The biosimilar market reached a value of US$ 2.9 Billion in 2017. 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$ 15.6 Billion by 2023, at a CAGR of around 30% 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 Biosimilars 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 Biosimilars 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 Strengths
7.9.2 Weaknesses
7.9.3 Opportunities
7.9.4 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 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
9.2 Contract Manufacturing
10 Market Breakup by Indication
10.1 Auto-Immune Diseases
10.2 Blood Disorder
10.3 Diabetes
10.4 Oncology
10.5 Growth Deficiency
10.6 Female Infertility
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 Figures
Figure 1: Global Biosimilars Market: Sales Value (in Million US$), 2012-2017
Figure 2: Global: Biosimilars Market: Breakup by Molecule (in %), 2017
Figure 3: Global: Biosimilars Market: Breakup by Manufacturer (in %), 2017
Figure 4: Global Biosimilar Market: Breakup by Indication (in %), 2017
Figure 5: Global Biosimilar Market: Breakup by Region (in %), 2017
Figure 6: Global: Biosimilars Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 7: Global Biosimilars Industry: SWOT Analysis
Figure 8: Global: Biosimilars Market: Value Chain Analysis
Figure 9: Global: Biosimilars Industry: Porter’s Five Forces Analysis
Figure 10: Global: Biosimilar Market: Average Price Trend of Inflectra
Figure 11: Global: Biosimilar Market: Average Price Trend of Zarxio
Figure 12: Biosimilars Industry: Breakup of Profit Margins at Various Level of the Value Chain
Figure 13: Rituximab: Biosimilars Market: Sales Value (in Million US$), 2016 & 2017
Figure 14: Infliximab: Biosimilars Market: Sales Value (in Million US$), 2015 - 2017
Figure 15: Insulin Glargine: Biosimilars Market: Sales Value (in Million US$), 2016 & 2017
Figure 16: Epoetin Alfa: Biosimilars Market: Sales Value (in Million US$), 2012 - 2017
Figure 17 Filgrastim: Biosimilars Market: Sales Value (in Million US$), 2012 - 2017
Figure 18: Somatropin: Biosimilars Market: Sales Value (in Million US$), 2012 - 2017
Figure 19: Etanercept: Biosimilars Market: Sales Value (in Million US$), 2016 & 2017
Figure 20: Follitropin Alfa: Biosimilars Market: Sales Value (in Million US$), 2015 – 2017
Figure 21: In-House Manufacturing: Biosimilars Market: Sales Value (in Million US$), 2012-2017
Figure 22: In-House Manufacturing: Biosimilars Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 23: Contract Manufacturing: Biosimilars Market: Sales Value (in Million US$), 2012-2017
Figure 24: Contract Manufacturing: Biosimilars Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 25: Global: Biosimilar Market Forecast (Autoimmune Diseases): Sales Value (in Million US$), 2018-2023
Figure 26: Global: Biosimilar Market Forecast (Blood Disorders): Sales Value (in Million US$), 2018-2023
Figure 27: Global: Biosimilar Market Forecast (Diabetes): Sales Value (in Million US$), 2018-2023
Figure 28: Global: Biosimilar Market Forecast (Oncology): Sales Value (in Million US$), 2018-2023
Figure 29: Global: Biosimilar Market Forecast (Growth Deficiency): Sales Value (in Million US$), 2018-2023
Figure 30: Global: Biosimilar Market Forecast (InFertility): Sales Value (in Million US$), 2018-2023
Figure 31: Europe: Biosimilars Market: Sales Value (in Million US$), 2010-2017
Figure 32: Europe: Biosimilars Market: Breakup by Country (in %), 2017
Figure 33: Europe: Biosimilars Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 34: Italy: Biosimilars Market: Sales Value (in Million US$), 2010-2017
Figure 35: Italy: Biosimilars Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 36: Germany: Biosimilars Market: Sales Value (in Million US$), 2010-2017
Figure 37: Germany: Biosimilars Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 38: France: Biosimilars Market: Sales Value (in Million US$), 2010-2017
Figure 39: France: Biosimilars Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 40: United Kingdom: Biosimilars Market: Sales Value (in Million US$), 2010-2017
Figure 41: United Kingdom: Biosimilars Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 42: Spain: Biosimilars Market: Sales Value (in Million US$), 2010-2017
Figure 43: Spain: Biosimilars Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 44: Rest of Europe: Biosimilars Market: Sales Value (in Million US$), 2010-2017
Figure 45: Rest of Europe: Biosimilars Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 46: United States: Biosimilars Market: Sales Value (in Million US$), 2015-2017
Figure 47: United States: Biosimilars Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 48: Japan: Biosimilars Market: Sales Value (in Million US$), 2012-2017
Figure 49: Japan: Biosimilars Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 50: India: Biosimilars Market: Sales Value (in Million US$), 2012-2017
Figure 51: India: Biosimilars Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 52: South Korea: Biosimilars Market: Sales Value (in Million US$), 2012-2017
Figure 53: South Korea: Biosimilars Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 54: Others: Biosimilars Market: Sales Value (in Million US$), 2012-2017
Figure 55: Others: Biosimilars Market Forecast: Sales Value (in Million US$), 2018-2023
Figure 56: Biosimilar Manufacturing: Detailed Process Flow
Figure 57: Biosimilar Manufacturing Plant: Raw Materials Requirement
Figure 58: Biosimilar Manufacturing Process: Conversion Rates of Products
Figure 59: Biosimilar Manufacturing Plant: Machinery Costs (in US$)
Figure 60: Biosimilar Manufacturing Plant: Primary Packaging
Figure 61: Biosimilar Manufacturing Plant: Secondary Packaging
Figure 62: Biosimilar Manufacturing Plant: Tertiary Packaging
List of Tables
Table 1: Global: Sales and Patent Expiry of Blockbuster Biological Drugs (in Million US$), 2017
Table 2: Global: Biosimilars Market: Biosimilars Vs Innovators Drug Development
Table 3: Global: Biosimilars Market: Biosimilars Vs Biologics Manufacturing
Table 4: Global: Biosimilars market: Key Industry Highlights, 2017 and 2023
Table 5: US: Biosimilars Market: Patent Landscape
Table 6: Europe: Biosimilars Market: Patent Landscape
Table 7: Japan: Biosimilars Market: Patent Landscape
Table 8: Global: Biosimilars Market: Price Comparison Between Biosimilar and Originator Drugs
Table 9: Global: Biosimilars Market: Breakup by Molecule (in Million US$), 2012-2017
Table 10: Global: Rituximab: Brand & Biosimilars Market Overview
Table 11: Global: Infliximab: Brand & Biosimilars Market Overview
Table 12: Global: Insulin Glargine: Brand & Biosimilars Market Overview
Table 13: Global: Epoetin Alfa: Brand & Biosimilars Market Overview
Table 14: Global: Filgrastim: Brand & Biosimilars Market Overview
Table 15: Global: Somatropin: Brand & Biosimilars Market Overview
Table 16: Global: Etanercept: Brand & Biosimilars Market Overview
Table 17: Global: Follitropin Alfa: Brand & Biosimilars Market Overview
Table 18: Global: Biosimilars Market Forecast: Breakup by Manufacturing Type (in Million US$), 2018-2023
Table 19: Global: Biosimilars Market Forecast: Breakup by Indication (in Million US$), 2018-2023
Table 20: Global: Biosimilars Market Forecast: Breakup by Region (in Million US$), 2018-2023
Table 21: Europe: Biosimilars Market: Key Players and Biosimilars
Table 22: Italy: Biosimilars Market: Key Players and Biosimilars
Table 23: Germany: Biosimilars Market: Key Players and Biosimilars
Table 24: France: Biosimilars Market: Key Players and Biosimilars
Table 25: United Kingdom: Biosimilars Market: Key Players and Biosimilars
Table 26: Spain: Biosimilars Market: Key Players and Biosimilars
Table 27: United States: Biosimilar Market: Key Players and Biosimilar
Table 28: United States: Biosimilars Market: Launch of Expected Biosimilar
Table 29: Japan: Biosimilars Market: Key Players and Biosimilars
Table 30: India: Biosimilars Market: Key Players and Biosimilars
Table 31: South Korea: Biosimilars 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