Global Biosimilars Market: Rising Demand and Future Growth Prospects 2024

 

Introduction to Biosimilars

Biosimilars are biologic drugs that closely resemble approved biologics, known as reference products, without any clinically meaningful differences in terms of safety, purity, or effectiveness. Developed using living systems such as yeast, bacteria, or animal cells, biosimilars are inherently complex and sensitive to manufacturing changes, distinguishing them from generic drugs, which are precise chemical replicas of small-molecule drugs. These products span multiple therapeutic categories, including monoclonal antibodies used in cancer and autoimmune conditions, hematopoietic agents like filgrastim that aid in blood cell production, hormonal treatments such as insulin and growth hormones, and anti-inflammatory medications for conditions like rheumatoid arthritis.

Expanding Applications of Biosimilars

Biosimilars play a crucial role in managing various diseases, including oncology treatments such as trastuzumab for cancer therapy, blood disorders like epoetin for anemia, autoimmune conditions such as infliximab for rheumatoid arthritis, and growth hormone deficiencies. Additional applications extend to chronic conditions like diabetes, immune system regulation for cardiovascular disorders, and infectious disease management. Following the expiration of reference product patents, biosimilars undergo rigorous evaluations by regulatory authorities like the FDA, EMA, and Health Canada to ensure they meet stringent quality, safety, and efficacy standards.

Market Size and Growth Trends

The global biosimilars market is projected to grow substantially, with an estimated value of US$34.8 billion in 2024, anticipated to reach US$93.1 billion by 2030, reflecting a robust compound annual growth rate (CAGR) of 17.8% from 2024 to 2030. This growth is driven primarily by the increasing cost of biologic drugs, prompting a surge in demand for cost-effective alternatives that offer comparable therapeutic results. Patent expirations of major biologics further contribute to market expansion, allowing biosimilar manufacturers to introduce more affordable options while maintaining similar efficacy.

Key Market Drivers

Additionally, the rising prevalence of chronic diseases such as cancer, kidney disease, arthritis, and Crohn's disease has led to greater reliance on biosimilars for treatment. Growing healthcare expenditures and the necessity to reduce drug costs have further incentivized governments and insurers to endorse biosimilars, facilitating their adoption. The market's expansion is also supported by regulatory advancements and rising approval rates in major regions, including the United States, the European Union, India, China, and Brazil. As awareness of biosimilars continues to increase alongside rising investments in research and development, the market is set to witness substantial growth in the coming years.

Regional Market Analysis

Europe currently dominates the global biosimilars market, accounting for an estimated 40.8% share in 2024. The region's strong healthcare infrastructure, high prevalence of chronic diseases, and supportive regulatory framework have fueled widespread adoption. Increased awareness among healthcare professionals and patients, coupled with competitive pricing, has significantly contributed to biosimilars’ growth in Europe. Meanwhile, the Asia-Pacific region is experiencing rapid expansion, with a projected CAGR of 20.3% from 2024 to 2030. Countries such as China, India, and Japan are driving this growth through increased investments in pharmaceutical research and development, a growing demand for affordable treatments, and aging populations. Additionally, rising disposable incomes and the increasing incidence of chronic illnesses, including cancer, diabetes, and autoimmune diseases, are further propelling the market in these nations.

Market Segmentation by Product Type

By product type, monoclonal antibodies (mAbs) lead the biosimilars market in 2024, capturing a 56% share due to their extensive applications in treating conditions such as cancer, rheumatoid arthritis, cardiovascular diseases, and multiple sclerosis. The expiration of patents for major monoclonal antibodies, including trastuzumab and adalimumab, has facilitated the adoption of their biosimilar counterparts as cost-effective alternatives. The erythropoietin (EPO) segment is expected to experience the fastest growth, with a projected CAGR of 19.2% during the forecast period. The increasing use of EPO biosimilars for managing anemia in patients with chronic kidney disease and those undergoing oncology treatments, along with growing regulatory approvals and financial pressures, is fueling their demand in the market.

Market Segmentation by Therapeutic Area

From a therapeutic perspective, oncology remains the largest and fastest-growing segment of the biosimilars market, estimated to hold a 42.6% share in 2024. With an anticipated CAGR of 18.4% from 2024 to 2030, this segment is benefiting from rising global cancer rates and the increasing use of biosimilars in treating breast, colorectal, and other solid tumors. The expiration of key biologic patents has accelerated the adoption of biosimilar monoclonal antibodies, while cost advantages continue to drive their utilization. The autoimmune diseases segment follows as the second-largest market, accounting for a 22.6% share in 2024. Growing cases of conditions such as rheumatoid arthritis and psoriasis, combined with biosimilars’ ability to offer affordable alternatives to expensive biologics, have bolstered this segment’s expansion. As regulatory approvals and acceptance increase, the demand for biosimilars in treating chronic autoimmune disorders is expected to witness significant growth.

Comprehensive Market Report Overview

The biosimilars market report provides a detailed analysis of the global and regional markets, segmented by product type and therapeutic area for the period 2024-2030. Market projections in terms of value (US$) are included, along with profiles of major industry players and coverage of the latest corporate and industrial developments. The market is analyzed across key geographic regions, including North America (United States, Canada, and Mexico), Europe (Germany, France, the United Kingdom, Italy, Spain, and the rest of Europe), Asia-Pacific (Japan, China, India, South Korea, and other Asia-Pacific countries), and the rest of the world (Brazil, Israel, and other emerging markets). The product type segmentation includes monoclonal antibodies (mAbs), erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), insulin, and other biosimilars such as interferons, follitropins, and recombinant proteins. The therapeutic area segmentation covers oncology, autoimmune disorders, blood disorders, growth hormone deficiency, and other conditions, including chronic diseases, infectious diseases, and cardiovascular disorders.

Conclusion

With the increasing adoption of biosimilars, driven by cost-effectiveness, regulatory support, and the rising prevalence of chronic diseases, the global biosimilars market is set to experience substantial growth over the next decade. As pharmaceutical companies continue to invest in biosimilar development and expand their product portfolios, the market is expected to provide significant benefits to patients, healthcare providers, and stakeholders worldwide.