Biosimilars

Biosimilars

Global Biosimilars Market to Reach US$135.9 Billion by 2030

The global market for Biosimilars estimated at US$37.8 Billion in the year 2023, is expected to reach US$135.9 Billion by 2030, growing at a CAGR of 20.1% over the analysis period 2023-2030. Recombinant Non-glycosylated Proteins, one of the segments analyzed in the report, is expected to record a 20.5% CAGR and reach US$62.4 Billion by the end of the analysis period. Growth in the Recombinant Glycosylated Proteins segment is estimated at 20.5% CAGR over the analysis period.

The U.S. Market is Estimated at US$10.7 Billion While China is Forecast to Grow at 19.6% CAGR

The Biosimilars market in the U.S. is estimated at US$10.7 Billion in the year 2023. China, the world`s second largest economy, is forecast to reach a projected market size of US$21.1 Billion by the year 2030 trailing a CAGR of 19.6% over the analysis period 2023-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 17.8% and 16.7% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 13.9% CAGR.

Biosimilars - Key Trends and Drivers

Biosimilars are biologic medical products that are highly similar to already approved reference biologics, with no significant differences in terms of safety, purity, and potency. These products are derived from living organisms, making their production and development significantly more complex than traditional small-molecule drugs. Biosimilars are used to treat a range of diseases, including cancers, autoimmune disorders, and chronic conditions like diabetes and rheumatoid arthritis. The development of biosimilars involves a rigorous process of demonstrating similarity to the reference product through comprehensive analytical studies, non-clinical assessments, and clinical trials. This ensures that biosimilars can effectively replace their more expensive counterparts, providing significant cost savings for healthcare systems and increasing patient access to critical treatments. The process includes demonstrating that the biosimilar has the same mechanism of action, route of administration, dosage form, and strength as the original biologic, ensuring that it delivers the same clinical benefits.

The biosimilars market has witnessed substantial growth and transformation over the past decade. Regulatory frameworks in major markets such as the United States, Europe, and Asia have evolved to support the approval and adoption of biosimilars. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established robust guidelines that streamline the approval process, fostering confidence among healthcare providers and patients. These guidelines require comprehensive comparative studies that confirm the biosimilar’s similarity to the reference biologic without clinically meaningful differences. Additionally, the patent expirations of several blockbuster biologics have opened the door for biosimilar competition. Pharmaceutical companies are investing heavily in the development and commercialization of biosimilars, leveraging advanced manufacturing technologies to ensure consistent quality and supply. This includes state-of-the-art cell culture processes, purification techniques, and stringent quality control measures. Collaborations and partnerships between biosimilar manufacturers and healthcare providers are also playing a critical role in expanding the market reach and acceptance of these products.

The growth in the biosimilars market is driven by several factors. Advances in biotechnology and manufacturing processes have enhanced the production efficiency and quality of biosimilars, making them more competitive with their reference biologics. The increasing prevalence of chronic diseases and the rising demand for cost-effective treatments are expanding the addressable market for biosimilars. For instance, as the incidence of conditions like cancer, diabetes, and autoimmune diseases continues to rise, so does the need for affordable treatment options. Healthcare cost containment measures and favorable reimbursement policies in various countries are also propelling the adoption of biosimilars. Governments and insurance providers are increasingly recognizing the potential of biosimilars to reduce healthcare expenditures, leading to supportive policies and incentives. Moreover, the growing acceptance of biosimilars among healthcare professionals and patients, driven by successful clinical outcomes and real-world evidence, is accelerating market growth. Strategic initiatives by pharmaceutical companies, such as expanding biosimilar portfolios and entering emerging markets, are further fueling the market`s expansion. These companies are also investing in extensive educational campaigns to build trust and acceptance among prescribers and patients. Additionally, efforts to educate stakeholders about the benefits and safety of biosimilars are enhancing their market penetration, ensuring that these life-saving therapies reach a broader patient population. As a result, biosimilars are poised to play an increasingly important role in global healthcare, offering high-quality, affordable alternatives to costly biologic therapies.

Select Competitors (Total 46 Featured) -

• Allergan Plc
• Amgen Inc.
• Biocon Ltd.
• Biopartners GmbH
• Boehringer Ingelheim International GmbH
• Celltrion Inc.
• Dr. Reddy`s Laboratories Ltd.
• Eli Lilly and Company
• Fresenius Kabi
• Intas Pharmaceuticals Ltd.
• Mylan NV
• Pfizer Inc.
• Samsung Bioepis Co. Ltd.
• Sandoz International GmbH
• STADA Arzneimittel AG
• Teva Pharmaceutical Industries Ltd.

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