PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1782000
PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1782000
Biosimilar and Biologics Market size was valued at US$ 556,309.44 Million in 2024, expanding at a CAGR of 7.81% from 2025 to 2032.
The biosimilars and biologics market represents one of the fastest-growing sectors in the global pharmaceutical industry. Biologics are large, complex molecules or mixtures of molecules derived from living cells used in the treatment, diagnosis, or prevention of diseases. Examples include monoclonal antibodies, vaccines, and recombinant proteins. Fueled by advances in biotechnology, rising prevalence of chronic diseases, patent expirations of blockbuster biologics, and increasing healthcare costs, the market is witnessing rapid transformation.
Biosimilar and Biologics Market- Market Dynamics
Patent Expiration of Blockbuster Biologics
One of the most significant growth drivers in the biosimilars market is the expiration of patents for major biologic drugs. These biologics, often called "blockbusters", generate billions in annual sales. When their patents expire, it opens the door for biosimilar manufacturers to develop and market more affordable alternatives. For instance, Adalimumab (Humira), one of the world's top-selling biologics used to treat rheumatoid arthritis and Crohn's disease, generated over $20 billion/year in revenue before biosimilars entered the market. The expiration of patents on blockbuster biologics is a fundamental driver of growth in the biosimilar market. It enables competition, reduces drug prices, and expands access to biologic therapies-ultimately creating a more sustainable global healthcare system. This trend will continue over the next decade as more biologics lose exclusivity, paving the way for a surge in biosimilar development and adoption.
Biosimilar and Biologics Market- Key Insights
As per the analysis shared by our research analyst, the global market is estimated to grow annually at a CAGR of around 7.81% over the forecast period (2025-2032)
Based on product type segmentation, Biologics was predicted to show maximum market share in the year 2024
Based on application segmentation, Oncology was the leading application in 2024
Based on distribution segmentation, Hospital Pharmacies was the leading distribution in 2024
On the basis of region, North America was the leading revenue generator in 2024
The Global Biosimilar and Biologics Market is segmented on the basis of Product Type, Application, Distribution, Manufacturing Type, and Region.
The market is divided into two categories based on product type: Biologics, and Biosimilars. Biologics and Biosimilars. Biologics are original, complex medicines made from living organisms, used to treat diseases like cancer and autoimmune disorders. Biosimilars are highly similar, lower-cost versions of approved biologics, developed after the original product's patent expires, offering comparable safety and effectiveness.
The market is divided into two categories based on application: Oncology, Infectious Diseases, Autoimmune Diseases (e.g., rheumatoid arthritis, psoriasis), Blood Disorders (e.g., anemia, hemophilia), Diabetes, Growth Hormone Deficiency, Ophthalmic Disorders (e.g., macular degeneration) and Others (e.g., rare diseases, fertility treatments). Cancer is one of the leading causes of death globally, with a rising incidence due to aging populations, lifestyle changes, and improved diagnostics. Biologics particularly monoclonal antibodies and targeted therapies-have revolutionized cancer treatment by offering personalized, effective solutions with fewer side effects compared to traditional chemotherapy. Additionally, oncology accounts for a large share of R&D investments, clinical trials, and regulatory approvals in both biologics and biosimilars, reinforcing its dominance. With cancer cases projected to rise and the focus on precision medicine growing, oncology will likely remain the most demanding and profitable application area in this market.
Biosimilar and Biologics Market- Geographical Insights
The biosimilar and biologics market shows varying growth patterns across different geographical regions. North America, particularly the United States, holds a major share in the biologics market due to advanced healthcare infrastructure, strong R&D investments, and the presence of key pharmaceutical players. Although biosimilar adoption was initially slow in the U.S. due to regulatory and market barriers, it is now accelerating following the expiration of patents for blockbuster drugs like Humira. Europe is the most mature and established market for biosimilars, driven by cost-containment policies, supportive regulatory frameworks by the European Medicines Agency (EMA), and high physician and patient acceptance. Asia-Pacific is the fastest-growing region, with countries like India, China, and South Korea emerging as major biosimilar manufacturers. This growth is supported by large patient populations, increasing healthcare access, and improving regulatory pathways. In Latin America, the market is expanding steadily as countries modernize their healthcare systems and encourage biosimilar use to reduce public spending. Lastly, the Middle East and Africa represent emerging markets with growing demand for affordable biologic treatments, although access and infrastructure challenges remain. Overall, while Europe leads in biosimilar adoption, North America and Asia-Pacific are set to drive future market growth.
The competitive landscape of the biosimilars and biologics market is characterized by intense rivalry among a mix of established pharmaceutical giants and emerging biotech companies. Major players like Amgen, Pfizer, Roche, Novartis (Sandoz), Samsung Bioepis, Biocon, Celltrion, and Mylan (Viatris) dominate the market, leveraging strong R&D capabilities, extensive manufacturing facilities, and global distribution networks to maintain and expand their market share. These companies are investing heavily in developing biosimilars for high-demand biologics whose patents have expired or are nearing expiration. Competition is not only based on pricing but also on product quality, regulatory approvals, patent strategies, and marketing efforts to build physician and patient trust. Additionally, strategic partnerships, collaborations, and mergers and acquisitions are common to enhance pipeline portfolios and access new markets. The landscape is further complicated by regional differences in regulatory requirements and market access, which influence how companies position their biosimilar products worldwide. As the market evolves, innovation in bioprocessing technologies and tailored therapies will be crucial for companies aiming to stay competitive in this rapidly growing sector.
In March 2025, Fresenius Kabi received U.S. FDA approval for two of their denosumab biosimilars, Conexxence and Bomyntra, which are now approved for the same indications as the original reference drugs, Prolia and Xgeva, respectively. This approval enhances treatment options for patients with osteoporosis and cancer-related bone loss, contributing to the growing acceptance of biosimilars in the U.S. market .