Global Biosimilars Market Projected to Reach $72.29 Billion by 2035

The Future of the Global Biosimilars Market

The biosimilars market is poised for remarkable growth, projected to reach an impressive $72.29 billion by 2035. According to MarketsandMarkets, the market was valued at $32.75 billion in 2024 and incrementally increased to $35.04 billion in 2025. This growth trajectory reflects a robust compound annual growth rate (CAGR) of 7.5% from 2025 to 2035, underscoring the increasing demand for affordable and effective healthcare solutions.

Key Growth Drivers

Several factors are propelling this expansion in the biosimilars arena. The number of regulatory approvals for biosimilars is on the rise, enabling quicker entry into the market. In addition, many major biologics are nearing the end of their patent protection, allowing room for more affordable alternatives to flourish. Coupled with the growing prevalence of chronic diseases that necessitate efficient treatment options, these dynamics are reshaping the healthcare landscape.

Cost containment remains a significant consideration for global healthcare systems, creating pressures to find effective yet affordable treatment options. Concurrently, increased collaboration in research and development (R&D) among biopharmaceutical companies is significantly enhancing the pace of biosimilars development and commercialization.

Importantly, the first biosimilar version of Semaglutide, a highly regarded GLP-1 agonist, is slated to launch in China by 2026 and is expected to account for approximately 25% of the biosimilars market share by 2035. This landmark introduction highlights the transformative potential biosimilars hold in addressing current healthcare challenges.

Oncology: The Leading Segment

Oncology emerges as the foremost segment in the biosimilars market, driven by the escalating global cancer burden and the steep costs associated with biologic therapies. Biosimilars present an economical option for reference products, enabling greater patient access to critical interventions. The sustained investment in R&D within oncology solidifies biosimilars as strategic solutions for healthcare systems seeking affordability in treatment options. Key biosimilars for oncological applications include trastuzumab, bevacizumab, and rituximab, among others. The continuous stream of regulatory approvals promises further expansion within this segment.

Drug Class Dynamics

From a drug classification standpoint, biologic therapeutics such as infliximab and adalimumab are crucial for managing autoimmune diseases, cancers, chronic conditions, and infectious diseases. These monoclonal antibodies are created through recombinant DNA (rDNA) technology, granting them the ability to target precise antigens effectively. The introduction of biosimilars for these established medications is anticipated to lower healthcare expenditures and improve the accessibility of vital therapies. With a wave of patent expirations for leading monoclonal antibodies, increased market competition is likely to drive down prices and draw more pharmaceutical investment into their development. The versatility and affordability of these biosimilars across oncological and autoimmune therapies suggest they will play a vital role in shaping therapeutic options moving forward.

Regional Insights

Geographically, Europe stands out as the leading contributor to the biosimilars sector, thanks to favorable government policies, increased investments in R&D, and a mounting disease burden. Countries like France, Italy, Spain, Germany, and the UK are prominent players in this market space. The European Medicines Agency (EMA) has granted approval for 132 biosimilars across various therapeutic classes, facilitating improved patient access and decreased treatment costs. For instance, the recent approval of YESINTEK, Biocon Biologics' biosimilar of ustekinumab in February 2025, reaffirms Europe’s commitment to enhancing access to biologic therapies, bolstering its leading position in the global biosimilars sector.

Leading Industry Players

The biosimilars market is home to several significant players, including Sandoz Group AG, Pfizer Inc., Amgen Inc., and Biocon among others. Sandoz Group has been particularly aggressive in launching first-to-market products for high-value biologics, enhancing its capabilities in manufacturing and production.

In March 2025, Biocon partnered with Civica to jointly market insulin Aspart in the U.S., while Dr. Reddy’s Laboratories collaborated with Shanghai Henlius Biotech to commercialize HLX15, a biosimilar candidate to Darzalex in both the U.S. and Europe.

As the biosimilars market evolves, collaboration among stakeholders and proactive regulatory frameworks will be crucial for overcoming manufacturing complexities and advancing market penetration.

Conclusion

The projected growth of the biosimilars market to $72.29 billion by 2035 signals a paradigm shift towards more sustainable healthcare solutions. As innovative collaborations and regulatory measures continue to shape this landscape, access to affordable medications may soon become an achievable reality for many patients globally.