Biosimilars Market, by Drug Class (Recombinant Human Growth Hormone, Granulocyte Colony-Stimulating Factor, Insulin, Anticoagulants, Fusion Proteins, Erythropoietin, Monoclonal Antibodies, Follitropin, and Others), by Therapy Type (Oncology, Immunology, Hematology, Hormone Therapy, Metabolic Disorders, and Others), by Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Specialty Pharmacies), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Outlook, and Opportunity Analysis, 2018-2026

  • Published On : Apr 2019 |
  • Pages : 231 Pages |
  • Format : CMI Insight PPT Format CMI Insight PDF Format

Biosimilars Market – Insights

Biosimilar products are suspected to continue to have a significant impact on the pharmaceutical industry. Many regulatory bodies have established clinical guidelines to support the development of biosimilars, laying down the requirements for demonstrating comparable pharmacokinetics, pharmacodynamics, safety and efficacy from Phase I on to controlled, randomized Phase III trials.

Although biosimilars are not required to undergo intense clinical trials for their approval, the data demonstrating their similarity to an original biologic in terms of clinical efficacy and safety is required. The adoption of biosimilars varies from country to country, which is invariably linked to regulatory and market access issues. The biosimilars market is expected to witness significant growth, owing to expiry and termination of existing drugs and presence of rich pipeline of biosimilar products especially those in Phase III stage.

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)

Increasing number of biosimilar approvals is expected to drive the growth of biosimilars market

Increase in number of approved biosimilars due to greater clarity in the U.S. Food and Drug Administration (FDA) review process other than manufacturing and development process are expected to drive biosimilars market growth. 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.

Moreover, the number of filed biosimilars applications has increased as manufacturers have become more comfortable with the complex regulatory and litigation schemes associated with filing a biosimilar application. For instance, since 2015, the U.S. FDA has approved 16 biosimilars and the number is expected to increase over the forecast period. Several other government agencies are also following similar trends for product approvals. For instance, 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).

Biosimilars Market – Restraints

Stringent regulatory guidelines for development and manufacturing of biosimilars in the U.S. is expected to restrain growth of the global biosimilars market. 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, several manufacturing challenges for biosimilars that primarily arise due to biologics being far more structurally complex and more difficult to characterize, produce, and reproduce than most small-molecule drugs are also expected to restrain the market growth. A small variations in the manufacturing process can potentially alter the medicine’s safety and efficacy.

Biosimilars Market - Regional Insights

On the basis of region, the global biosimilars market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. Europe is expected to be the most lucrative market for biosimilars over the forecast period. Increasing focus of regulatory bodies in development of novel biosimilars is expected to drive 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.

Asia Pacific biosimilars market size is expected to foresee a rapid growth, owing to significantly 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

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

Biosimilars are biopharmaceutical drugs that have active components and are similar to the drugs, which have been previously licensed. They are identical copies of the original product and can be manufactured only when the patent for the original innovator product expires. Biosimilars are majorly used in therapeutic applications for the treatment of various types of cancer and non-communicable diseases (asthma and arthritis).

Increasing prevalence of cancer is expected to boost growth of the biosimilars market. For instance, according to National Institute of Cancer Prevention and Research (NICPR), in 2018, 1,62,468 new cases and 87,090 deaths were reported due to breast cancer in India. Biosimilars are designed to be highly similar to originator biologic products, which represents an opportunity to increase access and reduce costs for patients and healthcare systems.

Market Dynamics

Increasing number of biosimilar approvals in clinical management of various diseases such as diabetes and hormonal imbalance is expected to drive growth of the biosimilars market. According to the Generics and Biosimilars Initiative (GABI) 2017 report, around 40 different biosimilars were approved in Europe, covering several different therapeutic classes: granulocyte colony-stimulating factors, and erythropoiesis-stimulating agents (ESAs), among others.

Moreover, increasing research and development in biosimilars, robust biosimilar pipeline portfolio, and support from healthcare regulatory bodies in fast lining biosimilar approvals are some of the major factors that are expected to drive growth of the market. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both provide guidance for the development of biosimilar drugs. However, stringent regulatory guidelines for development and manufacturing of biosimilars and fragile process of biosimilars production are expected to negatively impact growth of the global biosimilars market.

Key features of the study:

  • This report provides in-depth analysis of the biosimilars market, market size (US$ Mn), and Compound Annual Growth Rate (CAGR (%)) for the forecast period: 2018 – 2026, considering 2017, as the base year
  • It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the global biosimilars market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments, and strategies
  • Key players covered as a part of this study include Novartis AG, Pfizer, Inc., Teva Pharmaceutical Industries Ltd., Celltrion Healthcare Co., Ltd., Biocon Limited, Amgen, Inc., Dr. Reddy's Laboratories, and Sanofi S.A.
  • Insights from this report would allow marketers and management authorities of companies to make informed decision with respect to their future product launch, government initiatives, technological up-gradation, market expansion, and marketing tactics
  • The global biosimilars market report caters to various stakeholders in this industry, including investors, product manufacturers, distributors, and suppliers for biosimilars market, research and consulting firms, new entrants, and financial analysts

 

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:
        • U.K.
        • Germany
        • Italy
        • Spain
        • France
        • Russia
        • Rest of Europe
      • 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
    • Asia Pacific
      • By Country:
        • Australia
        • India
        • China
        • Japan
        • ASEAN
        • South Korea
        • Rest of Asia Pacific
      • 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
    • Latin America
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
      • 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
    • Middle East
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
      • 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
    • Africa
      • By Country:
        • South Africa
        • Central Africa
        • North Africa
      • 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
  • Company Profiles
    • Novartis AG *
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Recent Highlights
      • Strategies
    • Pfizer, Inc.
    • Teva Pharmaceutical Industries Ltd.
    • Celltrion Healthcare Co., Ltd.
    • Biocon Limited
    • Amgen, Inc.
    • Dr. Reddy's Laboratories
    • Sanofi S.A.

“*” marked represents similar segmentation in other categories in the respective section.

Table of Contents

  1. Research Objective and Assumption
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Overview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Drug Class
      • Market Snippet, By Therapy Type
      • Market Snippet, By Distribution Channel
      • Market Snippet, By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Market Trends
    • Key Developments
    • Pipeline Analysis
    • Supply Chain Analysis
    • Cost Effectiveness of Biosimilars
    • Reimbursement Scenario
    • Regulatory Landscape
    • Epidemiology Analysis
    • PEST Analysis
    • Porter’s Five Forces model
  4. Global Biosimilars Market, By Drug Class, 2018 – 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Recombinant Human Growth Hormone (rhGH)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
    • Granulocyte Colony-Stimulating Factor (Filgrastim)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
    • Insulin
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
    • Anticoagulants
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
    • Fusion Proteins
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
    • Erythropoietin (EPO)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
    • Monoclonal Antibodies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
    • Follitropin
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
  5. Global Biosimilars Market, By Therapy Type, 2018 – 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Oncology
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
    • Immunology
      • Introduction  
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
    • Hematology
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
    • Hormone Therapy
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
    • Metabolic Disorders
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
  6. Global Biosimilars Market, By Distribution Channel, 2018 – 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, 2017 – 2026
      • Segment Trends
    • Hospital Pharmacies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
    • Retail Pharmacies
      • Introduction  
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
    • Specialty Pharmacies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
  7. Global Biosimilars Market, By Region, 2018 – 2026, (US$ Million)
    • Introduction
      • Market Share Analysis, By Region, 2018 and 2026 (%)
      • Y-o-Y Growth Analysis, By Region, 2017 – 2026
      • Regional Trends
    • North America
      • Market Size and Forecast, By Drug Class, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Therapy Type, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Distribution Channel, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2018 – 2026, (US$ Million)
        • U.S.
        • Canada
    • Europe
      • Market Size and Forecast, By Drug Class, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Therapy Type, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Distribution Channel, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2018 – 2026, (US$ Million)
        • U.K.
        • Germany
        • Italy
        • France
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast, By Drug Class, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Therapy Type, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Distribution Channel, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2018 – 2026, (US$ Million)
        • China
        • Japan
        • India
        • ASEAN
        • Australia
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • Market Size and Forecast, By Drug Class, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Therapy Type, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Distribution Channel, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2018 – 2026, (US$ Million)
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Africa
      • Market Size and Forecast, By Drug Class, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Therapy Type, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Distribution Channel, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2018 – 2026, (US$ Million)
        • North Africa
        • Central Africa
        • South Africa
    • Middle East
      • Market Size and Forecast, By Drug Class, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Therapy Type, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Distribution Channel, 2018 – 2026, (US$ Million)
      • Market Size and Forecast, By Country, 2018 – 2026, (US$ Million)
        • GCC Countries
        • Israel
        • Rest of Middle East
  8. Competitive Landscape
    • Company Profiles
      • Novartis AG
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Pfizer, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Teva Pharmaceutical Industries Ltd.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Celltrion Healthcare Co., Ltd.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Biocon Limited
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Amgen, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Dr. Reddy's Laboratories
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
      • Sanofi S.A.
        • Company Overview
        • Product Portfolio
        • Financial Performance
        • Recent Highlights
        • Strategies
    • Analyst Views
  9. Section
    • References
    • Research Methodology
    • About Us and Sales Contact

*Browse 27 market data tables and 21 figures on "Biosimilars Market” - Global forecast to 2026”

Research Methodology

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  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.


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Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

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  • Trade association, National and international media and trade press.
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  • Scientific journals, and other technical magazines and whitepapers.

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Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization:

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

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Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

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  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

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