Biosimilars Market – Trends Forecast Till 2031

Market Snapshot

Market Overview

The global Biosimilars Market size was estimated at USD 24,000 million in 2024 and is projected to reach USD 84,058.8 million in 2031 at a CAGR of 19.61 % during the forecast period 2025-2031.

The biosimilars market refers to the segment of the pharmaceutical industry that deals with the development, production, and marketing of biologic medical products that are highly similar to already approved reference biologics. These products are typically large, complex molecules derived from living organisms, and they offer an alternative to expensive biologic treatments. Biosimilars are not identical to their reference products due to inherent variability in biologics, but they are proven to have no clinically meaningful differences in terms of safety, efficacy, and quality. The approval of biosimilars provides patients with access to more affordable treatment options for conditions such as cancer, autoimmune disorders, and chronic diseases.

The scope of the biosimilars market extends to a wide range of therapeutic areas, including oncology, immunology, haematology, and endocrinology. As more reference biologics lose patent protection, the biosimilars market is expected to experience significant growth. The market is primarily driven by the increasing demand for cost-effective healthcare solutions and the growing prevalence of chronic and life-threatening diseases. Additionally, the regulatory framework in regions such as the United States, Europe, and Japan has become more supportive of biosimilar approvals, further expanding the potential for market penetration.

Key trends in the biosimilars market include advancements in manufacturing technologies, which are reducing production costs and improving the scalability of biosimilar products. Additionally, there is a growing emphasis on the adoption of biosimilars in both emerging and developed markets, driven by the increasing healthcare burden and rising awareness about the affordability of biologic treatments. Strategic partnerships and collaborations between pharmaceutical companies, as well as acquisitions of biosimilar companies by established biopharma giants, are also contributing to market consolidation and accelerated product development.

Drivers of the biosimilars market include the expiring patents of blockbuster biologic drugs, which create opportunities for the development of biosimilars at a fraction of the cost. The global healthcare shift toward value-based care is also boosting demand for more affordable biologic therapies. Furthermore, government initiatives to regulate and incentivize the use of biosimilars, along with increasing public and healthcare provider awareness of their benefits, are enhancing the market's growth prospects. As biosimilars continue to gain approval and adoption, the market is poised to transform the landscape of biologic treatment options, making life-saving therapies more accessible to a broader population.

Delvens Industry Expert's Standpoint

Experts in the Biosimilars Market highlight several key trends driving growth and innovation. The biosimilars market focuses on the development, production, and marketing of biologic products that are highly similar to approved reference biologics, offering more affordable alternatives for treating conditions like cancer and autoimmune disorders. With the expiration of patents for several blockbuster biologic drugs, the market is experiencing significant growth, driven by the increasing demand for cost-effective healthcare solutions and the rising prevalence of chronic diseases. Key trends include advancements in manufacturing technologies, strategic partnerships, and expanding adoption in both emerging and developed markets. Regulatory support and government incentives further boost the market, making biosimilars an essential component of the evolving healthcare landscape.

Market Portfolio

Key Findings

• The biosimilars market is divided into filgrastim & peg-filgrastim, monoclonal antibodies, and other drug classes. The monoclonal antibodies segment has become a major player in the market, owing to the growing use of these therapeutics in treating chronic conditions, especially cancer. Market players are focused on obtaining regulatory approvals for their products across various indications, further propelling the segment's growth. An example of this trend is the agreement between Samsung Bioepis Co., Ltd. and Sandoz to commercialize SB17, a biosimilar to Janssen Pharmaceuticals' Stelara, which targets autoimmune disorders. The filgrastim & peg-filgrastim segment follows closely, as these drugs help reduce infection risks in cancer patients, offering benefits like longer half-life and slower elimination rates, which improve patient compliance and lower treatment costs. The other segment, which includes TNF blockers, insulins, and human parathyroid hormones, is expected to grow steadily over the coming years.

• The autoimmune diseases segment has been a leading force in the biosimilars market, as it includes prevalent conditions like arthritis and psoriasis. The increasing geriatric population, particularly those affected by autoimmune diseases, is driving the demand for affordable treatment options. This is reflected in the growing emphasis by market players on securing regulatory approvals for these indications. As an example, nearly half of people aged 65 and older are diagnosed with arthritis, highlighting the need for cost-effective solutions. The cancer segment holds the second-largest share, fueled by a growing pipeline of biosimilar candidates undergoing clinical trials for various types of cancer, promising further growth potential. The other segment, which covers retinal diseases and kidney conditions, is also expected to see steady demand.

• The hospital pharmacies segment was the largest distribution channel in the biosimilars market, driven by increasing awareness among patients regarding the cost and efficacy of biosimilars, often communicated by healthcare professionals. In addition, favorable reimbursement policies in certain regions are boosting product procurement within hospitals. The retail pharmacies segment holds a significant share of the market as well, benefiting from the efforts of biosimilar companies to expand their product availability through retail chains. Online pharmacies are expected to experience the fastest growth, due to the convenience of direct drug delivery, which has proven to be an appealing factor for consumers looking for timely access to medication.

• The market is also divided into various regions such as North America, Europe, Asia-Pacific, South America, and Middle East and Africa. Europe region is projected to hold the largest market share. Factors such as Patent Expirations, Cost-Effectiveness, Increasing Healthcare Demand, Regulatory Approvals, Improved Access, Technological Advancements, Rising Adoption in Oncology and Autoimmune Diseases, Government Support have triggered the Biosimilars Market in the region.

Regional Analysis

Europe to Dominate the Market

• North America is projected to experience significant growth, with an increasing market share over the forecast period. The U.S. FDA’s established regulatory approval pathway for biosimilars has accelerated product approvals. As more biosimilars gain approval, particularly in oncology, and as biological reference products lose exclusivity, the market is expected to witness a sharp rise. By offering more affordable alternatives and increasing price competition, biosimilars can help alleviate the economic strain on healthcare systems, thus driving growth across the region.

• Europe, valued at USD 10.31 billion in the forecast year, is likely to maintain its dominant position in the market throughout the forecast period. Recent updates to the regulatory framework regarding the interchangeability of biosimilars in Europe have reduced uncertainty and facilitated their clinical adoption. Since 2006, the European Medicines Agency has approved 86 biosimilars, primarily in oncology, diabetes, and rheumatoid arthritis. With biosimilars offering the same clinical benefits at a lower price, payers find them increasingly attractive, leading to substantial savings that can be reallocated to other areas of healthcare.

• Asia Pacific is forecasted to show strong market growth, with a projected uptick in demand driven by the cost-effectiveness of generic biosimilars. Regional market players are increasingly forming strategic partnerships to broaden their presence in emerging markets. For example, Biocon Ltd.'s agreement with Yoshindo Inc. to commercialize biosimilars in Japan is expected to increase access and adoption of these products. These efforts are likely to boost the overall market growth in the region as more patients benefit from affordable treatment options.

• Latin America and the Middle East & Africa are anticipated to experience more modest growth rates. However, growing expenditure on chronic disease treatments and the availability of cost-effective biosimilar drugs are expected to drive the market forward in these regions, albeit at a slower pace compared to other regions.

Competitive Landscape

• Novartis AG
• Pfizer Inc.
• Amgen Inc.
• Dr. Reddy’s Laboratories Ltd.
• Eli Lilly and Company
• Teva Pharmaceutical Industries
• Fresenius Kabi AG
• Stada Arzneimittel AG
• Boehringer Ingelheim International GmbH
• F. Hoffmann-La Roche Ltd
• Celltrion Healthcare Co., Ltd.
• Samsung Biologics
• Coherus Biosciences
• Biocon
• Amega Biotech
• Apotex Inc.
• BioCAD
• Mabxience
• Probiomed
• Fujifilm Kyowa Kirin Biologics Co., Ltd.
• Intas Pharmaceuticals Ltd.

Recent Developments

• In October 2023, Pfizer’s Abrilada (adalimumab-afzb) gained approval from the U.S. FDA as the second interchangeable Humira biosimilar. The interchangeable designation is granted to biosimilars that meet stringent data requirements, showing that switching between the reference product and the biosimilar results in the same clinical outcomes as treatment with the reference product alone.

• In July 2023, Boehringer Ingelheim introduced the first interchangeable branded version of Humira, Cyltezo (adalimumab-adbm), in the U.S. This launch aligns with their goal of offering a more affordable and accessible treatment option for patients across the U.S.

• In January 2023, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) authorized Ximluci, a ranibizumab biosimilar developed by STADA Arzneimittel and Xbrane Biopharma. This approval will enhance patient access to ranibizumab in the U.K.

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