Abstract
Summary
The global biosimilars market size is projected to reach USD 66.9 billion by 2028 from USD 29.4 billion in 2023, at a CAGR of 17.8% during the forecast period. Factors such as regulatory approvals, favorable reimbursement policies, rising demand for cost effective biosimilars is driving the market growth.
“The monoclonal antibodies product segment accounted for the highest growth rate in the biosimilars market, by drug class, during the forecast period”
In 2022, the monoclonal antibodies product segment accounted for the largest share of the biosimilars market, mainly due to the low prices of biosimilar monoclonal antibodies compared to the reference drugs and increased adoption of labs in the the treatment of cancer, autoimmune disorders, and osteoporosis. The growth of the fastest-growing segment was attributed to the rising incidence of cancer and chronic diseases globally. Increased approval for interchangeability insulin is likely to have positive impact on market.
“Oncology segment accounted for the largest share of the indication segment in 2022.”
Based on the indication, the biosimilars market is segmented into oncology, inflammatory and autoimmune diseases, chronic diseases, blood disorders, growth hormone deficiency, infectious diseases, and other indications. Rising demand for cancer drugs, growth hormones across various regions is propelling the growth of the market.
“Asia Pacific region is likely to grow at a faster pace.”
The biosimilars market is segmented into Europe, Asia Pacific, North America, latin America and Middle East and Africa. The APAC market is expected to be the fastest-growing regional segment during the forecast period due to the presence of numerous emerging players, less-stringent government regulations, and increasing cooperation among leading and regional players for development, manufacturing and commercialization of biosimilars.
The primary interviews conducted for this report can be categorized as follows:
• By Respondent: Supply Side- 70%, and Demand Side - 30%
• By Designation (Supply Side): Managers - 45%, CXOs & Directors - 30%, Executives- 25%
• By Region: North America -40%, Europe -25%, Asia-Pacific -20%, Latin America -10%, and Middle East and Africa -5%
Lists of Companies Profiled in the Report:
Novartis AG (Switzerland)
Pfizer Inc. (US)
Dr. Reddy’s Laboratories Ltd. (India)
F. Hoffmann-La Roche Ltd (Switzerland)
Eli Lilly & Company (US)
Amgen Inc. (US)
Teva Pharmaceutical Industries Ltd. (Israel)
Samsung Biologics (South Korea)
Fresenius SE & Co. KGaA (Germany)
Boehringer Ingelheim International GmbH. (Germany)
STADA Arzneimittel AG (Germany)
Coherus BioSciences (US)
FUJIFILM Kyova Kirin Biologics Co., Ltd. (Japan)
USV Limited (India),
Amneal Pharmaceuticals LLC. (US)
Celltrion Healthcare (South Korea)
Biocon (India)
Intas Pharmaceuticals Ltd. (India)
Reliance Life Sciences (India)
AMEGA Biotech (Argentina)
Apotex, Inc. (Canada)
BIOCAD (Russia)
mAbxience (Spain)
Probiomed (Mexico)
Kashiv BioSciences, LLC (US),
Formycon AG (Germany)
Polpharma Biologics Group (Poland)
Amphastar Pharmaceuticals, Inc. (US)
Alvotech (Iceland)
UCB SA, (Belgium)
Research Coverage:
This report provides a detailed picture of the biosimilars market. It aims at estimating the size and future growth potential of the market across different segments, such as drug class, indication and region. The report also includes an in-depth competitive analysis of the key market players, along with their company profiles, recent developments, and key market strategies.
Key Benefits of Buying the Report:
The report will help market leaders/new entrants by providing them with the closest approximations of the revenue numbers for the overall biosimilars market and its subsegments. It will also help stakeholders better understand the competitive landscape and gain more insights to better position their business and make suitable go-to-market strategies. This report will enable stakeholders to understand the market's pulse and provide them with information on the key market drivers, restraints, opportunities, and challenges.
The report provides insights on the following pointers:
• Analysis of key drivers (Increasing demand for biosimilars, launch of novel biosimilars, rising geriatric population & chronic disease incidence, abbreviated regulatory process & interchangeability), restraints (complexities in manufacturing), opportunities (emerging markets, patent expiry of blockbuster biologics and research on new indication), and challenges (excess competition & regulatory challenges) influencing the growth of biosimilars market.
• Product Development/Innovation: Detailed insights on newly launched products, and pipeline analysis of the biosimilars market.
• Market Development: Comprehensive information about lucrative markets – the report analyses the biosimilars market across varied regions.
• Market Diversification: Exhaustive information about new services, untapped geographies, recent developments, and investments in the biosimilars market.
• Competitive Assessment: In-depth assessment of market shares, growth strategies and service offerings of leading players like Novartis AG (Switzerland), Pfizer Inc. (US), Dr. Reddy’s Laboratories Ltd. (India), F. Hoffmann-La Roche Ltd (Switzerland), Eli Lilly & Company (US), Amgen Inc. (US) and among others in the biosimilars market.
Table of Contents
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
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
2.1.1 SECONDARY DATA 38
2.1.2 PRIMARY DATA 39
2.2 MARKET SIZE ESTIMATION 40
2.2.1 INSIGHTS FROM PRIMARIES 45
2.3 GROWTH RATE ASSUMPTIONS 46
2.4 MARKET BREAKDOWN AND DATA TRIANGULATION 47
2.5 RESEARCH ASSUMPTIONS 48
2.6 RISK ANALYSIS 49
2.7 BIOSIMILARS MARKET: RECESSION IMPACT ANALYSIS 49
3 EXECUTIVE SUMMARY 51
4 PREMIUM INSIGHTS 54
4.1 BIOSIMILARS MARKET OVERVIEW 54
4.2 NORTH AMERICA: BIOSIMILARS MARKET, BY DRUG CLASS AND COUNTRY (2022) 55
4.3 BIOSIMILARS MARKET: GEOGRAPHICAL SNAPSHOT 56
5 MARKET OVERVIEW 57
5.1 INTRODUCTION 57
5.2 MARKET DYNAMICS 57
5.2.1 DRIVERS 58
- 5.2.1.1 Increasing demand for biosimilars 58
- 5.2.1.2 Launch of novel biosimilars 59
- 5.2.1.3 Rising geriatric population and chronic disease incidence 60
- 5.2.1.4 Abbreviated regulatory approval process and interchangeability 62
5.2.2 RESTRAINTS 64
- 5.2.2.1 Complexities in manufacturing 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
5.2.4 CHALLENGES 66
- 5.2.4.1 High competition and regulatory challenges 66
5.3 VALUE CHAIN ANALYSIS 67
5.4 ECOSYSTEM MARKET MAP 70
5.5 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
5.7 KEY CONFERENCES AND EVENTS, 2023 78
5.8 KEY STAKEHOLDERS AND BUYING CRITERIA 78
5.9 PATENT ANALYSIS 79
5.10 PIPELINE ANALYSIS 80
5.11 PRICING ANALYSIS 81
5.12 TRENDS AND DISRUPTIONS IMPACTING CUSTOMERS’ BUSINESSES 82
6 BIOSIMILARS MARKET, BY DRUG CLASS 83
6.1 INTRODUCTION 84
6.2 MONOCLONAL ANTIBODIES 84
6.2.1 INFLIXIMAB 87
- 6.2.1.1 Infliximab to dominate mAbs market 87
6.2.2 RITUXIMAB 90
- 6.2.2.1 Rising incidences of autoimmune diseases and cancer to boost market growth 90
6.2.3 TRASTUZUMAB 92
- 6.2.3.1 Increasing breast cancer prevalence to drive market growth 92
6.2.4 ADALIMUMAB 95
- 6.2.4.1 Loss of patent exclusivity to drive research 95
6.2.5 OTHER MONOCLONAL ANTIBODIES 98
6.3 GRANULOCYTE COLONY-STIMULATING FACTOR 100
6.3.1 LAUNCH OF BIOSIMILARS TO PROMOTE MARKET GROWTH 100
6.4 INSULIN 104
6.4.1 INCREASING INCIDENCE OF DIABETES TO DRIVE MARKET 104
6.5 ERYTHROPOIETIN 106
6.5.1 RISING INCIDENCE OF BLOOD DISORDERS TO AUGMENT MARKET GROWTH 106
6.6 RECOMBINANT HUMAN GROWTH HORMONE 109
6.6.1 INCREASING INCIDENCE OF GROWTH DEFICIENCY DISORDERS TO PROPEL MARKET 109
6.7 ETANERCEPT 112
6.7.1 APAC TO WITNESS HIGHEST GROWTH IN ETANERCEPT MARKET 112
6.8 FOLLITROPIN 114
6.8.1 INCREASING APPLICATION OF FOLLITROPIN IN INFERTILITY TREATMENT TO DRIVE MARKET 114
6.9 TERIPARATIDE 116
6.9.1 INCREASING INCIDENCE OF OSTEOPOROSIS TO BOOST DEMAND 116
6.10 INTERFERONS 118
6.10.1 RISING INCIDENCE OF INFECTIOUS DISEASES TO SUPPORT MARKET GROWTH 118
6.11 ANTICOAGULANTS 119
6.11.1 WIDE RANGE OF APPLICATIONS TO DRIVE DEMAND FOR ENOXAPARIN SODIUM BIOSIMILARS 119
6.12 OTHER DRUG CLASSES 121
7 BIOSIMILARS MARKET, BY INDICATION 123
7.1 INTRODUCTION 124
7.2 ONCOLOGY 124
7.2.1 INCREASED APPROVALS AND LAUNCH OF BIOSIMILARS IN ONCOLOGY TO DRIVE MARKET 124
7.3 INFLAMMATORY & AUTOIMMUNE DISEASES 127
7.3.1 CHANGES IN LIFESTYLES AND ENVIRONMENTAL CONDITIONS TO INCREASE DISEASE INCIDENCE 127
7.4 CHRONIC DISEASES 129
7.4.1 HIGH BURDEN OF CVD AND DIABETES WORLDWIDE TO DRIVE MARKET GROWTH 129
7.5 BLOOD DISORDERS 132
7.5.1 INCREASING INCIDENCE OF BLOOD DISORDERS TO BOOST BIOSIMILAR DEMAND 132
7.6 GROWTH HORMONE DEFICIENCY 135
7.6.1 RISING USE OF BIOSIMILARS FOR TREATMENT TO SUPPORT MARKET GROWTH 135
7.7 INFECTIOUS DISEASES 137
7.7.1 BIOSIMILARS MARKET FOR INFECTIOUS DISEASES TO GROW RAPIDLY IN ASIA PACIFIC 137
7.8 OTHER INDICATIONS 139
8 BIOSIMILARS MARKET, BY REGION 142
8.1 INTRODUCTION 143
8.2 EUROPE 143
8.2.1 GERMANY 150
- 8.2.1.1 Germany to dominate European biosimilars market 150
8.2.2 UK 152
- 8.2.2.1 Increasing adoption of biosimilars to boost market 152
8.2.3 FRANCE 164
- 8.2.3.1 Rising geriatric population to drive market growth 164
8.2.4 ITALY 166
- 8.2.4.1 Favorable government policies to propel adoption of biosimilars 166
8.2.5 SPAIN 169
- 8.2.5.1 Favorable patient incentives to promote biosimilar use 169
8.2.6 REST OF EUROPE 171
8.2.7 EUROPE: RECESSION IMPACT 173
8.3 ASIA PACIFIC 173
8.3.1 CHINA 176
- 8.3.1.1 China to register highest growth in Asia Pacific market 176
8.3.2 SOUTH KOREA 179
- 8.3.2.1 Favorable government initiatives to support growth 179
8.3.3 INDIA 182
- 8.3.3.1 Increasing biosimilar launches and approvals to support market growth 182
8.3.4 JAPAN 187
- 8.3.4.1 Large geriatric population to drive market growth 187
8.3.5 AUSTRALIA 191
- 8.3.5.1 Favorable regulatory changes and increasing disease incidence to propel growth 191
8.3.6 REST OF ASIA PACIFIC 195
8.3.7 ASIA PACIFIC: RECESSION IMPACT 199
8.4 NORTH AMERICA 199
8.4.1 US 202
- 8.4.1.1 US to dominate North American biosimilars market 202
8.4.2 CANADA 206
- 8.4.2.1 Favorable government initiatives to support market 206
8.4.3 NORTH AMERICA: RECESSION IMPACT 208
8.5 LATIN AMERICA 209
8.5.1 RISING INCIDENCE OF CANCER TO DRIVE MARKET 209
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
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
9.3 REVENUE SHARE ANALYSIS 217
9.4 MARKET SHARE ANALYSIS 217
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
9.6 COMPETITIVE BENCHMARKING OF TOP 30 PLAYERS 221
9.6.1 COMPANY FOOTPRINT ANALYSIS (30 COMPANIES) 221
9.6.2 PRODUCT FOOTPRINT ANALYSIS (30 COMPANIES) 222
9.6.3 REGIONAL FOOTPRINT ANALYSIS (30 COMPANIES) 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
9.8 COMPETITIVE BENCHMARKING OF START-UPS/SMES 227
9.9 COMPETITIVE SCENARIO AND TRENDS 228
9.9.1 PRODUCT LAUNCHES & APPROVALS 228
9.9.2 DEALS 229
9.9.3 OTHER DEVELOPMENTS 230
10 COMPANY PROFILES 231
10.1 KEY MARKET PLAYERS 231
10.1.1 NOVARTIS AG 231
10.1.2 PFIZER INC 236
10.1.3 AMGEN INC 240
10.1.4 DR. REDDY’S LABORATORIES LTD 244
10.1.5 ELI LILLY AND COMPANY 247
10.1.6 TEVA PHARMACEUTICAL INDUSTRIES 250
10.1.7 FRESENIUS KABI AG 253
10.1.8 STADA ARZNEIMITTEL AG 257
10.1.9 BOEHRINGER INGELHEIM INTERNATIONAL GMBH 260
10.1.10 F. HOFFMANN-LA ROCHE LTD 263
10.1.11 CELLTRION HEALTHCARE CO., LTD 265
10.1.12 SAMSUNG BIOLOGICS 269
10.1.13 COHERUS BIOSCIENCES 274
10.1.14 BIOCON 276
10.1.15 AMEGA BIOTECH 280
10.1.16 APOTEX INC 282
10.1.17 BIOCAD 283
10.1.18 MABXIENCE 284
10.1.19 PROBIOMED 286
10.1.20 FUJIFILM KYOWA KIRIN BIOLOGICS CO., LTD 287
10.1.21 INTAS PHARMACEUTICALS LTD 288
10.1.22 RELIANCE LIFE SCIENCES 290
10.1.23 KASHIV BIOSCIENCES, LLC 292
10.1.24 USV PRIVATE LIMITED 294
10.1.25 AMNEAL PHARMACEUTICALS, INC 295
10.2 OTHER PLAYERS 296
10.2.1 FORMYCON AG 296
10.2.2 POLPHARMA BIOLOGICS GROUP 296
10.2.3 AMPHASTAR PHARMACEUTICALS, INC 297
10.2.4 ALVOTECH 297
10.2.5 UCB SA 298
11 APPENDIX 299
11.1 DISCUSSION GUIDE 299
11.2 KNOWLEDGESTORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 303
11.3 CUSTOMIZATION OPTIONS 305
11.4 RELATED REPORTS 305
11.5 AUTHOR DETAILS 306