Global Biosimilars and Follow-On Biologics Market Report 2024-2034 - Expanding the Portfolio of Biosimilars for Rare Diseases

Dublin, May 31, 2024 (GLOBE NEWSWIRE) -- The "Biosimilars and Follow-On Biologics Market Report 2024-2034" has been added to's offering.

World revenue for the Biosimilars and Follow-on Biologics Market is set to surpass US$33,000 million in 2024, with strong revenue growth through to 2034.

Increasing Demand of Drugs For Treating Chronic Conditions

The increasing demand for drugs stems from their remarkable efficacy in treating a wide array of chronic and complex diseases, ranging from cancer to autoimmune disorders and beyond. Chronic conditions such as diabetes, rheumatoid arthritis, and various forms of cancer are becoming increasingly prevalent, driving up the need for effective long-term treatments. This surge is propelled by various factors, including the aging population, the prevalence of lifestyle-related ailments, and advancements in medical science enabling earlier detection and prolonged treatment.

As our understanding of disease mechanisms deepens, biologics continue to be at the forefront of medical innovation, offering hope for patients with previously untreatable conditions. Additionally, heightened awareness and evolving healthcare policies advocating proactive management of chronic illnesses further contribute to the increasing demand for these drugs.

Favourable regulatory policies for approval of biosimilars

Regulatory agencies around the world have recognized the importance of establishing clear and transparent pathways for the approval of biosimilars, ensuring that these products meet stringent standards of quality, safety, and efficacy.

One of the key elements of favourable regulatory policies is the establishment of specific guidelines and frameworks tailored to the unique characteristics of biosimilars. Unlike small molecule drugs, which can be replicated with relative ease, biologics are large, complex molecules produced in living cells, making their development and characterization more challenging. Regulatory pathways allow biosimilar manufacturers to rely on existing clinical data for reference biologics, expediting the approval process while still requiring robust comparative analytical and clinical studies to demonstrate similarity and safety. By providing clear expectations and requirements, these guidelines enable manufacturers to navigate the regulatory process more efficiently and effectively, accelerating the development and approval of biosimilars.

Moreover, favourable regulatory policies include provisions to expedite the review and approval of biosimilar products, fostering competition and expanding patient access to affordable treatments. Regulatory agencies may employ mechanisms such as abbreviated pathways or priority review designations to streamline the approval process for biosimilars, particularly for products targeting diseases with significant unmet medical needs. These expedited pathways help bring biosimilar products to market more quickly, encouraging innovation and investment in the biosimilars space.

Forecasts to 2034 and other analyses reveal commercial prospects

  • In addition to revenue forecasting to 2034, the new study provides you with recent results, growth rates, and market shares.
  • You will find original analyses, with business outlooks and developments.
  • Discover qualitative analyses (including market dynamics, drivers, opportunities, restraints and challenges), cost structure, impact of rising Biosimilars and Follow-on Biologics prices and recent developments.

Key Market Dynamics

Market Driving Factors

  • Expiration of Patents for Original Biologics in the recent years
  • Increasing Incidence of Chronic Diseases
  • Established Clear Guidelines for the Approval of Biosimilars

Market Restraining Factors

  • High Development Costs of follow-on biologics
  • Lack of Interchangeability Between Biosimilars and Their Reference Biologics
  • Intellectual Property Issues and Other Legal Challenges

Market Opportunities

  • Development of Biosimilar Versions of Monoclonal Antibodies
  • Growing Demand for Affordable Biologics in Emerging Markets
  • Expanding the Portfolio of Biosimilars for Rare Diseases

Segments Covered in the Report

Product Type

  • Recombinant Non-Glycosylated Proteins
  • Human Growth Hormone
  • Granulocyte Colony-Stimulating Factor (Filgrastim)
  • Insulin
  • Interferon
  • Recombinant Glycosylated Proteins
  • Erythropoietin
  • Monoclonal Antibodies (Infliximab, Rituximab, Adalimumab, Trastuzumab, Bevacizumab, Etanercept)
  • Follitropin
  • Low Molecular Weight Heparin


  • Hematology
  • Neutropenia
  • Anemia
  • Others
  • Oncology
  • Lung Cancer
  • Brain Cancer
  • Breast Cancer
  • Cervical Cancer
  • Colorectal Cancer
  • Leukemia
  • Others
  • Autoimmune Disease
  • Arthritis (Rheumatoid Arthritis, Psoriatic Arthritis, Juvenile Arthritis, Ankylosing Spondylitis, Others)
  • Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Diseases, Others)
  • Psoriasis
  • Others
  • Growth Hormone Deficiency
  • Diabetes
  • Others


  • Recombinant DNA (rDNA) Technology
  • Monoclonal Antibodies (MAb) Technology


  • Contract Research and Manufacturing Services
  • In-house

In addition to the revenue predictions for the overall world market and segments, you will also find revenue forecasts for four regional and 27 leading national markets.

The report also includes profiles and for some of the leading companies in the Biosimilars and Follow-on Biologics Market, 2024 to 2034, with a focus on this segment of these companies' operations.

Leading companies profiled in the report

  • Amgen
  • Apotex
  • Biocad
  • Biocon Biologics Ltd.
  • Bio-Thera Solutions
  • Coherus Biosciences
  • Dr. Reddy's Laboratories
  • Fresenius Kabi
  • Intas Pharma
  • Pfizer
  • Reliance Life Sciences
  • Samsung Bioepis
  • Sandoz Group
  • Teva Pharmaceuticals

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