Worldwide Biosimilars Industry to 2026 - Key Players Include Amgen, AXXO and Biogen Among Others

DUBLIN, Jan. 25, 2021 /PRNewswire/ -- The "Global Biosimilars Market - Products, Applications and Regulations" report has been added to ResearchAndMarkets.com's offering.

Due to the COVID-19 Pandemic, telehealth and tele-detailing (also called remoter detailing or web calls) have set forth that allow a biosimilars companies' commercialization branch to have a wide range with less few reps. Also, the fluidity of the labor market is another new dynamic allowing for a greater diversity of commercialization build-out models. These new dynamics greatly change how companies should be building models of commercialization that also has vast implications for potential BD partnerships. The solution to 'build versus buy' is no longer driven by the size, scale, and cost of a sales force leading to outdated product P&L's. However, a hybrid solution that a partial build plus skilled, experienced contractors plus CSO for sales reps will be the optimal solution. This hybrid model could allow for greater biosimilar uptake and more efficient uptake.

Global market for Biosimilars is dominated by Oncology, estimated at US$5.4 billion (38.6% share) in 2020, which is anticipated to post the slowest CAGR of 29% between 2020 and 2026 and reach a projected US$24.8 billion by 2026.

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
• Patent Expirations of Major Biologics Leads Way for Biosimilars
• Role of Biosimilars in Continuous Manufacturing (CM) Development and Innovation
• Availability of Biosimilar May Affect Biologic Drug Pricing
• Key business trends focusing on product innovations/developments, M&As, JVs and other recent industry developments
• Major companies profiled - 36
• The industry guide includes the contact details for 155 companies

Product Outline

The report analyzes the market for the following key product types of Biosimilars:

• Monoclonal Antibodies (mAB)
• Erythropoietin (EPO)
• Granulocyte Colony-Stimulating Factor (G-CSF)
• Insulin
• Others (includes Interferons, Follitropins, Recombinant Proteins etc.)
• Therapeutic areas of Biosimilars analyzed in this study comprise the following:
• Oncology
• Autoimmune Disorders
• Blood Disorders
• Growth Hormone Deficiency
• Others (includes Chronic Diseases, Infectious Diseases, Cardiovascular Disorders etc.)

Analysis Period, Units and Growth Rates

• The report reviews, analyzes and projects the global Biosimilars market for the period 2017-2026 in terms of US$ and the compound annual growth rates (CAGRs) projected from 2019 through 2026

Geographic Coverage

• North America (The United States, Canada and Mexico)
• Europe (Germany, the United Kingdom, France, Spain, Italy and Rest of Europe)
• Asia-Pacific (China, India, Japan, South Korea and Rest of Asia-Pacific)
• Rest of World (Brazil, Israel and Other Rest of World)

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
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
2.1.4 FDA Issues New Regulatory Updates in 2020
2.2 European
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 Biosimilars of mAbs Approved: A Sneak Preview
3.2 Patent Expirations of Major Biologics Leads Way for Biosimilars
3.3 Role of Biosimilars in Continuous Manufacturing (CM) Development and Innovation
3.4 Availability of Biosimilar May Affect Biologic Drug Pricing
3.5 Asia-Pacific Witnessing a Boom of Biosimilars

4. RECENT BIOSIMILARS APPROVALS

5. KEY GLOBAL PLAYERS

• Amgen Inc. (The United States)
• AXXO GmbH (Germany)
• BIOCAD (Russia)
• Biogen, Inc. (The United States)
• Bioton S.A. (Poland)
• C.H. Boehringer Sohn AG & Co., KG. (Germany)
• Coherus Biosciences (The United States)
• Creative BioMart (The United States)
• Dong-A Socio Group (South Korea)
• Dr. Reddy's Laboratories Ltd. (India)
• Eli Lilly and Company (The United States)
• Genor Biopharma Co., Ltd. (China)
• Hetero Drugs Limited (India)
• Insud Pharma SL (Spain)
• mAbxience SA (Spain)
• Intas Pharmaceuticals Ltd. (India)
• Kashiv Biosciences LLC (The United States)
• LG Chem (South Korea)
• Lupin Limited (India)
• Mylan, Inc (The United States)
• Nippon Kayaku Co., Ltd. (Japan)
• Pfizer, Inc. (The 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)

6. KEY BUSINESS AND PRODUCT TRENDS

• AbbVie Inc and Frontier Collaborate on Novel Therapies and E3 Degraders
• Eli Lilly and UHG Collaborate on Bamlanivimab (LY-CoV555) Antibody Study
• Merck Receives FDA Review Acceptance for KEYTRUDA (pembrolizumab) Plus Chemotherapy
• Samsung Bioepis and Biogen File U.S FDA Acceptance of SB11 Biosimilar
• EMA Approves Roche's Xofluza Biosimilar
• Genor's New Drug Application for GB242 Infliximab Biosimilar is Under Review by NMPA
• NeuClone Discloses it's Stelara Biosimilar Candidate Clinical Trials
• FDA Approval for Anti-IL-4R? Monoclonal Antibody
• Pfizer's NYVEPRIAT Biosimilar Receives FDA Approval
• Biocon Ltd Establishes Biosimilar Plant in India
• Boehringer Acquires Northern Biologics, Inc
• Biocon Ltd. and Mylan N.V Unveils Fulphila Biosimilar
• mAbxience Establishes New Biosimilar Antibody Plant in Argentina
• CHMP Recommends RUXIENCET Biosimilar
• FDA Approval for ABP 798, a Biosimilar Candidate to Rituxan
• Amgen Receives FDA Approval for its AVSOLAT (Infliximab-axxq) Biosimilar Antibody
• 3SBio, Inc and Verseau Agree on Monoclonal Antibody Development - VTX-0811
• Boehringer Ingelheim Discloses GioTag Study Results
• Dr. Reddy's Lab Unveils Versavo Biosimilar
• Allergan and Gedeon Receive FDA Approval for VRAYLAR Drug Use
• Samsung Bioepis Signs Biosimilars Development and Marketing Agreement with C-Bridge Capital
• Biosimilar Association of Samsung Bioepis and 3SBio
• Kashiv Pharma Renamed as KashivBioSciences Post Acquiring Adello Biologics
• Intas Unveils New Pegylated G-CSF Biosimilar in Europe
• 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 MabionCD20 by EMA and Rituxan Expanded the Therapeutic Range
• Dr Reddy's Introduces Hervycta, A Trastuzumab Biosimilar in India
• Apotex Influence Canadian Biosimilar Market
• 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
• Amgen and Allergan Authorize ABP 980 Biosimilar
• OntruzantTrastuzumab 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

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
8.1 European Biosimilars Market Overview by Geographic Region
8.2 European Biosimilars Market Overview by Product Type
8.3 European Biosimilars Market Overview by Therapeutic Area
8.4 Major Market Players
8.5 Country-wise analysis of European Biosimilars Market

9. NORTH AMERICA
9.1 North American Biosimilars Market Overview by Geographic Region
9.2 North American Biosimilars Market Overview by Product Type
9.3 North American Biosimilars Market Overview by Therapeutic Area
9.4 Major Market Players
9.5 Country-wise Analysis of North American Biosimilars Market

10. ASIA-PACIFIC
10.1 Asia-Pacific Biosimilars Market Overview by Geographic Region
10.2 Asia-Pacific Biosimilars Market Overview by Product Type
10.3 Asia-Pacific Biosimilars Market Overview by Therapeutic Area
10.4 Major Market Players
10.5 Country-wise Analysis of Asia-Pacific Biosimilars Market

11. REST OF WORLD
11.1 Rest of World Biosimilars Market Overview by Geographic Region
11.2 Rest of World Biosimilars Market Overview by Product Type
11.3 Rest of World Biosimilars Market Overview by Therapeutic Area
11.4 Major Market Players
11.5 Country-wise Analysis of Rest of World Biosimilars Market

PART C: GUIDE TO THE INDUSTRY
1. North America
2. Europe
3. Asia-Pacific
4. Rest Of World

PART D: ANNEXURE
1. Research Methodology
2. Feedback

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