Biosimilars Market Size, Share, Trends & Competitive Analysis By Product Type (Recombinant Non-Glycosylated Proteins, Recombinant Glycosylated Proteins, Recombinant Peptides, Others); By Therapeutic Application (Oncology, Autoimmune Diseases, Blood Disorders, Infectious Diseases, Growth Hormone Deficiency, Others) By Manufacturing Process; By Distribution Channel: By End User: By Regions, and Industry Forecast, Global Report 2023-2030

The global Biosimilars Market size was valued at USD 26.8 billion in 2022 and is projected to expand at a compound annual growth rate (CAGR) of 19.4% during the forecast period, reaching a value of USD 88.05 billion by 2030.

Biosimilars Market research report by Future Data Stats, offers a comprehensive view of the market's historical data from 2017 to 2021, capturing trends, growth patterns, and key drivers. It establishes 2021 as the base year, analyzing the market landscape, consumer behavior, competition, and regulations. Additionally, the report presents a well-researched forecast period from 2022 to 2030, leveraging data analysis techniques to project the market's growth trajectory, emerging opportunities, and anticipated challenges.

MARKET OVERVIEW:

Biosimilars are a class of biological products that are highly similar to and have no clinically meaningful differences from approved reference biologic medicines. They are designed to offer affordable alternatives to expensive originator biologics, providing patients with increased access to vital treatments. Biosimilars are developed through a rigorous scientific process that involves demonstrating similarity in terms of quality, safety, and efficacy to the reference product.

Market research in the field of Biosimilars aims to assess market potential, identify key market players, analyze regulatory landscapes, evaluate pricing and reimbursement policies, and understand market dynamics and opportunities for growth. Understanding the market landscape and trends surrounding Biosimilars is crucial for stakeholders to make informed decisions and capitalize on the expanding opportunities in this evolving market segment.

MARKET DYNAMICS:

Firstly, the rising prevalence of chronic diseases, such as cancer, autoimmune disorders, and diabetes, has created a significant demand for cost-effective treatment options. Biosimilars offer a more affordable alternative to expensive biologic drugs, making them accessible to a larger patient population. Secondly, stringent regulatory frameworks and patent expirations of biologic drugs have opened up opportunities for biosimilar manufacturers to enter the market. With the growing emphasis on reducing healthcare costs, governments and healthcare organizations are actively promoting the adoption of biosimilars, further driving market growth.

However, the Biosimilars market also faces certain restraints. Intellectual property rights and complex regulatory processes pose significant challenges for manufacturers in obtaining approvals and launching biosimilar products. Moreover, the high development costs associated with biosimilar manufacturing and the need for extensive clinical trials to demonstrate similarity to reference products can hinder market growth. Additionally, safety concerns and the perception that biosimilars may not be as efficacious as the originator biologics could impact consumer acceptance and adoption.

Nevertheless, the Biosimilars market presents promising opportunities. The increasing number of biologic drugs going off-patent in the coming years creates a favorable environment for biosimilar manufacturers to expand their product portfolios and gain market share. Moreover, the growing acceptance and confidence in biosimilars among healthcare professionals, regulatory bodies, and payers are likely to drive market growth. Strategic collaborations and partnerships between biosimilar manufacturers and key market players can also unlock new opportunities, facilitating market expansion and market penetration into untapped regions.

BIOSIMILARS MARKET SEGMENTAL ANALYSIS

BY PRODUCT TYPE:

Recombinant Non-Glycosylated Proteins, Recombinant Glycosylated Proteins, Recombinant Peptides, and other product categories play a crucial role in shaping the market dynamics. These diverse product types cater to various therapeutic applications and patient needs, offering a wide range of treatment options.

Recombinant Non-Glycosylated Proteins, such as insulin and growth factors, are witnessing significant demand due to their effectiveness in treating conditions like diabetes and growth hormone deficiency. Similarly, Recombinant Glycosylated Proteins, including monoclonal antibodies, are extensively used in oncology and autoimmune disease treatments. Additionally, Recombinant Peptides are gaining prominence in managing conditions such as hormone imbalances and metabolic disorders. The presence of other product categories further contributes to the market's versatility, providing innovative solutions for unmet medical needs.

BY THERAPEUTIC APPLICATION:

Therapeutic areas such as Oncology, Autoimmune Diseases, Blood Disorders, Infectious Diseases, Growth Hormone Deficiency, and others play a pivotal role in shaping the market landscape. The prevalence of these medical conditions and the need for effective and affordable treatment options drive the demand for Biosimilars in each therapeutic category.

Oncology, being one of the largest segments, sees a high demand for Biosimilars due to the increasing incidence of cancer and the rising cost of biologic cancer treatments. Similarly, Biosimilars targeting autoimmune diseases, such as rheumatoid arthritis and psoriasis, provide cost-effective alternatives to biologics, expanding patient access to these critical therapies. Blood disorders, including anemia and hemophilia, also offer substantial opportunities for Biosimilar manufacturers to address the unmet medical needs in this field.

BY MANUFACTURING PROCESS:

The two primary manufacturing processes in focus are Mammalian Cell Culture and Microbial Fermentation, with other manufacturing methods also playing a role. These manufacturing processes are crucial determinants of the quality, scalability, and cost-effectiveness of Biosimilars production.

Mammalian Cell Culture is a widely adopted manufacturing process, particularly for complex biologic products. It involves using mammalian cell lines to produce biosimilars that closely resemble the structure and function of the reference biologics. This process offers high protein expression levels and ensures proper post-translational modifications, making it suitable for developing Biosimilars with glycosylated proteins and other complex molecules. On the other hand, Microbial Fermentation involves using microbial cells, such as bacteria or yeast, to produce biosimilars. This process is often employed for biosimilars with non-glycosylated proteins and peptides, offering cost and time advantages.

BY DISTRIBUTION CHANNEL:

Hospital Pharmacies serve as an important distribution channel, particularly for Biosimilars used in hospital settings and specialty care. They have established relationships with healthcare facilities, enabling direct access to physicians, nurses, and patients. Retail Pharmacies, on the other hand, cater to a broader patient population, providing Biosimilars in community-based settings. These pharmacies offer convenience and accessibility, allowing patients to obtain Biosimilars closer to their homes.

The rise of digital platforms has also led to the emergence of Online Pharmacies as a prominent distribution channel for Biosimilars. Online Pharmacies provide the convenience of home delivery and a wider range of products, attracting patients seeking cost-effective alternatives. Market research in this area focuses on analyzing the market share and growth potential of each distribution channel, understanding patient preferences, and assessing factors such as regulatory compliance, supply chain efficiency, and pricing strategies. Such insights help stakeholders in developing targeted distribution strategies, optimizing reach, and maximizing market penetration for Biosimilars in different healthcare settings.

BY END USER:

Hospitals are a major end user of Biosimilars, as they provide a wide range of medical services and treatments to patients. The adoption of Biosimilars in hospitals is driven by the need to manage healthcare costs while ensuring high-quality care. Clinics, including specialty clinics and outpatient centers, also contribute significantly to the demand for Biosimilars. These settings often focus on specific therapeutic areas and provide targeted treatments, making Biosimilars an attractive option due to their cost-effectiveness.

Research Institutes play a vital role in advancing scientific knowledge and conducting clinical trials related to Biosimilars. These institutions often collaborate with biosimilar manufacturers to evaluate safety, efficacy, and comparative effectiveness of Biosimilars, contributing to market growth. Other healthcare facilities, such as long-term care centers and rehabilitation centers, also present opportunities for Biosimilar adoption, especially for specific indications and patient populations.

REGIONAL ANALYSIS:

North America, comprising the United States and Canada, has been a prominent market for Biosimilars, driven by supportive regulatory pathways, the presence of well-established biopharmaceutical companies, and the need to address rising healthcare costs. Europe has also emerged as a key market, with countries like Germany, France, and the United Kingdom at the forefront of Biosimilar adoption. The European Medicines Agency (EMA) has implemented a robust regulatory framework, fostering a competitive market environment.

Asia Pacific offers immense growth potential in the Biosimilars market, driven by the increasing prevalence of chronic diseases, improving healthcare infrastructure, and a strong emphasis on cost-effective treatments. Countries such as India and South Korea have emerged as major players in Biosimilar manufacturing, catering to both domestic and international markets. Latin America and the Middle East and Africa regions are also witnessing a gradual uptake of Biosimilars, driven by improving healthcare access, increasing awareness, and government initiatives to promote affordable healthcare options.

COVID-19 IMPACT:

The pandemic has led to disruptions in the supply chain, manufacturing processes, and distribution networks of Biosimilars. Lockdown measures, travel restrictions, and temporary closures of manufacturing facilities have affected the production and availability of Biosimilars. Furthermore, healthcare resources and attention have been diverted towards managing COVID-19 patients, impacting the adoption and uptake of Biosimilars in some regions.

However, the pandemic has also highlighted the need for cost-effective treatments, driving the demand for Biosimilars in certain therapeutic areas. As healthcare systems face financial constraints, Biosimilars offer a more affordable alternative to expensive biologic drugs, making them an attractive option for healthcare providers and payers. Additionally, the pandemic has accelerated the adoption of telemedicine and digital health platforms, creating new opportunities for the promotion and distribution of Biosimilars through online channels.

INDUSTRY ANALYSIS:

Mergers & Acquisitions:

• Biocon Biologics acquired Viatris' global biosimilars business for $3 billion in 2022
• Fresenius Kabi acquired an initial 55% stake in Insud Pharma's biopharma unit, mAbxience in 2022
• Samsung Bioepis acquired Celltrion's biosimilars business in Europe in 2023
• Pfizer acquired Affinivax, a developer of next-generation pneumococcal vaccines in 2023

Product New Launches:

• Rezvoglar (insulin glargine) and Cimerli (ranibizumab) were designated as interchangeable biosimilars by the FDA. in 2022
• Amgen launched AMJEVITA (adalimumab-atto), a biosimilar to Humira in 2022
• Sandoz launched Zarxio (filgrastim-sndz), a biosimilar to Neupogen in 2023
• Teva launched Tevagra (pegfilgrastim-tev), a biosimilar to Neulasta in 2023

KEY MARKET PLAYERS:

• Pfizer Inc.
• Sandoz International GmbH (Novartis AG)
• Teva Pharmaceutical Industries Ltd.
• Celltrion Inc.
• Samsung Bioepis Co., Ltd.
• Amgen Inc.
• Biocon Ltd.
• Mylan N.V.
• Dr. Reddy's Laboratories Ltd.
• F. Hoffmann-La Roche Ltd.
• Boehringer Ingelheim International GmbH
• Merck & Co., Inc.
• Biogen Inc.
• Fresenius Kabi AG
• Amneal Pharmaceuticals LLC
• Stada Arzneimittel AG
• Accord Healthcare Ltd.
• Lupin Limited
• Sanofi S.A.
• Eli Lilly and Company
• Cipla Ltd.
• Apotex Inc.
• Torrent Pharmaceuticals Ltd.
• Zydus Cadila Healthcare Ltd.
• Hospira Inc. (Pfizer Inc.)