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

[253 Pages Report] The global biosimilars market is projected to reach USD 44.7 billion by 2026 from USD 15.6 billion in 2021, at a CAGR of 23.5% during the forecast period of 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 biosimilars market. However, 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

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COVID-19 impact on the Biosimilars Market

Coronavirus disease 2019 (COVID‐19) is an acute respiratory infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2). Largely unknown before the outbreak began in Wuhan (China) in December 2019, COVID-19 has moved from a regional crisis to a global pandemic in just a few weeks. The World Health Organization (WHO) declared COVID-19 as a pandemic on March 11, 2020. There has been a tremendous amount of effort put into developing new treatments and vaccines to cure the infection. Within a few weeks of research, companies started coming up with drugs and treatments to treat the infection.  

Global Biosimilars Market Dynamics

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

According to American Journal of Managed Care, biosimilars are priced around 20–30% lower than their parent/branded counterparts. This results in both cost-savings and access to highly effective treatments for patients. Biosimilars have lower R&D costs as compared to innovator biologics. Lower R&D costs lower the cost for biosimilars. 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.

RESTRAINTS: Complexities in manufacturing

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. Unlike the development of generic medicines, biosimilar manufacturers are required to invest in clinical trials and post-approval safety monitoring programs that are similar to that of the original innovator companies.

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. Biosimilars manufactured should comply with set quality standards in terms of safety and efficacy. Regulatory bodies may require additional preclinical and/or clinical data to demonstrate that the manufacturing process does not impact the efficacy or safety of the product and that no variability exists between the biosimilar and the biologic drug.

OPPORTUNITY:Patent expiry of blockbuster biologics and research on new indications

Most early biologic drugs lost their patent protection in the first half of the 20th century, while many of the current best-selling drugs are set to lose their patent protection in the coming years. This is creating new opportunities for biosimilar drugs. By 2023, patents of nearly 20 oncology biologics will expire, which could lead to more biosimilars in the field of oncology.

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.

CHALLENGES: Excess Competition

Competition in the biosimilars market is not just among biosimilar manufacturers but also from 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 the launch of second-generation products, reformulations, dosing improvements, supporting devices, and competing on prices.

The Oncology segment dominated the biosimilars market in 2020:

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 (infertility, hypoglycemia, myocardial infarction, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases). Oncology is the largest segment in this market owing to the availability of biosimilars at a lower price than innovative biologics and a large number of cancer patients. The availability of biosimilars in the field of oncology has lowered prices and made cancer treatment more affordable and accessible.  Also, due to the high incidence and prevalence of cancer, healthcare systems across the globe are focusing on reducing the burden of cancer by adopting cost effective treatment options. In this scenario, biosimilar drugs might witness widespread adoption in major markets such as the US, Europe, and the Asia Pacific. Considering these factors and the upending competition from biosimilars, many major biologic pharmaceutical companies are making significant investments in the development and approval of biosimilar drugs.

The monoclonal antibodies segment accounted for the largest share in 2020

Based on 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. Monoclonal antibodies accounted for a share of around 27%. Monoclonal antibodies and Insulin are seen to be the leading segments with respect to the growth rate during the forecast period as a result of wide applications of monoclonal antibodies in the treatment of cancer, autoimmune disorders and osteoporosis, and rising incidents of insulin dependent diabetes globally and increasing demand for cost-effective treatment options.

Biosimilars Market by Region

Europe was the largest regional market for biosimilars market in 2020.

Geographically, the biosimilars 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 biosimilars 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.

Key Market Players

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

Scope of the report

Report Metric

Details

Market size available for years

2019–2026

Base year considered

2020

Forecast period

2021–2026

Forecast units

Value (USD Billion)

Segments covered

Product, Indication and Region

Geographies covered

Europe, Asia Pacific, North America, Latin America, Middle East and Africa

Companies covered

Novartis AG (Switzerland), Pfizer, Inc. (US), Dr. Reddy’s Laboratories Ltd. (India), Amgen, Inc. (US), Eli Lilly and Company (US), Teva Pharmaceutical Industries Ltd. (Israel), Fresenius SE & Co. KGaA (Germany), STADA Arzneimittel AG (Germany), Boehringer Ingelheim (Germany), Gedeon Richter PLC (Hungary), Celltrion (South Korea), Samsung Biologics (South Korea), Coherus BioSciences (US), Biocon Limited (India), Viatris, Inc. (US), Amega Biotech (Argentina), Apotex, Inc. (Canada), Biocad (Russia), mAbxience (Spain), Probiomed S.A. De C.V. (Mexico), Fujifilm Kyowa Kirin Biologics Co., Ltd. (Japan), Intas Pharmaceuticals Ltd. (India), Thermex (UK), Reliance Life Sciences (India), Kashiv Biosciences (US)

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

Biosimilars Market, 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

Biosimilars Market, 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)

Biosimilars Market, 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 (USD BILLION)
    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 (USD MILLION)
    FIGURE 10 BIOSIMILARS MARKET, BY INDICATION, 2021 VS. 2026 (USD MILLION)
    FIGURE 11 BIOSIMILARS MARKET, BY REGION, 2021 VS. 2026 (USD MILLION)

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: BIOSIMILARS MARKET, BY PRODUCT AND COUNTRY (2020)
           FIGURE 13 INSULIN HELD THE LARGEST SHARE OF THE NORTH AMERICAN BIOSIMILARS MARKET IN 2020
    4.3 GEOGRAPHICAL SNAPSHOT OF THE BIOSIMILARS 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 (MILLION)
                               FIGURE 17 INCIDENCE OF DIABETES, BY REGION, 2019 VS. 2030 VS. 2045 (MILLION)
                    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 BIOSIMILARS 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 BIOSIMILARS 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 BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
    6.2 MONOCLONAL ANTIBODIES
           TABLE 9 BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 10 BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY REGION, 2019–2026 (USD MILLION)
           6.2.1 INFLIXIMAB
                    6.2.1.1 Infliximab accounted for the largest share of the monoclonal antibodies market
                               TABLE 11 BIOSIMILARS MARKET FOR INFLIXIMAB, BY REGION, 2019–2026 (USD MILLION)
           6.2.2 TRASTUZUMAB
                    6.2.2.1 Rising incidence of cancer to drive market growth
                               TABLE 12 BIOSIMILARS MARKET FOR TRASTUZUMAB, BY REGION, 2019–2026 (USD MILLION)
           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 (USD MILLION)
           6.2.4 ADALIMUMAB
                    6.2.4.1 Adalimumab to register the highest CAGR in the monoclonal antibodies market
                               TABLE 14 BIOSIMILARS MARKET FOR ADALIMUMAB, BY REGION, 2019–2026 (USD MILLION)
           6.2.5 OTHER MONOCLONAL ANTIBODIES
                    TABLE 15 BIOSIMILARS MARKET FOR OTHER MONOCLONAL ANTIBODIES, BY REGION, 2019–2026 (USD MILLION)
    6.3 INSULIN
           6.3.1 INCREASING INCIDENCE OF DIABETES TO SUPPORT MARKET GROWTH
                    TABLE 16 BIOSIMILARS MARKET FOR INSULIN, BY REGION, 2019–2026 (USD MILLION)
    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 BIOSIMILARS MARKET FOR GRANULOCYTE COLONY-STIMULATING FACTOR, BY REGION, 2019–2026 (USD MILLION)
    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 BIOSIMILARS MARKET FOR ERYTHROPOIETIN, BY REGION,2019–2026 (USD MILLION)
    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 (USD MILLION)
    6.7 ETANERCEPT
           6.7.1 APAC TO WITNESS THE HIGHEST GROWTH IN THE ETANERCEPT MARKET DURING THE FORECAST PERIOD
                    TABLE 22 BIOSIMILARS MARKET FOR ETANERCEPT, BY REGION,2019–2026 (USD MILLION)
    6.8 FOLLITROPIN
           6.8.1 INCREASING APPLICATION OF FOLLITROPIN IN INFERTILITY TREATMENT TO DRIVE MARKET GROWTH
                    TABLE 23 BIOSIMILARS MARKET FOR FOLLITROPIN, BY REGION, 2019–2026 (USD MILLION)
    6.9 TERIPARATIDE
           6.9.1 INCREASING INCIDENCE OF OSTEOPOROSIS IS THE MAJOR FACTOR DRIVING MARKET GROWTH
                    TABLE 24 BIOSIMILARS MARKET FOR TERIPARATIDE, BY REGION, 2019–2026 (USD MILLION)
    6.10 INTERFERONS
           6.10.1 RISING INCIDENCE OF INFECTIOUS DISEASES TO SUPPORT MARKET GROWTH
                    TABLE 25 BIOSIMILARS MARKET FOR INTERFERONS, BY REGION, 2019–2026 (USD MILLION)
    6.11 ENOXAPARIN SODIUM
           6.11.1 WIDE RANGE OF APPLICATIONS HAVE SUPPORTED THE DEMAND FOR ENOXAPARIN SODIUM BIOSIMILARS
                    TABLE 26 BIOSIMILARS MARKET FOR ENOXAPARIN SODIUM, BY REGION, 2019–2026 (USD MILLION)
    6.12 GLUCAGON
           6.12.1 SANDOZ IS A MAJOR PLAYER IN THE GLUCAGON BIOSIMILARS MARKET
                    TABLE 27 BIOSIMILARS MARKET FOR GLUCAGON, BY REGION, 2019–2026 (USD MILLION)
    6.13 CALCITONIN
           6.13.1 INCREASING INCIDENCE OF OSTEOPOROSIS TO DRIVE MARKET GROWTH
                    TABLE 28 BIOSIMILARS MARKET FOR CALCITONIN, BY REGION, 2019–2026 (USD MILLION)

7 BIOSIMILARS MARKET, BY INDICATION (Page No. - 79)
    7.1 INTRODUCTION
           TABLE 29 BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)
    7.2 ONCOLOGY
           7.2.1 RISING BURDEN OF CANCER TO DRIVE THE DEMAND FOR BIOSIMILARS
                    FIGURE 22 CANCER CASES, BY TYPE, 2020 (MILLION)
                    FIGURE 23 DEATHS DUE TO CANCER, BY TYPE, 2020 (MILLION)
                    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 BIOSIMILARS MARKET FOR ONCOLOGY, BY REGION, 2019–2026 (USD MILLION)
    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 (USD MILLION)
    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 BIOSIMILARS MARKET FOR CHRONIC DISEASES, BY REGION, 2019–2026 (USD MILLION)
    7.5 BLOOD DISORDERS
           7.5.1 INCREASING INCIDENCE OF BLOOD DISORDERS HAS INCREASED THE DEMAND FOR BIOSIMILARS FOR THIS INDICATION SEGMENT
                    TABLE 35 BIOSIMILARS MARKET FOR BLOOD DISORDERS, BY REGION, 2019–2026 (USD MILLION)
    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 BIOSIMILARS MARKET FOR GROWTH HORMONE DEFICIENCY, BY REGION, 2019–2026 (USD MILLION)
    7.7 INFECTIOUS DISEASES
           7.7.1 BIOSIMILARS MARKET FOR INFECTIOUS DISEASES IS EXPECTED TO BE THE HIGHEST IN THE ASIA PACIFIC
                    TABLE 37 BIOSIMILARS MARKET FOR INFECTIOUS DISEASES, BY REGION, 2019–2026 (USD MILLION)
    7.8 OTHER INDICATIONS
           TABLE 38 BIOSIMILARS MARKET FOR OTHER INDICATIONS, BY REGION, 2019–2026 (USD MILLION)

8 BIOSIMILARS MARKET, BY REGION (Page No. - 90)
    8.1 INTRODUCTION
           FIGURE 25 BIOSIMILARS MARKET: GEOGRAPHIC GROWTH OPPORTUNITIES
           TABLE 39 BIOSIMILARS MARKET, BY REGION, 2019–2026 (USD MILLION)
    8.2 EUROPE
           TABLE 40 LIST OF BIOSIMILARS APPROVED IN EUROPE
           FIGURE 26 EUROPE: BIOSIMILARS MARKET SNAPSHOT
           TABLE 41 EUROPE: BIOSIMILARS MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
           TABLE 42 EUROPE: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 43 EUROPE: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 44 EUROPE: BIOSIMILARS MARKET, BY INDICATION,2019–2026 (USD MILLION)
           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: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
                               TABLE 47 UK: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
                               TABLE 48 UK: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)
           8.2.2 FRANCE
                    8.2.2.1 Rising geriatric population will drive market growth
                               TABLE 49 FRANCE: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
                               TABLE 50 FRANCE: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
                               TABLE 51 FRANCE: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)
           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 (USD MILLION)
                               TABLE 53 GERMANY: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
                               TABLE 54 GERMANY: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)
           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 (USD MILLION)
                               TABLE 56 ITALY: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
                               TABLE 57 ITALY: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)
           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: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
                               TABLE 59 SPAIN: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
                               TABLE 60 SPAIN: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)
           8.2.6 REST OF EUROPE
                    TABLE 61 ROE: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
                    TABLE 62 ROE: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
                    TABLE 63 ROE: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)
    8.3 ASIA PACIFIC
           FIGURE 27 ASIA PACIFIC: BIOSIMILARS MARKET SNAPSHOT
           TABLE 64 ASIA PACIFIC: BIOSIMILARS MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
           TABLE 65 ASIA PACIFIC: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 66 ASIA PACIFIC: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 67 ASIA PACIFIC: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)
           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: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
                               TABLE 70 INDIA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
                               TABLE 71 INDIA: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)
           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 (USD MILLION)
                               TABLE 74 CHINA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
                               TABLE 75 CHINA: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)
           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: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
                               TABLE 78 SOUTH KOREA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
                               TABLE 79 SOUTH KOREA: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)
           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 (USD MILLION)
                               TABLE 82 JAPAN: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
                               TABLE 83 JAPAN: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)
           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 (USD MILLION)
                               TABLE 86 AUSTRALIA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
                               TABLE 87 AUSTRALIA: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)
           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 (USD MILLION)
                    TABLE 92 ROAPAC: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
                    TABLE 93 ROAPAC: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)
    8.4 NORTH AMERICA
           TABLE 94 NORTH AMERICA: BIOSIMILARS MARKET, BY COUNTRY, 2019–2026 (USD MILLION)
           TABLE 95 NORTH AMERICA: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
           TABLE 96 NORTH AMERICA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
           TABLE 97 NORTH AMERICA: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)
           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: BIOSIMILARS MARKET, BY PRODUCT, 2019–2026 (USD MILLION)
                               TABLE 100 US: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
                               TABLE 101 US: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)
           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 (USD MILLION)
                               TABLE 104 CANADA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
                               TABLE 105 CANADA: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)
    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 (USD MILLION)
                    TABLE 108 LATIN AMERICA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
                    TABLE 109 LATIN AMERICA: BIOSIMILARS MARKET, BY INDICATION,2019–2026 (USD MILLION)
    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 (USD MILLION)
                    TABLE 111 MIDDLE EAST AND AFRICA: BIOSIMILARS MARKET FOR MONOCLONAL ANTIBODIES, BY TYPE, 2019–2026 (USD MILLION)
                    TABLE 112 MIDDLE EAST AND AFRICA: BIOSIMILARS MARKET, BY INDICATION, 2019–2026 (USD MILLION)

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 BIOSIMILARS 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 (2020)
             10.1.2 PFIZER INC.
                        TABLE 114 PFIZER INC: BUSINESS OVERVIEW
                        FIGURE 34 PFIZER INC.: COMPANY SNAPSHOT (2020)
             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 (2020)
             10.1.4 AMGEN INC.
                        TABLE 116 AMGEN INC.: BUSINESS OVERVIEW
                        FIGURE 36 AMGEN INC.: COMPANY SNAPSHOT (2020)
             10.1.5 ELI LILLY AND COMPANY
                        TABLE 117 ELI LILLY AND COMPANY: BUSINESS OVERVIEW
                        FIGURE 37 ELI LILLY AND COMPANY: COMPANY SNAPSHOT (2020)
             10.1.6 TEVA PHARMACEUTICAL INDUSTRIES LTD.
                        TABLE 118 TEVA PHARMACEUTICAL INDUSTRIES LTD.: BUSINESS OVERVIEW
                        FIGURE 38 TEVA PHARMACEUTICAL INDUSTRIES LTD.: COMPANY SNAPSHOT (2020)
             10.1.7 FRESENIUS SE & CO. KGAA
                        TABLE 119 FRESENIUS SE & CO. KGAA: BUSINESS OVERVIEW
                        FIGURE 39 FRESENIUS SE & CO. KGAA: COMPANY SNAPSHOT (2020)
             10.1.8 STADA ARZNEIMITTEL AG
                        TABLE 120 STADA ARZNEIMITTEL: BUSINESS OVERVIEW
                        FIGURE 40 STADA ARZNEIMITTEL: COMPANY SNAPSHOT (2020)
             10.1.9 BOEHRINGER INGELHEIM
                        TABLE 121 BOEHRINGER INGELHEIM: BUSINESS OVERVIEW
                        FIGURE 41 BOEHRINGER INGELHEIM: COMPANY SNAPSHOT (2020)
             10.1.10 GEDEON RICHTER PLC
                        TABLE 122 GEDEON RICHTER PLC: BUSINESS OVERVIEW
                        FIGURE 42 GEDEON RICHTER PLC: COMPANY SNAPSHOT (2020)
             10.1.11 CELLTRION
                        TABLE 123 CELLTRION: BUSINESS OVERVIEW
                        FIGURE 43 CELLTRION: COMPANY SNAPSHOT (2020)
             10.1.12 SAMSUNG BIOLOGICS
                        TABLE 124 SAMSUNG BIOLOGICS: BUSINESS OVERVIEW
                        FIGURE 44 SAMSUNG BIOLOGICS: COMPANY SNAPSHOT (2020)
             10.1.13 COHERUS BIOSCIENCES
                        TABLE 125 COHERUS BIOSCIENCES: BUSINESS OVERVIEW
                        FIGURE 45 COHERUS BIOSCIENCES: COMPANY SNAPSHOT (2020)
             10.1.14 BIOCON LIMITED
                        TABLE 126 BIOCON LIMITED: BUSINESS OVERVIEW
                        FIGURE 46 BIOCON LIMITED: COMPANY SNAPSHOT (2020)
             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

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)
COVID-19

Get in-depth analysis of the COVID-19 impact on the Biosimilars Market

Benchmarking the rapid strategy shifts of the Top 100 companies in the Biosimilars Market

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