Dublin, May 22, 2019 (GLOBE NEWSWIRE) -- The "Global Biosimilars Market - Products, Applications and Regulations" report has been added to ResearchAndMarkets.com's offering.
Monoclonal Antibodies constitute the single largest product type in the global Biosimilars market, demand for which is estimated at US$4.4 billion in 2018 and is projected to reach US$28.8 billion by 2025. The overall Biosimilars market in 2019 is expected to reach US$10.4 billion.
Cost-effectiveness, increasing geriatric population, rising incidences and prevalence of chronic ailments such as Cancer, Autoimmune Disorders and Diabetes and supportive government regulations and guidelines are some of the factors fueling the biosimilars market. Patent expiry of most of the monoclonal antibody-based biologics drives the biosimilar monoclonal antibody market.
Oncology biosimilar market leads the biosimilars market and is primarily driven by the rising prevalence and incidence of cancer and patent expiry of the expensive biologics. On the other hand, the growth of the biosimilars market is retarded due to insufficient regulatory guidelines, expensive research and development procedures and preference of patented products by the patients, etc.
Research Findings & Coverage
- Global Biosimilars market is analyzed in this report with respect to key product types and major therapeutic areas
- The study exclusively analyzes the market for each product type and therapeutic area of Biosimilars by all major geographic regions/countries globally
- mAbs - All the Rage in Biosimilars' New Wave
- Biosimilars Slashes the Cancer Treatment Cost
- Novel mAb's Purification Approach to Maximize the Biosimilar Production
- Asia: A Preferred Manufacturing Hub for Biosimilars
- Key business trends focusing on product innovations/developments, M&As, JVs, and other recent industry developments
- Major companies profiled - 42
- The industry guide includes the contact details for 151 companies
Key Topics Covered:
PART A: GLOBAL MARKET PERSPECTIVE
1. INTRODUCTION
1.1 Product Outline
1.1.1 Biosimilars Defined
1.1.2 Backdrop
1.1.3 The Biologics Price Competition and Innovation Act (BPCI Act)
1.1.3.1 Data Exclusivity
1.1.4 Steps Involved in Biosimilar Synthesis
1.1.5 Key Regulatory Authorization Pathway - Synopsis
1.1.6 Biosimilars Types
1.1.6.1 Monoclonal Antibodies (mAB or moAB)
1.1.6.1.1 Production Process
1.1.6.1.1.1 Hybridoma Cell Production
1.1.6.1.2 Therapeutic Applications
1.1.6.2 Erythropoietin (EPO)
1.1.6.2.1 Functions of EPO
1.1.6.2.2 Mechanism of Action
1.1.6.2.3 Synthesis and Regulation
1.1.6.2.4 Uses in Medicine
1.1.6.3 Granulocyte Colony-Stimulating Factor (G-CSF)
1.1.6.3.1 Biological Function
1.1.6.3.2 Genetics
1.1.6.3.3 Use in Therapeutics
1.1.6.4 Insulin
1.1.6.4.1 Biosimilar Insulin
1.1.6.4.2 The Complexity in Producing Biosimilar Insulin
1.1.6.4.3 Biosimilar Insulins and the Regulatory Environment Surrounding Them
1.1.6.4.4 The Market for Biosimilar Insulins
1.1.6.5 Interferons
1.1.6.5.1 Interferon Categorization
1.1.6.5.2 Functions of Interferons
1.1.6.5.3 Interferon Alfa
1.1.6.5.4 Interferon Beta-1a
1.1.6.5.5 Interferon Gamma
1.1.6.6 Human Growth Hormone
1.1.6.6.1 Recombinant Human Growth Hormone
1.1.6.6.2 Managing Growth Disorders Using Recombinant Human Growth Hormone Biosimilars
1.1.6.7 Other Biosimilars
1.1.7 Biosimilars Therapeutic Areas
1.1.7.1 Oncology
1.1.7.1.1 Biosimilar G-CSF
1.1.7.2 Autoimmune Diseases
1.1.7.3 Blood Disorders
1.1.7.4 Growth Hormone Deficiency (GHD)
1.1.7.4.1 Growth Hormone Deficiency in Children
1.1.7.5 Infectious Diseases
1.1.7.5.1 Treatment of Infectious Diseases
2. REGULATORY LANDSCAPE
2.1 The United States Food and Drug Administration (USFDA)
2.1.1 Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
2.1.2 Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
2.1.3 Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
2.2 European Medicines Agency (EMA)
2.3 The World Health Organization (WHO)
2.4 Canada
2.5 South Korea
2.6 China
2.7 India
2.8 Japan
2.9 Mexico
2.10 Brazil
2.11 Argentina
3. KEY MARKET TRENDS
3.1 mAbs - All The Rage In Biosimilars' New Wave
3.1.1 The Buildup to the Biosimilar Industry
3.1.2 Current Players: A Sneak Preview
3.2 Biosimilars Slashes the Cancer Treatment Cost
3.3 Emerging Markets to Drive Biosimilars Growth
3.4 Asia: A Preferred Manufacturing Hub for Biosimilars
3.5 SPC Manufacturing Waiver Initiated by EU Commission
3.6 Novel mAb's Purification Approach to Maximize the Biosimilar Production
3.7 Biosimilars and Patent Dance
4. RECENT BIOSIMILARS APPROVALS
5. KEY GLOBAL PLAYERS
Adello Biologics (United States)
Amgen Inc. (United States)
AXXO GmbH (Germany)
BIOCAD (Russia)
Biogen, Inc. (United States)
CoherusBioSciences (United States)
Creative BioMart (United States)
Dong-A Socio Group (South Korea)
Dr. Reddy's Laboratories Ltd. (India)
Eli Lilly and Company (United States)
Genor Biopharma Co., Ltd. (China)
Hetero Drugs Limited (India)
Insud Pharma SL (Spain)
mAbxience SA (Spain)
Intas Pharmaceuticals Ltd. (India)
LG Chem (South Korea)
Lupin Limited (India)
Mylan, Inc (United States)
Nippon Kayaku Co., Ltd. (Japan)
Pfizer, Inc. (United States)
Reliance Life Sciences Pvt. Ltd. (India)
Sandoz International GmbH (Germany)
Shanghai Henlius Biotech, Inc. (China)
STADA Arzneimittel AG (Germany)
Teva Pharmaceutical Industries Limited (Israel)
Wockhardt Limited (India)
Zydus Cadila (India)
6. KEY BUSINESS AND PRODUCT TRENDS
Samsung Bioepis Signs Biosimilars Development and Marketing Agreement with C-Bridge Capital
Biosimilar Association of Samsung Bioepis and 3SBio
Kashiv Pharma Renamed as KashivBioSciences After Acquiring Adello Biologics
Japanese Release of Trastuzumab and Agalsidase Beta Biosimilar
Epoetin Alfa and Pegfilgrastim Biosimilars Now Accessible In the US at Considerable Concession
Biosimilars of Insulin Glargine Introduced in South Korea and the UK
CNDA Accepted Review of Adalimumab Biosimilar
Filgrastim Biosimilar Application Submitted to the US FDA
European Commercial Release of Amgevita and Imraldi
MHLW of Japan Received Approval Application for Dual Darbepoetin Alfa Copy Biologics
Evaluation of Adalimumab Biosimilar SB5 by USFDA
Acceptance of Approval Application by CFDA for Adalimumab Biosimilar
Review Acceptance for Mabion CD20 by EMA and Rituxan Expanded the Therapeutic Range
Dr Reddy's Introduces Hervycta, A Trastuzumab Biosimilar in India
Resubmission of Marketing Approval of Biosimilar Rituximab to FDA by Celltrion
Refusal of Trastuzumab and Rituximab Biosimilars Approval Applications by FDA
Rejection of Rituximab and Trastuzumab of Celltrion/Teva by FDA
Ontruzant Trastuzumab Biosimilar Released in the UK
Commercialization of Trastuzumab Biosimilar in South Korea By Daewoong
Commercial Release of Adalimumab Biosimilar in India by Hetero
Production of Denosumab Biosimilar in Australia
Acceptance of Applications for Adalimumab and Trastuzumab by FDA
USV's Filing for Pegfilgrastim Accepted by EMA
Acceptance of Pegfilgrastim and Trastuzumab Fillings by EMA
Introduction of Krabeva, a Bevacizumab Biosimilar, in India
Pegfilgrastim Filling Acceptance by EMA
Danish Company Appeals FDA for Clinical Studies Data of Victoza Copy Biologics
Postponement of Pegfilgrastim Biosimilar Approval of Biocon/Mylan by FDA
Acceptance of Pegfilgrastim Biosimilar Filling of Cinfa by EMA
The US Commercial Release of Adalimumab Biosimilar of Amgen After January 2023
Submission of Approval Application by JCR for Agalsidase Beta Biosimilar in Japan
Acceptance of Approval Filing of Filgrastim Biosimilar of Adello by FDA
Application Acceptance of Sandoz's Rituximab Biosimilar by FDA
Successful Submission of Dual Trastuzumab Biosimilar to the US FDA for Review
Biosimilar Business of Merck Taken Over by Fresenius Kabi
Merck Introduces RENFLEXIS in the US Market
Initiation of Phase III Interchangeability Study of Adalimumab Biosimilar by Boehringer
Acceptance of Regulatory Submission for Rituximab Biosimilar of Celltrion/Teva by FDA
Refusal of Approval Application of Epoetin Alfa Biosimilar of Pfizer by FDA
Registration of Biocad's Rituximab Biosimilars in Honduras and Bolivia
Re-evaluation of Bevacizumab and Trastuzumab by FDA Advisory Board
Rejection of Pegfilgrastim Biosimilar of Coherus by FDA
EMA Acceptance of Sandoz's Adalimumab and Infliximab Biosimilars for Re-evaluation
Epoetin Alfa of Pfizer Receives Approval Recommendation from FDA Advisors
Approval Application Acceptance of Fujifilm's Adalimumab Biosimilar by EMA
Australian Commercial Release of Infliximab Biosimilar in Second half of 2017
Submission of Approval Application in Japan for Trastuzumab Biosimilar
Introduction of Basal Analogue Insulin Biosimilar in Indonesia
Acceptance of Pegfilgrastim Filling of Mylan/Biocon by FDA
Japanese Approval Application Filed for Etanercept Biosimilar
Filing of Biosimilar Adalimumab Application by Boehringer to FDA and EMA As Well
Withdrawal of Biosimilar Pegfilgrastim Application by Sandoz
7. GLOBAL MARKET OVERVIEW
7.1 Global Biosimilars Market Overview by Product Type
7.1.1 Global Biosimilars Product Types Market Overview by Geographic Region
7.1.1.1 Monoclonal Antibodies
7.1.1.2 Erythropoietin
7.1.1.3 G-CSF
7.1.1.4 Insulin
7.1.1.5 Other Product Types
7.2 Global Biosimilars Market Overview by Therapeutic Area
7.2.1 Global Biosimilars Therapeutic Area Market Overview by Geographic Region
7.2.1.1 Oncology
7.2.1.2 Autoimmune Disorders
7.2.1.3 Blood Disorders
7.2.1.4 Growth Hormone Deficiency
7.2.1.5 Other Therapeutic Areas
PART B: REGIONAL MARKET PERSPECTIVE
REGIONAL MARKET OVERVIEW
8. EUROPE
Major Market Players
- Alvotech (Iceland)
- AXXO GmbH (Germany)
- BIOCAD (Russia)
- Insud Pharma SL (Spain)
- mAbxience SA (Spain)
- Sandoz International GmbH (Germany)
- STADA Arzneimittel AG (Germany)
- UGA Biopharma GmbH (Germany)
9. NORTH AMERICA
Major Market Players
- Adello Biologics (United States)
- Amgen Inc. (United States)
- Biogen, Inc. (United States)
- CoherusBioSciences(United States)
- Creative BioMart(United States)
- Eli Lilly and Company (United States)
- Harvest Moon Pharmaceuticals USA, Inc. (United States)
- Momenta Pharmaceuticals Inc. (United States)
- Mylan, Inc (United States)
- Pfizer, Inc. (United States)
10. ASIA-PACIFIC
Major Market Players
- 3SBIO, Inc (China)
- Biocon Limited (India)
- Biogenomics Limited (India)
- Bioviz Technologies Pvt. Ltd. (India)
- Celltrion, Inc. (South Korea)
- Dong-A Socio Group (South Korea)
- Dr. Reddy's Laboratories Ltd. (India)
- Fujifilm Kyowa Kirin Biologics Co., Ltd. (Japan)
- Genor Biopharma Co., Ltd. (China)
- Hetero Drugs Limited (India)
- Intas Pharmaceuticals Ltd (India)
- LG Chem (South Korea)
- Lupin Limited (India)
- Nippon Kayaku Co., Ltd. (Japan)
- Reliance Life Sciences Pvt. Ltd. (India)
- Samsung Bioepis Co., Ltd. (South Korea)
- SciGen Pte. Ltd. (Singapore)
- Shanghai Henlius Biotech, Inc. (China)
- Siam Bioscience Co., Ltd. (Thailand)
- Wockhardt Limited (India)
- YL Biologics Limited (Japan)
- Zydus Cadila (India)
11. REST OF WORLD
Major Market Players
- AMEGA Biotech (Argentina)
- Teva Pharmaceutical Industries Limited (Israel)
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