Biosimilars Market is Projected to Surpass USD 85 billion by 2031, Growing at CAGR 15.5%- Report by Transparency Market Research, Inc.

Biosimilars expand into new therapeutic areas, offering alternatives for complex diseases and improving patient access to vital treatments.

Wilmington, Delaware, United States, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Transparency Market Research Inc. - The global biosimilars market is estimated to flourish at a CAGR of 15.5% from 2022 to 2031. Transparency Market Research projects that the overall sales revenue for biosimilars is estimated to reach US$ 85 billion by the end of 2031. Ongoing research and development efforts focus on enhancing biosimilar formulations, delivery methods, and production processes to improve efficacy, safety, and patient outcomes.

Intensifying competition among biosimilar manufacturers prompts differentiation strategies, including pricing models, marketing approaches, and value-added services, stimulating market innovation and consumer choice. Increasing emphasis on establishing biosimilar interchangeability with reference biologics drives investment in clinical studies, real-world evidence, and regulatory pathways to validate safety and efficacy equivalence.

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Integration of biosimilars into healthcare systems through formulary inclusion, reimbursement policies, and prescribing guidelines promotes market adoption and utilization, ensuring broader patient access to cost-effective biologic therapies. Education initiatives targeting healthcare professionals, patients, and policymakers raise awareness about biosimilar safety, efficacy, and value proposition, fostering informed decision-making and increasing confidence in biosimilar therapies.

Key Findings of the Market Report

  • Monoclonal antibodies segment leads the biosimilars market due to extensive research, established manufacturing processes, and high demand for therapeutic applications.
  • Oncology segment leads the biosimilars market due to high demand for cost-effective alternatives in cancer treatment and management.
  • Europe leads the biosimilars market, driven by favorable regulatory frameworks, robust competition, and widespread acceptance of biosimilar therapies across healthcare systems.

Biosimilars Market Growth Drivers & Trends

  • Expired patents for biologic drugs create opportunities for biosimilar manufacturers to enter the market, offering cost-effective alternatives and driving competition.  
  • Demand for affordable treatment options fuels adoption of biosimilars, addressing rising healthcare expenditure and improving patient access to vital therapies.
  • Streamlined approval processes and supportive regulatory frameworks encourage biosimilar development, facilitating market entry and accelerating commercialization of biologic alternatives.
  • Healthcare professionals and patients increasingly embrace biosimilars as safe and effective alternatives to branded biologics, driving market acceptance and adoption across various therapeutic areas.
  • Expansion of biosimilar markets in emerging economies, driven by increasing healthcare investments, rising disease burden, and favorable regulatory environments, presents significant growth opportunities for industry players.

Global Biosimilars Market: Regional Profile

  • North America, spearheaded by the United States, stands as a pivotal market for biosimilars, driven by stringent regulatory pathways, increasing healthcare expenditure, and patent expiries of biologic drugs. Companies like Amgen and Pfizer lead the charge, leveraging expertise in biotechnology and strong distribution networks.
  • Europe emerges as a frontrunner in biosimilars adoption, propelled by favorable regulatory frameworks, cost containment measures, and robust market competition. The European Medicines Agency (EMA) plays a key role in streamlining approval processes, fostering market entry for players like Sandoz and Mylan.
  • Asia Pacific presents significant growth opportunities, fueled by rising healthcare demand, government initiatives for affordable healthcare access, and increasing acceptance of biosimilars. Countries like South Korea and India lead the region's biosimilars market, with companies such as Celltrion and Biocon driving innovation and market penetration.

Biosimilars Market: Competitive Landscape

The biosimilars market boasts a competitive landscape driven by industry giants and emerging players alike. Leading companies such as Amgen, Novartis, and Pfizer dominate with extensive experience, robust pipelines, and global reach. They invest heavily in research, development, and strategic partnerships to maintain market leadership.

Emerging players like Celltrion and Biocon challenge incumbents with niche expertise, cost-effective production, and regulatory compliance. Regional players also contribute significantly, offering localized solutions and catering to specific market segments. The competitive environment fosters innovation, affordability, and accessibility, driving the expansion and evolution of the biosimilars market worldwide. Some prominent players are as follows:

  • Pfizer Inc.
  • Intas Pharmaceuticals Ltd.
  • Biocon
  • Dr. Reddy’s Laboratories Ltd.
  • Teva Pharmaceutical Industries Ltd.
  • Sandoz International GmbH (A Novartis Division)
  • Celltrion Inc.
  • Amgen Inc.
  • STADA Arzneimittel AG
  • Apotex Inc.

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Product Portfolio

  • Celltrion Inc. is a leading biopharmaceutical company dedicated to developing innovative treatments for various diseases. With a focus on biosimilars and novel biologics, Celltrion strives to improve patient access to high-quality and affordable healthcare solutions, driving advancements in the global pharmaceutical industry.
  • Amgen Inc. is a pioneering biotechnology company committed to transforming patients' lives through innovative medicines. With a diverse portfolio spanning oncology, cardiovascular diseases, and bone health, Amgen continues to push the boundaries of science to address unmet medical needs and improve patient outcomes worldwide.
  • STADA Arzneimittel AG is a global pharmaceutical company dedicated to providing high-quality and affordable healthcare solutions. With a focus on generics, consumer health products, and specialty pharmaceuticals, STADA delivers trusted medicines to patients across the globe, ensuring accessibility and affordability in healthcare.

Biosimilars Market: Key Segments
By Product

  • Recombinant Glycosylated Proteins
  • Monoclonal Antibodies
  • Erythropoietin
  • Others
  • Recombinant Non-glycosylated Proteins
  • Insulin
  • Granulocyte Colony Stimulating Factor
  • Recombinant Human Growth Factor
  • Interferons
  • Recombinant Peptides

By Indication

  • Chronic Diseases
  • Oncology
  • Autoimmune Diseases
  • Infectious Diseases
  • Blood Disorders
  • Growth Hormone Deficiency
  • Others

By Region

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East & Africa

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