Global Biosimilar Market 2018-2023: Patent Expirees of Blockbuster Biological Drugs, Lower Prices, Rising Prevalence of Chronic Diseases, and Cost Saving Initiatives

DUBLIN, Sept. 7, 2018 /PRNewswire/ --

The "Biosimilar Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2018-2023" report has been added to ResearchAndMarkets.com's offering.

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.

Key Topics Covered:

1 Preface

2 Scope and 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
7.9 SWOT Analysis
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
7.12 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

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

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