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
Figure 2: Global: Biosimilar Market: Breakup by Molecule (in %), 2022
Figure 3: Global: Biosimilar Market: Breakup by Manufacturing Type (in %), 2022
Figure 4: Global: Biosimilar Market: Breakup by Indication (in %), 2022
Figure 5: Global: Biosimilar Market: Breakup by Region (in %), 2022
Figure 6: Global: Biosimilar Market Forecast: Sales Value (in Billion US$), 2023-2028
Figure 7: Global: Biosimilars Industry: SWOT Analysis
Figure 8: Global: Biosimilar Industry: Value Chain Analysis
Figure 9: Global: Biosimilars Industry: Porter’s Five Forces Analysis
Figure 10: Global: Biosimilar Market: Average Price Trends of Inflectra
Figure 11: Global: Biosimilar Market: Average Price Trends of Zarxio
Figure 12: Biosimilars Industry: Breakup of Profit Margins at Various Level of the Value Chain
Figure 13: Infliximab: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 14: Infliximab: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 15: Insulin Glargine: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 16: Insulin Glargine: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 17: Epoetin Alfa: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 18: Epoetin Alfa: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 19: Etanercept: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 20: Etanercept: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 21: Filgrastim: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 22: Filgrastim: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 23: Somatropin: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 24: Somatropin: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 25: Rituximab: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 26: Rituximab: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 27: Follitropin Alfa: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 28: Follitropin Alfa: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 29: Adalimumab: Biosimilar Market: Sales Value (in Million US$), 2018-2022
Figure 30: Adalimumab: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 31: Pegfilgrastim: Biosimilar Market: Sales Value (in Million US$), 2019-2022
Figure 32: Pegfilgrastim: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 33: Trastuzumab: Biosimilar Market: Sales Value (in Million US$), 2018-2022
Figure 34: Trastuzumab: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 35: Bevacizumab: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 36: Others: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 37: In-House Manufacturing: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 38: In-House Manufacturing: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 39: Contract Manufacturing: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 40: Contract Manufacturing: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 41: Global: Biosimilar Market (Autoimmune Diseases): Sales Value (in Million US$), 2017 & 2022
Figure 42: Global: Biosimilar Market Forecast (Autoimmune Diseases): Sales Value (in Million US$), 2023-2028
Figure 43: Global: Biosimilar Market (Blood Disorders): Sales Value (in Million US$), 2017 & 2022
Figure 44: Global: Biosimilar Market Forecast (Blood Disorders): Sales Value (in Million US$), 2023-2028
Figure 45: Global: Biosimilar Market (Diabetes): Sales Value (in Million US$), 2017 & 2022
Figure 46: Global: Biosimilar Market Forecast (Diabetes): Sales Value (in Million US$), 2023-2028
Figure 47: Global: Biosimilar Market (Oncology): Sales Value (in Million US$), 2017 & 2022
Figure 48: Global: Biosimilar Market Forecast (Oncology): Sales Value (in Million US$), 2023-2028
Figure 49: Global: Biosimilar Market (Growth Deficiency): Sales Value (in Million US$), 2017 & 2022
Figure 50: Global: Biosimilar Market Forecast (Growth Deficiency): Sales Value (in Million US$), 2023-2028
Figure 51: Global: Biosimilar Market (Female Infertility): Sales Value (in Million US$), 2017 & 2022
Figure 52: Global: Biosimilar Market Forecast (Female Infertility): Sales Value (in Million US$), 2023-2028
Figure 53: Global: Biosimilar Market (Others): Sales Value (in Million US$), 2017 & 2022
Figure 54: Global: Biosimilar Market Forecast (Others): Sales Value (in Million US$), 2023-2028
Figure 55: Europe: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 56: Europe: Biosimilar Market: Breakup by Country (in %), 2022
Figure 57: Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 58: Italy: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 59: Italy: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 60: Germany: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 61: Germany: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 62: France: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 63: France: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 64: United Kingdom: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 65: United Kingdom: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 66: Spain: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 67: Spain: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 68: Rest of Europe: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 69: Rest of Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 70: United States: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 71: United States: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 72: Japan: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 73: Japan: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 74: India: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 75: India: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 76: South Korea: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 77: South Korea: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 78: Others: Biosimilar Market: Sales Value (in Million US$), 2017-2022
Figure 79: Others: Biosimilar Market Forecast: Sales Value (in Million US$), 2023-2028
Figure 80: Biosimilar Manufacturing: Detailed Process Flow
Figure 81: Biosimilar Manufacturing Plant: Raw Materials Requirement
Figure 82: Biosimilar Manufacturing Process: Conversion Rates of Feedstocks
Figure 83: Biosimilar Manufacturing Plant: Machinery Costs (in US$)
Figure 84: Biosimilar Manufacturing Plant: Primary Packaging
Figure 85: Biosimilar Manufacturing Plant: Secondary Packaging
Figure 86: Biosimilar Manufacturing Plant: Tertiary Packaging
