The Molecular Diagnostics (MDX) Market Forecast 2014 2024

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Contents

1.1 The Molecular Diagnostics Market Overview

1.2 Molecular Diagnostics Market Segmentation

1.3 Why You Should Read This Report

1.4 How This Report Delivers

1.5 Key Questions Answered by This Analytical Report

1.6 Who is This Report For?

1.7 Methodology

1.8 Frequently Asked Questions (FAQ)

1.9 Associated Reports

1.10 About Visiongain

2.1 What are In Vitro Diagnostic (IVD) Tests?

2.2 Classifying In Vitro Diagnostics

2.2.1 FDA Classifications

2.2.2 IVD Classification in Australia

2.2.3 The EC (European Commission) Classification

2.3 IVD Submarkets

2.3.1 Clinical Chemistry

2.3.2 Immunochemistry

2.3.3 Point-of-care testing (Including Self-monitoring Blood Glucose Tests)

2.3.4 Molecular Diagnostics

2.3.4.1 Infectious Disease Testing

2.3.4.2 Oncology Testing

2.3.4.3 Blood Screening

2.3.4.4 Genetic Testing

1. Report Overview

2. Introduction to Molecular Diagnostics

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Contents 2.3.4.5 Tissue Typing (HLA Testing)

2.3.5 Clinical Microbiology

2.3.6 Haematology/ Haemostasis

2.4 Regulation of the IVD and MDx Market

2.4.1 FDA and CLIA Regulation of IVD and MDx Tests

2.4.1.1 Regulation of IVD/MDx Tests in the EU: The EC (European Commission)

Classification

2.4.2 Top Ten Challenges in Regulation for In-Vitro Diagnostics

2.4.2.1 Challenges in Regulations of MDx tests

2.5 Device Excise Tax: A Threat to the Diagnostics Manufacturers

3.1 Molecular Diagnostics in the IVD Market, 2013

3.2 Sales Forecast for the Global IVD Market 2014-2024

3.3 Molecular Diagnostics Gaining Greater Share of the IVD Market

4.1 The Molecular Diagnostic Market by Sectors, 2013

4.2 The Molecular Diagnostic Market by Sectors 2014-2024

4.2.1 Market Shares of the Molecular Diagnostics Sectors 2014-2024

4.3 The Infectious Disease Testing Market 2014-2024

4.3.1 Breakdown of the MDx Infectious Disease Testing Market by Disease, 2013

4.3.1.1HPV Testing

4.3.1.2 CT/NT

4.3.1.3 HIV

4.3.1.4 Hepatitis C (HCV)

4. The Molecular Diagnostics Market by Sectors, 2014-2024

3. The Molecular Diagnostics Segment Within the In Vitro

Diagnostics Market, 2014-2024

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Contents 4.3.1.5 MRSA/ C. diff

4.4 The Oncology Testing Market, 2014-2024

4.4.1Targeted Therapies: A Major Driver of the Oncology Testing Market

4.4.2 Molecular Diagnostics: Currently Concentrated on a Few Cancer Indications

4.4.2.1 Breast Cancer

4.4.2.2 Prostate Cancer

4.4.2.2.1 Pipeline Biomarker

4.4.2.2.1.1 TMPRSS2-ERG (OriGene)

4.4.2.2.1.2 PTEN

4.4.2.3 Colorectal Cancer

4.5 The Blood Screening Market 2014-2024

4.5.1 Grifols’ Acquisition of Novartis’s Blood Screening Unit

4.5.2 Leading Blood Screening Test Products

4.5.2.1 Cobas s 201 System (Roche Molecular)

4.5.2.2 Procleix Assays (Grifols)

4.6 The Genetic Testing Market 2014-2024

4.6.1 Genetic Testing by Clinical Impact Area

4.6.2 Genetic Testing: Potentially Many More Disease Indications

4.6.3 Cystic fibrosis

4.6.4 Factor V Leiden and Factor II Thrombophilia

4.6.5 Inflammatory diseases

4.6.5.1 Alzheimer’s Disease (AD)

4.6.5.2 Rheumatoid Arthritis

4.6.5.2.1 Vectra®DA (Crescendo Bioscience)

4.6.5.2.2 Quest Diagnostics: Biomarker Study

4.6.5.3 Rare Diseases

4.7 The Tissue Typing (HLA) Market 2014-2024

4.7.1 Tissue Typing: Next Generation Sequencing

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Contents

5.1 Regional Breakdown of the Global MDx Market, 2013

5.2 The Global MDx Market Forecast, 2014-2024

5.3 The Regional Market Shares of the MDx Market, 2014-2024

5.4 The US MDx Market 2013: Representing More than Half of the Global Market

5.4.1 The US MDx Market Forecast 2014-2024

5.4.1.1 United States: Diagnostic Reimbursement

5.5 The European MDx Markets Forecast,2014-2024

5.5.1 Changes in the Shares of the Leading European Markets, 2014-2024

5.5.2 The German MDx Market Forecast 2014-2024

5.5.3 The French MDx Market Forecast 2014-2024

5.5.4 The Italian MDx Market Forecast 2014-2024

5.5.5 The Spanish MDx Market Forecast 2014-2024

5.5.6 The UK MDx Market Forecast 2014-2024

5.5.7 The Other European MDx Markets Forecast 2014-2024

5.6 The Japanese MDx Market Forecast 2014-2024

5.7 The Chinese MDx Market Forecast 2014-2024

5.7.1 China: Increasing Cancer Burden

5.8 The Brazilian MDx Market Forecast 2014-2024

5.9 The Russian MDx Market Forecast 2014-2024

5.10 The Indian MDx Market Forecast 2014-2024

5.10.1 India: Expansion of Healthcare Provisions

5.11 The South Korean MDx Market Forecast 2014-2024

5.12 The Mexican MDx Market Forecast 2014-2024

5.13 The Rest of the World Market Forecast 2014-2024

5. The Leading Molecular Diagnostics National Markets, 2014-2024

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Contents

6.1 Roche Diagnostics

6.1.1 Roche: Global Presence

6.1.2 Roche Diagnostics, 2014-2024

6.1.3 Roche Diagnostics Business Performance within the IVD Market, 2013

6.1.3.1 Molecular Diagnostics Sales Performance, 2013

6.1.3.2 Molecular Diagnostic Sales by Region, 2013

6.1.4 Roche Diagnostics: MDx Product Launches and Indication Expansion, 2014

6.1.4.1 Roche Diagnostics: Product Launch Plans, 2014

6.1.4.2 Roche: Recent M&A Activity and Strategic Partnerships

6.2 Hologic Gen-Probe

6.2.1 Hologic Recent Sales Performance by Business Segment, 2013

6.2.2 Hologic Molecular Diagnostics: Product Portfolio

6.2.3 Product Pipeline: Infectious Disease Focus, but Prostate Cancer Diagnostics Shows

Promise

6.2.4 Changes in Molecular Diagnostic Operations Structuring

6.3 Qiagen

6.3.1 Sales and Recent Performance Analysis, 2013

6.3.2 Qiagen Sales by Region, 2013

6.3.3 Qiagen Sales by Segment, 2013

6.3.4 Qiagen: Molecular Diagnostics

6.3.5 Molecular Diagnostics: Product Expansion

6.3.5.1 QIASymphony

6.3.5.2 QuantiFERON-TB Gold: Expansion into China

6.3.5.3 Personalised Healthcare: Collaborative Efforts

6.3.5.4 Bioinformatics: Software Company Acquisitions

6.4 Becton, Dickinson & Company

6. The Leading Companies in the Molecular Diagnostics Market,

2014-2024

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Contents 6.4.1 Sales and Financial Performance, 2013

6.4.2 Sales and Financial Performance by Region, 2013

6.4.3 Becton Dickinson Diagnostics Sales and Financial Performance, 2012-2013

6.4.4 BD Diagnostics: Product Portfolio

6.4.5 BD Diagnostics: Mergers and Acquisitions

6.5 BioMérieux

6.5.1 Sales and Recent Performance Analysis, 2010-2013

6.5.2 Sales by Region, 2013

6.5.3 Sales by Technology, 2013

6.5.4 Molecular Diagnostics: Product Portfolio

6.5.5 Companion Diagnostics: Collaboration with GSK

6.5.6 Mergers and Acquisitions

6.5.7 bioTheranostics: Subsidiary for Oncology Diagnostics

6.6 Cepheid

6.6.1 Sales and Recent Performance Analysis, 2010-2013

6.6.2 Sales by Industry Segment, 2012-2013

6.6.3 Sales by Region, 2012-2013

6.6.4 Cepheid: Product Line

6.6.5 Cepheid: Business strategy

6.7 Agilent (Dako)

6.7.1 Sales and Recent Performance Analysis, 2013

6.7.2 Sales Performance by Business Segment, 2013

6.7.3 Agilent: Strong Player in Next Generation Sequencing

7.1 MDx Market: Drivers and Restraints

7.2 SWOT Analysis of the MDx Market, 2014-2024

7.3 Strength

7.3.1 Patient Demographics

7. Qualitative Analysis of the MDx Market, 2014-2024

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Contents 7.3.2 Increased Awareness

7.3.3 High Growth in Oncology Molecular Diagnostics

7.3.4 Increasing Laboratory Test Menus

7.3.5 Personalised Medicine: Optimising Treatment Outcomes

7.4 Weaknesses

7.4.1 Lack of Clear Regulatory Guidelines for Molecular Diagnostics

7.4.2 Reimbursement Challenges for Molecular Diagnostic Companies

7.4.2.1 Consolidation of Healthcare Systems Increases Pricing Pressure

7.4.2.2 Reimbursement Uncertainty Discourages Capital Investment

7.4.3 MDx: An Expensive, but Undervalued Diagnostic Tool

7.5 Opportunities

7.5.1 Next-generation Sequencing

7.5.2 Emerging Markets

7.5.3 The Emergence of New Microorganisms

7.6 Threats

7.6.1 US Medical Device Excise Tax

7.6.2 Gene Patents: Controversial Ruling

7.7 Porter’s Five Forces Analysis of the MDx Market

7.7.1 Rivalry Among Competitors [High]

7.7.2 Threat of New Entrants [Medium]

7.7.3 Power of Suppliers [Medium]

7.7.4 Power of Buyers [High]

7.7.5 Threat of Substitutes [High]

8.1 Mike Nugent, Worldwide Market Segment Leader BD MAX, BD Diagnostics

8.1.1 Becton Dickinson’s Leadership in Infectious Disease Molecular Diagnostics

8.1.2 BD MAX System: Becton Diagnostics Leading Product

8.1.3 The Changing Landscape of the MDx Industry

8. Expert Opinions

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Contents 8.1.4 Cost: A Deterrent of MDx Use

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9.1 The Molecular Diagnostics Market: Growing Market Share

9.2 Molecular Diagnostics: Oncology Testing Market Growth

9.3 Commercial Drivers of the Molecular Diagnostics Market

9.4 Commercial Restraints of the Molecular Diagnostics Market

9.5 Emerging Markets

9.6 Concluding Remarks

9. Conclusions

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The Molecular Diagnostics (MDx) Market Forecast 2014-2024: Opportunities for Leading Companies

4.4.2.2.1 Pipeline Biomarker

4.4.2.2.1.1 TMPRSS2-ERG (OriGene) The TMPRSS2-ERG gene rearrangements are commonly present in prostate cancer. The over-

expression of ERG has been considered as a specific prostate cancer biomarker. OriGene has

developed a powerful tool for detecting ERG over-expression using TissueScan™ Tissue cDNA

Arrays which contain panels of first strand cDNAs converted from RNA from cancer and normal

tissues.

4.4.2.2.1.2 PTEN Loss PTEN, known as a tumour suppressor gene, inhibits androgen receptor signalling and causes

resistance to androgen receptor-based therapies. PTEN deletion also has been associated with

poor outcomes, suggesting it may be of both prognostic and predictive importance.

4.4.2.3 Colorectal Cancer Colorectal cancer is the third most common cause of cancer-related death in the US. One strategy

to reduce the burden of colorectal cancer is to develop strategies for colorectal cancer screening

that will result in earlier detection. The CDC estimates that if everyone age 50 or older had regular

screening tests as recommended, at least 60% of colorectal cancer deaths could be avoided. The

current gold standard screening method for colon cancer is a colonoscopy. However, in August

2014, the US FDA approved the first non-invasive DNA screening test for colorectal cancer.

Cologuard, manufactured by Exact Sciences, analyses both stool DNA and blood biomarkers and

Table 4.14 Selected List of FDA Approved MDx tests for Prostate Cancer, 2014 Test Tumour Type Manufacturer Biomarker(s)

The CELLSEARCH® Circulating Tumor Cell Kit

Breast, prostate, colorectal Janssen Diagnostics

CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+ levels

Oncotype DXBreast, prostate, colorectal Genomic Health multiple biomarkers

Prolaris® Prostate Myriad Geneticsexpression levels of cell replication genes

PROGENSA® PCA3 test Prostate DiagnoCureProstate cancer gene 3 (PCA3 or DD3)

NADiA ProsVue Prostate Iris Molecular Diagnostics PSA levels in human serum Source: Visiongain2014

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traditionally uninsured such as those from low-income backgrounds. As of 2013 nearly every

Mexican has healthcare coverage, of which around 50% are covered by public insurance and

social security through their employer, 3% are privately covered, and practically all of the

remainder are covered by Seguro Popular.

Coverage of the Mexican population under the Seguro Popular insurance system increased from

10 million in 2004 to over 50 million by 2012, representing near-universal enrolment for the

previously uninsured. There was a corresponding expansion in healthcare infrastructure, including

the construction of 15 specialty centres, 200 hospitals and 2,000 clinics between 2001 and 2011,

and a roughly 50% expansion in the number of physicians. Consequently, public expenditure on

medicines has been increasing steadily. These radical expansions of the healthcare system should

allow for a growing number of MDx tests to be made available for use in the public healthcare

system.

Table 5.19 The Mexican MDx Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2013-2024

2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024Mexico ($bn) 0.03 0.04 0.04 0.05 0.06 0.07 0.09 0.10 0.12 0.15 0.17 0.21AGR (%) 18.0 18.1 18.3 18.3 18.4 18.5 18.5 18.6 18.6 18.7 18.7CAGR (%) 2013-2018CAGR (%) 2013-2024

18.2 2018-2024 18.618.4

Source: Visiongain2014

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diagnostic company Ipsogen. After the completion of that deal, Qiagen moved to acquire all

remaining shares of the French cancer molecular diagnostic firm. This acquisition has expanded

Qiagen’s portfolio of molecular diagnostic tests. From January 1st 2013, Ipsogen has changed its

Company name to Qiagen Marseille.

6.3.1 Sales and Recent Performance Analysis, 2013 In 2013, Qiagen achieved sales of $1301.98m, which was a 3.8% increase in sales from the

previous year. However, from 2009-2013, Qiagen have been facing a downward trend in profit

margin from 13.6% in 2009 to 5.3% in 2013. The decline in net income was reported to primarily be

due to the impacts of Qiagen’s recent restructuring efforts. The company have funded their growth

through internally generated funds, debt, and private and public sales of equity securities.

6.3.2 Qiagen Sales by Region, 2013 The U.S. represented the largest regional share of sales, generating 40.9% of Qiagen’s revenue,

followed closely by Europe with 37.0% of sales. The U.S. revenue sales in 2013 were $532.65m.

Figure 6.6Qiagen:Revenue ($m), Net Income ($m) and Profit Margin (%), 2009-2013

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Source: Qiagen 2013, Visiongain2014