Companion Diagnostics: Market Research Report

Date: January 5, 2016
Pages: 278
Price:
US$ 4,500.00
Publisher: Global Industry Analysts, Inc
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: C6930E73755EN
Leaflet:

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Companion Diagnostics: Market Research Report
This report analyzes the worldwide markets for Companion Diagnostics in US$ Million. The Global market is further analyzed by the following Therapeutic Areas: Oncology, Neurology, and Others. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, 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 80 companies including many key and niche players such as -
  • Abbott Molecular Inc.
  • Beckman Coulter, Inc.
  • bioMérieux SA
  • Dako A/S
  • Foundation Medicine, Inc.
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. INDUSTRY OVERVIEW

Companion Diagnostics: Enhancing Drug Efficacy
Companion Diagnostics: Challenging the One-Size-Fits-All Approach of the Pharmaceutical Industry
Broader Scope and Applications
Companion Diagnostics – Leading the Way to Personalized Medicine
Herceptin Lays the Road for Companion Diagnostics
Rise in Rx Companion Diagnostics

Table 1. Rise in CDx Numbers Over the years - No. of FDA-Approved Drugs Requiring CDx in 1998, 2005, 2008 & 2016 (includes corresponding Graph/Chart)

List of FDA-Approved Companion Diagnostic Devices (In-vitro and Imaging Tools): As of 2016
Current & Future Analysis
US Leads the Companion Diagnostics Market, Asia-Pacific to Witness Fastest Growth
Oncology and Neurology – Dominating Therapy Areas

Table 2. Global Companion Diagnostic Drugs Market by Therapeutic Area (2015) - Percentage Share Breakdown of Revenue of CDx for Oncology, CNS Disorders, Gastrointestinal Disorders, Cardiovascular Diseases, and Others (includes corresponding Graph/Chart)
Table 3. Oncology CDx Market by Cancer Type (2015) - Percentage Share Breakdown of Revenue of CDx for Breast, Colorectal, Lung, Melanoma, Gastric, and Other Cancers (includes corresponding Graph/Chart)

Next-Generation Sequencing and Technological Innovations to Boost Market
Market Restraints

2. COMPETITIVE SCENARIO

Table 4. Global Companion Diagnostic-Associated Drug Market by Leading Product (2013) - Percentage Share Breakdown of Revenue for Erbitux, Gleevec, Herceptin, Iressa, Sprycel, Tarceva, Tasigna, & Others (includes corresponding Graph/Chart)

3. MARKET TRENDS/GROWTH DRIVERS

Growing Significance of Personalized Medicine Remains a Major Market Driver

Table 5. Drug Ineffectiveness for Select Therapeutic Categories as a Percentage of Patient Population (includes corresponding Graph/Chart)

Rising Incidence of Cancer Propels the Need for Companion Diagnostics
Global Cancer Incidence on the Rise – Opportunity Indicators for Companion Diagnostics Market

Table 6. Worldwide Incidence of Cancer in Millions: 2012, 2020 & 2030 (includes corresponding Graph/Chart)
Table 7. World Cancer Incidence by Geographic Region and Gender (2012): Number of New Cancer Cases Reported (in Thousands) for Asia-Oceania, Europe, North America, Latin America & the Caribbean, and Africa (includes corresponding Graph/Chart)
Table 8. New Cancer Cases in the World by Affected Site: 2012 (in Thousands) (includes corresponding Graph/Chart)
Table 9. Global Cancer Incidence by Income Group: 2012 (in Thousands) (includes corresponding Graph/Chart)

Growing Aging Population and Prevalence of Chronic Diseases Spurs Companion Diagnostics Demand

Table 10. Global Population Statistics for the 65+ Age Group (2013) (includes corresponding Graph/Chart)
Table 11. Elderly Population (65+ Years) as a % of Total Population (2000 & 2025) (includes corresponding Graph/Chart)
Table 12. Percentage of Population Aged 65 and Above in EU-27 Countries, US and Japan (1960-2030) (includes corresponding Graph/Chart)

Increasing Partnerships between Pharmaceutical and Diagnostics Players
Select Deals between Pharmaceutical and Diagnostic Companies: 2015 & 2016
Companion Diagnostics Augur Well for Pharmaceutical Companies with Diagnostics Capabilities
Significant Role of Biomarkers in Companion Diagnostics
List of US-FDA Approved Biomarkers for Cancer
Companion Diagnostics Aid R&D Cost Reduction

Table 13. Per-Capita Healthcare Expenditure in Select Regions (2013) (includes corresponding Graph/Chart)
Table 14. Leading Countries with the Highest Healthcare Spending as a Percentage of GDP (2012) (includes corresponding Graph/Chart)

4. REGULATORY SCENARIO

Companion Diagnostics: What Various Stakeholders Expect?
Pharmaceutical Company (Drug Manufacturer)
Diagnostic Company (Companion Diagnostic Manufacturer)
Patients
Physician/Healthcare Professional
Payer
Revised Payer Strategy: Need of the Hour
Regulatory Scenario in Leading Global Markets
United States
Canada
Europe
List of Key Market Requirements for Companion Diagnostics across the World

5. PRODUCT OVERVIEW

Diagnostics in Personalized Medicine
Genetic Tests
Companion Diagnostics
Companion Diagnostics: What makes them work
Techniques Used in Companion Diagnostics
PCR Technology Proves to be of Significant Use in Companion Diagnostics
QuantaLife ddPCR System: A Breakthrough Innovation in the Field of Companion Diagnostics
Biomarkers as Companion Diagnostics
Herceptin and Vilazodone - References for Success of Biomarker Based Approach
Applications of Companion Diagnostics at a Glance
Role of Companion Diagnostics in the Drug Development Process
Companion Diagnostics in Clinical Trials
Companion Diagnostics in Select Therapeutic Areas
Companion Diagnostics in Oncology
Select Companion Diagnostics in Cancer
Molecular Grade Index (MGISM) (bioTheranostics)
Breast Cancer IndexSM (bioTheranostics)
KRAS Testing
HER2 Testing for Herceptin Treatment in Breast Cancer
Assays Used for HER2 Testing
MammaPrint
The EGFRx Assay to Aid Cancer Treatment
c-Kit pharmDx Assay to Aid Cancer Treatment (DakoCytomation)
Companion Diagnostics in Inflammatory Diseases
PROMETHEUS IBD Serology 7 for Irritable Bowel Disease
Companion Diagnostics in Infectious Diseases
Trofile Assay (Monogram Biosciences) to Aid in HIV Treatment
Companion Diagnostics in Drug Metabolism
AmpliChip CYP450 Test
HILOmet PhyzioType System (Genomas)
Warfarin Sensitivity Test
An Account of Companion Diagnostics Companies in the CNS Arena

6. RECENT INDUSTRY ACTIVITY

Avant Diagnostics Acquires Amarantus Diagnostics and Theranostics Health
Thermo Fisher Enters Into Agreement with Novartis and Pfizer for CDx
R-Biopharm to Collaborate on Companion Diagnostics with Merck
Myriad Genetics Expands CDx Research Collaboration with AbbVie
QIAGEN Reaches Record Milestone in Collaboration Agreements for CDx
NanoString and Medivation Collaborate with Astellas for CDx Assay Development
Ono Pharmaceutical to Develop Companion Diagnostic for its Cancer Drug Opdivo
Foundation Medicine and Mirati Collaborate to Develop CDx for NSCLS Drug Glesatinib
Almac to Collaborate with Illumina on NGS-Based Companion Diagnostics
NeoGenomics to Acquire Clarient
R-Biopharm to Take Over GeneWake
Dako Announces FDA Approval of Companion Diagnostic for NSCLC
BriaCell Therapeutics Launches R&D Program on Companion Diagnostic Product
Asuragen Enters into Agreement with Illumina for CDx Development
Roche Submits CDx to FDA for Premarket Approval
Shuwen Biotech and Jiangsu Enter into Collaboration for CDx Development
R-Biopharm AG and Apogenix Enter into R&D Collaboration
Qiagen Receives FDA Approval for CDx with AstraZeneca’s IRESSA
Almac to Develop CDx for OncoMed’s Novel Therapeutic Drug
Halozyme Therapeutics and Ventana Enter into Agreement to Develop CDx for Pancreatic Cancer Drug
AstraZeneca Collaborates with Abbott for Asthma CDx Tests
Invivoscribe Technologies Enters Into CDx Agreement with Astellas
Dako Announces Expanded Collaboration with Amgen on Companion Diagnostics
LabCorp Acquires Covance
Roche to Acquire Stake in Foundation Medicine
TESARO and Myriad Announce Collaboration on myChoice HRD CDx
Qiagen Signs Collaboration Agreement with Novartis
Qiagen Enters into Collaboration Agreement with Astellas
Illumina Enters Into Collaborations with AstraZeneca, Janssen & Sanofi
AstraZeneca Launches Collaborations with Qiagen and Roche
Illumina Acquires Myraqa
Cancer Genetics to Acquire Gentris Corporation
Biocartis and Abbott Announce Collaboration to Develop CDx
Quest Diagnostics Introduces FDA-Approved THxID- RAF test from bioMerieux
Roche’s Ventana Launches CDx Prototype Assays
AVEO and Biodesix Enter Into Development & Commercialization Agreement
Foundation Medicine and Clovis Oncology Expand Collaboration
Illumina Enters into Agreement with Amgen to Develop CDx for Colorectal Cancer Drug

7. FOCUS ON SELECT PLAYERS

Abbott Molecular Inc. (US)
Beckman Coulter, Inc. (US)
bioMérieux SA (France)
Dako A/S (Denmark)
Foundation Medicine, Inc. (US)
GE Healthcare Ltd. (UK)
Clarient Diagnostic Services, Inc. (US)
Laboratory Corporation of America Holdings (US)
Leica Biosystems Nussloch GmbH (Germany)
Merck & Co. Inc. (US)
Myriad Genetics, Inc. (US)
QIAGEN N. V. (Netherlands)
Quest Diagnostics, Inc. (US)
Roche Diagnostics Corp. (US)
Ventana Medical Systems, Inc. (US)
Thermo Fisher Scientific Inc. (US)

8. GLOBAL MARKET PERSPECTIVE

Table 15. World Recent Past, Current & Future Analysis for Companion Diagnostics Market by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 16. World 7-Year Perspective for Companion Diagnostics by Geographic Region - Percentage Breakdown of Dollar Revenues for US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets for Years 2016 & 2022 (includes corresponding Graph/Chart)

By Application

Table 17. World Recent Past, Current & Future Analysis for Companion Diagnostics Market by Application Segment - Oncology, Neurology, and Others Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 18. World 7-Year Perspective for Companion Diagnostics by Application Segment - Percentage Breakdown of Dollar Revenues for Oncology, Neurology, and Others Markets for Years 2016 & 2022 (includes corresponding Graph/Chart)

III. MARKET

1. THE UNITED STATES

A. Market Analysis
Current & Future Analysis

Table 19. Rise in CDx Numbers Over the years - No. of FDA-Approved Drugs requiring CDx in 1998, 2005, 2008 & 2016 (includes corresponding Graph/Chart)
Table 20. Leading FDA-Approved CDx Drugs (2015): Percentage Share Breakdown for Erbitux/Vectibix, Exjade, Gilotrif, Gleevec, Herceptin, Herceptin/Perjeta, Lynparza, Mekinist/Tafinlar, Tarceva, Xalkori, and Zelboraf (includes corresponding Graph/Chart)

List of FDA-Approved Companion Diagnostic Devices (In-vitro and Imaging Tools): As of 2016
Growing Cancer Incidence – An Opportunity Indicator for Companion Diagnostics

Table 21. New Cancer Cases in the US by Gender and Affected Site: 2014 (includes corresponding Graph/Chart)
Table 22. Incidence of Cancer for All Body Sites by Gender & Age Group in the US (2013): New Cancer Cases for Males & Females for the Age groups Under 45 years; 45 years and Above; Under 65 years; 65 years and Above (includes corresponding Graph/Chart)
Table 23. The US Breast Cancer Incidence in Women by State (2013): New Cases of Breast Cancer in Leading 15 States (includes corresponding Graph/Chart)

Pioneer in Development of Companion Diagnostics in Oncology
Ageing Demographics: A Key Market Driver

Table 24. North American Elderly Population by Age Group: 1975-2050 (includes corresponding Graph/Chart)

Robust Personalized Medicine Market Offers Potential for CDx
Biomarkers: A Novel Paradigm in Companion Diagnostics
Regulatory Scenario
Strategic Corporate Developments
Focus on Select Key Players
B. Market Analytics

Table 25. The US Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 26. The US Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

2. CANADA

A. Market Analysis
Current & Future Analysis
Cancer Incidence in Canada: Opportunity Indicator for Companion Diagnostics

Table 27. New Cancer Cases in Canada by Gender and Affected Site: 2014E (includes corresponding Graph/Chart)
Table 28. New Cancer Cases in Canada by Province: 2014E (includes corresponding Graph/Chart)
Table 29. New Cancer Cases in Canada by Age Group: 2014E (includes corresponding Graph/Chart)

Regulatory Scenario
B. Market Analytics

Table 30. Canadian Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3. JAPAN

A. Market Analysis
Graying Population Spurs Growth

Table 31. Japanese Elderly (65+ Years) Population: 2000-2020 (includes corresponding Graph/Chart)

Strategic Corporate Development
B. Market Analytics

Table 32. Japanese Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 33. Japanese Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4. EUROPE

A. Market Analysis
Current & Future Analysis
Regulatory Scenario in Europe
Personalized Medicine Market to Exhibit Robust Growth, Boding Well for CDx
Cancer Incidence in Europe: An Opportunity Indicator for CDx

Table 34. Number of New Cancer Cases in Europe: 2012-2030 (includes corresponding Graph/Chart)

Ageing Population Drives the Demand for Companion Diagnostics

Table 35. European Country-wise Statistics of 60+ Population as % of Total Population: 2013 (includes corresponding Graph/Chart)

B. Market Analytics

Table 36. European Recent Past, Current & Future Analysis for Companion Diagnostics Market 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 37. European Historic Review for Companion Diagnostics Market by Geographic Region - France, Germany, Italy, UK, Spain, and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 38. European 7-Year Perspective for Companion Diagnostics 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)

4A. FRANCE

A. Market Analysis
Current & Future Analysis
Change in IVD Reimbursement
bioMérieux SA – A Key Player
B. Market Analytics

Table 39. French Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 40. French Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4B. GERMANY

A. Market Analysis
Current & Future Analysis
Strategic Corporate Developments
Select Key Players
B. Market Analytics

Table 41. German Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 42. German Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4C. ITALY

A. Market Analysis
Current & Future Analysis
B. Market Analytics

Table 43. Italian Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 44. Italian Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4D. THE UNITED KINGDOM

A. Market Analysis
Current & Future Analysis
Strategic Corporate Developments
Key UK-Based Player – GE Healthcare Ltd.
B. Market Analytics

Table 45. UK Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 46. UK Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4E. SPAIN

A. Market Analysis
Current & Future Analysis
B. Market Analytics

Table 47. Spanish Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 48. Spanish Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

4F. REST OF EUROPE

A. Market Analysis
Current & Future Analysis
Strategic Corporate Developments
Select Key Players
B. Market Analytics

Table 49. Rest of European Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 50. Rest of Europe Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

5. ASIA-PACIFIC

A. Market Analysis
Current & Future Analysis
B. Market Analytics

Table 51. Asia-Pacific Recent Past, Current & Future Analysis for Companion Diagnostics Market by Geographic Region - China and Rest of Asia Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 52. Asia-Pacific 7-Year Perspective for Companion Diagnostics by Geographic Region - Percentage Breakdown of Dollar Revenues for China and Rest of Asia Pacific Markets for Years 2016 & 2022 (includes corresponding Graph/Chart)

5A. CHINA

A. Market Analysis
Current & Future Analysis
Breast Cancer CDx to Dominate
Strategic Corporate Development
B. Market Analytics

Table 53. Chinese Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

5B. REST OF ASIA-PACIFIC

A. Market Analysis
Current & Future Analysis
B. Market Analytics

Table 54. Rest of Asia-Pacific Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

6. LATIN AMERICA

A. Market Analysis
Current & Future Analysis
B. Market Analytics

Table 55. Latin American Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

7. REST OF WORLD

A. Market Analysis
Current & Future Analysis
B. Market Analytics

Table 56. Rest of World Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 80 (including Divisions/Subsidiaries - 89)
The United States (53)
Canada (2)
Europe (28)
  France (5)
  Germany (4)
  The United Kingdom (9)
  Spain (1)
  Rest of Europe (9)
Asia-Pacific (Excluding Japan) (5)
Middle East (1)
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