Biosimilars Market to Touch US$ 70 Billion during 2019 to 2026 | Finds, Coherent Market Insights

Biosimilars Market – Insights

A biosimilar is a biological product that is very similar to a reference biologic. Biosimilars are not required to undergo intense clinical trials for their approval. Commercialization of biosimilars requires that these products demonstrate effects similar to their original biologics in terms of clinical efficacy and safety. The global biosimilars market size was valued at US$ 5.0 billion in 2017, and is expected to witness a CAGR of 35.2% over the forecast period (2018 – 2026).

Global Biosimilars Market Share (%) Analysis, By Product Type, 2017

Source: Coherent Market Insights Analysis (2019)

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Biosimilars Market: Drivers

Increasing approval and launch of biosimilars is expected to boost growth of the global biosimilars market. Moreover, expiry and termination of existing drugs and presence of robust pipeline of biosimilar products is also expected to contribute to growth of the market over the forecast period. For instance, since 2015, the U.S. Food and Drug Administration (FDA) approved 16 biosimilars. In November 2017, Samsung Bioepis received two approval for its adalimumab biosimilar, Hadlima (SB5) and for its trastuzumab biosimilar, Samfenet (SB3), from the Korean Ministry of Food and Drug Safety (South Korea).

Several regulatory bodies have outlined clinical guidelines to support the development of biosimilars, which is also boosting growth of the market. For instance, in July 2018, the U.S. FDA introduced a Biosimilars Action Plan to encourage the development of biosimilars. This approval process encourages applicants to resolve patent disputes before launch of biosimilars.

Biosimilars Market: Restraints

A major factor hindering growth of the global biosimilars market is stringent regulatory guidelines for development and manufacturing of biosimilars. For instance, the U.S. FDA rejected four biosimilar applications during 2018. In April 2018, the U.S. FDA rejected Pfizer’s candidate trastuzumab biosimilar and Sandoz’s candidate rituximab biosimilar in May 2018.

Moreover, biologics are far more structurally complex and more difficult to characterize, produce, and reproduce compared to most small-molecule drugs. This in turn gives rise to several manufacturing challenges for biosimilars, thereby hindering the market growth.

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Biosimilars Market – Regional Analysis

Increasing initiatives of regulatory bodies for R&D of novel biosimilars is expected boost growth of the market in Europe. For instance, in July 2016, the European Medicines Agency (EMA) authorized the introduction and marketing of Thorinane and Inhixa, biosimilars of the Low Molecular Weight Heparin (LMWH), enoxaparin.

The market in Asia Pacific is driven by increasing number of biosimilar approvals. For instance, in 2017, Celltrion received approval from China Food and Drug Administration (CFDA) to start clinical trials for its infliximab biosimilar, Remsima (CT-P13), in China. This makes Celltrion the first foreign company to initiate clinical trials of an antibody biosimilar in China.

Global Biosimilars Market Value (US$ Bn) & Y-o-Y Growth (%), 2016-2026

Source: Coherent Market Insights Analysis (2019)

Biosimilars Market – Competitive Landscape

Major players operating in the global biosimilars market include, Celltrion Healthcare Co., Ltd., Novartis AG, Pfizer, Inc., Teva Pharmaceutical Industries Ltd., Biocon Limited, Amgen, Inc., Dr. Reddy’s Laboratories, and Sanofi S.A.

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Detailed Segmentation:

• Global Biosimilars Market, By Drug Class:
  • Recombinant Human Growth Hormone
  • Granulocyte Colony-Stimulating Factor
  • Insulin
  • Anticoagulants
  • Fusion Proteins
  • Erythropoietin
  • Monoclonal Antibodies
  • Follitropin
  • Others
• Global Biosimilars Market, By Therapy Type:
  • Oncology
  • Immunology
  • Hematology
  • Hormone Therapy
  • Metabolic Disorders
  • Others
• Global Biosimilars Market, By Distribution Channel:
  • Hospital Pharmacies
  • Retail Pharmacies
  • Specialty Pharmacies
• Global Biosimilars Market, By Region:
  • North America
    • By Country:
      • U.S.
      • Canada
    • By Drug Class:
      • Recombinant Human Growth Hormone
      • Granulocyte Colony-Stimulating Factor
      • Insulin
      • Anticoagulants
      • Fusion Proteins
      • Erythropoietin
      • Monoclonal Antibodies
      • Follitropin
      • Others
    • By Therapy Type:
      • Oncology
      • Immunology
      • Hematology
      • Hormone Therapy
      • Metabolic Disorders
      • Others
    • By Distribution Channel:
      • Hospital Pharmacies
      • Retail Pharmacies
      • Specialty Pharmacies
  • Europe
    • By Country:
    • By Drug Class:
    • By Therapy Type:
    • By Distribution Channel:
  • Asia Pacific
    • By Country:
    • By Drug Class:
    • By Therapy Type:
    • By Distribution Channel:
  • Latin America
    • By Country:
    • By Drug Class:
    • By Therapy Type:
    • By Distribution Channel:
  • Middle East
    • By Country:
    • By Drug Class:
    • By Therapy Type:
    • By Distribution Channel:
  • Africa
    • By Country:
    • By Drug Class:
    • By Therapy Type:
    • By Distribution Channel:

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