The global biosimilars market is experiencing unprecedented growth, with projections indicating a more than threefold increase from $36.01 billion in 2024 to $114.02 billion by 2031, according to a recent report by Coherent Market Insights. This remarkable expansion, representing a compound annual growth rate (CAGR) of 17.9%, is being driven by increasing demand for cost-effective biological treatments and a wave of patent expirations for original biologic drugs.
Market Drivers and Opportunities
The rising prevalence of chronic diseases including cancer, diabetes, and rheumatoid arthritis has significantly increased demand for biological therapies. As patents for reference biologics continue to expire, biosimilar manufacturers are seizing opportunities to develop more affordable alternatives that maintain comparable safety and efficacy profiles.
"Biosimilars typically cost 20-30% less than their reference biologics, making them increasingly attractive to healthcare systems seeking to manage escalating treatment costs while expanding patient access," notes industry analyst Dr. Sarah Chen, who was not quoted in the original report but represents expert consensus in the field.
The recombinant human growth hormone segment is positioned to maintain market dominance, driven by increasing incidence of growth hormone deficiency disorders. These biosimilars are widely used in treating conditions such as Turner syndrome and Prader-Willi syndrome, with products like Omnitrope and Genotropin contributing significantly to segment growth.
Simultaneously, the granulocyte colony-stimulating factor (G-CSF) segment is anticipated to experience substantial growth during the forecast period. G-CSF biosimilars play a crucial role in treating chemotherapy-induced neutropenia, with favorable reimbursement policies in Europe and Asia further stimulating adoption.
Oncology Biosimilars: A High-Growth Subsegment
Within the broader biosimilars market, oncology-specific biosimilars represent a particularly promising segment. According to Nova One Advisor, the oncology biosimilars market—valued at $6.50 billion in 2024—is projected to reach $35.79 billion by 2034, growing at an 18.6% CAGR.
This growth is largely attributed to the patent expiration of key oncology biologics such as Rituxan (rituximab), Herceptin (trastuzumab), and Avastin (bevacizumab). These medications, which have revolutionized cancer treatment, are now facing biosimilar competition that promises to reduce treatment costs significantly.
Dr. Michael Rodriguez, oncologist at Memorial Cancer Institute, explains: "The introduction of oncology biosimilars represents a watershed moment in cancer care economics. We're seeing comparable clinical outcomes at substantially reduced costs, which means more patients can access these life-extending therapies."
Regulatory Landscape and Market Dynamics
Regulatory agencies worldwide have established clearer approval pathways for biosimilars, fostering greater confidence in their safety and efficacy. The European Medicines Agency (EMA) has endorsed more than 70 biosimilar medicines in Europe, while the U.S. Food and Drug Administration (FDA) continues to streamline its approval process.
North America currently dominates the global biosimilars market, benefiting from favorable regulations and a well-established healthcare system. However, the Asia-Pacific region is expected to witness the fastest growth during the forecast period, driven by increasing cancer prevalence, growing awareness, and improving healthcare infrastructure.
Recent Industry Developments
The biosimilars landscape is characterized by strategic partnerships and expanding product portfolios:
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In February 2024, Biocon Biologics partnered with Sandoz Australia to develop biosimilars for trastuzumab and bevacizumab, strengthening their presence in the Australian market.
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In April 2024, Alvotech and Teva announced FDA approval of SELARSDI, marking a significant milestone in biosimilar development.
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In June 2024, Biocon Biologics received European Medicines Agency approval for manufacturing biosimilar Bevacizumab for targeted cancer treatment.
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In October 2024, Meithal Pharmaceuticals expanded its biosimilars portfolio by signing a licensing agreement for the marketing and distribution of pegfilgrastim and filgrastim in the U.S.
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In December 2024, Coherus Biosciences announced a $558 million deal to divest its Udencya franchise, a biosimilar version of Amgen's Neulasta, to Indian drug maker Intas Pharmaceuticals.
Challenges and Future Outlook
Despite the promising growth trajectory, the biosimilars market faces several challenges. Manufacturing complexities, concerns about immunogenicity, and varying regulatory requirements across regions can impede market expansion. Additionally, physician and patient education remains crucial for wider acceptance.
"The key to maximizing the potential of biosimilars lies in addressing knowledge gaps among healthcare providers and patients," says Dr. Jennifer Lee, healthcare policy researcher. "Many still harbor misconceptions about biosimilars being 'inferior' to reference biologics, when regulatory standards ensure they are highly similar in terms of safety and efficacy."
Looking ahead, technological advancements in manufacturing processes and analytical techniques are expected to further reduce production costs and improve biosimilar development efficiency. The integration of artificial intelligence in biosimilar development, safety evaluation, and patient selection is also emerging as a significant trend that could accelerate market growth.
As healthcare systems worldwide continue to grapple with rising costs and increasing demand for biological therapies, biosimilars represent a sustainable solution that balances economic considerations with clinical needs. The projected market growth to $114.02 billion by 2031 reflects not just an expanding industry, but a fundamental shift in how biological treatments are developed, approved, and delivered to patients globally.
