Market Forecast by Regions and Countries (North America, Europe, LATAM, Middle East, Asia and Africa), By Product (Insulin, Follitropin, Calcitonin, Glucagon, Teriparatide, Others), By Indication (Oncology, Offsite Treatment, Chronic Disorders, Blood Disorders, Infectious Diseases, Others), By Manufacturing (Outsourced, In-house) And Competitive Landscape
| Product Code: ETC13408472 | Publication Date: Apr 2025 | Updated Date: Jul 2025 | Product Type: Market Research Report | |
| Publisher: 6Wresearch | Author: Ravi Bhandari | No. of Pages: 190 | No. of Figures: 80 | No. of Tables: 40 |
According to 6Wresearch internal database and industry insights, the Global Biosimilars Market size was estimated at USD 30.7 billion in 2025 and is anticipated to reach USD 90 billion by 2032, representing a CAGR of 13.3% during the forecast period 2026-2032.
Below is the evaluation of years-wise growth rate along with core growth drivers:
| Year | Est. Annual Growth (%) | Growth Drivers |
| 2021 | 3.1% | Regulatory approvals increased and adoption of cost-effective biosimilars in oncology and chronic disorder treatment. |
| 2022 | 5.5% | Awareness raised among healthcare professionals and patients about the affordability and efficacy of biosimilars. |
| 2023 | 7.6% | Biosimilars developed into new therapeutic areas, including autoimmune disorders and blood disorders. |
| 2024 | 9.2% | Production capabilities grew and more pharmaceutical companies entered the market. |
| 2025 | 11.5% | Biosimilar acceptance enhanced the emerging markets, as result demand for accessible biologic treatments increased. |
The Global Biosimilars Market report thoroughly covers the market by product, by indication, by manufacturing type, and by region. The report provides an unbiased and detailed analysis of ongoing market trends, opportunities/high growth areas, and market drivers, which would help stakeholders devise and align their market strategies according to current and future market dynamics.
| Report Name | Global Biosimilars Market |
| Forecast Period | 2026-2032 |
| CAGR | 13.3% |
| Growing Sector | Pharmaceuticals |
| Market Size | USD 90 billion by 2032 |
Global Biosimilars Market is experiencing rapid growth throughout the years due to growing adoption of biosimilars, which offer a cost-effective alternative to high-cost biologic drugs. As the chronic diseases prevails, including cancer and autoimmune disorders combined with the shift toward personalized medicine, is further accelerating the demand for biosimilars. Apart from this, shift is rising towards biosimilars in both developed and emerging markets is poised to continue, driven by the growing focus on reducing healthcare costs while maintaining therapeutic efficacy.
Below are the key growth drivers and their impacts on the market dynamics:
| Drivers | Primary Segments Affected | Why it matters (evidence) |
| Increasing Demand for Cost-Effective Treatments | By Product, By Indication | Rising healthcare costs are encouraging the adoption of biosimilars as affordable alternatives to branded biologics. |
| Expanding Approval of Biosimilars | By Product, By Manufacturing | A growing number of regulatory agencies are approving biosimilars, allowing for broader market access. |
| Rising Prevalence of Chronic Diseases | By Indication | Diseases such as cancer, autoimmune disorders, and chronic conditions drive the demand for more accessible biologic treatments. |
| Advancements in Biosimilar Manufacturing | By Manufacturing | Improved manufacturing processes enhance the cost-efficiency and scalability of biosimilar production, making them more competitive. |
| Increased Healthcare Awareness | By Product, By Indication | Enhanced awareness about the benefits of biosimilars is driving demand among healthcare professionals and patients. |
Global Biosimilars Market is estimated to grow at a strong CAGR of 13.3% during the forecast period from 2026 to 2032. There are many growth drivers which are contributing in the expansion of the market which include the increasing demand for affordable biologic treatments, a large number of regulatory approvals. Alongside, the market penetration is expanding in both developed and emerging economies. Further, advancements are occurring in biosimilar manufacturing processes and the growing prevalence of chronic diseases will provide further momentum for the market’s expansion.
Below are the major restraints and their influence on the market dynamics:
| Restraints | Primary Segments Affected | What this means (evidence) |
| High Development and Manufacturing Costs | By Product, By Manufacturing | As development and manufacturing biosimilars is expansive that can restrict market growth, especially in emerging economies. |
| Regulatory Barriers | By Product | Regulatory hurdles, for example approval process for biosimilars, can delay their market entry and hinder adoption. |
| Lack of Physician and Patient Awareness | By Product, By Indication | As awareness is growing among consumers, many physicians and patients started preferring branded biologics due to limited familiarity with biosimilars. |
| Patent Disputes and Legal Challenges | By Product | Consumers may face delays in the approval and commercialization of biosimilars due to current patent disputes and intellectual property issues. |
| Limited Access in Low-Income Regions | By Region | For low-income or rural regions, the adoption of biosimilars is low due to pricing and supply chain issues. |
There are many challenges affecting the Global Biosimilars Market Growth that could create also hurdles in the future. Some of the major issues are the high development costs, along with regulatory barriers, create significant entry barriers for new biosimilar products. Further, patent disputes and legal challenges further delay market entry. Also, there is a lack of awareness about biosimilars among physicians and patients, as well as limited access in low-income regions, can hinder the broader adoption of these products. To address these challenges will be major step to ensure the sustained growth of the biosimilars market.
Below are the major trends reshaping the landscape of Global Biosimilars Market, including:
Several investment opportunities exist in the Global Biosimilars Market which include:
Some of the leading companies operating the Global Biosimilars Market which include:
| Company Name | Sandoz |
| Established Year | 2003 |
| Headquarters | Basel, Switzerland |
| Official Website | Click Here |
This is a global leader in biosimilars, offering a broad portfolio across therapeutic areas including oncology, immunology, and haematology.
| Company Name | Amgen Inc. |
| Established Year | 1980 |
| Headquarters | Thousand Oaks, California, USA |
| Official Website | Click Here |
This has a significant biosimilars portfolio, with key offerings in oncology and nephrology, and is investing in expanding its biosimilars presence.
| Company Name | Samsung Bioepis |
| Established Year | 2012 |
| Headquarters | Incheon, South Korea |
| Official Website | Click Here |
This is specialized in the development and commercialization of high-quality biosimilars for multiple therapeutic areas.
| Company Name | Celltrion |
| Established Year | 2002 |
| Headquarters | Incheon, South Korea |
| Official Website | Click Here |
This is a major player in the biosimilars market, focusing on biologics and biosimilars in oncology and autoimmune disorders.
| Company Name | Mylan |
| Established Year | 1961 |
| Headquarters | Canonsburg, Pennsylvania, USA |
| Official Website | Click Here |
This company offers a range of biosimilars with a focus on affordability, providing access to biologic treatments in oncology, immunology, and other therapeutic areas.
Global Biosimilars Market is evolving with the regulatory frameworks, with agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the World Health Organization (WHO) developing clearer guidelines for biosimilar approval. The aim of these regulations is to ensure the safety, efficacy, and quality of biosimilars while promoting their accessibility and affordability. In many regions, biosimilars are subject to the same rigorous standards as the reference biologics which include clinical trials and post-marketing surveillance.
The future of Global Biosimilars Industry is expected to continue its rapid growth. In the expansion of market, there are many growth factors are set to contribute such as rising demand for affordable biologic treatments, regulatory advancements, and broader therapeutic applications. As the acceptance of biosimilars is growing in oncology, autoimmune disorders, and chronic conditions, the market will see expanded opportunities for both established players and new entrants. Now the main things for attention are sustainability, cost reduction, and healthcare accessibility that will also drive the adoption.
The report offers a comprehensive study of the following market segments and their leading categories:
According to Vasu, Senior Research Analyst, 6Wresearch, Insulin and glucagon biosimilars dominate the market due to the rising prevalence of diabetes, followed by growth in biosimilars for chronic conditions like rheumatoid arthritis and osteoporosis.
Oncology biosimilars lead the market, with increasing demand for biologic cancer therapies. Autoimmune disorders and chronic disorders are also significant segments, driven by high disease burden.
Outsourced manufacturing is becoming increasingly popular due to cost advantages, while in-house manufacturing remains dominant for companies that control the entire production process.
North America is set to hold the largest Global Biosimilars Market Share due to regulatory advancements and established healthcare systems, while the Asia Pacific region is expected to grow rapidly due to increased biosimilar adoption and manufacturing expansion.
The report provides a detailed analysis of the following market segments:
| 1 Executive Summary |
| 2 Introduction |
| 2.1 Key Highlights of the Report |
| 2.2 Report Description |
| 2.3 Market Scope & Segmentation |
| 2.4 Research Methodology |
| 2.5 Assumptions |
| 3 Global Biosimilars Market Overview |
| 3.1 Global Regional Macro Economic Indicators |
| 3.2 Global Biosimilars Market Revenues & Volume, 2022 & 2032F |
| 3.3 Global Biosimilars Market - Industry Life Cycle |
| 3.4 Global Biosimilars Market - Porter's Five Forces |
| 3.5 Global Biosimilars Market Revenues & Volume Share, By Regions, 2022 & 2032F |
| 3.6 Global Biosimilars Market Revenues & Volume Share, By Product, 2022 & 2032F |
| 3.7 Global Biosimilars Market Revenues & Volume Share, By Indication, 2022 & 2032F |
| 3.8 Global Biosimilars Market Revenues & Volume Share, By Manufacturing, 2022 & 2032F |
| 4 Global Biosimilars Market Dynamics |
| 4.1 Impact Analysis |
| 4.2 Market Drivers |
| 4.3 Market Restraints |
| 5 Global Biosimilars Market Trends |
| 6 Global Biosimilars Market, 2022 - 2032F |
| 6.1 Global Biosimilars Market, Revenues & Volume, By Product, 2022 - 2032F |
| 6.1.1 Overview & Analysis |
| 6.1.2 Global Biosimilars Market, Revenues & Volume, By Insulin, 2022 - 2032F |
| 6.1.3 Global Biosimilars Market, Revenues & Volume, By Follitropin, 2022 - 2032F |
| 6.1.4 Global Biosimilars Market, Revenues & Volume, By Calcitonin, 2022 - 2032F |
| 6.1.5 Global Biosimilars Market, Revenues & Volume, By Glucagon, 2022 - 2032F |
| 6.1.6 Global Biosimilars Market, Revenues & Volume, By Teriparatide, 2022 - 2032F |
| 6.1.7 Global Biosimilars Market, Revenues & Volume, By Others, 2022 - 2032F |
| 6.2 Global Biosimilars Market, Revenues & Volume, By Indication, 2022 - 2032F |
| 6.2.1 Overview & Analysis |
| 6.2.2 Global Biosimilars Market, Revenues & Volume, By Oncology, 2022 - 2032F |
| 6.2.3 Global Biosimilars Market, Revenues & Volume, By Offsite Treatment, 2022 - 2032F |
| 6.2.4 Global Biosimilars Market, Revenues & Volume, By Chronic Disorders, 2022 - 2032F |
| 6.2.5 Global Biosimilars Market, Revenues & Volume, By Blood Disorders, 2022 - 2032F |
| 6.2.6 Global Biosimilars Market, Revenues & Volume, By Infectious Diseases, 2022 - 2032F |
| 6.2.7 Global Biosimilars Market, Revenues & Volume, By Others, 2022 - 2032F |
| 6.3 Global Biosimilars Market, Revenues & Volume, By Manufacturing, 2022 - 2032F |
| 6.3.1 Overview & Analysis |
| 6.3.2 Global Biosimilars Market, Revenues & Volume, By Outsourced, 2022 - 2032F |
| 6.3.3 Global Biosimilars Market, Revenues & Volume, By In-house, 2022 - 2032F |
| 7 North America Biosimilars Market, Overview & Analysis |
| 7.1 North America Biosimilars Market Revenues & Volume, 2022 - 2032F |
| 7.2 North America Biosimilars Market, Revenues & Volume, By Countries, 2022 - 2032F |
| 7.2.1 United States (US) Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 7.2.2 Canada Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 7.2.3 Rest of North America Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 7.3 North America Biosimilars Market, Revenues & Volume, By Product, 2022 - 2032F |
| 7.4 North America Biosimilars Market, Revenues & Volume, By Indication, 2022 - 2032F |
| 7.5 North America Biosimilars Market, Revenues & Volume, By Manufacturing, 2022 - 2032F |
| 8 Latin America (LATAM) Biosimilars Market, Overview & Analysis |
| 8.1 Latin America (LATAM) Biosimilars Market Revenues & Volume, 2022 - 2032F |
| 8.2 Latin America (LATAM) Biosimilars Market, Revenues & Volume, By Countries, 2022 - 2032F |
| 8.2.1 Brazil Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 8.2.2 Mexico Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 8.2.3 Argentina Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 8.2.4 Rest of LATAM Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 8.3 Latin America (LATAM) Biosimilars Market, Revenues & Volume, By Product, 2022 - 2032F |
| 8.4 Latin America (LATAM) Biosimilars Market, Revenues & Volume, By Indication, 2022 - 2032F |
| 8.5 Latin America (LATAM) Biosimilars Market, Revenues & Volume, By Manufacturing, 2022 - 2032F |
| 9 Asia Biosimilars Market, Overview & Analysis |
| 9.1 Asia Biosimilars Market Revenues & Volume, 2022 - 2032F |
| 9.2 Asia Biosimilars Market, Revenues & Volume, By Countries, 2022 - 2032F |
| 9.2.1 India Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 9.2.2 China Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 9.2.3 Japan Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 9.2.4 Rest of Asia Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 9.3 Asia Biosimilars Market, Revenues & Volume, By Product, 2022 - 2032F |
| 9.4 Asia Biosimilars Market, Revenues & Volume, By Indication, 2022 - 2032F |
| 9.5 Asia Biosimilars Market, Revenues & Volume, By Manufacturing, 2022 - 2032F |
| 10 Africa Biosimilars Market, Overview & Analysis |
| 10.1 Africa Biosimilars Market Revenues & Volume, 2022 - 2032F |
| 10.2 Africa Biosimilars Market, Revenues & Volume, By Countries, 2022 - 2032F |
| 10.2.1 South Africa Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 10.2.2 Egypt Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 10.2.3 Nigeria Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 10.2.4 Rest of Africa Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 10.3 Africa Biosimilars Market, Revenues & Volume, By Product, 2022 - 2032F |
| 10.4 Africa Biosimilars Market, Revenues & Volume, By Indication, 2022 - 2032F |
| 10.5 Africa Biosimilars Market, Revenues & Volume, By Manufacturing, 2022 - 2032F |
| 11 Europe Biosimilars Market, Overview & Analysis |
| 11.1 Europe Biosimilars Market Revenues & Volume, 2022 - 2032F |
| 11.2 Europe Biosimilars Market, Revenues & Volume, By Countries, 2022 - 2032F |
| 11.2.1 United Kingdom Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 11.2.2 Germany Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 11.2.3 France Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 11.2.4 Rest of Europe Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 11.3 Europe Biosimilars Market, Revenues & Volume, By Product, 2022 - 2032F |
| 11.4 Europe Biosimilars Market, Revenues & Volume, By Indication, 2022 - 2032F |
| 11.5 Europe Biosimilars Market, Revenues & Volume, By Manufacturing, 2022 - 2032F |
| 12 Middle East Biosimilars Market, Overview & Analysis |
| 12.1 Middle East Biosimilars Market Revenues & Volume, 2022 - 2032F |
| 12.2 Middle East Biosimilars Market, Revenues & Volume, By Countries, 2022 - 2032F |
| 12.2.1 Saudi Arabia Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 12.2.2 UAE Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 12.2.3 Turkey Biosimilars Market, Revenues & Volume, 2022 - 2032F |
| 12.3 Middle East Biosimilars Market, Revenues & Volume, By Product, 2022 - 2032F |
| 12.4 Middle East Biosimilars Market, Revenues & Volume, By Indication, 2022 - 2032F |
| 12.5 Middle East Biosimilars Market, Revenues & Volume, By Manufacturing, 2022 - 2032F |
| 13 Global Biosimilars Market Key Performance Indicators |
| 14 Global Biosimilars Market - Export/Import By Countries Assessment |
| 15 Global Biosimilars Market - Opportunity Assessment |
| 15.1 Global Biosimilars Market Opportunity Assessment, By Countries, 2022 & 2032F |
| 15.2 Global Biosimilars Market Opportunity Assessment, By Product, 2022 & 2032F |
| 15.3 Global Biosimilars Market Opportunity Assessment, By Indication, 2022 & 2032F |
| 15.4 Global Biosimilars Market Opportunity Assessment, By Manufacturing, 2022 & 2032F |
| 16 Global Biosimilars Market - Competitive Landscape |
| 16.1 Global Biosimilars Market Revenue Share, By Companies, 2025 |
| 16.2 Global Biosimilars Market Competitive Benchmarking, By Operating and Technical Parameters |
| 17 Top 10 Company Profiles |
| 18 Recommendations |
| 19 Disclaimer |