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

1. The Companion Diagnostics (CDx)
Market 2014-2024
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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
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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
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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
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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
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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
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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
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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
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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
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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 ($m), AGR (%), CAGR
(%), 2018-2024
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11. Contents
Table 4.20 The Chinese Companion Diagnostics Market Forecasts: Revenues ($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
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12. Contents
Table 7.4 List of Recent Companion Diagnostics Partnerships, 2013
Table 9.1 Theranostics and Other Diagnostics: World Sales Forecast ($bn), 2012, 2017, and
2024
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13. Contents
List of Figures
Figure 2.1 The Pillars of Personalised Medicine
Figure 2.2 Type of Companion Diagnostics on the Basis of Purpose/Use, 2012
Figure 2.3 Development of Biomarkers into Companion Diagnostics, 2013
Figure 3.1 World Companion Diagnostics Market Share (%) in the IVD Market, 2012
Figure 3.2 World IVD and Companion Diagnostics Market: Sales Forecast ($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 ($m), 2012-2024
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14. Contents
Figure 4.13 The Chinese Companion Diagnostics Market Forecast ($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
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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
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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
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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
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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
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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
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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
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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.
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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
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