Biosimilars Market Set to Reach USD 86 Billion by 2030, Driven by Rising Demand for Affordable Biologic Treatments

According to Next Move Strategy Consulting, the global Biosimilars Market is on track for substantial growth, with an estimated market size forecast to reach USD 86 billion by 2030. This growth is anticipated to occur at a compound annual growth rate (CAGR) of 16% by 2030, according to a new report. Biosimilars, which are closely identical copies of approved biological drugs, are transforming the medical landscape by offering cost-effective alternatives to expensive biologics, making life-saving treatments more accessible to patients around the world.

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Market Overview

Biosimilars are biological medications derived from living organisms that undergo rigorous testing to confirm their safety, efficacy, and quality in comparison to the original branded drugs. Unlike traditional generic drugs, biosimilars are more complex and require extensive regulatory approval due to their intricate manufacturing processes. These therapies are primarily used for treating chronic conditions such as cancer, autoimmune diseases (e.g., rheumatoid arthritis, Crohn's disease), and diabetes. They provide a more affordable alternative to original biologic drugs, significantly reducing healthcare costs while maintaining the same therapeutic benefits.

Key Market Drivers

The demand for biosimilars is largely driven by the rising incidence of chronic diseases globally. According to the World Health Organization’s 2023 report, noncommunicable diseases (NCDs) such as cancer, diabetes, and autoimmune disorders are responsible for 74% of global deaths, with cancer alone causing 9.3 million deaths annually. As the global burden of these diseases grows, particularly in aging populations and developing regions, the need for more affordable and accessible treatment options becomes critical.

Biosimilars address this need by offering a cost-effective alternative to expensive biologic drugs, providing similar therapeutic outcomes at a lower price. With healthcare systems under pressure to reduce costs while ensuring effective treatment, biosimilars are emerging as a vital solution to the growing demand for biologic therapies.

In addition to rising disease prevalence, significant investments in biopharmaceutical R&D are accelerating the development and manufacturing of biosimilars. These investments are boosting innovation and efficiency in biosimilar production, making it possible to meet increasing demand across diverse regions.

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Emerging Trends and Market Opportunities

There is a strong focus on product development, with major companies working to expand their biosimilar portfolios. For example, two biosimilars of Enbrel, Eticovo and Erelzi, are expected to be released in 2029, while Soliris's Phase 3 trials for its biosimilar are slated to be completed by 2025. Furthermore, the surge in FDA approvals for biosimilars, exemplified by 50 biosimilars receiving approval in a single week in April 2024, is creating substantial opportunities for market expansion and cost savings.

Despite these growth drivers, the biosimilars market faces challenges such as high development costs and complex regulatory processes. The intricate manufacturing procedures required for biosimilars demand significant investments in infrastructure, and navigating diverse regulatory frameworks across regions adds complexity to the approval process. However, the growing number of FDA approvals and the increasing focus on biosimilar affordability are helping to overcome these hurdles.

Geographical Insights

North America currently dominates the biosimilars market and is expected to maintain its leadership during the forecast period. The region’s high incidence of chronic diseases, particularly cancer, is driving the demand for biosimilars. With cancer being the second leading cause of death in the U.S., there is an increasing need for affordable biologic treatments. Furthermore, rising R&D investments in the U.S. and Canada are accelerating innovation in the biosimilar sector.

Asia-Pacific, on the other hand, is projected to witness substantial growth due to the rising prevalence of diabetes, which is driving demand for biosimilar treatments. According to the International Diabetes Federation, the number of people living with diabetes in the Western Pacific region is expected to reach 238.3 million by 2030, up from 205.64 million in 2021. The development of biosimilars in this region is also being supported by collaborations, such as the partnership between Humira and Stelara to launch biosimilars in South Korea.

Competitive Landscape

The biosimilars market is highly competitive, with major players including Sandoz Group, Pfizer Inc., Celltrion, Samsung Bioepis Co., Ltd, Amgen Inc., Biocon, Dr. Reddy’s Laboratories, Mylan N.V., and Teva Pharmaceutical Industries. These companies are making significant strides through product launches, strategic partnerships, and global expansion.

Conclusion

The global biosimilars market is poised for rapid growth, driven by increasing chronic disease prevalence, rising healthcare costs, and a surge in biopharma investment. With biosimilars offering affordable treatment alternatives for chronic conditions like cancer, autoimmune disorders, and diabetes, they are reshaping the healthcare landscape by making life-saving therapies more accessible and cost-effective. Despite the challenges posed by complex development and regulatory requirements, the future of the biosimilars market looks promising, with continued innovation and growing market opportunities.

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