Biosimilars Market Report, Size, Share, Insights 2024-2031 - Amgen Inc, Novartis AG & Pfizer Inc.

The global biosimilars market, valued at USD 30.1 billion in 2022, is poised for significant expansion, with projections estimating it will reach USD 76.7 billion by 2031. This growth represents a robust CAGR of 12.8% from 2024 to 2031.

Biosimilars are biological products designed to be highly similar to already approved reference biologics, demonstrating no significant clinical differences in terms of efficacy, safety, and quality. They are used to treat a range of conditions across various therapeutic areas, including rheumatology, oncology, hematology, gastroenterology, and endocrinology.

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Market Trends:

The rising number of biosimilar drug approvals by the FDA drives global biosimilar market growth.

The global biosimilars market is anticipated to grow significantly, driven by the increase in approved biosimilars due to enhanced FDA review processes and advancements in manufacturing and development techniques. For instance, in March 2022, Amneal Pharmaceuticals, Inc. received FDA approval for filgrastim-ayow, a biosimilar to Neupogen, which will be marketed under the RELEUKO brand. This approval reflects the growing familiarity of manufacturers with the complex regulatory and legal frameworks for biosimilars, leading to a rise in biosimilar submissions.

However, the development of biosimilars is hampered by high costs and long timelines. Producing a biosimilar can take 7 to 8 years and cost between $100 million and $300 million, which poses a significant barrier to market growth, particularly in lower-income regions. The substantial research and development expenses contribute to the slow acceptance and proliferation of biosimilars, affecting overall market expansion.

Market Segmentation:

By Product: Monoclonal Antibodies,Recombinant Human Growth Hormone (rhGH), Insulin, Anti-coagulants, Erythropoietin, Fusion Proteins, Granulocyte Colony Stimulating Factor, Follitropin.

By Technology: Recombinant DNA Technology (rDNA technology), Monoclonal Antibodies (MAb) Technology.

By Application: Oncology, Chronic and Immune Diseases, Infectious Diseases, Growth Hormone Deficiency, Blood Disorders.

By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies.

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Competitive Landscape:

• Amgen Inc.
• Teva Pharmaceutical Industries Ltd.
• Novartis AG
• Pfizer Inc.
• Biocon
• Samsung Bioepis
• Mylan NV
• Celltrion
• Biogen
• Intas Pharmaceutical Ltd

Regional Analysis:

The Biosimilars Market report focuses on six major regions: North America, Latin America, Europe, Asia Pacific, the Middle East, and Africa. The report offers detailed insight into new product launches, new technology evolutions, innovative services, and ongoing R&D. The report discusses a qualitative and quantitative market analysis, including PEST analysis, SWOT analysis, and Porter's five force analysis. The Biosimilars Market report also provides fundamental details such as raw material sources, distribution networks, methodologies, production capacities, industry supply chain, and product specifications.

Key Developments:

In May 2023, Gulf Pharmaceutical Industries PJSC (Julphar), a major pharmaceutical producer in the Middle East and Africa, announced a strategic licensing agreement with Sunshine Lake Pharma, a Chinese pharmaceutical company. This partnership will position Julphar as the first manufacturer of modern insulin biosimilars in the MENA region, marking a significant milestone in the regional pharmaceutical industry.

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