The biosimilar market reached a value of US$ 3.8 Billion in 2018. This market is currently being driven by a number of factors such as patent expires of blockbuster biological drugs, lower prices, rising prevalence of chronic diseases, and cost-saving initiatives from governments and third-party payers. Catalyzed by these factors, the market is further projected to reach US$ 20.2 Billion by 2024, growing at a CAGR of nearly 33% during the next five years.
Biosimilars, also known as follow-on biologics, refers to a biotherapeutic product which is highly similar to a reference biologic drug. It is produced using living organisms or cells and has a complex molecular structure. When the patent of a biologic drug expires, manufacturers resort to the approval from the regulatory authorities so as to start the production of biosimilars. For being labelled as a biosimilar, a biological drug should be proved similar in terms of quality, safety and efficacy. In comparison with generic drugs, biosimilars are expensive as their production process is more complex and requires higher investment in research and development.
Global Biosimilar Market Drivers/Constraints:
- Over the years, the patents of several blockbuster biologic drugs have expired and a number of blockbuster drugs are further expected to lose patent protection in the coming years. This is expected to provide tremendous opportunities for biosimilar manufacturers in the near future.
- Cost-saving initiatives undertaken by governments and third-party payers have encouraged the use of biosimilars over branded biologics, thereby propelling the demand of biosimilars.
- Some of the other factors bolstering the demand for biosimilars include cost-effectiveness, rising prevalence of chronic diseases (such as autoimmune diseases and cancer) and growing geriatric population.
- There are some factors hampering the growth of the biosimilars market. This includes negative perception from physicians, patent extensions, lower price differential compared to small-molecule generics, etc.
Molecule insights:
On the basis of molecule, the market has been segmented as Infliximab, Insulin Glargine, Epoetin Alfa, Etanercept, Filgrastim, Somatropin, Rituximab, Follitropin Alfa, etc. Currently, Infliximab dominates the market, holding the largest share.
Indication Insights:
Based on the indication, autoimmune diseases account for the majority of the total market share. Other major indications include oncology, diabetes, blood disorder, growth deficiency, female infertility, etc.
Manufacturing Insights:
Based on the type of manufacturing, the market is segregated into in-house manufacturing and contract manufacturing. Amongst these, in-house manufacturing accounts for the majority of the market share.
Regional Insights:
Region-wise, the market has been segmented into the United States, Germany, France, Italy, Spain, United Kingdom, Japan, India, South Korea and Others. Amongst these, Italy is the biggest market, accounting for the majority of the global biosimilar market.
Competitive Landscape:
The competitive landscape of the global biosimilar market has also been analysed. Some of the leading players operating in the market are:
- Novartis
- Pfizer
- Teva
- Celltrion
- Merck & Co
- Samsung Bioepis
- Eli Lilly
- Biocon
- Dr. Reddy's Laboratories
- Amgen
- Boehringer Ingelheim
This report provides a deep insight into the global biosimilars market covering all its essential aspects. This ranges from macro overview of the market to micro details of the industry performance, recent trends, key market drivers and challenges, SWOT analysis, Porter’s five forces analysis, value chain analysis, etc. This report is a must-read for entrepreneurs, investors, researchers, consultants, business strategists, and all those who have any kind of stake or are planning to foray into the biosimilars market in any manner.
Key Questions Answered in This Report:
- How has the global biosimilars market performed so far and how will it perform in the coming years?
- What are the key regional markets in the global biosimilar industry?
- What are the major molecule types in the global biosimilar industry?
- What are the various manufacturing types in the global biosimilar industry?
- What are the various indications in the global biosimilar industry?
- What are the price trends of biosimilars?
- What are the various stages in the value chain of the global biosimilar industry?
- What are the key driving factors and challenges in the global biosimilar industry?
- What is the structure of the global biosimilar industry and who are the key players?
- What is the degree of competition in the global biosimilar industry?
- What are the key requirements for setting up a biosimilar manufacturing plant?
- How are biosimilars manufactured?
- What are the machinery requirements for setting up a biosimilar manufacturing plant?
- What is the capital cost for setting up a biosimilar manufacturing plant?
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 Market Breakup by Segment
7.4 Market Breakup by Manufacturer Type
7.5 Market Breakup by Indication
7.6 Market Breakup by Region
7.7 Market Forecast
7.8 Biosimilar Patent Landscape
7.8.1 Patent Landscape in the US
7.8.2 Patent Landscape in Europe
7.8.3 Patent Landscape in Japan
7.9 SWOT Analysis
7.9.1 Overview
7.9.2 Strengths
7.9.3 Weaknesses
7.9.4 Opportunities
7.9.5 Threats
7.10 Value Chain Analysis
7.10.1 Characterizing the Existing Innovator Drug
7.10.2 Research and Development
7.10.2.1 Characterization of Biosimilars
7.10.2.2 Developing a Unique Cell Line
7.10.3 Product Development
7.10.3.1 Pre-Testing
7.10.3.2 Intermediary Clinical Testing (PK/PD)
7.10.3.3 Confirmatory Clinical Phase-III
7.10.4 Final Product Formulation
7.10.5 Marketing and Distribution
7.11 Porter’s Five Forces Analysis
7.11.1 Overview
7.11.2 Bargaining Power of Buyers
7.11.3 Bargaining Power of Suppliers
7.11.4 Degree of Competition
7.11.5 Threat of New Entrants
7.11.6 Threat of Substitutes
7.12 Price Analysis
7.12.1 Key Price Indicators
7.12.2 Price Trends
7.12.3 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 Type of Manufacturing
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
List of Figure
Figure 1: Global: Biosimilar Market: Sales Value (in Billion US$), 2012-2018
Figure 2: Global: Biosimilar Market: Breakup by Molecule (in %), 2018
Figure 3: Global: Biosimilar Market: Breakup by Manufacturer (in %), 2018
Figure 4: Global: Biosimilar Market: Breakup by Indication (in %), 2018
Figure 5: Global: Biosimilar Market: Breakup by Region (in %), 2018
Figure 6: Global: Biosimilar Market Forecast: Sales Value (in Billion US$), 2019-2024
Figure 7: Global Biosimilars Industry: SWOT Analysis
Figure 8: Global: Biosimilar Market: 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: Rituximab: Biosimilar Market: Sales Value (in Million US$), 2016 & 2017
Figure 14: Infliximab: Biosimilar Market: Sales Value (in Million US$), 2015 - 2017
Figure 15: Insulin Glargine: Biosimilar Market: Sales Value (in Million US$), 2016 & 2017
Figure 16: Epoetin Alfa: Biosimilar Market: Sales Value (in Million US$), 2012 - 2017
Figure 17 Filgrastim: Biosimilar Market: Sales Value (in Million US$), 2012 - 2017
Figure 18: Somatropin: Biosimilar Market: Sales Value (in Million US$), 2012 - 2017
Figure 19: Etanercept: Biosimilar Market: Sales Value (in Million US$), 2016 & 2017
Figure 20: Follitropin Alfa: Biosimilar Market: Sales Value (in Million US$), 2015 – 2017
Figure 21: In-House Manufacturing: Biosimilar Market: Sales Value (in Million US$), 2012-2018
Figure 22: In-House Manufacturing: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
Figure 23: Contract Manufacturing: Biosimilar Market: Sales Value (in Million US$), 2012-2018
Figure 24: Contract Manufacturing: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
Figure 31: Global: Biosimilar Market (Autoimmune Diseases): Sales Value (in Million US$), 2012 & 2018
Figure 32: Global: Biosimilar Market Forecast (Autoimmune Diseases): Sales Value (in Million US$), 2019-2024
Figure 33: Global: Biosimilar Market (Blood Disorders): Sales Value (in Million US$), 2012 & 2018
Figure 34: Global: Biosimilar Market Forecast (Blood Disorders): Sales Value (in Million US$), 2019-2024
Figure 35: Global: Biosimilar Market (Diabetes): Sales Value (in Million US$), 2012 & 2018
Figure 36: Global: Biosimilar Market Forecast (Diabetes): Sales Value (in Million US$), 2019-2024
Figure 37: Global: Biosimilar Market (Oncology): Sales Value (in Million US$), 2012 & 2018
Figure 38: Global: Biosimilar Market Forecast (Oncology): Sales Value (in Million US$), 2019-2024
Figure 39: Global: Biosimilar Market (Growth Deficiency): Sales Value (in Million US$), 2012 & 2018
Figure 40: Global: Biosimilar Market Forecast (Growth Deficiency): Sales Value (in Million US$), 2019-2024
Figure 41: Global: Biosimilar Market (Female Infertility): Sales Value (in Million US$), 2012 & 2018
Figure 42: Global: Biosimilar Market Forecast (Female Infertility): Sales Value (in Million US$), 2019-2024
Figure 43: Europe: Biosimilar Market: Sales Value (in Million US$), 2012-2018
Figure 44: Europe: Biosimilar Market: Breakup by Country (in %), 2018
Figure 45: Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
Figure 46: Italy: Biosimilar Market: Sales Value (in Million US$), 2012-2018
Figure 47: Italy: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
Figure 48: Germany: Biosimilar Market: Sales Value (in Million US$), 2012-2018
Figure 49: Germany: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
Figure 50: France: Biosimilar Market: Sales Value (in Million US$), 2012-2018
Figure 51: France: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
Figure 52: United Kingdom: Biosimilar Market: Sales Value (in Million US$), 2012-2018
Figure 53: United Kingdom: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
Figure 54: Spain: Biosimilar Market: Sales Value (in Million US$), 2012-2018
Figure 55: Spain: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
Figure 56: Rest of Europe: Biosimilar Market: Sales Value (in Million US$), 2012-2018
Figure 57: United States: Biosimilar Market: Sales Value (in Million US$), 2012-2018
Figure 58: United States: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
Figure 59: Japan: Biosimilar Market: Sales Value (in Million US$), 2012-2018
Figure 60: Japan: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
Figure 61: India: Biosimilar Market: Sales Value (in Million US$), 2012-2018
Figure 62: India: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
Figure 63: South Korea: Biosimilar Market: Sales Value (in Million US$), 2012-2018
Figure 64: South Korea: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
Figure 65: Others: Biosimilar Market: Sales Value (in Million US$), 2012-2018
Figure 66: Others: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
Figure 67: Biosimilar Manufacturing: Detailed Process Flow
Figure 68: Biosimilar Manufacturing Plant: Raw Materials Requirement
Figure 69: Biosimilar Manufacturing Process: Conversion Rates of Feedstocks
Figure 70: Biosimilar Manufacturing Plant: Machinery Costs (in US$)
Figure 71: Biosimilar Manufacturing Plant: Primary Packaging
Figure 72: Biosimilar Manufacturing Plant: Secondary Packaging
Figure 73: Biosimilar Manufacturing Plant: Tertiary Packaging
List of Table
Table 1: Global: Sales and Patent Expiry of Blockbuster Biological Drugs (in Million US$), 2017
Table 2: Global: Biosimilar Market: Biosimilars Vs Innovators Drug Development
Table 3: Global: Biosimilar Market: Biosimilars Vs Biologics Manufacturing
Table 4: Global: Biosimilar Market: Key Industry Highlights, 2018 and 2024
Table 5: US: Biosimilar Market: Patent Landscape
Table 6: Europe: Biosimilar Market: Patent Landscape
Table 7: Japan: Biosimilar Market: Patent Landscape
Table 8: Global: Biosimilar Market: Price Comparison Between Biosimilar and Originator Drugs
Table 9: Global: Biosimilar Market: Breakup by Molecule (in Million US$), 2012-2017
Table 10: Global: Rituximab: Brand & Biosimilar Market Overview
Table 11: Global: Infliximab: Brand & Biosimilar Market Overview
Table 12: Global: Insulin Glargine: Brand & Biosimilar Market Overview
Table 13: Global: Epoetin Alfa: Brand & Biosimilar Market Overview
Table 14: Global: Filgrastim: Brand & Biosimilar Market Overview
Table 15: Global: Somatropin: Brand & Biosimilar Market Overview
Table 16: Global: Etanercept: Brand & Biosimilar Market Overview
Table 17: Global: Follitropin Alfa: Brand & Biosimilar Market Overview
Table 18: Global: Biosimilar Market Forecast: Breakup by Manufacturing Type (in Million US$), 2019-2024
Table 19: Global: Biosimilar Market Forecast: Breakup by Indication (in Million US$), 2019-2024
Table 20: Global: Biosimilar Market Forecast: Breakup by Region (in Million US$), 2019-2024
Table 21: Europe: Biosimilar Market: Key Players and Biosimilars
Table 22: Italy: Biosimilar Market: Key Players and Biosimilars
Table 23: Germany: Biosimilar Market: Key Players and Biosimilars
Table 24: France: Biosimilar Market: Key Players and Biosimilars
Table 25: United Kingdom: Biosimilar Market: Key Players and Biosimilars
Table 26: Spain: Biosimilar Market: Key Players and Biosimilars
Table 27: United States: Biosimilar Market: Key Players and Biosimilar
Table 28: United States: Biosimilar Market: Launch of Expected Biosimilar
Table 29: Japan: Biosimilar Market: Key Players and Biosimilars
Table 30: India: Biosimilar Market: Key Players and Biosimilars
Table 31: South Korea: Biosimilar Market: Key Players and Biosimilar
Table 32: Biosimilar Manufacturing Plant: Manpower Requirements
Table 33: Biosimilar Market: Competitive Structure
Table 34: Global: Biosimilar Market: Key Players