Biosimilars Market

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

Report Code: PH 7582 Sep, 2021, by marketsandmarkets.com

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

Biosimilars Market Size

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Biosimilars Market Dynamics

Growth Drivers: Increasing demand for biosimilar drugs due to their cost-effectiveness

As a biosimilar is likely to be less expensive than the comparator biological, the assessment of the cost-effectiveness of a biosimilar depends on the relative effectiveness. According to American Journal of Managed Care, biosimilars are priced around 30% lower than their parent/branded counterparts. Therefore biosimilars are both cost-savings and access to highly effective treatments for patients. Biosimilars have lower R&D costs as compared to innovator biologics. Due to Lower R&D costs, the cost of biosimilar will be lower. Lower-priced biosimilars also tend to have a downward effect on the prices of reference biologics through price competition among manufacturers. This significant cost-to-benefit ratio offered by biosimilar drugs is expected to increase their demand in the coming years.

Growth Opportunities: Patent expiry of blockbuster biologics and research on new indications

Currently available biosimilars are used to treat a wide range of diseases and disorders, including cancer, rheumatoid arthritis, infectious disorders, psoriasis, anemia, kidney failure, type 1 and type 2 diabetes, post-menopausal osteoporosis, and growth hormone disorders. The key target therapeutic areas for which various biosimilars are in the pipeline include oncology, autoimmune disorders, diabetes, and hepatitis. Besides these, biosimilars can be developed for other chronic disorders, such as meningitis, breast cancer, adult T-cell leukemia, obesity, hypertension, and hepatitis E.

Restraints: Complexities in manufacturing

Developing a biosimilar medicine requires significant expertise to ensure that it is “highly similar” to the reference biologic with no clinically meaningful differences in the safety profile, efficacy, or potency. This means extensively identifying and comparing the structural and functional properties of the biosimilar, using state-of-the-art technology. For a biosimilar, comparative structural and functional characterization will provide the greatest contribution to clinical predictability. The development of biosimilars is a highly complex and costly process that requires significant investments, technical capabilities, clinical trial expertise, scientific standards, and quality systems. Another key challenge in manufacturing biosimilars is the ability to control variability during the manufacturing process, wherein the end products are similar to their biological products.

Challenges: Excess Competition

Competition in the biosimilars market is for both, biosimilar manufacturers and originator biologic manufacturers. Upon the entry of new biosimilar products in the market, the originator biologic manufacturer may defend the competition using various means such as competing on prices, launch of second-generation products, reformulations, dosing improvements, and supporting devices.

The Oncology segment dominated the biosimilars market

On the basis of the indication, the biosimilars market is segmented into oncology, inflammatory and autoimmune diseases, chronic diseases, blood disorders, growth hormone deficiency, infectious diseases, and other indications (infertility, hypoglycemia, myocardial infarction, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases). In 2020, Oncology is the largest segment in this market. Factors such as the lower price of biosimilars than innovative biologics and high incidence and prevalence of cancer are responsible for growth in this segment.

The monoclonal antibodies segment accounted for the largest share

On the basis of the product, the biosimilars market is segmented into monoclonal antibodies; insulin; Granulocyte Colony-Stimulating Factor; Erythropoietin; Recombinant Human Growth Hormone; Etanercept; Follitropin; Teriparatide; Interferons; Enoxaparin Sodium; Glucagon and Calcitonin. In 2020, Monoclonal antibodies accounted for a significant share in the market. Factors such as wide applications of monoclonal antibodies in the treatment of cancer, autoimmune disorders and osteoporosis coupled with cost-effectiveness associated with such treatments are driving the market.

Biosimilars Market by Region

Europe was the largest regional market for biosimilars market

Geographically, the global market is segmented Europe, the Asia Pacific, North America, Latin America and Middle East and Africa. In 2020, Europe accounted for the largest share of the global market, followed by Asia Pacific & North America. Growth in these markets is primarily driven by several factors, such as the impending patent expiry of biologic products and the launch of new biosimilars, the rising incidence of chronic disorders, the emergence of new players and early entry into the market.

Biosimilars Market Key Players

Key players in this market includes Novartis AG (Switzerland), Pfizer, Inc. (US), Dr. Reddy’s Laboratories Ltd. (India), Amgen, Inc. (US) and Eli Lilly and Company (US).

Biosimilars Market Report Scope

Report Metric 

Details 

Market Revenue in 2021

$15.6 billion

Estimated Value by 2026

$44.7 billion

Growth Rate

poised to grow at a CAGR of 23.5%

Largest Share Segments

Oncology & Monoclonal Antibodies

Market Report Segmentation

Product, Indication & Region

Growth Drivers

  • Rising incidence of chronic diseases and increasing demand of biosimilars for their cost-effectiveness
  • Regulatory approvals and other regulations favouring biosimilars adoption in different countries

Growth Opportunities

  • Patent expiry of blockbuster biologics
  • Research on new indications

Geographies covered

North America, Europe, Asia Pacific, and Rest of the World

This report categorizes the global biosimilars market into the following segments and subsegments:

By Product

  • Monoclonal Antibodies
    • Infliximab
    • Trastuzumab
    • Rituximab
    • Adalimumab
    • Other monoclonal antibodies (bevacizumab, cetuximab, ranibizumab, denosumab, and eculizumab)
  • Insulin
  • Granulocyte Colony-Stimulating Factor
  • Erythropoietin
  • Recombinant Human Growth Hormone
  • Etanercept
  • Follitropin
  • Teriparatide
  • Interferons
  • Enoxaparin Sodium
  • Glucagon
  • Calcitonin

By Indication

  • Oncology
  • Inflammatory & Autoimmune Disorders
  • Chronic Diseases
  • Blood Disorders
  • Growth Hormone Deficiency
  • Infectious Diseases
  • Other Indications (infertility, hypoglycemia, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases)

By Region

  • Europe
    • UK
    • France
    • Germany
    • Italy
    • Spain
    • Rest of Europe (RoE)
  • Asia Pacific (APAC)
    • India
    • China
    • South Korea
    • Japan
    • Australia
    • Rest of Asia Pacific (RoAPAC)
  • North America
    • US
    • Canada
  • Latin America
  • Middle East and Africa

Recent Developments

  • In July 2021, Biocon Ltd (Biocon Biologics) in partnership with Viatris, Inc. received FDA approval for the first interchangeable biosimilar SEMGLEE (insulin glargine-yfgn injection) for the treatment of diabetes.
  • In April 2021, Novartis AG (Sandoz) signed an agreement with Bio-Thera Solutions (China) to commercialize BAT1706 (proposed bevacizumab biosimilar by Bio-Thera Solutions) in the US, Europe, Canada, and other international markets.

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TABLE OF CONTENTS

1 INTRODUCTION (Page No. - 26)
    1.1 OBJECTIVES OF THE STUDY
    1.2 MARKET DEFINITION
           1.2.1 INCLUSIONS & EXCLUSIONS OF THE STUDY
                    TABLE 1 BIOSIMILARS MARKET: INCLUSIONS & EXCLUSIONS
    1.3 MARKET SCOPE
           1.3.1 MARKETS COVERED
           1.3.2 YEARS CONSIDERED FOR THE STUDY
    1.4 CURRENCY
    1.5 STAKEHOLDERS
    1.6 LIMITATIONS
    1.7 SUMMARY OF CHANGES

2 RESEARCH METHODOLOGY (Page No. - 31)
    2.1 RESEARCH APPROACH
           FIGURE 1 RESEARCH DESIGN
    2.2 SECONDARY DATA
           FIGURE 2 SECONDARY SOURCES
    2.3 PRIMARY DATA
           FIGURE 3 KEY DATA FROM PRIMARY SOURCES
           FIGURE 4 BREAKDOWN OF PRIMARY INTERVIEWS: BY COMPANY TYPE, DESIGNATION, AND REGION
    2.4 MARKET BREAKDOWN AND DATA TRIANGULATION
           FIGURE 5 DATA TRIANGULATION METHODOLOGY
    2.5 MARKET ESTIMATION METHODOLOGY
           2.5.1 BOTTOM-UP APPROACH
           2.5.2 TOP-DOWN APPROACH
           FIGURE 6 TOP-DOWN APPROACH
           FIGURE 7 BIOSIMILARS MARKET: FINAL MARKET SIZE
    2.6 GROWTH RATE ASSUMPTIONS/GROWTH FORECAST
    2.7 INSIGHTS FROM PRIMARIES
           FIGURE 8 MARKET VALIDATION FROM PRIMARY EXPERTS
    2.8 RESEARCH ASSUMPTIONS
    2.9 LIMITATIONS
    2.10 RISK ASSESSMENT

3 EXECUTIVE SUMMARY (Page No. - 41)
    FIGURE 9 BIOSIMILARS MARKET, BY PRODUCT, 2021 VS. 2026
    FIGURE 10 GLOBAL MARKET, BY INDICATION, 2021 VS. 2026
    FIGURE 11 GLOBAL MARKET, BY REGION, 2021 VS. 2026

4 PREMIUM INSIGHTS (Page No. - 44)
    4.1 BIOSIMILARS MARKET OVERVIEW
           FIGURE 12 RISING INCIDENCE OF CHRONIC DISEASES TO DRIVE MARKET GROWTH
    4.2 NORTH AMERICA: MARKET, BY PRODUCT AND COUNTRY
           FIGURE 13 INSULIN HELD THE LARGEST SHARE OF THE NORTH AMERICAN MARKET IN 2020
    4.3 GEOGRAPHICAL SNAPSHOT OF THE GLOBAL MARKET
           FIGURE 14 ASIA PACIFIC TO REGISTER THE HIGHEST GROWTH DURING THE FORECAST PERIOD

5 MARKET OVERVIEW (Page No. - 47)
    5.1 INTRODUCTION
    5.2 MARKET DYNAMICS
           FIGURE 15 BIOSIMILARS MARKET: DRIVERS, RESTRAINTS, OPPORTUNITIES, & CHALLENGES
           5.2.1 DRIVERS
                    5.2.1.1 Increasing demand for biosimilar drugs due to their cost-effectiveness
                    5.2.1.2 Rising geriatric population and the increasing incidence of chronic diseases
                               FIGURE 16 GERIATRIC POPULATION, BY REGION, 2020 VS. 2030 VS. 2050
                               FIGURE 17 INCIDENCE OF DIABETES, BY REGION, 2019 VS. 2030 VS. 2045
                    5.2.1.3 Abbreviated regulatory approval process and concept of interchangeability
                               FIGURE 18 COMPARISON OF REFERENCE PRODUCTS, BIOSIMILARS, AND INTERCHANGEABLE PRODUCTS
           5.2.2 RESTRAINTS
                    5.2.2.1 Complexities in manufacturing
                    5.2.2.2 Resistance from biologics manufacturers
           5.2.3 OPPORTUNITIES
                    5.2.3.1 Emerging markets
                    5.2.3.2 Patent expiry of blockbuster biologics and research on new indications
                               TABLE 2 LIST OF KEY BIOLOGICS UNDER THE THREAT OF PATENT EXPIRY
           5.2.4 CHALLENGES
                    5.2.4.1 Excess competition
           5.2.5 TRENDS
                    5.2.5.1 Collaborations for biosimilar research and clinical trials
                               TABLE 3 MAJOR COLLABORATIONS IN THE GLOBAL MARKET (2017–2020)
    5.3 COVID-19 IMPACT ANALYSIS
    5.4 TECHNOLOGY ANALYSIS
           TABLE 4 COMPARISON OF ORIGINAL BIOLOGICS WITH BIOSIMILARS
           TABLE 5 GENERIC DRUGS VS. BIOSIMILARS
    5.5 VALUE CHAIN ANALYSIS
           FIGURE 19 VALUE CHAIN ANALYSIS FOR BIOSIMILARS
    5.6 ECOSYSTEM MARKET MAP
           FIGURE 20 ECOSYSTEM MARKET MAP FOR BIOSIMILARS
    5.7 SUPPLY CHAIN ANALYSIS
    5.8 PORTER’S FIVE FORCES ANALYSIS
           TABLE 6 PORTER’S FIVE FORCES: IMPACT ANALYSIS ON THE BIOSIMILARS MARKET
           5.8.1 THREAT FROM NEW ENTRANTS
           5.8.2 THREAT FROM SUBSTITUTES
           5.8.3 BARGAINING POWER OF SUPPLIERS
           5.8.4 BARGAINING POWER OF BUYERS
           5.8.5 INTENSITY OF COMPETITION RIVALRY
    5.9 REGULATORY LANDSCAPE
           TABLE 7 REGULATORY LANDSCAPE FOR THE GLOBAL MARKET

6 BIOSIMILARS MARKET, BY PRODUCT (Page No. - 63)
    6.1 INTRODUCTION
           FIGURE 21 BIOSIMILARS APPROVED IN THE US, EUROPE, AND CHINA, BY TYPE
           TABLE 8 GLOBAL MARKET, BY PRODUCT, 2019–2026
    6.2 MONOCLONAL ANTIBODIES
           TABLE 9 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
           TABLE 10 GLOBAL MARKET FOR MONOCLONAL ANTIBODIES, BY REGION, 2019–2026
           6.2.1 INFLIXIMAB
                    6.2.1.1 Infliximab accounted for the largest share of the monoclonal antibodies market
                               TABLE 11 GLOBAL MARKET FOR INFLIXIMAB, BY REGION, 2019–2026
           6.2.2 TRASTUZUMAB
                    6.2.2.1 Rising incidence of cancer to drive market growth
                               TABLE 12 GLOBAL MARKET FOR TRASTUZUMAB, BY REGION, 2019–2026
           6.2.3 RITUXIMAB
                    6.2.3.1 Rising incidence of autoimmune diseases and cancer are key drivers for market growth
                               TABLE 13 BIOSIMILARS MARKET FOR RITUXIMAB, BY REGION, 2019–2026
           6.2.4 ADALIMUMAB
                    6.2.4.1 Adalimumab to register the highest CAGR in the monoclonal antibodies market
                               TABLE 14 GLOBAL MARKET FOR ADALIMUMAB, BY REGION, 2019–2026
           6.2.5 OTHER MONOCLONAL ANTIBODIES
                    TABLE 15 GLOBAL MARKET FOR OTHER MONOCLONAL ANTIBODIES, BY REGION, 2019–2026
    6.3 INSULIN
           6.3.1 INCREASING INCIDENCE OF DIABETES TO SUPPORT MARKET GROWTH
                    TABLE 16 GLOBAL MARKET FOR INSULIN, BY REGION, 2019–2026
    6.4 GRANULOCYTE COLONY-STIMULATING FACTOR
           6.4.1 G-CSF IS USED TO TREAT CANCER PATIENTS WITH NEUTROPENIA OCCURRING AFTER CHEMOTHERAPY
                    TABLE 17 LIST OF APPROVED BIOSIMILARS FOR G-CSF
                    TABLE 18 GLOBAL MARKET FOR GRANULOCYTE COLONY-STIMULATING FACTOR, BY REGION, 2019–2026
    6.5 ERYTHROPOIETIN
           6.5.1 RISING INCIDENCE OF BLOOD DISORDERS WILL DRIVE MARKET GROWTH
                    TABLE 19 LIST OF APPROVED BIOSIMILARS FOR ERYTHROPOIETIN
                    TABLE 20 GLOBAL MARKET FOR ERYTHROPOIETIN, BY REGION,2019–2026
    6.6 RECOMBINANT HUMAN GROWTH HORMONE
           6.6.1 MARKET GROWTH IS DRIVEN PRIMARILY BY THE INCREASING INCIDENCE OF GROWTH DEFICIENCY DISORDERS
                    TABLE 21 BIOSIMILARS MARKET FOR RECOMBINANT HUMAN GROWTH HORMONE,BY REGION, 2019–2026
    6.7 ETANERCEPT
           6.7.1 APAC TO WITNESS THE HIGHEST GROWTH IN THE ETANERCEPT MARKET DURING THE FORECAST PERIOD
                    TABLE 22 GLOBAL MARKET FOR ETANERCEPT, BY REGION,2019–2026
    6.8 FOLLITROPIN
           6.8.1 INCREASING APPLICATION OF FOLLITROPIN IN INFERTILITY TREATMENT TO DRIVE MARKET GROWTH
                    TABLE 23 GLOBAL MARKET FOR FOLLITROPIN, BY REGION, 2019–2026
    6.9 TERIPARATIDE
           6.9.1 INCREASING INCIDENCE OF OSTEOPOROSIS IS THE MAJOR FACTOR DRIVING MARKET GROWTH
                    TABLE 24 GLOBAL MARKET FOR TERIPARATIDE, BY REGION, 2019–2026
    6.10 INTERFERONS
           6.10.1 RISING INCIDENCE OF INFECTIOUS DISEASES TO SUPPORT MARKET GROWTH
                    TABLE 25 GLOBAL MARKET FOR INTERFERONS, BY REGION, 2019–2026
    6.11 ENOXAPARIN SODIUM
           6.11.1 WIDE RANGE OF APPLICATIONS HAVE SUPPORTED THE DEMAND FOR ENOXAPARIN SODIUM BIOSIMILARS
                    TABLE 26 GLOBAL MARKET FOR ENOXAPARIN SODIUM, BY REGION, 2019–2026
    6.12 GLUCAGON
           6.12.1 SANDOZ IS A MAJOR PLAYER IN THE GLUCAGON BIOSIMILARS MARKET
                    TABLE 27 GLOBAL MARKET FOR GLUCAGON, BY REGION, 2019–2026
    6.13 CALCITONIN
           6.13.1 INCREASING INCIDENCE OF OSTEOPOROSIS TO DRIVE MARKET GROWTH
                    TABLE 28 GLOBAL MARKET FOR CALCITONIN, BY REGION, 2019–2026

7 BIOSIMILARS MARKET, BY INDICATION (Page No. - 79)
    7.1 INTRODUCTION
           TABLE 29 GLOBAL MARKET, BY INDICATION, 2019–2026
    7.2 ONCOLOGY
           7.2.1 RISING BURDEN OF CANCER TO DRIVE THE DEMAND FOR BIOSIMILARS
                    FIGURE 22 CANCER CASES, BY TYPE, 2020
                    FIGURE 23 DEATHS DUE TO CANCER, BY TYPE, 2020
                    TABLE 30 BIOSIMILARS APPROVED BY THE US FDA FOR ONCOLOGICAL INDICATIONS, 2018-2020
                    FIGURE 24 ARTICLES PUBLISHED ON BIOSIMILARS FOR ONCOLOGY, 2012–2020
                    TABLE 31 GLOBAL MARKET FOR ONCOLOGY, BY REGION, 2019–2026
    7.3 INFLAMMATORY & AUTOIMMUNE DISEASES
           7.3.1 CHANGES IN LIFESTYLE AND ENVIRONMENTAL CONDITIONS HAVE INCREASED THE INCIDENCE OF INFLAMMATORY & AUTOIMMUNE DISEASES
                    TABLE 32 BIOSIMILARS MARKET FOR INFLAMMATORY AND AUTOIMMUNE DISEASES, BY REGION, 2019–2026
    7.4 CHRONIC DISEASES
           7.4.1 HIGH BURDEN OF CVD & DIABETES WORLDWIDE TO DRIVE MARKET GROWTH
                    TABLE 33 BIOSIMILARS APPROVED BY THE US FDA FOR CHRONIC DISEASES, 2018–2020
                    TABLE 34 GLOBAL MARKET FOR CHRONIC DISEASES, BY REGION, 2019–2026
    7.5 BLOOD DISORDERS
           7.5.1 INCREASING INCIDENCE OF BLOOD DISORDERS HAS INCREASED THE DEMAND FOR BIOSIMILARS FOR THIS INDICATION SEGMENT
                    TABLE 35 GLOBAL MARKET FOR BLOOD DISORDERS, BY REGION, 2019–2026
    7.6 GROWTH HORMONE DEFICIENCY
           7.6.1 GROWING USE OF BIOSIMILARS FOR THE TREATMENT OF THIS MEDICAL CONDITION TO SUPPORT MARKET GROWTH
                    TABLE 36 GLOBAL MARKET FOR GROWTH HORMONE DEFICIENCY, BY REGION, 2019–2026
    7.7 INFECTIOUS DISEASES
           7.7.1 BIOSIMILARS MARKET FOR INFECTIOUS DISEASES IS EXPECTED TO BE THE HIGHEST IN THE ASIA PACIFIC
                    TABLE 37 GLOBAL MARKET FOR INFECTIOUS DISEASES, BY REGION, 2019–2026
    7.8 OTHER INDICATIONS
           TABLE 38 GLOBAL MARKET FOR OTHER INDICATIONS, BY REGION, 2019–2026

8 BIOSIMILARS MARKET, BY REGION (Page No. - 90)
    8.1 INTRODUCTION
           FIGURE 25 GLOBAL MARKET: GEOGRAPHIC GROWTH OPPORTUNITIES
           TABLE 39 GLOBAL MARKET, BY REGION, 2019–2026
    8.2 EUROPE
           TABLE 40 LIST OF BIOSIMILARS APPROVED IN EUROPE
           FIGURE 26 EUROPE: BIOSIMILARS MARKET SNAPSHOT
           TABLE 41 EUROPE: MARKET, BY COUNTRY, 2019–2026
           TABLE 42 EUROPE: MARKET, BY PRODUCT, 2019–2026
           TABLE 43 EUROPE: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
           TABLE 44 EUROPE: MARKET, BY INDICATION,2019–2026
           8.2.1 UK
                    8.2.1.1 The UK holds the largest share of the biosimilars market in Europe
                               TABLE 45 LIST OF BIOSIMILARS IN THE UK
                               TABLE 46 UK: MARKET, BY PRODUCT, 2019–2026
                               TABLE 47 UK: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
                               TABLE 48 UK: MARKET, BY INDICATION, 2019–2026
           8.2.2 FRANCE
                    8.2.2.1 Rising geriatric population will drive market growth
                               TABLE 49 FRANCE: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026
                               TABLE 50 FRANCE: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
                               TABLE 51 FRANCE: MARKET, BY INDICATION, 2019–2026
           8.2.3 GERMANY
                    8.2.3.1 Presence of a favorable pricing system has supported biosimilar adoption in Germany
                               TABLE 52 GERMANY: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026
                               TABLE 53 GERMANY: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
                               TABLE 54 GERMANY: MARKET, BY INDICATION, 2019–2026
           8.2.4 ITALY
                    8.2.4.1 Rising geriatric population in Italy will support the adoption of biosimilars in the country
                               TABLE 55 ITALY: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026
                               TABLE 56 ITALY: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
                               TABLE 57 ITALY: MARKET, BY INDICATION, 2019–2026
           8.2.5 SPAIN
                    8.2.5.1 Patient incentives to promote biosimilar use is a key growth driver for the biosimilars market in Spain
                               TABLE 58 SPAIN: MARKET, BY PRODUCT, 2019–2026
                               TABLE 59 SPAIN: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
                               TABLE 60 SPAIN: MARKET, BY INDICATION, 2019–2026
           8.2.6 REST OF EUROPE
                    TABLE 61 ROE: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026
                    TABLE 62 ROE: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
                    TABLE 63 ROE: MARKET, BY INDICATION, 2019–2026
    8.3 ASIA PACIFIC
           FIGURE 27 ASIA PACIFIC: BIOSIMILARS MARKET SNAPSHOT
           TABLE 64 ASIA PACIFIC: MARKET, BY COUNTRY, 2019–2026
           TABLE 65 ASIA PACIFIC: MARKET, BY PRODUCT, 2019–2026
           TABLE 66 ASIA PACIFIC: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
           TABLE 67 ASIA PACIFIC: MARKET, BY INDICATION, 2019–2026
           8.3.1 INDIA
                    8.3.1.1 India held the largest share of the APAC biosimilars market
                               TABLE 68 BIOSIMILARS APPROVED AND MARKETED IN INDIA
                               TABLE 69 INDIA: MARKET, BY PRODUCT, 2019–2026
                               TABLE 70 INDIA: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
                               TABLE 71 INDIA: MARKET, BY INDICATION, 2019–2026
           8.3.2 CHINA
                    8.3.2.1 China is the fastest-growing market for biosimilars in the APAC
                               TABLE 72 BIOSIMILARS APPROVED IN CHINA
                               TABLE 73 CHINA: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026
                               TABLE 74 CHINA: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
                               TABLE 75 CHINA: MARKET, BY INDICATION, 2019–2026
           8.3.3 SOUTH KOREA
                    8.3.3.1 Favorable government initiatives to drive the market in South Korea
                               TABLE 76 LIST OF BIOSIMILARS APPROVED IN SOUTH KOREA
                               TABLE 77 SOUTH KOREA: MARKET, BY PRODUCT, 2019–2026
                               TABLE 78 SOUTH KOREA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
                               TABLE 79 SOUTH KOREA: MARKET, BY INDICATION, 2019–2026
           8.3.4 JAPAN
                    8.3.4.1 Large geriatric population in the country to drive market growth
                               TABLE 80 LIST OF BIOSIMILARS APPROVED IN JAPAN
                               TABLE 81 JAPAN: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026
                               TABLE 82 JAPAN: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
                               TABLE 83 JAPAN: MARKET, BY INDICATION, 2019–2026
           8.3.5 AUSTRALIA
                    8.3.5.1 Incremental changes in biosimilar regulations and increasing incidence of chronic diseases to drive market growth
                               TABLE 84 LIST OF BIOSIMILARS APPROVED IN AUSTRALIA
                               TABLE 85 AUSTRALIA: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026
                               TABLE 86 AUSTRALIA: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
                               TABLE 87 AUSTRALIA: MARKET, BY INDICATION, 2019–2026
           8.3.6 REST OF ASIA PACIFIC
                    TABLE 88 LIST OF BIOSIMILARS APPROVED IN NEW ZEALAND
                    TABLE 89 LIST OF BIOSIMILARS APPROVED IN MALAYSIA
                    TABLE 90 LIST OF BIOSIMILARS APPROVED IN SINGAPORE
                    TABLE 91 ROAPAC: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026
                    TABLE 92 ROAPAC: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
                    TABLE 93 ROAPAC: MARKET, BY INDICATION, 2019–2026
    8.4 NORTH AMERICA
           TABLE 94 NORTH AMERICA: BIOSIMILARS MARKET, BY COUNTRY, 2019–2026
           TABLE 95 NORTH AMERICA: MARKET, BY PRODUCT, 2019–2026
           TABLE 96 NORTH AMERICA: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
           TABLE 97 NORTH AMERICA: MARKET, BY INDICATION, 2019–2026
           8.4.1 US
                    8.4.1.1 The US dominates the North American biosimilars market
                               TABLE 98 LIST OF BIOSIMILARS APPROVED IN THE US
                               TABLE 99 US: MARKET, BY PRODUCT, 2019–2026
                               TABLE 100 US: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
                               TABLE 101 US: MARKET, BY INDICATION, 2019–2026
           8.4.2 CANADA
                    8.4.2.1 Favorable government initiatives to support market growth
                               TABLE 102 LIST OF BIOSIMILARS APPROVED IN CANADA
                               TABLE 103 CANADA: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026
                               TABLE 104 CANADA: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
                               TABLE 105 CANADA: MARKET, BY INDICATION, 2019–2026
    8.5 LATIN AMERICA
           8.5.1 RISING INCIDENCE OF CANCER TO DRIVE MARKET GROWTH
                    TABLE 106 LIST OF BIOSIMILARS APPROVED IN LATIN AMERICA
                    TABLE 107 LATIN AMERICA: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026
                    TABLE 108 LATIN AMERICA: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
                    TABLE 109 LATIN AMERICA: MARKET, BY INDICATION,2019–2026
    8.6 MIDDLE EAST AND AFRICA
           8.6.1 FAVORABLE REGULATORY REFORMS AND INFRASTRUCTURAL DEVELOPMENT TO FAVOR MARKET GROWTH
                    TABLE 110 MIDDLE EAST AND AFRICA: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026
                    TABLE 111 MIDDLE EAST AND AFRICA: MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026
                    TABLE 112 MIDDLE EAST AND AFRICA: MARKET, BY INDICATION, 2019–2026

9 COMPETITIVE LANDSCAPE (Page No. - 146)
    9.1 INTRODUCTION
    9.2 RIGHT-TO-WIN APPROACH
           FIGURE 28 KEY DEVELOPMENTS OF MAJOR PLAYERS, JANUARY 2018–AUGUST 2021
    9.3 REVENUE SHARE ANALYSIS OF KEY MARKET PLAYERS
           FIGURE 29 REVENUE ANALYSIS FOR KEY COMPANIES OVER THE PAST THREE YEARS
    9.4 MARKET SHARE ANALYSIS
           FIGURE 30 GLOBAL BIOSIMILARS MARKET SHARE ANALYSIS, BY KEY PLAYER, 2020
    9.5 COMPANY EVALUATION QUADRANT
           9.5.1 STARS
           9.5.2 EMERGING LEADERS
           9.5.3 PERVASIVE PLAYERS
           9.5.4 PARTICIPANTS
                    FIGURE 31 GLOBAL MARKET: COMPANY EVALUATION QUADRANT, 2020
    9.6 COMPANY EVALUATION QUADRANT: START-UPS/SMES
           9.6.1 PROGRESSIVE COMPANIES
           9.6.2 STARTING BLOCKS
           9.6.3 RESPONSIVE COMPANIES
           9.6.4 DYNAMIC COMPANIES
                    FIGURE 32 BIOSIMILARS MARKET: COMPANY EVALUATION QUADRANT FOR START-UPS/SMES, 2020
    9.7 COMPETITIVE BENCHMARKING
           9.7.1 COMPANY PRODUCT FOOTPRINT
           9.7.2 COMPANY INDICATION FOOTPRINT
           9.7.3 COMPANY REGIONAL FOOTPRINT
    9.8 GROWTH STRATEGIES ADOPTED BY EMERGING AND KEY PLAYERS
           9.8.1 PRODUCT LAUNCHES & APPROVALS
           9.8.2 DEALS
           9.8.3 OTHER DEVELOPMENTS

10 COMPANY PROFILES (Page No. - 159)
     10.1 MAJOR PLAYERS     
(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
                        TABLE 113 NOVARTIS AG: BUSINESS OVERVIEW
                        FIGURE 33 SANDOZ: COMPANY SNAPSHOT
             10.1.2 PFIZER INC.
                        TABLE 114 PFIZER INC: BUSINESS OVERVIEW
                        FIGURE 34 PFIZER INC.: COMPANY SNAPSHOT
             10.1.3 DR. REDDY’S LABORATORIES LTD.
                        TABLE 115 DR. REDDY’S LABORATORIES: BUSINESS OVERVIEW
                        FIGURE 35 DR. REDDY’S LABORATORIES LTD.: COMPANY SNAPSHOT
             10.1.4 AMGEN INC.
                        TABLE 116 AMGEN INC.: BUSINESS OVERVIEW
                        FIGURE 36 AMGEN INC.: COMPANY SNAPSHOT
             10.1.5 ELI LILLY AND COMPANY
                        TABLE 117 ELI LILLY AND COMPANY: BUSINESS OVERVIEW
                        FIGURE 37 ELI LILLY AND COMPANY: COMPANY SNAPSHOT
             10.1.6 TEVA PHARMACEUTICAL INDUSTRIES LTD.
                        TABLE 118 TEVA PHARMACEUTICAL INDUSTRIES LTD.: BUSINESS OVERVIEW
                        FIGURE 38 TEVA PHARMACEUTICAL INDUSTRIES LTD.: COMPANY SNAPSHOT
             10.1.7 FRESENIUS SE & CO. KGAA
                        TABLE 119 FRESENIUS SE & CO. KGAA: BUSINESS OVERVIEW
                        FIGURE 39 FRESENIUS SE & CO. KGAA: COMPANY SNAPSHOT
             10.1.8 STADA ARZNEIMITTEL AG
                        TABLE 120 STADA ARZNEIMITTEL: BUSINESS OVERVIEW
                        FIGURE 40 STADA ARZNEIMITTEL: COMPANY SNAPSHOT
             10.1.9 BOEHRINGER INGELHEIM
                        TABLE 121 BOEHRINGER INGELHEIM: BUSINESS OVERVIEW
                        FIGURE 41 BOEHRINGER INGELHEIM: COMPANY SNAPSHOT
             10.1.10 GEDEON RICHTER PLC
                        TABLE 122 GEDEON RICHTER PLC: BUSINESS OVERVIEW
                        FIGURE 42 GEDEON RICHTER PLC: COMPANY SNAPSHOT
             10.1.11 CELLTRION
                        TABLE 123 CELLTRION: BUSINESS OVERVIEW
                        FIGURE 43 CELLTRION: COMPANY SNAPSHOT
             10.1.12 SAMSUNG BIOLOGICS
                        TABLE 124 SAMSUNG BIOLOGICS: BUSINESS OVERVIEW
                        FIGURE 44 SAMSUNG BIOLOGICS: COMPANY SNAPSHOT
             10.1.13 COHERUS BIOSCIENCES
                        TABLE 125 COHERUS BIOSCIENCES: BUSINESS OVERVIEW
                        FIGURE 45 COHERUS BIOSCIENCES: COMPANY SNAPSHOT
             10.1.14 BIOCON LIMITED
                        TABLE 126 BIOCON LIMITED: BUSINESS OVERVIEW
                        FIGURE 46 BIOCON LIMITED: COMPANY SNAPSHOT
             10.1.15 VIATRIS
                        TABLE 127 VIATRIS: BUSINESS OVERVIEW
     10.2 OTHER PLAYERS
             10.2.1 AMEGA BIOTECH
                        TABLE 128 AMEGA BIOTECH: BUSINESS OVERVIEW
             10.2.2 APOTEX INC.
                        TABLE 129 APOTEX INC.: BUSINESS OVERVIEW
             10.2.3 BIOCAD
                        TABLE 130 BIOCAD: BUSINESS OVERVIEW
             10.2.4 MABXIENCE
                        TABLE 131 MABXIENCE: BUSINESS OVERVIEW
             10.2.5 PROBIOMED S.A. DE C.V.
                        TABLE 132 PROBIOMED: BUSINESS OVERVIEW
             10.2.6 FUJIFILM KYOWA KIRIN BIOLOGICS CO., LTD.
                        TABLE 133 FUJIFILM KYOWA KIRIN BIOLOGICS: BUSINESS OVERVIEW
             10.2.7 INTAS PHARMACEUTICALS LTD.
                        TABLE 134 INTAS PHARMACEUTICALS LTD.: BUSINESS OVERVIEW
             10.2.8 THERAMEX
                        TABLE 135 THERAMEX: BUSINESS OVERVIEW
             10.2.9 RELIANCE LIFE SCIENCES
                        TABLE 136 RELIANCE LIFE SCIENCES: BUSINESS OVERVIEW
             10.2.10 KASHIV BIOSCIENCES
                         TABLE 137 KASHIV BIOSCIENCES: BUSINESS OVERVIEW
*Details on Business Overview, Products Offered, Recent Developments, and MnM View (Key strengths/Right to Win, Strategic Choices Made, and Weaknesses and Competitive Threats) might not be captured in case of unlisted companies. 

11 APPENDIX (Page No. - 222)
     11.1 DISCUSSION GUIDE
     11.2 KNOWLEDGE STORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL
     11.3 AVAILABLE CUSTOMIZATIONS
     11.4 RELATED REPORTS
     11.5 AUTHOR DETAILS

This market research study involves the extensive use of secondary sources, directories, and databases to identify and collect information useful for this technical, market-oriented, and financial study of the global biosimilars market. Interviews were conducted with various primary respondents, including key industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry consultants, to obtain and verify critical qualitative and quantitative information and assess market prospects. The biosimilars market size was estimated through various secondary research approaches and triangulated with inputs from primary research.

Secondary Research

The secondary sources referred to for this research study include publications from government sources [such as the World Bank, World Health Organization (WHO), United States Food and Drug Administration (US FDA), European Medicines Agency (EMA), National Centre for Biotechnology Information (NCBI), Therapeutic Goods Administration (TGA), and Centers for Disease Control and Prevention (CDC)]; sites like ClinicalTrials.gov, Generics and Biosimilars Initiative (GaBI), fiercebiotech, and annual reports; SEC filings; press releases; investor presentations; journals; expert interviews; MarketsandMarkets analysis; business magazines and research journals; press releases; and trade, business, and professional associations. Secondary data was collected and analyzed to arrive at the overall size of the global biosimilars market, which was validated through primary research.

Primary Research

After acquiring basic knowledge about the global biosimilars market scenario through secondary research, extensive primary research was conducted. Several primary interviews were conducted with market experts from both the biologic manufacturers and independent consultants and the supply side participants (such as biosimilar product companies ) across four major regions—North America, Europe, the Asia Pacific, and the Rest of the World. Approximately 80% and 20% of primary interviews were conducted with supply-side and demand-side participants, respectively. This primary data was collected through questionnaires, e-mails, online surveys, personal interviews, and telephonic interviews. The following is a breakdown of the primary respondents:

Biosimilars Market Size, and Share

To know about the assumptions considered for the study, download the pdf brochure

Biosimilars Market Size Estimation

The global size of the biosimilars market was estimated through different approaches. A detailed market estimation approach was followed to estimate and validate the global market value and other dependent submarkets, as mentioned below. Both top-down and bottom-up approaches were used to estimate and validate the total size of the biosimilars market. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:

  • The key players in the industry and market have been identified through extensive secondary research
  • The revenues generated from the biosimilar business of leading players have been determined through primary and secondary research
  • All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources.

Data Triangulation

After arriving at the overall market size from the market size estimation process, the total market was split into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments, data triangulation and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides.

Report Objectives

  • To define, describe, segment, and forecast the biosimilars market by product, indication, and region
  • To forecast the size of the market with respect to five regional segments—North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa
  • To provide detailed information regarding the major factors influencing the market growth (drivers, restraints, opportunities, and challenges)
  • To strategically analyze micromarkets1 with respect to individual growth trends, prospects, and contributions to the overall market
  • To analyze opportunities in the market for stakeholders and provide details of the competitive landscape for market leaders
  • To profile the key players and comprehensively analyze their market shares and core competencies2 in terms of market developments and growth strategies
  • To track and analyze competitive developments such as product launches and approvals, collaborations, partnerships, acquisitions, and expansions in the biosimilars market

Available Customizations

With the given market data, MarketsandMarkets offers customizations as per the company’s specific needs. The following customization options are available for this report:

Geographic Analysis

Further breakdown of the biosimilars market into specific countries/regions in Europe, Latin America, and the Middle East & Africa

Company Information

Detailed analysis and profiling of additional market players (up to 5), inclusive of:

  • Business Overview
  • Financial Information
  • Product Portfolio
  • Developments (Last Three Years)
Report Code
PH 7582
Published ON
Sep, 2021
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