Biosimilar Market

1   Preface
2   Scope and Methodology
    2.1    Objectives of the Study
    2.2    Stakeholders
    2.3    Data Sources
        2.3.1    Primary Sources
        2.3.2    Secondary Sources
    2.4    Market Estimation
        2.4.1    Bottom-Up Approach
        2.4.2    Top-Down Approach
    2.5    Forecasting Methodology
3   Executive Summary
4   Biosimilar Market – Introduction
    4.1    Overview
    4.2    WHO and FDA Terminology on Biosimilars
    4.3    Biosimilars and Generics
    4.4    Biosimilars and Branded Biological Products
5   Why are Biosimilars So Lucrative?
    5.1    Patent Expiry of Blockbuster Biological Drugs
    5.2    Significant Price Differential between Biosimilars and Innovator Drugs
    5.3    Savings for the Government and Third Party Payers
    5.4    Rising Prevalence of Lifestyle Diseases
    5.5    Incentives for Prescribers, Pharmacists and Patients
    5.6    Emergence of New Players in Europe and Emerging Markets
    5.7    Increasing Product Differentiation as Manufacturers Tie-Up with Drug Delivery Device Companies
6   Biosimilar Research, Development and Manufacturing
    6.1    Research and Development: Biosimilars vs. Innovator Drugs
    6.2    Manufacturing: Biosimilars vs. Innovator Drugs
7   Global Biosimilar Market
    7.1    Market Overview
    7.2    Historical Performance
    7.3    Impact of COVID-19
    7.4    Market Breakup by Segment
    7.5    Market Breakup by Manufacturing Type
    7.6    Market Breakup by Indication
    7.7    Market Breakup by Region
    7.8    Market Forecast
    7.9    Biosimilar Patent Landscape
        7.9.1 Patent Landscape in the US
        7.9.2 Patent Landscape in Europe
        7.9.3 Patent Landscape in Japan
    7.10    SWOT Analysis
        7.10.1 Overview
        7.10.2 Strengths
        7.10.3 Weaknesses
        7.10.4 Opportunities
        7.10.5 Threats
    7.11    Value Chain Analysis
        7.11.1 Characterizing the Existing Innovator Drug
        7.11.2 Research and Development
            7.11.2.1 Characterization of Biosimilars
            7.11.2.2 Developing a Unique Cell Line
        7.11.3   Product Development
            7.11.3.1 Pre-Testing
            7.11.3.2 Intermediary Clinical Testing (PK/PD)
            7.11.3.3 Confirmatory Clinical Phase-III
        7.11.4 Final Product Formulation
        7.11.5 Marketing and Distribution
   7.12    Porter’s Five Forces Analysis
        7.12.1 Overview
        7.12.2 Bargaining Power of Buyers
        7.12.3 Bargaining Power of Suppliers
        7.12.4 Degree of Competition
        7.12.5 Threat of New Entrants
        7.12.6 Threat of Substitutes
    7.13    Price Analysis
        7.13.1 Key Price Indicators
        7.13.2 Price Trends
        7.13.3 Margin Analysis
8   Market Breakup by Molecule
    8.1    Infliximab
    8.2    Insulin Glargine
    8.3    Epoetin Alfa
    8.4    Etanercept
    8.5    Filgrastim
    8.6    Somatropin
    8.7    Rituximab
    8.8    Follitropin Alfa
    8.9    Adalimumab
    8.10    Pegfilgrastim
    8.11    Trastuzumab
    8.12    Bevacizumab
    8.13    Others
9   Market Breakup by Manufacturing Type
    9.1    In-house Manufacturing
        9.1.1 Market Trends
        9.1.2 Market Forecast
    9.2    Contract Manufacturing
        9.2.1 Market Trends
        9.2.2 Market Forecast
10  Market Breakup by Indication
    10.1    Auto-Immune Diseases
        10.1.1 Market Trends
        10.1.2 Market Forecast
    10.2    Blood Disorder
        10.2.1 Market Trends
        10.2.2 Market Forecast
    10.3    Diabetes
        10.3.1 Market Trends
        10.3.2 Market Forecast
    10.4    Oncology
        10.4.1 Market Trends
        10.4.2 Market Forecast
    10.5    Growth Deficiency
        10.5.1 Market Trends
        10.5.2 Market Forecast
    10.6    Female Infertility
        10.6.1 Market Trends
        10.6.2 Market Forecast
    10.7    Others
        10.7.1 Market Trends
        10.7.2 Market Forecast
11  Market Breakup by Region
    11.1    Europe
        11.1.1 Market Performance
        11.1.2 Key Players and Biosimilars
        11.1.3 Market Breakup by Country
        11.1.4 Market Forecast
        11.1.5 Italy
            11.1.5.1 Market Performance
            11.1.5.2 Key Players and Biosimilars
            11.1.5.3 Market Forecast
        11.1.6 Germany
            11.1.6.1 Market Performance
            11.1.6.2 Key Players and Biosimilars
            11.1.6.3 Market Forecast
        11.1.7 France
            11.1.7.1 Market Performance
            11.1.7.2 Key Players and Biosimilars
            11.1.7.3 Market Forecast
        11.1.8 United Kingdom
            11.1.8.1 Market Performance
            11.1.8.2 Key Players and Biosimilars
            11.1.8.3 Market Forecast
        11.1.9 Spain
            11.1.9.1 Market Performance
            11.1.9.2 Key Players and Biosimilars
            11.1.9.3 Market Forecast
        11.1.10 Rest of Europe
            11.1.10.1 Market Performance
            11.1.10.2 Market Forecast
    11.2    United States
        11.2.1 Current Market Trends
        11.2.2 Key Players and Biosimilars
        11.2.3 Market Forecast
    11.3    Japan
        11.3.1 Market Performance
        11.3.2 Key Players and Biosimilars
        11.3.3 Market Forecast
    11.4    India
        11.4.1 Current Market Trends
        11.4.2 Key Players and Biosimilars
        11.4.3 Market Forecast
    11.5    South Korea
        11.5.1 Current Market Trends
        11.5.2 Key Players and Biosimilars
        11.5.3 Market Forecast
    11.6    Rest of the World
        11.6.1 Current Market Trends
        11.6.2 Market Forecast
12  Requirements for Setting Up a Biosimilar Manufacturing Plant
    12.1    Manufacturing Process
    12.2    Raw Material Requirements
    12.3    Raw Material Pictures
    12.4    Land and Construction Requirements
    12.5    Machinery and Infrastructure Requirements
    12.6    Machinery Pictures
    12.7    Plant Layout
    12.8    Packaging Requirements
    12.9    Utility Requirements
    12.10    Manpower Requirements
13  Competitive Landscape
    13.1    Market Structure
    13.2    Key Players
    13.3    Profiles of Key Players
        13.3.1    Sandoz International GmbH
        13.3.2    Pfizer Inc.
        13.3.3    Teva Pharmaceutical Industries Limited 
        13.3.4    Celltrion Inc. 
        13.3.5    Biocon Limited
        13.3.6    Samsung Biologics 
        13.3.7    Amgen, Inc.
        13.3.8    Dr. Reddy's Laboratories Limited
        13.3.9    Stada Arzneimittel Ag

List of Figures

Figure 1: Global: Biosimilar Market: Sales Value (in Billion USD), 2019-2024
Figure 2: Global: Biosimilar Market: Breakup by Molecule (in %), 2024
Figure 3: Global: Biosimilar Market: Breakup by Manufacturing Type (in %), 2024
Figure 4: Global: Biosimilar Market: Breakup by Indication (in %), 2024
Figure 5: Global: Biosimilar Market: Breakup by Region (in %), 2024
Figure 6: Global: Biosimilar Market Forecast: Sales Value (in Billion USD), 2025-2033
Figure 7: Global: Biosimilars Industry: SWOT Analysis
Figure 8: Global: Biosimilar Industry: Value Chain Analysis
Figure 9: Global: Biosimilars Industry: Porter’s Five Forces Analysis
Figure 10: Global: Biosimilar Market: Average Price Trends of Inflectra
Figure 11: Global: Biosimilar Market: Average Price Trends of Zarxio
Figure 12: Biosimilars Industry: Breakup of Profit Margins at Various Level of the Value Chain
Figure 13: Infliximab: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 14: Infliximab: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 15: Insulin Glargine: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 16: Insulin Glargine: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 17: Epoetin Alfa: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 18: Epoetin Alfa: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 19: Etanercept: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 20: Etanercept: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 21: Filgrastim: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 22: Filgrastim: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 23: Somatropin: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 24: Somatropin: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 25: Rituximab: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 26: Rituximab: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 27: Follitropin Alfa: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 28: Follitropin Alfa: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 29: Adalimumab: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 30: Adalimumab: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 31: Pegfilgrastim: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 32: Pegfilgrastim: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 33: Trastuzumab: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 34: Trastuzumab: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 35: Bevacizumab: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 36: Others: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 37: In-House Manufacturing: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 38: In-House Manufacturing: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 39: Contract Manufacturing: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 40: Contract Manufacturing: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 41: Global: Biosimilar Market (Autoimmune Diseases): Sales Value (in Million USD), 2019 & 2024
Figure 42: Global: Biosimilar Market Forecast (Autoimmune Diseases): Sales Value (in Million USD), 2025-2033
Figure 43: Global: Biosimilar Market (Blood Disorders): Sales Value (in Million USD), 2019 & 2024
Figure 44: Global: Biosimilar Market Forecast (Blood Disorders): Sales Value (in Million USD), 2025-2033
Figure 45: Global: Biosimilar Market (Diabetes): Sales Value (in Million USD), 2019 & 2024
Figure 46: Global: Biosimilar Market Forecast (Diabetes): Sales Value (in Million USD), 2025-2033
Figure 47: Global: Biosimilar Market (Oncology): Sales Value (in Million USD), 2019 & 2024
Figure 48: Global: Biosimilar Market Forecast (Oncology): Sales Value (in Million USD), 2025-2033
Figure 49: Global: Biosimilar Market (Growth Deficiency): Sales Value (in Million USD), 2019 & 2024
Figure 50: Global: Biosimilar Market Forecast (Growth Deficiency): Sales Value (in Million USD), 2025-2033
Figure 51: Global: Biosimilar Market (Female Infertility): Sales Value (in Million USD), 2019 & 2024
Figure 52: Global: Biosimilar Market Forecast (Female Infertility): Sales Value (in Million USD), 2025-2033
Figure 53: Global: Biosimilar Market (Others): Sales Value (in Million USD), 2019 & 2024
Figure 54: Global: Biosimilar Market Forecast (Others): Sales Value (in Million USD), 2025-2033
Figure 55: Europe: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 56: Europe: Biosimilar Market: Breakup by Country (in %), 2024
Figure 57: Europe: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 58: Italy: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 59: Italy: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 60: Germany: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 61: Germany: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 62: France: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 63: France: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 64: United Kingdom: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 65: United Kingdom: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 66: Spain: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 67: Spain: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 68: Rest of Europe: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 69: Rest of Europe: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 70: United States: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 71: United States: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 72: Japan: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 73: Japan: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 74: India: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 75: India: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 76: South Korea: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 77: South Korea: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 78: Others: Biosimilar Market: Sales Value (in Million USD), 2019-2024
Figure 79: Others: Biosimilar Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 80: Biosimilar Manufacturing: Detailed Process Flow
Figure 81: Biosimilar Manufacturing Plant: Raw Materials Requirement
Figure 82: Biosimilar Manufacturing Process: Conversion Rates of Feedstocks
Figure 83: Biosimilar Manufacturing Plant: Machinery Costs (in USD)
Figure 84: Biosimilar Manufacturing Plant: Primary Packaging
Figure 85: Biosimilar Manufacturing Plant: Secondary Packaging
Figure 86: Biosimilar Manufacturing Plant: Tertiary Packaging 

List of Tables

Table 1: Global: Sales and Patent Expiry of Blockbuster Biological Drugs (in Million USD), 2024
Table 2: Global: Biosimilar Market: Biosimilars Vs Innovators Drug Development
Table 3: Global: Biosimilar Market: Biosimilars Vs Biologics Manufacturing
Table 4: Global: Biosimilar Market: Key Industry Highlights, 2024 and 2033
Table 5: US: Biosimilar Market: Patent Landscape
Table 6: Europe: Biosimilar Market: Patent Landscape
Table 7: Japan: Biosimilar Market: Patent Landscape
Table 8: Global: Biosimilar Market: Price Comparison Between Biosimilar and Originator Drugs
Table 9: Global: Biosimilar Market: Breakup by Molecule (in Million USD), 2025-2033
Table 10: Global: Infliximab: Brand & Biosimilar Market Overview
Table 11: Global: Insulin Glargine: Brand & Biosimilar Market Overview
Table 12: Global: Epoetin Alfa: Brand & Biosimilar Market Overview
Table 13: Global: Etanercept: Brand & Biosimilar Market Overview
Table 14: Global: Filgrastim: Brand & Biosimilar Market Overview
Table 15: Global: Somatropin: Brand & Biosimilar Market Overview
Table 16: Global: Rituximab: Brand & Biosimilar Market Overview
Table 17: Global: Follitropin Alfa: Brand & Biosimilar Market Overview
Table 18: Global: Adalimumab: Brand & Biosimilar Market Overview
Table 19: Global: Pegfilgrastim: Brand & Biosimilar Market Overview
Table 20: Global: Trastuzumab: Brand & Biosimilar Market Overview
Table 21: Global: Bevacizumab: Brand & Biosimilar Market Overview
Table 22: Global: Biosimilar Market Forecast: Breakup by Manufacturing Type (in Million USD), 2025-2033
Table 23: Global: Biosimilar Market Forecast: Breakup by Indication (in Million USD), 2025-2033
Table 24: Global: Biosimilar Market Forecast: Breakup by Region (in Million USD), 2025-2033
Table 25: Europe: Biosimilar Market: Key Players and Biosimilars
Table 26: Italy: Biosimilar Market: Key Players and Biosimilars
Table 27: Germany: Biosimilar Market: Key Players and Biosimilars
Table 28: France: Biosimilar Market: Key Players and Biosimilars
Table 29: United Kingdom: Biosimilar Market: Key Players and Biosimilars
Table 30: Spain: Biosimilar Market: Key Players and Biosimilars
Table 31: United States: Biosimilar Market: Key Players and Biosimilar
Table 32: United States: Biosimilar Market: Launch of Expected Biosimilar
Table 33: Japan: Biosimilar Market: Key Players and Biosimilars
Table 34: India: Biosimilar Market: Key Players and Biosimilars
Table 35: South Korea: Biosimilar Market: Key Players and Biosimilar
Table 36: Biosimilar Manufacturing Plant: Manpower Requirements
Table 37: Biosimilar Market: Competitive Structure
Table 38: Global: Biosimilar Market: Key Players