Companion Diagnostics: Market Research Report

January 2019 | 245 pages | ID: C6930E73755EN
Global Industry Analysts, Inc

Abstracts

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
• Agilent Technologies, Inc.
• bioMerieux SA
• Danaher Corporation
• F. Hoffmann-La Roche Ltd.
• Merck & Co. Inc..

Contents

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

Companion Diagnostics: An Introductory Prelude
Quashing the One-Size-Fits-All Approach, CDx Wield Great Promise for Streamlined Drug Discovery & Development
Broader Scope and Applications Rev Up Growth Opportunities
Healthy Growth Projected over the Next Few Years
Developed Regions: Key Revenue Contributors

Table 1. Developed Regions Account for Lion's Share of World CDx Market: Percentage Breakdown of Revenues for Developed and Developing Regions (2018E & 2022P) (includes corresponding Graph/Chart)

Market Witnesses Fast Paced Growth in Developing Regions

Table 2. Global CDx Market - Geographic Regions Ranked by CAGR (Revenues) for 2015-2022: Asia-Pacific, Latin America, Rest of World, Canada, Europe, US and Japan (includes corresponding Graph/Chart)

Northbound Trajectory in R&D Spending Creates Conducive Environment

Table 3. Global Pharmaceutical R&D Spending (in US$ Billion) for the Years 2010 through 2017 (includes corresponding Graph/Chart)

Table 4. Leading Countries with Highest Healthcare Spending as a Percentage (%) of GDP (2016) (includes corresponding Graph/Chart)

Table 5. Per Capita Healthcare Spending (in US$) in Select Countries for the Year 2016 (includes corresponding Graph/Chart)

Prevailing Economic Scenario Favors Funding Pattern

Table 6. World Real GDP Growth Rates in % (2016-2019P): Breakdown by Country/Region (includes corresponding Graph/Chart)

3. MARKET TRENDS, GROWTH DRIVERS & ISSUES

Growing Significance of Personalized Medicine Remains a Major Market Driver

Table 7. World Market for Personalized Medicine: Breakdown of Revenues (in US$ Billion) for 2014, 2018E and 2022P (includes corresponding Graph/Chart)

Table 8. World Personalized Medicine Market by Region/Country (2018E): Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific and Rest of World (includes corresponding Graph/Chart)

Table 9. Drug Ineffectiveness for Select Therapeutic Categories as a Percentage of Patient Population (includes corresponding Graph/Chart)

Companion Diagnostics Lead the Way to Personalized Medicine
Significant Cost Reductions in Personalized Medicine R&D Made Possible with CDx
Emphasis on Improving Targeted Therapies with CDx Tests Steers Momentum
Herceptin Lays the Road for Companion Diagnostics

Table 10. Global Companion Diagnostic-Associated Drug Market by Drug (2016): Percentage Breakdown of Revenue for Erbitux, Gleevec, Herceptin, Iressa, Tarceva, Tasigna, & Others (includes corresponding Graph/Chart)

Oncology – Dominant Therapy Area for CDx

Table 11. Percentage (%) Share of Oncology in Worldwide CDx Revenues (2018E & 2022P) (includes corresponding Graph/Chart)

Table 12. Oncology CDx Market by Cancer Type (2016): Percentage Breakdown of Revenues for Breast, Colorectal, Gastric, Lung, Melanoma, and Other Cancers (includes corresponding Graph/Chart)

Rising Incidence of Cancer Propels the Need for CDx Tests

Table 13. Global Cancer Incidence (2015): Number of New Cancer Cases in Thousands by Type and Gender (includes corresponding Graph/Chart)

Table 14. Global Cancer Mortality (2015): Number of Cancer Related Deaths in Thousands by Type and Gender (includes corresponding Graph/Chart)

Table 15. Worldwide Incidence of Cancer in Millions: 2012, 2020P & 2030P (includes corresponding Graph/Chart)

Technology Advancements to Widen CDx Use Case
PCR: Dominant Technology Type for CDx Testing
QuantaLife ddPCR System: Breakthrough Innovation in the PCR CDx Vertical
Next-Generation Sequencing (NGS) Gains Widespread Traction in CDx Testing
Significant Role of Biomarkers in Companion Diagnostics
Critical Healthcare Needs of Aging Population Underpin CDx Sales

Table 16. Global Aging Population (in Thousands) by Age Group: 1975-2050 (includes corresponding Graph/Chart)

Table 17. Global Population Statistics for the 60+ Age Group by Region: 2017 (includes corresponding Graph/Chart)

Table 18. Global Population Statistics for the 65+ Age Group by Select Countries: 2016 (includes corresponding Graph/Chart)

Table 19. Global Life Expectancy at Birth (Years) by Geographic Region: 1950-2050 (includes corresponding Graph/Chart)

Regulatory Scenario Favors CDx Market
List of Key Market Requirements for CDx in US, Canada and Europe
Resolving Prevailing Challenges: Critical for Future Growth of CDx Market
Key Issues in a Nutshell

4. PRODUCT OVERVIEW

Diagnostics in Personalized Medicine
Genetic Tests
Companion Diagnostics
Companion Diagnostics: What Makes them Work
Techniques Used in Companion Diagnostics
Biomarkers as Companion Diagnostics
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
Oncotype DX
Quantitative Recurrence Score
Oncotype DX Test in Oncology: Stage of Intervention in Adjuvant Treatment Decision
Eligibility
The Test Procedure
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 to Aid in HIV Treatment
Companion Diagnostics in Drug Metabolism
AmpliChip CYP450 Test
HILOmet PhyzioType System (Genomas)
Warfarin Sensitivity Test
Companion Diagnostics: In Stakeholders’ Perspective
Pharmaceutical Company (Drug Manufacturer)
Diagnostic Company (Companion Diagnostic Manufacturer)
Patients
Physician/Healthcare Professional
Payer

5. COMPETITIVE LANDSCAPE

Leading Players in the World Companion Diagnostics Market
Vendors Rely on Collaborations to Widen Market Footprint
Select CDx Collaborative Deals Announced in the Recent Past
5.1. Focus on Select Global Players
Abbott Molecular (USA)
Agilent Technologies, Inc. (USA)
bioMérieux SA (France)
Danaher Corporation (USA)
Cepheid (USA)
Leica Biosystems Nussloch GmbH (Germany)
F. Hoffmann-La Roche Ltd. (Switzerland)
Foundation Medicine, Inc. (USA)
Laboratory Corporation of America Holdings (USA)
Merck & Co. Inc. (USA)
Myriad Genetics, Inc. (USA)
NeoGenomics, Inc. (USA)
QIAGEN N. V. (Netherlands)
Quest Diagnostics, Inc. (USA)
Thermo Fisher Scientific, Inc. (USA)
5.2 Product Approvals/Launches
Foundation Medicine Unveils FoundationOne CDx
Agilent Bags FDA Approval for Dako PD-L1 IHC 22C3 pharmDx Assay for Expanded Use in Urothelial Carcinoma
Roche Receives US FDA Approval for PMA Supplement for cobas EGFR Mutation Test v2
Myriad Bags Manufacturing & Marketing Approval for BRACAnalysis Diagnostic System in Japan
Roche Wins US FDA Approval for cobas EGFR Mutation Test v2 as a CDx with IRESSA
Myriad Genetics Bags US FDA Approval for BRACAnalysis CDx
MolecularMD Bags US FDA Authorization for CDx to Novartis CML Drug
Thermo Fisher Scientific Receives US FDA Approval for Oncomine Dx Target Test for Three NSCLC Treatments
5.3 Recent Industry Activity
Roche to Fully Acquire Foundation Medicine
Thermo Fisher Scientific Joins Hands with Takeda Pharmaceutical and Daiichi Sankyo
Spectrum Pharmaceuticals Inks NGS Companion Diagnostic Partnership with Thermo Fisher Scientific
Qiagen and Freenome to Develop NGS-based Companion Diagnostics
Bristol-Myers Squibb Joins Hands with Illumina
QIAGEN to Acquire STAT-Dx
PPD forms Strategic Alliance with NeoGenomics
LabCorp Collaborates with Unilabs
Merck KGaA and ArcherDX to Develop NGS-based CDx Assay
QIAGEN Teams Up with SRL
Shuwen Biotech Partners with Bliss Biopharmaceutical
Foundation Medicine and Merck to Develop CDx Tests
Pierre Fabre Extends CDx Collaboration with Roche
Agena Bioscience Inks CDx Collaboration Deal with Simcere Diagnostics in China
Foundation Medicine Inks CDx Partnership Deal with Pfizer
NeoGenomics to Join Thermo Fisher’s CDx Center of Excellence Program
LabCorp Inaugurates New Covance CDx Facility in North Carolina
Myriad Genetics Signs CDx Development Collaboration Deal with BeiGene
Myriad Genetics to Provide BRACAnalysis CDx to Clovis Oncology
Loxo Oncology Inks Collaboration Agreement with Ventana Medical Systems
Thermo Fisher Scientific Inks New Oncology CDx Development Agreement with Blueprint Medicines
Thermo Fisher Scientific Partners with Agios Pharmaceuticals
Cancer Genetics and LabCorp Join Thermo Fisher’s CDx Center of Excellence Program
Bristol-Myers Squibb Joins Hands with GRAIL
Bristol-Myers Squibb Teams Up with QIAGEN

6. GLOBAL MARKET PERSPECTIVE

Table 20. 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 21. World 5-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 2018 & 2022 (includes corresponding Graph/Chart)

By Application

Table 22. 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 23. World 5-Year Perspective for Companion Diagnostics by Application Segment - Percentage Breakdown of Dollar Revenues for Oncology, Neurology, and Others Markets for Years 2018 & 2022 (includes corresponding Graph/Chart)

7. REGIONAL MARKET PERSPECTIVE

7.1 The United States
A. Market Analysis
The United States: Prime Market for Companion Diagnostics

Table 24. US Accounts for over 2/5th of World CDx Market: Percentage Breakdown of CDx Revenues for US and Rest of World (2018E and 2022P) (includes corresponding Graph/Chart)

Companion Diagnostics Augur Well for Pharmaceutical Companies with Diagnostic Capabilities
Growing Cancer Incidence – An Opportunity Indicator for Companion Diagnostics

Table 25. Cancer Incidence in the US by Gender (2018E): Estimated New Cases for Men and Women (includes corresponding Graph/Chart)

Table 26. Cancer Incidence in the US by Gender (2018E): Estimated Deaths for Men and Women (includes corresponding Graph/Chart)

Pioneering Efforts in Oncology CDx Testing
Robust Personalized Medicine Market Offers Potential

Table 27. US Personalized Medicine Market: Breakdown of Revenues (in US$ Billion) for 2014, 2018E and 2022P (includes corresponding Graph/Chart)

Biomarkers: A Novel Paradigm in Companion Diagnostics
List of US-FDA Approved Biomarkers for Cancer
Ageing Demographics: A Key Market Driver

Table 28. North American Elderly Population by Age Group: 1975-2050 (includes corresponding Graph/Chart)

Competitive Scenario
Regulatory Overview
FDA Requirements in Drug Development Fuel Demand

Table 29. Rise in CDx Numbers Over the Years: Number of FDA-Approved Drugs Requiring CDx for Year 1998, 2005, 2008 & 2016 (includes corresponding Graph/Chart)

List of FDA-Approved Companion Diagnostics: As of H1 2018

Table 30. Leading FDA-Approved CDx Drugs in the US (2016): Percentage Breakdown of Revenues for Erbitux/Vectibix, Gleevec, Herceptin, Lynparza, Mekinist+Tafinlar, Perjeta, Tarceva, and Others (includes corresponding Graph/Chart)

B. Market Analytics

Table 31. 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 32. 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)

7.2 Canada
A. Market Analysis
Higher R&D Spending to Underpin CDx Revenues
Cancer Incidence in Canada: Opportunity Indicator for Companion Diagnostics

Table 33. New Cancer Cases in Canada by Gender (2017): Breakdown of Cancer Incidence for Male and Female Population (in Thousands) (includes corresponding Graph/Chart)

Table 34. Cancer Related Deaths in Canada (2017): Percentage Breakdown of Number of Deaths by Gender and Affected Site (includes corresponding Graph/Chart)

Regulatory Scenario
B. Market Analytics

Table 35. 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)

7.3 Japan
A. Market Analysis
Graying Population Spurs Growth

Table 36. Japanese Elderly (65+ Years) Population: 2000-2020 (includes corresponding Graph/Chart)

Table 37. Japanese Population by Age Group (2017): Percentage Breakdown for 0-14 Years, 15-24 Years, 25-54 Years, 55-64 Years, 65 Years and Above (includes corresponding Graph/Chart)

B. Market Analytics

Table 38. 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 39. Japanese Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

7.4 Europe
A. Market Analysis
A Mature yet Growing Market
CDx Gain from Healthy Momentum in Research Programs
Growing Role of Personalized Medicine Bodes Well for CDx

Table 40. Europe Personalized Medicine Market: Breakdown of Revenues (in US$ Billion) for 2014, 2018E and 2022P (includes corresponding Graph/Chart)

Cancer Incidence in Europe: An Opportunity Indicator

Table 41. Number of New Cancer Cases in Europe: 2012-2030 (includes corresponding Graph/Chart)

Ageing Population Drives Demand

Table 42. EU-28 Country-wise Statistics of 65+ Population as % of Total Population: 2016 (includes corresponding Graph/Chart)

Regulatory Scenario in Europe
B. Market Analytics

Table 43. 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 44. 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 45. European 5-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 2018 & 2022 (includes corresponding Graph/Chart)

  7.4.1 France
Market Analysis

Table 46. 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 47. French Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

  7.4.2 Germany
Market Analysis

Table 48. 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 49. German Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

  7.4.3 Italy
Market Analysis

Table 50. 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 51. Italian Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

  7.4.4 The United Kingdom
Market Analysis

Table 52. The 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 53. The UK Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

  7.4.5 Spain
Market Analysis

Table 54. 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 55. Spanish Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)

  7.4.6 Rest of Europe
Market Analysis

Table 56. Rest of Europe 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 57. 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)

7.5 Asia-Pacific
A. Market Analysis
A Rapidly Growing Market
Uptrend in IVD Sales Augurs Well for Market Growth
B. Market Analytics

Table 58. 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 59. Asia-Pacific 5-Year Perspective for Companion Diagnostics by Geographic Region - Percentage Breakdown of Dollar Revenues for China and Rest of Asia-Pacific Markets for Years 2018 & 2022 (includes corresponding Graph/Chart)

  7.5.1 China
A. Market Analysis
Breast Cancer CDx: Dominant Category
Laboratory Equipment & Supplies Sector in China: An Overview
B. Market Analytics

Table 60. 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)

  7.5.2 Rest of Asia-Pacific
Market Analysis

Table 61. 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)

7.6 Latin America
Market Analysis

Table 62. 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)

7.7 Rest of World
Market Analysis

Table 63. 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)

8. COMPANY PROFILES

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)