Biosimilars & Follow-On Biologics Market – By Technology , By Route of Administration , By Application , By Distribution Channel , By Geography - Opportunity Analysis & Industry Forecast, 2025-2031
Biosimilars & Follow-On Biologics Market Overview:
The Biosimilars & Follow-On Biologics Market size is estimated to reach $1050 billion by 2031, growing at a CAGR of 20.6% during the forecast period 2025-2031. The Biosimilars & Follow-On Biologics Market is witnessing robust growth due to the need for more affordable alternatives to expensive biologic treatments, especially in areas like cancer, immune system disorders and chronic conditions. The expiration of patents for popular biologic drugs and the rising healthcare needs in both developed and emerging countries are also contributing to the market's expansion.
Advancements in s helping global healthcare systems integrate biosimilars into care models, reduce costs, and support treatment decision-making. In October 2024, Archon Biosciences, with $20 million in seed funding to advance its computationally designed Antibody Cages. Additionally, patient and physician awareness is a growing trend too. For example, in April 2024, the US FDA launched the Biosimilars Action Plan to encourage innovation and competition in the biologics market. The plan outlines the FDA's commitments and focuses on initiatives that support the development of biosimilars and interchangeable biosimilars, aiming to improve patient access to these therapies and increase awareness among healthcare providers.
Market Snapshot:
Biosimilars & Follow-On Biologics Market - Report Coverage:
The “Biosimilars & Follow-On Biologics Market Report - Forecast (2025-2031)” by IndustryARC, covers an in-depth analysis of the following segments in the Biosimilars & Follow-On Biologics Market.
Key Takeaways:
Europe Leads the Market
In 2024, Europe leads the global biosimilars and follow-on biologics market, particularly in the insulin segment, thanks to its robust regulatory framework, early adoption of biosimilar policies, and strong emphasis on cost-effective healthcare. According to IQVIA, biologics represent 40% of medicine spending in Europe at list prices in 2024, underscoring their significant role in the region's pharmaceutical landscape. Global spending on medicines using list prices grew by 35% over the past five years and is projected to increase by 38% through 2028, with Europe expected to contribute an additional $70 billion in spending during this period. This growth is driven by new brands but will be offset by the increasing use of generics and biosimilars, which help control costs. According to Medicines in Europe, in December 2024, Biosimilar medicines competition has already delivered €56 billion in cumulative biologic treatment cost reductions across Europe.
Oncology is the largest
According to a February 2024 article by WHO, it is predicted that over 35 million new cancer cases will be diagnosed by 2050, marking a 77% increase from the 20 million cases estimated in 2022. Biologics, which harness the body's immune system to treat cancer, play a critical role in combating tumors, especially when other treatments are ineffective. As seen in a May 2024 strategic collaboration between Glenmark and BeiGene, Glenmark will oversee the development, registration, and distribution of BeiGene's innovative oncology medicines, Tislelizumab and Zanubrutinib, offering access to these life-saving treatments for cancer patients in India. This collaboration exemplifies the growing emphasis on biologics in the fight against cancer and highlights the increasing demand for biologic therapies in cancer care.
Monoclonal Antibodies are the largest segment
Monoclonal antibodies (mAbs) held the largest market share in 2024, due to their broad range of applications in both therapeutic and diagnostic settings. In June 2024, the U.S. Department of Defense (DoD) enlisted Just – Evotec Biologics, a subsidiary of Evotec, in a multi-year antibody manufacturing program, with a potential award of up to $39 million. The initiative focuses on accelerating monoclonal antibody development and manufacturing to enhance the U.S. government's rapid response capabilities for biologic medical countermeasures. Additionally, in November 2024, Precision Biologics, Inc. reported advancements in its monoclonal antibody PB-223, with research on its affinity maturation and characterization set to be presented at the Society for Immunotherapy of Cancer (SITC).
Increasing acceptance of biosimilars due to their cost-effectiveness drives the Market
As biosimilars enhance competition in the biopharmaceutical market, they are expected to reduce the costs associated with expensive biological medicines. A Jan 2025 article by the National Institute of Health highlights the positive impact of biosimilars, reporting that in Denmark, a nationwide mandatory switch from the originator drug (Humira) to biosimilar adalimumab did not increase total healthcare costs over a nine-month period. In fact, hospital costs even decreased for those who switched to the biosimilar, reinforcing the potential for biosimilars to lower healthcare expenses while providing effective alternatives to costly originator biologics.
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Key Market Players:
Product/Service launches, approvals, patents and events, acquisitions, partnerships, and collaborations are key strategies adopted by players in the Biosimilars & Follow-On Biologics Market. The top 10 companies in this industry are listed below:
- Pfizer Inc.
- Eli Lilly and Company
- Novartis AG
- Amgen Inc.
- Celltrion Inc.
- Samsung Bioepis Co., Ltd.
- Novo Nordisk A/S
- Bristol Myers Squibb Co.
- Sanofi S.A
- Dr. Reddy's Laboratories
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