Biosimilars Market Growth

Updated on : June 26, 2024

Biosimilars Market Overview and Growth Projections

Biosimilars market growth forecasted to transform from 29.4 billion in 2023 to USD 66.9 billion by 2028, driven by a CAGR of 17.8%. The market, focusing on drug classes such as Monoclonal Antibodies (including Adalimumab, Infliximab, Rituximab, and Trastuzumab), Insulin, Erythropoietin, and Anticoagulants, is poised for substantial growth. This market is driven by increasing demand for cost-effective treatments amidst rising chronic disease rates and the patent expirations of major biologics. Key trends include the rapid approval and adoption of biosimilars, particularly in oncology. Challenges include complex manufacturing processes and regulatory obstacles, which are countered by opportunities in less regulated markets like Asia Pacific. Leading players such as Novartis, Pfizer, and Amgen are pivotal in shaping industry dynamics through innovation and strategic expansions.

Biosimilars Market Key Takeaways

• FDA Approvals: 40 biosimilars approved by December 2022; 25 launched in US.
• Manufacturing Challenges: High costs and complex processes hinder new entrants.
• Asia Pacific Growth: Emerging market with favorable regulations and lower costs.
• Competitive Landscape: Intensified competition drives innovation and pricing strategies.
• Oncology Dominance: Leading segment due to affordability and accessibility.
• Regional Dynamics: North America leads; Europe and Asia Pacific follow.

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Biosimilars Market Trends

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Biosimilars Market Dynamics

DRIVER: Launch of Novel Biosimilars

Several key market players are focusing heavily on biosimilar development. By December 2022, the FDA had approved 40 biosimilars, with 25 launched in the US. Despite a slowdown in approvals during the COVID-19 pandemic, 2022 saw a rebound with seven new biosimilar approvals. All approved biosimilars in 2022 referenced previously approved products; none introduced new reference products. The year also witnessed four new product launches, including the first two Lucentis biosimilars. In addition, the FDA designated two new interchangeable biosimilars: Rezvoglar (for Lantus) and Cimerli (for Lucentis). Although approvals dipped from 2020 to 2021, the number of biosimilar development programs participating in the FDA's Biosimilar Development Program has steadily risen. As of April 2023, around 60–70 biosimilars are in pipeline studies, with half expected to launch in the next three to four years, driving market expansion.

RESTRAINT: Complexities in Manufacturing

The development of biosimilars is intricate and costly, demanding significant investments, technical expertise, clinical trial capabilities, and adherence to stringent quality standards. Unlike generic drugs, biosimilar development requires extensive clinical trials and post-approval safety monitoring akin to original innovator products. The manufacturing process involves intricate steps using proprietary cell lines and processes owned by the original manufacturers. For new entrants, costs can range from USD 100–250 million, including construction of large-scale production facilities. Setting up such facilities can take five to seven years, with varying costs based on location. High initial investments delay breakeven and returns on investment, giving established biologics manufacturers like Amgen and Biogen Idec a competitive edge due to their extensive experience in biologics manufacturing, R&D, and market presence.

OPPORTUNITY: Emerging Markets

Asia Pacific, Latin America (LATAM), and the Middle East present significant growth prospects for biosimilar manufacturers due to less stringent regulatory environments compared to established markets. These regions differ in regulatory pathways, payer perceptions, pricing, affordability, and competitive landscapes, making them attractive for biosimilar development. China and India, with their lower labor and laboratory setup costs and abundant skilled resources, are particularly appealing for global biosimilar R&D outsourcing. Leading players like Celltrion, Samsung Bioepis, Dr. Reddy’s Laboratories, Biocon, and Shanghai Henlius Biotech are spearheading biosimilar innovation and commercialization in Asia Pacific, fostering dynamic industry growth.

CHALLENGE: Increased Competition and Regulatory Hurdles

Competition in the biosimilars market intensifies among manufacturers and originator biologic companies. Upon new biosimilar entries, originator biologic manufacturers may respond with second-generation products, reformulations, dosage improvements, supportive devices, and competitive pricing strategies to defend their market share.

Biosimilars Market Ecosystem

The Oncology segment dominated the biosimilars industry in 2022.

Based on the indication, the biosimilars market is segmented into oncology, inflammatory and autoimmune diseases, chronic diseases, blood disorders, growth hormone deficiency, infectious diseases, and other indications (infertility, hypoglycemia, myocardial infarction, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases). Oncology is the largest segment in this market owing to the availability of biosimilars at a lower price than innovative biologics and a large number of cancer patients. The availability of biosimilars in the field of oncology has lowered prices and made cancer treatment more affordable and accessible.  Also, due to the high incidence and prevalence of cancer, healthcare systems across the globe are focusing on reducing the burden of cancer by adopting cost effective treatment options. In this scenario, biosimilar drugs might witness widespread adoption in major markets such as the US, Europe, and the Asia Pacific. Considering these factors and the upending competition from biosimilars, many major biologic pharmaceutical companies are making significant investments in the development and approval of biosimilar drugs.

Monoclonal antibodies segment dominated biosimilars industry in 2022

Based on the product, the biosimilars market is segmented into monoclonal antibodies; insulin; Granulocyte Colony-Stimulating Factor; Erythropoietin; Recombinant Human Growth Hormone; Etanercept; Follitropin; Teriparatide; Interferons; anticoagulants; other drug class. Monoclonal antibodies accounted for a share. Insulin is segment has gained momentum in last few years, approvals for interchangebility is likely to project the growth of the segment. Launch of novel mabs biosimialrs in various regions coupled with substantial number of products under pipeline studies is likely to have positive impact on the growth of the market.

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North America dominated the biosimilars industry in 2022.

Geographically, the biosimilars market is segmented Europe, the Asia Pacific, North America, Latin America and Middle East and Africa. In 2022, Europe accounted for the largest share of the market, followed by Asia Pacific & North America. Growth in these markets is primarily driven by several factors, such as the impending patent expiry of biologic products and the launch of new biosimilars, the rising incidence of chronic disorders, the emergence of new players and early entry into the market.

Key players in the biosimilars market include Novartis AG (Switzerland), Pfizer, Inc. (US), Dr. Reddy’s Laboratories Ltd. (India), Amgen, Inc. (US) and Eli Lilly and Company (US).

Scope of the Biosimilars Industry

This report categorizes the biosimilars market to forecast revenue and analyze trends in each of the following submarkets:

By Drug Class

• Monoclonal Antibodies
  • Infliximab
  • Trastuzumab
  • Rituximab
  • Adalimumab
  • Other monoclonal antibodies
• Insulin
• Granulocyte Colony-Stimulating Factor
• Erythropoietin
• Recombinant Human Growth Hormone
• Etanercept
• Follitropin
• Teriparatide
• Interferons
• Anticoagulants
• Other drug class

By Indication

• Oncology
• Inflammatory & Autoimmune Disorders
• Chronic Diseases
• Blood Disorders
• Growth Hormone Deficiency
• Infectious Diseases
• Other Indications

By Region

• Europe
  • UK
  • France
  • Germany
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia Pacific (APAC)
  • India
  • China
  • South Korea
  • Japan
  • Australia
  • Rest of Asia Pacific (RoAPAC)
• North America
  • US
  • Canada
• Latin America
• Middle East and Africa

Recent Developments of Biosimilars Industry:

• In January 2023, Amgen Inc. launched AMJEVITA (adalimumab-atto), a biosimilar to Humira (adalimumab) in United States
• In October 2022, Biocon and Yoshindo Inc., entered into an agreement for commercializing Biocon’s pipeline products ustekinumab and bDenosumab in Japan

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