According to this latest report, ‘Global Biosimilar Market Report and Forecast 2021-2026’, 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.
The market report analyses the market based on segmentations such as molecule, type of manufacturing, indication, and major regions.
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.
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.
Market Segmentation
The market report analyses the market based on segmentations such as molecule, type of manufacturing, indication, and major regions.
Market Breakup by Molecule
- Infliximab
- Insulin Glargine
- Epoetin Alfa
- Etanercept
- Filgrastim
- Somatropin
- Rituximab
- Follitropin Alfa
Market Breakup by Type of Manufacturing
- In-house Manufacturing
- Contract Manufacturing
Market Breakup by Indication
- Auto-Immune Diseases
- Blood Disorder
- Diabetes
- Oncology
- Growth Deficiency
- Female Infertility
Market Breakup by Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa
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.
- Others
Table of Contents
1 Preface2 Report Coverage - Key Segmentation and Scope4 Key Assumptions7 Industry Opportunities and Challenges13 Price Analysis16 Events and Developments
3 Report Description
5 Executive Summary
6 Snapshot
8 Global Biosimilar Market Analysis
9 Regional Analysis
10 Market Dynamics
11 Biosimilar Patent Landscape
12 Value Chain Analysis
14 Requirements for Setting Up a Biosimilar Manufacturing Plant
15 Competitive Landscape
Companies Mentioned
- Pfizer Inc.
- Celltrion Inc.
- Novartis AG
- AMGen Inc.,
- Teva Pharmaceutical Industries Ltd.
- Samsung Bioepis
- Biocon Ltd.
Methodology
LOADING...
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 241 |
| Published | October 2021 |
| Forecast Period | 2016 - 2026 |
| Estimated Market Value ( USD | $ 2450 Million |
| Forecasted Market Value ( USD | $ 48681 Million |
| Compound Annual Growth Rate | 34.8% |
| Regions Covered | Global |
| No. of Companies Mentioned | 7 |
