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Companion Diagnostics Market (2nd Edition), 2014-2024

  • June 2014
  • -
  • Roots Analysis Private Ltd.
  • -
  • 233 pages

INTRODUCTION

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.

EXAMPLE HIGHLIGHTS

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.

RESEARCH METHODOLOGY

Most of the data presented in this report has been gathered by secondary research. We have also conducted interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will shape up across different regions and drug segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Other analysts’ opinion reports

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES

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

Companion Diagnostics Market (2nd Edition), 2014-2024
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 FIGURES

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 bioMerieux 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

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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 bioMerieux Sales, 2013 - by Business Segments (USD million, %)
Table 12.86 Cost of Genome Sequencing (USD) - per Megabase, 2001-2012



The following companies have been mentioned in this report.

1. 20/20 GeneSystems
2. AandG 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. bioMerieux
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 Securite Sanitaire des Produits de Sante)
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 Autorite de Sante (HAS)
15. INCa
16. Institut Merieux
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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