such as the US, Europe, and the Asia Pacific. Considering these factors and the upending competition from biosimilars, many major biologic pharmaceutical companies are making significant investments in the development and approval of biosimilar drugs.

“Asia Pacific: The fastest-growing regionin thebiosimilarsmarket”
Thebiosimilarsmarket is segmented into Europe, Asia Pacific, North America, latin America and Middle East and Africa. The APAC market, on the other hand, is expected to be the fastest-growing regional segment during the forecast period due to the presence of many emerging players, less-stringent regulations, and increasing cooperation among leading and regional players for development, manufacture and commercialization of biosimilars.

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

• By Respondent: Supply Side- 80%and Demand Side 20%
• By Designation: Managers – 55%, CXOs – 20%, and Executives – 25%
• By Region: North America -50%, Europe -20%, Asia-Pacific -20%, RoW -10%
Lists of Companies Profiled in the Report:
• Novartis AG (Switzerland)
• Pfizer, Inc. (US)
• Dr. Reddy’s Laboratories Ltd (India)
• Amgen, Inc. (US)
• Eli Lilly and Company (US)
• Teva Pharmaceutical Industries Ltd. (Israel)
• Fresenius SE & Co. KGaA (Germany)
• STADA Arzneimittel AG (Germany)
• Boehringer Ingelheim (Germany)
• Gedeon Richter PLC (Hungary)
• Celltrion (South Korea)
• Samsung Biologics (South Korea)
• CoherusBioSciences (US)
• Biocon Limited (India)
• Viatris, Inc. (US)
• Amega Biotech (Argentina)
• Apotex, Inc. (Canada)
• Biocad (Russia)
• mAbxience (Spain)
• Probiomed S.A. De C.V. (Mexico)
• Fujifilm Kyowa Kirin Biologics Co., Ltd. (Japan)
• Intas Pharmaceuticals Ltd. (India)
• Theramex (UK)
• Reliance Life Sciences (India)
• Kashiv Biosciences (US)
Research Coverage:
This report provides a detailed picture of thebiosimilars market. It aims at estimating the size and future growth potential of the market across different segments such as theproduct,indication and region. The report also includes an in-depth competitive analysis ofthe key market players along with their company profiles recent developments and key market strategies.

Key Benefits of Buying the Report:
The report will help market leaders/new entrants by providing them with the closest approximations of the revenue numbers for the overall biosimilars marketand its subsegments.It will also help stakeholders better understand the competitive landscape and gain more insights to better position their business 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,trends,challengesand opportunities.


目次

1 INTRODUCTION 26
1.1 OBJECTIVES OF THE STUDY 26
1.2 MARKET DEFINITION 26
1.2.1 INCLUSIONS & EXCLUSIONS OF THE STUDY 27
TABLE 1 BIOSIMILARS MARKET: INCLUSIONS & EXCLUSIONS 27
1.3 MARKET SCOPE 28
1.3.1 MARKETS COVERED 28
1.3.2 YEARS CONSIDERED FOR THE STUDY 28
1.4 CURRENCY 29
1.5 STAKEHOLDERS 29
1.6 LIMITATIONS 29
1.7 SUMMARY OF CHANGES 29
2 RESEARCH METHODOLOGY 31
2.1 RESEARCH APPROACH 31
FIGURE 1 RESEARCH DESIGN 31
2.2 SECONDARY DATA 32
FIGURE 2 SECONDARY SOURCES 32
2.3 PRIMARY DATA 33
FIGURE 3 KEY DATA FROM PRIMARY SOURCES 34
FIGURE 4 BREAKDOWN OF PRIMARY INTERVIEWS: BY COMPANY TYPE, DESIGNATION, AND REGION 34
2.4 MARKET BREAKDOWN AND DATA TRIANGULATION 35
FIGURE 5 DATA TRIANGULATION METHODOLOGY 35
2.5 MARKET ESTIMATION METHODOLOGY 36
2.5.1 BOTTOM-UP APPROACH 36
2.5.2 TOP-DOWN APPROACH 36
FIGURE 6 TOP-DOWN APPROACH 36
FIGURE 7 BIOSIMILARS MARKET: FINAL MARKET SIZE (USD BILLION) 37
2.6 GROWTH RATE ASSUMPTIONS/GROWTH FORECAST 37
2.7 INSIGHTS FROM PRIMARIES 38
FIGURE 8 MARKET VALIDATION FROM PRIMARY EXPERTS 38
2.8 RESEARCH ASSUMPTIONS 39
2.9 LIMITATIONS 40
2.10 RISK ASSESSMENT 40

3 EXECUTIVE SUMMARY 41
FIGURE 9 BIOSIMILARS MARKET, BY PRODUCT, 2021 VS. 2026 (USD MILLION) 41
FIGURE 10 BIOSIMILARS MARKET, BY INDICATION, 2021 VS. 2026 (USD MILLION) 42
FIGURE 11 BIOSIMILARS MARKET, BY REGION, 2021 VS. 2026 (USD MILLION) 43
4 PREMIUM INSIGHTS 44
4.1 BIOSIMILARS MARKET OVERVIEW 44
FIGURE 12 RISING INCIDENCE OF CHRONIC DISEASES TO DRIVE MARKET GROWTH 44
4.2 NORTH AMERICA: BIOSIMILARS MARKET, BY PRODUCT AND COUNTRY (2020) 45
FIGURE 13 INSULIN HELD THE LARGEST SHARE OF THE NORTH AMERICAN BIOSIMILARS MARKET IN 2020 45
4.3 GEOGRAPHICAL SNAPSHOT OF THE BIOSIMILARS MARKET 46
FIGURE 14 ASIA PACIFIC TO REGISTER THE HIGHEST GROWTH DURING THE FORECAST PERIOD 46
5 MARKET OVERVIEW 47
5.1 INTRODUCTION 47
5.2 MARKET DYNAMICS 47
FIGURE 15 BIOSIMILARS MARKET: DRIVERS, RESTRAINTS, OPPORTUNITIES, & CHALLENGES 47
5.2.1 DRIVERS 48
5.2.1.1 Increasing demand for biosimilar drugs due to their cost-effectiveness 48
5.2.1.2 Rising geriatric population and the increasing incidence of chronic diseases 48
FIGURE 16 GERIATRIC POPULATION, BY REGION, 2020 VS. 2030 VS. 2050 (MILLION) 48
FIGURE 17 INCIDENCE OF DIABETES, BY REGION, 2019 VS. 2030 VS. 2045 (MILLION) 49
5.2.1.3 Abbreviated regulatory approval process and concept of interchangeability 50
FIGURE 18 COMPARISON OF REFERENCE PRODUCTS, BIOSIMILARS, AND INTERCHANGEABLE PRODUCTS 50
5.2.2 RESTRAINTS 51
5.2.2.1 Complexities in manufacturing 51
5.2.2.2 Resistance from biologics manufacturers 51
5.2.3 OPPORTUNITIES 52
5.2.3.1 Emerging markets 52
5.2.3.2 Patent expiry of blockbuster biologics and research on new indications 52
TABLE 2 LIST OF KEY BIOLOGICS UNDER THE THREAT OF PATENT EXPIRY 53
5.2.4 CHALLENGES 54
5.2.4.1 Excess competition 54
5.2.5 TRENDS 55
5.2.5.1 Collaborations for biosimilar research and clinical trials 55
TABLE 3 MAJOR COLLABORATIONS IN THE BIOSIMILARS MARKET (2017–2020) 55
5.3 COVID-19 IMPACT ANALYSIS 55
5.4 TECHNOLOGY ANALYSIS 56
TABLE 4 COMPARISON OF ORIGINAL BIOLOGICS WITH BIOSIMILARS 56
TABLE 5 GENERIC DRUGS VS. BIOSIMILARS 57
5.5 VALUE CHAIN ANALYSIS 57
FIGURE 19 VALUE CHAIN ANALYSIS FOR BIOSIMILARS 57
5.6 ECOSYSTEM MARKET MAP 58
FIGURE 20 ECOSYSTEM MARKET MAP FOR BIOSIMILARS 58
5.7 SUPPLY CHAIN ANALYSIS 58
5.8 PORTER’S FIVE FORCES ANALYSIS 59
TABLE 6 PORTER’S FIVE FORCES: IMPACT ANALYSIS ON THE BIOSIMILARS MARKET 59
5.8.1 THREAT FROM NEW ENTRANTS 59
5.8.2 THREAT FROM SUBSTITUTES 59
5.8.3 BARGAINING POWER OF SUPPLIERS 59
5.8.4 BARGAINING POWER OF BUYERS 60
5.8.5 INTENSITY OF COMPETITION RIVALRY 60
5.9 REGULATORY LANDSCAPE 61
TABLE 7 REGULATORY LANDSCAPE FOR THE BIOSIMILARS MARKET 61
6 BIOSIMILARS MARKET, BY PRODUCT 63
6.1 INTRODUCTION 64
FIGURE 21 BIOSIMILARS APPROVED IN THE US, EUROPE, AND CHINA, BY TYPE 64
TABLE 8 BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION) 64
6.2 MONOCLONAL ANTIBODIES 65
TABLE 9 BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,
2019–2026 (USD MILLION) 65
TABLE 10 BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY REGION,
2019–2026 (USD MILLION) 65
6.2.1 INFLIXIMAB 66
6.2.1.1 Infliximab accounted for the largest share of the monoclonal antibodies market 66
TABLE 11 BIOSIMILARS MARKET FOR INFLIXIMAB, BY REGION,
2019–2026 (USD MILLION) 66
6.2.2 TRASTUZUMAB 66
6.2.2.1 Rising incidence of cancer to drive market growth 66
TABLE 12 BIOSIMILARS MARKET FOR TRASTUZUMAB, BY REGION,
2019–2026 (USD MILLION) 67
6.2.3 RITUXIMAB 67
6.2.3.1 Rising incidence of autoimmune diseases and cancer are key drivers for market growth 67
TABLE 13 BIOSIMILARS MARKET FOR RITUXIMAB, BY REGION,
2019–2026 (USD MILLION) 67
6.2.4 ADALIMUMAB 68
6.2.4.1 Adalimumab to register the highest CAGR in the monoclonal antibodies market 68
TABLE 14 BIOSIMILARS MARKET FOR ADALIMUMAB, BY REGION,
2019–2026 (USD MILLION) 68
6.2.5 OTHER MONOCLONAL ANTIBODIES 69
TABLE 15 BIOSIMILARS MARKET FOR OTHER MONOCLONAL ANTIBODIES, BY REGION, 2019–2026 (USD MILLION) 69
6.3 INSULIN 69
6.3.1 INCREASING INCIDENCE OF DIABETES TO SUPPORT MARKET GROWTH 69
TABLE 16 BIOSIMILARS MARKET FOR INSULIN, BY REGION,
2019–2026 (USD MILLION) 70
6.4 GRANULOCYTE COLONY-STIMULATING FACTOR 70
6.4.1 G-CSF IS USED TO TREAT CANCER PATIENTS WITH NEUTROPENIA OCCURRING AFTER CHEMOTHERAPY 70
TABLE 17 LIST OF APPROVED BIOSIMILARS FOR G-CSF 70
TABLE 18 BIOSIMILARS MARKET FOR GRANULOCYTE COLONY-STIMULATING FACTOR, BY REGION, 2019–2026 (USD MILLION) 71
6.5 ERYTHROPOIETIN 71
6.5.1 RISING INCIDENCE OF BLOOD DISORDERS WILL DRIVE MARKET GROWTH 71
TABLE 19 LIST OF APPROVED BIOSIMILARS FOR ERYTHROPOIETIN 72
TABLE 20 BIOSIMILARS MARKET FOR ERYTHROPOIETIN, BY REGION,
2019–2026 (USD MILLION) 72
6.6 RECOMBINANT HUMAN GROWTH HORMONE 73
6.6.1 MARKET GROWTH IS DRIVEN PRIMARILY BY THE INCREASING INCIDENCE OF GROWTH DEFICIENCY DISORDERS 73
TABLE 21 BIOSIMILARS MARKET FOR RECOMBINANT HUMAN GROWTH HORMONE,
BY REGION, 2019–2026 (USD MILLION) 73
6.7 ETANERCEPT 74
6.7.1 APAC TO WITNESS THE HIGHEST GROWTH IN THE ETANERCEPT MARKET DURING THE FORECAST PERIOD 74
TABLE 22 BIOSIMILARS MARKET FOR ETANERCEPT, BY REGION,
2019–2026 (USD MILLION) 74
6.8 FOLLITROPIN 74
6.8.1 INCREASING APPLICATION OF FOLLITROPIN IN INFERTILITY TREATMENT TO DRIVE MARKET GROWTH 74
TABLE 23 BIOSIMILARS MARKET FOR FOLLITROPIN, BY REGION,
2019–2026 (USD MILLION) 75
6.9 TERIPARATIDE 75
6.9.1 INCREASING INCIDENCE OF OSTEOPOROSIS IS THE MAJOR FACTOR DRIVING MARKET GROWTH 75
TABLE 24 BIOSIMILARS MARKET FOR TERIPARATIDE, BY REGION,
2019–2026 (USD MILLION) 75
6.10 INTERFERONS 76
6.10.1 RISING INCIDENCE OF INFECTIOUS DISEASES TO
SUPPORT MARKET GROWTH 76
TABLE 25 BIOSIMILARS MARKET FOR INTERFERONS, BY REGION,
2019–2026 (USD MILLION) 76
6.11 ENOXAPARIN SODIUM 76
6.11.1 WIDE RANGE OF APPLICATIONS HAVE SUPPORTED THE DEMAND FOR ENOXAPARIN SODIUM BIOSIMILARS 76
TABLE 26 BIOSIMILARS MARKET FOR ENOXAPARIN SODIUM, BY REGION,
2019–2026 (USD MILLION) 77
6.12 GLUCAGON 77
6.12.1 SANDOZ IS A MAJOR PLAYER IN THE GLUCAGON BIOSIMILARS MARKET 77
TABLE 27 BIOSIMILARS MARKET FOR GLUCAGON, BY REGION,
2019–2026 (USD MILLION) 77
6.13 CALCITONIN 78
6.13.1 INCREASING INCIDENCE OF OSTEOPOROSIS TO DRIVE MARKET GROWTH 78
TABLE 28 BIOSIMILARS MARKET FOR CALCITONIN, BY REGION,
2019–2026 (USD MILLION) 78
7 BIOSIMILARS MARKET, BY INDICATION 79
7.1 INTRODUCTION 80
TABLE 29 BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION) 80
7.2 ONCOLOGY 80
7.2.1 RISING BURDEN OF CANCER TO DRIVE THE DEMAND FOR BIOSIMILARS 80
FIGURE 22 CANCER CASES, BY TYPE, 2020 (MILLION) 81
FIGURE 23 DEATHS DUE TO CANCER, BY TYPE, 2020 (MILLION) 81
TABLE 30 BIOSIMILARS APPROVED BY THE US FDA FOR ONCOLOGICAL INDICATIONS, 2018-2020 82
FIGURE 24 ARTICLES PUBLISHED ON BIOSIMILARS FOR ONCOLOGY, 2012–2020 83
TABLE 31 BIOSIMILARS MARKET FOR ONCOLOGY, BY REGION,
2019–2026 (USD MILLION) 84
7.3 INFLAMMATORY & AUTOIMMUNE DISEASES 84
7.3.1 CHANGES IN LIFESTYLE AND ENVIRONMENTAL CONDITIONS HAVE INCREASED THE INCIDENCE OF INFLAMMATORY & AUTOIMMUNE DISEASES 84
TABLE 32 BIOSIMILARS MARKET FOR INFLAMMATORY AND AUTOIMMUNE DISEASES, BY REGION, 2019–2026 (USD MILLION) 85
7.4 CHRONIC DISEASES 85
7.4.1 HIGH BURDEN OF CVD & DIABETES WORLDWIDE TO DRIVE MARKET GROWTH 85
TABLE 33 BIOSIMILARS APPROVED BY THE US FDA FOR CHRONIC DISEASES,
2018–2020 86
TABLE 34 BIOSIMILARS MARKET FOR CHRONIC DISEASES, BY REGION,
2019–2026 (USD MILLION) 86
7.5 BLOOD DISORDERS 86
7.5.1 INCREASING INCIDENCE OF BLOOD DISORDERS HAS INCREASED THE DEMAND FOR BIOSIMILARS FOR THIS INDICATION SEGMENT 86
TABLE 35 BIOSIMILARS MARKET FOR BLOOD DISORDERS, BY REGION,
2019–2026 (USD MILLION) 87
7.6 GROWTH HORMONE DEFICIENCY 87
7.6.1 GROWING USE OF BIOSIMILARS FOR THE TREATMENT OF THIS MEDICAL CONDITION TO SUPPORT MARKET GROWTH 87
TABLE 36 BIOSIMILARS MARKET FOR GROWTH HORMONE DEFICIENCY, BY REGION, 2019–2026 (USD MILLION) 88
7.7 INFECTIOUS DISEASES 88
7.7.1 BIOSIMILARS MARKET FOR INFECTIOUS DISEASES IS EXPECTED TO BE THE HIGHEST IN THE ASIA PACIFIC 88
TABLE 37 BIOSIMILARS MARKET FOR INFECTIOUS DISEASES, BY REGION,
2019–2026 (USD MILLION) 89
7.8 OTHER INDICATIONS 89
TABLE 38 BIOSIMILARS MARKET FOR OTHER INDICATIONS, BY REGION,
2019–2026 (USD MILLION) 89
8 BIOSIMILARS MARKET, BY REGION 90
8.1 INTRODUCTION 91
FIGURE 25 BIOSIMILARS MARKET: GEOGRAPHIC GROWTH OPPORTUNITIES 91
TABLE 39 BIOSIMILARS MARKET, BY REGION, 2019–2026 (USD MILLION) 92
8.2 EUROPE 92
TABLE 40 LIST OF BIOSIMILARS APPROVED IN EUROPE 92
FIGURE 26 EUROPE: BIOSIMILARS MARKET SNAPSHOT 95
TABLE 41 EUROPE: BIOSIMILARS MARKET, BY COUNTRY, 2019–2026 (USD MILLION) 96
TABLE 42 EUROPE: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION) 96
TABLE 43 EUROPE: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION) 97
TABLE 44 EUROPE: BIOSIMILARS MARKET, BY INDICATION,
2019–2026 (USD MILLION) 97
8.2.1 UK 98
8.2.1.1 The UK holds the largest share of the biosimilars market in Europe 98
TABLE 45 LIST OF BIOSIMILARS IN THE UK 98
TABLE 46 UK: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION) 99
TABLE 47 UK: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,
2019–2026 (USD MILLION) 99
TABLE 48 UK: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION) 100
8.2.2 FRANCE 100
8.2.2.1 Rising geriatric population will drive market growth 100
TABLE 49 FRANCE: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION) 101
TABLE 50 FRANCE: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION) 101
TABLE 51 FRANCE: BIOSIMILARS MARKET, BY INDICATION,
2019–2026 (USD MILLION) 102
8.2.3 GERMANY 102
8.2.3.1 Presence of a favorable pricing system has supported biosimilar adoption in Germany 102
TABLE 52 GERMANY: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION) 103
TABLE 53 GERMANY: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION) 103
TABLE 54 GERMANY: BIOSIMILARS MARKET, BY INDICATION,
2019–2026 (USD MILLION) 104
8.2.4 ITALY 104
8.2.4.1 Rising geriatric population in Italy will support the adoption of biosimilars in the country 104
TABLE 55 ITALY: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION) 105
TABLE 56 ITALY: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION) 105
TABLE 57 ITALY: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION) 106
8.2.5 SPAIN 106
8.2.5.1 Patient incentives to promote biosimilar use is a key growth driver for the biosimilars market in Spain 106
TABLE 58 SPAIN: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION) 107
TABLE 59 SPAIN: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION) 107
TABLE 60 SPAIN: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION) 108
8.2.6 REST OF EUROPE 108
TABLE 61 ROE: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION) 109
TABLE 62 ROE: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION) 109
TABLE 63 ROE: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION) 110
8.3 ASIA PACIFIC 110
FIGURE 27 ASIA PACIFIC: BIOSIMILARS MARKET SNAPSHOT 111
TABLE 64 ASIA PACIFIC: BIOSIMILARS MARKET, BY COUNTRY,
2019–2026 (USD MILLION) 112
TABLE 65 ASIA PACIFIC: BIOSIMILARS MARKET, BY PRODUCT,
2019–2026 (USD MILLION) 112
TABLE 66 ASIA PACIFIC: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES,
BY TYPE, 2019–2026 (USD MILLION) 113
TABLE 67 ASIA PACIFIC: BIOSIMILARS MARKET, BY INDICATION,
2019–2026 (USD MILLION) 113
8.3.1 INDIA 114
8.3.1.1 India held the largest share of the APAC biosimilars market 114
TABLE 68 BIOSIMILARS APPROVED AND MARKETED IN INDIA 114
TABLE 69 INDIA: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION) 117
TABLE 70 INDIA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION) 117
TABLE 71 INDIA: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION) 118
8.3.2 CHINA 118
8.3.2.1 China is the fastest-growing market for biosimilars in the APAC 118
TABLE 72 BIOSIMILARS APPROVED IN CHINA 119
TABLE 73 CHINA: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION) 119
TABLE 74 CHINA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION) 120
TABLE 75 CHINA: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION) 120
8.3.3 SOUTH KOREA 120
8.3.3.1 Favorable government initiatives to drive the market in South Korea 120
TABLE 76 LIST OF BIOSIMILARS APPROVED IN SOUTH KOREA 121
TABLE 77 SOUTH KOREA: BIOSIMILARS MARKET, BY PRODUCT,
2019–2026 (USD MILLION) 121
TABLE 78 SOUTH KOREA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES,
BY TYPE, 2019–2026 (USD MILLION) 122
TABLE 79 SOUTH KOREA: BIOSIMILARS MARKET, BY INDICATION,
2019–2026 (USD MILLION) 122
8.3.4 JAPAN 122
8.3.4.1 Large geriatric population in the country to drive market growth 122
TABLE 80 LIST OF BIOSIMILARS APPROVED IN JAPAN 123
TABLE 81 JAPAN: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION) 125
TABLE 82 JAPAN: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION) 125
TABLE 83 JAPAN: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION) 126
8.3.5 AUSTRALIA 126
8.3.5.1 Incremental changes in biosimilar regulations and increasing incidence of chronic diseases to drive market growth 126
TABLE 84 LIST OF BIOSIMILARS APPROVED IN AUSTRALIA 127
TABLE 85 AUSTRALIA: BIOSIMILARS MARKET, BY PRODUCT,
2019–2026 (USD MILLION) 129
TABLE 86 AUSTRALIA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES,
BY TYPE, 2019–2026 (USD MILLION) 129
TABLE 87 AUSTRALIA: BIOSIMILARS MARKET, BY INDICATION,
2019–2026 (USD MILLION) 130
8.3.6 REST OF ASIA PACIFIC 130
TABLE 88 LIST OF BIOSIMILARS APPROVED IN NEW ZEALAND 130
TABLE 89 LIST OF BIOSIMILARS APPROVED IN MALAYSIA 131
TABLE 90 LIST OF BIOSIMILARS APPROVED IN SINGAPORE 131
TABLE 91 ROAPAC: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION) 132
TABLE 92 ROAPAC: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION) 132
TABLE 93 ROAPAC: BIOSIMILARS MARKET, BY INDICATION,
2019–2026 (USD MILLION) 133
8.4 NORTH AMERICA 133
TABLE 94 NORTH AMERICA: BIOSIMILARS MARKET, BY COUNTRY,
2019–2026 (USD MILLION) 133
TABLE 95 NORTH AMERICA: BIOSIMILARS MARKET, BY PRODUCT,
2019–2026 (USD MILLION) 134
TABLE 96 NORTH AMERICA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION) 134
TABLE 97 NORTH AMERICA: BIOSIMILARS MARKET, BY INDICATION,
2019–2026 (USD MILLION) 135
8.4.1 US 135
8.4.1.1 The US dominates the North American biosimilars market 135
TABLE 98 LIST OF BIOSIMILARS APPROVED IN THE US 136
TABLE 99 US: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION) 137
TABLE 100 US: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE,
2019–2026 (USD MILLION) 138
TABLE 101 US: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION) 138
8.4.2 CANADA 138
8.4.2.1 Favorable government initiatives to support market growth 138
TABLE 102 LIST OF BIOSIMILARS APPROVED IN CANADA 139
TABLE 103 CANADA: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION) 139
TABLE 104 CANADA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION) 140
TABLE 105 CANADA: BIOSIMILARS MARKET, BY INDICATION,
2019–2026 (USD MILLION) 140
8.5 LATIN AMERICA 140
8.5.1 RISING INCIDENCE OF CANCER TO DRIVE MARKET GROWTH 140
TABLE 106 LIST OF BIOSIMILARS APPROVED IN LATIN AMERICA 141
TABLE 107 LATIN AMERICA: BIOSIMILARS MARKET, BY PRODUCT,
2019–2026 (USD MILLION) 142
TABLE 108 LATIN AMERICA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES,
BY TYPE, 2019–2026 (USD MILLION) 142
TABLE 109 LATIN AMERICA: BIOSIMILARS MARKET, BY INDICATION,
2019–2026 (USD MILLION) 143
8.6 MIDDLE EAST AND AFRICA 143
8.6.1 FAVORABLE REGULATORY REFORMS AND INFRASTRUCTURAL DEVELOPMENT TO FAVOR MARKET GROWTH 143
TABLE 110 MIDDLE EAST AND AFRICA: BIOSIMILARS MARKET, BY PRODUCT,
2019–2026 (USD MILLION) 144
TABLE 111 MIDDLE EAST AND AFRICA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION) 144
TABLE 112 MIDDLE EAST AND AFRICA: BIOSIMILARS MARKET, BY INDICATION,
2019–2026 (USD MILLION) 145
9 COMPETITIVE LANDSCAPE 146
9.1 INTRODUCTION 146
9.2 RIGHT-TO-WIN APPROACH 146
FIGURE 28 KEY DEVELOPMENTS OF MAJOR PLAYERS, JANUARY 2018–AUGUST 2021 147
9.3 REVENUE SHARE ANALYSIS OF KEY MARKET PLAYERS 148
FIGURE 29 REVENUE ANALYSIS FOR KEY COMPANIES OVER THE PAST THREE YEARS 148
9.4 MARKET SHARE ANALYSIS 149
FIGURE 30 GLOBAL BIOSIMILARS MARKET SHARE ANALYSIS, BY KEY PLAYER, 2020 149
9.5 COMPANY EVALUATION QUADRANT 150
9.5.1 STARS 150
9.5.2 EMERGING LEADERS 150
9.5.3 PERVASIVE PLAYERS 150
9.5.4 PARTICIPANTS 150
FIGURE 31 BIOSIMILARS MARKET: COMPANY EVALUATION QUADRANT, 2020 151

9.6 COMPANY EVALUATION QUADRANT: START-UPS/SMES 151
9.6.1 PROGRESSIVE COMPANIES 151
9.6.2 STARTING BLOCKS 151
9.6.3 RESPONSIVE COMPANIES 152
9.6.4 DYNAMIC COMPANIES 152
FIGURE 32 BIOSIMILARS MARKET: COMPANY EVALUATION QUADRANT FOR START-UPS/SMES, 2020 152
9.7 COMPETITIVE BENCHMARKING 153
9.7.1 COMPANY PRODUCT FOOTPRINT 153
9.7.2 COMPANY INDICATION FOOTPRINT 155
9.7.3 COMPANY REGIONAL FOOTPRINT 156
9.8 GROWTH STRATEGIES ADOPTED BY EMERGING AND KEY PLAYERS 157
9.8.1 PRODUCT LAUNCHES & APPROVALS 157
9.8.2 DEALS 158
9.8.3 OTHER DEVELOPMENTS 158
10 COMPANY PROFILES 159
10.1 MAJOR PLAYERS 159
(Business Overview, Products Offered, Recent Developments, and MnM View (Key strengths/Right to Win, Strategic Choices Made, and Weaknesses and Competitive Threats))*
10.1.1 NOVARTIS AG 159
TABLE 113 NOVARTIS AG: BUSINESS OVERVIEW 159
FIGURE 33 SANDOZ: COMPANY SNAPSHOT (2020) 160
10.1.2 PFIZER INC. 163
TABLE 114 PFIZER INC: BUSINESS OVERVIEW 163
FIGURE 34 PFIZER INC.: COMPANY SNAPSHOT (2020) 164
10.1.3 DR. REDDY’S LABORATORIES LTD. 167
TABLE 115 DR. REDDY’S LABORATORIES: BUSINESS OVERVIEW 167
FIGURE 35 DR. REDDY’S LABORATORIES LTD.: COMPANY SNAPSHOT (2020) 168
10.1.4 AMGEN INC. 170
TABLE 116 AMGEN INC.: BUSINESS OVERVIEW 170
FIGURE 36 AMGEN INC.: COMPANY SNAPSHOT (2020) 171
10.1.5 ELI LILLY AND COMPANY 174
TABLE 117 ELI LILLY AND COMPANY: BUSINESS OVERVIEW 174
FIGURE 37 ELI LILLY AND COMPANY: COMPANY SNAPSHOT (2020) 175
10.1.6 TEVA PHARMACEUTICAL INDUSTRIES LTD. 177
TABLE 118 TEVA PHARMACEUTICAL INDUSTRIES LTD.: BUSINESS OVERVIEW 177
FIGURE 38 TEVA PHARMACEUTICAL INDUSTRIES LTD.: COMPANY SNAPSHOT (2020) 177
10.1.7 FRESENIUS SE & CO. KGAA 179
TABLE 119 FRESENIUS SE & CO. KGAA: BUSINESS OVERVIEW 179
FIGURE 39 FRESENIUS SE & CO. KGAA: COMPANY SNAPSHOT (2020) 180
10.1.8 STADA ARZNEIMITTEL AG 182
TABLE 120 STADA ARZNEIMITTEL: BUSINESS OVERVIEW 182
FIGURE 40 STADA ARZNEIMITTEL: COMPANY SNAPSHOT (2020) 183
10.1.9 BOEHRINGER INGELHEIM 185
TABLE 121 BOEHRINGER INGELHEIM: BUSINESS OVERVIEW 185
FIGURE 41 BOEHRINGER INGELHEIM: COMPANY SNAPSHOT (2020) 186
10.1.10 GEDEON RICHTER PLC 187
TABLE 122 GEDEON RICHTER PLC: BUSINESS OVERVIEW 187
FIGURE 42 GEDEON RICHTER PLC: COMPANY SNAPSHOT (2020) 188
10.1.11 CELLTRION 190
TABLE 123 CELLTRION: BUSINESS OVERVIEW 190
FIGURE 43 CELLTRION: COMPANY SNAPSHOT (2020) 190
10.1.12 SAMSUNG BIOLOGICS 193
TABLE 124 SAMSUNG BIOLOGICS: BUSINESS OVERVIEW 193
FIGURE 44 SAMSUNG BIOLOGICS: COMPANY SNAPSHOT (2020) 193
10.1.13 COHERUS BIOSCIENCES 197
TABLE 125 COHERUS BIOSCIENCES: BUSINESS OVERVIEW 197
FIGURE 45 COHERUS BIOSCIENCES: COMPANY SNAPSHOT (2020) 197
10.1.14 BIOCON LIMITED 199
TABLE 126 BIOCON LIMITED: BUSINESS OVERVIEW 199
FIGURE 46 BIOCON LIMITED: COMPANY SNAPSHOT (2020) 200
10.1.15 VIATRIS 204
TABLE 127 VIATRIS: BUSINESS OVERVIEW 204
10.2 OTHER PLAYERS 205
10.2.1 AMEGA BIOTECH 205
TABLE 128 AMEGA BIOTECH: BUSINESS OVERVIEW 205
10.2.2 APOTEX INC. 207
TABLE 129 APOTEX INC.: BUSINESS OVERVIEW 207
10.2.3 BIOCAD 208
TABLE 130 BIOCAD: BUSINESS OVERVIEW 208
10.2.4 MABXIENCE 210
TABLE 131 MABXIENCE: BUSINESS OVERVIEW 210
10.2.5 PROBIOMED S.A. DE C.V. 212
TABLE 132 PROBIOMED: BUSINESS OVERVIEW 212
10.2.6 FUJIFILM KYOWA KIRIN BIOLOGICS CO., LTD. 213
TABLE 133 FUJIFILM KYOWA KIRIN BIOLOGICS: BUSINESS OVERVIEW 213
10.2.7 INTAS PHARMACEUTICALS LTD. 215
TABLE 134 INTAS PHARMACEUTICALS LTD.: BUSINESS OVERVIEW 215
10.2.8 THERAMEX 217
TABLE 135 THERAMEX: BUSINESS OVERVIEW 217
10.2.9 RELIANCE LIFE SCIENCES 219
TABLE 136 RELIANCE LIFE SCIENCES: BUSINESS OVERVIEW 219
10.2.10 KASHIV BIOSCIENCES 221
TABLE 137 KASHIV BIOSCIENCES: BUSINESS OVERVIEW 221
*Details on Business Overview, Products Offered, Recent Developments, and MnM View (Key strengths/Right to Win, Strategic Choices Made, and Weaknesses and Competitive Threats) might not be captured in case of unlisted companies.
11 APPENDIX 222
11.1 DISCUSSION GUIDE 222
11.2 KNOWLEDGE STORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 225
11.3 AVAILABLE CUSTOMIZATIONS 227
11.4 RELATED REPORTS 228
11.5 AUTHOR DETAILS 229


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