Biosimilars & Follow-On Biologics Market to Touch $ 1050 Billion by 2031

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, according to a recent report published by IndustryARC, titled, “Biosimilars & Follow-On Biologics Market – By Technology (Mammalian Expression Systems, Microbial Expression Systems, Yeast Expression Systems, Plant-Based Expression Systems), Product ( Monoclonal Antibodies, Insulin, Granulocyte Colony-Stimulating Factor, Erythropoietin, Recombinant Human Growth Hormone, Etanercept, Follitropin, Teriparatide, Interferons, Anticoagulants and Others), By Route of Administration (Oral, Injectable and Topical), By Application (Blood Disorder, Cancer, Chronic and Autoimmune Disease, Hormone Disorders, Infectious Diseases and Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies and Online Pharmacies), By Geography - Opportunity Analysis & Industry Forecast, 2025-2031

The rising prevalence of cancer rates is driving the market, as more patients seek affordable and effective treatment options. Furthermore, the expiration of patents on many blockbusters biologic drugs is fueling market expansion, providing opportunities for biosimilar manufacturers to introduce competitive alternatives, thus lowering treatment costs and expanding patient access to life-saving therapies.

Europe accounted for the largest share of 36% of the Biosimilars & Follow-On Biologics Market in 2024, reflecting the region's robust regulatory framework, healthcare infrastructure, and increasing adoption of biosimilars. This growth is driven by the demand for affordable biologics and the availability of effective treatments for various conditions.For instance, in June 2024, STADA acquired the marketing license for Alvotech’s proposed biosimilar referencing Prolia®/Xgeva® (denosumab) in Europe, including Switzerland and the UK, as well as rights to selected markets in Central Asia and the Middle East. This partnership focuses on the osteoporosis and cancer-related molecule and builds upon the existing strategic alliance between the two companies in Europe. The first product launched under this collaboration was Hukyndra®, a high-concentration biosimilar to Humira® (adalimumab).

Advancements in regulatory frameworks play a pivotal role in the growth of the Biosimilars & Follow-On Biologics market. These changes are essential to streamline the approval process, making biosimilars more accessible and cost-effective to healthcare systems globally. In November 2024, an article by Pinsent Masons highlighted that the European Medicines Agency (EMA) is considering proposals to relax the requirements for comparative efficacy trials in the development of biosimilars. This potential regulatory shift could significantly accelerate the approval process for biosimilars, enhancing their market availability and affordability.

The expiration of patents on biologics is driving significant growth in the biosimilars market. As major biologic drugs are anticipated to lose exclusivity over the next five years, the market for biosimilars is expected to gain considerable prominence. According to a June 2024 article by BioSpace, more than 190 biologic products are expected to go off-patent between 2022 and 2030. This patent expiration presents an opportunity for the biosimilar market to flourish, as biosimilars offer a more affordable alternative, leading to substantial cost savings for patients while maintaining similar therapeutic efficacy.

Key companies profiled in the Biosimilars & Follow-On Biologics Market are 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 and others.

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