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
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.
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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.
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 |
|
|
Growth Opportunities |
|
|
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.
Frequently Asked Questions (FAQs):
What is the size of Biosimilars Market?
The global Biosimilars Market size is projected to reach USD 44.7 billion by 2026, growing at a CAGR of 23.5%.
Why is Biosimilars Market Growing?
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.
Who all are the prominent players of Biosimilars Market?
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).
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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:
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)
Growth opportunities and latent adjacency in Biosimilars Market
I would like to know how much Covid-19 impacted the global revenue growth of the Biosimilars Market.
According to your study, what are some of the significant factors driving the growth of the biosimilars market?