Table of Content

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 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

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

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 Novartis
13.3.2 Pfizer
13.3.3 Teva
13.3.4 Celltrion
13.3.5 Merck & Co
13.3.6 Samsung Bioepis
13.3.7 Eli Lilly
13.3.8 Biocon
13.3.9 Amgen
13.3.10 Dr. Reddy’s Laboratories
13.3.11 Boehringer Ingelheim