出版：MarketsandMarkets（マーケッツアンドマーケッツ） 出版年月：2024年5月
Biologics Safety Testing Market – Global Forecast to 2029
生物製剤安全性試験市場 : 製品とサービス (消耗品、機器、サービス)、検査タイプ (マイコプラズマ、無菌性、エンドトキシン、バイオバーデン、ウイルス安全性)、用途 (ワクチン、モノクローナル抗体、細胞＆遺伝子治療、血液製剤) – 2029年までの世界予測
Biologics Safety Testing Market by Product & Service (Consumables, Instrument, Services), Test Type (Mycoplasma, Sterility, Endotoxin, Bioburden, Virus Safety), Application (Vaccines, mAbs, Cell & Gene Therapy, Blood Products) – Global Forecast to 2029
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Report Overview
The biologics safety testing market is projected to reach USD 7.2 billion by 2029 from an estimated USD 4.2 billion in 2024, at a CAGR of 11.1% from 2024 to 2029.
生物製剤安全性試験市場は、2024年に42億米ドルと見積もられているが、2024年から2029年までCAGR 11.1%で、2029年までに72億米ドルに達すると予測されています。
The growth of this market can be attributed to the increasing focus on the development and manufacturing of novel biologics. The rising demand for advanced therapies such as cell and gene therapies due to the growing rate of chronic diseases is propelling the growth of biologics safety testing. This trend is expected to drive the growth of the biologics safety testing market in the coming years.
“The monoclonal antibodies development and manufacturing segment accounted for the largest share of by application segment in 2023.”
In 2023, the monoclonal antibodies development and manufacturing segment accounted for the largest share of the global biologics safety testing market by application. Growing investments and funding in the development of novel biotherapeutics and rising demand for biological therapies for the treatment of chronic diseases are promoting the segment’s growth in the biologics safety testing market.
“The US has continued to dominate the biologics safety testing market from 2024 to 2029.”
The US dominated the biologics safety testing market in North America in 2023. The US is the world’s largest biopharmaceutical market and a leader in biopharmaceutical research/investments. Also, US has strong healthcare infrastructure which drives the research and development in life sciences sector. Additionally, US has large number of biopharmaceutical companies; thus, increasing number of biopharmaceutical companies and growing research activities in biotechnology sector are propelling the market growth in US. Moreover, increasing approvals for biosimilars are also driving the growth of biologics safety testing market.
The primary interviews conducted for this report can be categorized as follows:
• By Respondent: Supply Side- 60% and Demand Side 40%
• By Designation: Managers – 45%, CXO & Directors – 30%, and Executives – 25%
• By Region: North America – 40%, Europe -25%, Asia-Pacific -25%, Latin America -5% and Middle East & Africa- 5%
List of Companies Profiled in the Report:
• Thermo Fisher Scientific Inc. (US)
• Merck KGaA (Germany)
• Lonza (Switzerland)
• FUJIFILM Corporation (Japan)
• Sartorius AG (Germany)
• F. Hoffmann-La Roche Ltd (Switzerland)
• Charles River Laboratories (US)
• BIOMÉRIEUX (France)
• Maravai LifeSciences (US)
• WuXi AppTec (China)
• SGS Société Générale de Surveillance SA. (Switzerland)
• Sotera Health (Nelson Laboratories, LLC) (US)
• Samsung Biologics (South Korea)
• GenScript (US)
• Agilent Technologies, Inc. (US)
• Syngene International Limited (India)
• Eurofins Scientific (Luxembourg)
• Laboratory Corporation of America Holdings (US)
• Bio-Rad Laboratories, Inc. (US)
• QIAGEN (Netherlands)
• Promega Corporation (US)
• Catalent, Inc (US)
• ASSOCIATES OF CAPE COD, INC. (US)
• Pacific BioLabs (US)
• Clean Biologics (France)
• PathoQuest (France)
• ARL Bio Pharma, Inc. (US)
• Frontage Labs (US)
• Creative Biogene (US)
• Advaxia Biologics (Italy)
Research Coverage:
This research report categorizes the biologics safety testing market by product & service (services (mycoplasma testing services, sterility testing services, endotoxin testing services, virus safety testing services, bioburden testing services, and other testing services), consumables, and instrument), test type (residual host-cell proteins & DNA detection tests, mycoplasma tests, sterility tests, endotoxin tests, virus safety tests, bioburden tests, other biologics safety tests), application (monoclonal antibodies development and manufacturing, vaccine development and manufacturing, cellular & gene therapy products development and manufacturing, blood & blood products development and manufacturing, other applications), end user (pharmaceutical & biotechnology companies, CROs and CDMOs, and academic & research institutes), 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 biologics safety testing market. A thorough analysis of the key industry players has been done to provide insights into their business overview, products, services, solutions, key strategies, collaborations, partnerships, and agreements. Also, it includes new product launches, collaborations and acquisitions, and recent developments associated with the biologics safety testing market.
Key Benefits of Buying the Report:
The report will help market leaders/new entrants by providing the closest approximations of the revenue numbers for the overall biologics safety testing market and its subsegments. It will also help stakeholders better understand the competitive landscape and gain more insights to position their business better 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 (growing development of mAbs and biosimilars, rising investments and fundings in biopharmaceutical industry, and stringent regulatory guidelines for biologics safety), restraints (ethical concern regarding animal testing), opportunities (growing opportunities in emerging economies, increasing focus on next generation therapeutics), and Challenges (high cost of biologics) influencing the growth of the market.
• Product Development/Innovation: Detailed insights on newly launched products of the biologics safety testing 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 biologics safety testing market
• Competitive Assessment: Thermo Fisher Scientific Inc. (US), Merck KGaA (Germany), Lonza (Switzerland), FUJIFILM Corporation (Japan), Sartorius AG (Germany), F. Hoffmann-La Roche Ltd (Switzerland), Charles River Laboratories (US), BIOMÉRIEUX (France), Maravai LifeSciences (US), WuXi AppTec (China), SGS Société Générale de Surveillance SA. (Switzerland), Sotera Health (Nelson Laboratories, LLC) (US), Samsung Biologics (South Korea), GenScript (US), Agilent Technologies, Inc. (US), Syngene International Limited (India), Eurofins Scientific (Luxembourg), Laboratory Corporation of America Holdings (US), Bio-Rad Laboratories, Inc. (US), QIAGEN (Netherlands), Promega Corporation (US), Catalent, Inc (US), ASSOCIATES OF CAPE COD, INC. (US), Pacific BioLabs (US), Clean Biologics (France), PathoQuest (France), ARL Bio Pharma, Inc. (US), Frontage Labs (US), Creative Biogene (US), Advaxia Biologics (Italy), among others in the market.
Table of Contents
1 INTRODUCTION 52
1.1 STUDY OBJECTIVES 52
1.2 MARKET DEFINITION 52
1.2.1 INCLUSIONS & EXCLUSIONS 53
1.3 STUDY SCOPE 53
1.3.1 MARKET SEGMENTATION 54
1.3.2 REGIONS COVERED 54
1.4 YEARS CONSIDERED 55
1.5 CURRENCY CONSIDERED 55
1.6 STAKEHOLDERS 55
1.7 LIMITATIONS 55
1.8 SUMMARY OF CHANGES 56
1.9 RECESSION IMPACT 58
2 RESEARCH METHODOLOGY 59
2.1 RESEARCH DATA 59
FIGURE 1 RESEARCH DESIGN 59
2.1.1 SECONDARY DATA 60
2.1.2 PRIMARY DATA 60
FIGURE 2 BIOLOGICS SAFETY TESTING MARKET: BREAKDOWN OF PRIMARIES 61
2.2 MARKET ESTIMATION METHODOLOGY 62
2.2.1 GLOBAL MARKET SIZE ESTIMATION (BOTTOM-UP APPROACH) 62
FIGURE 3 BIOLOGICS SAFETY TESTING MARKET SIZE ESTIMATION (SUPPLY-SIDE ANALYSIS), 2023 62
FIGURE 4 BIOLOGICS SAFETY TESTING MARKET SIZE ESTIMATION: APPROACH 1 (COMPANY REVENUE ANALYSIS-BASED ESTIMATION), 2023 63
FIGURE 5 REVENUE SHARE ANALYSIS: ILLUSTRATIVE EXAMPLE OF THERMO FISHER SCIENTIFIC INC. (2023) 64
2.2.2 INSIGHTS FROM PRIMARY EXPERTS 65
FIGURE 6 MARKET SIZE VALIDATION FROM PRIMARY SOURCES 65
2.2.3 SEGMENTAL MARKET ASSESSMENT (TOP-DOWN APPROACH) 65
FIGURE 7 SEGMENTAL MARKET SIZE ESTIMATION METHODOLOGY: TOP-DOWN APPROACH 65
2.3 MARKET GROWTH RATE PROJECTIONS 66
FIGURE 8 BIOLOGICS SAFETY TESTING MARKET: CAGR PROJECTIONS 67
TABLE 1 IMPACT ANALYSIS OF SUPPLY-SIDE AND DEMAND-SIDE FACTORS 67
2.4 DATA TRIANGULATION 69
FIGURE 9 DATA TRIANGULATION METHODOLOGY 69
2.5 RESEARCH ASSUMPTIONS 70
2.6 RISK ANALYSIS 70
2.7 RECESSION IMPACT ANALYSIS 70
3 EXECUTIVE SUMMARY 72
FIGURE 10 BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2024 VS. 2029 (USD MILLION) 72
FIGURE 11 BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2024 VS. 2029 (USD MILLION) 73
FIGURE 12 BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2024 VS. 2029 (USD MILLION) 73
FIGURE 13 BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2024 VS. 2029 (USD MILLION) 74
FIGURE 14 GEOGRAPHICAL SNAPSHOT OF BIOLOGICS SAFETY TESTING MARKET 75
4 PREMIUM INSIGHTS 76
4.1 BIOLOGICS SAFETY TESTING MARKET OVERVIEW 76
FIGURE 15 INCREASING DEVELOPMENT OF MONOCLONAL ANTIBODIES AND BIOSIMILARS TO SUPPORT MARKET GROWTH 76
4.2 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE AND COUNTRY (2023) 77
FIGURE 16 SERVICES SEGMENT ACCOUNTED FOR LARGEST SHARE IN 2023 77
4.3 BIOLOGICS SAFETY TESTING MARKET SHARE, BY APPLICATION, 2023 77
FIGURE 17 MONOCLONAL ANTIBODIES SEGMENT ACCOUNTED FOR LARGEST MARKET SHARE IN 2023 77
4.4 BIOLOGICS SAFETY TESTING MARKET SHARE, BY END USER, 2023 78
FIGURE 18 PHARMACEUTICAL & BIOPHARMACEUTICAL COMPANIES SEGMENT DOMINATED MARKET IN 2023 78
4.5 BIOLOGICS SAFETY TESTING MARKET: GEOGRAPHIC GROWTH OPPORTUNITIES 78
FIGURE 19 ASIA PACIFIC COUNTRIES TO REGISTER HIGHER GROWTH DURING FORECAST PERIOD 78
5 MARKET OVERVIEW 79
5.1 INTRODUCTION 79
5.2 MARKET DYNAMICS 79
FIGURE 20 BIOLOGICS SAFETY TESTING MARKET: DRIVERS, RESTRAINTS, OPPORTUNITIES, AND CHALLENGES 79
TABLE 2 BIOLOGICS SAFETY TESTING MARKET: IMPACT ANALYSIS 80
5.2.1 DRIVERS 80
5.2.1.1 Development of mAbs and biosimilars 80
TABLE 3 LIST OF FDA-APPROVED BIOSIMILAR PRODUCTS, 2022–2024 81
FIGURE 21 NUMBER OF ANTIBODY THERAPEUTICS GRANTED A FIRST APPROVAL IN US OR EU, 2012–2023 81
5.2.1.2 Growing concerns over cell culture contamination 82
5.2.1.3 Rising investments in biopharmaceutical R&D 82
FIGURE 22 WORLDWIDE TOTAL PHARMACEUTICAL R&D SPEND, 2014–2028 83
TABLE 4 PHARMACEUTICAL R&D SPENDING, BY COMPANY, 2020 VS. 2026 (USD BILLION) 83
5.2.1.4 Increasing demand for advanced therapy medicinal products (ATMPs) 84
TABLE 5 LIST OF APPROVED GENE THERAPIES, 2023–2024 84
5.2.1.5 Stringent regulatory requirements for biologics safety testing 84
5.2.2 RESTRAINTS 85
5.2.2.1 Ethical concerns related to animal testing 85
5.2.3 OPPORTUNITIES 85
5.2.3.1 Growth opportunities in emerging markets 85
5.2.3.2 Increasing outsourcing of biopharmaceutical activities to CROs 86
5.2.3.3 Rising focus on next-generation therapeutics 87
5.2.4 CHALLENGES 87
5.2.4.1 High cost of biologics 87
TABLE 6 PRICING OF ADVANCED THERAPIES 88
5.2.4.2 Challenges related to biologics complexity and heterogenicity 88
5.3 TECHNOLOGY ANALYSIS 88
5.3.1 KEY TECHNOLOGIES 88
5.3.1.1 Polymerase chain reaction (PCR) 88
TABLE 7 APPLICATIONS OF PCR IN BIOLOGICS SAFETY TESTING 89
5.3.1.2 Next-generation sequencing (NGS) 89
5.3.2 COMPLEMENTARY TECHNOLOGIES 90
5.3.2.1 Lab-on-a-chip (LOC) systems 90
5.3.2.2 High-content screening (HCS) 90
5.3.3 ADJACENT TECHNOLOGIES 90
5.3.3.1 Bioinformatics and computational biology 90
5.4 SUPPLY CHAIN ANALYSIS 91
FIGURE 23 BIOLOGICS SAFETY TESTING MARKET: SUPPLY CHAIN ANALYSIS 92
5.5 VALUE CHAIN ANALYSIS 92
FIGURE 24 BIOLOGICS SAFETY TESTING MARKET: VALUE CHAIN ANALYSIS 93
5.6 PRICING ANALYSIS 94
TABLE 8 AVERAGE SELLING PRICE TREND OF KEY PLAYERS, BY PRODUCT 94
TABLE 9 AVERAGE SELLING PRICE OF BIOLOGICS SAFETY TESTING PRODUCTS, BY REGION 95
5.7 ECOSYSTEM ANALYSIS 95
FIGURE 25 BIOLOGICS SAFETY TESTING MARKET: ECOSYSTEM ANALYSIS 96
5.7.1 RAW MATERIAL VENDORS IN BIOLOGICS SAFETY TESTING MARKET 97
TABLE 10 BIOLOGICS SAFETY TESTING MARKET: ROLE OF RAW MATERIAL VENDORS 97
5.7.2 PRODUCT VENDORS IN BIOLOGICS SAFETY TESTING MARKET 97
TABLE 11 BIOLOGICS SAFETY TESTING MARKET: ROLE OF PRODUCT VENDORS 97
5.7.3 SERVICE PROVIDERS IN BIOLOGICS SAFETY TESTING MARKET 97
TABLE 12 BIOLOGICS SAFETY TESTING MARKET: ROLE OF SERVICE PROVIDERS 98
5.7.4 END USERS IN BIOLOGICS SAFETY TESTING MARKET 98
TABLE 13 BIOLOGICS SAFETY TESTING MARKET: ROLE OF END USERS 98
5.7.5 REGULATORY BODIES GOVERNING BIOLOGICS SAFETY TESTING MARKET 98
TABLE 14 BIOLOGICS SAFETY TESTING MARKET: ROLE OF REGULATORY BODIES 99
5.8 TRENDS/DISRUPTIONS IMPACTING CUSTOMERS’ BUSINESSES 99
FIGURE 26 TRENDS/DISRUPTIONS IMPACTING CUSTOMERS’ BUSINESSES 99
5.9 PATENT ANALYSIS 100
5.9.1 METHODOLOGY 100
5.9.2 PATENTS FILED, BY DOCUMENT TYPE, 2014–2024 100
TABLE 15 PATENTS FILED, 2014–2024 100
5.9.3 INNOVATION AND PATENT APPLICATIONS 100
FIGURE 27 TOTAL NUMBER OF PATENTS GRANTED, 2014–2024 101
5.9.4 TOP APPLICANTS 101
FIGURE 28 TOP TEN PLAYERS WITH HIGHEST NUMBER OF PATENT APPLICATIONS, 2014–2024 101
TABLE 16 TOP 20 PATENT OWNERS IN BIOLOGICS SAFETY TESTING MARKET, 2014–2024 102
TABLE 17 PATENTS IN BIOLOGICS SAFETY TESTING MARKET, 2024 103
5.10 KEY CONFERENCES & EVENTS 104
TABLE 18 BIOLOGICS SAFETY TESTING MARKET: KEY CONFERENCES & EVENTS, 2024–2025 104
5.11 REGULATORY LANDSCAPE 105
5.11.1 INTRODUCTION 105
5.11.2 REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 106
TABLE 19 NORTH AMERICA: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 106
TABLE 20 EUROPE: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 106
TABLE 21 ASIA PACIFIC: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 107
TABLE 22 REST OF THE WORLD: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 108
5.11.3 REGULATORY SCENARIO 109
TABLE 23 BIOLOGICS SAFETY TESTING MARKET: REGULATORY GUIDELINES 109
5.12 PORTER’S FIVE FORCES ANALYSIS 111
FIGURE 29 BIOLOGICS SAFETY TESTING MARKET: PORTER’S FIVE ANALYSIS 112
TABLE 24 BIOLOGICS SAFETY TESTING MARKET: PORTER’S FIVE FORCES ANALYSIS 112
5.12.1 THREAT OF NEW ENTRANTS 113
5.12.2 THREAT OF SUBSTITUTES 113
5.12.3 BARGAINING POWER OF SUPPLIERS 113
5.12.4 BARGAINING POWER OF BUYERS 113
5.12.5 INTENSITY OF COMPETITIVE RIVALRY 113
5.13 KEY STAKEHOLDERS & BUYING CRITERIA 114
5.13.1 KEY STAKEHOLDERS IN BUYING PROCESS 114
FIGURE 30 INFLUENCE OF STAKEHOLDERS ON BUYING PROCESS OF BIOLOGICS SAFETY TESTING PRODUCTS 114
5.13.2 BUYING CRITERIA FOR BIOLOGICS SAFETY TESTING MARKET 115
FIGURE 31 KEY BUYING CRITERIA FOR END USERS 115
TABLE 25 BUYING CRITERIA FOR BIOLOGICS SAFETY TESTING PRODUCTS & SERVICES, BY END USER 115
5.14 INVESTMENT/FUNDING SCENARIO 116
6 BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE 117
6.1 INTRODUCTION 118
TABLE 26 BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 118
6.2 SERVICES 118
TABLE 27 BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 119
TABLE 28 BIOLOGICS SAFETY TESTING SERVICES MARKET, BY REGION, 2022–2029 (USD MILLION) 119
TABLE 29 NORTH AMERICA: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 120
TABLE 30 EUROPE: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 120
TABLE 31 ASIA PACIFIC: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 121
TABLE 32 LATIN AMERICA: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 121
TABLE 33 MIDDLE EAST: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 121
TABLE 34 GCC COUNTRIES: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 122
6.2.1 MYCOPLASMA TESTING SERVICES 122
6.2.1.1 Increasing focus on development of biologics and biosimilars to support segmental growth 122
TABLE 35 MYCOPLASMA TESTING SERVICES MARKET, BY REGION, 2022–2029 (USD MILLION) 122
TABLE 36 NORTH AMERICA: MYCOPLASMA TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 123
TABLE 37 EUROPE: MYCOPLASMA TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 123
TABLE 38 ASIA PACIFIC: MYCOPLASMA TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 124
TABLE 39 LATIN AMERICA: MYCOPLASMA TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 124
TABLE 40 MIDDLE EAST: MYCOPLASMA TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 124
TABLE 41 GCC COUNTRIES: MYCOPLASMA TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 125
6.2.2 STERILITY TESTING SERVICES 125
6.2.2.1 Rising focus on development of biologics and biosimilars to drive demand for sterility testing services 125
TABLE 42 STERILITY TESTING SERVICES MARKET, BY REGION, 2022–2029 (USD MILLION) 126
TABLE 43 NORTH AMERICA: STERILITY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 126
TABLE 44 EUROPE: STERILITY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 126
TABLE 45 ASIA PACIFIC: STERILITY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 127
TABLE 46 LATIN AMERICA: STERILITY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 127
TABLE 47 MIDDLE EAST: STERILITY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 127
TABLE 48 GCC COUNTRIES: STERILITY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 128
6.2.3 ENDOTOXIN TESTING SERVICES 128
6.2.3.1 Stringent regulatory requirements to drive market 128
TABLE 49 ENDOTOXIN TESTING SERVICES MARKET, BY REGION, 2022–2029 (USD MILLION) 128
TABLE 50 NORTH AMERICA: ENDOTOXIN TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 129
TABLE 51 EUROPE: ENDOTOXIN TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 129
TABLE 52 ASIA PACIFIC: ENDOTOXIN TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 130
TABLE 53 LATIN AMERICA: ENDOTOXIN TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 130
TABLE 54 MIDDLE EAST: ENDOTOXIN TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 130
TABLE 55 GCC COUNTRIES: ENDOTOXIN TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 131
6.2.4 VIRUS SAFETY TESTING SERVICES 131
6.2.4.1 Rising focus on development of advanced therapies to drive growth 131
TABLE 56 VIRUS SAFETY TESTING SERVICES MARKET, BY REGION, 2022–2029 (USD MILLION) 132
TABLE 57 NORTH AMERICA: VIRUS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 132
TABLE 58 EUROPE: VIRUS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 132
TABLE 59 ASIA PACIFIC: VIRUS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 133
TABLE 60 LATIN AMERICA: VIRUS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 133
TABLE 61 MIDDLE EAST: VIRUS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 133
TABLE 62 GCC COUNTRIES: VIRUS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 134
6.2.5 BIOBURDEN TESTING SERVICES 134
6.2.5.1 Growing adoption of advanced testing solutions for contamination risk mitigation to propel growth 134
TABLE 63 BIOBURDEN TESTING SERVICES MARKET, BY REGION, 2022–2029 (USD MILLION) 135
TABLE 64 NORTH AMERICA: BIOBURDEN TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 135
TABLE 65 EUROPE: BIOBURDEN TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 135
TABLE 66 ASIA PACIFIC: BIOBURDEN TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 136
TABLE 67 LATIN AMERICA: BIOBURDEN TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 136
TABLE 68 MIDDLE EAST: BIOBURDEN TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 136
TABLE 69 GCC COUNTRIES: BIOBURDEN TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 137
6.2.6 OTHER BIOLOGICS SAFETY TESTING SERVICES 137
TABLE 70 OTHER BIOLOGICS SAFETY TESTING SERVICES MARKET, BY REGION, 2022–2029 (USD MILLION) 137
TABLE 71 NORTH AMERICA: OTHER BIOLOGICS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 138
TABLE 72 EUROPE: OTHER BIOLOGICS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 138
TABLE 73 ASIA PACIFIC: OTHER BIOLOGICS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 139
TABLE 74 LATIN AMERICA: OTHER BIOLOGICS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 139
TABLE 75 MIDDLE EAST: OTHER BIOLOGICS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 139
TABLE 76 GCC COUNTRIES: OTHER BIOLOGICS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 140
6.3 CONSUMABLES 140
6.3.1 INCREASING DEMAND FOR HIGH-QUALITY ASSAYS AND REAGENTS TO DRIVE MARKET 140
TABLE 77 BIOLOGICS SAFETY TESTING CONSUMABLES MARKET, BY REGION, 2022–2029 (USD MILLION) 141
TABLE 78 NORTH AMERICA: BIOLOGICS SAFETY TESTING CONSUMABLES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 141
TABLE 79 EUROPE: BIOLOGICS SAFETY TESTING CONSUMABLES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 141
TABLE 80 ASIA PACIFIC: BIOLOGICS SAFETY TESTING CONSUMABLES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 142
TABLE 81 LATIN AMERICA: BIOLOGICS SAFETY TESTING CONSUMABLES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 142
TABLE 82 MIDDLE EAST: BIOLOGICS SAFETY TESTING CONSUMABLES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 142
TABLE 83 GCC COUNTRIES: BIOLOGICS SAFETY TESTING CONSUMABLES MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 143
6.4 INSTRUMENTS 143
6.4.1 RISING ADOPTION OF ADVANCED TECHNOLOGIES TO SUPPORT MARKET GROWTH 143
TABLE 84 BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET, BY REGION, 2022–2029 (USD MILLION) 144
TABLE 85 NORTH AMERICA: BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 144
TABLE 86 EUROPE: BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 145
TABLE 87 ASIA PACIFIC: BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 145
TABLE 88 LATIN AMERICA: BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 146
TABLE 89 MIDDLE EAST: BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 146
TABLE 90 GCC COUNTRIES: BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 146
7 BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE 147
7.1 INTRODUCTION 148
TABLE 91 BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 148
7.2 RESIDUAL HOST CELL PROTEINS & DNA DETECTION TESTS 148
7.2.1 STRINGENT REGULATORY GUIDELINES FOR BIOLOGIC DRUG MANUFACTURING TO PROPEL MARKET 148
TABLE 92 RESIDUAL HOST CELL PROTEINS & DNA DETECTION TESTS MARKET, BY REGION, 2022–2029 (USD MILLION) 149
TABLE 93 NORTH AMERICA: RESIDUAL HOST CELL PROTEINS & DNA DETECTION TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 149
TABLE 94 EUROPE: RESIDUAL HOST CELL PROTEINS & DNA DETECTION TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 150
TABLE 95 ASIA PACIFIC: RESIDUAL HOST CELL PROTEINS & DNA DETECTION TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 150
TABLE 96 LATIN AMERICA: RESIDUAL HOST CELL PROTEINS & DNA DETECTION TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 151
TABLE 97 MIDDLE EAST: RESIDUAL HOST CELL PROTEINS & DNA DETECTION TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 151
TABLE 98 GCC COUNTRIES: RESIDUAL HOST CELL PROTEINS & DNA DETECTION TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 151
7.3 MYCOPLASMA TESTS 152
7.3.1 RISING CONCERNS OF CELL CULTURE CONTAMINATION TO DRIVE MARKET 152
TABLE 99 MYCOPLASMA TESTS MARKET, BY REGION, 2022–2029 (USD MILLION) 152
TABLE 100 NORTH AMERICA: MYCOPLASMA TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 153
TABLE 101 EUROPE: MYCOPLASMA TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 153
TABLE 102 ASIA PACIFIC: MYCOPLASMA TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 153
TABLE 103 LATIN AMERICA: MYCOPLASMA TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 154
TABLE 104 MIDDLE EAST: MYCOPLASMA TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 154
TABLE 105 GCC COUNTRIES: MYCOPLASMA TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 154
7.4 STERILITY TESTS 155
7.4.1 COMPULSORY STERILITY TESTING AT EACH STAGE IN DRUG DEVELOPMENT AND PRODUCTION PROCESS TO SUPPORT SEGMENT GROWTH 155
TABLE 106 STERILITY TESTS MARKET, BY REGION, 2022–2029 (USD MILLION) 155
TABLE 107 NORTH AMERICA: STERILITY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 156
TABLE 108 EUROPE: STERILITY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 156
TABLE 109 ASIA PACIFIC: STERILITY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 156
TABLE 110 LATIN AMERICA: STERILITY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 157
TABLE 111 MIDDLE EAST: STERILITY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 157
TABLE 112 GCC COUNTRIES: STERILITY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 157
7.5 ENDOTOXIN TESTS 158
7.5.1 INCREASING RESEARCH AND DEVELOPMENT FOR PRODUCTION OF BIOLOGICS TO DRIVE MARKET 158
TABLE 113 ENDOTOXIN TESTS MARKET, BY REGION, 2022–2029 (USD MILLION) 158
TABLE 114 NORTH AMERICA: ENDOTOXIN TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 159
TABLE 115 EUROPE: ENDOTOXIN TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 159
TABLE 116 ASIA PACIFIC: ENDOTOXIN TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 159
TABLE 117 LATIN AMERICA: ENDOTOXIN TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 160
TABLE 118 MIDDLE EAST: ENDOTOXIN TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 160
TABLE 119 GCC COUNTRIES: ENDOTOXIN TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 160
7.6 VIRUS SAFETY TESTS 161
7.6.1 GROWING DEMAND FOR BIOLOGICS AND BIOSIMILARS TO DRIVE SEGMENT GROWTH 161
TABLE 120 VIRUS SAFETY TESTS MARKET, BY REGION, 2022–2029 (USD MILLION) 161
TABLE 121 NORTH AMERICA: VIRUS SAFETY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 162
TABLE 122 EUROPE: VIRUS SAFETY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 162
TABLE 123 ASIA PACIFIC: VIRUS SAFETY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 162
TABLE 124 LATIN AMERICA: VIRUS SAFETY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 163
TABLE 125 MIDDLE EAST: VIRUS SAFETY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 163
TABLE 126 GCC COUNTRIES: VIRUS SAFETY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 163
7.7 BIOBURDEN TESTS 164
7.7.1 GROWING STRINGENCY OF DRUG SAFETY STANDARDS TO INCREASE DEMAND FOR MICROBIOLOGICAL BIOBURDEN TESTING 164
TABLE 127 BIOBURDEN TESTS MARKET, BY REGION, 2022–2029 (USD MILLION) 164
TABLE 128 NORTH AMERICA: BIOBURDEN TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 165
TABLE 129 EUROPE: BIOBURDEN TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 165
TABLE 130 ASIA PACIFIC: BIOBURDEN TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 165
TABLE 131 LATIN AMERICA: BIOBURDEN TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 166
TABLE 132 MIDDLE EAST: BIOBURDEN TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 166
TABLE 133 GCC COUNTRIES: BIOBURDEN TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 166
7.8 OTHER BIOLOGICS SAFETY TESTS 166
TABLE 134 OTHER BIOLOGICS SAFETY TESTS MARKET, BY REGION, 2022–2029 (USD MILLION) 167
TABLE 135 NORTH AMERICA: OTHER BIOLOGICS SAFETY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 167
TABLE 136 EUROPE: OTHER BIOLOGICS SAFETY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 168
TABLE 137 ASIA PACIFIC: OTHER BIOLOGICS SAFETY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 168
TABLE 138 LATIN AMERICA: OTHER BIOLOGICS SAFETY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 169
TABLE 139 MIDDLE EAST: OTHER BIOLOGICS SAFETY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 169
TABLE 140 GCC COUNTRIES: OTHER BIOLOGICS SAFETY TESTS MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 169
8 BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION 170
8.1 INTRODUCTION 171
TABLE 141 BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 171
8.2 MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING 171
8.2.1 GROWING REGULATORY APPROVALS FOR MONOCLONAL ANTIBODIES TO SUPPORT MARKET GROWTH 171
TABLE 142 BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY REGION, 2022–2029 (USD MILLION) 172
TABLE 143 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 172
TABLE 144 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 173
TABLE 145 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 173
TABLE 146 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 174
TABLE 147 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY REGION, 2022–2029 (USD MILLION) 174
TABLE 148 GCC: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 174
8.3 VACCINES DEVELOPMENT AND MANUFACTURING 175
8.3.1 RISING PREVALENCE OF INFECTIOUS DISEASES TO DRIVE GROWTH 175
TABLE 149 BIOLOGICS SAFETY TESTING MARKET FOR VACCINES DEVELOPMENT AND MANUFACTURING, BY REGION, 2022–2029 (USD MILLION) 176
TABLE 150 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR VACCINES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 176
TABLE 151 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR VACCINES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 176
TABLE 152 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR VACCINES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 177
TABLE 153 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR VACCINES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 177
TABLE 154 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET FOR VACCINES DEVELOPMENT AND MANUFACTURING, BY REGION, 2022–2029 (USD MILLION) 177
TABLE 155 GCC: BIOLOGICS SAFETY TESTING MARKET FOR VACCINES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 178
8.4 CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING 178
8.4.1 INCREASING INVESTMENTS FOR DEVELOPMENT OF CELLULAR & GENE THERAPIES TO DRIVE GROWTH 178
TABLE 156 BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING, BY REGION, 2022–2029 (USD MILLION) 179
TABLE 157 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 179
TABLE 158 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 180
TABLE 159 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 180
TABLE 160 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 181
TABLE 161 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING, BY REGION, 2022–2029 (USD MILLION) 181
TABLE 162 GCC: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 181
8.5 BLOOD & BLOOD PRODUCTS DEVELOPMENT AND MANUFACTURING 182
8.5.1 GROWING DEMAND FOR BLOOD PRODUCTS TO PROPEL GROWTH 182
TABLE 163 BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS DEVELOPMENT AND MANUFACTURING, BY REGION, 2022–2029 (USD MILLION) 182
TABLE 164 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 183
TABLE 165 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 183
TABLE 166 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 184
TABLE 167 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 184
TABLE 168 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS DEVELOPMENT AND MANUFACTURING, BY REGION, 2022–2029 (USD MILLION) 184
TABLE 169 GCC: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2022–2029 (USD MILLION) 185
8.6 OTHER APPLICATIONS 185
TABLE 170 BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY REGION, 2022–2029 (USD MILLION) 186
TABLE 171 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2022–2029 (USD MILLION) 186
TABLE 172 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2022–2029 (USD MILLION) 186
TABLE 173 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2022–2029 (USD MILLION) 187
TABLE 174 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2022–2029 (USD MILLION) 187
TABLE 175 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY REGION, 2022–2029 (USD MILLION) 187
TABLE 176 GCC: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2022–2029 (USD MILLION) 188
9 BIOLOGICS SAFETY TESTING MARKET, BY END USER 189
9.1 INTRODUCTION 190
TABLE 177 BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 190
9.2 PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES 190
9.2.1 INCREASING PHARMACEUTICAL R&D SPENDING AND GROWING STRATEGIC ALLIANCES TO DRIVE GROWTH 190
FIGURE 32 GLOBAL PHARMACEUTICAL R&D SPENDING, 2014–2028 (USD BILLION) 191
TABLE 178 BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY REGION, 2022–2029 (USD MILLION) 191
TABLE 179 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2022–2029 (USD MILLION) 192
TABLE 180 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2022–2029 (USD MILLION) 192
TABLE 181 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2022–2029 (USD MILLION) 192
TABLE 182 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2022–2029 (USD MILLION) 193
TABLE 183 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY REGION, 2022–2029 (USD MILLION) 193
TABLE 184 GCC: BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES, BY COUNTRY, 2022–2029 (USD MILLION) 193
9.3 CROS & CDMOS 194
9.3.1 INCREASING FOCUS ON EXPANSION OF CROS AND CDMOS TO PROPEL GROWTH 194
TABLE 185 BIOLOGICS SAFETY TESTING MARKET FOR CROS & CDMOS, BY REGION, 2022–2029 (USD MILLION) 194
TABLE 186 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR CROS & CDMOS, BY COUNTRY, 2022–2029 (USD MILLION) 195
TABLE 187 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR CROS & CDMOS, BY COUNTRY, 2022–2029 (USD MILLION) 195
TABLE 188 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR CROS & CDMOS, BY COUNTRY, 2022–2029 (USD MILLION) 196
TABLE 189 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR CROS & CDMOS, BY COUNTRY, 2022–2029 (USD MILLION) 196
TABLE 190 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET FOR CROS & CDMOS, BY REGION, 2022–2029 (USD MILLION) 196
TABLE 191 GCC: BIOLOGICS SAFETY TESTING MARKET FOR CROS & CDMOS, BY COUNTRY, 2022–2029 (USD MILLION) 197
9.4 ACADEMIC & RESEARCH INSTITUTES 197
9.4.1 SURGE IN R&D ACTIVITIES FOR DEVELOPMENT OF ADVANCED THERAPIES TO BOOST MARKET GROWTH 197
TABLE 192 BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY REGION, 2022–2029 (USD MILLION) 198
TABLE 193 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY COUNTRY, 2022–2029 (USD MILLION) 198
TABLE 194 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY COUNTRY, 2022–2029 (USD MILLION) 198
TABLE 195 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY COUNTRY, 2022–2029 (USD MILLION) 199
TABLE 196 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY COUNTRY, 2022–2029 (USD MILLION) 199
TABLE 197 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY REGION, 2022–2029 (USD MILLION) 199
TABLE 198 GCC: BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY COUNTRY, 2022–2029 (USD MILLION) 200
10 BIOLOGICS SAFETY TESTING MARKET, BY REGION 201
10.1 INTRODUCTION 202
TABLE 199 BIOLOGICS SAFETY TESTING MARKET, BY REGION, 2022–2029 (USD MILLION) 202
10.2 NORTH AMERICA 202
FIGURE 33 NUMBER OF BIOSIMILARS APPROVED ANNUALLY BY US FDA, 2015 TO 2023 203
10.2.1 NORTH AMERICA: RECESSION IMPACT 203
FIGURE 34 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET SNAPSHOT 204
TABLE 200 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 204
TABLE 201 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 205
TABLE 202 NORTH AMERICA: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 205
TABLE 203 NORTH AMERICA: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 206
TABLE 204 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 206
TABLE 205 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 207
10.2.2 US 207
10.2.2.1 Increasing investments in biotechnology industry to drive market growth 207
FIGURE 35 TOTAL US NIH BIOTECHNOLOGY FUNDING, FY 2013 TO FY 2024 208
TABLE 206 US: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 208
TABLE 207 US: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 209
TABLE 208 US: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 209
TABLE 209 US: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 210
TABLE 210 US: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 210
10.2.3 CANADA 210
10.2.3.1 Investments for expanding biomanufacturing capacity to propel market growth 210
TABLE 211 CANADA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 211
TABLE 212 CANADA: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 211
TABLE 213 CANADA: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 212
TABLE 214 CANADA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 212
TABLE 215 CANADA: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 213
10.3 EUROPE 213
TABLE 216 EUROPE: INDICATIVE LIST OF APPROVED MONOCLONAL ANTIBODY TREATMENTS 213
10.3.1 EUROPE: RECESSION IMPACT 214
TABLE 217 EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY COUNTRY/REGION, 2022–2029 (USD MILLION) 214
TABLE 218 EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 215
TABLE 219 EUROPE: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 215
TABLE 220 EUROPE: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 216
TABLE 221 EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 216
TABLE 222 EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 217
10.3.2 GERMANY 217
10.3.2.1 Expansion initiatives by key market players to support market growth 217
TABLE 223 GERMANY: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 217
TABLE 224 GERMANY: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 218
TABLE 225 GERMANY: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 218
TABLE 226 GERMANY: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 219
TABLE 227 GERMANY: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 219
10.3.3 UK 220
10.3.3.1 Emphasis on vaccine manufacturing and biotech R&D to drive market 220
TABLE 228 UK: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 220
TABLE 229 UK: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 220
TABLE 230 UK: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 221
TABLE 231 UK: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 221
TABLE 232 UK: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 222
10.3.4 FRANCE 222
10.3.4.1 Rising focus on cell & gene therapy R&D to promote market growth 222
TABLE 233 FRANCE: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 222
TABLE 234 FRANCE: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 223
TABLE 235 FRANCE: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 223
TABLE 236 FRANCE: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 224
TABLE 237 FRANCE: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 224
10.3.5 ITALY 225
10.3.5.1 Rising life sciences R&D and growing biotech industry to boost market 225
TABLE 238 ITALY: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 225
TABLE 239 ITALY: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 225
TABLE 240 ITALY: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 226
TABLE 241 ITALY: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 226
TABLE 242 ITALY: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 227
10.3.6 SPAIN 227
10.3.6.1 Growing expansion of biotech companies and increasing R&D expenditure to drive market 227
TABLE 243 SPAIN: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 228
TABLE 244 SPAIN: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 228
TABLE 245 SPAIN: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 229
TABLE 246 SPAIN: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 229
TABLE 247 SPAIN: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 230
10.3.7 REST OF EUROPE 230
TABLE 248 REST OF EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 230
TABLE 249 REST OF EUROPE: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 231
TABLE 250 REST OF EUROPE: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 231
TABLE 251 REST OF EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 232
TABLE 252 REST OF EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 232
10.4 ASIA PACIFIC 233
10.4.1 ASIA PACIFIC: RECESSION IMPACT 233
FIGURE 36 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET SNAPSHOT 234
TABLE 253 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 235
TABLE 254 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 235
TABLE 255 ASIA PACIFIC: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 236
TABLE 256 ASIA PACIFIC: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 236
TABLE 257 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 237
TABLE 258 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 237
10.4.2 CHINA 237
10.4.2.1 China to dominate APAC market 237
TABLE 259 CHINA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 238
TABLE 260 CHINA: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 238
TABLE 261 CHINA: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 239
TABLE 262 CHINA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 239
TABLE 263 CHINA: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 240
10.4.3 JAPAN 240
10.4.3.1 Growing government initiatives and expansion of biopharma companies to boost market 240
TABLE 264 JAPAN: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 240
TABLE 265 JAPAN: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 241
TABLE 266 JAPAN: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 241
TABLE 267 JAPAN: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 242
TABLE 268 JAPAN: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 242
10.4.4 INDIA 242
10.4.4.1 Funding for biopharma sector and focus on cell-based therapies to propel market growth 242
TABLE 269 INDIA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 243
TABLE 270 INDIA: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 243
TABLE 271 INDIA: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 244
TABLE 272 INDIA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 244
TABLE 273 INDIA: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 245
10.4.5 SOUTH KOREA 245
10.4.5.1 Growing focus on advancing bioprocessing sector to drive market 245
TABLE 274 SOUTH KOREA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 245
TABLE 275 SOUTH KOREA: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 246
TABLE 276 SOUTH KOREA: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 246
TABLE 277 SOUTH KOREA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 247
TABLE 278 SOUTH KOREA: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 247
10.4.6 AUSTRALIA 247
10.4.6.1 Rising incidence of chronic diseases and booming life science sector to drive market 247
TABLE 279 AUSTRALIA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 248
TABLE 280 AUSTRALIA: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 248
TABLE 281 AUSTRALIA: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 249
TABLE 282 AUSTRALIA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 249
TABLE 283 AUSTRALIA: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 250
10.4.7 REST OF ASIA PACIFIC 250
TABLE 284 REST OF ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 250
TABLE 285 REST OF ASIA PACIFIC: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 251
TABLE 286 REST OF ASIA PACIFIC: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 251
TABLE 287 REST OF ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 252
TABLE 288 REST OF ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 252
10.5 LATIN AMERICA 252
10.5.1 LATIN AMERICA: RECESSION IMPACT 253
TABLE 289 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY COUNTRY/REGION, 2022–2029 (USD MILLION) 253
TABLE 290 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 253
TABLE 291 LATIN AMERICA: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 254
TABLE 292 LATIN AMERICA: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 254
TABLE 293 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 255
TABLE 294 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 255
10.5.2 BRAZIL 256
10.5.2.1 Brazil to hold largest share of LATAM market 256
TABLE 295 BRAZIL: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 256
TABLE 296 BRAZIL: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 257
TABLE 297 BRAZIL: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 257
TABLE 298 BRAZIL: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 258
TABLE 299 BRAZIL: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 258
10.5.3 MEXICO 258
10.5.3.1 Increasing government support for biopharmaceutical production to drive market 258
TABLE 300 MEXICO: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 259
TABLE 301 MEXICO: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 259
TABLE 302 MEXICO: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 260
TABLE 303 MEXICO: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 260
TABLE 304 MEXICO: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 261
10.5.4 REST OF LATIN AMERICA 261
TABLE 305 REST OF LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 261
TABLE 306 REST OF LATIN AMERICA: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 262
TABLE 307 REST OF LATIN AMERICA: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 262
TABLE 308 REST OF LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 263
TABLE 309 REST OF LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 263
10.6 MIDDLE EAST 263
10.6.1 MIDDLE EAST: RECESSION IMPACT 264
TABLE 310 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET, BY REGION, 2022–2029 (USD MILLION) 264
TABLE 311 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 264
TABLE 312 MIDDLE EAST: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 265
TABLE 313 MIDDLE EAST: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 265
TABLE 314 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 266
TABLE 315 MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 266
10.6.2 GCC COUNTRIES 266
TABLE 316 GCC COUNTRIES: BIOLOGICS SAFETY TESTING MARKET, BY COUNTRY, 2022–2029 (USD MILLION) 267
TABLE 317 GCC COUNTRIES: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 267
TABLE 318 GCC COUNTRIES: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 267
TABLE 319 GCC COUNTRIES: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 268
TABLE 320 GCC COUNTRIES: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 268
TABLE 321 GCC COUNTRIES: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 269
10.6.2.1 Saudi Arabia 269
10.6.2.1.1 Increasing healthcare expenditure and rising focus of key players on expansion to support growth 269
TABLE 322 SAUDI ARABIA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 269
TABLE 323 SAUDI ARABIA: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 270
TABLE 324 SAUDI ARABIA: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 270
TABLE 325 SAUDI ARABIA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 271
TABLE 326 SAUDI ARABIA: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 271
10.6.2.2 United Arab Emirates 271
10.6.2.2.1 Developing biopharma sector to drive market 271
TABLE 327 UAE: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 272
TABLE 328 UAE: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 272
TABLE 329 UAE: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 273
TABLE 330 UAE: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 273
TABLE 331 UAE: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 274
10.6.2.3 Rest of GCC countries 274
TABLE 332 REST OF GCC COUNTRIES: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 274
TABLE 333 REST OF GCC COUNTRIES: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 275
TABLE 334 REST OF GCC COUNTRIES: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 275
TABLE 335 REST OF GCC COUNTRIES: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 276
TABLE 336 REST OF GCC COUNTRIES: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 276
10.6.3 REST OF MIDDLE EAST 276
TABLE 337 REST OF MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 277
TABLE 338 REST OF MIDDLE EAST: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 277
TABLE 339 REST OF MIDDLE EAST: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 278
TABLE 340 REST OF MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 278
TABLE 341 REST OF MIDDLE EAST: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 279
10.7 AFRICA 279
10.7.1 RISING PREVALENCE OF CHRONIC DISEASES AND INCREASING GRANTS & FUNDS FOR BIOPHARMA SECTOR TO FUEL MARKET GROWTH 279
10.7.2 AFRICA: RECESSION IMPACT 279
TABLE 342 AFRICA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2022–2029 (USD MILLION) 280
TABLE 343 AFRICA: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY TYPE, 2022–2029 (USD MILLION) 280
TABLE 344 AFRICA: BIOLOGICS SAFETY TESTING PRODUCTS MARKET, BY TEST TYPE, 2022–2029 (USD MILLION) 281
TABLE 345 AFRICA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022–2029 (USD MILLION) 281
TABLE 346 AFRICA: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2022–2029 (USD MILLION) 282
11 COMPETITIVE LANDSCAPE 283
11.1 INTRODUCTION 283
11.2 KEY PLAYER STRATEGY/RIGHT TO WIN 283
TABLE 347 BIOLOGICS SAFETY TESTING MARKET: STRATEGIES ADOPTED 283
11.3 REVENUE ANALYSIS 285
FIGURE 37 REVENUE ANALYSIS OF KEY PLAYERS (2019–2023) 286
11.4 MARKET SHARE ANALYSIS 286
FIGURE 38 MARKET SHARE ANALYSIS OF KEY PLAYERS (2023) 287
TABLE 348 BIOLOGICS SAFETY TESTING MARKET: DEGREE OF COMPETITION 287
11.5 BRAND/PRODUCT COMPARISON 289
FIGURE 39 BIOLOGICS SAFETY TESTING MARKET: BRAND/PRODUCT COMPARISON 289
11.6 COMPANY EVALUATION MATRIX: KEY PLAYERS, 2023 289
11.6.1 STARS 290
11.6.2 EMERGING LEADERS 290
11.6.3 PERVASIVE PLAYERS 290
11.6.4 PARTICIPANTS 290
FIGURE 40 BIOLOGICS SAFETY TESTING MARKET: COMPANY EVALUATION MATRIX (KEY PLAYERS), 2023 291
11.6.5 COMPANY FOOTPRINT: KEY PLAYERS, 2023 292
11.6.5.1 Overall footprint 292
FIGURE 41 BIOLOGICS SAFETY TESTING MARKET: OVERALL FOOTPRINT 292
11.6.5.2 Product and service footprint 293
TABLE 349 BIOLOGICS SAFETY TESTING MARKET: PRODUCT AND SERVICE FOOTPRINT 293
11.6.5.3 Regional footprint 293
TABLE 350 BIOLOGICS SAFETY TESTING MARKET: REGIONAL FOOTPRINT 294
11.6.5.4 Test type footprint 295
TABLE 351 BIOLOGICS SAFETY TESTING MARKET: TEST TYPE FOOTPRINT 295
11.6.5.5 Application footprint 296
TABLE 352 BIOLOGICS SAFETY TESTING MARKET: APPLICATION FOOTPRINT 296
11.7 COMPANY EVALUATION MATRIX: START-UPS/SMES, 2023 297
11.7.1 PROGRESSIVE COMPANIES 297
11.7.2 RESPONSIVE COMPANIES 297
11.7.3 DYNAMIC COMPANIES 297
11.7.4 STARTING BLOCKS 298
FIGURE 42 BIOLOGICS SAFETY TESTING MARKET: COMPANY EVALUATION MATRIX (START-UPS/SMES), 2023 298
11.7.5 COMPETITIVE BENCHMARKING: START-UPS/SMES, 2023 299
TABLE 353 BIOLOGICS SAFETY TESTING MARKET: DETAILED LIST OF KEY START-UPS/SMES 299
TABLE 354 BIOLOGICS SAFETY TESTING MARKET: COMPETITIVE BENCHMARKING OF KEY START-UPS/SMES 300
11.8 VALUATION AND FINANCIAL METRICS 301
FIGURE 43 EV/EBITDA OF KEY VENDORS 301
FIGURE 44 YEAR-TO-DATE (YTD) PRICE TOTAL RETURN AND 5-YEAR STOCK BETA OF KEY VENDORS 301
11.9 COMPETITIVE SCENARIO 302
11.9.1 PRODUCT LAUNCHES 302
TABLE 355 BIOLOGICS SAFETY TESTING MARKET: PRODUCT LAUNCHES, JANUARY 2021–JANUARY 2024 302
11.9.2 DEALS 303
TABLE 356 BIOLOGICS SAFETY TESTING MARKET: DEALS, JANUARY 2021–JANUARY 2024 303
11.9.3 EXPANSIONS 304
TABLE 357 BIOLOGICS SAFETY TESTING MARKET: EXPANSIONS, JANUARY 2021–JANUARY 2024 304
12 COMPANY PROFILES 306
12.1 INTRODUCTION 306
12.2 KEY PLAYERS 306
(Business Overview, Products Offered, Recent Developments, and MnM View (Key strengths/Right to Win, Strategic Choices Made, and Weaknesses and Competitive Threats))*
12.2.1 THERMO FISHER SCIENTIFIC INC. 306
TABLE 358 THERMO FISHER SCIENTIFIC INC.: COMPANY OVERVIEW 306
FIGURE 45 THERMO FISHER SCIENTIFIC INC.: COMPANY SNAPSHOT 307
TABLE 359 THERMO FISHER SCIENTIFIC INC.: PRODUCTS/SERVICES/SOLUTIONS OFFERED 308
TABLE 360 THERMO FISHER SCIENTIFIC INC.: DEALS 310
TABLE 361 THERMO FISHER SCIENTIFIC INC.: EXPANSIONS 310
12.2.2 CHARLES RIVER LABORATORIES 312
TABLE 362 CHARLES RIVER LABORATORIES: COMPANY OVERVIEW 312
FIGURE 46 CHARLES RIVER LABORATORIES: COMPANY SNAPSHOT 313
TABLE 363 CHARLES RIVER LABORATORIES: PRODUCTS/SERVICES/SOLUTIONS OFFERED 313
TABLE 364 CHARLES RIVER LABORATORIES: PRODUCT LAUNCHES 315
TABLE 365 CHARLES RIVER LABORATORIES: DEALS 316
12.2.3 LABORATORY CORPORATION OF AMERICA HOLDINGS 318
TABLE 366 LABORATORY CORPORATION OF AMERICA HOLDINGS: COMPANY OVERVIEW 318
FIGURE 47 LABORATORY CORPORATION OF AMERICA HOLDINGS: COMPANY SNAPSHOT 319
TABLE 367 LABORATORY CORPORATION OF AMERICA HOLDINGS: PRODUCTS/SERVICES/SOLUTIONS OFFERED 320
TABLE 368 LABORATORY CORPORATION OF AMERICA HOLDINGS: DEALS 320
TABLE 369 LABORATORY CORPORATION OF AMERICA HOLDINGS: EXPANSIONS 321
12.2.4 F. HOFFMANN-LA ROCHE LTD. 323
TABLE 370 F. HOFFMANN-LA ROCHE LTD.: COMPANY OVERVIEW 323
FIGURE 48 F. HOFFMANN-LA ROCHE LTD.: COMPANY SNAPSHOT 324
TABLE 371 F. HOFFMANN-LA ROCHE LTD.: PRODUCTS/SERVICES/SOLUTIONS OFFERED 324
12.2.5 MERCK KGAA 326
TABLE 372 MERCK KGAA: COMPANY OVERVIEW 326
FIGURE 49 MERCK KGAA: COMPANY SNAPSHOT 327
TABLE 373 MERCK KGAA: PRODUCTS/SERVICES/SOLUTIONS OFFERED 328
TABLE 374 MERCK KGAA: EXPANSIONS 329
12.2.6 SARTORIUS AG 331
TABLE 375 SARTORIUS AG: COMPANY OVERVIEW 331
FIGURE 50 SARTORIUS AG: COMPANY SNAPSHOT 332
TABLE 376 SARTORIUS AG: PRODUCTS/SERVICES/SOLUTIONS OFFERED 332
12.2.7 LONZA 334
TABLE 377 LONZA: COMPANY OVERVIEW 334
FIGURE 51 LONZA: COMPANY SNAPSHOT 335
TABLE 378 LONZA: PRODUCTS/SERVICES/SOLUTIONS OFFERED 335
TABLE 379 LONZA: PRODUCT LAUNCHES 338
TABLE 380 LONZA: DEALS 338
TABLE 381 LONZA: EXPANSIONS 339
12.2.8 FUJIFILM CORPORATION 340
TABLE 382 FUJIFILM CORPORATION: COMPANY OVERVIEW 340
FIGURE 52 FUJIFILM CORPORATION: COMPANY SNAPSHOT 341
TABLE 383 FUJIFILM CORPORATION: PRODUCTS/SERVICES/SOLUTIONS OFFERED 341
TABLE 384 FUJIFILM CORPORATION: PRODUCT LAUNCHES 343
TABLE 385 FUJIFILM CORPORATION: DEALS 343
TABLE 386 FUJIFILM CORPORATION: EXPANSIONS 344
12.2.9 BIOMÉRIEUX 345
TABLE 387 BIOMÉRIEUX: COMPANY OVERVIEW 345
FIGURE 53 BIOMÉRIEUX: COMPANY SNAPSHOT 346
TABLE 388 BIOMÉRIEUX: PRODUCTS/SERVICES/SOLUTIONS OFFERED 347
12.2.10 MARAVAI LIFESCIENCES 348
TABLE 389 MARAVAI LIFESCIENCES: COMPANY OVERVIEW 348
FIGURE 54 MARAVAI LIFESCIENCES: COMPANY SNAPSHOT 349
TABLE 390 MARAVAI LIFESCIENCES: PRODUCTS/SERVICES/SOLUTIONS OFFERED 349
TABLE 391 MARAVAI LIFESCIENCES: PRODUCT LAUNCHES 350
TABLE 392 MARAVAI LIFESCIENCES: DEALS 351
12.2.11 WUXI APPTEC 352
TABLE 393 WUXI APPTEC: COMPANY OVERVIEW 352
FIGURE 55 WUXI APPTEC: COMPANY SNAPSHOT 353
TABLE 394 WUXI APPTEC: PRODUCTS/SERVICES/SOLUTIONS OFFERED 354
TABLE 395 WUXI APPTEC: DEALS 354
TABLE 396 WUXI APPTEC: EXPANSIONS 355
12.2.12 SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA. 356
TABLE 397 SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA: COMPANY OVERVIEW 356
FIGURE 56 SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA: COMPANY SNAPSHOT 357
TABLE 398 SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA: PRODUCTS/SERVICES/SOLUTIONS OFFERED 358
TABLE 399 SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA: EXPANSIONS 359
12.2.13 SOTERA HEALTH 360
TABLE 400 SOTERA HEALTH: COMPANY OVERVIEW 360
FIGURE 57 SOTERA HEALTH: COMPANY SNAPSHOT 361
TABLE 401 SOTERA HEALTH: PRODUCTS/SERVICES/SOLUTIONS OFFERED 362
TABLE 402 SOTERA HEALTH: DEALS 362
TABLE 403 SOTERA HEALTH: EXPANSIONS 362
12.2.14 SAMSUNG BIOLOGICS 363
TABLE 404 SAMSUNG BIOLOGICS: COMPANY OVERVIEW 363
FIGURE 58 SAMSUNG BIOLOGICS: COMPANY SNAPSHOT 363
TABLE 405 SAMSUNG BIOLOGICS: PRODUCTS/SERVICES/SOLUTIONS OFFERED 364
TABLE 406 SAMSUNG BIOLOGICS: DEALS 364
TABLE 407 SAMSUNG BIOLOGICS: EXPANSIONS 365
12.2.15 GENSCRIPT 366
TABLE 408 GENSCRIPT: COMPANY OVERVIEW 366
FIGURE 59 GENSCRIPT: COMPANY SNAPSHOT 367
TABLE 409 GENSCRIPT: PRODUCTS/SERVICES/SOLUTIONS OFFERED 368
12.2.16 AGILENT TECHNOLOGIES, INC. 369
TABLE 410 AGILENT TECHNOLOGIES, INC.: COMPANY OVERVIEW 369
FIGURE 60 AGILENT TECHNOLOGIES, INC.: COMPANY SNAPSHOT 370
TABLE 411 AGILENT TECHNOLOGIES, INC.: PRODUCTS/SERVICES/SOLUTIONS OFFERED 370
12.2.17 SYNGENE INTERNATIONAL LIMITED 372
TABLE 412 SYNGENE INTERNATIONAL LIMITED: COMPANY OVERVIEW 372
FIGURE 61 SYNGENE INTERNATIONAL LIMITED: COMPANY SNAPSHOT 372
TABLE 413 SYNGENE INTERNATIONAL LIMITED: PRODUCTS/SERVICES/SOLUTIONS OFFERED 373
TABLE 414 SYNGENE INTERNATIONAL LIMITED: DEALS 373
TABLE 415 SYNGENE INTERNATIONAL LIMITED: EXPANSIONS 374
12.2.18 EUROFINS SCIENTIFIC 375
TABLE 416 EUROFINS SCIENTIFIC: COMPANY OVERVIEW 375
FIGURE 62 EUROFINS SCIENTIFIC: COMPANY SNAPSHOT 376
TABLE 417 EUROFINS SCIENTIFIC: PRODUCTS/SERVICES/SOLUTIONS OFFERED 377
TABLE 418 EUROFINS SCIENTIFIC: DEALS 378
12.2.19 BIO-RAD LABORATORIES, INC. 379
TABLE 419 BIO-RAD LABORATORIES, INC.: COMPANY OVERVIEW 379
FIGURE 63 BIO-RAD LABORATORIES, INC.: COMPANY SNAPSHOT 380
TABLE 420 BIO-RAD LABORATORIES, INC.: PRODUCTS/SERVICES/SOLUTIONS OFFERED 381
TABLE 421 BIO-RAD LABORATORIES, INC.: PRODUCT LAUNCHES 381
TABLE 422 BIO-RAD LABORATORIES, INC.: DEALS 382
12.2.20 QIAGEN 383
TABLE 423 QIAGEN: COMPANY OVERVIEW 383
FIGURE 64 QIAGEN: COMPANY SNAPSHOT 384
TABLE 424 QIAGEN: PRODUCTS/SERVICES/SOLUTIONS OFFERED 384
TABLE 425 QIAGEN: PRODUCT LAUNCHES 385
12.3 OTHER PLAYERS 386
12.3.1 PROMEGA CORPORATION 386
TABLE 426 PROMEGA CORPORATION: COMPANY OVERVIEW 386
12.3.2 CATALENT, INC. 387
TABLE 427 CATALENT, INC.: COMPANY OVERVIEW 387
12.3.3 ASSOCIATES OF CAPE COD, INC. 388
TABLE 428 ASSOCIATES OF CAPE COD, INC.: COMPANY OVERVIEW 388
12.3.4 CLEAN BIOLOGICS 389
TABLE 429 CLEAN BIOLOGICS: COMPANY OVERVIEW 389
12.3.5 PATHOQUEST 390
TABLE 430 PATHOQUEST: COMPANY OVERVIEW 390
12.3.6 PACIFIC BIOLABS 391
TABLE 431 PACIFIC BIOLABS: COMPANY OVERVIEW 391
12.3.7 ARL BIO PHARMA, INC. 392
TABLE 432 ARL BIO PHARMA, INC.: COMPANY OVERVIEW 392
12.3.8 FRONTAGE LABS 393
TABLE 433 FRONTAGE LABS: COMPANY OVERVIEW 393
12.3.9 CREATIVE BIOGENE 394
TABLE 434 CREATIVE BIOGENE: COMPANY OVERVIEW 394
12.3.10 ADVAXIA BIOLOGICS 395
TABLE 435 ADVAXIA BIOLOGICS: COMPANY OVERVIEW 395
*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.
13 DISCUSSION GUIDE 396
13.1 KNOWLEDGESTORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 401
13.2 CUSTOMIZATION OPTIONS 403
13.3 RELATED REPORTS 403
13.4 AUTHOR DETAILS 404