Global Biosimilar Market: By Molecule; By Type of Manufacturing; By Indication; Regional Analysis; Historical Market and Forecast (2015-2025); Market Dynamics; Biosimilar Patent Landscape; Value Chain Analysis; Requirements for Setting Up a Biosimilar Manufacturing Plant; Competitive Landscape; Industry Events and Developments

Global Biosimilar Market Outlook

The global biosimilar market size reached a value of almost USD 5.3 billion in the year 2019. The biosimilar market is further expected to grow at a CAGR of 32% between 2020 and 2025 to reach a value of almost USD 28 billion by 2025. 

The global biosimilar market has Europe as the leading region, accounting for about more than half of the global market share. The industry is led by the increasing number of ageing population within Europe. Following Europe, the United States, Japan, India, and South Korea are the other significant markets for biosimilar.

 

Properties and Applications

Biosimilars, variously known as subsequent entry biologics (SEBs) or follow-on biologics, are referred to as the FDA-approved biotherapeutic products that are similar to their reference biologics. It can only be manufactured after the expiration of the patent of the reference product.

The biosimilar market is divided on the basis of molecule into:

  • Infliximab
  • Insulin Glargine
  • Epoetin Alfa
  • Etanercept
  • Filgrastim
  • Somatropin
  • Rituximab
  • Follitropin Alfa

Presently, infliximab dominates the industry, accounting for the largest share in the industry.

On the basis of type of manufacturing, the biosimilar market is segmented into:

  • In-house Manufacturing
  • Contract Manufacturing

Among all of these, in-house manufacturing holds the majority of the share of the industry.

On the basis of indication, the biosimilar market is divided into:

  • Auto-Immune Diseases
  • Blood Disorder
  • Diabetes
  • Oncology
  • Growth Deficiency
  • Female Infertility

Amongst these, autoimmune diseases account for the majority of the total biosimilar market share.

The report also covers the major regions for biosimilar like North America, Europe, the Asia Pacific, Latin America, and the Middle East and Africa.

 

Market Analysis 

The global biosimilar market is driven by the increasing demand for the product in the recent years owing to the help they provide in reducing the total cost of the treatment for a range of chronic diseases, such as autoimmune diseases, cancers, growth hormone deficiency, kidney failure, diabetes, infectious diseases, rheumatoid arthritis, haematological disorders, diabetes, CVDs, etc. The industry is further aided by the expiration of the patents of numerous blockbuster biologic drugs and a number of blockbuster drugs that are yet to lose patent protection in the forecast period, as it will boost the opportunities for manufacturers within the biosimilar industry for future.

The governments and third-party payers are undertaking cost-saving initiatives to encourage the use of biosimilars in place of branded biologics. Consequently, propelling the biosimilar market growth. Several factors influencing the industry include cost-effectiveness and the rising geriatric population. The industry may find hindrance owing to the negative perception from physicians, lower price differential compared to small-molecule generics, and patent extensions, among others.

 

Competitive Landscape

The report gives a detailed analysis of the following key players in the global biosimilar market, covering their competitive landscape, capacity, and latest developments like mergers, acquisitions, and investments, expansions of capacity, and plant turnarounds:

  • Pfizer Inc.
  • Celltrion Inc.
  • Novartis AG
  • Merck Sharp & Dohme Corp., 
  • Eli Lilly and Company.
  • Samsung Bioepis
  • Accord-UK Ltd.
  • Others

The comprehensive EMR report provides an in-depth assessment of the industry based on the Porter's five forces model along with giving a SWOT analysis. 

1    Preface
2    Report Coverage – Key Segmentation and Scope
3    Report Description

    3.1    Market Definition and Outlook
    3.2    Properties and Applications
    3.3    Market Analysis
    3.4    Key Players
4    Key Assumptions
5    Executive Summary

    5.1    Overview
    5.2    Key Drivers
    5.3    Key Developments
    5.4    Competitive Structure
    5.5    Key Industrial Trends
6    Snapshot
    6.1    Europe
    6.2    Regional
7    Industry Opportunities and Challenges
8    Global Biosimilar Market Analysis

    8.1    Key Industry Highlights
    8.2    Global Biosimilar Historical Market (2015-2019) 
    8.3    Global Biosimilar Market Forecast (2020-2025)
    8.4    Global Biosimilar Market by Molecule
        8.4.1    Infliximab
            8.4.1.1    Market Share
            8.4.1.2    Historical Trend (2015-2019)
            8.4.1.3    Forecast Trend (2020-2025)
        8.4.2    Insulin Glargine
            8.4.2.1    Market Share
            8.4.2.2    Historical Trend (2015-2019)
            8.4.2.3    Forecast Trend (2020-2025)
        8.4.3    Epoetin Alfa
            8.4.3.1    Market Share
            8.4.3.2    Historical Trend (2015-2019)
            8.4.3.3    Forecast Trend (2020-2025)
        8.4.4    Etanercept
            8.4.4.1    Market Share
            8.4.4.2    Historical Trend (2015-2019)
            8.4.4.3    Forecast Trend (2020-2025)
        8.4.5    Filgrastim
            8.4.5.1    Market Share
            8.4.5.2    Historical Trend (2015-2019)
            8.4.5.3    Forecast Trend (2020-2025)
        8.4.6    Somatropin
            8.4.6.1    Market Share
            8.4.6.2    Historical Trend (2015-2019)
            8.4.6.3    Forecast Trend (2020-2025)
        8.4.7    Rituximab
            8.4.7.1    Market Share
            8.4.7.2    Historical Trend (2015-2019)
            8.4.7.3    Forecast Trend (2020-2025)
        8.4.8    Follitropin Alfa
            8.4.8.1    Market Share
            8.4.8.2    Historical Trend (2015-2019)
            8.4.8.3    Forecast Trend (2020-2025)
    8.5    Global Biosimilar Market by Type of Manufacturing
        8.5.1    In-house Manufacturing
            8.5.1.1    Market Share
            8.5.1.2    Historical Trend (2015-2019)
            8.5.1.3    Forecast Trend (2020-2025)
        8.5.2    Contract Manufacturing
            8.5.2.1    Market Share
            8.5.2.2    Historical Trend (2015-2019)
            8.5.2.3    Forecast Trend (2020-2025)
    8.6    Global Biosimilar Market by Indication
        8.6.1    Auto-Immune Diseases
            8.6.1.1    Market Share
            8.6.1.2    Historical Trend (2015-2019)
            8.6.1.3    Forecast Trend (2020-2025)
        8.6.2    Blood Disorder
            8.6.2.1    Market Share
            8.6.2.2    Historical Trend (2015-2019)
            8.6.2.3    Forecast Trend (2020-2025)
        8.6.3    Diabetes
            8.6.3.1    Market Share
            8.6.3.2    Historical Trend (2015-2019)
            8.6.3.3    Forecast Trend (2020-2025)
        8.6.4    Oncology
            8.6.4.1    Market Share
            8.6.4.2    Historical Trend (2015-2019)
            8.6.4.3    Forecast Trend (2020-2025)
        8.6.5    Growth Deficiency
            8.6.5.1    Market Share
            8.6.5.2    Historical Trend (2015-2019)
            8.6.5.3    Forecast Trend (2020-2025)
        8.6.6    Female Infertility
            8.6.6.1    Market Share
            8.6.6.2    Historical Trend (2015-2019)
            8.6.6.3    Forecast Trend (2020-2025)
    8.7    Global Biosimilar Market by Region
        8.7.1    Market Share
            8.7.1.1    North America
            8.7.1.2    Europe
            8.7.1.3    Asia Pacific
            8.7.1.4    Latin America
            8.7.1.5    Middle East and Africa
9    Regional Analysis
    9.1    North America
        9.1.1    Historical Trend (2015-2019)
        9.1.2    Forecast Trend (2020-2025)
        9.1.3    Breakup by Country
            9.1.3.1    United States of America 
            9.1.3.2    Canada
    9.2    Europe
        9.2.1    Historical Trend (2015-2019)
        9.2.2    Forecast Trend (2020-2025)
        9.2.3    Breakup by Country
            9.2.3.1    United Kingdom
            9.2.3.2    Germany
            9.2.3.3    France
            9.2.3.4    Italy
            9.2.3.5    Others
    9.3    Asia Pacific
        9.3.1    Historical Trend (2015-2019)
        9.3.2    Forecast Trend (2020-2025)
        9.3.3    Breakup by Country
            9.3.3.1    China
            9.3.3.2    Japan
            9.3.3.3    India
            9.3.3.4    ASEAN
            9.3.3.5    Australia
            9.3.3.6    Others
    9.4    Latin America
        9.4.1    Historical Trend (2015-2019)
        9.4.2    Forecast Trend (2020-2025)
        9.4.3    Breakup by Country
            9.4.3.1    Brazil
            9.4.3.2    Argentina
            9.4.3.3    Mexico
            9.4.3.4    Others
    9.5    Middle East and Africa
        9.5.1    Historical Trend (2015-2019)
        9.5.2    Forecast Trend (2020-2025)
        9.5.3    Breakup by Country
            9.5.3.1    Saudi Arabia
            9.5.3.2    United Arab Emirates
            9.5.3.3    Nigeria
            9.5.3.4    South Africa
            9.5.3.5    Others
10    Market Dynamics
    10.1    SWOT Analysis
        10.1.1    Strengths
        10.1.2    Weaknesses
        10.1.3    Opportunities
        10.1.4    Threats
    10.2    Porter’s Five Forces Analysis
        10.2.1    Supplier’s Power
        10.2.2    Buyers Power
        10.2.3    Threat of New Entrants
        10.2.4    Degree of Rivalry
        10.2.5    Threat of Substitutes
    10.3    EMR’s Key Indicators for Demand
    10.4    EMR’s Key Indicators for Price
11    Biosimilar Patent Landscape
    11.1    Patent Landscape in the US
    11.2    Patent Landscape in Europe
    11.3    Patent Landscape in Japan
12    Value Chain Analysis
    12.1    Characterizing the Existing Innovator Drug
    12.2    Research and Development
        12.2.1    Characterization of Biosimilars
        12.2.2    Developing a Unique Cell Line
    12.3    Product Development
        12.3.1    Pre-Testing
        12.3.2    Intermediary Clinical Testing (PK/PD)
        12.3.3    Confirmatory Clinical Phase-III
    12.4    Final Product Formulation
    12.5    Marketing and Distribution
13    Price Analysis
    13.1    North America Historical Price Trends (2015-2019) and Forecast (2020-2025)
    13.2    Europe Historical Price Trends (2015-2019) and Forecast (2020-2025)
    13.3    Asia Pacific Historical Price Trends (2015-2019) and Forecast (2020-2025)
    13.4    Latin America Historical Price Trends (2015-2019) and Forecast (2020-2025)
    13.5    Middle East and Africa Historical Price Trends (2015-2019) and Forecast (2020-2025)
14    Requirements for Setting Up a Biosimilar Manufacturing Plant
    14.1    Manufacturing Process
    14.2    Raw Material Requirements
    14.3    Raw Material Pictures
    14.4    Land and Construction Requirements
    14.5    Machinery and Infrastructure Requirements
    14.6    Machinery Pictures
    14.7    Plant Layout
    14.8    Packaging Requirements
    14.9    Utility Requirements
    14.10    Manpower Requirements
15    Competitive Landscape
    15.1    Market Structure
    15.2    Key Players’ Market Share
    15.3    Company Profiles
        15.3.1    Pfizer Inc.
            15.3.1.1    Company Overview
            15.3.1.2    Product Portfolio
            15.3.1.3    Demographic Reach and Achievements
            15.3.1.4    Financial Summary
            15.3.1.5    Certifications
        15.3.2    Celltrion Inc.
            15.3.2.1    Company Overview
            15.3.2.2    Product Portfolio
            15.3.2.3    Demographic Reach and Achievements
            15.3.2.4    Financial Summary
            15.3.2.5    Certifications
        15.3.3    Novartis AG
            15.3.3.1    Company Overview
            15.3.3.2    Product Portfolio
            15.3.3.3    Demographic Reach and Achievements
            15.3.3.4    Financial Summary
            15.3.3.5    Certifications
        15.3.4    Merck Sharp & Dohme Corp., 
            15.3.4.1    Company Overview
            15.3.4.2    Product Portfolio
            15.3.4.3    Demographic Reach and Achievements
            15.3.4.4    Financial Summary
            15.3.4.5    Certifications
        15.3.5    Eli Lilly and Company.
            15.3.5.1    Company Overview
            15.3.5.2    Product Portfolio
            15.3.5.3    Demographic Reach and Achievements
            15.3.5.4    Financial Summary
            15.3.5.5    Certifications
        15.3.6    Samsung Bioepis
            15.3.6.1    Company Overview
            15.3.6.2    Product Portfolio
            15.3.6.3    Demographic Reach and Achievements
            15.3.6.4    Financial Summary
            15.3.6.5    Certifications
        15.3.7    Accord-UK Ltd.
            15.3.7.1    Company Overview
            15.3.7.2    Product Portfolio
            15.3.7.3    Demographic Reach and Achievements
            15.3.7.4    Financial Summary
            15.3.7.5    Certifications
        15.3.8    Others
16    Events and Developments

 
List of Figures and Tables

1.    Global Biosimilar Market: Key Industry Highlights, 2015 and 2025
2.    Global Biosimilar Historical Market: Breakup by Molecule (USD Billion), 2015-2019
3.    Global Biosimilar Market Forecast: Breakup by Molecule (USD Billion), 2020-2025
4.    Global Biosimilar Historical Market: Breakup by Indication (USD Billion), 2015-2019
5.    Global Biosimilar Market Forecast: Breakup by Indication (USD Billion), 2020-2025
6.    Global Biosimilar Historical Market: Breakup by Type of Manufacturing (USD Billion), 2015-2019
7.    Global Biosimilar Market Forecast: Breakup by Type of Manufacturing (USD Billion), 2020-2025
8.    Global Biosimilar Historical Market: Breakup by Region (USD Billion), 2015-2019
9.    Global Biosimilar Market Forecast: Breakup by Region (USD Billion), 2020-2025
10.    North America Biosimilar Historical Market: Breakup by Country (USD Billion), 2015-2019
11.    North America Biosimilar Market Forecast: Breakup by Country (USD Billion), 2020-2025
12.    Europe Biosimilar Historical Market: Breakup by Country (USD Billion), 2015-2019
13.    Europe Biosimilar Market Forecast: Breakup by Country (USD Billion), 2020-2025
14.    Asia Pacific Biosimilar Historical Market: Breakup by Country (USD Billion), 2015-2019
15.    Asia Pacific Biosimilar Market Forecast: Breakup by Country (USD Billion), 2020-2025
16.    Latin America Biosimilar Historical Market: Breakup by Country (USD Billion), 2015-2019
17.    Latin America Biosimilar Market Forecast: Breakup by Country (USD Billion), 2020-2025
18.    Middle East and Africa Biosimilar Historical Market: Breakup by Country (USD Billion), 2015-2019
19.    Middle East and Africa Biosimilar Market Forecast: Breakup by Country (USD Billion), 2020-2025
20.    North America Historical Price Trends and Forecast 2015-2025
21.    Europe Historical Price Trends and Forecast 2015-2025
22.    Asia Pacific Historical Price Trends and Forecast 2015-2025
23.    Latin America Historical Price Trends and Forecast 2015-2025
24.    Middle East and Africa Historical Price Trends and Forecast 2015-2025
25.    Global Biosimilar Market Structure

Key Questions Answered in the Report

In 2019, the global biosimilar market attained a value of nearly USD 5.3 billion.

In the forecast period of 2020-2025, the industry is projected to grow at a CAGR of 32%.

By 2025, the market is estimated to reach a value of about USD 28 billion. 

The major drivers of the industry such as rising disposable incomes, increasing geriatric population, reduction in the cost of the treatment for chronic and autoimmune diseases, and the upcoming expiration of many blockbuster biologic patents are expected to aid the market growth.

The cost-saving initiatives by governments and third-party payers encouraging the use of biosimilars over branded biologics are the major trends expected to drive the market growth. 

The major regions in the industry are North America, Europe, the Asia Pacific, Latin America, and the Middle East and Africa, with Europe accounting for the largest market share. 

The leading molecule type in the industry is Infliximab.

The major manufacturing type in the market is in-house manufacturing.

Autoimmune diseases account for the leading market share among other indication types.

The key players in the industry are Pfizer Inc., Celltrion Inc., Novartis AG, Merck Sharp & Dohme Corp., Eli Lilly and Company, Samsung Bioepis, and Accord-UK Ltd., among others.

Analyst Review

The global biosimilar market attained a value of nearly USD 5.3 billion in 2019 driven by the growing occurrence of chronic and autoimmune diseases. Aided by the upcoming expiration of many blockbuster biologic patents, the market is expected to witness a further growth in the forecast period of 2020-2025, growing at a CAGR of 32%. The market is projected to reach USD 28 billion by 2025.

EMR’s meticulous research methodology delves deep into the market, covering the macro and micro aspects of the industry. Based on molecule, the biosimilar market is divided into Infliximab, Insulin Glargine, Epoetin Alfa, Etanercept, Filgrastim, Somatropin, Rituximab, and Follitropin Alfa, with Infliximab accounting for the largest share in the industry. On the basis of manufacturing type, the industry is bifurcated into in-house and contract manufacturing, with in-house manufacturing leading the market. Autoimmune diseases account for the largest market share based on indication. The major regional markets for biosimilar are North America, Europe, the Asia Pacific, Latin America, and the Middle East and Africa, with Europe accounting for the largest share of the market. The key players in the above industry include Pfizer Inc., Celltrion Inc., Novartis AG, Merck Sharp & Dohme Corp., Eli Lilly and Company, Samsung Bioepis, and Accord-UK Ltd., among others.

EMR’s research methodology uses a combination of cutting-edge analytical tools and the expertise of their highly accomplished team, thus, providing their customers with market insights that are accurate, actionable, and help them remain ahead of their competition.

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