Biosimilars Market Scope

The biosimilars industry is poised for significant growth due to increasing demand for cost-effective alternatives to biologic drugs. With the rise in chronic diseases and the impending patent expiration of blockbuster biologics, the biosimilars market is becoming a key focus for healthcare innovation and investment globally.

An integral component of the Biosimilars Market is the emergence of follow-on biologics. These biologics, which closely resemble existing biologic drugs, offer additional options for patients and healthcare providers. Follow-on biologics undergo rigorous testing to demonstrate similarity to the reference product, ensuring interchangeability and therapeutic equivalence. With their introduction, follow-on biologics stimulate competition in the biopharmaceutical industry, driving down prices and promoting innovation. As the demand for cost-effective biologic therapies continues to grow, the Biosimilars Market stands to benefit from the availability and acceptance of follow-on biologics, expanding treatment options and improving patient outcomes.

According to Market Research Future (MRFR), the biosimilars market insights report has valued the industry size USD 23.97 billion in 2022 and is projected to grow from USD 29.70 Billion in 2024 to USD 161.95 billion by 2034, exhibiting a compound annual growth rate (CAGR) of 23.90% during the forecast period (2025 - 2034).

Market Growth Trends

1. Rising Demand for Cost-Efficient Drugs
   The increasing cost of biologic drugs is driving the demand for biosimilars. Governments and healthcare systems worldwide are promoting biosimilars to reduce healthcare expenditures while maintaining treatment efficacy.

2. Patent Expirations
   Many leading biologic drugs, such as Humira, Remicade, and Herceptin, have faced or are about to face patent cliffs, creating significant opportunities for biosimilar manufacturers.

3. Regulatory Approvals and Pathways
   Regulatory agencies such as the FDA and EMA have streamlined approval processes for biosimilars, which is accelerating market entry and expansion.

4. Technological Advancements
   Innovations in manufacturing and analytical techniques are improving the quality, safety, and efficacy of biosimilars, boosting consumer confidence and adoption rates.

Biosimilars Market: Latest News and Developments

• The FDA has approved the first Humira biosimilar. Adalimumab-bwwd (Cyltezo), a Humira biosimilar, received FDA approval in January 2023 for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.
• Rising use of biosimilars in the treatment of cancer. A growing number of biosimilars are being used to treat cancer. The FDA authorised filgrastim-sndz (Zarxio), pegfilgrastim-jmdb (Onpro), and trastuzumab-dkst (Herzuma) as three biosimilars for the treatment of cancer in 2022.

Market Segmentation

Biosimilars industry can be considered with respect to product, applications, and end users.

The products based on which the market has been split into are recombinant glycosylated proteins, recombinant peptides, and recombinant non-glycosylated proteins. Recombinant non-glycosylated proteins are the biggest segment in the global market, thanks to the soaring cases of chronic disorders ranging from growth hormone deficiency to diabetes. As a result, recombinant non-glycosylated proteins are therapeutically used as they are readily available and are cost-effective.

Application-wise, the biosimilars market caters to chronic diseases, oncology, blood disorders, autoimmune diseases, infectious diseases, growth hormone deficiency, and more. Blood disorders have emerged as the top segment, as a result of the rising burden of the condition worldwide and the increased use of biosimilars by virtue of their low cost and the overall reduction in the treatment cost.

Major end users in the global market are hospitals and clinics as well as research institutes. Hospital and clinics are healthcare settings where treatment options and skilled professionals are easily available, and therefore, have emerged as the leading segment in the global industry.

Regional Outlook

North America

• Growth Drivers: Increasing regulatory approvals by the FDA, high healthcare expenditure, and a growing geriatric population.
• Key Development: The US has seen the rapid adoption of biosimilars in oncology and autoimmune diseases, with Medicare policies supporting their usage.

Europe

• Growth Drivers: Favorable regulatory landscape and established biosimilar guidelines.
• Key Development: Europe leads in biosimilar adoption, driven by countries like Germany, the UK, and France, where government initiatives encourage biosimilar substitution.

Asia-Pacific

• Growth Drivers: Expanding healthcare infrastructure and growing investments in biopharmaceutical research.
• Key Development: Countries like India and China are emerging as manufacturing hubs due to cost-effective production and skilled labor.

Middle East & Africa

• Growth Drivers: Rising prevalence of chronic diseases and growing demand for affordable biologics.
• Key Development: Biosimilars are gaining traction in Gulf countries, where healthcare reforms aim to enhance treatment accessibility.

Latin America

• Growth Drivers: Increasing awareness and governmental support for biosimilars.
• Key Development: Brazil and Mexico are leading biosimilar development and adoption due to supportive policies and collaborations with global players.

Eminent Vendors

Top global key players listed by biosimilars market outlook report include Stada Arzneimittel AG (Germany), Teva Pharmaceuticals (Israel), Biocon (India), Pfizer (US), Sandoz International (Germany), Eli Lily & Company (US), Actavis, Inc. (US), Dr. Reddy’s Laboratories (India), Cipla Ltd (India), Amgen, Inc. (US), Samsung Biologics (South Korea), Hospira Inc.(US), Mylan, Inc.(US), Celltrion (South Korea), to mention a few.

Recent Developments

1. Strategic Collaborations
   Partnerships between global pharmaceutical giants and local companies are enhancing market penetration and supply chain efficiency.

2. Expanding Portfolios
   Companies are diversifying their biosimilar offerings, focusing on high-demand therapeutic areas like oncology, immunology, and diabetes.

3. Market Entry of New Players
   The biosimilar market has witnessed an influx of small and medium enterprises, intensifying competition and fostering innovation.

4. Investments in R&D
   Major market players are increasing investments in R&D to improve biosimilar formulations and gain a competitive edge.

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