The Biosimilars Market, estimated at USD 42.53 Bn in 2025, is expected to exhibit a CAGR of 18.1% and reach USD 136.37 Bn by 2032.
The market growth is fueled by rising demand for advanced biotechnology solutions that improve healthcare outcomes, along with increasing adoption in areas such as drug development, diagnostics, and personalized medicine. Innovations in genomics, cell and gene therapies, and biomanufacturing, supported by strong R&D investments, are enhancing treatment effectiveness, efficiency, and accessibility. Furthermore, favorable regulatory support, strategic collaborations, and the growing focus on precision medicine are accelerating market expansion and opening new opportunities for industry participants.
Market Dynamics:
Global biosimilars market growth is primarily driven by patent expiries of blockbuster biologics and significant cost savings opportunities. Patent expiries of blockbuster biologics such as Remicade, Herceptin, Avastin and others have led to the launch of biosimilar versions at lower price points as compared to reference products. This offered significant growth opportunities for biosimilar manufacturers globally. Furthermore, biosimilars offer cost savings of 20-30% over their reference products, thus, providing positive reimbursement environment for widespread adoption. Rising healthcare budgets and need for cost-effective treatment options can drive the biosimilars market growth. However, regulatory complexities especially in developed markets and associated development challenges can hamper the market growth. With advancements in manufacturing technologies and growing acceptance, global biosimilars market can witness growth over the forecast period.
Growing Demand for Cost-Effective Biologics
Rising costs of biologic drugs have placed a significant financial burden on healthcare systems around the world. As many blockbuster biologics are approaching patent expiry, biosimilars provide a more affordable alternative for patients and payers. With biosimilars offered at a discounted price compared to original biologics, healthcare systems are able to expand patient access to important treatments while saving valuable healthcare dollars. This growing demand for lower-cost yet high-quality biologic options can drive the biosimilars market growth.
Increasing Number of Biologic Patent Expiries
As patents for many first-generation biologics start to expire, it opens the door for biosimilar manufacturers to enter the market. Some of the biggest biologic blockbusters such as infliximab, rituximab and trastuzumab have already lost exclusivity in recent years. More biologic patents will reach the end of their patent life over the next decade, thus, boosting sales of biosimilar and offering growth opportunities for players in this industry. The wave of biologic patent expiries can drive the global biosimilars market growth.
Unclear Regulatory Guidelines
Regulatory pathways and approval guidelines for biosimilars are still evolving in many parts of the world. Unlike the well-established frameworks in regions such as Europe and the U.S., other emerging markets lack clear regulations and standards, raising uncertainty around the development and approval process for biosimilar products. This regulatory ambiguity poses challenges for companies seeking to expand into new global markets and hampers the market growth.
Physician Resistance and Patient Concerns
Despite demonstrating equivalent efficacy and safety, some physicians remain reluctant to widely prescribe biosimilars due to lingering doubts about interchangeability. Patient advocacy groups raise concerns around the substitution of biologics with similar but not identical copies. This reluctance from both physicians and patients hampers acceptance and uptake of biosimilars.
Growing Biosimilar Acceptance in Emerging Markets
While developed healthcare systems have boosted adoption of biosimilars, emerging markets in Asia, Latin America, Africa and Eastern Europe can drive the market growth. As regulatory frameworks solidify and healthcare budgets tighten in these regions, biosimilars provide an appealing solution to expand affordable access to biologic treatments. With their large populations and rapidly developing healthcare infrastructure, emerging markets will offer significant growth opportunities.
Pipeline of New Biosimilar Approvals
In addition to gaining approvals for direct copies of biologics that have lost patent protection, biosimilar developers are pipeline numerous "line extensions" - biosimilars that target distinct indications or delivery methods of the reference biologic. These next-generation pipeline assets could allow biosimilar companies to gain first-mover advantages. The rich pipeline of potential biosimilar approvals across different drug classes, routes of administration and global regions can drive the market growth.
Link: https://www.coherentmarketinsights.com/market-insight/biosimilars-market-750
Key Developments
- In July 2024, Amneal Pharmaceuticals, Inc., a pharmaceutical company, announced the inclusion of omalizumab, a biosimilar referencing XOLAIR, in its pipeline. Developed by Kashiv BioSciences, LLC, this humanized monoclonal antibody targets free immunoglobulin E (IgE) and is currently undergoing Phase III clinical trials initiated in Q3 2023.
- In May 2024, Biocon Biologics Ltd (BBL), a global biosimilars company and subsidiary of Biocon Ltd, received FDA approval for Yesafili (aflibercept-jbvf), an interchangeable biosimilar of EYLEA (aflibercept). Yesafili is a vascular endothelial growth factor (VEGF) inhibitor used to treat various ophthalmic conditions.
- In May 2022, Amneal Pharmaceuticals, Inc. received USFDA approval for a Biologics License Application (BLA) for pegfilgrastim-pbbk, a biosimilar of Neulasta, which will be marketed as FYLNETRA. This approval marks a significant milestone in the biosimilar landscape.
- In September 2021, Samsung Bioepis and Biogen announced USFDA approval of BYOOVIZ (ranibizumab-nuna), a biosimilar to LUCENTIS (ranibizumab), for treating neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. BYOOVIZ is notable as the first biosimilar in ophthalmology approved in the U.S.
Key Players: Amgen Inc., Pfizer Inc., Samsung Bioepis Co., Ltd., Sandoz International GmbH , Celltrion Healthcare Co., Ltd., Biocon Limited, Dr. Reddy's Laboratories Ltd., Teva Pharmaceutical Industries Ltd., Boehringer Ingelheim International GmbH, Fresenius Kabi AG, Merck & Co., Inc., Biogen Idec Inc, Coherus BioSciences, Stada Arzneimittel AG
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