Table of Content

1 INTRODUCTION 33
1.1 STUDY OBJECTIVES 33
1.2 MARKET DEFINITION 33
1.2.1 INCLUSIONS AND EXCLUSIONS 33
1.3 MARKET SCOPE 34
FIGURE 1 BIOSIMILARS MARKET SEGMENTATION 34
1.3.1 YEARS CONSIDERED 34
1.4 CURRENCY CONSIDERED 35
1.5 LIMITATIONS 35
1.6 STAKEHOLDERS 35
1.7 SUMMARY OF CHANGES 36
1.8 RECESSION IMPACT 36
2 RESEARCH METHODOLOGY 37
2.1 RESEARCH DATA 37
FIGURE 2 RESEARCH DESIGN 37
2.1.1 SECONDARY DATA 38
2.1.2 PRIMARY DATA 39
FIGURE 3 BIOSIMILARS MARKET: BREAKDOWN OF PRIMARIES 39
2.2 MARKET SIZE ESTIMATION 40
FIGURE 4 BIOSIMILARS MARKET SIZE ESTIMATION (SUPPLY-SIDE ANALYSIS), 2022 40
FIGURE 5 MARKET SIZE ESTIMATION: APPROACH 1 (REVENUE SHARE ANALYSIS), 2022 41
FIGURE 6 ILLUSTRATIVE EXAMPLE OF REVENUE SHARE ANALYSIS AND SEGMENTAL ANALYSIS, 2022 42
FIGURE 7 ILLUSTRATIVE EXAMPLE OF REVENUE SHARE FOR DRUG CLASS & INDICATION, 2022 43
2.2.1 INSIGHTS FROM PRIMARIES 45
FIGURE 8 MARKET VALIDATION FROM PRIMARY EXPERTS 45
FIGURE 9 MARKET SIZE ESTIMATION METHODOLOGY: TOP-DOWN APPROACH 45
2.3 GROWTH RATE ASSUMPTIONS 46
FIGURE 10 BIOSIMILARS MARKET: CAGR PROJECTIONS, 2023–2028 46
FIGURE 11 BIOSIMILARS MARKET: GROWTH ANALYSIS OF DRIVERS, RESTRAINTS, CHALLENGES, AND OPPORTUNITIES 47
2.4 MARKET BREAKDOWN AND DATA TRIANGULATION 47
FIGURE 12 DATA TRIANGULATION METHODOLOGY 48
2.5 RESEARCH ASSUMPTIONS 48
2.6 RISK ANALYSIS 49
2.7 BIOSIMILARS MARKET: RECESSION IMPACT ANALYSIS 49
TABLE 1 GLOBAL INFLATION RATE PROJECTIONS, 2024–2027 (% GROWTH) 50
TABLE 2 US HEALTH EXPENDITURE, 2019–2027 (USD MILLION) 50
TABLE 3 US HEALTH EXPENDITURE, 2023–2027 (USD MILLION) 50
3 EXECUTIVE SUMMARY 51
FIGURE 13 BIOSIMILARS MARKET, BY DRUG CLASS, 2023 VS. 2028 (USD MILLION) 51
FIGURE 14 BIOSIMILARS MARKET, BY INDICATION, 2023 VS. 2028 (USD MILLION) 52
FIGURE 15 BIOSIMILARS MARKET, BY REGION, 2023 VS. 2028 (USD MILLION) 52
4 PREMIUM INSIGHTS 54
4.1 BIOSIMILARS MARKET OVERVIEW 54
FIGURE 16 RISING INCIDENCE OF CHRONIC DISEASES TO DRIVE MARKET GROWTH 54
4.2 NORTH AMERICA: BIOSIMILARS MARKET, BY DRUG CLASS AND COUNTRY (2022) 55
FIGURE 17 MONOCLONAL ANTIBODIES AND US TO DOMINATE NORTH AMERICAN MARKET 55
4.3 BIOSIMILARS MARKET: GEOGRAPHICAL SNAPSHOT 56
FIGURE 18 ASIA PACIFIC TO REGISTER HIGHEST GROWTH OVER FORECAST PERIOD 56
5 MARKET OVERVIEW 57
5.1 INTRODUCTION 57
5.2 MARKET DYNAMICS 57
FIGURE 19 BIOSIMILARS MARKET: DRIVERS, RESTRAINTS, OPPORTUNITIES, AND CHALLENGES 57
TABLE 4 BIOSIMILARS MARKET: IMPACT ANALYSIS 58
5.2.1 DRIVERS 58
5.2.1.1 Increasing demand for biosimilars 58
5.2.1.2 Launch of novel biosimilars 59
FIGURE 20 US: NUMBER OF APPROVED AND LAUNCHED BIOSIMILARS, 2015 TO 2022 59
5.2.1.3 Rising geriatric population and chronic disease incidence 60
FIGURE 21 GERIATRIC POPULATION, BY REGION, 2020 VS. 2030 VS. 2050 (MILLION) 60
FIGURE 22 ESTIMATED NUMBER OF NEW CANCER CASES FROM 2020 TO 2030 61
FIGURE 23 INCIDENCE OF DIABETES, BY REGION, 2019 VS. 2030 VS. 2045 (MILLION) 61
5.2.1.4 Abbreviated regulatory approval process and interchangeability 62
TABLE 5 APPROVED BIOSIMILARS WITH INTERCHANGEABLE DESIGNATION 62
FIGURE 24 COMPARISON OF REFERENCE PRODUCTS, BIOSIMILARS, AND INTERCHANGEABLE PRODUCTS 63
5.2.2 RESTRAINTS 64
5.2.2.1 Complexities in manufacturing 64
TABLE 6 COMPARISON OF DRUG DEVELOPMENT PROCESSES, BY TYPE 64
5.2.3 OPPORTUNITIES 64
5.2.3.1 Emerging markets 64
5.2.3.2 Patent expiries of blockbuster biologics and research into new indications 65
TABLE 7 LIST OF KEY BIOLOGICS FACING PATENT EXPIRY 66
5.2.4 CHALLENGES 66
5.2.4.1 High competition and regulatory challenges 66
5.3 VALUE CHAIN ANALYSIS 67
FIGURE 25 VALUE CHAIN ANALYSIS FOR BIOSIMILARS 67
5.4 ECOSYSTEM MARKET MAP 70
FIGURE 26 ECOSYSTEM MARKET MAP FOR BIOSIMILARS 70
5.5 PORTER’S FIVE FORCES ANALYSIS 70
TABLE 8 BIOSIMILARS MARKET: PORTER’S FIVE FORCES ANALYSIS 70
5.5.1 THREAT OF NEW ENTRANTS 71
5.5.2 THREAT OF SUBSTITUTES 71
5.5.3 BARGAINING POWER OF SUPPLIERS 71
5.5.4 BARGAINING POWER OF BUYERS 71
5.5.5 INTENSITY OF COMPETITIVE RIVALRY 72
5.6 REGULATORY LANDSCAPE 72
TABLE 9 BIOSIMILARS MARKET: REGULATORY LANDSCAPE 72
TABLE 10 REGULATORY BODIES, GOVERNMENT AGENCIES & OTHER ORGANIZATIONS 74
TABLE 11 NORTH AMERICA: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 75
TABLE 12 EUROPE: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 75
TABLE 13 ASIA PACIFIC: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 76
TABLE 14 ROW: REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 77
5.7 KEY CONFERENCES AND EVENTS, 2023 78
TABLE 15 BIOSIMILARS MARKET: DETAILED LIST OF CONFERENCES & EVENTS, 2023 78
5.8 KEY STAKEHOLDERS AND BUYING CRITERIA 78
FIGURE 27 KEY STAKEHOLDERS IN BUYING PROCESS 78
FIGURE 28 INFLUENCE OF END USERS ON BUYING PROCESS 79
5.9 PATENT ANALYSIS 79
5.10 PIPELINE ANALYSIS 80
5.11 PRICING ANALYSIS 81
TABLE 16 BIOSIMILAR PRICE, BY INDICATION AND REGION 81
5.12 TRENDS AND DISRUPTIONS IMPACTING CUSTOMERS’ BUSINESSES 82
6 BIOSIMILARS MARKET, BY DRUG CLASS 83
6.1 INTRODUCTION 84
TABLE 17 BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 84
6.2 MONOCLONAL ANTIBODIES 84
TABLE 18 BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 85
TABLE 19 BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY REGION, 2021–2028 (USD MILLION) 86
TABLE 20 NORTH AMERICA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY COUNTRY, 2021–2028 (USD MILLION) 86
TABLE 21 EUROPE: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY COUNTRY, 2021–2028 (USD MILLION) 87
TABLE 22 ASIA PACIFIC: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY COUNTRY, 2021–2028 (USD MILLION) 87
6.2.1 INFLIXIMAB 87
6.2.1.1 Infliximab to dominate mAbs market 87
TABLE 23 BIOSIMILARS MARKET FOR INFLIXIMAB, BY REGION, 2021–2028 (USD MILLION) 88
TABLE 24 NORTH AMERICA: BIOSIMILARS MARKET FOR INFLIXIMAB, BY COUNTRY, 2021–2028 (USD MILLION) 88
TABLE 25 EUROPE: BIOSIMILARS MARKET FOR INFLIXIMAB, BY COUNTRY, 2021–2028 (USD MILLION) 89
TABLE 26 ASIA PACIFIC: BIOSIMILARS MARKET FOR INFLIXIMAB, BY COUNTRY, 2021–2028 (USD MILLION) 89
6.2.2 RITUXIMAB 90
6.2.2.1 Rising incidences of autoimmune diseases and cancer to boost market growth 90
TABLE 27 BIOSIMILARS MARKET FOR RITUXIMAB, BY REGION, 2021–2028 (USD MILLION) 90
TABLE 28 NORTH AMERICA: BIOSIMILARS MARKET FOR RITUXIMAB, BY COUNTRY, 2021–2028 (USD MILLION) 91
TABLE 29 EUROPE: BIOSIMILARS MARKET FOR RITUXIMAB, BY COUNTRY, 2021–2028 (USD MILLION) 91
TABLE 30 ASIA PACIFIC: BIOSIMILARS MARKET FOR RITUXIMAB, BY COUNTRY, 2021–2028 (USD MILLION) 92
6.2.3 TRASTUZUMAB 92
6.2.3.1 Increasing breast cancer prevalence to drive market growth 92
TABLE 31 BIOSIMILARS MARKET FOR TRASTUZUMAB, BY REGION, 2021–2028 (USD MILLION) 93
TABLE 32 NORTH AMERICA: BIOSIMILARS MARKET FOR TRASTUZUMAB, BY COUNTRY, 2021–2028 (USD MILLION) 93
TABLE 33 EUROPE: BIOSIMILARS MARKET FOR TRASTUZUMAB, BY COUNTRY, 2021–2028 (USD MILLION) 94
TABLE 34 ASIA PACIFIC: BIOSIMILARS MARKET FOR TRASTUZUMAB, BY COUNTRY, 2021–2028 (USD MILLION) 94
6.2.4 ADALIMUMAB 95
6.2.4.1 Loss of patent exclusivity to drive research 95
TABLE 35 FDA APPROVAL AND EU LAUNCH STATUS OF BIOSIMILARS TO HUMIRA 95
TABLE 36 BIOSIMILARS MARKET FOR ADALIMUMAB, BY REGION, 2021–2028 (USD MILLION) 96
TABLE 37 NORTH AMERICA: BIOSIMILARS MARKET FOR ADALIMUMAB, BY COUNTRY, 2021–2028 (USD MILLION) 96
TABLE 38 EUROPE: BIOSIMILARS MARKET FOR ADALIMUMAB, BY COUNTRY, 2021–2028 (USD MILLION) 97
TABLE 39 ASIA PACIFIC: BIOSIMILARS MARKET FOR ADALIMUMAB, BY COUNTRY, 2021–2028 (USD MILLION) 97
6.2.5 OTHER MONOCLONAL ANTIBODIES 98
TABLE 40 BIOSIMILARS MARKET FOR OTHER MONOCLONAL ANTIBODIES, BY REGION, 2021–2028 (USD MILLION) 98
TABLE 41 NORTH AMERICA: BIOSIMILARS MARKET FOR OTHER MONOCLONAL ANTIBODIES, BY COUNTRY, 2021–2028 (USD MILLION) 99
TABLE 42 EUROPE: BIOSIMILARS MARKET FOR OTHER MONOCLONAL ANTIBODIES, BY COUNTRY, 2021–2028 (USD MILLION) 99
TABLE 43 ASIA PACIFIC: BIOSIMILARS MARKET FOR OTHER MONOCLONAL ANTIBODIES, BY COUNTRY, 2021–2028 (USD MILLION) 100
6.3 GRANULOCYTE COLONY-STIMULATING FACTOR 100
6.3.1 LAUNCH OF BIOSIMILARS TO PROMOTE MARKET GROWTH 100
TABLE 44 LIST OF APPROVED BIOSIMILARS FOR G-CSF 101
TABLE 45 BIOSIMILARS MARKET FOR GRANULOCYTE COLONY-STIMULATING FACTOR, BY REGION, 2021–2028 (USD MILLION) 102
TABLE 46 NORTH AMERICA: BIOSIMILARS MARKET FOR GRANULOCYTE COLONY-STIMULATING FACTOR, BY COUNTRY, 2021–2028 (USD MILLION) 102
TABLE 47 EUROPE: BIOSIMILARS MARKET FOR GRANULOCYTE COLONY-STIMULATING FACTOR, BY COUNTRY, 2021–2028 (USD MILLION) 103
TABLE 48 ASIA PACIFIC: BIOSIMILARS MARKET FOR GRANULOCYTE COLONY-STIMULATING FACTOR, BY COUNTRY, 2021–2028 (USD MILLION) 103
6.4 INSULIN 104
6.4.1 INCREASING INCIDENCE OF DIABETES TO DRIVE MARKET 104
TABLE 49 BIOSIMILARS MARKET FOR INSULIN, BY REGION, 2021–2028 (USD MILLION) 104
TABLE 50 NORTH AMERICA: BIOSIMILARS MARKET FOR INSULIN, BY COUNTRY, 2021–2028 (USD MILLION) 105
TABLE 51 EUROPE: BIOSIMILARS MARKET FOR INSULIN, BY COUNTRY, 2021–2028 (USD MILLION) 105
TABLE 52 ASIA PACIFIC: BIOSIMILARS MARKET FOR INSULIN, BY COUNTRY, 2021–2028 (USD MILLION) 106
6.5 ERYTHROPOIETIN 106
6.5.1 RISING INCIDENCE OF BLOOD DISORDERS TO AUGMENT MARKET GROWTH 106
TABLE 53 LIST OF APPROVED BIOSIMILARS FOR ERYTHROPOIETIN 107
TABLE 54 BIOSIMILARS MARKET FOR ERYTHROPOIETIN, BY REGION, 2021–2028 (USD MILLION) 107
TABLE 55 NORTH AMERICA: BIOSIMILARS MARKET FOR ERYTHROPOIETIN, BY COUNTRY, 2021–2028 (USD MILLION) 108
TABLE 56 EUROPE: BIOSIMILARS MARKET FOR ERYTHROPOIETIN, BY COUNTRY, 2021–2028 (USD MILLION) 108
TABLE 57 ASIA PACIFIC: BIOSIMILARS MARKET FOR ERYTHROPOIETIN, BY COUNTRY, 2021–2028 (USD MILLION) 109
6.6 RECOMBINANT HUMAN GROWTH HORMONE 109
6.6.1 INCREASING INCIDENCE OF GROWTH DEFICIENCY DISORDERS TO PROPEL MARKET 109
TABLE 58 BIOSIMILARS MARKET FOR RECOMBINANT HUMAN GROWTH HORMONE, BY REGION, 2021–2028 (USD MILLION) 110
TABLE 59 NORTH AMERICA: BIOSIMILARS MARKET FOR RECOMBINANT HUMAN GROWTH HORMONE, BY COUNTRY, 2021–2028 (USD MILLION) 110
TABLE 60 EUROPE: BIOSIMILARS MARKET FOR RECOMBINANT HUMAN GROWTH HORMONE, BY COUNTRY, 2021–2028 (USD MILLION) 111
TABLE 61 ASIA PACIFIC: BIOSIMILARS MARKET FOR RECOMBINANT HUMAN GROWTH HORMONE, BY COUNTRY, 2021–2028 (USD MILLION) 111
6.7 ETANERCEPT 112
6.7.1 APAC TO WITNESS HIGHEST GROWTH IN ETANERCEPT MARKET 112
TABLE 62 BIOSIMILARS MARKET FOR ETANERCEPT, BY REGION, 2021–2028 (USD MILLION) 112
TABLE 63 NORTH AMERICA: BIOSIMILARS MARKET FOR ETANERCEPT, BY COUNTRY, 2021–2028 (USD MILLION) 112
TABLE 64 EUROPE: BIOSIMILARS MARKET FOR ETANERCEPT, BY COUNTRY, 2021–2028 (USD MILLION) 113
TABLE 65 ASIA PACIFIC: BIOSIMILARS MARKET FOR ETANERCEPT, BY COUNTRY, 2021–2028 (USD MILLION) 113
6.8 FOLLITROPIN 114
6.8.1 INCREASING APPLICATION OF FOLLITROPIN IN INFERTILITY TREATMENT TO DRIVE MARKET 114
TABLE 66 BIOSIMILARS MARKET FOR FOLLITROPIN, BY REGION, 2021–2028 (USD MILLION) 114
TABLE 67 NORTH AMERICA: BIOSIMILARS MARKET FOR FOLLITROPIN, BY COUNTRY, 2021–2028 (USD MILLION) 114
TABLE 68 EUROPE: BIOSIMILARS MARKET FOR FOLLITROPIN, BY COUNTRY, 2021–2028 (USD MILLION) 115
TABLE 69 ASIA PACIFIC: BIOSIMILARS MARKET FOR FOLLITROPIN, BY COUNTRY, 2021–2028 (USD MILLION) 115
6.9 TERIPARATIDE 116
6.9.1 INCREASING INCIDENCE OF OSTEOPOROSIS TO BOOST DEMAND 116
TABLE 70 BIOSIMILARS MARKET FOR TERIPARATIDE, BY REGION, 2021–2028 (USD MILLION) 116
TABLE 71 NORTH AMERICA: BIOSIMILARS MARKET FOR TERIPARATIDE, BY COUNTRY, 2021–2028 (USD MILLION) 116
TABLE 72 EUROPE: BIOSIMILARS MARKET FOR TERIPARATIDE, BY COUNTRY, 2021–2028 (USD MILLION) 117
TABLE 73 ASIA PACIFIC: BIOSIMILARS MARKET FOR TERIPARATIDE, BY COUNTRY, 2021–2028 (USD MILLION) 117
6.10 INTERFERONS 118
6.10.1 RISING INCIDENCE OF INFECTIOUS DISEASES TO SUPPORT MARKET GROWTH 118
TABLE 74 BIOSIMILARS MARKET FOR INTERFERONS, BY REGION, 2021–2028 (USD MILLION) 118
TABLE 75 ASIA PACIFIC: BIOSIMILARS MARKET FOR INTERFERONS, BY COUNTRY, 2021–2028 (USD MILLION) 119
6.11 ANTICOAGULANTS 119
6.11.1 WIDE RANGE OF APPLICATIONS TO DRIVE DEMAND FOR ENOXAPARIN SODIUM BIOSIMILARS 119
TABLE 76 BIOSIMILARS MARKET FOR ANTICOAGULANTS, BY REGION, 2021–2028 (USD MILLION) 119
TABLE 77 NORTH AMERICA: BIOSIMILARS MARKET FOR ANTICOAGULANTS, BY COUNTRY, 2021–2028 (USD MILLION) 120
TABLE 78 EUROPE: BIOSIMILARS MARKET FOR ANTICOAGULANTS, BY COUNTRY, 2021–2028 (USD MILLION) 120
TABLE 79 ASIA PACIFIC: BIOSIMILARS MARKET FOR ANTICOAGULANTS, BY COUNTRY, 2021–2028 (USD MILLION) 121
6.12 OTHER DRUG CLASSES 121
TABLE 80 BIOSIMILARS MARKET FOR OTHER DRUG CLASSES, BY REGION, 2021–2028 (USD MILLION) 121
TABLE 81 ASIA PACIFIC: BIOSIMILARS MARKET FOR OTHER DRUG CLASSES, BY COUNTRY, 2021–2028 (USD MILLION) 122
7 BIOSIMILARS MARKET, BY INDICATION 123
7.1 INTRODUCTION 124
TABLE 82 BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 124
7.2 ONCOLOGY 124
7.2.1 INCREASED APPROVALS AND LAUNCH OF BIOSIMILARS IN ONCOLOGY TO DRIVE MARKET 124
TABLE 83 BIOSIMILARS MARKET FOR ONCOLOGY, BY REGION, 2021–2028 (USD MILLION) 125
TABLE 84 NORTH AMERICA: BIOSIMILARS MARKET FOR ONCOLOGY, BY COUNTRY, 2021–2028 (USD MILLION) 126
TABLE 85 EUROPE: BIOSIMILARS MARKET FOR ONCOLOGY, BY COUNTRY, 2021–2028 (USD MILLION) 126
TABLE 86 ASIA PACIFIC: BIOSIMILARS MARKET FOR ONCOLOGY, BY COUNTRY, 2021–2028 (USD MILLION) 127
7.3 INFLAMMATORY & AUTOIMMUNE DISEASES 127
7.3.1 CHANGES IN LIFESTYLES AND ENVIRONMENTAL CONDITIONS TO INCREASE DISEASE INCIDENCE 127
TABLE 87 BIOSIMILARS MARKET FOR INFLAMMATORY & AUTOIMMUNE DISEASES, BY REGION, 2021–2028 (USD MILLION) 128
TABLE 88 NORTH AMERICA: BIOSIMILARS MARKET FOR INFLAMMATORY & AUTOIMMUNE DISEASES, BY COUNTRY, 2021–2028 (USD MILLION) 128
TABLE 89 EUROPE: BIOSIMILARS MARKET FOR INFLAMMATORY & AUTOIMMUNE DISEASES, BY COUNTRY, 2021–2028 (USD MILLION) 129
TABLE 90 ASIA PACIFIC: BIOSIMILARS MARKET FOR INFLAMMATORY & AUTOIMMUNE DISEASES, BY COUNTRY, 2021–2028 (USD MILLION) 129
7.4 CHRONIC DISEASES 129
7.4.1 HIGH BURDEN OF CVD AND DIABETES WORLDWIDE TO DRIVE MARKET GROWTH 129
TABLE 91 BIOSIMILARS MARKET FOR CHRONIC DISEASES, BY REGION, 2021–2028 (USD MILLION) 130
TABLE 92 NORTH AMERICA: BIOSIMILARS MARKET FOR CHRONIC DISEASES, BY COUNTRY, 2021–2028 (USD MILLION) 131
TABLE 93 EUROPE: BIOSIMILARS MARKET FOR CHRONIC DISEASES, BY COUNTRY, 2021–2028 (USD MILLION) 131
TABLE 94 ASIA PACIFIC: BIOSIMILARS MARKET FOR CHRONIC DISEASES, BY COUNTRY, 2021–2028 (USD MILLION) 132
7.5 BLOOD DISORDERS 132
7.5.1 INCREASING INCIDENCE OF BLOOD DISORDERS TO BOOST BIOSIMILAR DEMAND 132
TABLE 95 BIOSIMILARS MARKET FOR BLOOD DISORDERS, BY REGION, 2021–2028 (USD MILLION) 133
TABLE 96 NORTH AMERICA: BIOSIMILARS MARKET FOR BLOOD DISORDERS, BY COUNTRY, 2021–2028 (USD MILLION) 133
TABLE 97 EUROPE: BIOSIMILARS MARKET FOR BLOOD DISORDERS, BY COUNTRY, 2021–2028 (USD MILLION) 134
TABLE 98 ASIA PACIFIC: BIOSIMILARS MARKET FOR BLOOD DISORDERS, BY COUNTRY, 2021–2028 (USD MILLION) 134
7.6 GROWTH HORMONE DEFICIENCY 135
7.6.1 RISING USE OF BIOSIMILARS FOR TREATMENT TO SUPPORT MARKET GROWTH 135
TABLE 99 BIOSIMILARS MARKET FOR GROWTH HORMONE DEFICIENCY, BY REGION, 2021–2028 (USD MILLION) 135
TABLE 100 NORTH AMERICA: BIOSIMILARS MARKET FOR GROWTH HORMONE DEFICIENCY, BY COUNTRY, 2021–2028 (USD MILLION) 136
TABLE 101 EUROPE: BIOSIMILARS MARKET FOR GROWTH HORMONE DEFICIENCY, BY COUNTRY, 2021–2028 (USD MILLION) 136
TABLE 102 ASIA PACIFIC: BIOSIMILARS MARKET FOR GROWTH HORMONE DEFICIENCY, BY COUNTRY, 2021–2028 (USD MILLION) 137
7.7 INFECTIOUS DISEASES 137
7.7.1 BIOSIMILARS MARKET FOR INFECTIOUS DISEASES TO GROW RAPIDLY IN ASIA PACIFIC 137
TABLE 103 BIOSIMILARS MARKET FOR INFECTIOUS DISEASES, BY REGION, 2021–2028 (USD MILLION) 138
TABLE 104 ASIA PACIFIC: BIOSIMILARS MARKET FOR INFECTIOUS DISEASES, BY COUNTRY, 2021–2028 (USD MILLION) 138
7.8 OTHER INDICATIONS 139
TABLE 105 BIOSIMILARS MARKET FOR OTHER INDICATIONS, BY REGION, 2021–2028 (USD MILLION) 139
TABLE 106 NORTH AMERICA: BIOSIMILARS MARKET FOR OTHER INDICATIONS, BY COUNTRY, 2021–2028 (USD MILLION) 140
TABLE 107 EUROPE: BIOSIMILARS MARKET FOR OTHER INDICATIONS, BY COUNTRY, 2021–2028 (USD MILLION) 140
TABLE 108 ASIA PACIFIC: BIOSIMILARS MARKET FOR OTHER INDICATIONS, BY COUNTRY, 2021–2028 (USD MILLION) 141
8 BIOSIMILARS MARKET, BY REGION 142
8.1 INTRODUCTION 143
TABLE 109 BIOSIMILARS MARKET, BY REGION, 2021–2028 (USD MILLION) 143
8.2 EUROPE 143
TABLE 110 EUROPE: LIST OF APPROVED BIOSIMILARS 144
FIGURE 29 EUROPE: BIOSIMILARS MARKET SNAPSHOT 147
TABLE 111 EUROPE: BIOSIMILARS MARKET, BY COUNTRY, 2021–2028 (USD MILLION) 148
TABLE 112 EUROPE: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 148
TABLE 113 EUROPE: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 149
TABLE 114 EUROPE: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 149
8.2.1 GERMANY 150
8.2.1.1 Germany to dominate European biosimilars market 150
TABLE 115 GERMANY: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 151
TABLE 116 GERMANY: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 151
TABLE 117 GERMANY: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 152
8.2.2 UK 152
8.2.2.1 Increasing adoption of biosimilars to boost market 152
TABLE 118 UK: LIST OF APPROVED BIOSIMILARS 153
TABLE 119 UK: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 163
TABLE 120 UK: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 163
TABLE 121 UK: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 164
8.2.3 FRANCE 164
8.2.3.1 Rising geriatric population to drive market growth 164
TABLE 122 FRANCE: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 165
TABLE 123 FRANCE: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 166
TABLE 124 FRANCE: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 166
8.2.4 ITALY 166
8.2.4.1 Favorable government policies to propel adoption of biosimilars 166
TABLE 125 ITALY: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 167
TABLE 126 ITALY: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 168
TABLE 127 ITALY: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 168
8.2.5 SPAIN 169
8.2.5.1 Favorable patient incentives to promote biosimilar use 169
TABLE 128 SPAIN: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 170
TABLE 129 SPAIN: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 170
TABLE 130 SPAIN: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 171
8.2.6 REST OF EUROPE 171
TABLE 131 REST OF EUROPE: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 172
TABLE 132 REST OF EUROPE: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 172
TABLE 133 REST OF EUROPE: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 173
8.2.7 EUROPE: RECESSION IMPACT 173
8.3 ASIA PACIFIC 173
FIGURE 30 ASIA PACIFIC: BIOSIMILARS MARKET SNAPSHOT 174
TABLE 134 ASIA PACIFIC: BIOSIMILARS MARKET, BY COUNTRY, 2021–2028 (USD MILLION) 175
TABLE 135 ASIA PACIFIC: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 175
TABLE 136 ASIA PACIFIC: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 176
TABLE 137 ASIA PACIFIC: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 176
8.3.1 CHINA 176
8.3.1.1 China to register highest growth in Asia Pacific market 176
TABLE 138 BIOSIMILARS APPROVED IN CHINA 177
TABLE 139 CHINA: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 178
TABLE 140 CHINA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 178
TABLE 141 CHINA: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 179
8.3.2 SOUTH KOREA 179
8.3.2.1 Favorable government initiatives to support growth 179
TABLE 142 SOUTH KOREA: LIST OF APPROVED BIOSIMILARS 180
TABLE 143 SOUTH KOREA: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 181
TABLE 144 SOUTH KOREA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 181
TABLE 145 SOUTH KOREA: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 182
8.3.3 INDIA 182
8.3.3.1 Increasing biosimilar launches and approvals to support market growth 182
TABLE 146 BIOSIMILARS APPROVED AND MARKETED IN INDIA 183
TABLE 147 INDIA: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 185
TABLE 148 INDIA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 186
TABLE 149 INDIA: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 186
8.3.4 JAPAN 187
8.3.4.1 Large geriatric population to drive market growth 187
TABLE 150 JAPAN: LIST OF APPROVED BIOSIMILARS 188
TABLE 151 JAPAN: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 189
TABLE 152 JAPAN: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 190
TABLE 153 JAPAN: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 190
8.3.5 AUSTRALIA 191
8.3.5.1 Favorable regulatory changes and increasing disease incidence to propel growth 191
TABLE 154 AUSTRALIA: LIST OF APPROVED BIOSIMILARS 192
TABLE 155 AUSTRALIA: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 194
TABLE 156 AUSTRALIA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 195
TABLE 157 AUSTRALIA: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 195
8.3.6 REST OF ASIA PACIFIC 195
TABLE 158 NEW ZEALAND: LIST OF APPROVED BIOSIMILARS 196
TABLE 159 MALAYSIA: LIST OF APPROVED BIOSIMILARS 196
TABLE 160 SINGAPORE: LIST OF APPROVED BIOSIMILARS 197
TABLE 161 REST OF ASIA PACIFIC: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 197
TABLE 162 REST OF ASIA PACIFIC: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 198
TABLE 163 REST OF ASIA PACIFIC: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 198
8.3.7 ASIA PACIFIC: RECESSION IMPACT 199
8.4 NORTH AMERICA 199
TABLE 164 NORTH AMERICA: BIOSIMILARS MARKET, BY COUNTRY, 2021–2028 (USD MILLION) 200
TABLE 165 NORTH AMERICA: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 200
TABLE 166 NORTH AMERICA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 201
TABLE 167 NORTH AMERICA: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 201
8.4.1 US 202
8.4.1.1 US to dominate North American biosimilars market 202
TABLE 168 US: LIST OF APPROVED BIOSIMILARS 203
TABLE 169 US: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 204
TABLE 170 US: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 205
TABLE 171 US: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 205
8.4.2 CANADA 206
8.4.2.1 Favorable government initiatives to support market 206
TABLE 172 CANADA: LIST OF APPROVED BIOSIMILARS 206
TABLE 173 CANADA: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 207
TABLE 174 CANADA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 207
TABLE 175 CANADA: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 208
8.4.3 NORTH AMERICA: RECESSION IMPACT 208
8.5 LATIN AMERICA 209
8.5.1 RISING INCIDENCE OF CANCER TO DRIVE MARKET 209
TABLE 176 LATIN AMERICA: LIST OF APPROVED BIOSIMILARS 210
TABLE 177 LATIN AMERICA: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 211
TABLE 178 LATIN AMERICA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 211
TABLE 179 LATIN AMERICA: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 212
8.5.2 LATIN AMERICA: RECESSION IMPACT 212
8.6 MIDDLE EAST AND AFRICA 213
8.6.1 FAVORABLE REGULATORY REFORMS AND INFRASTRUCTURAL DEVELOPMENT TO FAVOR MARKET GROWTH 213
TABLE 180 MIDDLE EAST AND AFRICA: BIOSIMILARS MARKET, BY DRUG CLASS, 2021–2028 (USD MILLION) 213
TABLE 181 MIDDLE EAST AND AFRICA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2021–2028 (USD MILLION) 214
TABLE 182 MIDDLE EAST AND AFRICA: BIOSIMILARS MARKET, BY INDICATION, 2021–2028 (USD MILLION) 214
8.6.2 MIDDLE EAST AND AFRICA: RECESSION IMPACT 215
9 COMPETITIVE LANDSCAPE 216
9.1 INTRODUCTION 216
9.2 STRATEGIES ADOPTED BY KEY PLAYERS 216
FIGURE 31 BIOSIMILARS MARKET: STRATEGIES ADOPTED BY KEY PLAYERS 216
9.3 REVENUE SHARE ANALYSIS 217
FIGURE 32 REVENUE ANALYSIS OF KEY PLAYERS, 2020–2023 217
9.4 MARKET SHARE ANALYSIS 217
FIGURE 33 MARKET SHARE ANALYSIS OF KEY PLAYERS, 2022 218
TABLE 183 BIOSIMILARS MARKET: DEGREE OF COMPETITION 218
9.5 COMPANY EVALUATION QUADRANT, 2022 219
9.5.1 STARS 219
9.5.2 EMERGING LEADERS 219
9.5.3 PERVASIVE PLAYERS 220
9.5.4 PARTICIPANTS 220
FIGURE 34 BIOSIMILARS MARKET: COMPANY EVALUATION QUADRANT, 2022 220
9.6 COMPETITIVE BENCHMARKING OF TOP 30 PLAYERS 221
9.6.1 COMPANY FOOTPRINT ANALYSIS (30 COMPANIES) 221
TABLE 184 BIOSIMILARS MARKET: COMPANY FOOTPRINT ANALYSIS 221
9.6.2 PRODUCT FOOTPRINT ANALYSIS (30 COMPANIES) 222
TABLE 185 BIOSIMILARS MARKET: PRODUCT FOOTPRINT ANALYSIS 222
9.6.3 REGIONAL FOOTPRINT ANALYSIS (30 COMPANIES) 224
TABLE 186 BIOSIMILARS MARKET: REGIONAL FOOTPRINT ANALYSIS 224
9.7 COMPANY EVALUATION QUADRANT FOR START-UPS/SMES, 2022 225
9.7.1 PROGRESSIVE COMPANIES 225
9.7.2 STARTING BLOCKS 225
9.7.3 RESPONSIVE COMPANIES 225
9.7.4 DYNAMIC COMPANIES 226
FIGURE 35 BIOSIMILARS MARKET: COMPANY EVALUATION MATRIX FOR START-UPS/SMES, 2022 226
9.8 COMPETITIVE BENCHMARKING OF START-UPS/SMES 227
TABLE 187 BIOSIMILARS MARKET: DETAILED LIST OF KEY START-UPS/SMES 227
TABLE 188 BIOSIMILARS MARKET: COMPETITIVE BENCHMARKING OF START-UPS/SMES 227
9.9 COMPETITIVE SCENARIO AND TRENDS 228
9.9.1 PRODUCT LAUNCHES & APPROVALS 228
TABLE 189 BIOSIMILARS MARKET: PRODUCT LAUNCHES, JANUARY 2020–APRIL 2023 228
9.9.2 DEALS 229
TABLE 190 BIOSIMILARS MARKET: DEALS, JANUARY 2020–APRIL 2023 229
9.9.3 OTHER DEVELOPMENTS 230
TABLE 191 BIOSIMILARS MARKET: OTHER DEVELOPMENTS, JANUARY 2020–APRIL 2023 230
10 COMPANY PROFILES 231
10.1 KEY MARKET PLAYERS 231
(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 231
TABLE 192 NOVARTIS AG: BUSINESS OVERVIEW 231
FIGURE 36 NOVARTIS AG: COMPANY SNAPSHOT (2022) 232
10.1.2 PFIZER INC. 236
TABLE 193 PFIZER INC.: BUSINESS OVERVIEW 236
FIGURE 37 PFIZER INC.: COMPANY SNAPSHOT (2022) 237
10.1.3 AMGEN INC. 240
TABLE 194 AMGEN INC.: BUSINESS OVERVIEW 240
FIGURE 38 AMGEN INC.: COMPANY SNAPSHOT (2022) 241
10.1.4 DR. REDDY’S LABORATORIES LTD. 244
TABLE 195 DR. REDDY’S LABORATORIES LTD.: BUSINESS OVERVIEW 244
FIGURE 39 DR. REDDY’S LABORATORIES LTD.: COMPANY SNAPSHOT (2022) 245
10.1.5 ELI LILLY AND COMPANY 247
TABLE 196 ELI LILLY AND COMPANY: BUSINESS OVERVIEW 247
FIGURE 40 ELI LILLY AND COMPANY: COMPANY SNAPSHOT (2022) 248
10.1.6 TEVA PHARMACEUTICAL INDUSTRIES 250
TABLE 197 TEVA PHARMACEUTICAL INDUSTRIES: BUSINESS OVERVIEW 250
FIGURE 41 TEVA PHARMACEUTICAL INDUSTRIES: COMPANY SNAPSHOT (2022) 251
10.1.7 FRESENIUS KABI AG 253