Biosimilars: Market Research Report

Date: January 7, 2016
Pages: 278
Price:
US$ 4,500.00
Publisher: Global Industry Analysts, Inc
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: B4CF055F0A1EN
Leaflet:

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Biosimilars: Market Research Report
This report analyzes the worldwide markets for Biosimilars in US$ Million.

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.

Also, a six-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs.

The report profiles 71 companies including many key and niche players such as -
  • Amgen Inc.
  • Allergan Plc
  • Biocon Ltd.
  • Biopartners GmbH
  • Boehringer Ingelheim GmbH
I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study

II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW

Introduction to Biosimilars
Biosimilars Set to Revolutionize Healthcare Sector
Biosimilars Offer Great Promise despite Challenges
Specific Guidelines for Biosimilars in Various Countries with Year of Publication
List of Approved Biosimilars & Pending Biosimilar Applications in the EU
List of Approved Biosimilars & Pending Biosimilar Applications in the US
List of Approved Biosimilars in South Korea
Biosimilars Find More Growth in Emerging Markets
Comparison of Entry Barriers for Biogenerics in Select Global Markets
Market Drivers
Patent Expiry of Leading Biopharmaceuticals Leads Way for Biosimilars
Patent Expiries of Major Biopharmaceutical Drugs in the US and Europe
Cost Containment Measures

Table 1. Per-Capita Healthcare Expenditure in Select Regions: 2013 (includes corresponding Graph/Chart)
Table 2. Leading Countries with the Highest Healthcare Spending as a Percentage of GDP (2012) (includes corresponding Graph/Chart)

Growing Aging Population

Table 3. Global Population Statistics for the 65+ Age Group (2013) (includes corresponding Graph/Chart)
Table 4. Elderly Population (65+ Years) as a % of Total Population (2000 & 2025) (includes corresponding Graph/Chart)
Table 5. Percentage of Population Aged 65 and Above in EU-27 Countries, US and Japan (1960-2030) (includes corresponding Graph/Chart)

Presence of Major Players
Growth Restraints
Uncertain Regulations
High Lead-time
High Manufacturing Costs
Delivery and Commercialization
Automatic Substitution
Other Impediments to Market Acceptance
Strategies to Aid Survival of Companies

2. RECENT BIOSIMILAR APPROVALS AND PIPELINE ANALYSIS

Biosimilar Approvals in 2016, 2015, & 2014
Select Biosimilar Candidates in Late-Stage Pipeline: 2016
Biosimilars in Pipeline for Major Biologic Drugs: 2016
Increasing Collaborations, Licensing Routes and Partnerships
Indian & Chinese Companies to Emerge Strong in Western Markets
Improved Regulatory Framework
European Union Ahead in the Biosimilars Race
Biosimilars Regulatory Agencies in Select Regional Markets
US Passes Act to Create Biosimilars Pathway, Finally

3. MARKET DYNAMICS & TRENDS

Increased Penetration of Biosimilars – Implications for Manufacturers
Efforts to Push Up Biosimilar Adoption
Improvements in Nomenclature and Interchangeability
Contract Manufacturing Favored by Emerging & Major Biosimilar Players
Companies Eye Human Insulin Biosimilars

Table 6. Global Basal Insulin Market by Brand (2016E, 2018E & 2020E): Percentage Market Share Breakdown of Revenues for Basalgar, Lantus, Levemir, Peg Lispro, Toujeo, and Tresiba (includes corresponding Graph/Chart)

Monoclonal Antibodies – A Key Growth Segment for Biosimilars
Approved Monoclonal Antibodies for Therapeutic Use: 1986-2014
Biobetters: Potential Industry Challenge?
High Cost of Biologics – Favorable for Biosimilars

Table 7. Treatment Costs by Drug (2015): Comparative Analysis of Daily Treatment costs with Branded Small-molecule Drug, Generic Small-molecule Drug, and Biologics (Humira, Kadcyla, & Cerezyme) (includes corresponding Graph/Chart)

R&D Funding Crucial

Table 8. Global Biopharmaceutical R&D Expenditure: 2010-2015E (includes corresponding Graph/Chart)

Growing Biosimilars Market – A Clear Advantage for Bioseparation Technologies

4. GLOBAL BIOLOGICS MARKET

Global Biopharmaceutical Drug Market – A Primer

Table 9. Increasing Share of Biologics in the Global Pharmaceutical Market: 2013-2020 (includes corresponding Graph/Chart)

US – The Largest Biologics Market Worldwide

Table 10. Global Biologics Market by Region: Percentage Share Breakdown for US, Canada, Japan, Europe, Asia-Pacific, and Rest of World for 2007, 2015 and 2020 (includes corresponding Graph/Chart)

Increasing Share of Biotechnological Drugs to Drive Biosimilars Market
Intensifying Consolidation Activity
Recent M&A Activity in the Biologics Industry: 2014 & 2015

5. PRODUCT OVERVIEW

Introduction
Characteristics of Biosimilars
Biological Drugs
Biological Drugs Manufacturing Process
Development Cycle of Biosimilars
Industry Participants

6. PRODUCT APPROVALS/INTRODUCTIONS

Mylan and Biocon Co-develop trastuzumab Biosimilar
EC Approves Remicade Biosimilar Flixabi Developed by Samsung Bioepis
Samsung’s BLA for Remicade Biosimilar Accepted by USFDA
EMA Approves rituximab Biosimilar Developed by Sandoz
EC Approves New Route of Administration for Sandoz’s Biosimilar Binocrit
USFDA Approves INFLECTRA, Celltrion’s Biosimilar to Remicade
Japanese Ministry Approves Biocon’s Biosimilar Insulin Glargine
EMA Accepts Sandoz’s MAA for Neulasta Biosimilar
FDA Accepts Amgen’s BLA for ABP-501
EC Approves Benepali (Enbrel Biosimilar) Developed by Samsung Bioepis
Torrent Pharmaceuticals Launches adalimumab Biosimilar
EMA Accepts Sandoz’s MAA for Enbrel Biosimilar
RENFLEXIS by Samsung Bioepis Approved by Korea’s MFDS
Amgen Submits ABP-501 Marketing Authorization Application to EMA
FDA Approves Sandoz’s BLA for Proposed Enbrel Biosimilar
Amgen and Allergan Announce Positive Phase 3 Study Results for Biosimilar ABP
Korean Ministry Approves BRENZYS Co-developed by Merck and Samsung
Intas Pharmaceuticals Launches Biosimilar to Lucentis
USFDA Approves First Biosimilar Zarxio from Sandoz
Mundipharma Launches Biosimilar MAb Remsima in 6 European Markets
Intas Pharmaceuticals Launches filgrastim Biosimilar Accofil
Cadila Launches adalimumab Biosimilar
EPIRUS Biopharmaceuticals Launches infliximab Biosimilar
Celltrion Receives Japan's MHLW Approval for Remsima
Cipla Launches Biosimilar Darbepoetin alfa Under Actorise Brand
Celltrion Announces Approval of biosimilar mAb Herzuma by MFDS

7. RECENT INDUSTRY ACTIVITY

Alvotech Acquires Baliopharm GmbH
Dr. Reddy’s Inks Collaboration Agreement with TR-Pharm
Premier and Oncobiologics Collaborate to Enhance Biosimilars Adoption
Sandoz Acquires Rights to infliximab Biosimilar from Pfizer
Sandoz Enters into Exclusive License Agreement with Kyowa Hakko Kirin
Mylan Enters Into Biosimilars Development Partnership with Momenta Pharmaceuticals
Merck to Bring Biosimilars to Canada through its Agreement with Samsung
EPIRUS Biopharmaceuticals to Expand Biosimilar Pipeline through Acquisition of Bioceros
Pfizer Acquires Hospira
Astrazeneca Enters into JV with Fujifilm Kyowa Kirin Biologics
STADA and Richter Sign License/Disribution Agreement for Pegfilgrastim Biosimilar
Coherus and Baxter Amend Collaboration Agreement for CHS-0214
Torrent Pharmaceuticals Enters into Licensing Agreement with Reliance Life Sciences
Mabion Ext,mends Agreement with Altiora for rituximab Biosimilar MabionCD20
STADA and mAbxience Enter Into In-licensing Agreement for Humira Biosimilar
Xbrane Bioscience Signs Agreement with Indian Pharmaceutical Major
Cipla Acquires Mabpharm
EPIRUS Biopharmaceuticals Merges with Zalicus
mAbxience Acquires Genhelix
Ipca and Oncobiologics Enter into Alliance for Development of Biosimilar MAbs
Lupin and Yoshindo Form Joint Venture YLB for Biosimilar Commercialization
Bionovis and Merck Sign Agreement
Catalent Signs Agreement with HISUN
Aurobindo Pharma Acquires Western European Operations of Actavis
Samsung and Merck Expand Collaboration to Develop MK-1293 Insulin Glargine Biosimilar

8. FOCUS ON SELECT MARKET PLAYERS

Amgen Inc. (US)
Allergan Plc. (Ireland)
Biocon Ltd. (India)
Biopartners GmbH (Switzerland)
Boehringer Ingelheim GmbH (Germany)
Celltrion Inc. (South Korea)
Cipla Ltd. (India)
Cipla BioTec Private Ltd. (India)
Dr. Reddy's Laboratories Ltd. (India)
Eli Lilly and Company (US)
EPIRUS Biopharmaceuticals, Inc. (US)
Hospira, Inc. (US)
Intas Biopharmaceuticals Ltd. (India)
Merck KGaA (Germany)
Mylan N. V. (US)
Pfizer Inc. (US)
Samsung Bioepis Co., Ltd. (Korea)
Sandoz International GmbH (Germany)
STADA Arzneimittel AG (Germany)
Teva Pharmaceutical Industries Ltd. (Israel)

9. GLOBAL MARKET PERSPECTIVE

Table 11. World Recent Past, Current, and Future Analysis for Biosimilars by Geographic Region - US, Japan, Europe and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 12. World 7-Year Perspective for Biosimilars by Geographic Region - Percentage Breakdown of Dollar Revenues for US, Japan, Europe and Rest of World Markets for Years 2016 & 2022 (includes corresponding Graph/Chart)

III. MARKET

1. THE UNITED STATES

A. Market Analysis
Market Overview
Latest Developments in the Biosimilars Space
Slow Take-Off in the US Market
List of Approved Biosimilars & Pending Biosimilar Applications in the US
Challenges in the US Drug Approval Pathway for Biosimilars
Growing Legal Challenges in the Domestic Market
Need to Cut Down Prices for Increased Adoption
Patent Expiry of Leading Biopharmaceuticals Presents Ray of Hope
Patent Expiries of Major Biopharmaceutical Drugs in the US
Significant Biosimilar Pipeline Products
Product Introductions
Strategic Corporate Developments
Select Key Players
B. Market Analytics

Table 13. The US Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

2. JAPAN

A. Market Analysis
Growing Market for Biosimilars
Product Introductions
Strategic Corporate Developments
B. Market Analytics

Table 14. Japanese Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3. EUROPE

A. Market Analysis
List of Approved Biosimilars & Pending Biosimilar Applications in the EU
Patent Expiry of Leading Biopharmaceuticals Leads Way for Biosimilars
Patent Expiries of Major Biopharmaceutical Drugs in Europe
Biosimilar Pricing Competition to Intensify Further
Clarity Needed Regarding Extrapolation of Biosimilars for Other Indications
Demand for Rituximab Biosimilars
Nascent UK Biosimilars Market
NICE’s Latest Ruling Bodes Well for Biosimilars
Spanish Biosimilars Market: A Brief Review
Biosimilar-related Developments in Russia
Biosimilars Regulatory Framework: Well-Established
Biosimilar Regulatory Timeline from Legislation to Approval in the EU
Growth Drivers
Payers Eye Biosimilars to Curtail Costs
Challenges Ahead
Heavy Investment and Regulations
Complex Production Process
Biocapacity
Product Introductions
Strategic Corporate Developments
Select Key Players
B. Market Analytics

Table 15. European Recent Past, Current & Future Analysis for Biosimilars by Geographic Region - France, Germany, Italy, UK, Spain and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 16. European 7-Year Perspective for Biosimilars by Geographic Region - Percentage Breakdown of Dollar Revenues for France, Germany, Italy, UK, Spain and Rest of Europe Markets for Years 2016 & 2022 (includes corresponding Graph/Chart)

3A. FRANCE

Market Analysis

Table 17. French Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3B. GERMANY

Market Analysis

Table 18. German Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3C. ITALY

Market Analysis

Table 19. Italian Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3D. UNITED KINGDOM

Market Analysis

Table 20. The UK Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3E. SPAIN

Market Analysis

Table 21. Spanish Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3F. REST OF EUROPE

Market Analysis

Table 22. Rest of European Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

4. REST OF WORLD

A. Market Analysis
Asia-Pacific: Market with High Potential
Regulatory Framework
Asia-Pacific
List of Approved Biosimilars in South Korea
Latin America
Middle East and North Africa
Sub-Saharan Africa
High Costs and Counteractive Measures
Indian Biopharmaceutical Industry Makes Rapid Progress
Competition from Western Counterparts in Biosimilar Development
China Issues New Guidelines on Biosimilars
Overview of Biosimilars in Sub-Saharan Africa
Canada
Biosimilars Set to Register Gains in Pharmaceutical Sector
Future Scenario
Regulatory Framework
Product Introductions
Strategic Corporate Developments
Select Key Players
B. Market Analytics

Table 23. Rest of World Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 71 (including Divisions/Subsidiaries - 77)
The United States (15)
Canada (1)
Japan (3)
Europe (25)
  France (1)
  Germany (8)
  The United Kingdom (5)
  Spain (1)
  Rest of Europe (10)
Asia-Pacific (Excluding Japan) (30)
Latin America (1)
Middle-East (2)
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