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Report Description
Targeted therapeutics and companion diagnostics are the pillars of personalised medicine. Personalised medicine is a genome-based therapeutic approach that aims to adopt customised treatment for each individual. It uses aspects of genetic testing for checking potential abnormalities and tailoring the treatment so as to make it as individualised as the disease itself.
Targeted drugs have been fast to overshadow the traditional drugs, which favour the concept of one-size-fits-all. This has primarily been due to their superior efficacy and safety profile. More recently, several targeted drugs are being developed in association with a companion diagnostic test, which aids the identification of target population most likely to benefit from the therapy. The biopharmaceutical industry has been sceptical and slow to adopt the concept of companion diagnostics, as it limits the target population for the drug. However, their use also allows the companies to command premium prices in the market for their targeted drugs. Several companion drugs have reached blockbuster status even after targeting a limited audience, including Herceptin and Glivec.
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 limited target population. In this report, we look at the extent of use of some popular companion diagnostic tests - Her-2/neu, KRAS, EGFR and c-kit - across some leading national markets.
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 successful development of a commercial companion diagnostic test. The 2012-2023 period will see the launch of numerous new companion diagnostics. We have explored the opportunities for growth in this niche market for both pharmaceutical and diagnostic companies, presented case studies of some marketed drug-diagnostic combinations, analysed the rich pipeline and looked at the recent collaborations that will drive this market. Additionally, we have also analysed the current and future state of the molecular and tissue diagnostics market, to which all companion diagnostic tests belong.
Scope of the Report
The 'Companion Diagnostics Market 2012-2023' report provides an extensive study of the emerging market of companion diagnostics. The report differentiates personalised medicine diagnostics and companion diagnostics; we have separately defined these two closely associated markets and provided our estimates of the market size for each. The report covers various aspects, such as, advantages of personalised medicine over traditional medicine and the need for companion diagnostics.
One of the key objectives of this report is to understand the current state of the companion diagnostics market. This is done by analysing
The market for companion diagnostics has also been evaluated regionally; this provides a greater clarity in the differing approaches various regions have towards personalised medicine and companion diagnostics. In parallel, we have also analysed the market for companion drugs that are associated with companion diagnostics.
The report provides market forecasts for the period 2012 - 2023. We have discussed, in detail, the key drivers behind the regional and global growth. 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 analysed from publicly available information. The figures mentioned in this report are in USD, unless otherwise specified.
Contents
Chapter 1 is a high level Executive Summary of the key market insights presented in the report.
Chapter 2 provides a general introduction on personalised medicine. We have also explained, in detail, companion diagnostics and their development from pharmacogenomics biomarkers.
Chapter 3 analyses 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 4 analyses the global companion diagnostics market, identifying the currently marketed diagnostics and those in the pipeline. The chapter includes analysis of the in vitro diagnostic and personalised medicine diagnostic as well. We have also analysed the state of the current tissue and molecular diagnostics market.
Chapter 5 provides a detailed analysis on the regional market for companion diagnostics. The major markets covered include the US, Japan, Germany, France, Italy, Spain and the UK. The chapter highlights the policies that govern the approval and reimbursement of in vitro diagnostics, in particular companion diagnostics in the regions mentioned. We have also identified the companion diagnostics approved in these countries, including the historical data on number of tests conducted in some of the regions.
Chapter 6 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 7 analyses the theranostics market as a whole with detailed discussion on the role of various stakeholders in the market. The chapter examines the benefits reaped by each stakeholder. We havealso covered the recent partnerships that have taken place in the theranostics market to develop drug-diagnostic combinations.
Chapter 8 focuses on the need for companion diagnostics in detail, 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 9 summarises 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.
Chapter 10 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
1. EXECUTIVE SUMMARY
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
1.4. Key Highlights
1.4.1. Oncology is the Leading Indication for Companion Drugs
1.4.2. Roche is One of the Most Active Companies in the Market
1.4.3. Partnership is the Preferred Model for Companion Diagnostics Development
1.4.4. US is the Largest Market for Companion Diagnostics
1.4.5. Opportunities Outpace the Threats
2. INTRODUCTION
2.1. Traditional Medicine and Diagnostics: The One for All Concept
2.2. Milestone in Biotechnology: Decoding of Human Genetic Code in 2003
2.3. Changing Face of Medicine: Personalised Medicine and Diagnostics
2.3.1. Personalised Medicine vs. Traditional Medicine
2.3.2. Personalised Medicine Diagnostics
2.3.3. Personalised Medicine Diagnostics and Pharmacogenomic Biomarkers
2.3.3.1. Development of Biomarkers Into Companion Diagnostics
2.3.3.2. The Three Entry Points for a Companion Diagnostic to Associate with a Drug
2.3.3.3. Low Translation Rates of Biomarkers to Companion Diagnostics
2.4. Companion Diagnostic: Definition
2.4.1. Types of Companion Diagnostics
2.4.2. Advantages of Companion Diagnostics
3. COMPANION DRUGS MARKET, 2012
3.1. Chapter Overview
3.2. 41.2% of the New Molecular Entities were Approved with a Pharmacogenomic Biomarker by the FDA
3.3. Companion Drugs in the Market
3.3.1. Companion Drugs in the Market have Achieved Blockbuster Status as Well
3.3.2. Oncology was the Leading Indication Targeted by Companion Drugs
3.3.2.1. Roche Laboratories had the Most Number of Successful Companion Diagnostics
3.4. Case Studies
3.4.1. Trastuzumab (Herceptin): A Successful Example of Personalised Medicine
3.4.2. Crizotinib (Xalkori): From Conception to Market in Four Years
3.4.3. Vemurafenib (Zelboraf): Co-development with Companion Diagnostic Accelerating the Time to Market
3.5. Gefitinib (Iressa): Revival with Companion Diagnostic
4. COMPANION DIAGNOSTICS MARKET, 2012-2023
4.1. Chapter Overview
4.2. Personalised Medicine Diagnostics as a Subset of In Vitro Diagnostics
4.2.1. Personalised Medicine Diagnostics Market, 2012
4.3. Companion Diagnostics Represented 10.1% of the Personalised Medicine Diagnostics Market in 2012
4.4. Companion Diagnostics Market, 2012
4.5. Companion Diagnostics Market, 2013-2023
4.6. Molecular and Tissue Diagnostics Market, 2012
4.6.1. Molecular and Tissue Diagnostics Market, 2013-2018
4.7. Marketed Companion Diagnostics, 2012
4.7.1. Preference of LDTs Over Kits
4.8. Companion Diagnostics in Pipeline: Story of New Entrants
4.8.1. Oncology Dominates the Pipeline as Well
4.8.2. Collaboration of Drug-Diagnostic Developers is the Most Common Model
4.8.3. Start-Ups Gaining Attention
5. REGIONAL MARKETS FOR COMPANION DIAGNOSTICS, 2012-2023
5.1. Chapter Overview
5.2. Companion Diagnostics Market: Regional Outlook
5.3. The US Market For Companion Diagnostics, 2012
5.3.1. Current FDA Classification of IVD Tests
5.3.2. Companion Diagnostic Testing
5.3.3. FDA Promoting the Development of Companion Diagnostics
5.4. The European Market for Companion Diagnostics, 2012
5.4.1. Regulation of IVDs in Europe: Current State
5.4.2. Proposed Change in Classification to Alter the Regulation of Companion Diagnostics
5.4.3. Companion Diagnostics Market in Europe (EU5), 2012
5.4.3.1. Germany
5.4.3.1.1. Companion Diagnostic Testing
5.4.3.1.2. Investments in Personalised Healthcare
5.4.3.2. France
5.4.3.2.1. Diagnostic Testing in France
5.4.3.2.2. Companion Diagnostic Testing
5.4.3.2.3. Challenges in the French Companion Diagnostics Market
5.4.3.2.4. Investments for Future Personalised Diagnostics
5.4.3.3. UK
5.4.3.3.1. Diagnostic Testing in the UK
5.4.3.3.2. State of HER2, KRAS and EGFR Testing
5.4.3.4. Investments for Future Personalised Diagnostics
5.4.3.5. Italy
5.4.3.6. Spain
5.5. The Japanese Market For Companion Diagnostics, 2012
5.5.1. Companion Diagnostics Testing
5.5.2. Driving Factors for Growth
5.6. Rest of the World Companion Diagnostics Market, 2012
5.6.1. Companion Diagnostic Testing in China: Tests and Companies
5.7. Regional Markets for Companion Diagnostics, 2012-2023
6. PROFILES OF LEADING COMPANIES
6.1. Abbott Molecular
6.1.1. Marketed and Pipeline Companion Diagnostics
6.1.2. Financial Performance
6.2. Qiagen
6.2.1. Expanding Through Acquisitions
6.2.2. Marketed and Pipeline Products
6.2.3. Financial Performance
6.2.4. Recent Developments
6.3. Dako (a Subsidiary of Agilent Technologies)
6.3.1. Marketed and Pipeline Products
6.3.2. Financial Performance
6.3.3. Recent Developments
6.4. Roche Laboratories: Theranostics Market Giant
6.4.1. Marketed and Pipeline Products
6.4.1.1. Marketed Products
6.4.1.2. Products In the Pipeline
6.4.1.3. Preferred Partner for Companion Diagnostics
6.4.2. Financial Performance
7. ANALYSIS OF THERANOSTICS MARKET: STAKEHOLDERS AND BUSINESS MODELS
7.1. Chapter Overview
7.2. Theranostics Market in 2012
7.3. Stakeholders in the Market
7.3.1. Theranostic Development Agencies
7.3.1.1. Pharmaceutical Company
7.3.1.1.1. Traits a Pharmaceutical Company Looks for in a Companion Diagnostics Developer
7.3.1.1.2. Pharmaceutical Company Business Models
7.3.1.2. The Companion Diagnostic Developer
7.3.1.2.1. Companion Diagnostic Company Business Models
7.3.1.3. Recent Partnerships
7.3.2. Testing Laboratories
7.3.3. Contract Research Organisations (CROs)
7.3.4. Regulatory Authorities
7.3.5. Buyers/Target Audience
7.3.6. Payers
8. NEED FOR COMPANION DIAGNOSTICS
8.1. Low Drug Efficacy Rates
8.2. Poor Drug Compliance
8.3. High Cost of Drug Development
8.4. Phase II and III Drug Failures
8.5. Drug Recalls
8.6. Tools and Technologies Enabling the Move to Companion Diagnostics
8.6.1. Growing Significance of Biomarkers
8.6.2. Reducing Costs of Genome Sequencing
8.7. SWOT Analysis
8.7.1. Strengths
8.7.2. Weaknesses
8.7.3. Opportunities
8.7.4. Threats
9. CONCLUSIONS
9.1. Companion Diagnostics: An Emerging Market
9.2. Co-Development and Approval of Companion Diagnostic will be the Preferred Route of Development
9.3. Key Driving Factors
9.4. Concluding Remarks
10. APPENDIX 1: TABLES
11. APPENDIX 2: LIST OF COMPANIES AND ORGANISATIONS
FIGURE 2.1 Segments of Personalised Medicine Diagnostics
FIGURE 2.2 Biomarker to Companion Diagnostics
FIGURE 3.1 NME Approved by the FDA, 2011 - With or Without Biomarker (%)
FIGURE 3.2 Companion Drugs Market, 2012 - By Leading Drugs (USD MM, %)
FIGURE 3.3 Companion Drugs Market, 2012 - By Leading Indication (USD MM, %)
FIGURE 3.4 Companion Drugs Market, 2012 - by Leading Companies (USD MM, %)
FIGURE 3.5 HER2 Expression in Breast Cancer Patients (%)
FIGURE 3.6 Herceptin Sales, 1998 - 2012 (USD MM)
FIGURE 3.7 EML4-ALK Expression in Non Small Cell Lung Cancer Patients (%)
FIGURE 3.8 Timeline for Development of Xalkori and Companion Diagnostic, 2005 - Current
FIGURE 3.9 BRAF V600E Expression in Metastatic Melanoma Patients (%)
FIGURE 3.10 Timeline for Development of Zelboraf and Companion Diagnostic, 2006 - Current
FIGURE 3.11 Iressa Sales, 2005 - 2012 (USD MM)
FIGURE 4.1 In Vitro Diagnostics Market - by Intent of Use (USD BN, %)
FIGURE 4.2 Personalised Medicine Diagnostics Market, 2012 - by Type (USD MM, %)
FIGURE 4.3 Revenues Generated by Services and Sales of Companion Diagnostic Products, 2012 (USD MM, %)
FIGURE 4.4 Companion Diagnostics Market, Short-Mid Term Forecast: 2013-2018 (USD MM)
FIGURE 4.5 Companion Diagnostics Market, Long Term Forecast: 2019-2023 (USD MM)
FIGURE 4.6 Molecular and Tissue Diagnostics Market, 2012 (USD BN, %)
FIGURE 4.7 Molecular Diagnostics Market, 2012 - by Leading Companies (%)
FIGURE 4.8 Molecular and Tissue Diagnostics Market, 2012-2018 (USD BN)
FIGURE 5.1 Companion Diagnostics Market, 2012 - by Regions (USD MM, %)
FIGURE 5.2 European Companion Diagnostics Market, 2012 - by Countries (USD MM, %)
FIGURE 5.3 Number of KRAS Tests Performed in France, 2007-2010
FIGURE 5.4 Number of EGFR Tests Performed in France, 2008-2011
FIGURE 5.5 Number of HER2, KRAS, EGFR and KIT Tests Performed in England, 2010 - 2011
FIGURE 5.6 Number of EGFR Tests Performed in the UK, August 2009 - July
2010
FIGURE 5.7 Companion Diagnostics Market, Short-Mid Term Forecast: 2012-2018, by Leading Countries (USD MM)
FIGURE 5.8 Companion Diagnostics Market, Long Term Forecast: 2019-2023, by Leading Countries (USD MM)
FIGURE 6.1 Abbott Laboratories Sales, 2012 - by Business Segments (USD MM, %)
FIGURE 6.2 Abbott Laboratories Sales, 2012 – Diagnostics Segment (USD MM, %)
FIGURE 6.3 Qiagen Sales, 2012 - by Business Segments (USD MM, %)
FIGURE 6.4 Qiagen Personalised Healthcare Sales, 2012 (USD MM, %)
FIGURE 6.5 Agilent Technologies Sales, 2012 - by Business Segments (USD MM, %)
FIGURE 6.6 Roche Group Sales, 2012 - by Business Segments (USD MM, %)
FIGURE 6.7 Roche Diagnostics Sales, 2012 - by Segments (USD MM, %)
FIGURE 7.1 Theranostic Sales, 2012 - by Segments (USD MM, %)
FIGURE 7.2 Stakeholders in the Theranostics Market
FIGURE 7.3 Business Models for Companion Diagnostic Development
FIGURE 8.1 Efficacy Rate of Drugs (%)
FIGURE 8.2 Reasons for Drug Failure in Phase II of Clinical Trials, 2008-2010
FIGURE 8.3 Reasons for Drug Failure in Phase III of Clinical Trials, 2007-2010
FIGURE 8.4 Pipeline Drugs Attached with Biomarkers - by Phase of Development (%)
FIGURE 8.5 Cost of Genome Sequencing (USD) - per Megabase, 2001-2012
TABLE 3.1 Companion Drugs Approved by the FDA,
TABLE 3.2 Companion Drugs Approved by the EMA
TABLE 4.1 List of Marketed Companion Diagnostic Tests, 2012
TABLE 4.2 List of Companion Diagnostics in Pipeline
TABLE 5.2 Proposed Classification of IVDs
TABLE 5.3 List of Companion Diagnostics Tests Conducted in France, 2012
TABLE 5.4 NICE Approved Oncology Drugs Associated with Companion Diagnostics
TABLE 5.5 Japan’s Population Over 65 - 2010, 2015 and 2020 (‘000, %)
TABLE 7.1 Deals and Collaborations for Companion Diagnostic Development, January 2011 - Present
TABLE 8.1 Drug Recalls from the US Market, 1996-2007
TABLE 8.2 SWOT Analysis of Companion Diagnostics Market
TABLE 10.1 List of New Molecular Entities (NMEs) Approved with Pharmacogenomic Biomarker
TABLE 10.2 Companion Drugs Market, 2012 - by Leading Drugs (USD MM)
TABLE 10.3 Companion Drugs Market, 2012 - by Leading Indication (USD MM, %)
TABLE 10.4 Companion Drugs Market, 2012 - by Leading Companies (USD MM, %)
TABLE 10.5 Herceptin Sales, 1998 - 2012 (USD MM)
TABLE 10.6 Iressa Sales, 2005 - 2012 (USD MM)
TABLE 10.7 In Vitro Diagnostics Market, 2012 - by Intent of Use (USD BN, %)
TABLE 10.8 Personalised Medicine Diagnostics Market, 2012 - by Type (USD MM, %)
TABLE 10.9 Revenues Generated by Service Providers and Sales of Companion Diagnostic Products, 2012 (USD MM, %)
TABLE 10.10 Companion Diagnostics Market, Short-Mid Term Forecast: 2013-2018 (USD MM)
TABLE 10.11 Companion Diagnostics Market, Long Term Forecast: 2019-2023 (USD MM)
TABLE 10.12 Molecular and Tissue Diagnostics Market, 2012 (USD BN, %)
TABLE 10.13 Molecular and Tissue Diagnostics Market, 2012-2018 (USD BN)
TABLE 10.14 Companion Diagnostics Market, 2012 - by Leading Regions (USD MM, %)
TABLE 10.15 European Companion Diagnostics Market, 2012 - by Leading Countries (USD MM, %)
TABLE 10.16 Number of KRAS Tests Performed in France, 2007-2010
TABLE 10.17 Number of EGFR Tests Performed in France, 2008-2011
TABLE 10.18 Number of HER2, KRAS, EGFR and KIT Tests Performed in England, 2010 - 2011
TABLE 10.19 Companion Diagnostics Market, Short-Mid Term Forecast: 2012-2018, by Leading Countries (USD MM)
TABLE 10.20 Companion Diagnostics Market, Long Term Forecast: 2019-2023, by Leading Countries (USD MM)
TABLE 10.21 Abbott Laboratories Sales, 2012 - by Business Segments (USD MM, %)
TABLE 10.22 Abbott Laboratories Sales, 2012 – Diagnostics Segments (USD MM, %)
TABLE 10.23 Qiagen Sales, 2012 - by Business Segments (USD MM, %)
TABLE 10.24 Qiagen Personalised Healthcare Sales, 2012 (USD MM, %)
TABLE 10.25 Agilent Technologies Sales, 2012 - by Business Segments (USD MM, %)
TABLE 10.26 Roche Group Sales, 2012 - by Business Segments (USD MM, %)
TABLE 10.27 Roche Diagnostics Sales, 2012 - by Segments (USD MM, %)
TABLE 10.28 Theranostic Sales, 2012 - by Segments (USD MM, %)
TABLE 10.29 Cost of Genome Sequencing (USD) - per Megabase, 2001-2012
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