Global Biosimilars Strategic Markets Report 2018-2024 - Patent Expiry of Major Biopharmaceutical Drugs Leads Way for Biosimilars

DUBLIN, Sept 19, 2018 /PRNewswire/ --

The "Biosimilars - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering.

The report provides separate comprehensive analytics for the US, Japan, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2015 through 2022. This report analyzes the worldwide markets for Biosimilars in US$ Million.

The report profiles 71 companies including many key and niche players such as:

• Allergan Plc (Ireland)
• Amgen, Inc. (USA)
• Biocon Ltd. (India)
• Biopartners GmbH (Switzerland)
• Boehringer Ingelheim International GmbH (Germany)
• Celltrion, Inc. (South Korea)
• Dr. Reddy's Laboratories Ltd. (India)
• Eli Lilly and Company (USA)
• Fresenius Kabi (Germany)
• Intas Pharmaceuticals Ltd. (India)
• Mylan N.V. (USA)
• Pfizer, Inc. (USA)
• Samsung Bioepis Co., Ltd. (Korea)
• Sandoz International GmbH (Germany)
• STADA Arzneimittel AG (Germany)
• Teva Pharmaceutical Industries Ltd. (Israel)

Key Topics Covered:

1. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study

2. INDUSTRY OVERVIEW
Biosimilars: An Introductory Prelude
World Healthcare Sector Gears Up for Biosimilar Wave
Biosimilars Offer Great Promise Despite Challenges
The US & Europe Drive Momentum in Worldwide Biosimilars Sales
Emerging Markets also Offer Robust Growth Opportunities
R&D Funding: Crucial for Future Expansion of Biosimilars Market
Prevailing Economic Scenario Favors Funding Pattern

3. NOTEWORTHY MARKET TRENDS, GROWTH DRIVERS & ISSUES
Slew of Product Approvals Scale Up Market Revenues
Biosimilar Approvals in Europe (as of H1 2018)
Biosimilar Approvals in the US (as of H1 2018)
Pipeline Biosimilar Products in the US (as of H1 2018)
Biosimilar Approvals in South Korea (as of H1 2018)
Patent Expiry of Major Biopharmaceutical Drugs Leads Way for Biosimilars
Patent Expiries of Major Biopharmaceutical Drugs in the US and Europe
Cost Containment Measures Put Focus on Biosimilars
High Cost of Biologics - Favorable for Biosimilars
Efforts to Push Up Biosimilar Adoption Aid Market Expansion
Increasing Share of Biotech Drugs to Drive Biosimilars Market
Progressive Regulatory Framework Accelerates Product Approvals & Subsequently Market Revenues
Specific Guidelines for Biosimilars in Various Countries with Year of Publication
Biosimilars Regulatory Agencies in Select Regional Markets
Improvement in Nomenclature & Interchangeability Enhance Appeal & Image of Biosimilars
Human Insulin Biosimilars Eye Potential Opportunities
Monoclonal Antibodies - A Key Segment for Biosimilars
Approved Monoclonal Antibodies (2014-2017)
Rituximab Biosimilars to Proliferate the Market
Growing Incidence of Chronic Diseases & Ageing Population Widen Prospects for Biosimilars
Growing Biosimilars Market - A Clear Advantage for Bioseparation Technologies
Growth Restraints
Lack of Uniform Regulations
High Lead-time
High Manufacturing Costs
Difficulties in Delivery & Commercialization
Automatic Substitution
Biobetters: A Potential Industry Challenge
Other Impediments to Market Acceptance

4. PRODUCT OVERVIEW
Biological Drugs: An Introduction
Biosimilars: Overview
Characteristics of Biosimilars
Development Cycle of Biosimilars
Industry Participants

5. COMPETITIVE LANDSCAPE
Leading Players in the World Biosimilars Market
Indian & Chinese Companies Seek Opportunities
Increased Penetration of Biosimilars - Implications for Manufacturers
Comparison of Entry Barriers for Biogenerics in Select Global Markets
Vendors Emphasize Novel Strategies to Stay Competitive
Licensing Deals and Development & Commercialization Partnerships Find Favor
Select Biosimilar Licensing Deals & Collaborations Announced in the Recent Past
Contract Manufacturing Gains Traction

5.1 Focus on Select Global Players

5.2 Product Approvals/Introductions
Pfizer Bags FDA Approval for NIVESTYM
Pfizer Wins FDA Approval for Retacrit Biosimilar Epoetin Alfa
Amgen Achieves Top-Line Results for infliximab Biosimilar in Phase 3 Study
Mylan Receives FDA Approval for Fulphila
Apobiologix Wins Health Canada Approval for Lapelga Biosimilar
Mylan Wins Marketing Authorization for Semglee Biosimilar Insulin Glargine in Europe
Amgen Receives CHMP Positive Opinion for ABP 980 Trastuzumab Biosimilar
Celltrion Bags European Approval for Herzuma Trastuzumab Biosimilar
Amgen and Allergan Receive European Marketing Authorization for MVASI Biosimilar Bevacizumab
Intas Pharmaceuticals Launches Pelgraz Pegfilgrastim Biosimilar in Europe
Mabion Receives EMA Review Acceptance for MabionCD20
Pfizer Receives EC Approval for TRAZIMERA
Sandoz Bags Marketing Authorization for Hyrimoz in Europe
Mylan and Fujifilm Receive CHMP Positive Opinion for Hulio Adalimumab Biosimilar
Dr. Reddy's Introduces Hervycta in India
Celltrion Receives FDA Approval for BLA Review for CT-P6 mAb Biosimilar
Celltrion Receives FDA BLA Review Acceptance for CT-P10 mAb Biosimilar
Merck Rolls Out RENFLEXIS infliximab-abda in the US
Pfizer Receives FDA Approval for IXIFI Monoclonal Antibody
Mylan Wins FDA Approval for Ogivri
Samsung Bioepis Wins Marketing Authorization for ONTRUZANT in Europe
Fresenius Kabi Submits Marketing Authorization Application for MSB11022 in Europe
Sandoz Bags European Approval for Erelzi to Treat Mutiple Immunological Diseases
Fujifilm Kyowa Kirin Receives EMA's MAA Review Acceptance for FKB327 Biosimilar
Celltrion Bags EMA Approval for Truxima Biosimilar mAb
Biocon Introduces KRABEVA in India
Mylan Receives Brazilian Approval for Biosimilar Trastuzumab
Celltrion Submits Sales Approval Application for Herzuma in Japan

5.3 Recent Industry Activity
Biogen Acquires Additional Stake in Samsung Bioepis
AbbVie and Mylan Ink Patent License Agreement for HUMIRA
Amneal Pharmaceuticals and Impax Laboratories Merge
Amneal Signs Licensing Agreement with mAbxience for Bevacizumab Biosimilar
Valerius Biopharma Teams Up with Catalent Pharma for Biosimilars Production
Fresenius Kabi Expands Operations in Runcorn
STADA to Acquire Additional Stake in BIOCEUTICALS Arzneimittel
Biocon and Sandoz Ink Global Partnership Deal
Eli Lilly Partneres with Cipla to Market Basaglar in India
Cipla to Discontinue to In-House Production of Biosimilar Drugs
Merck Divests Biosimilars Business to Fresenius
Nidda Healthcare Holding Acquires STADA Arzneimittel
Amgen and Simcere to Co-develop and Commercialize New Biosimilars in China
Aurobindo Pharma Acquires Four Biosimilar Products from TL Biopharmaceutical

6. GLOBAL MARKET PERSPECTIVE

7. REGIONAL MARKET PERSPECTIVE

7.1 The United States
A. Market Analysis
Spectacular Rise on the Cards
Latest Developments in the Biosimilars Space
Challenges in the US Drug Approval Pathway for Biosimilars
Critical Requirements for Marketing Approval
Need to Cut Down Prices for Increased Adoption
B. Market Analytics

7.2 Japan
Market Analysis

7.3 Europe
A. Market Analysis
Europe: The Foremost Propagator of Biosimilars
Europe Stays Ahead in the Biosimilars Race
Segment-Wise Analysis
Payers Eye Biosimilars to Curtail Costs
Biosimilar Pricing Competition to Intensify Further
Biosimilars Regulatory Framework: Well-Established
Biosimilar Regulatory Timeline from Legislation to Approval in the EU
Further Clarity Needed Regarding Extrapolation of Biosimilars for Multiple Indications
Challenges Ahead
Heavy Investment and Regulations
Complex Production Process
Biocapacity
B. Market Analytics

7.3.1 France
Market Analysis

7.3.2 Germany
Market Analysis

7.3.3 Italy
Market Analysis

7.3.4 The United Kingdom
A. Market Analysis
Nascent UK Biosimilars Market
NICE's Latest Ruling Bodes Well for Biosimilars
B. Market Analytics

7.3.5 Spain
Market Analysis

7.3.6 Rest of Europe
A. Market Analysis
Biosimilar-related Developments in Russia
B. Market Analytics

7.4 Rest of World
A. Market Analysis
Asia-Pacific: Market Laden with Opportunities
High Costs of Biologics Grant Edge to Biosimilars
India
Biosimilars Evolve into a Niceh Segment within the Thriving Indian Biopharma Industry
Collaborations with Western Counterparts in Biosimilar Development
Guidelines for Biosimilars in India
China
New Guidelines to Underpin Sales Growth
Asia-Pacific: Regulatory Framework
Latin America
The Middle East and North Africa
Sub-Saharan Africa
Canada
Biosimilars Set to Register Gains in Canada
Future Scenario
Regulatory Framework
B. Market Analytics

8. COMPANY PROFILES

Total Companies Profiled: 71 (including Divisions/Subsidiaries - 77)

• The United States (15)
• Canada (1)
• Japan (3)
• Europe (26)
• France (1)
• Germany (8)
• The United Kingdom (5)
• Spain (1)
• Rest of Europe (11)
• Asia-Pacific (Excluding Japan) (29)
• Middle East (2)
• Latin America (1)
  

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