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Biosimilar Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028

Publisher IMARC Services Pvt. Ltd.
Published May 29, 2023
Length 148 Pages
SKU # IMRC17986134

Description

Biosimilar Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028


Global Biosimilar Market Outlook 2023-2028

The global biosimilar market size reached US$ 16.8 Billion in 2022. 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 expected to reach US$ 77.1 Billion by 2028, exhibiting a growth rate (CAGR) of 25.9% during 2023-2028.

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 Industry 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 biosimilars market growth. This includes negative perception from physicians, patent extensions, lower price differential compared to small-molecule generics, etc.

Key Market Segmentation:

IMARC Group provides an analysis of the key trends in each sub-segment of the global biosimilar market report, along with forecasts at the global and regional level from 2023-2028. Our report has categorized the market based on molecule, indication and manufacturing type.

Molecule insights:

Infliximab

Insulin Glargine

Epoetin Alfa

Etanercept

Filgrastim

Somatropin

Rituximab

Follitropin Alfa

Adalimumab

Pegfilgrastim

Trastuzumab

Bevacizumab

Others

On the basis of the molecule, the market has been segmented as Infliximab, Insulin Glargine, Epoetin Alfa, Etanercept, Filgrastim, Somatropin, Rituximab, Follitropin Alfa, Adalimumab, Pegfilgrastim, Trastuzumab, Bevacizumab, and Others.

Indication Insights:

Auto-Immune Diseases

Blood Disorder

Diabetes

Oncology

Growth Deficiency

Female Infertility

Others

On the basis of the indication, the market has been segmented as Auto-Immune Diseases, Blood Disorders, Diabetes, Oncology, Growth Deficiency, Female Infertility, and Others.

Manufacturing Type Insights:

In-house Manufacturing

Contract Manufacturing

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:

Europe

Germany

France

Italy

Spain

United Kingdom

Rest of Europe

United States

Japan

India

South Korea

Others

Region-wise, the market has been segmented into Europe (Germany, France, Italy, Spain, the United Kingdom and Rest of Europe), the United States, Japan, India, South Korea and Others.

Competitive Landscape:

The competitive landscape of the global biosimilar market has also been analysed. Some of the leading players operating in the market are:

Sandoz International GmbH

Pfizer Inc.

Teva Pharmaceutical Industries Limited

Celltrion Inc.

Biocon Limited

Samsung Biologics

Amgen, Inc.

Dr. Reddy's Laboratories Limited

Stada Arzneimittel Ag

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

1. What was the size of the global biosimilar market in 2022?

2. What is the expected growth rate of the global biosimilar market during 2023-2028?

3. What are the key factors driving the global biosimilar market?

4. What has been the impact of COVID-19 on the global biosimilar market?

5. What is the breakup of the global biosimilar market based on the molecule?

6. What is the breakup of the global biosimilar market based on the indication?

7. What is the breakup of the global biosimilar market based on the manufacturing type?

8. What are the key regions in the global biosimilar market?

9. Who are the key companies/players in the global biosimilar market?

Table of Contents

148 Pages
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

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