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The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
The Companion Diagnostics (CDx) 2014 2024
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The Companion Diagnostics (CDx) 2014 2024

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For an Executive Summary of this report please contact ediz.ibrahim@visiongain.com (+44 (0)20 7549 9976) or refer to our website …

For an Executive Summary of this report please contact ediz.ibrahim@visiongain.com (+44 (0)20 7549 9976) or refer to our website http://www.visiongain.com/Report/1173/The-Companion-Diagnostics-%28CDx%29-Market-2014-2024

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  • 1. The Companion Diagnostics (CDx) Market 2014-2024 ©notice This material is copyright by visiongain. It is against the law to reproduce any of this material without the prior written agreement of visiongain. You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each purchase and single copy is for personal use only.
  • 2. Contents 1. Executive Summary 1.1 Overview of Findings 1.2 Aims, Scope and Format of the Report 1.2.1 Chapter Outline 1.3 Research and Analysis Methods 2. Introduction to Companion Diagnostics 2.1 Companion Diagnostic Overview 2.2 What is Personalised Medicine? 2.3 In Vitro Diagnostics (IVD) and Targeted Therapies: The Core of Personalised Medicine 2.3.1 What are In Vitro Diagnostic (IVD) Tests? 2.3.2 How IVDs Help Provide Personalised Treatment 2.4 Companion Diagnostics: Tools for Personalised Medicine 2.4.1 Theranostics: A Subset of Companion Diagnostics 2.5 Biomarkers to Companion Diagnostics 2.5.1 Genomic Biomarkers 2.5.2 Genomic Biomarkers in Oncology 2.6 Development of Companion Diagnostics 3. The World Companion Diagnostics Market 2014-2024 3.1 Scope and Limitations 3.2 The World Companion Diagnostics Market 2012-2013 3.3 Sales Forecast for Global Companion Diagnostics Market, 2014-2024 3.4 Companion Diagnostics is One of the Fastest Growing Segments in the IVD Market www.visiongain.com
  • 3. Contents 3.4.1 Companion Diagnostics Gaining Greater Share of the IVD Market 3.5 Breakdown of the Companion Diagnostics Market by Segment 3.6 How Fast will the Theranostics Market Grow to 2024? 3.6.1 Theranostics Gaining Greater Share of the Companion Diagnostics Market 4. Leading National Markets for Companion Diagnostics 2014-2024 4.1 Leading National Markets for Companion Diagnostics 4.1.2 Leading National Markets for Companion Diagnostics: Market Forecast 2014-2024 4.2 The US Companion Diagnostic Market 2014-2024 4.2.1 The US Continues to be the Largest Market 4.3 The Japanese Companion Diagnostics Market 2014-2024 4.4 The EU5 Markets Forecast 2014-2024 4.4.1 Companion Diagnostics Trends in the EU5 Markets 4.4.2 The German Companion Diagnostic Market 2014-2024 4.4.3 The French Companion Diagnostic Market 2014-2024 4.4.4 The Italian Companion Diagnostics Market 2014-2024 4.4.5 The Spanish Companion Diagnostics Market 2014-2024 4.5.6 The UK Companion Diagnostics Market 2014-2024 4.5 The Chinese Companion Diagnostics Market 2014-2024 4.6 The Indian Companion Diagnostics Market 2014-2024 5. Competitive Environment and Current Business Models in the Companion Diagnostics Market 5.1 Competitive Landscape 2012-2013 5.2 Stakeholders in the Companion Diagnostics Market www.visiongain.com
  • 4. Contents 5.2.1 Regulatory Authorities 5.2.2 Testing Laboratories 5.2.3 Physicians and Patients 5.2.4 Payers 5.3 Business Models for the Development of Companion Diagnostics 5.4 Market for Companion Diagnostics: Small, but Growing 5.5 A Complex Market with Multiple Regulatory Pathways 5.6 Oncology is the Leading Indication for the Development of Companion Diagnostics 5.7 Factors Driving Companies to Enter the Companion Diagnostics Market 5.7.1 Regulatory Authorities Promoting the Development of Companion Diagnostics 5.7.2 Benefits of Employing Companion Diagnostics: Perspective of Pharmaceutical and Diagnostic Companies 5.8 Companies in the Companion Diagnostics Market 5.8.1 Companies in the Companion Diagnostics Market: Developing Products and Providing Services 5.8.2 Few Pharmaceutical Companies Have Dedicated Diagnostics Units 5.8.3 Collaborating with Pharmaceuticals: A Win-Win for Diagnostic Companies 6. Leading Companies in the Companion Diagnostic Market 6.1 Roche: Leaders in Companion Diagnostics 6.1.1 Sales and Recent Performance Analysis, 2012-2013 6.1.2 Roche Diagnostics by Region, 2012 6.1.3 Pipeline Drugs 6.1.4 Roche’s Growing Portfolio of Companion Diagnostics 6.2 Qiagen: Growing on the Partnership Model 6.2.1 Sales and Recent Performance Analysis, 2012 6.2.2 Qiagen’s Strategy for the Future www.visiongain.com
  • 5. Contents 6.2.3 Provider of Choice for Molecular Companion Diagnostics 6.2.4 New Products on Qiagen’s list 6.3 Myriad Genetics 6.3.1 Sales and Recent Performance Analysis, Myriad Genetics 6.3.2 Myriad Genetics’ M&A Activity and Recent Partnerships 6.3.2.1 Acquisition of Myriad RBM 6.3.2.2 Myriad RBM 6.3.2.3 Strategic Debt Investment in Crescendo Bioscience 6.3.2.4 Agreement with Cephalon 6.3.2.5 Agreement with Tesaro 6.3.2.6 Agreement with PharmaMar 6.3.3 New Growth Opportunities 6.4 Siemens Diagnostics 6.4.1 Siemens Healthcare Research and Development for Diagnostics 6.4.2 Outperforming the Market 6.4.3 Siemens Partnerships 6.4.3.1 Partnership with ViiV Healthcare 6.4.3.2 Partnership with Tocagen 6.4.3.3 Collaboration with Janssen Pharmaceutical 6.5 Abbott Molecular 6.5.1 Sales and Recent Performance Analysis, 2012 6.5.2 Recent M&A Activity and Strategic Collaborations 6.5.2.1 Collaboration with GSK 6.5.2.2 Collaboration with Merck 6.5.2.3 Acquisition of STARLIMS Technologies 6.5.2.4 Acquisition of Ibis Biosciences, Inc. 6.6 BioMérieux 6.6.1 Recent M&A Activity and Collaborations 6.6.1.1 Partnership with GSK 6.6.1.2 Partnership with Ipsen www.visiongain.com
  • 6. Contents 6.6.1.3 Partnership with Institute Merieux and Institute Pasteur 6.6.1.4 Collaboration with Hospices Civils de Lyon 6.6.1.5 Acquisition of ARGENE 6.6.1.6 Equity Interest in Knome, Inc. 6.6.1.7 Partnership with Thermo Fisher Scientific Inc. 6.6.1.8 Partnership with Genome Institute 6.6.1.9 Exclusive rights to Quanterix’s Simoa 6.7 Danaher 6.7.1 Sales and Recent Performance Analysis, 2012 6.7.2 Danaher’s Acquisitions 6.7.2.1 Acquisition of Leica Microsystems 6.7.2.2 Acquisition of Vision Systems 6.7.2.3 Acquisition of Genetix 6.7.2.4 Acquisition of Beckman Coulter 6.7.2.5 Acquisition of Iris International and Aperis Technologies 7. SWOT Analysis of the Companion Diagnostics Market 7.1 Introduction 7.2 Strengths 7.2.1 Maximising Benefits to Healthcare Stakeholders 7.2.2 Helps Stratify Patient Population on the Basis of Safety and Effectiveness 7.2.3 Increasing Signals from Regulators of Support for Companion Diagnostics 7.2.4 Increasing Compliance 7.2.5 Reduce Adverse Drug Reactions 7.2.6 Reducing the Cost of Healthcare 7.3 Opportunities 7.3.1 Fast Growing Emerging Markets 7.3.2 Many New partnerships and Business Models www.visiongain.com
  • 7. Contents 7.3.3 Emerging therapeutic Areas in the Market 7.3.4 Reviving Failed or Withdrawn Drugs 7.3.5 Many Oncology Drugs in Pipeline with Companion Diagnostics 7.4 Weaknesses 7.4.1 Reimbursement Challenges for Diagnostic Companies 7.4.2 Lack of Clear Regulatory Guidelines on Companion Diagnostics 7.4.3 Unpredictable Clinical Efficacy of Companion Diagnostic 7.4.4 Difficult Development Coordination 7.5 Threats 7.5.1 Complex Business Models and Business Partnerships 8. Expert Opinion 8.1 Interview with Arsalan Kharazmi, Ph.D, CEO of Biomonitor A/S 8.1.1 The Importance of Cell-Based Assays as a Companion Diagnostic Test 8.1.2 The Potential Growth of the Theranostics Market 8.1.3 The Potential in Emerging Markets 8.1.4 The Business Model for Theranostics 8.1.5 The Competitive Landscape for Companion Diagnostics 8.2 Interview with Ardy Arianpour, MBA, Senior Vice President of Business Development at Ambry Genetics 8.2.1 The Future for Companion Diagnostics 8.2.2 The Business Model for Companion Diagnostic Market 8.2.3 The Challenges in Companion Diagnostics www.visiongain.com
  • 8. Contents 9. Conclusions 9.1 Overview 9.2 Prominent Companies in the Market 9.3 Companion Diagnostics Are Changing the Traditional Pharmaceutical Model 9.4 Commercial Drivers of the Companion Diagnostics Market 9.5 Personalised Medicine is a Strong Driver of the Theranostics Sector 9.6 Emerging Markets 9.7 Commercial Restraints in the Companion Diagnostics Market 9.8 Targeted Therapies Are Revolutionising the Current Model of Pharmaceutical R&D 9.9 Future Outlook and Concluding Remarks www.visiongain.com
  • 9. Contents List of Tables Table 2.1 Differences Between Traditional & Personalised Medicine, 2013 Table 2.2 List of Approved Drugs Paired with a Companion Diagnostic, 2012-2013 Table 2.3 Examples of Clinically Relevant Cancer Biomarkers Table 3.1 World In Vitro Diagnostics Market: Revenues ($bn) and Market Share (%) by Segment, 2012 Table 3.2 World Companion Diagnostics Market: Revenues ($bn), AGR (%), CAGR (%), 20122017 Table 3.3 World Companion Diagnostics Market: Revenues ($bn), AGR (%), CAGR (%), 20182024 Table 3.4 Market Shares (%) of Companion Diagnostics in the IVD Market, 2012, 2017 & 2024 Table 3.5 World Companion Diagnostics Market: Revenues ($bn) and Market Shares (%) by Segment, 2012 Table 3.6 World Companion Diagnostics Market Forecast: Revenues ($bn), AGR (%), CAGR (%) by Segment. 2012-2017 Table 3.7 World Companion Diagnostics Market Forecast: Revenues ($bn), AGR (%), CAGR (%) by Segment. 2018-2024 Table 3.8 Market Shares (%) of Theranostics in the Companion Diagnostics Market in 2012, 2017 & 2024 Table 4.1 The Leading National Markets for Companion Diagnostics ($m), 2012 Table 4.2 The Leading National Companion Diagnostics Market Forecast : Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 4.3 The Leading National Companion Diagnostics Market Forecast : Revenues ($m), AGR (%), CAGR (%), 2018-2024 Table 4.4 The US Companion Diagnostics Market Forecast : Revenues ($m), AGR (%), CAGR (%), 2012-2017 www.visiongain.com
  • 10. Contents Table 4.5 The US Companion Diagnostics Market Forecast : Revenues ($m), AGR (%), CAGR (%), 2018-2024 Table 4.6 The Japanese Companion Diagnostics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 4.7 The Japanese Companion Diagnostics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2018-2024 Table 4.8 EU5 Companion Diagnostic National Market Forecasts: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 4.9 EU5 Companion Diagnostic National Market Forecasts: Revenues ($m), AGR (%), CAGR (%), 2018-2024 Table 4.10 The German Companion Diagnostics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 4.11 The German Companion Diagnostics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2018-2024 Table 4.12 The French Companion Diagnostics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 4.13 The French Companion Diagnostics Market Forecast :Revenues ($m), AGR (%), CAGR (%), 2018-2024 Table 4.14 The Italian Companion Diagnostics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 4.15 The Italian Companion Diagnostics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2018-2024 Table 4.16 The Spanish Companion Diagnostics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 4.17 The Spanish Companion Diagnostics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2018-2024 Table 4.18 The UK Companion Diagnostics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 4.19 The UK Companion Diagnostics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2018-2024 www.visiongain.com
  • 11. Contents Table 4.20 The Chinese Companion Diagnostics Market Forecasts: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 4.21 The Chinese Companion Diagnostics Market Forecasts: Revenues ($m), AGR (%), CAGR (%), 2018-2024 Table 4.22 The Indian Companion Diagnostics Market Forecasts: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 4.23 The Indian Companion Diagnostics Market Forecasts: Revenues ($m), AGR (%), CAGR (%), 2018-2024 Table 5.1 Growth of Companion Diagnostics: Benefits for Pharmaceutical and Diagnostic Companies, 2013 Table 5.2 List of Other Companies in the Companion Diagnostics Market, 2013 Table 6.1 Roche: Revenue ($bn) and Revenue Shares (%) by Sector, 2012 Table 6.2 Roche Diagnostics: Revenue ($bn) and Revenue Shares (%), by Region 2012 Table 6.3 Roche Diagnostics: List of Selected Products with an In-house Companion Diagnostic Drug Program Table 6.4 Roche Diagnostics: List of Marketed Companion Diagnostics, 2013 Table 6.5 Qiagen: Sales ($m) by Business Sector, 2012 Table 6.6 Myriad Genetics: Revenue ($m), and Shares (%) by Sector, 2012 Table 6.7 Myriad Genetics: Revenue ($m), Revenue Share (%), Percentage Change (%) by Product, 2011-2012 Table 6.8 Myriad Genetics: Biomarker Product Portfolio, 2013 Table 6.9 Siemens Diagnostics: Ranking (#) by Sector, 2011 Table 6.10 Abbott Molecular: Diagnostics Sales ($m) by Division in the US and Internationally, 1Q13 Table 6.11 Biomérieux: Revenues Sales ($m), Percentage Change (%) by Region, 2011-2012 Table 6.12 Danaher: Revenue Shares (%) by Segment, 2010-2012 Table 6.13 Danaher Life Sciences and Diagnostics: Revenue Shares (%) by Region, 2012 Table 7.1 SWOT Analysis of the Companion Diagnostics Market, 2012-2024 Table 7.2 Average Response Rates to Treatment for Various Diseases, 2013 Table 7.3 Drugs Metabolised by CYP450: 2C19 and 2D6, 2012 www.visiongain.com
  • 12. Contents Table 7.4 List of Recent Companion Diagnostics Partnerships, 2013 Table 9.1 Theranostics and Other Diagnostics: World Sales Forecast ($bn), 2012, 2017, and 2024 www.visiongain.com
  • 13. Contents List of Figures Figure 2.1 The Pillars of Personalised Medicine Figure 2.2 Type of Companion Diagnostics on the Basis of Purpose/Use, 2012 Figure 2.3 Development of Biomarkers into Companion Diagnostics, 2013 Figure 3.1 World Companion Diagnostics Market Share (%) in the IVD Market, 2012 Figure 3.2 World IVD and Companion Diagnostics Market: Sales Forecast ($bn), 2012-2024 Figure 3.3 World Companion Diagnostics Market and IVD Market Forecast: AGRs (%), 20132024 Figure 3.4 World Companion Diagnostics Market Share (%) in the IVD Market, 2017 Figure 3.5 World Companion Diagnostics Market Share (%) in the IVD Market, 2024 Figure 3.6 World Companion Diagnostics Market: Market Shares (%) by Segment, 2012 Figure 3.7 World Companion Diagnostics Sub-Markets: Sales Forecasts ($bn), 2012-2024 Figure 3.8 Companion Diagnostics Market Shares (%) by Sector in the IVD Market, 2012 Figure 3.9 World Theranostics Market Share (%) in the Companion Diagnostics Market, 2012 Figure 3.10 Market Shares (%) of Theranostics in the Companion Diagnostics Market, 2017 Figure 3.11 Market Shares (%) of Theranostics in the Companion Diagnostics Market, 2024 Figure 4.1 The Leading National Markets for Companion Diagnostics by Market Share (%), 2012 Figure 4.2 The Companion Diagnostics Market Forecast: Revenues ($m) by Region, 2012-2017 Figure 4.3 The Companion Diagnostics Market Forecast: Revenues ($m) by Region, 2018-2024 Figure 4.4 The US Companion Diagnostics Market Forecast ($m), 2012-2024 Figure 4.5 The Japanese Companion Diagnostics Market Forecast ($m), 2012-2024 Figure 4.6 The EU5 Companion Diagnostics Market Forecast ($m) by Country, 2012-2024 Figure 4.7 EU5 Market Breakdown by Country: Market Shares (%), 2012 Figure 4.8 The German Companion Diagnostics Market Forecast ($m), 2012-2024 Figure 4.9 The French Companion Diagnostics Market Forecast ($m), 2012-2024 Figure 4.10 The Italian Companion Diagnostics Market Forecast ($m), 2012-2024 Figure 4.11 The Spanish Companion Diagnostics Market Forecast ($m), 2012-2024 Figure 4.12 The UK Companion Diagnostics Market Forecast ($m), 2012-2024 www.visiongain.com
  • 14. Contents Figure 4.13 The Chinese Companion Diagnostics Market Forecast ($m), 2012-2024 Figure 4.14 The Indian Companion Diagnostics Market Forecasts ($m), 2012-2024 Figure 5.1 Stakeholders in the Companion Diagnostics Market, 2013 Figure 5.2 Current Business Models for the Development of Companion Diagnostics, 2012 Figure 6.1 Roche: Revenue Shares (%) by Sector, 2012 Figure 6.2 Roche: Revenues ($bn) by Sector, 2012 Figure 6.3 Roche: Revenues ($bn) by Sector, 1Q 2013 Figure 6.4 Qiagen: Revenue ($m), Net Income ($m) and Profit Margin (%), 2008-2012 Figure 6.5 Myriad Genetics: Historical Net Revenues ($m), 2005-2012 Figure 6.6 Myriad Genetics: Revenue Shares (%) by Product , 2012 Figure 6.7 Siemens Diagnostics: Profit ($m), 2011-2012 Figure 6.8 Abbott Molecular Diagnostic: Historical Sales ($m), 2010-2012 Figure 6.9 Abbott Laboratories: Sales (%), by Division, 2012 Figure 6.10 BioMeriéux: Sales ($m), 2011-2012 Figure 6.11 Biomeriéux: Sales by Region (%), 2012 Figure 6.12 Biomeriéux: Sales by Region ($m), 2012 Figure 6.13 Danaher Life Sciences and Diagnostics: Revenue Shares (%) by Region, 2012 Figure 7.1 Average Response Rates (%) for Various Diseases, 2013 Figure 7.2 Number of Companion Diagnostics Partnering by Therapeutic Area Since 2007 Figure 7.3 Developing Oncology Drugs Breakdown by Biomarker (%) Figure 9.1 Companion Diagnostics Market: World Sales Forecast ($bn), 2012, 2017, and 2024 Figure 9.2 Theranostics and Other Diagnostics: World Sales Forecast ($bn), 2012, 2017, and 2024 Figure 9.3 Companion Diagnostics Market Forecast: AGRs (%) in India, China and Global Market, 2012-2024 www.visiongain.com
  • 15. Contents Companies Listed Abbott Molecular Agendia Alacris Theranostics GmbH AltheaDx Ambry Genetics Amgen ARGENE ARIAD Pharmaceuticals Astellas AstraZeneca Beckman Coulter BioMérieux Biomonitor Boehringer Ingelheim Brain Resource Company Bristol-Myers Squibb CancerGuide Diagnostics Caprion Proteomics Caris Life Sciences Celera (acquired by Quest Diagnostics in May 2011) Cell Signalling Technologies Cephalon Cepheid ChemGenex Pharmaceuticals Clinical Reference Laboratory CompanDx Crescendo Bioscience www.visiongain.com
  • 16. Contents Curidium Medica Cytyc Corporation Dako Danaher DiagnoCure Dx assays DxS Eli Lilly Endocyte Exosome Diagnostics Flagship Biosciences Foundation Medicine Genentech Genetix Genfit GenMark Diagnostics Genome Institute Genomic Health GSK Hatteras Venture Partners HistologiX Hospices Civils de Lyon Ibis Biosciences, Inc. ImCloneSystems InDex Pharmaceuticals Institute Merieux Institute Pasteur Intersouth Partners Inverness Medical Innovations Invivoscribe www.visiongain.com
  • 17. Contents Ipsen Ipsogen Iris International and Aperis Technologies Janssen Pharmaceutical Kimball Genetics (a division of LabCorp) Knome, Inc Lab21 Laboratory for Personalized Molecular Medicine Leica Leica Microsystems Life Technologies Merck Molecular MD Myriad Genetics Myriad RBM Nanosphere Novartis Opko Health OSI Pharmaceuticals Oxford BioTherapeutics (earlier Oxford Genome Sciences) Pfizer PharmaMar Progenika Biopharma Prometheus Qiagen Quanterix Quintiles Transnational Corporation Randox Pharma Services RAS Lifesciences Pvt. Ltd (RAS) RiboMed Biotechnologies www.visiongain.com
  • 18. Contents Roche Molecular Systems Rules-Based Medicines Inc. Saladax Biomedical Siemens Signal Genetics Sirius Genetics Skyline Diagnostics STARLIMS technologies Takeda Target Discovery TcLand Expression Telegraph Hill Partners Tesaro Teva Pharmaceutical Industries Theranostics (NZ) Theranostics Health Thermo Fisher Scientific Inc. Third Wave Technologies (a wholly owned subsidiary of Hologic) TIB MolBiol Tocagen Tragara Pharmaceuticals Transgene Transgenomic TrimGen Corporation Unilabs Ventana Medical Systems ViiV Healthcare Vision Systems Weisenthal Cancer Group Zinfandel www.visiongain.com
  • 19. Contents Other Organisations Mentioned in This Report Cancer Research UK Columbia University European Medicines Agency (EMA) Food and Drug Administration (FDA) Haute Autorité de Santé (HAS) Medical Research Council National Health Service (NHS) National Institute for Health and Care Excellence (NICE) National Institutes of Health (NIH) ServizioSanitarioNazionale (SSN) The Association of British Pharmaceutical Industries (ABPI) Tufts Center for the Study of Drug Development www.visiongain.com
  • 20. The Companion Diagnostics (CDx) Market 2014-2024 4.4.3 The French Companion Diagnostic Market 2014-2024 The French companion diagnostics market will rise steadily over the forecast period from $114.80m in 2012 to $260.92m in 2024. The compound annual growth rate will remain steady at 7% throughout the forecast period (table 4.12, table 4.13 and figure 4.9). The French population is almost universally covered (99% of the population) by statutory health insurance (Assurancemaladie), managed by the Haute Autorité de Santé (HAS). France has long been thought as one of the most generous national healthcare care systems. It is currently making modest cuts in the healthcare system in an effort to control government spending. Recently, the French healthcare system has become more selective in terms of reimbursement. The idea of taking or keeping some services off the list is now accepted, especially in terms of drugs and new products. On the one hand, this will benefit the companion diagnostics markets because physicians may use companion diagnostics to be more discerning about which sub-population would benefit from a particular drug. On the other hand, the current national health system has a very high level of extra billing for medical devices and this may hinder the ready adoption of companion diagnostics into the market. Table 4.12 The French Companion Diagnostics Market Forecast: Revenues ($m), AGR (%), CAGR (%), 2012-2017 2012 2013 2014 2015 2016 2017 114.80 121.69 128.99 138.02 147.68 159.49 6 France ($m) 6 7 7 8 Annual Growth Rate (%) CAGR (%, 2012-2017) 7 Source: Visiongain 2013 Table 4.13 The French Companion Diagnostics Market Forecast :Revenues ($m), AGR (%), CAGR (%), 2018-2024 2018 France ($m) 2019 2020 2021 2022 2023 2024 172.25 186.03 199.06 212.99 227.90 243.85 260.92 8 8 7 7 7 7 7 Annual Growth Rate (%) CAGR (%, 2018-2024) CAGR (%, 2012-2024) 7 7 Source: Visiongain 2013 www.visiongain.com Page 61
  • 21. The Companion Diagnostics (CDx) Market 2014-2024 Figure 5.2 Current Business Models for the Development of Companion Diagnostics, 2012 Source: Visiongain 2013 5.4 Market for Companion Diagnostics: Small, but Growing The companion diagnostic market is relatively new, but fast growing. The first companion diagnostic – Her2/neu test – received market approval in 1998, along with the approval of breast cancer drug Herceptin. Following this, a wave of companion diagnostics has been developed. www.visiongain.com Page 75
  • 22. The Companion Diagnostics (CDx) Market 2014-2024 6.2 Qiagen: Growing on the Partnership Model The UK based Qiagen is one of the leading diagnostic companies, second only to Roche Diagnostics. It is one of the leading diagnostic companies in the field of companion diagnostics, with more than 20 assays available and 15 projects in the pipeline. Qiagen achieved this position in the companion diagnostics sector with the acquisition of UK based DxS in 2009 for $95m. The company opened a global center of excellence for companion diagnostics in Manchester in 2010. In July 2011, the company purchased 62.5% stake in France based diagnostic company Ipsogen. This acquisition will expand Qiagen’s portfolio of molecular diagnostic tests. Ipsogen has a competitive portfolio in haematologic (blood) cancer testing with assays covering 15 biomarkers for patient profiling and monitoring. 6.2.1 Sales and Recent Performance Analysis, 2012 After a difficult year in 2011 where net income was reported to have declined primarily due to the impact of a $75m restructuring charge. However, in 2012, the company looks to be making a turnaround as both net income and profit margins increased the fourth quarter of 2011. They had a five-year CAGR of approximately 14% in net sales and 21 % in net income through to 2012 (figure 6.4). The net sales increased from $1169.75m in 2011 to $1254.46m in 2012. This increase in net sales was driven by business expansion in all customer classes – particularly Molecular Diagnostics and Applied Testing – and all geographic regions. Figure 6.4 Qiagen: Revenue ($m), Net Income ($m) and Profit Margin (%), 2008-2012 Net Income Profit Margin (%) 16 1,254.46 1,169.75 14 1400 Revenue ($m) 1200 1000 892.98 1,009.83 12 1,087.43 10 800 8 600 6 400 200 0 89.03 2008 137.77 2009 144.31 2010 Fiscal Year 4 96.04 2011 129.51 2012 Profit Margin (%) Revenue 2 0 Source: Qiagen 2012; Visiongain 2013 www.visiongain.com Page 92

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