Overview:
Biosimilars are biopharmaceutical drugs with active components. These are same as the drugs that have been previously approved. Biosimilars are likely to keep impacting the pharmaceutical industry. Many of the governing organizations are forming clinical guidelines to support the biosimilars development providing needs for demonstrating coparable pharmacodynamics, pharmacokinetics, efficiency and safety from Phase I to controlled randomized Phase III trials.
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The approval process of biosimilars requires the data that shows the similarity in clinical efficiency and safety to an original biologic, eliminating the need of intense clinical trials of biosimilars for their approvals. The use of biosimilars is different in each country depending on regulatory and market access issues. Presence of rich pipeline of biosimilars products in Phase III stage as well as termination and expiry of pre-existing drugs are expected to boost growth of the global biosimilars market.
The global biosimilars market size was valued at US$ 5.0 billion in 2017, and is expected to witness a CAGR of 35.2% over the forecast period (2018 – 2026).
Drivers:
Frequent approvals of biosimilars, owing to higher clarity in the review process of the U.S. FDA than development and manufacturing procedures are expected to augment growth of the biosimilars market. For instance, in July 2018, the U.S. FDA launched a Biosimilars Action Plan, designed to boost development of biosimilars.
Furthermore, increasing number of filed applications of biosimilars is also expected to propel growth of the biosimilars market. With the increasing complex litigation and regulatory schemes related to filing of biosimilar application, the market players are becoming more comfortable with it. For instance, from 2015, the U.S. FDA has granted approval to 16 biosimilars and the number is likely to rise during the forecast period. Moreover, in November 2017, following the same trends for product approvals, the the Korean Ministry of Food and Drug Safety (South Korea) approved trastuzumab biosimilar, Samfenet (SB3) of Samsung Bioepis.
Restraints:
Strict rules and regulation for development and production of biosimilars in the U.S. is expected to hamper growth of the global biosimilars market. For instance, in April 2019, trastuzumab biosimilar of Pfizer and Sandoz’s candidate rituximab biosimilar did not get approval of the U.S. FDA. During 2018, the FDA rejected four biosimilar applications.
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Furthermore, numerous problems regarding to manufacturing biosimilars arriving due to complexity and difficulty in characterization, production and reproduction of biologics are also likely to hinder growth of the biosimilars market.
Regional analysis:
The global biosimilars market is regionally divided into North America, Europe, Latin America, Middle East, Asia Pacific, and Africa.
Among regions, Europe is expected to witness robust growth in the biosimilars market during the forecast period, owing to growing focus of regulatory organisations in advancement of new biosimilars products. For instance, in July 2016, the European Medicines Agency (EMA) granted clearance to launch and marketing of Thorinane and Inhixa, which are the biosimilars of the enoxaparin, the Low Molecular Weight Heparin (LMWH).
Moreover, Asia Pacific is witnessing strong growth in the biosimilars market due to frequent approvals of biosimilars. For instance, in 2017, the China Food and Drug Administration (CFDA) granted approval to Celltrion for clinical trials of infliximab biosimilar, Remsima (CT-P13) in China making Celltrion the first foreign organization to start antibody biosimilar clinical trials in China.
Key products:
Major players operating in the global biosimilars market are, Pfizer, Inc., Celltrion Healthcare Co., Ltd., Amgen, Inc., Sanofi S.A., Novartis AG, Teva Pharmaceutical Industries Ltd., Biocon Limited, and Dr. Reddy’s Laboratories.
Reasons to Purchase this Report
• Current and future of global Biosimilars Market outlook in the developed and emerging markets
• The segment that is expected to dominate the market as well as the segment which holds highest CAGR in the forecast period.
• Regions/countries that are expected to witness the fastest growth rates during the forecast period
• The latest developments, market shares, and strategies that are employed by the major market players
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Table of Contents
- Research Objective and Assumption
- Research Objectives
- Assumptions
- Abbreviations
- Market Overview
- Report Description
- Market Definition and Scope
- Executive Summary
- Market Snippet, By Drug Class
- Market Snippet, By Therapy Type
- Market Snippet, By Distribution Channel
- Market Snippet, By Region
- Coherent Opportunity Map (COM)
- Report Description
- Market Dynamics, Regulations, and Trends Analysis
- Market Dynamics
- Drivers
- Restraints
- Market Opportunities
- Impact Analysis
- Market Trends
- Key Developments
- Pipeline Analysis
- Supply Chain Analysis
- Cost Effectiveness of Biosimilars
- Reimbursement Scenario
- Regulatory Landscape
- Epidemiology Analysis
- PEST Analysis
- Porter’s Five Forces model
- Market Dynamics
- Global Biosimilars Market, By Drug Class, 2018 – 2026, (US$ Million)
- Introduction
- Market Share Analysis, 2018 and 2026 (%)
- Y-o-Y Growth Analysis, 2017 – 2026
- Segment Trends
- Recombinant Human Growth Hormone (rhGH)
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Granulocyte Colony-Stimulating Factor (Filgrastim)
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Insulin
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Anticoagulants
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Fusion Proteins
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Erythropoietin (EPO)
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Monoclonal Antibodies
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Follitropin
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Others
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Introduction
- Global Biosimilars Market, By Therapy Type, 2018 – 2026, (US$ Million)
- Introduction
- Market Share Analysis, 2018 and 2026 (%)
- Y-o-Y Growth Analysis, 2017 – 2026
- Segment Trends
- Oncology
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Immunology
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Hematology
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Hormone Therapy
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Metabolic Disorders
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Others
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Introduction
- Global Biosimilars Market, By Distribution Channel, 2018 – 2026, (US$ Million)
- Introduction
- Market Share Analysis, 2018 and 2026 (%)
- Y-o-Y Growth Analysis, 2017 – 2026
- Segment Trends
- Hospital Pharmacies
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Retail Pharmacies
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Specialty Pharmacies
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2018 – 2026, (US$ Million)
- Introduction
- Global Biosimilars Market, By Region, 2018 – 2026, (US$ Million)
- Introduction
- Market Share Analysis, By Region, 2018 and 2026 (%)
- Y-o-Y Growth Analysis, By Region, 2017 – 2026
- Regional Trends
- North America
- Market Size and Forecast, By Drug Class, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Therapy Type, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Distribution Channel, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Country, 2018 – 2026, (US$ Million)
- U.S.
- Canada
- Europe
- Market Size and Forecast, By Drug Class, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Therapy Type, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Distribution Channel, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Country, 2018 – 2026, (US$ Million)
- U.K.
- Germany
- Italy
- France
- Spain
- Russia
- Rest of Europe
- Asia Pacific
- Market Size and Forecast, By Drug Class, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Therapy Type, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Distribution Channel, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Country, 2018 – 2026, (US$ Million)
- China
- Japan
- India
- ASEAN
- Australia
- South Korea
- Rest of Asia Pacific
- Latin America
- Market Size and Forecast, By Drug Class, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Therapy Type, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Distribution Channel, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Country, 2018 – 2026, (US$ Million)
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- Africa
- Market Size and Forecast, By Drug Class, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Therapy Type, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Distribution Channel, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Country, 2018 – 2026, (US$ Million)
- North Africa
- Central Africa
- South Africa
- Middle East
- Market Size and Forecast, By Drug Class, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Therapy Type, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Distribution Channel, 2018 – 2026, (US$ Million)
- Market Size and Forecast, By Country, 2018 – 2026, (US$ Million)
- GCC Countries
- Israel
- Rest of Middle East
- Introduction
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