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Global Biosimilar Market Research Report 2021 with Biosimilar Patent Landscape Scenario in United States, Europe, & japan

·4-min read

Dublin, Jan. 07, 2022 (GLOBE NEWSWIRE) -- The "Global Biosimilar Market Report and Forecast 2021-2026" report has been added to ResearchAndMarkets.com's offering.

The global biosimilar market size reached a value of almost USD 16646 million in the year 2020. The biosimilar market is further expected to grow at a CAGR of 18.1% between 2021 and 2026 to reach a value of almost USD 48681 million by 2026.

A biosimilar is a biologic that is similar to a previously approved biologic drug (known as a reference product) by the United States Food and Drug Administration (FDA). In terms of safety, purity, and potency, biosimilars are very comparable to the reference product, but clinically inactive components may differ significantly.

The FDA may require manufacturers to complete a clinical trial adequate to show safety, purity, or potency in one or more purposes. The reference product is licenced, and the biosimilar seeks licensure when approving biosimilars. It can only be produced when the patent on the reference product has expired.

The market is driven by factors such as the rising prevalence of chronic diseases such as cancer and diabetes that supplement the growing demands of pharmaceutical drugs, especially for the high-priced patented drugs and the increasing demand for biosimilars for their cost-effectiveness.

The industry will also benefit from the expiration of patents on a number of biologic drugs and a number of blockbuster drugs that are still to lose patent protection in the forecast period, as this will increase future opportunities for biosimilar makers.

Regulatory approvals and other regulations favouring the adoption of biosimilars in different countries is also a major driving factor in the biosimilars market. Governments and third-party payers are implementing cost-cutting programmes to encourage biosimilars instead of branded biologics, which boosts the biosimilar market.

Another aspect driving market expansion is the growing geriatric population. The market is predicted to increase because of rising FDA approvals and increasing research and development activity by key manufacturers focused on oncology.

Global market growth is boosted by an expanding product pipeline and new product launches. With favourable government laws and flexible and ineffective regulations, several countries dominate the market.

Competitive Landscape

The report looks into the market shares, plant turnarounds, capacities, investments, and mergers and acquisitions, among other major developments, of the key players in the industry.

Some of the major players in the market explored in the report are:

  • Pfizer Inc.

  • Celltrion Inc.

  • Novartis AG

  • AMGen Inc.

  • Teva Pharmaceutical Industries Ltd.

  • Samsung Bioepis

  • Biocon Ltd.

Key Topics Covered:

1 Preface

2 Report Coverage - Key Segmentation and Scope

3 Report Description
3.1 Market Definition and Outlook
3.2 Properties and Applications
3.3 Market Analysis
3.4 Key Players

4 Key Assumptions

5 Executive Summary
5.1 Overview
5.2 Key Drivers
5.3 Key Developments
5.4 Competitive Structure
5.5 Key Industrial Trends

6 Snapshot
6.1 Europe
6.2 Regional

7 Industry Opportunities and Challenges

8 Global Biosimilar Market Analysis
8.1 Key Industry Highlights
8.2 Global Biosimilar Historical Market (2016-2020)
8.3 Global Biosimilar Market Forecast (2021-2026)
8.4 Global Biosimilar Market by Molecule
8.4.1 Infliximab
8.4.2 Insulin Glargine
8.4.3 Epoetin Alfa
8.4.4 Etanercept
8.4.5 Filgrastim
8.4.6 Somatropin
8.4.7 Rituximab
8.4.8 Follitropin Alfa
8.5 Global Biosimilar Market by Type of Manufacturing
8.5.1 In-house Manufacturing
8.5.2 Contract Manufacturing
8.6 Global Biosimilar Market by Indication
8.6.1 Auto-Immune Diseases
8.6.2 Blood Disorder
8.6.3 Diabetes
8.6.4 Oncology
8.6.5 Growth Deficiency
8.6.6 Female Infertility

9 Regional Analysis
9.1 Historical Trend (2016-2020)
9.2 Forecast Trend (2021-2026)
9.3 Breakup by Country

10 Market Dynamics
10.1 SWOT Analysis
10.2 Porter's Five Forces Analysis
10.3 Key Indicators for Demand
10.4 Key Indicators for Price

11 Biosimilar Patent Landscape
11.1 Patent Landscape in the US
11.2 Patent Landscape in Europe
11.3 Patent Landscape in Japan

12 Value Chain Analysis
12.1 Characterizing the Existing Innovator Drug
12.2 Research and Development
12.2.1 Characterization of Biosimilars
12.2.2 Developing a Unique Cell Line
12.3 Product Development
12.3.1 Pre-Testing
12.3.2 Intermediary Clinical Testing (PK/PD)
12.3.3 Confirmatory Clinical Phase-III
12.4 Final Product Formulation
12.5 Marketing and Distribution

13 Price Analysis

14 Requirements for Setting Up a Biosimilar Manufacturing Plant
14.1 Manufacturing Process
14.2 Raw Material Requirements
14.3 Raw Material Pictures
14.4 Land and Construction Requirements
14.5 Machinery and Infrastructure Requirements
14.6 Machinery Pictures
14.7 Plant Layout
14.8 Packaging Requirements
14.9 Utility Requirements
14.10 Manpower Requirements

15 Competitive Landscape
15.1 Market Structure
15.2 Company Profiles

16 Events and Developments

For more information about this report visit https://www.researchandmarkets.com/r/22176x


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