Biosimilars Market Size
| Study Period | 2019 - 2029 |
| Market Size (2024) | USD 35.47 Billion |
| Market Size (2029) | USD 82.27 Billion |
| CAGR (2024 - 2029) | 18.32 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Need a report that reflects how COVID-19 has impacted this market and its growth?
Biosimilars Market Analysis
The Global Biosimilars Market size is estimated at USD 35.47 billion in 2024, and is expected to reach USD 82.27 billion by 2029, growing at a CAGR of 18.32% during the forecast period (2024-2029).
The impact of COVID-19 on the biosimilars market may be significant, and it has imposed a great challenge on the pharmaceutical companies focused on biosimilar development. The reduction in the approval by regulatory bodies of non-COVID therapeutics during the current pandemic is expected to delay the process of product approvals and launches, hindering the biosimilars market growth. Additionally, as per the research article titled "Impact of Covid-19 on Cancer Care: A Global Collaborative Study" published in September 2020, nearly 88% of the cancer care centers faced challenges in delivering usual cancer care for many reasons, including preventive measures, lack of personal protective equipment, and staff shortages due to COVID-19. As biosimilars are injections that need experts to be administered and as the supply chain was greatly impaired in the early pandemic phase, it has significantly impacted the market growth. Therefore, COVID-19 impacted the growth of the biosimilars industry in its initial phase, however, the resumption of supply chain activities and clinical trials for drug development globally will boost the biosimilars market growth rate over the coming years.
Moreover, several blockbuster biologic drugs of major pharmaceutical companies, such as Truvada, Chantix, Forteo, Ciprodex, Afinitor, and many other drugs, lost United States exclusivity in 2020. In the coming decade, there will be a rise in the patent expiration of several existing biological drugs, such as Erbitux, Avastin, and Orencia, which would provide an opportunity for many biosimilar companies as well as generic manufacturers to offer services specially tailored toward biosimilars. Factors such as the cost-effective nature of biosimilars, rising acceptance and adoption by various stakeholders, the need for diversification in technology and business models, and the growing prevalence of chronic diseases are expected to drive the global biosimilar market.
Furthermore, the growing burden of cancer and increasing deaths due to it create the need for affordable treatment and thus boost the growth of the biosimilars in the market. For instance, according to GLOBOCAN 2020, in the United States, there were 2,281,658 estimated new cases of cancer and nearly 612,390 deaths in 2020. Additionally, the largest biosimilar companies anticipated market growth over the forecast period through various strategic activities, such as product launches, mergers, and acquisitions. For instance, in July 2021, the Food and Drug Administration (FDA) approved Viatris Inc.'s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin-glargine-yfgn), a biosimilar to LANTUS (insulin glargine).
On the other hand, factors such as lack of definitive standards for approval and adequate profitability, given the greater risk with concerns regarding substitutability and interchangeability, discourage many companies from investing in this market, thereby impeding the growth of the biosimilars market.
Biosimilars Market Trends
The Oncology Segment Holds the Major Share in the Global Biosimilars Industry
The oncology biosimilars market segment is expected to hold the major share, and the high incidence of cancers worldwide is the major factor driving the growth of the studied segment over the forecast period. According to the International Agency for Research on Cancer 2020, the estimated number of new leukemia cases in 2020 was 474,519 globally. According to the same source, the disease also had significantly high mortality, with a total global death toll of 311,594. Additionally, according to estimates from the International Agency for Research on Cancer (IARC), by 2040, the global burden of cancer is expected to grow to 27.5 million new cancer cases and 16.3 million deaths worldwide. The increasing incidence of cancer cases is expected to drive the need for advanced cancer drugs for the effective treatment of patients.
Additionally, the increasing research and development activities by key players focused on oncology, along with rising approvals by different regulatory bodies, are expected to drive the studied oncology biosimilar industry 's growth. For instance, in December 2020, Amgen received United States Food and Drug Administration (USFDA) approval for its RIABNI (rituximab-arrx), a biosimilar to Rituxan (rituximab), for the treatment of adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis. Moreover, in May 2022, Biocon Biologics Ltd. and Viatris Inc. received approval from Health Canada across four oncology indications for Abevmy (Bevacizumab), a biosimilar to Roche's Avastin (Bevacizumab).
Thus, because of the factors mentioned above, the oncology segment is anticipated to witness significant growth over the forecast period.
North America Holds the Major Share and is Expected to Dominate the Biosimilars Market Over the Forecast Period
North America is anticipated to observe a significant CAGR over the forecast period in the biosimilars market share. The major factors driving the growth of the market studied in the region include the high incidence of chronic diseases, such as cancers, along with the increased investment in research and development activities by the top biosimilar companies. According to GLOBOCAN 2020, the number of new cancer cases diagnosed was 2,281,658 in the United States in 2020, with 612,390 deaths. Among all cancers, breast cancer had the highest incidence with 253,465 cases, followed by lung (227,875), prostate (209,512), and colon (101,809).
Moreover, North America is the hub for many key players in the market, such as Pfizer Inc., Mylan NV, Amgen Inc., and Coherus Biosciences Inc., among others. The increasing pipeline of products and new product launches increase the market growth in the region. For instance, in June 2020, Pfizer Inc. received United States approval for its pegfilgrastim biosimilar, Nyvepria, indicated for lowering infection incidence. Additionally, in February 2021, Coherus BioSciences, Inc. reported that the United States Food and Drug Administration ("FDA") has accepted for review the 351(k) Biologics License Application ("BLA") for CHS-1420, a Humira (adalimumab) biosimilar product candidate.
Thus, the market is expected to propel significantly over the forecast period in North America due to the high incidence of chronic diseases, such as cancer, and increasing R&D activities.
Biosimilars Industry Overview
The market is highly competitive, with many of the largest biosimilar companies dominating the market. The major players in the studied market comprise Novartis AG, Pfizer Inc., Amgen Inc., Coherus Biosciences Inc., Mylan NV (Viatris Inc.), and Samsung Bioepis Co., Ltd., among others. Most top biosimilar companies are adopting various growth strategies, such as acquisitions, partnerships, and new product launches, to secure their position in the global market.
Biosimilars Market Leaders
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Pfizer Inc
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Novartis AG
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Samsung Bioepies Co., Ltd
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Coherus Biosciences, Inc.
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Amgen Inc
*Disclaimer: Major Players sorted in no particular order
Biosimilars Market News
- In May 2022, Amneal Pharmaceuticals, Inc. received United States Food and Drug Administration ("FDA") approval for a Biologics License Application ("BLA") for pegfilgrastim-pbbk, a biosimilar referencing Neulasta. The product will be marketed under the proprietary name FYLNETRA.
- In September 2021, Samsung Bioepis and Biogen announced that the Food and Drug Administration (FDA) had approved BYOOVIZ (ranibizumab-nuna), a biosimilar to LUCENTIS (ranibizumab), for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. BYOOVIZ was the first ophthalmology biosimilar approved in the United States.
Biosimilars Market Report - Table of Contents
1. INTRODUCTION
- 1.1 Study Assumptions and Market Definition
- 1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
- 4.1 Market Overview
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4.2 Market Drivers
- 4.2.1 Several Blockbuster Biopharmaceuticals Going Off-patent over the Next Five to Ten Years
- 4.2.2 Growing Burden of Chronic Diseases and Increasing R&D Investments
- 4.2.3 Increasing Demand for Biosimilar Drugs Due to Their Cost Effectiveness
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4.3 Market Restraints
- 4.3.1 Concerns Regarding Substitutability and Interchangeability
- 4.3.2 Regulatory Uncertainty and Growing Competition from Biobetters
- 4.3.3 High Cost Involvement and Complexities in Manufacturing
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4.4 Porter's Five Forces Analysis
- 4.4.1 Threat of New Entrants
- 4.4.2 Bargaining Power of Buyers/Consumers
- 4.4.3 Bargaining Power of Suppliers
- 4.4.4 Threat of Substitute Products
- 4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD million)
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5.1 By Product Class
- 5.1.1 Monoclonal Antibodies
- 5.1.2 Recombinant Hormones
- 5.1.3 Immunomodulators
- 5.1.4 Anti-Inflammatory Agents
- 5.1.5 Other Product Classes
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5.2 By Application
- 5.2.1 Blood Disorders
- 5.2.2 Growth Hormonal Deficiency
- 5.2.3 Chronic and Autoimmune Disorders
- 5.2.4 Oncology
- 5.2.5 Other Applications
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5.3 Geography
- 5.3.1 North America
- 5.3.1.1 United States
- 5.3.1.2 Canada
- 5.3.1.3 Mexico
- 5.3.2 Europe
- 5.3.2.1 Germany
- 5.3.2.2 United Kingdom
- 5.3.2.3 France
- 5.3.2.4 Italy
- 5.3.2.5 Spain
- 5.3.2.6 Rest of Europe
- 5.3.3 Asia-Pacific
- 5.3.3.1 China
- 5.3.3.2 Japan
- 5.3.3.3 India
- 5.3.3.4 Australia
- 5.3.3.5 South Korea
- 5.3.3.6 Rest of Asia-Pacific
- 5.3.4 Middle East and Africa
- 5.3.4.1 GCC
- 5.3.4.2 South Africa
- 5.3.4.3 Rest of Middle East and Africa
- 5.3.5 South America
- 5.3.5.1 Brazil
- 5.3.5.2 Argentina
- 5.3.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
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6.1 Company Profiles
- 6.1.1 Pfizer Inc.
- 6.1.2 Eli Lilly and Company
- 6.1.3 Celltrion Healthcare
- 6.1.4 Viatris Inc. (Mylan)
- 6.1.5 Novartis AG
- 6.1.6 Samsung Bioepis Co. Ltd
- 6.1.7 Stada Arzneimittel AG
- 6.1.8 Teva Pharmaceutical Industries Ltd
- 6.1.9 Intas Pharmaceutical Ltd
- 6.1.10 LG Life Sciences (LG Chem)
- 6.1.11 Biocon Limited
- 6.1.12 Amgen Inc.
- 6.1.13 Dr. Reddy's Laboratories
- 6.1.14 Coherus Biosciences Inc.
- 6.1.15 Biocad
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
Biosimilars Industry Segmentation
As per the scope of the report, a biosimilar is a biologic that is "similar" to another biologic medicine (known as a reference product) that is already licensed by the US Food and Drug Administration (FDA). Biosimilars are highly similar to the reference product in terms of safety, purity, and potency but may have minor differences in clinically inactive components. In approving biosimilars, the FDA may require that manufacturers conduct a clinical study (or studies) sufficient to establish safety, purity, or potency in one or more uses for which the reference product is licensed, and the biosimilar seeks licensure. The biosimilars market is segmented by product class (monoclonal antibodies, recombinant hormones, immunomodulators, anti-inflammatory agents, and other product classes), application (blood disorders, growth hormonal deficiency, chronic and autoimmune disorders, oncology, and other applications), and geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated global biosimilar market sizes and trends for 17 countries across various regions. The report offers the value (USD million) for the above-mentioned segments.
| By Product Class | Monoclonal Antibodies | |
| Recombinant Hormones | ||
| Immunomodulators | ||
| Anti-Inflammatory Agents | ||
| Other Product Classes | ||
| By Application | Blood Disorders | |
| Growth Hormonal Deficiency | ||
| Chronic and Autoimmune Disorders | ||
| Oncology | ||
| Other Applications | ||
| Geography | North America | United States |
| Canada | ||
| Mexico | ||
| Geography | Europe | Germany |
| United Kingdom | ||
| France | ||
| Italy | ||
| Spain | ||
| Rest of Europe | ||
| Geography | Asia-Pacific | China |
| Japan | ||
| India | ||
| Australia | ||
| South Korea | ||
| Rest of Asia-Pacific | ||
| Geography | Middle East and Africa | GCC |
| South Africa | ||
| Rest of Middle East and Africa | ||
| Geography | South America | Brazil |
| Argentina | ||
| Rest of South America |
Biosimilars Market Research FAQs
How big is the Global Biosimilars Market?
The Global Biosimilars Market size is expected to reach USD 35.47 billion in 2024 and grow at a CAGR of 18.32% to reach USD 82.27 billion by 2029.
What is the current Global Biosimilars Market size?
In 2024, the Global Biosimilars Market size is expected to reach USD 35.47 billion.
Who are the key players in Global Biosimilars Market?
Pfizer Inc, Novartis AG, Samsung Bioepies Co., Ltd, Coherus Biosciences, Inc. and Amgen Inc are the major companies operating in the Global Biosimilars Market.
Which is the fastest growing region in Global Biosimilars Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Global Biosimilars Market?
In 2024, the North America accounts for the largest market share in Global Biosimilars Market.
What years does this Global Biosimilars Market cover, and what was the market size in 2023?
In 2023, the Global Biosimilars Market size was estimated at USD 28.97 billion. The report covers the Global Biosimilars Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Global Biosimilars Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
What are the growth drivers of the Biosimilar Market?
The growth drivers of the Biosimilar Market are a) Several blockbuster biopharmaceuticals going off-patent over the next five to ten years b) The increasing demand for biosimilar drugs due to their cost effectiveness
What are the major restraints in the Biosimilars Market?
The major restraints in the Biosimilars Market are a) High-cost involvement and complexities in manufacturing b) Concerns regarding substitutability and interchangeability
Biosimilars Industry Report
This comprehensive report offers a deep dive into the biosimilar industry, providing a detailed analysis of key market drivers and market segments. Mordor Intelligence offers customization based on your specific interests, including: 1. Type of Manufacturing: In-House Manufacturing and Contract Manufacturing 2. Procedure: Invasive and Non-Invasive 3. End Users: Hospitals, Clinics, Diagnostic Centers and Others
