Biosimilars Market Expands with Patent Expiries and Growing Need for Cost-Effective Biologics | Amgen Inc., Pfizer Inc., Sandoz Group AG, Teva Pharmaceuticals USA, Inc., Biogen

Global biosimilars market size reached US$ 22.58 billion in 2024 and is expected to reach US$ 171.79 billion by 2033, growing at a CAGR of 25.5% during the forecast period 2025-2033.

Biosimilars Market Report by DataM Intelligence offers a detailed assessment of the global pharmaceutical and healthcare landscape, highlighting market size, key players, and critical growth drivers. With patent expirations, supportive regulatory pathways, and the demand for cost-effective biologics, the report delivers strategic insights to support stakeholders in capturing biosimilar adoption trends from 2025 to 2033.

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Biosimilars are highly similar, but not identical, versions of approved biologic drugs. They offer cost-effective alternatives to branded biologics, especially in oncology, autoimmune, and metabolic disorders. The market is booming due to patent expirations, regulatory support, and efforts to lower healthcare costs, although physician and patient acceptance still varies by region.

Biosimilars Market Competitors Overview:

Amgen Inc., Pfizer Inc., Sandoz Group AG, Teva Pharmaceuticals USA, Inc., Biogen, Biocon Biologics Inc., Boehringer Ingelheim International GmbH, Samsung Bioepis, Dr. Reddy's Laboratories Ltd., Fresenius Kabi AG and among others.

Important Industry Updates of 2023, 2024 and 2025:

✅ In March 2025, Celltrion announced the U.S. launch of STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab), following approval by the U.S. Food and Drug Administration (FDA) in December 2024. STEQEYMA is approved for the same indications as STELARA, providing consistency in treatment for patients and healthcare providers.

✅ The first biosimilar approved by the FDA, Zarxio (a biosimilar of Neupogen), was approved in 2015 and marked a significant milestone. Since then, there have been 71 biosimilars approved by the U.S. Food and Drug Administration (FDA). The most recent biosimilar approval was Omlyclo (omalizumab-igec) on March 7, 2025, contributing to significant market growth in North America.

Methodology and Scope

The Biosimilars Market Report is built on a rigorous research methodology that integrates primary interviews, expert insights, and validated secondary data from company reports, industry publications, and reliable databases. Utilizing both bottom-up and top-down approaches, the analysis ensures high data accuracy through triangulation. The report covers current market dynamics, growth opportunities, and key strategic developments across global and regional markets.

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Biosimilars Market Segments Overview:

∎ By Product Type (Monoclonal Antibodies, Recombinant Human Growth Hormone (rhGH), Insulin, Anti-coagulants, Erythropoietin, Granulocyte Colony Stimulating Factor, Follitropin, Interferons and Others)
∎ By Application (Oncology, Chronic Diseases, Autoimmune Diseases, Infectious Diseases, Growth Hormone Deficiency, Hematology and Others)

The monoclonal antibodies (mAbs) segment will command the highest market share owing to the high cost and widespread use of original biologics like adalimumab and trastuzumab.

Regional Overview for Biosimilars Market:

⇥ North America (U.S., Canada, Mexico)
⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)
⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)
⇥ South America (Colombia, Brazil, Argentina, Rest of South America)
⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Europe leads the biosimilars market thanks to favorable regulatory policies and early market adoption. Asia Pacific is growing the fastest as local manufacturers expand, and biosimilar approvals rise across countries like China, India, and South Korea.

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The Report Covers:

➡ In-depth analysis of the demand-supply gap, market size estimates, SWOT and PESTEL analysis, along with global market forecasts.
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➡ Identification of high-potential and niche segments and regions demonstrating strong growth prospects.

People Also Ask:

➤ What are the current global trends in sales, production, imports, and exports within the Biosimilars market?
➤ Who are the leading manufacturers, and what are their production volumes, pricing strategies, and revenue metrics?
➤ What are the major opportunities and challenges facing vendors in this market?
➤ Which product categories, applications, or end-user segments are contributing most to market growth and share?
➤ What are the primary factors driving and restraining growth in the Biosimilars market?

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