Biosimilars Market

Biosimilars Market
Trends,
Opportunity Analysis, 2018-2026
Outlook,
and
Biosimilar products are suspected to continue to have a significant impact on the
pharmaceutical industry. Many regulatory bodies have established clinical guidelines to support
the development of biosimilars, laying down the requirements for demonstrating comparable
pharmacokinetics, pharmacodynamics, safety and efficacy from Phase I on to controlled,
randomized Phase III trials.
Browse Complete Report For More Information @
https://www.coherentmarketinsights.com/market-insight/biosimilars-market-750
Although biosimilars are not required to undergo intense clinical trials for their approval, the
data demonstrating their similarity to an original biologic in terms of clinical efficacy and safety
is required. The adoption of biosimilars varies from country to country, which is invariably
linked to regulatory and market access issues. The biosimilars market is expected to witness
significant growth, owing to expiry and termination of existing drugs and presence of rich
pipeline of biosimilar products especially those in Phase III stage.
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).
Report includes chapters which deeply display the following deliverable about industry :
• Biosimilars Market Research Objective and Assumption
• Biosimilars Market Purview - Report Description, Executive Summary, and Coherent
Opportunity Map (COM)
• Biosimilars Market Dynamics, Regulations, and Trends Analysis - Market Dynamics, Regulatory
Scenario, Industry Trend, Merger and Acquisitions, New system Launch/Approvals, Value Chain
Analysis, Porter’s Analysis, and PEST Analysis
• Global Biosimilars Market, By Regions
• Biosimilars Market Competition by Manufacturers including Production, Share, Revenue,
Average Price, Manufacturing Base Distribution, Sales Area and Product Type.
• Biosimilars Market Manufacturers Profiles/Analysis including Company Basic Information,
Manufacturing Base and Its Competitors.
• Biosimilars Market Manufacturing Cost Analysis including Key Raw Materials and Key
Suppliers of Raw Materials.
• Industrial Chain, Sourcing Strategy and Downstream Buyers including Upstream Raw Materials
Sourcing and Downstream Buyers
• Marketing Strategy Analysis, Distributors/Traders including Marketing Channel, Market
Positioning and Distributors/Traders List.
• Market Effect Factors Analysis including Technology Progress/Risk, Consumer Needs/Customer
Preference Change and Economic/Political Environmental Change.
• Biosimilars Market Forecast including Production, Consumption, Import and Export Forecast by
Type, Applications and Region.
• Research Findings and Conclusion
Increasing number of biosimilar approvals is expected to drive the growth of biosimilars market
Increase in number of approved biosimilars due to greater clarity in the U.S. Food and Drug
Administration (FDA) review process other than manufacturing and development process are
expected to drive biosimilars market growth. For instance, in July 2018, the U.S. FDA
introduced a Biosimilars Action Plan to encourage the development of biosimilars. This approval
process encourages applicants to resolve patent disputes before launch of biosimilars.
Moreover, the number of filed biosimilars applications has increased as manufacturers have
become more comfortable with the complex regulatory and litigation schemes associated with
filing a biosimilar application. For instance, since 2015, the U.S. FDA has approved 16
biosimilars and the number is expected to increase over the forecast period. Several other
government agencies are also following similar trends for product approvals. For instance, in
November 2017, Samsung Bioepis received two approval for its adalimumab biosimilar, Hadlima
(SB5) and for its trastuzumab biosimilar, Samfenet (SB3), from the Korean Ministry of Food and
Drug Safety (South Korea).
Market Dynamics
Increasing number of biosimilar approvals in clinical management of various diseases such as
diabetes and hormonal imbalance is expected to drive growth of the biosimilars market.
According to the Generics and Biosimilars Initiative (GABI) 2017 report, around 40 different
biosimilars were approved in Europe, covering several different therapeutic classes: granulocyte
colony-stimulating factors, and erythropoiesis-stimulating agents (ESAs), among others.
Request Sample Copy of Research Report @
https://www.coherentmarketinsights.com/insight/request-sample/750
Moreover, increasing research and development in biosimilars, robust biosimilar pipeline
portfolio, and support from healthcare regulatory bodies in fast lining biosimilar approvals are
some of the major factors that are expected to drive growth of the market. The U.S. Food and
Drug Administration (FDA) and the European Medicines Agency (EMA) both provide guidance
for the development of biosimilar drugs. However, stringent regulatory guidelines for
development and manufacturing of biosimilars and fragile process of biosimilars production are
expected to negatively impact growth of the global biosimilars market.
Biosimilars Market - Competitive Landscape
Key players operating in the global biosimilars market include, Novartis AG, Pfizer, Inc., Teva
Pharmaceutical Industries Ltd., Celltrion Healthcare Co., Ltd., Biocon Limited, Amgen, Inc., Dr.
Reddy's Laboratories, and Sanofi S.A.
About Coherent Market Insights
Coherent Market Insights is a prominent market research and consulting firm offering actionready syndicated research reports, custom market analysis, consulting services, and competitive
analysis through various recommendations related to emerging market trends, technologies, and
potential absolute dollar opportunity.
Contact Us
Mr. Shah
Coherent Market Insights
1001 4th Ave, #3200
Seattle, WA 98154
Tel: +1-206-701-6702
Email: [email protected]

Biosimilars are biopharmaceutical drugs that have active components and are similar to the drugs, which have been previously licensed.