Global Biosimilars Markets Research report 2018: 2016-2017 Data & Projections to 2022

4/6/2018, 9:33 AM (Source: GlobeNewswire)

Dublin, April 06, 2018 (GLOBE NEWSWIRE) -- The "Biosimilars: Global Markets" report has been added to ResearchAndMarkets.com's offering.

Biosimilars are replicas of the innovator biopharmaceuticals. They offer the advantage of being less expensive as compared to their expensive counterparts. The structural and manufacturing complexities associated with their development have led to extensive approval guidelines and regulations by the federal agencies. This report examines the biosimilar drugs in detail and provides an updated overview including its applications in various arenas of disease sectors. The importance of analytical technologies in the biosimilar manufacturing led the researchers to focus specifically on the current and emerging trends in biosimilar manufacturing and analytical testing.

The scope of the study is global. The researchers analyze each market and its application, new products and advancements, market projections and market shares. This study surveys each market in all the geographic regions including North America, Europe and Emerging markets. The Emerging market covers all major countries like India, China, South Korea, Taiwan, Australia, New Zealand, Canada, Latin America, much of Africa, etc.

Also included in the report are relevant patent analysis and comprehensive profiles of companies that lead the biosimilar drugs industry. The company profiles highlight the bosimilar pipelines of relevant companies. Some of the major players of the market include Pfizer Inc., Sandoz International GmbH, Biocon Ltd., Dr Reddy's Laboratories Ltd., Amgen Inc., Teva Pharmaceuticals Inc., Celltrion Inc., Samsung Bioepis, and others.

The publisher analyzes the current market situation by critically discussing the strengths, weaknesses, threats, and opportunities for the global biosimilars market. The market projections and market shares are examined for each region and type. The latest news articles including new products, acquisitions and collaborations in each market are also dealt with in sufficient detail.

The report has also dealt with biobetters, their approval mechanisms and importance in the industry. (Biobetters are described as new molecular entities that are related to existing biologics by target or action, but they are deliberately altered to improve disposition, safety, efficacy, or manufacturing attributes.)

Excluded from this report are the generics of small-molecule drugs, and the biologics per se. The different requirements for approval and bioequivalence between generics and biosimilars puts them in an entirely different regime. The diagnostic methods for monitoring disease progression are also outside the scope of this report.

Report Includes:

  • 80 data tables and 16 additional tables
  • An overview of the global market for biosimilars
  • Analyses of global market trends, with data from 2016 and 2017, and projections of compound annual growth rates (CAGRs) through 2022
  • A look at biosimilar product classes in various regions worldwide, as well as the worldwide pipeline for biosimilars
  • Detailed analysis of the emerging framework in regulated markets, as well as comparisons of biosimilar guidelines in Europe, the U.S., Japan, Canada, as well the guidelines developed by the - World Health Organization
  • Technology trends and patent analyses
  • Comprehensive company profiles of key players in the market, including Allergan Plc., Bioton S.A., Cinnagen, Emcure Pharmaceuticals Ltd., LG Life Sciences, Neuclone and Pfizer Inc.

Key Topics Covered:

1 Introduction

2 Summary and Highlights

3 Market and Technology Background
Lifecycle of a Biosimilar Drug
Development of a Biosimilar
Manufacturing of a Biosimilar
Preclinical Studies and Validation of a Biosimilar
Clinical Trials
Approval by Regulatory Agencies
Pharmacovigilance/Post-Approval Monitoring
Popular Biosimilar Candidates
Recombinant Hormones
Recombinant Growth Factors
Monoclonal Antibodies (mAbs)
Fusion Proteins
Others
Definitions
EMA Terminology Related to Biosimilars
FDA Terminology Related to Biosimilars
WHO Terminology Related to Biosimilars
Differences Between Common Drug Classifications
Small Molecule Drugs vs. Biologics
Generics vs. Biosimilars
Biosimilars vs. Biobetters
Strategies to Develop Biobetters
PEGylation
Glycosylation
Fusion Proteins

4 Market Breakdown by Technology Type
Market by Biosimilar Types
Market Revenue
Market Shares
Recombinant Hormone Biosimilars
Market Overview
Market Revenue
Recombinant Growth Factor Biosimilars
Market Overview
Market Revenue
Monoclonal Antibodies Biosimilars
Market Overview
Market Revenue
Fusion Protein Biosimilars
Market Overview
Market Revenue
Others
Market Overview
Market Revenue

5 Market Breakdown by Application
Market by Biosimilar Applications
Cancer Biosimilars
Blood Disorders
Diabetes
Growth Hormone Deficiency
Infectious Diseases
Autoimmune Diseases
Other Diseases

6 Market Breakdown by Region
Patent Challenges
Interchangeability
Pricing
Market by Geographical Region
Market Revenue
Market Shares
Recombinant Hormone Biosimilars
Somatotropin Biosimilars
Follitropin alfa Biosimilars
Insulin Glargine Biosimilars
Teriparatide Biosimilars
Recombinant Growth Factors Biosimilars
Erythropoietin Biosimilars
Darbepoetin alfa Biosimilars
Filgrastim Biosimilars
Pegfilgrastim Biosimilars
Monoclonal Antibody Biosimilars
Adalimumab Biosimilars
Bevacizumab Biosimilars
Infliximab Biosimilars
Ranibizumab Biosimilars
Rituximab Biosimilars
Trastuzumab Biosimilars
Fusion Protein Biosimilars
Interferon Biosimilars
Enoxaparin Sodium Biosimilars

7 Industry Structure
Types of Market Players
Established Biologics Companies
Established Generics Companies
Bio-intellectual Companies
Opportunistic Companies
Emerging Trends in Biosimilar Industry Structure
Collaborations and Partnerships
Mergers and Acquisitions
Contract Manufacturing Organizations (CMOs)
Leading Manufacturers/Suppliers of Biosimilar Drugs
Recombinant Hormones
Market Share
Recombinant Growth Factors
Market Share
Monoclonal Antibodies
Market Share
Fusion Proteins
Market Share
Others
Market Share

8 Patent Review
Patent Regulations in Favor of Branded Biologics
Market Exclusivity
Patent Dance
Licensing Notice
Patent Regulations in Favor of Biosimilars-Emerging Trends
Market Exclusivity Option
Patent Dance Developments
Licensing Notice
Product vs Process Patents
Patent Activity in Biosimilars, 2015-2017
United States Patents
European Patents

9 New Developments
Major Companies in the Biosimilars Market
Biosimilars in Clinical Trials
Overview
Biosimilar Recombinant Hormones in Clinical Trials
Biosimilar Recombinant Growth Factors in Clinical Trials
Biosimilar Monoclonal Antibodies in Clinical Trials
Biosimilar Fusion Proteins in Clinical Trials
Other Biosimilars in Clinical Trials
Bio-betters in Clinical Trials

10 Regulatory Aspects
Biosimilar Regulations in Europe
Biosimilar Regulations in U.S.
Principle of Exclusivity
Requirement of 351(k) Application
Approaches to Demonstrate Biosimilarity
Biosimilar Regulations in Emerging Markets
Biosimilar Guidelines in India
Biosimilar Regulations in China
Biosimilar Regulations in South Korea
Biosimilar Regulations in Japan
Significant Regulatory Activities
Regulatory Guidelines for Bio-betters
Naming of Biosimilars
Naming Convention by FDA
Naming Convention by WHO
Naming Convention by EMA

11 Technologies Used in Biosimilar Manufacturing and Analytical Testing, Emerging Trends
Emerging Trends in Biosimilar Manufacturing
Improvements in Cell Lines
Clone Screening
Single-Use Technologies (SUTs)
Continuous Manufacturing
Process Analytical Technologies and Quality by Design (QbD)
Outsourcing-Contract Manufacturing Organizations (CMOs)
Emerging Trends in Analytical Methods
Popular Analytical Technologies for Biosimilar Characterization

12 Analysis of Market Opportunities
Strengths of Biosimilars Market
Growing Aging Population
Rising Incidence of Diseases
Patent Expirations
Growing Pipeline
Drive to Reduce Costs
Government Incentives
Collaborations and Partnerships
Mergers and Acquisitions
Weaknesses of Biosimilars Market
Manufacturing Process of Biosimilars
Process Definition and Testing and Validation
Lack of Skilled Personnel
Regulatory Guidelines
Patent Litigation
Threats of Biosimilars Market
Unpredictable Regulatory Landscape
Prescription by Medical Practitioners/Pharmacies
Competition
Opportunities of Biosimilars Market
Emerging Markets
Technological Innovation and Improved Process Knowledge
Pricing

13 Company Profiles

  • 3S Bio Inc.
  • Allergan PLC.
  • Amgen Inc.
  • Anhui Anke Biotechnology (Group) Co. Ltd.
  • Apotex Inc.
  • Avesthagen Ltd.
  • Bharat Serums And Vaccines Ltd.
  • Biocad
  • Biocon Ltd.
  • Biosidus S.A.
  • Bioton S. A.
  • Bioxpress Therapeutics S.A.
  • Blau Farmaceutica S/A
  • Boehringer Ingelheim
  • Celltrion Inc.
  • China National Biotec Group (Cnbg)
  • Cinnagen
  • Cipla Biotec Pvt. Ltd.
  • Coherus Biosciences
  • DM Bio Ltd.
  • Dong-A Socio Holdings
  • Dr. Reddy's Laboratories Ltd.
  • Emcure Pharmaceuticals Ltd.
  • Epirus Biopharmaceuticals Inc.
  • Fujifilm Diosynth Biotechnologies
  • Gedeon Richter Plc
  • Genescience Pharmaceuticals Co. Ltd.
  • Genexine Inc.
  • Green Cross Corp.
  • Hanall Biopharma
  • Hangzhou Jiuyuan Gene Engineering Co. Ltd.
  • Hanwha Chemical Corp.
  • Harvest Moon Pharmaceuticals Usa Inc.
  • Intas Pharmaceuticals Ltd.
  • JCR Pharmaceuticals Co. Ltd.
  • JHL Biotech Inc.
  • Kissei Pharmaceutical Co. Ltd.
  • LG Life Sciences
  • Lupin Ltd.
  • Mabxience S.A.
  • Medice Arzneimittel Putter Gmbh And Co. Kg
  • Merck Kgaa
  • Mochida Pharmaceutical Co. Ltd.
  • Momenta Pharmaceuticals
  • Mycenax Biotech Inc.
  • Mylan N.V.
  • Nanogen Biopharmaceutical Co.
  • Neuclone
  • Nippon Kayaku Co. Ltd.
  • Pfenex Inc.
  • Pfizer Inc.
  • Pharmapark Llc
  • Plantform Corp.
  • Prestige Biopharma Pte Ltd.
  • Probiomed, S.A. De C.V.
  • Reliance Life Sciences
  • Samsung Bioepis Co. Ltd.
  • Sandoz International Gmbh
  • Scinopharm Taiwan Ltd.
  • Stada Arzneimittel Ag
  • Tanvex Biopharma Inc.
  • Teva Pharmaceuticals Industries Ltd
  • USV Pvt. Ltd.
  • Wockhardt Ltd.
  • Xiamen Amoytop Biotech Co. Ltd.
  • Zhongshan Hygene Biopharm Co. Ltd.
  • Zydus Cadila

For more information about this report visit https://www.researchandmarkets.com/research/xr9c59/global?w=12



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