Table of Content

1 INTRODUCTION 30
1.1 STUDY OBJECTIVES 30
1.2 MARKET DEFINITION 30
1.2.1 INCLUSIONS AND EXCLUSIONS 31
1.2.2 MARKETS COVERED 32
FIGURE 1 BIOLOGICS SAFETY TESTING MARKET SEGMENTATION 32
1.2.3 YEARS CONSIDERED 32
1.3 CURRENCY CONSIDERED 33
1.4 LIMITATIONS 33
1.5 STAKEHOLDERS 33
1.6 SUMMARY OF CHANGES 33
2 RESEARCH METHODOLOGY 35
2.1 RESEARCH APPROACH 35
FIGURE 2 RESEARCH DESIGN 35
2.1.1 SECONDARY DATA 36
2.1.2 PRIMARY DATA 37
FIGURE 3 BREAKDOWN OF PRIMARIES: BIOLOGICS SAFETY TESTING MARKET 37
2.1.3 DATA TRIANGULATION APPROACH 38
2.2 DATA TRIANGULATION 38
FIGURE 4 DATA TRIANGULATION METHODOLOGY 38
2.3 MARKET ESTIMATION METHODOLOGY 39
FIGURE 5 MARKET SIZE ESTIMATION: COMPANY REVENUE ANALYSIS-BASED ESTIMATION 39
FIGURE 6 MARKET SIZE ESTIMATION: SEGMENTAL ANALYSIS-BASED ESTIMATION 39
FIGURE 7 BIOLOGICS SAFETY TESTING MARKET: FINAL CAGR PROJECTION (2022?2027) 40
FIGURE 8 BIOLOGICS SAFETY TESTING: CAGR PROJECTION FROM ANALYSIS OF DRIVERS, RESTRAINTS, OPPORTUNITIES, AND CHALLENGES 41
2.4 INDUSTRY INSIGHTS 42
2.5 RESEARCH ASSUMPTIONS 42
2.6 RECESSION IMPACT 42
TABLE 1 GLOBAL INFLATION RATE PROJECTION, 2024?2027 (% GROWTH) 42
3 EXECUTIVE SUMMARY 44
FIGURE 9 BIOLOGICS SAFETY TESTING MARKET SHARE, BY PRODUCT & SERVICE (2021) 44
FIGURE 10 BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2022 VS. 2027 (USD MILLION) 45
FIGURE 11 BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2022 VS. 2027 (USD MILLION) 46
FIGURE 12 BIOLOGICS SAFETY TESTING MARKET: GEOGRAPHICAL GROWTH OPPORTUNITIES 47
4 PREMIUM INSIGHTS 48
4.1 BIOLOGICS SAFETY TESTING MARKET OVERVIEW 48
FIGURE 13 RISING DEVELOPMENT OF BIOLOGICS AND BIOSIMILARS TO DRIVE MARKET 48
4.2 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION AND COUNTRY (2021) 49
FIGURE 14 MONOCLONAL ANTIBODIES MANUFACTURING SEGMENT ACCOUNTED FOR LARGEST SHARE IN 2021 49
4.3 BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE 50
FIGURE 15 RESIDUAL HOST-CELL PROTEINS AND DNA DETECTION TESTS SEGMENT TO REGISTER HIGHEST CAGR DURING FORECAST PERIOD 50
5 MARKET OVERVIEW 51
5.1 MARKET DYNAMICS 51
FIGURE 16 BIOLOGICS SAFETY TESTING MARKET: DRIVERS, RESTRAINTS, OPPORTUNITIES, AND CHALLENGES 51
5.1.1 DRIVERS 52
5.1.1.1 Growing development of biosimilars and biologics 52
TABLE 2 LIST OF BIOLOGICAL LICENSE APPLICATION APPROVALS IN US, 2021 52
TABLE 3 LIST OF BIOLOGICS APPROVED BY US FDA (2021) 53
5.1.1.2 Growing concerns over cell culture contamination 54
5.1.1.3 Rising investments in biopharmaceutical R&D 54
TABLE 4 PHARMACEUTICAL R&D SPENDING, BY COMPANY, 2020 VS. 2026 (USD BILLION) 54
FIGURE 17 PHARMACEUTICAL & BIOPHARMACEUTICAL R&D EXPENDITURE,
2017–2024 55
5.1.2 RESTRAINTS 55
5.1.2.1 Shortage of skilled professionals 55
5.1.3 OPPORTUNITIES 56
5.1.3.1 Emerging markets 56
5.1.3.2 Increasing outsourcing of biopharmaceutical activities to CROs 56
5.1.4 CHALLENGES 57
5.1.4.1 High cost of biologics 57
5.2 PRICING ANALYSIS 57
TABLE 5 AVERAGE SELLING PRICE OF BIOLOGICS SAFETY TESTING PRODUCTS
(2020-2021) 57
5.2.1 PRICING TREND ANALYSIS 57
5.3 VALUE CHAIN ANALYSIS 58
FIGURE 18 BIOLOGICS SAFETY TESTING MARKET: VALUE CHAIN ANALYSIS 58
5.4 ECOSYSTEM ANALYSIS 59
FIGURE 19 BIOLOGICS SAFETY TESTING MARKET: ECOSYSTEM ANALYSIS 59
5.5 TRENDS/DISRUPTIONS IMPACTING CUSTOMERS’ BUSINESSES 59
FIGURE 20 REVENUE SHIFT FOR BIOLOGICS SAFETY TESTING PROVIDERS 59
5.6 PATENT ANALYSIS 60
FIGURE 21 TOP APPLICANTS & OWNERS (COMPANIES/INSTITUTIONS) FOR BIOLOGICS SAFETY PATENTS (JANUARY 2012?NOVEMBER 2022) 60
TABLE 6 BIOLOGICS SAFETY TESTING MARKET: INDICATIVE LIST OF PATENTS 61
5.7 REGULATORY ANALYSIS 62
5.7.1 US 62
5.7.2 EUROPE 63
5.7.3 ASIA PACIFIC 64
5.7.4 LATIN AMERICA 64
5.7.5 MIDDLE EAST AND AFRICA 64
5.7.6 REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 65
TABLE 7 NORTH AMERICA: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 65
TABLE 8 EUROPE: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 65
TABLE 9 ASIA PACIFIC: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 66
TABLE 10 REST OF THE WORLD: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 66
5.8 PORTER’S FIVE FORCES ANALYSIS 67
TABLE 11 BIOLOGICS SAFETY TESTING MARKET: PORTER’S FIVE FORCES ANALYSIS 67
5.8.1 THREAT OF NEW ENTRANTS 67
5.8.2 THREAT OF SUBSTITUTES 67
5.8.3 BARGAINING POWER OF BUYERS 67
5.8.4 BARGAINING POWER OF SUPPLIERS 68
5.8.5 INTENSITY OF COMPETITIVE RIVALRY 68
5.9 KEY CONFERENCES AND EVENTS IN 2022–2023 68
TABLE 12 BIOLOGICS SAFETY TESTING MARKET: CONFERENCES AND EVENTS 68
5.10 KEY STAKEHOLDERS AND BUYING CRITERIA 69
FIGURE 22 INFLUENCE OF STAKEHOLDERS ON BUYING PROCESS FOR PRODUCTS & SERVICES 69
FIGURE 23 BUYING CRITERIA FOR BIOLOGICS SAFETY TESTING PRODUCTS & SERVICES 69
6 BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE 70
6.1 INTRODUCTION 71
TABLE 13 BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2020–2027 (USD MILLION) 71
6.2 SERVICES 71
6.2.1 INCREASING OUTSOURCING OF SERVICES TO CROS TO DRIVE MARKET 71
TABLE 14 BIOLOGICS SAFETY TESTING SERVICES MARKET, BY REGION, 2020–2027 (USD MILLION) 72
TABLE 15 NORTH AMERICA: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 72
TABLE 16 EUROPE: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 72
TABLE 17 ASIA PACIFIC: BIOLOGICS SAFETY TESTING SERVICES MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 73
6.3 CONSUMABLES 73
6.3.1 RECURRENT PURCHASE OF ASSAYS, KITS, AND REAGENTS TO DRIVE MARKET 73
TABLE 18 BIOLOGICS SAFETY TESTING CONSUMABLES MARKET, BY REGION, 2020–2027 (USD MILLION) 74
TABLE 19 NORTH AMERICA: BIOLOGICS SAFETY TESTING CONSUMABLES MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 74
TABLE 20 EUROPE: BIOLOGICS SAFETY TESTING CONSUMABLES MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 74
TABLE 21 ASIA PACIFIC: BIOLOGICS SAFETY TESTING CONSUMABLES MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 75
6.4 INSTRUMENTS 75
6.4.1 LONGER SHELF LIFE OF INSTRUMENTS TO RESTRAIN MARKET 75
TABLE 22 BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET, BY REGION, 2020–2027 (USD MILLION) 76
TABLE 23 NORTH AMERICA: BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 76
TABLE 24 EUROPE: BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 76
TABLE 25 ASIA PACIFIC: BIOLOGICS SAFETY TESTING INSTRUMENTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 77
7 BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE 78
7.1 INTRODUCTION 79
TABLE 26 BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2020–2027 (USD MILLION) 79
7.2 RESIDUAL HOST-CELL PROTEINS AND DNA DETECTION TESTS 79
7.2.1 GROWING USE OF RDNA IN VARIOUS MANUFACTURING STAGES TO DRIVE MARKET 79
TABLE 27 RESIDUAL HOST-CELL PROTEINS AND DNA DETECTION TESTS MARKET, BY REGION, 2020–2027 (USD MILLION) 80
TABLE 28 NORTH AMERICA: RESIDUAL HOST-CELL PROTEINS AND DNA DETECTION TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 80
TABLE 29 EUROPE: RESIDUAL HOST-CELL PROTEINS AND DNA DETECTION TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 80
TABLE 30 ASIA PACIFIC: RESIDUAL HOST-CELL PROTEINS AND DNA DETECTION TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 81
7.3 MYCOPLASMA TESTS 81
7.3.1 GROWING CONCERNS OVER CELL CULTURE CONTAMINATION TO DRIVE MARKET 81
TABLE 31 MYCOPLASMA TESTS MARKET, BY REGION, 2020–2027 (USD MILLION) 82
TABLE 32 NORTH AMERICA: MYCOPLASMA TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 82
TABLE 33 EUROPE: MYCOPLASMA TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 82
TABLE 34 ASIA PACIFIC: MYCOPLASMA TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 83
7.4 STERILITY TESTS 83
7.4.1 MANDATORY TESTING CONDUCTED FOR DRUG DEVELOPMENT & PRODUCTION TO DRIVE MARKET 83
TABLE 35 STERILITY TESTS MARKET, BY REGION, 2020–2027 (USD MILLION) 84
TABLE 36 NORTH AMERICA: STERILITY TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 84
TABLE 37 EUROPE: STERILITY TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 84
TABLE 38 ASIA PACIFIC: STERILITY TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 85
7.5 ENDOTOXIN TESTS 85
7.5.1 RISING DEMAND FOR LAL TESTING TO SUPPORT MARKET GROWTH 85
TABLE 39 ENDOTOXIN TESTS MARKET, BY REGION, 2020–2027 (USD MILLION) 86
TABLE 40 NORTH AMERICA: ENDOTOXIN TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 86
TABLE 41 EUROPE: ENDOTOXIN TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 86
TABLE 42 ASIA PACIFIC: ENDOTOXIN TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 87
7.6 VIRUS SAFETY TESTS 87
7.6.1 RISING UPTAKE IN VACCINE DEVELOPMENT AND CELL & GENE THERAPY TO SUPPORT MARKET 87
TABLE 43 VIRUS SAFETY TESTS MARKET, BY REGION, 2020–2027 (USD MILLION) 88
TABLE 44 NORTH AMERICA: VIRUS SAFETY TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 88
TABLE 45 EUROPE: VIRUS SAFETY TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 88
TABLE 46 ASIA PACIFIC: VIRUS SAFETY TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 89
7.7 BIOBURDEN TESTS 89
7.7.1 GROWING CONCERNS FOR DRUG SAFETY STANDARDS TO PROPEL MARKET 89
TABLE 47 BIOBURDEN TESTS MARKET, BY REGION, 2020–2027 (USD MILLION) 89
TABLE 48 NORTH AMERICA: BIOBURDEN TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 90
TABLE 49 EUROPE: BIOBURDEN TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 90
TABLE 50 ASIA PACIFIC: BIOBURDEN TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 90
7.8 OTHER BIOLOGICS SAFETY TESTS 91
TABLE 51 OTHER BIOLOGICS SAFETY TESTS MARKET, BY REGION, 2020–2027 (USD MILLION) 91
TABLE 52 NORTH AMERICA: OTHER BIOLOGICS SAFETY TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 91
TABLE 53 EUROPE: OTHER BIOLOGICS SAFETY TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 92
TABLE 54 ASIA PACIFIC: OTHER BIOLOGICS SAFETY TESTS MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 92
8 BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION 93
8.1 INTRODUCTION 94
TABLE 55 BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2020–2027 (USD MILLION) 94
8.2 MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING 94
8.2.1 RISING APPROVALS FOR BIOSIMILAR MABS TO DRIVE MARKET 94
TABLE 56 BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY REGION, 2020–2027 (USD MILLION) 95
TABLE 57 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2020–2027 (USD MILLION) 95
TABLE 58 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2020–2027 (USD MILLION) 96
TABLE 59 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR MONOCLONAL ANTIBODIES DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2020–2027 (USD MILLION) 96
8.3 VACCINE DEVELOPMENT AND MANUFACTURING 96
8.3.1 GROWING PREVALENCE OF INFECTIOUS DISEASES TO DRIVE MARKET 96
TABLE 60 BIOLOGICS SAFETY TESTING MARKET FOR VACCINE DEVELOPMENT AND MANUFACTURING, BY REGION, 2020–2027 (USD MILLION) 97
TABLE 61 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR VACCINE DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2020–2027 (USD MILLION) 97
TABLE 62 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR VACCINE DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2020–2027 (USD MILLION) 98
TABLE 63 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR VACCINE DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2020–2027 (USD MILLION) 98
8.4 CELLULAR & GENE THERAPY PRODUCT DEVELOPMENT AND MANUFACTURING 98
8.4.1 RISING ADOPTION OF CELLULAR IMMUNOTHERAPIES FOR CANCER TREATMENT TO DRIVE MARKET 98
TABLE 64 BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCT DEVELOPMENT AND MANUFACTURING, BY REGION, 2020–2027 (USD MILLION) 99
TABLE 65 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2020–2027 (USD MILLION) 99
TABLE 66 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCT DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2020–2027 (USD MILLION) 100
TABLE 67 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR CELLULAR & GENE THERAPY PRODUCTS DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2020–2027 (USD MILLION) 100
8.5 BLOOD & BLOOD PRODUCT DEVELOPMENT AND MANUFACTURING 100
8.5.1 RISING UPTAKE OF STERILITY TESTS TO SUPPORT MARKET GROWTH 100
TABLE 68 BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCT DEVELOPMENT AND MANUFACTURING, BY REGION, 2020–2027 (USD MILLION) 101
TABLE 69 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCT DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2020–2027 (USD MILLION) 101
TABLE 70 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCT DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2020–2027 (USD MILLION) 102
TABLE 71 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR BLOOD & BLOOD PRODUCT DEVELOPMENT AND MANUFACTURING, BY COUNTRY, 2020–2027 (USD MILLION) 102
8.6 OTHER APPLICATIONS 102
TABLE 72 BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY REGION, 2020–2027 (USD MILLION) 103
TABLE 73 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2020–2027 (USD MILLION) 103
TABLE 74 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2020–2027 (USD MILLION) 104
TABLE 75 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR OTHER APPLICATIONS, BY COUNTRY, 2020–2027 (USD MILLION) 104
9 BIOLOGICS SAFETY TESTING MARKET, BY END USER 105
9.1 INTRODUCTION 106
TABLE 76 BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2020–2027 (USD MILLION) 106
9.2 PHARMACEUTICAL & BIOPHARMACEUTICAL COMPANIES 106
9.2.1 GROWING R&D EXPENDITURE FOR DRUG DEVELOPMENT TO DRIVE MARKET 106
FIGURE 24 PHARMACEUTICAL R&D SPENDING (2014–2028) 107
TABLE 77 BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOPHARMACEUTICAL COMPANIES, BY REGION, 2020–2027 (USD MILLION) 107
TABLE 78 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOPHARMACEUTICAL COMPANIES, BY COUNTRY, 2020–2027 (USD MILLION) 108
TABLE 79 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOPHARMACEUTICAL COMPANIES, BY COUNTRY, 2020–2027 (USD MILLION) 108
TABLE 80 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR PHARMACEUTICAL & BIOPHARMACEUTICAL COMPANIES, BY COUNTRY, 2020–2027 (USD MILLION) 108
9.3 CONTRACT RESEARCH ORGANIZATIONS AND CONTRACT DEVELOPMENT & MANUFACTURING ORGANIZATIONS (CROS AND CDMOS) 109
9.3.1 ABILITY TO PROVIDE SPECIALIZED MANUFACTURING AND SAFETY TESTING TECHNOLOGIES TO DRIVE MARKET 109
TABLE 81 BIOLOGICS SAFETY TESTING MARKET FOR CROS AND CDMOS, BY REGION, 2020–2027 (USD MILLION) 109
TABLE 82 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR CRS AND CDMOS, BY COUNTRY, 2020–2027 (USD MILLION) 110
TABLE 83 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR CROS AND CDMOS,
BY COUNTRY, 2020–2027 (USD MILLION) 110
TABLE 84 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR CROS AND CDMOS, BY COUNTRY, 2020–2027 (USD MILLION) 110
9.4 ACADEMIC & RESEARCH INSTITUTES 111
9.4.1 AVAILABILITY OF ADVANCED EQUIPMENT AND SPECIALIZED R&D PERSONNEL TO SUPPORT MARKET GROWTH 111
TABLE 85 BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY REGION, 2020–2027 (USD MILLION) 111
TABLE 86 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY COUNTRY, 2020–2027 (USD MILLION) 112
TABLE 87 EUROPE: BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY COUNTRY, 2020–2027 (USD MILLION) 112
TABLE 88 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET FOR ACADEMIC & RESEARCH INSTITUTES, BY COUNTRY, 2020–2027 (USD MILLION) 112
10 BIOLOGICS SAFETY TESTING MARKET, BY REGION 113
10.1 INTRODUCTION 114
TABLE 89 BIOLOGICS SAFETY TESTING MARKET, BY REGION, 2020–2027 (USD MILLION) 114
10.2 NORTH AMERICA 114
FIGURE 25 BIOLOGICS SAFETY TESTING MARKET: NORTH AMERICA MARKET SNAPSHOT 115
TABLE 90 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 116
TABLE 91 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2020–2027 (USD MILLION) 116
TABLE 92 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2020–2027 (USD MILLION) 116
TABLE 93 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2020–2027 (USD MILLION) 117
TABLE 94 NORTH AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2020–2027 (USD MILLION) 117
10.2.1 US 118
10.2.1.1 High investments in biopharmaceutical R&D to drive market 118
TABLE 95 US: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE,
2020–2027 (USD MILLION) 118
TABLE 96 US: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE,
2020–2027 (USD MILLION) 119
TABLE 97 US: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION,
2020–2027 (USD MILLION) 119
TABLE 98 US: BIOLOGICS SAFETY TESTING MARKET, BY END USER,
2020–2027 (USD MILLION) 120
10.2.2 CANADA 120
10.2.2.1 Presence of R&D clusters and growing life sciences research to drive market 120
TABLE 99 CANADA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2020–2027 (USD MILLION) 121
TABLE 100 CANADA: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE,
2020–2027 (USD MILLION) 121
TABLE 101 CANADA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION,
2020–2027 (USD MILLION) 122
TABLE 102 CANADA: BIOLOGICS SAFETY TESTING MARKET, BY END USER,
2020–2027 (USD MILLION) 122
10.2.3 NORTH AMERICA: RECESSION IMPACT 123
10.3 EUROPE 124
TABLE 103 EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY COUNTRY,
2020–2027 (USD MILLION) 124
TABLE 104 EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2020–2027 (USD MILLION) 125
TABLE 105 EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2020–2027 (USD MILLION) 125
TABLE 106 EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2020–2027 (USD MILLION) 126
TABLE 107 EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2020–2027 (USD MILLION) 126
10.3.1 GERMANY 127
10.3.1.1 Favorable R&D funding by federal and state governments to propel market 127
TABLE 108 GERMANY: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2020–2027 (USD MILLION) 127
TABLE 109 GERMANY: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2020–2027 (USD MILLION) 128
TABLE 110 GERMANY: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2020–2027 (USD MILLION) 128
TABLE 111 GERMANY: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2020–2027 (USD MILLION) 129
10.3.2 UK 129
10.3.2.1 Growing focus on investments in vaccine manufacturing to drive market 129
TABLE 112 UK: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2020–2027 (USD MILLION) 130
TABLE 113 UK: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2020–2027 (USD MILLION) 130
TABLE 114 UK: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2020–2027 (USD MILLION) 131
TABLE 115 UK: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2020–2027 (USD MILLION) 131
10.3.3 FRANCE 131
10.3.3.1 Government initiatives to strengthen R&D activities to support market growth 131
TABLE 116 FRANCE: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2020–2027 (USD MILLION) 132
TABLE 117 FRANCE: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2020–2027 (USD MILLION) 132
TABLE 118 FRANCE: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2020–2027 (USD MILLION) 133
TABLE 119 FRANCE: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2020–2027 (USD MILLION) 133
10.3.4 ITALY 134
10.3.4.1 Favorable government support for establishment of biotech startups to propel market 134
TABLE 120 ITALY: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2020–2027 (USD MILLION) 134
TABLE 121 ITALY: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2020–2027 (USD MILLION) 135
TABLE 122 ITALY: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2020–2027 (USD MILLION) 135
TABLE 123 ITALY: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2020–2027 (USD MILLION) 136
10.3.5 SPAIN 136
10.3.5.1 Increasing biologics production and outsourcing testing services to support market growth 136
TABLE 124 SPAIN: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2020–2027 (USD MILLION) 137
TABLE 125 SPAIN: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2020–2027 (USD MILLION) 137
TABLE 126 SPAIN: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2020–2027 (USD MILLION) 138
TABLE 127 SPAIN: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2020–2027 (USD MILLION) 138
10.3.6 REST OF EUROPE 138
TABLE 128 REST OF EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2020–2027 (USD MILLION) 139
TABLE 129 REST OF EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2020–2027 (USD MILLION) 139
TABLE 130 REST OF EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2020–2027 (USD MILLION) 140
TABLE 131 REST OF EUROPE: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2020–2027 (USD MILLION) 140
10.3.7 EUROPE: RECESSION IMPACT 141
10.4 ASIA PACIFIC 141
FIGURE 26 BIOLOGICS SAFETY TESTING MARKET: ASIA PACIFIC MARKET SNAPSHOT 142
TABLE 132 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY COUNTRY, 2020–2027 (USD MILLION) 143
TABLE 133 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2020–2027 (USD MILLION) 143
TABLE 134 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2020–2027 (USD MILLION) 143
TABLE 135 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2020–2027 (USD MILLION) 144
TABLE 136 ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY END USERS, 2020–2027 (USD MILLION) 144
10.4.1 CHINA 145
10.4.1.1 Rising approvals for drug applications and high R&D innovation to drive market 145
TABLE 137 CHINA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2020–2027 (USD MILLION) 145
TABLE 138 CHINA: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2020–2027 (USD MILLION) 146
TABLE 139 CHINA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2020–2027 (USD MILLION) 146
TABLE 140 CHINA: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2020–2027 (USD MILLION) 147
10.4.2 JAPAN 147
10.4.2.1 Rising investments for establishment of cell & gene therapy facilities to propel market 147
TABLE 141 JAPAN: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2020–2027 (USD MILLION) 147
TABLE 142 JAPAN: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2020–2027 (USD MILLION) 148
TABLE 143 JAPAN: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2020–2027 (USD MILLION) 148
TABLE 144 JAPAN: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2020–2027 (USD MILLION) 149
10.4.3 INDIA 149
10.4.3.1 High demand for export of pharmaceuticals and vaccines to drive market 149
TABLE 145 INDIA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2020–2027 (USD MILLION) 150
TABLE 146 INDIA: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2020–2027 (USD MILLION) 150
TABLE 147 INDIA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2020–2027 (USD MILLION) 151
TABLE 148 INDIA: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2020–2027 (USD MILLION) 151
10.4.4 REST OF ASIA PACIFIC 151
TABLE 149 REST OF ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2020–2027 (USD MILLION) 152
TABLE 150 REST OF ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2020–2027 (USD MILLION) 152
TABLE 151 REST OF ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2020–2027 (USD MILLION) 153
TABLE 152 REST OF ASIA PACIFIC: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2020–2027 (USD MILLION) 153
10.4.5 ASIA PACIFIC: RECESSION IMPACT 154
10.5 LATIN AMERICA 154
10.5.1 GROWING APPROVAL OF BIOSIMILARS TO SUPPORT MARKET GROWTH 154
TABLE 153 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2020–2027 (USD MILLION) 155
TABLE 154 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2020–2027 (USD MILLION) 155
TABLE 155 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2020–2027 (USD MILLION) 156
TABLE 156 LATIN AMERICA: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2020–2027 (USD MILLION) 156
10.5.2 LATIN AMERICA: RECESSION IMPACT 157
10.6 MIDDLE EAST & AFRICA 157
10.6.1 RISING FOCUS ON DRUG DISCOVERY AND DEVELOPMENT TO SUPPORT MARKET GROWTH 157
TABLE 157 MIDDLE EAST & AFRICA: BIOLOGICS SAFETY TESTING MARKET, BY PRODUCT & SERVICE, 2020–2027 (USD MILLION) 158
TABLE 158 MIDDLE EAST & AFRICA: BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE, 2020–2027 (USD MILLION) 158
TABLE 159 MIDDLE EAST & AFRICA: BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION, 2020–2027 (USD MILLION) 159
TABLE 160 MIDDLE EAST & AFRICA: BIOLOGICS SAFETY TESTING MARKET, BY END USER, 2020–2027 (USD MILLION) 159
10.6.2 MIDDLE EAST & AFRICA: RECESSION IMPACT 159
11 COMPETITIVE LANDSCAPE 161
11.1 OVERVIEW 161
11.2 RIGHT-TO-WIN STRATEGIES ADOPTED BY KEY PLAYERS 161
FIGURE 27 BIOLOGICS SAFETY TESTING MARKET: KEY PLAYER STRATEGIES (2019–2022) 162
11.3 MARKET SHARE ANALYSIS 163
FIGURE 28 BIOLOGICS SAFETY TESTING MARKET: MARKET SHARE ANALYSIS OF KEY PLAYERS, 2021 (TOP EIGHT) 163
TABLE 161 BIOLOGICS SAFETY TESTING MARKET: INTENSITY OF COMPETITIVE RIVALRY 164
11.4 REVENUE SHARE ANALYSIS OF KEY PLAYERS 165
FIGURE 29 BIOLOGICS SAFETY TESTING MARKET: REVENUE SHARE ANALYSIS OF KEY PLAYERS (TOP EIGHT) 165
11.5 COMPANY EVALUATION MATRIX 165
11.5.1 STARS 166
11.5.2 EMERGING LEADERS 166
11.5.3 PERVASIVE PLAYERS 166
11.5.4 PARTICIPANTS 166
FIGURE 30 BIOLOGICS SAFETY TESTING MARKET: COMPANY EVALUATION MATRIX, 2021 167
11.6 COMPETITIVE LEADERSHIP MAPPING FOR STARTUPS 167
11.6.1 PROGRESSIVE COMPANIES 167
11.6.2 STARTING BLOCKS 167
11.6.3 DYNAMIC COMPANIES 168
11.6.4 RESPONSIVE COMPANIES 168
FIGURE 31 BIOLOGICS SAFETY TESTING: COMPETITIVE LEADERSHIP MAPPING FOR STARTUPS (2021) 168
11.7 COMPETITIVE BENCHMARKING 169
11.7.1 COMPANY PRODUCT FOOTPRINT 169
TABLE 162 BIOLOGICS SAFETY TESTING MARKET: PRODUCT PORTFOLIO ANALYSIS 169
11.7.2 COMPANY TEST TYPE FOOTPRINT 170
TABLE 163 BIOLOGICS SAFETY TESTING MARKET: TEST TYPE ANALYSIS 170
11.7.3 COMPANY GEOGRAPHIC FOOTPRINT 171
TABLE 164 BIOLOGICS SAFETY TESTING MARKET: GEOGRAPHIC ANALYSIS 171
11.7.4 OVERALL COMPANY FOOTPRINT (25 COMPANIES) 172
TABLE 165 BIOLOGICS SAFETY TESTING MARKET: COMPANY FOOTPRINT 172
11.7.4.1 COMPETITIVE BENCHMARKING FOR STARTUPS 173
TABLE 166 BIOLOGICS SAFETY TESTING MARKET: KEY STARTUPS 173
TABLE 167 BIOLOGICS SAFETY TESTING MARKET: COMPETITIVE BENCHMARKING OF KEY STARTUPS 174
11.8 COMPETITIVE SCENARIO 175
11.8.1 BIOLOGICS SAFETY TESTING MARKET: PRODUCT LAUNCHES (JANUARY 2019?DECEMBER 2022) 175
11.8.2 BIOLOGICS SAFETY TESTING MARKET: DEALS (JANUARY 2019?DECEMBER 2022) 176
11.8.3 BIOLOGICS SAFETY TESTING MARKET: OTHER DEVELOPMENTS (JANUARY 2019?DECEMBER 2022) 177
12 COMPANY PROFILES 178
12.1 KEY PLAYERS 178
(Business Overview, Products Offered, Recent Developments, and MnM View (Key strengths/Right to Win, Strategic Choices Made, and Weaknesses and Competitive Threats))*
12.1.1 CHARLES RIVER LABORATORIES 178
TABLE 168 CHARLES RIVER LABORATORIES: BUSINESS OVERVIEW 178
FIGURE 32 CHARLES RIVER LABORATORIES: COMPANY SNAPSHOT (2021) 179
12.1.2 LONZA 184
TABLE 169 LONZA: BUSINESS OVERVIEW 184
FIGURE 33 LONZA: COMPANY SNAPSHOT (2021) 185
12.1.3 THERMO FISHER SCIENTIFIC, INC. 189
TABLE 170 THERMO FISHER SCIENTIFIC: BUSINESS OVERVIEW 189
FIGURE 34 THERMO FISHER SCIENTIFIC, INC.: COMPANY SNAPSHOT (2020) 190
12.1.4 MERCK KGAA 193
TABLE 171 MERCK KGAA: BUSINESS OVERVIEW 193
FIGURE 35 MERCK KGAA: COMPANY SNAPSHOT (2021) 194
12.1.5 LABORATORY CORPORATION OF AMERICA HOLDINGS (LABCORP) 197
FIGURE 36 LABORATORY CORPORATION OF AMERICA HOLDINGS: COMPANY SNAPSHOT (2021) 198
12.1.6 SGS SA 201
TABLE 173 SGS SA: BUSINESS OVERVIEW 201
FIGURE 37 SGS SA: COMPANY SNAPSHOT (2021) 20