Biosimilars Market Size, Share & Trends Analysis By Product (Recombinant Glycosylated Proteins, Recombinant Non-Glycosylated Proteins), By Application (Rheumatoid Arthritis, Oncology), By Region- Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2024-2033

The global biosimilars market size was valued at USD 29.45 billion in 2023 and is anticipated to reach around USD 150.26 billion by 2033, growing at a CAGR of 17.7% from 2024 to 2033.

Biosimilars Market Key Takeaways

• North America biosimilars market size accounted for USD 6.43 billion in 2023 and is expected to reach around USD 31.71 billion by 2032, growing at a CAGR of 17.3% from 2024 to 2033.
• Asia Pacific biosimilars market size was valued at USD 8.43 billion in 2023 and is projected to surpass around USD 46.03 billion by 2033, expanding at a CAGR of 18.5% from 2023 to 2033.
• The Europe biosimilars market size was valued at USD 9.84 billion in 2023 and is estimated to reach around USD 47.30 billion by 2033, growing at a CAGR of 17% between 2024 and 2033.
• North America dominated the market with the largest revenue share of 41.0% in 2023.
• Europe is the fastest growing in the market with market share of 25.11% in 2023.
• Asia Pacific is expected to expand at the fastest CAGR of 18.5% during the forecast period.
• By product, the monoclonal antibodies segment has captured around 41.19% of revenue share in 2023.
• By product, the insulin segment is projected to grow at a double-digit CAGR of 17.8% during the forecast period.
• By application, the oncology segment has contributed the largest market share of 24.51% in 2023.
• By application, the chronic and autoimmune disorders segment is growing at a CAGR of 17.9% during the forecast period.
• By manufacturer, the in-house segment accounted for the biggest market share of 84.71% in 2023.
• By manufacturer, the contract research and manufacturing services segment is poised to grow at a remarkable CAGR of 17.9% during the forecast period.

Market Overview

The biosimilars market represents one of the most transformative frontiers in modern pharmaceuticals. A biosimilar is a biologic medical product that is nearly identical to an original product (reference biologic) in terms of safety, efficacy, and quality, but is typically developed and marketed after the patent expiration of the original. Unlike generic small-molecule drugs, biosimilars are highly complex, requiring sophisticated manufacturing, testing, and regulatory pathways.

With biologics playing a central role in the treatment of cancer, autoimmune disorders, hormonal deficiencies, and more, their cost burden on healthcare systems is immense. Biosimilars offer a much-needed opportunity to reduce healthcare costs while maintaining therapeutic standards. In this context, global regulatory agencies, including the FDA (U.S.), EMA (Europe), and others, have developed dedicated pathways to fast-track the approval of biosimilars under rigorous comparability criteria.

Over the past decade, the biosimilars industry has rapidly matured. Major pharmaceutical companies have entered this space through in-house R&D and strategic partnerships. In parallel, emerging markets, particularly in Asia, are becoming manufacturing hubs due to cost advantages and supportive policies. The market's trajectory is being shaped by patent expirations of blockbuster biologics, rising biologic prescriptions, the global push for affordable healthcare, and greater acceptance among prescribers and patients.

However, the market still faces hurdles, particularly around physician education, switching hesitancy, pricing competition, and manufacturing complexities. Despite these, biosimilars are poised to drive significant change in global therapeutics access and reshape competitive dynamics across various therapeutic areas.

Major Trends in the Market

• Increased Approvals of Monoclonal Antibody (mAb) Biosimilars: Following the patent cliffs of blockbuster mAbs like Rituximab and Trastuzumab, biosimilar versions are rapidly gaining global regulatory approvals.

• Rapid Expansion in Oncology Therapeutics: Biosimilars are becoming mainstream in cancer treatment, supported by data from large real-world studies and clinical trials confirming their equivalence to originators.

• Growth of Contract Development and Manufacturing Organizations (CDMOs): More pharma companies are outsourcing biosimilar development to CDMOs to reduce costs and speed up time-to-market.

• Emergence of Interchangeability Designations: In markets like the U.S., the FDA is beginning to designate biosimilars as interchangeable, enabling pharmacy-level substitution and boosting uptake.

• Asia-Pacific as a Biosimilar Manufacturing Hub: India, South Korea, and China are leading in biosimilar production, driven by cost-effectiveness, skilled manpower, and regulatory agility.

• Shifting Physician and Payer Perceptions: Clinical confidence in biosimilars is improving, with insurers pushing for inclusion in formularies and therapeutic substitution in several therapeutic areas.

• Digital and AI Integration in Development: AI-powered platforms are now being utilized to predict molecular behavior, reduce development cycles, and enhance product comparability testing.

• Strategic Partnerships and Co-development Models: Global pharmaceutical giants are entering alliances with local firms to co-develop and commercialize biosimilars across various geographies.

Biosimilars Market Report Scope

Biosimilars Market Dynamics

DRIVER: Launch of novel biosimilars

Various key market players operating in the market have a strong emphasis on the development of biosimilars. As of December 2022, FDA has approved 40 biosimilars, and 25 have launched in the US. During the COVID-19 pandemic, FDA approvals slowed significantly; however, approvals rebounded in 2022, with seven new biosimilar approvals. All seven biosimilars approved in 2022 referenced products with previously approved biosimilars; no biosimilars were approved in 2022 referencing new reference products. 2022 also registered four new product launches, including the first two Lucentis (ranibizumab) biosimilars. Additionally, in 2022, FDA designated two new interchangeable biosimilars: Rezvoglar (referencing Lantus (insulin glargine)) and Cimerli (referencing Lucentis (ranibizumab)). Although there was an overall decline in approvals during the 2020 to 2021 timeframe, the number of development programs participating in the FDA’s Biosimilar Development Program has continued to rise. As of April 2023, there are around 60–70 biosimilars under pipeline studies. (Clinical.gov); half of them will be launched in three to four years. Growing approvals of biosimilars will ensure access to a greater pool of therapeutics and drive market growth.

RESTRAINT: Complexities in Manufacturing

Developing 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 must invest in clinical trials and post-approval safety monitoring programs similar to that of the original innovator companies. Developing a biosimilar is a complex process. Biosimilars, like all biologics, are produced through an intricate, multistep process using living cells. However, the cell line and manufacturing process of the reference product are proprietary and belong to the original manufacturer.

For new entrants, the cost of developing biosimilars ranges from USD 100–250 million, including the cost of constructing a plant capable of producing biosimilars on a large scale. Besides this, the estimated timeframe for setting up a biosimilar/biological production capacity is anywhere from five to seven years; the cost can vary based on the location. The requirement for such high investments extends the time for companies to break even or to get sufficient returns on investment. In addition, companies with manufacturing experience (especially in biologics), such as Amgen and Biogen Idec, will have a considerable advantage over new companies with no such manufacturing experience. Hence, large pharmaceutical companies are expected to dominate the market as they bring marketing, sales, R&D, and manufacturing expertise.

OPPORTUNITY: Emerging markets

Markets across the Asia Pacific, Latin America (LATAM), and the Middle East offer significant growth opportunities to biosimilar manufacturers primarily due to the presence of less-stringent regulatory guidelines in developing countries. They differ from established markets regarding regulatory pathways, payer perceptions, pricing, affordability, and competitive landscapes. China and India are considered attractive destinations for R&D outsourcing for global biosimilar development and manufacturing companies, mainly due to their low labor & laboratory setup costs and the availability of skilled resources. This has drawn significant attention from key market players.

The market in Asia Pacific is a dynamic and rapidly evolving industry, with several key players leading the way: Celltrion (South Korea), Samsung Bioepis (South Korea), Dr. Reddy’s Laboratories (India), Biocon, and Shanghai Henlius Biotech (China). These companies have been instrumental in developing and commercializing biosimilars in the region and are expected to continue driving innovation and growth in the coming years..

By Product

Monoclonal antibodies (mAbs) dominate the product segment, as they represent the largest class of biologics whose biosimilar versions are now entering the market. Blockbusters such as Trastuzumab (Herceptin), Adalimumab (Humira), and Rituximab (Rituxan) have biosimilar equivalents available across the U.S., Europe, and Asia. Due to their broad application in oncology and autoimmune conditions, they account for the highest revenue share. The extensive clinical data supporting their efficacy and safety has further enhanced their adoption, making them a pillar of the biosimilars industry.

Interferons and Teriparatide are among the fastest-growing biosimilar segments, albeit from a smaller base. Interferon biosimilars are widely used in hepatitis and multiple sclerosis management, particularly in emerging economies. Teriparatide biosimilars are increasingly used in osteoporosis treatment, especially in aging populations where affordability becomes critical. With the market expanding into more niche and specialized biologics, these segments are projected to grow steadily over the next decade.

By Application

Oncology holds the dominant application share due to the high cost burden of biologic cancer therapies. Biosimilars of Trastuzumab, Bevacizumab, and Rituximab are already integrated into cancer treatment guidelines in the U.S., EU, and Asia-Pacific. Hospitals and oncology clinics are increasingly turning to these alternatives to manage cost while maintaining treatment efficacy. Real-world studies further support their adoption, making biosimilars indispensable in modern oncology practice.

Chronic and autoimmune disorders are the fastest-growing application segment, driven by biosimilars of Etanercept, Adalimumab, and Infliximab being used to treat conditions such as rheumatoid arthritis, Crohn’s disease, and psoriasis. Payers are increasingly incentivizing biosimilar use through policy reforms and formulary changes. As awareness among patients and physicians increases, this segment is expected to witness exponential growth, particularly in developed markets.

Regional Analysis

Europe leads the global biosimilars market, largely due to its early adoption, favorable regulatory environment, and widespread physician confidence. The European Medicines Agency (EMA) approved the first biosimilar (Omnitrope) in 2006, setting a precedent for other global markets. With over 80 biosimilars approved and implemented across multiple therapeutic classes, Europe serves as the most mature market in terms of policy, adoption, and pricing transparency.

Germany, France, and the UK have robust biosimilar uptake rates, supported by government-driven substitution policies and value-based pricing models. The EU also maintains a streamlined regulatory pathway, encouraging faster access and broader product availability. Public health systems across Europe have incorporated biosimilars into standard treatment protocols, driving cost efficiency while maintaining quality standards.

Asia-Pacific is the fastest-growing region in the biosimilars landscape, fueled by large patient populations, improving healthcare access, and competitive manufacturing capabilities. Countries like India, China, and South Korea are leading biosimilar production and export due to cost-effective infrastructure and a skilled scientific workforce.

India's Biocon, for example, has successfully developed biosimilars of Trastuzumab and Insulin Glargine and partnered with global players for international distribution. South Korea’s Samsung Bioepis has emerged as a global biosimilar force, with products approved in the EU, U.S., and Latin America. Government incentives, expanding insurance coverage, and increasing biologic prescriptions are rapidly boosting regional demand.

Recent Developments

• March 2025: Amgen announced the European launch of Bekemv® (biosimilar of Eculizumab), a new entrant targeting rare blood disorders with a focus on pricing advantage and expanded access.

• January 2025: Biocon Biologics and Viatris launched Abevmy™, a biosimilar of Bevacizumab, in Canada and Latin America, extending their oncology portfolio across the Americas.

• December 2024: Samsung Bioepis entered a strategic collaboration with Organon to co-develop biosimilars in women’s health and autoimmunity, aiming for launch by 2027.

• October 2024: Celltrion received FDA approval for Zymfentra™, the first subcutaneous biosimilar of Infliximab, enabling improved administration convenience.

• August 2024: Pfizer launched a new biosimilar, Trazimera™ (Trastuzumab), in the Middle East and North Africa, aiming to boost access in cost-sensitive markets.

Biosimilars Market Top Key Companies:

• Novartis
• Synthon Pharmaceuticals, Inc.
• TevaPharmaceutical Industries Ltd.
• LG Life Sciences
• Celltrion
• Biocon
• Hospira
• Merck Serono
• Biogen idec, Inc.
• Genentech

Biosimilars Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Biosimilars market.

By Product

• Monoclonal Antibodies
  • Infliximab
  • Trastuzumab
  • Rituximab
  • Adalimumab
  • Other monoclonal antibodies
• Insulin
• Granulocyte Colony-Stimulating Factor
• Erythropoietin
• Recombinant Human Growth Hormone
• Etanercept
• Follitropin
• Teriparatide
• Interferons
• Anticoagulants
• Other drug class

By Application

• Oncology
• Growth Hormonal Deficiency
• Blood Disorders
• Chronic & Autoimmune Disorders
• Infectious Disease
• Others

By Manufacturer

• Contract Research and Manufacturing Services
• In-house

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)