BIOSIMILARS MARKET ANALYSIS

Market Size and Trends

Global biosimilars market is estimated to be valued at USD 36.01 Bn in 2024 and is expected to reach USD 114.02 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 18.4% from 2024 to 2031.

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 Growing demand for affordable biological drugs along with patent expiries of major biologics drugs can drive the market growth. Increasing investments by market players for research & development and production of biosimilars coupled with supportive regulatory framework can also boost demand for biosimilars. Moreover, biosimilars provide similar therapeutic efficacy in comparison to reference biologics with significant cost savings, which makes them an attractive alternative. However, manufacturing challenges associated with biosimilars can hinder the market growth over the forecast period.

Global Adoption of Biosimilars

Rising healthcare costs in many countries across the globe has increased pressure on governments and private healthcare payers to reduce prescription drug costs. Biosimilars provide significant cost savings as compared to their referenced biologic drugs while providing similar clinical outcomes. Over the past decade, major markets like EU and countries like India, China, Brazil and others have laid out a structured pathway and clear guidelines for the development and approval of biosimilars. This not only boosted investor confidence but also encouraged many generic drug makers to enter this space. As more biosimilars get approved and commercialized in these regions, their cost effectiveness is persuading physicians, hospitals as well as private and public payers to increase their usage over their biologic counterparts for treatment of chronic diseases. This growing acceptance and uptake of affordable biosimilars instead of biologics can drive the market growth.

Market Concentration and Competitive Landscape

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Patent expiry of blockbuster biologics

The expiry of patents on major biologic drugs known as blockbusters can drive the biosimilars market growth. When the original manufacturer's patent expires, it offers opportunity for other companies to develop and market biosimilar versions. Notable patent expires in recent years have included Humira, Remicade, Herceptin, Rituxan and MabThera. For instance, AbbVie's Humira, the world's top-selling prescription drug, had worldwide sales of over US$ 20 billion in 2020, according to the STAT Medical Research Guide. With Humira losing exclusivity in Europe in 2018 and the U.S. in 2023, this has encouraged many biosimilar manufacturers to enter the market. In the European Union, biosimilar competition has led to price reductions as high as 80% off the original biologic drug. Greater patient access as well as savings for healthcare systems boosts adoption of lower-cost biosimilars.

According to the WHO Essential Medicines and Health Products List, between 2023 and 2026, blockbusters worth a combined estimated US$ 72 billion in annual sales are forecast to face upcoming patent cliffs. ,. This includes Enbrel, Lantus, Avastin and Harvoni. As more high-profile biologics complete their exclusivity period, their biosimilar counterparts are expected to capture greater market shares over the next decade.

Key Takeaways from Analyst:

Global biosimilars market can witness growth as many blockbuster biologics are expected to go off-patent in the near future. This offers significant opportunities for biosimilar manufacturers to enter the market with more affordable treatment options. Europe has been the dominant market due to early regulatory approvals and positive reimbursement policies that encourage biosimilar adoption. However, with many large markets like the U.S. getting established, North America increasingly contribute to global biosimilars revenue.

Patent expiries of major biologics and cost savings potential as compared to originator biologics will allow greater patient access to important drugs. Biosimilars approval pathways have become more established and predictable globally which provides confidence to manufacturers. Interchangeability regulations outside of Europe could hamper automatic substitution which is integral to uptake. Clinical trial requirements can increase cost as compared to small molecules. Manufacturing complexities also present difficulties in replicating biologics exactly.

Market Challenges: The expiry of patents and data

The expiry of patents and data exclusivity protection of major blockbuster biologics can offer significant opportunities for biosimilar manufacturers. As patents expire in therapeutic areas such as oncology, immunology, endocrinology and ophthalmology, biosimilar manufacturers will be able to develop biosimilar versions of top-selling biologics. This will provide more treatment options to patients, as well as potential cost savings to healthcare systems globally. Many biosimilar developers are actively working on expanding into new therapeutic indications beyond just oncology, where most biosimilars are currently concentrated. For example, in 2022, the World Health Organization’s essential medicines list added several newly off-patent biologics used for diabetes and Non-communicable lung diseases. This prioritization highlights growing global burden of diseases that could potentially be treated more affordably with biosimilars. Some manufacturers have also announced pipeline biosimilars in development for auto-immune disorders such as rheumatoid arthritis. Successful approvals and launches in diverse therapeutic areas would provide opportunities to achieve blockbuster revenues for certain biosimilar products.

Market Opportunities: Potential entry of biosimilars into new therapeutic areas

Global biosimilars market has traditionally been dominated by a small number of therapeutic areas such as oncology, hematology and immunology. However, as several blockbuster biologics are nearing patent expiry in disease areas such as diabetes, autoimmune disorders and ophthalmology, this provides a massive opportunity for biosimilar manufacturers to enter new therapeutic segments. As per the World Health Organization, over 422 million people worldwide had diabetes in 2014, showing a significant patient population available for affordable biosimilar treatment options.

As biosimilar companies gain more experience and success in demonstrating interchangeability in areas like oncology through post-marketing studies, it will give them more confidence to invest in biosimilar development for other complex disease classes and expand their portfolio. This will allow more patients access to important biologics that were previously financially out of reach for treatment. For example, the approval of the first interchangeable biosimilar insulin product in the U.S. in 2023, demonstrated that biosimilars can successfully compete even in therapeutic areas like diabetes that require a cold chain and are administered by patients themselves. The entry of multiple biosimilar competitors can considerablylower drug prices, providing both healthcare systems and patients with significant savings. These savings could then be redistributed to expand access to other novel therapies. This makes the potential for biosimilars in new disease areas an extremely valuable opportunity to make biologics truly affordable and sustainable for patients as well as governments globally.

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By Drug Class - Versatility and Wide Range of Applications Drive Recombinant Human Growth Hormone Segment

In terms of drug class, recombinant human growth hormone segment is estimated to contribute the highest market share of 20% in 2024, owing to its versatility and wide range of applications. Recombinant human growth hormone is used to treat a variety of conditions related to growth hormone deficiency in both pediatric and adult patients. Some of the major conditions treated with recombinant human growth hormone include turner syndrome, Prader-Willi syndrome, chronic renal insufficiency, and AIDS-related wasting. Its ability to stimulate growth in both children and adults through different growth-promoting effects makes it a favorable treatment option for doctors and patients. Recombinant human growth hormone witness widespread usage in the treatment of growth hormone deficiency, which commonly occurs in children born small for gestational age or with genetic mutations or abnormalities. It is also prescribed to treat short stature in children not caused by any underlying disease condition. Recombinant human growth hormone treatment has applications in improving body composition and quality of life in adult patients with growth hormone deficiency. Its anabolic properties make it beneficial for increasing muscle mass and strength.

By Therapy Type - High Disease Prevalence and Efficacy Drive Oncology Segment

In terms of therapy type, oncology segment is estimated to contribute the highest market share of 25.12 % in 2024, owing to the high prevalence of cancer and efficacy of biosimilars in oncological treatment. Cancer has a huge disease burden worldwide with an estimated 19 million new cases and 10 million cancer deaths in 2020. The continually growing cancer patient pool boosts demand for cost-effective oncology biosimilars. Many blockbuster biologic drugs have lost exclusivity in recent years, providing opportunities for oncology biosimilars. Areas such as non-Hodgkin's lymphoma, breast cancer, and colorectal cancer with large biologic drug consuming patient bases are prime market targets. Biosimilars of widely prescribed biologics like bevacizumab, trastuzumab, rituximab and cetuximab witness huge uptake due to demonstrated similar clinical outcomes. The introduction of multiple biosimilars has also increased treatment affordability and accessibility. Biosimilars offer cost savings of 20-30% compared to reference products enabling more patients to be treated. With cancer management shifting towards prolonged maintenance therapies, biosimilars play a vital role in treatment sustainability.

By Distribution Channel- Cost Savings and Procurement Advantages Drive Hospital Pharmacies Segment

In terms of distribution channel, hospital pharmacies segment is estimated to contribute the highest market share of 30% in 2024, owing to the potential for cost savings and bulk procurement advantages. Hospital pharmacies treat a large volume of patients on a daily basis requiring immense drug budgets. Biosimilars enable substantial drug expenditure reductions for cash strapped hospitals. Their lower prices compared to reference biologics result in significant budgetary relief without compromising treatment quality. Furthermore, hospitals can leverage their bulk purchasing power to negotiate additional discounts on biosimilar prices from manufacturers. Centralized hospital dispensing also allows better inventory management and control over drug usage. Tight formulary management ensures prescribed medicines conform to insurance plans or hospital networks. This streamlines the reimbursement process reducing the scope for expensive treatment costs. As the main drug procurement agencies for in-patients, hospital pharmacies also influence out-patient physician prescribing through educational campaigns and incentives.

Regional Insights

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North America currently dominates the global biosimilars market, accounting for over 40.2% of the worldwide market share in 2024. With biosimilars expected to drive down healthcare costs in the U.S., the U.S. FDA has approved over 20 biosimilars to date in an effort to increase competition. Major players in the U.S. market include Pfizer, Novartis, and Merck who are well positioned to leverage their pharmaceutical expertise and capture market share as familiar biosimilars continue to go off-patent.

Despite facing initial payer resistance and slower than expected uptake in some therapeutic areas, revenue from biosimilars in the U.S. crossed US$ 1 billion in 2021. The U.S. market offers lucrative opportunities for biosimilar manufacturers due to its size, favorable regulatory guidelines, and the number of blockbuster biological drugs set to lose patent protection over the coming years. Additionally, incentives for U.S. consumers and payers to reduce drug costs will support ongoing transition to more affordable biosimilar options. The European Union is currently the fastest-growing regional market for biosimilars globally. Countries like Germany, France, and the U.K. have particularly strong biosimilar markets and industry presence. Europe was the first region to approve and adopt biosimilars at a commercial level and has progressed much further down the adoption curve compared to other regionss. Germany in particular has emerged as a biosimilars manufacturing powerhouse with several local companies, attracting global biosimilar developers through its strategically strong position in the value chain.

Market Report Scope

Key Developments

• On July 2024, Amneal Pharmaceuticals, Inc. Pharmaceutical company has announced the inclusion of omalizumab, a biosimilar referencing XOLAIR, in its pipeline. Developed by Kashiv BioSciences, LLC, this humanized monoclonal antibody targets free immunoglobulin E (IgE) and is currently undergoing Phase III clinical trials initiated in Q3 2023.
• In May 2024, Biocon Biologics Ltd (BBL), a global biosimilars company and subsidiary of Biocon Ltd, has received FDA approval for Yesafili (aflibercept-jbvf), an interchangeable* biosimilar of EYLEA (aflibercept). Yesafili is a vascular endothelial growth factor (VEGF) inhibitor used to treat various ophthalmic conditions.
• In May 2022, Amneal Pharmaceuticals, Inc. received FDA approval for a Biologics License Application (BLA) for pegfilgrastim-pbbk, a biosimilar of Neulasta, which will be marketed as FYLNETRA. This approval marks a significant milestone in the biosimilar landscape.
• In September 2021, Samsung Bioepis and Biogen announced FDA approval of BYOOVIZ (ranibizumab-nuna), a biosimilar to LUCENTIS (ranibizumab), for treating neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. BYOOVIZ is notable as the first biosimilar in ophthalmology approved in the United States.

*Definition: The global biosimilars market refers to the market for biological medicinal products that are similar to already approved original branded biologic medicines. Biosimilar medicines compete with innovator biologic medicines after the patent and exclusivity period ends. The global biosimilars market has seen significant growth in recent years as patents of large biologics expire and more biosimilars are approved. Various factors such as rising healthcare costs, patent expiries of major biologics, and regulatory support for biosimilars are driving the demand in this market across regions.

Market Segmentation

•  Drug Class Insights (Revenue, USD Bn, 2019 - 2031)
  • Recombinant Human Growth Hormone
  • Granulocyte Colony-Stimulating Factor
  • Insulin
  • Anticoagulants
  • Fusion Proteins Erythropoietin
  • Monoclonal Antibodies
  • Follitropin
  • Others
•  Therapy Type Insights (Revenue, USD Bn, 2019 - 2031)
  • Oncology
  • Immunology
  • Hematology
  • Hormone Therapy
  • Metabolic Disorders
  • Others
•  Distribution Channel Insights (Revenue, USD Bn, 2019 - 2031)
  • Hospital Pharmacies
  • Retail Pharmacies
  • Specialty Pharmacies
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Amgen Inc.
  • Pfizer Inc.
  • Samsung Bioepis Co., Ltd.
  • Sandoz International GmbH
  • Celltrion Healthcare Co., Ltd.
  • Biocon Limited
  • Dr. Reddy's Laboratories Ltd.
  • Teva Pharmaceutical Industries Ltd.
  • Boehringer Ingelheim International GmbH
  • Fresenius Kabi AG
  • Merck & Co., Inc.
  • Biogen Idec Inc
  • Coherus BioSciences
  • Stada Arzneimittel AG