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Companion Diagnostics Market, 2014 - 2024

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    June 2014

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  1. The global companion diagnostics market is likely to grow at an annualized rate of 22.9% over the next ten years; by 2024, over 10 million tests are expected to be conducted annually across various indications.
  2. In 2013, 18.5% of the new molecular entities (NMEs) were approved with a pharmacogenomic biomarker by the FDA.
  3. The sales of marketed companion drugs generated estimated revenues of more than USD 26 billion in 2013, with six drugs achieving blockbuster status.
  4. The pipeline for companion diagnostics is rich with most products being developed with the collaborative effort of pharmaceutical and diagnostics companies; we have identified over 75 drugs which are being co-developed with predictive biomarkers.
  5. Partnership seems to be the most preferred model for development; since January 2011, there have been more than 90 collaborations between pharmaceutical and diagnostic companies.
  6. Pharmaceutical companies have displayed keen interest in companion diagnostic start-ups such as Epic Sciences and Nodality. Specifically, Epic Sciences has inked deals with at least six pharmaceutical companies (including Genentech, Celgene and Pfizer) for development of companion diagnostics for cancer drugs.

Overview

With an influx of new technologies and increasing awareness about personalized medicine, the pharmaceutical industry has steadily started to adopt a more customized drug development model. The concept of companion diagnostics holds huge potential for pharma companies as well as medical community. This new approach to medication is expected to transform healthcare by improving treatment outcomes, eliminating adverse reactions and reducing cost and time barriers associated with the conventional methods of medication.

In fact, targeted drugs have been fast to overshadow traditional drugs, which favour the concept of one-size-fits-all. Several targeted drugs are being developed in association with a companion diagnostic test and have reached blockbuster status despite targeting a limited audience. Both large and small biopharmaceutical companies are now actively developing drug-diagnostic combination products. The success of Herceptin and Glivec has proved that the benefits of use of companion diagnostics far outweigh the challenge of a limited target population. There are ample opportunities for growth in this niche market for both pharmaceutical and diagnostic companies.

The journey of a biomarker to a companion diagnostic is a long one, with the regulatory authorities favouring the co-development and approval of companion drug and diagnostic. Although complex, the pipeline for companion diagnostics is rich. In the future, the launch and success of drugs will also be governed by the successful development of a commercial companion diagnostic test. The 2014-2024 period is likely to see launch of many new companion diagnostics, transforming the promise into reality.

 

Scope of the Report

The ‘Companion Diagnostics Market, 2014-2024’ report provides an extensive study of the growing market of companion diagnostics. The report differentiates personalized medicine diagnostics and companion diagnostics; we have separately defined these two closely associated markets. The research covers various aspects, such as, advantages of personalized medicine over traditional medicine and the need for companion diagnostics. In addition to evaluating the marketed and pipeline companion diagnostic tests, we have also provided our views on the current state of the companion drugs market.

One of the key objectives of this report is to understand the future evolution of the companion diagnostics market. Our proprietary ‘Companion Diagnostics Market Forecasting Model’ allows us to predict the likely growth of companion diagnostics tests across various parameters. The model, built over a ten year horizon, offers valuable insights on the following:

  • Global market evolution, both in terms of volume (number of tests) and the associated sales value (USD billion)
  • Regional variation, specifically in the US and European (Germany, Italy, France, Spain and the UK) markets
  • Likely adoption of marketed / pipeline tests for specific biomarkers (e.g. EGFR, KRAS, ALK, HER2 and BRAF) till 2024
  • Likely adoption of various marketed / pipeline tests for specific indications (e.g. metastatic non-small cell lung cancer, metastatic colorectal cancer, breast cancer and melanoma) till 2024

We have discussed, in detail, the key drivers behind the regional and global growth. The regional evaluation extends to other markets such as Japan, China and Australia. This provides a greater clarity in the differing approaches various regions have towards personalized medicine and companion diagnostics.

The research, analysis and insights presented in this report include the sales of all companion diagnostic tests that are essential before prescription of any companion drug. All actual figures have been sourced and analyzed from publicly available information. The figures mentioned in this report are in USD, unless otherwise specified.

Contents

Chapter 2  provides an executive summary of the insights captured in our research. The summary offers a high level view on the likely evolution of companion diagnostics market.

Chapter 3  provides a general introduction on personalized medicine. We have also explained, in detail, companion diagnostics and their development from pharmacogenomics biomarkers.

Chapter 4  analyzes the global companion drugs market, including the FDA and EMA approved companion drugs. The chapter provides details on leading companion drugs and indications. It also highlights leading pharmaceutical companies active in this market, along with case studies of some well-known companion drugs.

Chapter 5  analyzes the global companion diagnostics market, identifying the currently marketed diagnostics and those in the pipeline. In this chapter, we have included our estimates on how the overall market is going to evolve globally over the next ten years. We adopted a bottom-up approach to forecast details on the number of tests and associated sales value for different biomarker and indication combinations.

Chapter 6  provides a detailed analysis on the regional market for companion diagnostics. The major markets covered include the US and Europe (Germany, France, Italy, Spain and the UK). We have also included details on companion diagnostic testing in Japan, China and Australia. The chapter highlights policies that govern the approval and reimbursement of in vitro diagnostics (in particular companion diagnostics) and investments made in the field of personalized medicine. In addition, we have identified the companion diagnostics approved in these countries, including the historical data on number of tests conducted in some of the regions. For the US and EU5 markets, we have provided our regional market forecast over the next ten years, both in terms of volume and value (by type of biomarker and by type of indication).

Chapter 7  includes profiles of the key companies in the companion diagnostics market. Each company profile includes information such as financial performance, geographical presence, marketed / pipeline products (including companion drugs and diagnostics) and recent developments.

Chapter 8  analyzes the theranostics market as a whole with detailed discussion on the role of various stakeholders in the market. We have also covered the recent partnerships that have taken place in the theranostics market to develop drug-diagnostic combinations.

Chapter 9  focuses on the key drivers of companion diagnostics, expanding on the advantages they hold for the delivery of healthcare. We have included a discussion on the tools and technologies promoting their use. The chapter also provides a SWOT analysis capturing the key elements likely to influence future growth.

Chapter 10  is a collection of transcripts of interviews conducted during the course of this study.

Chapter 11  summarizes the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.

Chapters 12 and 13  are appendices. These provide tabulated data for all the figures provided in the report and a list of companies / organizations mentioned in the report.

Table of Contents

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
 
2. EXECUTIVE SUMMARY
 
3. INTRODUCTION
3.1. Context and Background
3.2. Traditional Medicine and Diagnostics: The One for All Concept
3.3. Milestone in Biotechnology: Decoding of Human Genetic Code in 2003
3.4. Changing Face of Medicine: Personalized Medicine and Diagnostics
3.4.1. Personalized Medicine vs. Traditional Medicine
3.4.2. Personalized Medicine Diagnostics
3.4.3. Pharmacogenomic Biomarkers
3.4.4. Development of Biomarkers Into Companion Diagnostics
3.4.5. The Three Entry Points for a Companion Diagnostic to Associate with a Drug
3.4.6. Low Translation Rates of Biomarkers to Companion Diagnostics
 
4. COMPANION DRUGS MARKET, 2013
4.1. Chapter Overview
4.2. 18.5% of the New Molecular Entities were Approved with a Pharmacogenomic Biomarker by FDA
4.3. Companion Drugs in the Market
4.3.1. Companion Drugs in the Market have Achieved Blockbuster Status as Well
4.3.2. Oncology was the Leading Indication Targeted by Companion Drugs
4.3.3. Roche Laboratories had the Most Number of Successful Companion Diagnostics
4.4. Case Studies
4.4.1. Trastuzumab (Herceptin): A Successful Example of Personalized Medicine
4.4.2. Crizotinib (Xalkori): From Conception to Market in Four Years
4.4.3. Vemurafenib (Zelboraf): Co-development with Companion Diagnostic Accelerating the Time to Market
4.4.4. Gefitinib (Iressa): Revival with Companion Diagnostic
4.4.5. Kalydeco (Ivacaftor): Strong Start to a Promising Future
 
5. GLOBAL MARKET FOR COMPANION DIAGNOSTICS, 2014 - 2024
5.1. Chapter Overview
5.2. Companion Diagnostic: Definition
5.3. Marketed Companion Diagnostics, 2014
5.3.1. Preference of LDTs Over Kits
5.4. Companion Diagnostics in Pipeline: Story of New Entrants
5.4.1. Oncology Dominates the Pipeline as Well
5.4.2. Collaboration of Drug-Diagnostic Developers is the Most Common Model
 
5.4.3. Start-Ups Gaining Attention
5.4.4. Companion Imaging Diagnostics on rise
5.5. Forecast Methodology
5.6. Global Companion Diagnostics Market, 2014 – 2024: Distribution by Type of Test
5.6.1. Global KRAS Market, 2014 - 2024: Number of Tests and Sales Forecast
5.6.2. Global EGFR Market, 2014 - 2024: Number of Tests and Sales Forecast
5.6.3. Global HER2 Market, 2014 - 2024: Number of Tests and Sales Forecast
5.6.4. Global ALK Market, 2014 - 2024: Number of Tests and Sales Forecast
5.6.5. Other Companion Diagnostics, 2014 - 2024: Number of Tests and Sales Forecast
5.7. Global Companion Diagnostics Market, 2014 - 2024: Distribution by Type of Indication
5.7.1. Global Metastatic non-Small Cell Lung Cancer Companion Diagnostics Market, 2014 - 2024
5.7.2. Global Metastatic Colorectal Cancer Companion Diagnostics Market, 2014 - 2024
5.7.3. Global Breast Cancer Companion Diagnostics Market, 2014 - 2024
5.7.4. Global Melanoma Companion Diagnostics Market, 2014 - 2024
 
6. REGIONAL MARKET FOR COMPANION DIAGNOSTICS, 2014 - 2024
6.1. Chapter Overview
6.2. United States
6.2.1. Current FDA Classification of IVD Tests
6.2.2. Companion Diagnostic Testing
6.2.3. FDA Promoting the Development of Companion Diagnostics
6.2.4. Overall US Market for Companion Diagnostics, 2014 - 2024
6.2.5. The US KRAS Market, 2014 - 2024: Number of Tests and Sales Forecast
6.2.6. The US EGFR Market, 2014 - 2024: Number of Tests and Sales Forecast
6.2.7. The US HER2 Market, 2014 - 2024: Number of Tests and Sales Forecast
6.2.8. The US ALK Market, 2014 - 2024: Number of Tests and Sales Forecast
6.2.9. Other Companion Diagnostic Tests in the US, 2014 - 2024: Number of Tests and Sales Forecast
6.2.10. The US Companion Diagnostics Market, 2014 - 2024: Distribution by Type of Indication
6.2.10.1. The US Metastatic non-Small Cell Lung Cancer Companion Diagnostics Market, 2014 – 2024
6.2.10.2. The US Metastatic Colorectal Cancer Companion Diagnostics Market, 2014 - 2024
6.2.10.3 The US Breast Cancer Companion Diagnostics Market, 2014 - 2024
6.2.10.4. The US Melanoma Companion Diagnostics Market, 2014 - 2024
 
6.3. Europe (Germany, France, The UK, Italy, Spain)
6.3.1. Regulation of IVDs in Europe: Current State
6.3.2. Proposed Change in Classification to Alter the Regulation of Companion Diagnostics
6.3.3. Other Proposed Changes
 
6.3.4. Germany
6.3.4.1. Companion Diagnostic Testing
6.3.4.2. Investments in Personalized Healthcare
6.3.4.3. Reimbursement System in Germany
 
6.3.5. France
6.3.5.1. Diagnostic Testing in France
6.3.5.2. Reimbursement System in France
6.3.5.3. Companion Diagnostic Testing
6.3.5.4. Challenges in the French Companion Diagnostics Market
6.3.5.5. Investments for Future Personalized Diagnostics
 
6.3.6. The UK
6.3.6.1. Diagnostic Testing in the UK
6.3.6.2. State of HER2, KRAS and EGFR Testing
6.3.6.3. Investments for Future Personalized Diagnostics
 
6.3.7. Italy
6.3.8. Spain
6.3.8.1. Investments in the field of Personalized Healthcare
 
6.3.9. Overall EU5 Market for Companion Diagnostics, 2014 - 2024
6.3.10. EU5 KRAS Market, 2014 - 2024: Number of Tests and Sales Forecast
6.3.11. EU5 EGFR Market, 2014 - 2024: Number of Tests and Sales Forecast
6.3.12. EU5 HER2 Market, 2014 - 2024: Number of Tests and Sales Forecast
6.3.13. EU5 ALK Market, 2014 - 2024: Number of Tests and Sales Forecast
6.3.14. Other Companion Diagnostics in EU5, 2014 - 2024: Number of Tests and Sales Forecast
6.4. EU5 Companion Diagnostics Market, 2014 - 2024: Distribution by Type of Indication
6.4.1. EU5 Metastatic non-Small Cell Lung Cancer Companion Diagnostics Market, 2014 – 2024
6.4.2. EU5 Metastatic Colorectal Cancer Companion Diagnostics Market, 2014 - 2024
6.4.3. EU5 Breast Cancer Companion Diagnostics Market, 2014 - 2024
6.4.4. EU5 Melanoma Companion Diagnostics Market, 2014 - 2024
 
6.5. Japan
6.5.1. Companion Diagnostics Testing
6.5.2. Growth Drivers
 
6.6. Rest of the World
6.6.1. Companion Diagnostic Testing in China: Tests and Companies
6.6.2. Companion Diagnostic Testing in Australia
6.6.2.1. Regulatory Framework in Australia
6.6.2.2. Reimbursement Schemes
6.6.2.3. Therapies and Companion Diagnostic Tests
6.6.2.4. Investments in the field of Personalized Medicine
 
7. PROFILES OF LEADING COMPANIES
7.1. Chapter Overview
 
7.2. Abbott Molecular
7.2.1. Marketed Companion Diagnostics
7.2.2. Pipeline Companion Diagnostics
7.2.3. Partnerships
7.2.4. Financial Performance
 
7.3. Qiagen
7.3.1. Expanding Through Acquisitions
7.3.2. Marketed Companion Diagnostics
7.3.3. Pipeline Companion Diagnostics
7.3.4. Partnerships
7.3.5. Financial Performance
7.3.6. Recent Developments
 
7.4. Dako (a Subsidiary of Agilent Technologies)
7.4.1. Marketed Products
7.4.2. Pipeline Products
7.4.3. Partnerships
7.4.4. Financial Performance
7.4.5. Recent Developments
 
7.5. Roche Laboratories
7.5.1. Marketed and Pipeline Products
7.5.1.1. Marketed Products
7.5.2. Pipeline Products
7.5.3. Preferred Partner for Companion Diagnostics
7.5.4. Financial Performance
 
7.6. Novartis
7.6.1. Marketed and Pipeline products
7.6.1.1. Marketed products
7.6.1.2. Pipeline Products
7.6.2. Partnerships
7.6.3. Financial Performance
 
7.7. bioMerieux
7.7.1. Expanding through Acquisitions
7.7.2. Marketed and Pipeline Products
7.7.3. Partnerships
7.7.4. Financial Performance
 
8. ANALYSIS OF THERANOSTICS MARKET: STAKEHOLDERS AND BUSINESS MODELS
8.1. Chapter Overview
8.2. Stakeholders in the Market
8.3. Theranostic Development Agencies
8.3.1. Pharmaceutical Company
8.3.1.1. Traits a Pharmaceutical Company Looks for in a Companion Diagnostics Developer
8.3.1.2. Pharmaceutical Company Business Models
8.3.2. The Companion Diagnostic Developer
8.3.2.1. Companion Diagnostic Company Business Models
8.3.3. Recent Partnerships
8.3.4. Testing Laboratories
8.3.5. Contract Research Organizations (CROs)
8.3.6. Regulatory Authorities
8.3.7. Buyers/Target Audience
8.3.8. Payers
8.3.9. Companies Providing Ancillary Services
 
9. MARKET GROWTH DRIVERS
9.1. Chapter Overview
9.2. Low Drug Efficacy Rates
9.3. Poor Drug Compliance
9.4. High Cost of Drug Development
9.5. Phase II and III Drug Failures
9.6. Drug Recalls
9.7. Tools and Technologies Enabling the Move to Companion Diagnostics
9.7.1. Growing Significance of Biomarkers
9.7.2. Reducing Costs of Genome Sequencing
9.8. SWOT Analysis
9.8.1. Strengths
9.8.2. Weaknesses
9.8.3. Opportunities
9.8.4. Threats
 
10. INTERVIEW TRANSCRIPTS
 
11. CONCLUSION
11.1. Companion Diagnostics: An Emerging Market
11.2. Co-Development and Approval of Companion Diagnostic will be the Preferred Route of Development
11.3. Key Driving Factors
11.4. Opportunities Outpace the Threats
11.5. Concluding Remarks
 
12. APPENDIX 1: TABULATED DATA
 
13. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

List of Figuers

Figure 3.1  Segments of Personalized Medicine Diagnostics
Figure 3.2  Biomarker to Companion Diagnostics
Figure 4.1  NME Approved by the FDA, 2013 - With or Without Biomarker (%)
Figure 4.2  Companion Drugs Market, 2013 - By Leading Drugs (USD Million, %)
Figure 4.3  Companion Drugs Market, 2013 - By Leading Indication (USD Million, %)
Figure 4.4  Companion Drugs Market, 2013- by Leading Companies (USD million, %)
Figure 4.5  HER2 Expression in Breast Cancer Patients (%)
Figure 4.6  Herceptin Sales, 1998 - 2013 (USD Million)
Figure 4.7  EML4-ALK Expression in non-Small Cell Lung Cancer Patients (%)
Figure 4.8  Timeline for Development of Xalkori and Companion Diagnostic, 2005 - Current
Figure 4.9  Xalkori Sales, 2011- 2013 (USD Million)
Figure 4.10  BRAF V600E Expression in Metastatic Melanoma Patients (%)
Figure 4.11  Timeline for Development of Zelboraf and Companion Diagnostic, 2006 - Current
Figure 4.12  Zelboraf Sales, 2011- 2013 (USD Million)
Figure 4.13  Iressa Sales, 2005 - 2013 (USD Million)
Figure 4.14  G551D Mutation in Cystic Fibrosis Patients (%)
Figure 4.15 Kalydeco Sales, 2012 - 2013 (USD Million)
Figure 5.1  Global Companion Diagnostics Market, Number of Tests: Split by Category, 2014 - 2024 (# '000)
Figure 5.2  Global Companion Diagnostics Market, Sales Forecast: Split by Category, 2014 - 2024 (USD MM)
Figure 5.3  US Companion Diagnostics Market, Number of Tests: Split by Category, 2014 - 2024 (# '000)
Figure 5.4  US Companion Diagnostics Market, Sales Forecast: Split by Category, 2014 - 2024 (USD MM)
Figure 5.5  EU5 Companion Diagnostics Market, Number of Tests: Split by Category, 2014 - 2024 (# '000)
Figure 5.6  EU5 Companion Diagnostics Market, Sales Forecast: Split by Category, 2014 - 2024 (USD MM)
Figure 5.7  Global KRAS Market, Number of Tests, 2014 - 2024 (# '000)
Figure 5.8  Global KRAS Market, Sales Forecast, 2014 - 2024 (USD MM)
Figure 5.9  Global EGFR Market, Number of Tests: Split by Indication, 2014 - 2024 (# '000)
Figure 5.10  Global EGFR Market, Sales Forecast: Split by Indication, 2014 - 2024 (USD MM)
Figure 5.11  Global HER2 Market, Number of Tests: Split by Indication, 2014 - 2024 (# '000)
Figure 5.12  Global HER2 Market, Sales Forecast: Split by Indication, 2014 - 2024 (USD MM)
Figure 5.13  Global ALK Market, Number of Tests, 2014 - 2024 (# '000)
Figure 5.14  Global ALK Market, Sales Forecast, 2014 - 2024 (USD MM)
Figure 5.15 Other Companion Diagnostics, Global Number of Tests, 2014 - 2024 (# '000)
Figure 5.16  Other Companion Diagnostics, Global Sales Forecast, 2014 - 2024 (USD MM)
Figure 5.17  Global Metastatic NSCLC Companion Diagnostic Tests, 2014 - 2024 (# '000)
Figure 5.18  Global Metastatic NSCLC Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Figure 5.19  Global Metastatic Colorectal Cancer Companion Diagnostic Tests, 2014 - 2024 (# '000)
Figure 5.20  Global Metastatic Colorectal Cancer Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Figure 5.21  Global Breast Cancer Companion Diagnostic Tests, 2014 - 2024 (# '000)
Figure 5.22  Global Breast Cancer Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Figure 5.23  Global Melanoma Companion Diagnostic Tests, 2014 - 2024 (# '000)
Figure 5.24  Global Melanoma Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Figure 6.1  US Marketed Companion Diagnostics, Number of Tests: Split by Type of Test, 2014 - 2024 (# '000)
Figure 6.2 US Marketed Companion Diagnostics, Sales Forecast: Split by Type of Test, 2014 - 2024 (USD MM)
Figure 6.3  US Pipeline Companion Diagnostics, Number of Tests, 2014 - 2024 (# '000)
Figure 6.4  US Pipeline Companion Diagnostics, Sales Forecast, 2014 - 2024 (USD MM)
Figure 6.5  US KRAS Market, Number of Tests, 2014 - 2024 (# '000)
Figure 6.6  US KRAS Market, Sales Forecast, 2014 - 2024 (USD MM)
Figure 6.7  US EGFR Market, Number of Tests: Split by Indication, 2014 - 2024 (# '000)
Figure 6.8  US EGFR Market, Sales Forecast: Split by Indication, 2014 - 2024 (USD MM)
Figure 6.9  US HER2 Market, Number of Tests: Split by Indication, 2014 - 2024 (# '000)
Figure 6.10  US HER2 Market, Sales Forecast: Split by Indication, 2014 - 2024 (USD MM)
Figure 6.11  US ALK Market, Number of Tests: Split by Indication, 2014 - 2024 (# '000)
Figure 6.12  US ALK Market, Sales Forecast: Split by Indication, 2014 - 2024 (USD MM)
Figure 6.13 Other Companion Diagnostics in the US, Number of Tests, 2014 - 2024 (# '000)
Figure 6.14  Other Companion Diagnostics in the US, Sales Forecast, 2014 - 2024 (USD MM) 
Figure 6.15  US Metastatic NSCLC Companion Diagnostic Tests, 2014 - 2024 (# '000)
Figure 6.16  US Metastatic NSCLC Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Figure 6.17  US Metastatic Colorectal Cancer Companion Diagnostic Tests, 2014 - 2024 (# '000)
Figure 6.18  US Metastatic Colorectal Cancer Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Figure 6.19  US Breast Cancer Companion Diagnostic Tests, 2014 - 2024 (# '000)
Figure 6.20  US Breast Cancer Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Figure 6.21  US Melanoma Companion Diagnostic Tests, 2014 - 2024 (# '000)
Figure 6.22  US Melanoma Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Figure 6.23  Number of KRAS Tests Performed in France, 2007-2012
Figure 6.24  Number of EGFR Tests Performed in France, 2008-2012
Figure 6.25  Percentage of EGFR+ Patients in France
Figure 6.26  Number of HER2 Tests Performed in France, 2008-2011
Figure 6.27  Number of HER2, KRAS, EGFR and KIT Tests Performed in England, 2010 - 2011
Figure 6.28  Number of EGFR Tests Performed in the UK, August 2009 - July2010
Figure 6.29  EU5 Marketed Companion Diagnostics, Number of Tests: Split by Type of Test, 2014 - 2024 (# '000)
Figure 6.30  EU5 Marketed Companion Diagnostics, Sales Forecast: Split by Type of Test, 2014 - 2024 (USD MM)
Figure 6.31  EU5 Pipeline Companion Diagnostics, Number of Tests, 2014 - 2024 (# '000)
Figure 6.32  EU5 Pipeline Companion Diagnostics, Sales Forecast, 2014 - 2024 (USD MM)
Figure 6.33  EU5 KRAS Market, Number of Tests, 2014 - 2024 (# '000)
Figure 6.34  EU5 KRAS Market, Sales Forecast, 2014 - 2024 (USD MM)
Figure 6.35  EU5 EGFR Market, Number of Tests: Split by Indication, 2014 - 2024 (# '000)
Figure 6.36  EU5 EGFR Market, Sales Forecast: Split by Indication, 2014 - 2024 (USD MM)
Figure 6.37  EU5 HER2 Market, Number of Tests: Split by Indication, 2014 - 2024 (# '000)
Figure 6.38  EU5 HER2 Market, Sales Forecast: Split by Indication, 2014 - 2024 (USD MM)
Figure 6.39  EU5 ALK Market, Number of Tests: Split by Indication, 2014 - 2024 (# '000)
Figure 6.40  EU5 ALK Market, Sales Forecast: Split by Indication, 2014 - 2024 (USD MM)
Figure 6.41 Other Companion Diagnostics in EU5, Number of Tests, 2014 - 2024 (# '000)
Figure 6.42  Other Companion Diagnostics in EU5, Sales Forecast, 2014 - 2024 (USD MM)
Figure 6.43  EU5 Metastatic NSCLC Companion Diagnostic Tests, 2014 - 2024 (# '000)
Figure 6.44  EU5 Metastatic NSCLC Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Figure 6.45  EU5 Metastatic Colorectal Cancer Companion Diagnostic Tests, 2014 - 2024 (# '000)
Figure 6.46  EU5 Metastatic Colorectal Cancer Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Figure 6.47  EU5 Breast Cancer Companion Diagnostic Tests, 2014 - 2024 (# '000)
Figure 6.48  EU5 Breast Cancer Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Figure 6.49  EU5 Melanoma Companion Diagnostic Tests, 2014 - 2024 (# '000)
Figure 6.50  EU5 Melanoma Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Figure 7.1  Abbott Laboratories Sales, 2013 - by Business Segments (USD million, %)
Figure 7.2  Abbott Laboratories Sales, 2013–Diagnostics Segment (USD million, %)
Figure 7.3  Qiagen Sales, 2013 – Split by Business Segments (USD Million, %)
Figure 7.4  Qiagen Personalized Healthcare Sales, 2012 (USD million, %)
Figure 7.5  Agilent Technologies Sales, 2013 –Split by Business Segments (USD Million, %)
Figure 7.6  Roche: Phase 1 Pipeline Molecules (With and Without Companion Diagnostic Development)
Figure 7.7  Roche: Phase 2 Pipeline Molecules (With and Without Companion Diagnostic Development)
Figure 7.8  Roche: Phase 3 Pipeline Molecules (With and Without Companion Diagnostic Development)
Figure 7.9  Roche Group Sales, 2013-Split by Business Segments (USD Million, %)
Figure 7.10  Roche Diagnostics Sales, 2013–Split by Segments (USD Million, %)
Figure 7.11 Novartis Sales, 2013 –Split by Business Segments (USD Million, %)
Figure 7.12  bioMérieux Sales, 2013 –Split by Business Segments (USD Million, %)
Figure 8.1  Stakeholders in the Theranostics Market
Figure 8.2  Business Models for Companion Diagnostic Development
Figure 9.1  Efficacy Rate of Drugs (%)
Figure 9.2  Reasons for Drug Failure in Phase II of Clinical Trials, 2008-2010
Figure 9.3  Reasons for Drug Failure in Phase III of Clinical Trials, 2007-2010
Figure 9.4  Pipeline Drugs Attached with Biomarkers - by Phase of Development (%)
Figure 9.5  Cost of Genome Sequencing (USD) - per Mega base, 2001-2012

List of Tables

Table 4.1  Companion Drugs Approved by FDA
Table 4.2  Companion Drugs Approved by the EMA
Table 5.1  List of Marketed Companion Diagnostic Tests, 2014
Table 5.2  List of Companion Diagnostics in Pipeline
Table 6.1  Proposed Classification of IVDs
Table 6.2  List of Companion Diagnostics Tests Conducted in France, 2013
Table 6.3  NICE Technology Appraisals of Drugs with Companion Diagnostics
Table 6.4  Japan’s Population Over 65 - 2010, 2015 and 2020 (‘000, %)
Table 7.1  Abbott Molecular: Marketed Companion Diagnostic Tests
Table 7.2  Abbott Molecular: Pipeline Companion Diagnostic Tests
Table 7.3  Qiagen: Marketed Companion Diagnostic Tests
Table 7.4  Qiagen: Pipeline Companion Diagnostic Tests 
Table 7.5  Dako: Marketed Companion Diagnostic Tests
Table 7.6  Roche: Marketed Companion Diagnostic Tests 
Table 7.7  Novartis: Marketed Companion Drugs
Table 7.8  Novartis: Pipeline Companion Diagnostic Tests
Table 8.1  Deals and Collaborations for Companion Diagnostic Development, January 2011 - Present
Table 8.2  Companies providing Ancillary Services
Table 9.1  Drug Recalls from the US Market, 1996-2007
Table 9.2  SWOT Analysis of Companion Diagnostics Market
Table 12.1  List of New Molecular Entities (NMEs) Approved with Pharmacogenomic Biomarker
Table 12.2  Companion Drugs Market, 2013 - by Leading Drugs (USD million)
Table 12.3  Companion Drugs Market, 2013 - by Leading Indication (USD million, %)
Table 12.4  Companion Drugs Market, 2013- by Leading Companies (USD million, %)
Table 12.5  Herceptin Sales, 1998 - 2013 (USD million)
Table 12.6  Xalkori Sales, 2011- 2013 (USD Million)
Table 12.7  Zelboraf Sales, 2011- 2013 (USD Million)
Table 12.8  Iressa Sales, 2005 - 2013 (USD million)
Table 12.9  Kalydeco Sales, 2012- 2013 (USD Million)
Table 12.10  Global Companion Diagnostics Market, Number of Tests: Split by Category, 2014 - 2024 (# '000)
Table 12.11  Global Companion Diagnostics Market, Sales Forecast: Split by Category, 2014 - 2024 (USD MM)
Table 12.12  US Companion Diagnostics Market, Number of Tests: Split by Category, 2014 - 2024 (# '000)
Table 12.13  US Companion Diagnostics Market, Sales Forecast: Split by Category, 2014 - 2024 (USD MM)
Table 12.14  EU5 Companion Diagnostics Market, Number of Tests: Split by Category, 2014 - 2024 (# '000)
Table 12.15  EU5 Companion Diagnostics Market, Sales Forecast: Split by Category, 2014 - 2024 (USD MM)
Table 12.16  Global KRAS Market, Number of Tests, 2014 - 2024 (# '000)
Table 12.17  Global KRAS Market, Sales Forecast, 2014 - 2024 (USD MM)
Table 12.18  Global EGFR Market, Number of Tests: Split by Indication, 2014 - 2024 (# '000)
Table 12.19  Global EGFR Market, Sales Forecast: Split by Indication, 2014 - 2024 (USD MM)
Table 12.20  Global HER2 Market, Number of Tests: Split by Indication, 2014 - 2024 (# '000)
Table 12.21  Global HER2 Market, Sales Forecast: Split by Indication, 2014 - 2024 (USD MM)
Table 12.22  Global ALK Market, Number of Tests, 2014 - 2024 (# '000)
Table 12.23  Global ALK Market, Sales Forecast, 2014 - 2024 (USD MM)
Table 12.24  Other Companion Diagnostics, Global Number of Tests, 2014 - 2024 (# '000)
Table 12.25  Other Companion Diagnostics, Global Sales Forecast, 2014 - 2024 (USD MM)
Table 12.26  Global Metastatic NSCLC Companion Diagnostic Tests, 2014 - 2024 (# '000)
Table 12.27  Global Metastatic NSCLC Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Table 12.28  Global Metastatic Colorectal Cancer Companion Diagnostic Tests, 2014 - 2024 (# '000)
Table 12.29  Global Metastatic Colorectal Cancer Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Table 12.30  Global Breast Cancer Companion Diagnostic Tests, 2014 - 2024 (# '000)
Table 12.31  Global Breast Cancer Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Table 12.32  Global Melanoma Companion Diagnostic Tests, 2014 - 2024 (# '000)
Table 12.33  Global Melanoma Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Table 12.34  US Marketed and Pipeline Companion Diagnostics, Number of Tests: Split by Type of Test, 2014 - 2024 (# '000)
Table 12.35  US Marketed and Pipeline Companion Diagnostics, Sales Forecast: Split by Type of Test, 2014 - 2024 (USD MM)
Table 12.36  US KRAS Market, Number of Tests, 2014 - 2024 (# '000)
Table 12.37  US KRAS Market, Sales Forecast, 2014 - 2024 (USD MM)
Table 12.38  US EGFR Market, Number of Tests: Split by Indication, 2014 - 2024 (# '000)
Table 12.39  US EGFR Market, Sales Forecast: Split by Indication, 2014 - 2024 (USD MM)
Table 12.40  US HER2 Market, Number of Tests: Split by Indication, 2014 - 2024 (# '000)
Table 12.41  US HER2 Market, Sales Forecast: Split by Indication, 2014 - 2024 (USD MM)
Table 12.42  US ALK Market, Number of Tests: Split by Indication, 2014 - 2024 (# '000)
Table 12.43  US ALK Market, Sales Forecast: Split by Indication, 2014 - 2024 (USD MM)
Table 12.44  Other Companion Diagnostics in the US, Number of Tests, 2014 - 2024 (# '000)
Table 12.45  Other Companion Diagnostics in the US, Sales Forecast, 2014 - 2024 (USD MM)
Table 12.46  US NSCLC Companion Diagnostic Tests, 2014 - 2024 (# '000)
Table 12.47  US NSCLC Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Table 12.48  US Metastatic Colorectal Cancer Companion Diagnostic Tests, 2014 - 2024 (# '000)
Table 12.49  US Metastatic Colorectal Cancer Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Table 12.50  US Breast Cancer Companion Diagnostic Tests, 2014 - 2024 (# '000)
Table 12.51  US Breast Cancer Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Table 12.52  US Melanoma Companion Diagnostic Tests, 2014 - 2024 (# '000)
Table 12.53  US Melanoma Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Table 12.54  Number of KRAS Tests Performed in France, 2007-2012
Table 12.55  Number of EGFR Tests Performed in France, 2008-2011
Table 12.56  Number of HER2, KRAS, EGFR and KIT Tests Performed in England, 2010 - 2011
Table 12.57  EU5 Marketed and Pipeline Companion Diagnostics, Number of Tests: Split by Type of Test, 2014 - 2024 (#  '000)
Table 12.58  EU5 Marketed and Pipeline Companion Diagnostics, Sales Forecast: Split by Type of Test, 2014 - 2024 (USD MM)
Table 12.59  EU5 KRAS Market, Number of Tests, 2014 - 2024 (# '000)
Table 12.60  EU5 KRAS Market, Sales Forecast, 2014 - 2024 (USD MM)
Table 12.61 EU5 EGFR Market, Number of Tests: Split by Indication, 2014 - 2024 (# '000)
Table 12.62  EU5 EGFR Market, Sales Forecast: Split by Indication, 2014 - 2024 (USD MM)
Table 12.63  EU5 HER2 Market, Number of Tests: Split by Indication, 2014 - 2024 (# '000)
Table 12.64  EU5 HER2 Market, Sales Forecast: Split by Indication, 2014 - 2024 (USD MM)
Table 12.65  EU5 ALK Market, Number of Tests: Split by Indication, 2014 - 2024 (# '000)
Table 12.67  Other Companion Diagnostics in EU5, Number of Tests, 2014 - 2024 (# '000)
Table 12.68  Other Companion Diagnostics in EU5, Sales Forecast, 2014 - 2024 (USD MM)
Table 12.69  EU5 Metastatic NSCLC Companion Diagnostic Tests, 2014 - 2024 (# '000)
Table 12.70  EU5 Metastatic NSCLC Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Table 12.71  EU5 Metastatic Colorectal Cancer Companion Diagnostic Tests, 2014 - 2024 (# '000)
Table 12.72  EU5 Metastatic Colorectal Cancer Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Table 12.73  EU5 Breast Cancer Companion Diagnostic Tests, 2014 - 2024 (# '000)
Table 12.74  EU5 Breast Cancer Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Table 12.75  EU5 Melanoma Companion Diagnostic Tests, 2014 - 2024 (# '000)
Table 12.76  EU5 Melanoma Companion Diagnostic Test Sales Forecast, 2014 - 2024 (USD MM)
Table 12.77  Abbott Laboratories Sales, 2013 - by Business Segments (USD million, %)
Table 12.78  Abbott Laboratories Sales, 2013 – Diagnostics Segments (USD million, %)
Table 12.79  Qiagen Sales, 2013 - by Business Segments (USD million, %)
Table 12.80  Qiagen Personalized Healthcare Sales, 2012 (USD million, %)
Table 12.81  Agilent Technologies Sales, 2013 - by Business Segments (USD million, %)
Table 12.82  Roche Group Sales, 2013 - by Business Segments (USD million, %)
Table 12.83  Roche Diagnostics Sales, 2013 - by Segments (USD million, %)
Table 12.84  Novartis Sales, 2013 - by Business Segments (USD million, %)
Table 12.85  bioMérieux Sales, 2013 - by Business Segments (USD million, %)
Table 12.86  Cost of Genome Sequencing (USD) - per Megabase, 2001-2012

Listed Companies

The following companies have been mentioned in this report.

  1. 20/20 GeneSystems
  2. A&G Pharmaceutical
  3. AB Science
  4. Abbott Molecular
  5. Abkine Pharmaceutical
  6. AdeptBio
  7. Advanced Cell Diagnostics
  8. AES Laboratoire
  9. Aeterna Zentaris
  10. Affymetrix
  11. Agendia
  12. Agilent Technologies
  13. Agios Pharmaceuticals
  14. Almac
  15. AltheaDx
  16. Ameritox
  17. Amgen
  18. Amoy Diagnostics Co.
  19. Applied Biocode
  20. Argene
  21. Ariad Pharmaceuticals
  22. Arno Therapeutics
  23. AstraZeneca
  24. Asuragen
  25. AviaraDx
  26. Bayer
  27. Beckman Coulter
  28. Becton Dickinson
  29. Biocartis
  30. Biocrates Life sciences AG
  31. Biodesix
  32. BioFire Diagnostics
  33. Biogen Idec
  34. BioGenex Laboratories
  35. BioMarin Pharmaceutical
  36. BioMarker Strategies
  37. bioMérieux
  38. Biotage
  39. Boehringer Ingelheim
  40. Brain Resource Company
  41. Bristol Myers Squibb
  42. Bruker Daltonics
  43. CancerGuide Diagnostics
  44. Celgene
  45. Cell Signaling Technology (CST)
  46. Celldex Therapeutics
  47. Cellestis Limited
  48. Cenix BioScience
  49. Cephalon
  50. Cepheid
  51. ChemGenX Pharmaceuticals
  52. Claros Diagnostics
  53. Clovis Oncology
  54. CompanDx
  55. Corgenix
  56. Covance
  57. Crescendo Bioscience
  58. Curidium Medica 
  59. Cyprotex
  60. Cytyc Corporation
  61. Daiichi Sankyo
  62. Dako
  63. Danaher
  64. Debiopharm Diagnostics
  65. Diagnocure
  66. DNA Vision
  67. Drug Response Dx
  68. Dx assays
  69. DxS
  70. Eisai
  71. Eli Lilly
  72. Empire genomics
  73. Endocyte
  74. Enzo Biochem
  75. Epic Sciences
  76. Epigenomics
  77. Epizyme
  78. ERYtech Pharma
  79. Evotec
  80. Exosome Diagnostics
  81. Flagship Biosciences
  82. Fougera pharmaceuticals
  83. Foundation Medicine
  84. Galena Biopharma
  85. Genentech
  86. GenMark Diagnostics
  87. Genomic Health
  88. Genoptix
  89. Gen-probe
  90. Genzyme Genetics
  91. GlaxoSmithKline
  92. Hatteras Venture Partners
  93. Horizon Discovery
  94. Ibis Biosciences
  95. ICON
  96. Ikonisys
  97. Illumina
  98. ImaginAb
  99. Imclone
  100. Immunex
  101. ImmusantT
  102. IncellDx
  103. Incyte
  104. InDex pharmaceuticals
  105. InsermTransfert
  106. Insight Genetics
  107. Intelligent Bio-Systems
  108. InterSouth partners
  109. Intezyne technology
  110. Inverness Medical Innovations
  111. Invitrogen
  112. Invivoscribe Technologies
  113. Ipsen
  114. Janssen Biotech
  115. Lab21
  116. LabCorp
  117. Leica Biosystems
  118. Life Technologies Corporation
  119. Luminex Corporation
  120. M2 gen
  121. MacroGenics
  122. MDx Health
  123. Merck
  124. Metabolon
  125. Millennium
  126. Molecular MD
  127. Monogram Biosciences
  128. Myriad Genetics
  129. Nanosphere
  130. Neovacs
  131. Nodality
  132. Novartis
  133. NuvOx
  134. OncoMed Pharmaceuticals
  135. On-Q-ity
  136. OPKO Health 
  137. Optherion
  138. OriGene Technologies
  139. Orion Genomics
  140. Ortho-Clinical Diagnostics
  141. OSI Pharmaceuticals
  142. Oxford Biotherapeutics
  143. PamGene International B.V.
  144. Panacea Pharmaceuticals
  145. Personal Genome Diagnostics
  146. Pfizer
  147. Pharma Mar
  148. Pharmacyclics
  149. Plexxikon
  150. PrimeraDx
  151. Progenika Biopharma
  152. Psynova Neurotech
  153. Qiagen
  154. Quanterix Corporation
  155. Quest Diagnostics
  156. Quintiles Translational Corporation
  157. RAS Lifesciences
  158. Regulus Therapeutics
  159. ResearchDx
  160. Resonance Health
  161. Response Genetics
  162. RiboMed technologies
  163. Ridge Diagnostics
  164. Roche Laboratories
  165. Rules-Based Medicine
  166. Saladax Biomedical
  167. Sanofi
  168. Seattle Genetics
  169. Sequenom
  170. Shionogi
  171. Shire
  172. Siemens
  173. Signature Diagnostics
  174. Sirius Genomics
  175. Skuldtech
  176. Skyline Diagnostics
  177. STARLIMS technologies
  178. Sundance Diagnostics
  179. Syndax Pharmaceuticals
  180. Synthon Biopharmaceuticals
  181. Sysmex Inostics
  182. TcLand Expression
  183. Tesaro
  184. Thermo Fisher Scientific
  185. Third wave technologies
  186. TIB MolBiol
  187. Tocagen
  188. Tragara Pharmaceuticals
  189. Transgene
  190. Transgenomic
  191. Trimgen
  192. UCB Pharma
  193. Unidex
  194. Unilabs
  195. Validus
  196. Vatera Healthcare Partners
  197. Ventana Medical Systems
  198. Verastem
  199. Vertex Pharmaceuticals
  200. ViiV Healthcare
  201. Xdx
  202. Xenon Health
  203. Zinfandel

 

The following organizations have been mentioned in this report.

 

  1. AFSSAPS (Agence Française de Securité Sanitaire des Produits de Santé)
  2. American Society of Clinical Oncology (ASCO)
  3. BC Cancer Agency
  4. British In Vitro Diagnostics Association (BIVDA)
  5. Cancer Research, UK
  6. Center for Cooperative Research in Biosciences Biogene
  7. Centers for Medicare and Medicaid Services (CMS)
  8. Chinese Anti-Cancer Association (CACA)
  9. Committee for Medicinal Products for Human Use (CHMP)
  10. Cystic Fibrosis Foundation
  11. European Medicines Agency (EMA)
  12. European Personalized Medicine Organization (EPEMED)
  13. Food and Drug Administration (FDA)
  14. Haute Autorité de Santé (HAS)
  15. INCa
  16. Institut Mérieux
  17. Institute for Quality and Efficiency in Healthcare (IQWiG)
  18. Italian Medicines Agency (AIFA)
  19. Jichi Medical University
  20. Massachusetts General Hospital (MGH) 
  21. Medical Devices Evaluation Committee (MDEC)
  22. Medical Research Council (MRC)
  23. Medical Services Advisory Committee (MSAC)
  24. Medicines and Healthcare products Regulatory Agency (MHRA)
  25. Ministry of Health, Labour and Welfare (MHLW)
  26. National Association of Testing Authorities (NATA)
  27. National Health Service (NHS)
  28. National Human Genome Research Institute (NHGRI)
  29. National Institute for Clinical Excellence (NICE)
  30. National Institutes of Health
  31. Novartis Institutes for Biomedical Research (NIBR)
  32. Pharmaceutical Benefits Advisory Committee (PBAC)
  33. Pharmaceutical Research and Manufacturers of America (PhRMA)
  34. Public Health England (PHE)
  35. Spanish Ministry of Health (MSC)
  36. Statutory Health Insurance (SHI)
  37. Technology Strategy Board (TSB)
  38. The Carlos III Health Institute
  39. The Federal Joint Committee (GBA)
  40. The Pharmaceuticals and Medical Devices Agency (PMDA)
  41. United Nations Population Division (UNPD)
  42. US Department of Energy

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