Biosimilars are highly identical to approved biological drugs. They have similar properties in terms of safety, potency, and efficacy to original biologic products but they have minor differences in clinically inactive components. Regulations for biosimilars play important role in maintaining the viability and balance between reference product and biosimilars product. Various regulatory authorizes like FDA and EMA actively regulate the development and commercialization of biosimilars.
The rise in number of biosimilar approvals is the key driving factor which is expected to boost the global biosimilars market growth. For instance, in July 2018, the USFDA (U.S. Food and Drug Administration) had introduced a biosimilars action plan to encourage the development of biosimilars. Furthermore, increases in prevalence of chronic diseases like cancer will positively contribute the market growth. For instance, in 2018, as per the NCI (National Cancer Institute) information approximates 1,735,350 new cases of cancer likely to be diagnosed in United States. Moreover, increase in research and development activities as well as government initiatives will fuel the global biosimilars market growth during this forecast period. Many governments are emphasizing on cost-effective drug synthesis. The united Ststes is the popular country with highest health expenditure.
However, a complexity in manufacturing is the major restraining factor which is expected to hinder the global biosimilars market growth. Also, stringent rules and regulations for development and manufacturing of biosimilars will affect the market growth.
Global Biosimilars Market is segmented into drug class such as Recombinant Human Growth Hormone, Granulocyte Colony-Stimulating Factor, Fusion Proteins, Insulin, Monoclonal Antibodies, Erythropoietin, Follitropin, Anticoagulants, and others, by therapy type such as Immunology, Oncology, Hematology, Hormone Therapy, Metabolic Disorders, and Others. Further, market is segmented into distribution channel such as Hospital Pharmacies, Retail Pharmacies, and Speciality Pharmacies.
Also, Global Biosimilars Market is segmented into is segmented into five regions such as North America, Latin America, Europe, Asia Pacific, and Middle East & Africa.
Various key players are discussed in this report such as Novartis AG, Pfizer Inc. Celltrion Healthcare Co., Ltd, Teva Pharmaceutical, Biocon Limited, Dr. Reddy's Laboratories, Amgen, Inc.,and Sanofi S.A.
By Drug Class
Recombinant Human Growth Hormone Granulocyte Colony-Stimulating Factor Fusion Proteins Insulin Erythropoietin Monoclonal Antibodies Follitropin Anticoagulants Others
By Therapy Type
Immunology Oncology Hematology Hormone Therapy Metabolic Disorders Others
By Distribution Channel
Hospital Pharmacies Retail Pharmacies Specialty Pharmacies
1.1 Objective of the Study
1.2 Market definition
1.3 Market Scope
2 Research Methodology
2.1 Data Mining
2.2 Validation
2.3 Primary Interviews
2.4 List of Data Sources
3 Executive Summary
4 Global Biosimilars Market Outlook
4.1 Overview
4.2 Market Dynamics
4.2.1 Drivers
4.2.2 Restraints
4.2.3 Opportunities
4.3 Porters Five Force Model
4.4 Value Chain Analysis
5 Global Biosimilars Market, By Drug Class
5.1 Y-o-Y Growth Comparison, By Drug Class
5.2 Global Biosimilars Market Share Analysis, By Drug Class
5.3 Global Biosimilars Market Size and Forecast, By Drug Class
5.3.1 Recombinant Human Growth Hormone
5.3.2 Granulocyte Colony-Stimulating Factor
5.3.3 Fusion Proteins
5.3.4 Insulin
5.3.5 Monoclonal Antibodies
5.3.6 Erythropoietin
5.3.7 Follitropin
5.3.8 Anticoagulants
5.3.9 Others
6 Global Biosimilars Market, By Therapy Class
6.1 Y-o-Y Growth Comparison, By Therapy Class
6.2 Global Biosimilars Market Share Analysis, By Therapy Class
6.3 Global Biosimilars Market Size and Forecast, By Therapy Class
6.3.1 Immunology
6.3.2 Oncology
6.3.3 Hematology
6.3.4 Hormone Therapy
6.3.5 Metaboloc Disorders
6.3.6 Others
7 Global Biosimilars Market, By Distribution Channel
7.1 Y-o-Y Growth Comparison, By Distribution Channel
7.2 Global Biosimilars Market Share Analysis, By Distribution Channel
7.3 Global Biosimilars Market Size and Forecast, By Distribution Channel
7.3. 1Hospital Pharmacies
7.3.2. Retail Pharmacies
7.3.3. Specialty Pharmacies
8Global Biosimilars Market, By Region
8.1 Global Biosimilars Market Share Analysis, By Region
8.2 Global Biosimilars Market Share Analysis, By Region
8.3 Global Biosimilars Market Size and Forecast, By Region
9 North America Biosimilars Market Analysis and Forecast (2019-2030)
9.1 Introduction
9.2 North America Biosimilars Market Share Analysis, By Drug Class
9.3 North America Biosimilars Market Size and Forecast, By Therapy Class
9.4 North America Biosimilars Market Size and Forecast, By Distribution Channel
9.5 North America Biosimilars Market Size and Forecast, By Country
9.5.1 U.S.
9.5.2 Canada
9.5.3 Mexico
10EuropeBiosimilars Market Analysis and Forecast (2019-2030)
10.1 Introduction
10.2 Europe Biosimilars Market Share Analysis, By Drug Class
10.3 Europe Biosimilars Market Size and Forecast, By Therapy Class
10.4 Europe Biosimilars Market Size and Forecast, By Distribution Channel
10.5 Europe Biosimilars Market Size and Forecast, By Country
10.5.1 Germany
10.5.2 France
10.5.3 UK
10.54. Rest of Europe
11Asia Pacific Biosimilars Market Analysis and Forecast (2019-2030)
11.1 Introduction
11.2 Asia Pacific Biosimilars Market Share Analysis, By Drug Class
11.3 Asia Pacific Biosimilars Market Size and Forecast, By Therapy Class
11.4 Asia Pacific Biosimilars Market Size and Forecast, By Distribution Channel
11.5 Asia Pacific Biosimilars Market Size and Forecast, By Country
11.5.1 China
11.5.2 Japan
11.5.3 India
11.5.4. Rest of Asia Pacific
12Latin America Biosimilars Market Analysis and Forecast (2019-2030)
12.1 Introduction
12.2 Latin America Biosimilars Market Share Analysis, By Drug Class
12.3 Latin America Biosimilars Market Size and Forecast, By Therapy Class
12.4 Latin America Biosimilars Market Size and Forecast, By Distribution Channel
12.5 Latin America Biosimilars Market Size and Forecast, Country
13Middle East Biosimilars Market Analysis and Forecast (2019-2030)
13.1 Introduction
13.2 Middle East Biosimilars Market Share Analysis, By Drug Class
13.3 Middle East Biosimilars Market Size and Forecast, By Therapy Class
13.4 Middle East Biosimilars Market Size and Forecast, By Distribution Channel
13.5 Middle East Biosimilars Market Size and Forecast, By Country
14Competitive Analysis
14.1 Competition Dashboard
14.2 Market share Analysis of Top Vendors
14.3 Key Development Strategies
15Company Profiles
15.1 Novartis AG
15.1.1 Overview
15.1.2 Offerings
15.1.3 Key Financials
15.1.4 Business Segment & Geographic Overview
15.1.5 Key Market Developments
15.1.6 Key Strategies
15.2. Pfizer Inc
15.2.1 Overview
15.2.2 Offerings
15.2.3 Key Financials
15.2.4 Business Segment & Geographic Overview
15.2.5 Key Market Developments
15.2.6 Key Strategies
15.3. Celltrion Healthcare Co., Ltd
15.3.1 Overview
15.3.2 Offerings
15.3.3 Key Financials
15.3.4 Business Segment & Geographic Overview
15.3.5 Key Market Developments
15.3.6 Key Strategies
15.4 Teva Pharmaceutical
15.4.1 Overview
15.4.2 Offerings
15.4.3 Key Financials
15.4.4 Business Segment & Geographic Overview
15.4.5 Key Market Developments
15.4.6 Key Strategies
15.5 Biocon Limited
15.5.1 Overview
15.5.2 Offerings
15.5.3 Key Financials
15.5.4 Business Segment & Geographic Overview
15.5.5 Key Market Developments
15.5.6 Key Strategies
15.6 Dr. Reddy's Laboratories
15.6.1 Overview
15.6.2 Offerings
15.6.3 Key Financials
15.6.4 Business Segment & Geographic Overview
15.6.5 Key Market Developments
15.6.6 Key Strategies
15.7 Amgen, Inc
15.7.1 Overview
15.7.2 Offerings
15.7.3 Key Financials
15.7.4 Business Segment & Geographic Overview
15.7.5 Key Market Developments
15.7.6 Key Strategies
15.8 Sanofi S.A.
15.8.1 Overview
15.8.2 Offerings
15.8.3 Key Financials
15.8.4 Business Segment & Geographic Overview
15.8.5 Key Market Developments
15.8.6 Key Strategies
