©noticeThis material is copyright by visiongain. It is against the law to reproduce any of this material without the prior written agreement of vision-gain. You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each pur-chase and single copy is for personal use only.

The Companion Diagnostics (CDx) Market 2014-2024

www.visiongain.com

Contents

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

2.1 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

3.1 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

1. Executive Summary

2. Introduction to Companion Diagnostics

3. The World Companion Diagnostics Market 2014-2024

www.visiongain.com

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

4.1 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

5.1 Competitive Landscape 2012-2013

5.2 Stakeholders in the Companion Diagnostics Market

4. Leading National Markets for Companion Diagnostics 2014-2024

5. Competitive Environment and Current Business Models in the

Companion Diagnostics Market

www.visiongain.com

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

6.1 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

6. Leading Companies in the Companion Diagnostic Market

www.visiongain.com

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

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

7.1 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

7. SWOT Analysis of the Companion Diagnostics Market

www.visiongain.com

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

8.1 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

8. Expert Opinion

www.visiongain.com

Contents

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

9. Conclusions

www.visiongain.com

Contents

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 (%), 2012-

2017

Table 3.3 World Companion Diagnostics Market: Revenues ($bn), AGR (%), CAGR (%), 2018-

2024

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

List of Tables

www.visiongain.com

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

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

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

Contents

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 (%), 2013-

2024

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

List of Figures

www.visiongain.com

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

Contents

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

Companies Listed

www.visiongain.com

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

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

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

Contents

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

Other Organisations Mentioned in This Report

Page 61

www.visiongain.com

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 (Assurance-

maladie), 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 2017France ($m) 114.80 121.69 128.99 138.02 147.68 159.49Annual Growth Rate (%) 6 6 7 7 8CAGR (%, 2012-2017) 7 Table 4.13 The French Companion Diagnostics Market Forecast :Revenues ($m), AGR (%), CAGR (%), 2018-2024

2018 2019 2020 2021 2022 2023 2024France ($m) 172.25 186.03 199.06 212.99 227.90 243.85 260.92Annual Growth Rate (%) 8 8 7 7 7 7 7CAGR (%, 2018-2024) 7CAGR (%, 2012-2024) 7 Source: Visiongain 2013

Source: Visiongain 2013

Page 75

www.visiongain.com

The Companion Diagnostics (CDx) Market 2014-2024

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.

Figure 5.2 Current Business Models for the Development of Companion Diagnostics, 2012

Source: Visiongain 2013

Page 92

www.visiongain.com

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

892.98 1,009.83

1,087.43

1,169.75 1,254.46

89.03 137.77 144.31 96.04 129.51

0

2

4

6

8

10

12

14

16

0

200

400

600

800

1000

1200

1400

2008 2009 2010 2011 2012

Prof

it M

argi

n (%

)

Rev

enue

($m

)

Fiscal Year

Revenue Net Income Profit Margin (%)

Source: Qiagen 2012; Visiongain 2013