Biosimilars Market Outlook
The biosimilar market size was valued at USD 24.5 billion in 2023, driven by an increase in patent expiration of biologic drugs across the globe. The market size is anticipated to grow at a CAGR of 17.60% during the forecast period of 2024-2032 to achieve a value of USD 105.1 billion by 2032.
Biosimilars: Introduction
Biosimilars are biologic medical products that are highly similar to, but not exact copies of, an original biologic medication that has already been approved for use, known as a reference product. These products are derived from living organisms and involve complex manufacturing processes, making exact replication impossible. Biosimilars are developed to have no clinically meaningful differences in terms of safety, purity, and potency when compared to their reference products. They are introduced into the market to offer more cost-effective alternatives to existing biologic therapies, expanding access to treatment for patients.
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Key Trends in the Global Biosimilars Market
Some key trends in the market include:
- Patent Expirations of Biologics: A significant driver for the biosimilar market is the expiration of patents on major biologic drugs. As these patents expire, biosimilar manufacturers can introduce cheaper alternatives to expensive brand-name biologics, thereby increasing competition and accessibility.
- Cost Reduction Pressure: Healthcare systems worldwide are under increasing pressure to reduce costs while maintaining high standards of care. Biosimilars offer a cost-effective solution by being priced lower than their reference biologics, which helps in controlling healthcare spending and expanding patient access to necessary treatments.
- Regulatory Enhancements: There has been a notable improvement in the regulatory framework for biosimilars, with agencies like the FDA and EMA streamlining approval pathways. These enhanced regulatory guidelines help reduce uncertainties in the development and approval processes, encouraging more companies to enter the biosimilar market.
- Increasing Acceptance and Adoption: As the market matures, there is a growing acceptance of biosimilars among healthcare providers and patients, driven by positive clinical experiences and increasing awareness of their safety and efficacy. Educational efforts by stakeholders and successful case studies are further easing concerns about switching from biologics to biosimilars.
- Global Expansion in Emerging Markets: Emerging markets are becoming increasingly significant for biosimilars due to rising healthcare needs and improving regulatory frameworks. Countries like India, China, and Brazil are seeing a surge in demand for affordable biologic treatments, which biosimilars can provide.
- Technological Advancements in Manufacturing: Advances in biotechnology are enabling more efficient and cost-effective manufacturing processes for biosimilars. These technological improvements are critical for ensuring that biosimilars meet the stringent requirements for similarity to their reference products in terms of quality, safety, and efficacy.
- Strategic Collaborations and Partnerships: Pharmaceutical companies are increasingly entering into partnerships and collaborations to enhance their capabilities in biosimilar development and commercialization. These alliances help in sharing the financial risk and combining technical and market expertise.
Biosimilars Market Segmentation
Market Breakup by Product Type
- Recombinant Glycosylated Proteins
- Monoclonal Antibodies
- Erythropoietin
- Recombinant Non-Glycosylated Proteins
- Insulins
- Granulocyte Colony Stimulating Factors
- Interferons
- Others
Market Breakup by Drug Class
- Insulin
- Recombinant Human Growth Hormone (RHGH)
- Granulocyte Colony-Stimulating Factor
- Interferon
- Erythropoietin
- Etanercept
- Monoclonal Antibodies
- Follitropin
- Glucagon
- Calcitonin
- Teriparatide
- Enoxaparin Sodium
- Others
Market Breakup by Indications
- Chronic Diseases
- Oncology
- Autoimmune Diseases
- Infectious Diseases
- Blood Disorders
- Growth Hormone Deficiency
- Others
Market Breakup by Procedure
- Invasive
- Non-Invasive
Market Breakup by Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa
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Biosimilars Market Overview
North America is experiencing significant growth, driven by the increasing adoption of biosimilars as cost-effective alternatives to expensive biologics. The region’s growth is fueled by the expiration of numerous biologic patents, encouraging competition and innovation within the biosimilar space. Regulatory support from entities like the FDA, which has streamlined approval processes for biosimilars, further bolsters market growth. As healthcare costs continue to rise, both public and private healthcare providers in North America are increasingly turning to biosimilars to reduce expenditure, signaling robust growth potential in the coming years.
Europe remains at the forefront of the biosimilar market, thanks to an established regulatory framework and extensive experience with biosimilars. The European Medicines Agency (EMA) has been a pioneer in creating and refining biosimilar guidelines, which has helped build confidence among healthcare providers and patients. European countries have been proactive in integrating biosimilars into their healthcare systems, driven by government-led initiatives that encourage the use of biosimilars to manage and control public healthcare spending.
The Asia Pacific region shows the fastest growth in the biosimilar market, attributed to its dynamic economies and rapidly evolving healthcare sectors. Countries like India, South Korea, and China are investing heavily in biopharmaceutical R&D and manufacturing capabilities, positioning themselves as major players in the global biosimilars market. The region benefits from a large patient base requiring treatment for chronic and autoimmune diseases, where biosimilars offer a less expensive alternative to biologics.
Latin America and the Middle East and Africa are emerging as important growth areas in the biosimilar market. These regions are seeing a gradual shift towards accepting and integrating biosimilars into their healthcare systems, driven by the need to reduce healthcare costs and increase access to essential medicines. Regulatory improvements and governmental support for biosimilars are beginning to take shape, offering the potential for substantial market development. As awareness and acceptance of biosimilars grow, coupled with economic development and healthcare investments, both Latin America and the Middle East and Africa are expected to contribute increasingly to the global biosimilar market growth in the forecast period.
Biosimilars Market: Competitor Landscape
The key features of the market report include patent analysis, grants analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:
- Novartis AG
Novartis AG, based in Basel, Switzerland, is one of the world’s leading pharmaceutical companies by both market capitalization and sales. Novartis is known for its focus on a wide range of therapeutic areas, including cardiovascular, oncology, immunology, and ophthalmology. The company is committed to innovation, often leading the way in the development of new drugs and therapies that improve patient outcomes. Novartis is also heavily involved in both cutting-edge research and generic drug production via its Sandoz division, making significant contributions to both patented and generic medicine markets.
- Orion Pharma
Orion Pharma, part of the Finnish Orion Corporation, is a globally operating Finnish pharmaceutical company known for its R&D and manufacture of human and veterinary pharmaceuticals and active pharmaceutical ingredients. The company is particularly strong in Europe but is expanding its influence in emerging markets. Orion Pharma has a diversified product range that includes treatments for central nervous system disorders, oncology, and respiratory diseases among others. Orion Pharma is dedicated to enhancing people’s health and quality of life through innovative and effective medications.
- Pfizer Inc.
Pfizer Inc., headquartered in New York, USA, is one of the largest pharmaceutical companies in the world. Pfizer develops and produces medicines and vaccines for a wide range of medical disciplines, including immunology, oncology, cardiology, endocrinology, and neurology. The company has gained additional fame for its role in developing one of the first widely used COVID-19 vaccines. Pfizer is known for its strong research capabilities and has a robust pipeline of new drugs and treatments that contribute to its leadership in the global healthcare market.
- Samsung Bioepis
Samsung Bioepis, co-founded by Samsung Biologics and Biogen, is a biopharmaceutical company based in Incheon, South Korea. Specializing in the development and production of biosimilars, its mission is to increase patient access to high-quality biologic medicines and contribute to the sustainability of healthcare systems globally. Samsung Bioepis has developed biosimilars across various therapeutic areas, including immunology, oncology, and diabetes, demonstrating a strong commitment to quality and clinical excellence.
- Coherus BioSciences, Inc.
Coherus BioSciences, Inc., based in Redwood City, California, USA, is a biopharmaceutical company focused on increasing patient access to cost-effective, high-quality biosimilars. The company is particularly focused on biosimilar therapeutics in oncology and immunology. Coherus prides itself on a strategic model that emphasizes collaboration with other biopharmaceutical entities to streamline development and delivery, effectively managing the complexities and costs associated with bringing biosimilars to market.
Other key players in the market include Amgen Inc., Eli Lilly and Company, Takeda Pharmaceutical Company Limited, Bristol-Myers Squibb Company, Merck KGaA, Teva Pharmaceutical Industries Ltd., Biocon, Bayer AG, AbbVie Inc, Allergan, Dr. Reddy’s Laboratories Ltd., Boehringer Ingelheim International GmbH, and Biogen
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