Biosimilar Market is Projected to Reach USD 210.4 Billion by 2034 | At CAGR 22.90%

Biosimilar Market Overview:

The global biosimilar market size was valued at USD 32.9 Billion in 2025. Looking forward, IMARC Group estimates the market to reach USD 210.4 Billion by 2034, exhibiting a CAGR of 22.90% from 2026-2034. Europe currently dominates the market. The expiration of patents for major biological drugs, growing awareness about the efficacy and cost-effectiveness of biosimilars, rising prevalence of chronic diseases worldwide, and continual advancements in biopharmaceutical manufacturing technologies are driving this growth. The biosimilar market size is expanding rapidly due to increasing demand for affordable alternatives to expensive biologics and growing recognition of biosimilars' therapeutic equivalence to reference biologics.

Biosimilars are highly similar versions of approved biological drugs, offering comparable safety, efficacy, and quality at significantly lower costs. Rising incidence of chronic and autoimmune diseases, along with supportive regulatory frameworks, are fueling global demand. Manufacturers are expanding their biosimilar portfolios across oncology, autoimmune disorders, diabetes, and blood disorders to attract healthcare providers and patients seeking cost-effective treatments. Additionally, the expansion of healthcare investments, streamlined approval processes, and strategic collaborations between biosimilar manufacturers and healthcare providers are expected to further boost the global biosimilar market size over the forecast period.

Study Assumption Years

• Base Year: 2025
• Historical Year/Period: 2020-2025
• Forecast Year/Period: 2026-2034

Biosimilar Market Key Takeaways

• Current Market Size: USD 32.9 Billion (2025)
• CAGR: 22.90% (2026-2034)
• Forecast Period: 2026-2034
• Europe dominates as the largest market, driven by supportive regulatory frameworks and early adoption of biosimilars.
• Infliximab is the leading molecule segment, while autoimmune diseases represent the largest indication segment.
• In-house manufacturing is the dominant production method, with growing acceptance among healthcare professionals.
• Market growth is supported by patent expirations of blockbuster biologics, regulatory support, and demand for affordable healthcare solutions.

Sample Request Link: https://www.imarcgroup.com/biosimilar-market/requestsample

Market Growth Factors

The biosimilar market is being propelled by increasing patent expirations of blockbuster biologics, rising healthcare costs, and growing prevalence of chronic diseases. Many blockbuster biologics that have proved critical in treating chronic diseases are nearing the end of their patent protection. Big pharmaceutical companies such as Bristol Myers Squibb, Merck, and Johnson & Johnson face threats that will put tens of billions of dollars in sales at risk between now and 2030, as key blockbuster drugs approach patent expiration. When patents expire, it opens the door for biosimilar manufacturers to develop and market similar products at lower prices, making vital treatments more accessible to a larger patient population. Chronic diseases responsible for 75% of all global deaths are rapidly increasing, driving urgent healthcare concerns worldwide and creating substantial demand for cost-effective therapeutic alternatives.

Regulatory support and streamlined approval processes are significantly contributing to market growth. Regulatory agencies such as the FDA and EMA have established robust frameworks and guidelines to ensure the safety, efficacy, and quality of biosimilars. These supportive regulatory environments facilitate the approval and market entry of biosimilars. For instance, in February 2024, the European Medicines Agency (EMA) proposed to waive comparative efficacy studies for biosimilars with straightforward mechanisms of action, such as monoclonal antibodies and recombinant proteins, to decrease the number of human investigations required. The implementation of supportive policies, such as the Biologics Price Competition and Innovation Act (BPCIA) in the United States, encourages biosimilar approval and market access. Clear regulatory pathways and streamlined approval processes enhance confidence among healthcare providers and patients, encouraging biosimilar adoption.

Another contributor is the increasing demand for affordable healthcare solutions amid rising treatment costs. The increasing cost of healthcare, particularly in managing chronic diseases such as cancer, diabetes, and autoimmune disorders, is raising demand for cost-effective alternatives to expensive biologics. In a recent study conducted by the Postgraduate Institute of Medical Education and Research (PGI), it was found that cancer treatment costs during outpatient consultations are substantially higher than hospitalization costs. Diagnostics accounted for 36.4% of total expenditure, with medicines making up an additional 28%. Biosimilars offer similar therapeutic benefits at a fraction of the cost, making them attractive options for both healthcare providers and patients. The push for affordable healthcare solutions is further supported by governments and insurance companies seeking to manage healthcare expenditures without compromising on care quality.

Technological advancements in biopharmaceutical manufacturing have also enhanced biosimilar production. Advances in scientific research and technology have expedited biosimilar development, allowing for improvements to biologics introduced over a decade ago. Biosimilars are emerging as an important drug category, offering therapeutic options comparable to biologics in efficacy, safety, and immunogenicity, but at reduced costs.

Advanced analytical tools and manufacturing processes enable biosimilar developers to demonstrate clinical safety and efficacy while maintaining stringent quality standards. For instance, in May 2024, Biocon Biologics announced that the U.S. FDA approved its biosimilar aflibercept, Yesafili, a vascular endothelial growth factor (VEGF) inhibitor approved for treating several ophthalmic conditions. The growing number of collaborations between biosimilar manufacturers and healthcare providers, along with strategic acquisitions, have strengthened distribution networks, ensuring broader patient access to these therapies.

Market Segmentation

• Molecule:

o Infliximab: Leads the market in 2024; this monoclonal antibody is used specifically in autoimmune diseases such as rheumatoid arthritis and Crohn's disease, offering cost-efficient biological treatments following the patent expiration of Remicade.

o Insulin Glargine: Used for diabetes management, providing affordable alternatives for long-acting insulin therapy.

o Epoetin Alfa: Treats anemia associated with chronic kidney disease and chemotherapy.

o Etanercept: Used for treating autoimmune diseases including rheumatoid arthritis and psoriasis.

o Filgrastim: Stimulates white blood cell production in cancer patients undergoing chemotherapy.

o Rituximab: Used in oncology and autoimmune disease treatment.

o Adalimumab: Treats various autoimmune conditions with biosimilar versions gaining market traction.

o Trastuzumab and Bevacizumab: Important oncology biosimilars for breast and colorectal cancer treatment.

o Others: Including Somatropin, Follitropin Alfa, and Pegfilgrastim.

• Indication:

o Autoimmune Diseases: Lead the market in 2024; includes rheumatoid arthritis, psoriasis, and inflammatory bowel disease, where biosimilars provide affordable treatment for chronic conditions.

o Oncology: Growing segment with biosimilars addressing various cancer types, reducing treatment costs significantly.

o Diabetes: Biosimilar insulin products offer cost-effective management for diabetic patients.

o Blood Disorders: Includes treatments for anemia and neutropenia.

o Growth Deficiency: Somatropin biosimilars for growth hormone deficiency.

o Female Infertility: Follitropin biosimilars for fertility treatments.

o Others: Additional therapeutic areas with emerging biosimilar applications.

• Manufacturing Type:

o In-house Manufacturing: Leads the market in 2024, allowing companies control over quality, cost, and scalability; enables streamlined processes, stringent quality standards, and quick market response.

o Contract Manufacturing: Outsourced production to specialized manufacturers, offering flexibility and reduced capital investment for biosimilar developers.

Regional Insights

Europe currently dominates the market in 2024, driven by a supportive regulatory environment that has allowed several biosimilars to enter the European market before other regions. The European Medicines Agency (EMA) has been a forerunner in creating clear and supportive regulatory frameworks for biosimilar approval since 2005, earlier than many other regions. This early start enabled Europe to gain significant market share. The increasing awareness and acceptance of biosimilars among healthcare professionals and patients in Europe increases uptake across the region. For instance, in January 2024, Sandoz announced the launch of Tyruko® (natalizumab) in Germany, the first and only biosimilar designed to treat relapsing-remitting multiple sclerosis (RRMS). The rising number of cancer cases in Europe further drives biosimilar adoption, with cancer fatalities climbing 2.4% in 2022 compared to 2020, while new cancer cases grew 2.3% to 2.74 million.

The United States is witnessing significant growth due to the need for cost-efficient healthcare, as biosimilars offer options for lowering the high cost of biologic drugs. The US accounts for approximately USD 4.3 Trillion of the USD 10 Trillion global healthcare expenditure, driving growing investments in healthcare infrastructure and advanced treatments. The implementation of supportive policies, such as the Biologics Price Competition and Innovation Act (BPCIA), encourages biosimilar approval. Growing collaborations between biosimilar manufacturers and healthcare providers, along with strategic acquisitions, have strengthened distribution networks. For instance, in January 2024, Sandoz announced an agreement to acquire the U.S. biosimilar ranibizumab, CIMERLI®, from Coherus BioSciences for USD 170 Million, strengthening Sandoz's ophthalmology portfolio.

Asia-Pacific is experiencing rapid growth driven by the rising prevalence of chronic diseases, particularly diabetes. According to WHO, approximately 77 million adults in India suffer from type 2 diabetes, with nearly 25 million others at high risk due to prediabetes. There is increased demand for affordable treatments in the region due to diabetes-related health issues. Healthcare systems in countries with large diabetic populations use biosimilars to reduce the economic burden that diabetes care imposes. As regional healthcare systems continue to emerge, biosimilars are taking on a growing role in disease management.

Latin America's market growth is influenced by the expanding pharmaceutical sector. Brazil ranks sixth in the world for medications and pharmaceuticals, with a 26.2% rise in sales in 2022 over 2021. This growth encourages biosimilar uptake as they provide more affordable treatment choices. The pharmaceutical sector's expansion supports the creation and accessibility of biosimilar treatments, with biosimilars forming an important part of sustainable healthcare growth.

The Middle East and Africa market is driven by government policies and measures to expand healthcare services. Saudi Arabia allocated 60% of the GCC's healthcare expenditure, budgeting USD 50.4 Billion for healthcare and social development in 2023, representing 16.96% of the national budget. These regions try to bridge gaps in healthcare delivery and increase access to essential medicines, with biosimilars providing cost-efficient treatment options for rising cases of cancer, diabetes, and cardiovascular diseases.

Recent Developments & News

• May 2024: Biocon Biologics announced that the U.S. FDA approved its biosimilar aflibercept, Yesafili, a VEGF inhibitor approved for treating several ophthalmic conditions including neovascular age-related macular degeneration and diabetic macular edema.

• January 2024: Sandoz announced an agreement to acquire the U.S. biosimilar ranibizumab, CIMERLI®, from Coherus BioSciences for USD 170 Million, including biologics license application, product inventory, and ophthalmology sales talent.

• January 2024: Sandoz launched Tyruko® (natalizumab) in Germany, the first and only biosimilar designed to treat relapsing-remitting multiple sclerosis.

• February 2024: The European Medicines Agency (EMA) proposed to waive comparative efficacy studies for biosimilars with straightforward mechanisms of action to decrease the number of human investigations required.

• September 2023: CVS launched a new biosimilar brand, signaling increasing investment in the biosimilar space.

Key Players

• Sandoz International GmbH
• Pfizer Inc.
• Teva Pharmaceutical Industries Limited
• Celltrion Inc.
• Biocon Limited
• Samsung Biologics
• Amgen, Inc.
• Dr. Reddy's Laboratories Limited
• Stada Arzneimittel AG

If you require any specific information that is not covered currently within the scope of the report, we will provide the same as a part of the customization.

Ask An Analyst: https://www.imarcgroup.com/request?type=report&id=497&flag=C

About Us

IMARC Group is a global management consulting firm that helps the world's most ambitious changemakers to create a lasting impact. The company provide a comprehensive suite of market entry and expansion services. IMARC offerings include thorough market assessment, feasibility studies, company incorporation assistance, factory setup support, regulatory approvals and licensing navigation, branding, marketing and sales strategies, competitive landscape and benchmarking analyses, pricing and cost research, and procurement research.

Contact Us
IMARC Group,
134 N 4th St. Brooklyn, NY 11249, USA,
Email: sales@imarcgroup.com,
Tel No: (D) +91 120 433 0800,
United States: +1-201971-6302

This release was published on openPR.