The Molecular Diagnostics (MDX) Market Forecast 2014 2024

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<ul><li> 1. Contents1. Report Overview1.1 The Molecular Diagnostics Market Overview1.2 Molecular Diagnostics Market Segmentation1.3 Why You Should Read This Report1.4 How This Report Delivers1.5 Key Questions Answered by This Analytical Report1.6 Who is This Report For?1.7 Methodology1.8 Frequently Asked Questions (FAQ)1.9 Associated Reports1.10 About Visiongain2. Introduction to Molecular Diagnostics2.1 What are In Vitro Diagnostic (IVD) Tests?2.2 Classifying In Vitro Diagnostics2.2.1 FDA Classifications2.2.2 IVD Classification in Australia2.2.3 The EC (European Commission) Classification2.3 IVD Submarkets2.3.1 Clinical Chemistry2.3.2 Immunochemistry2.3.3 Point-of-care testing (Including Self-monitoring Blood Glucose Tests)2.3.4 Molecular Diagnostics2.3.4.1 Infectious Disease Testing2.3.4.2 Oncology Testing2.3.4.3 Blood Screening2.3.4.4 Genetic</li></ul> <p> 2. Contents2.3.4.5 Tissue Typing (HLA Testing)2.3.5 Clinical Microbiology2.3.6 Haematology/ Haemostasis2.4 Regulation of the IVD and MDx Market2.4.1 FDA and CLIA Regulation of IVD and MDx Tests2.4.1.1 Regulation of IVD/MDx Tests in the EU: The EC (European Commission)Classification2.4.2 Top Ten Challenges in Regulation for In-Vitro Diagnostics2.4.2.1 Challenges in Regulations of MDx tests2.5 Device Excise Tax: A Threat to the Diagnostics Manufacturers3. The Molecular Diagnostics Segment Within the In VitroDiagnostics Market, 2014-20243.1 Molecular Diagnostics in the IVD Market, 20133.2 Sales Forecast for the Global IVD Market 2014-20243.3 Molecular Diagnostics Gaining Greater Share of the IVD Market4. The Molecular Diagnostics Market by Sectors, 2014-20244.1 The Molecular Diagnostic Market by Sectors, 20134.2 The Molecular Diagnostic Market by Sectors 2014-20244.2.1 Market Shares of the Molecular Diagnostics Sectors 2014-20244.3 The Infectious Disease Testing Market 2014-20244.3.1 Breakdown of the MDx Infectious Disease Testing Market by Disease, 20134.3.1.1HPV Testing4.3.1.2 CT/NT4.3.1.3 HIV4.3.1.4 Hepatitis C (HCV) 3. Contents4.3.1.5 MRSA/ C. diff4.4 The Oncology Testing Market, 2014-20244.4.1Targeted Therapies: A Major Driver of the Oncology Testing Market4.4.2 Molecular Diagnostics: Currently Concentrated on a Few Cancer Indications4.4.2.1 Breast Cancer4.4.2.2 Prostate Cancer4. Pipeline Biomarkerwww.visiongain.com4. TMPRSS2-ERG (OriGene) PTEN4.4.2.3 Colorectal Cancer4.5 The Blood Screening Market 2014-20244.5.1 Grifols Acquisition of Novartiss Blood Screening Unit4.5.2 Leading Blood Screening Test Products4.5.2.1 Cobas s 201 System (Roche Molecular) Procleix Assays (Grifols)4.6 The Genetic Testing Market 2014-20244.6.1 Genetic Testing by Clinical Impact Area4.6.2 Genetic Testing: Potentially Many More Disease Indications4.6.3 Cystic fibrosis4.6.4 Factor V Leiden and Factor II Thrombophilia4.6.5 Inflammatory diseases4.6.5.1 Alzheimers Disease (AD) Rheumatoid Arthritis4. VectraDA (Crescendo Bioscience) Quest Diagnostics: Biomarker Study4.6.5.3 Rare Diseases4.7 The Tissue Typing (HLA) Market 2014-20244.7.1 Tissue Typing: Next Generation Sequencing 4. Contents5. The Leading Molecular Diagnostics National Markets, 2014-20245.1 Regional Breakdown of the Global MDx Market, 20135.2 The Global MDx Market Forecast, 2014-20245.3 The Regional Market Shares of the MDx Market, 2014-20245.4 The US MDx Market 2013: Representing More than Half of the Global Market5.4.1 The US MDx Market Forecast 2014-20245.4.1.1 United States: Diagnostic Reimbursement5.5 The European MDx Markets Forecast,2014-20245.5.1 Changes in the Shares of the Leading European Markets, 2014-20245.5.2 The German MDx Market Forecast 2014-20245.5.3 The French MDx Market Forecast 2014-20245.5.4 The Italian MDx Market Forecast 2014-20245.5.5 The Spanish MDx Market Forecast 2014-20245.5.6 The UK MDx Market Forecast 2014-20245.5.7 The Other European MDx Markets Forecast 2014-20245.6 The Japanese MDx Market Forecast 2014-20245.7 The Chinese MDx Market Forecast 2014-20245.7.1 China: Increasing Cancer Burden5.8 The Brazilian MDx Market Forecast 2014-20245.9 The Russian MDx Market Forecast 2014-20245.10 The Indian MDx Market Forecast 2014-20245.10.1 India: Expansion of Healthcare Provisions5.11 The South Korean MDx Market Forecast 2014-20245.12 The Mexican MDx Market Forecast 2014-20245.13 The Rest of the World Market Forecast 5. Contents6. The Leading Companies in the Molecular Diagnostics Market,2014-20246.1 Roche Diagnostics6.1.1 Roche: Global Presence6.1.2 Roche Diagnostics, 2014-20246.1.3 Roche Diagnostics Business Performance within the IVD Market, 20136.1.3.1 Molecular Diagnostics Sales Performance, 20136.1.3.2 Molecular Diagnostic Sales by Region, 20136.1.4 Roche Diagnostics: MDx Product Launches and Indication Expansion, 20146.1.4.1 Roche Diagnostics: Product Launch Plans, 20146.1.4.2 Roche: Recent M&amp;A Activity and Strategic Partnerships6.2 Hologic Gen-Probe6.2.1 Hologic Recent Sales Performance by Business Segment, 20136.2.2 Hologic Molecular Diagnostics: Product Portfolio6.2.3 Product Pipeline: Infectious Disease Focus, but Prostate Cancer Diagnostics ShowsPromise6.2.4 Changes in Molecular Diagnostic Operations Structuring6.3 Qiagen6.3.1 Sales and Recent Performance Analysis, 20136.3.2 Qiagen Sales by Region, 20136.3.3 Qiagen Sales by Segment, 20136.3.4 Qiagen: Molecular Diagnostics6.3.5 Molecular Diagnostics: Product Expansion6.3.5.1 QIASymphony6.3.5.2 QuantiFERON-TB Gold: Expansion into China6.3.5.3 Personalised Healthcare: Collaborative Efforts6.3.5.4 Bioinformatics: Software Company Acquisitions6.4 Becton, Dickinson &amp; 6. Contents6.4.1 Sales and Financial Performance, 20136.4.2 Sales and Financial Performance by Region, 20136.4.3 Becton Dickinson Diagnostics Sales and Financial Performance, 2012-20136.4.4 BD Diagnostics: Product Portfolio6.4.5 BD Diagnostics: Mergers and Acquisitions6.5 BioMrieux6.5.1 Sales and Recent Performance Analysis, 2010-20136.5.2 Sales by Region, 20136.5.3 Sales by Technology, 20136.5.4 Molecular Diagnostics: Product Portfolio6.5.5 Companion Diagnostics: Collaboration with GSK6.5.6 Mergers and Acquisitions6.5.7 bioTheranostics: Subsidiary for Oncology Diagnostics6.6 Cepheid6.6.1 Sales and Recent Performance Analysis, 2010-20136.6.2 Sales by Industry Segment, 2012-20136.6.3 Sales by Region, 2012-20136.6.4 Cepheid: Product Line6.6.5 Cepheid: Business strategy6.7 Agilent (Dako)6.7.1 Sales and Recent Performance Analysis, 20136.7.2 Sales Performance by Business Segment, 20136.7.3 Agilent: Strong Player in Next Generation Sequencing7. Qualitative Analysis of the MDx Market, 2014-20247.1 MDx Market: Drivers and Restraints7.2 SWOT Analysis of the MDx Market, 2014-20247.3 Strength7.3.1 Patient 7. Contents7.3.2 Increased Awareness7.3.3 High Growth in Oncology Molecular Diagnostics7.3.4 Increasing Laboratory Test Menus7.3.5 Personalised Medicine: Optimising Treatment Outcomes7.4 Weaknesses7.4.1 Lack of Clear Regulatory Guidelines for Molecular Diagnostics7.4.2 Reimbursement Challenges for Molecular Diagnostic Companies7.4.2.1 Consolidation of Healthcare Systems Increases Pricing Pressure7.4.2.2 Reimbursement Uncertainty Discourages Capital Investment7.4.3 MDx: An Expensive, but Undervalued Diagnostic Tool7.5 Opportunities7.5.1 Next-generation Sequencing7.5.2 Emerging Markets7.5.3 The Emergence of New Microorganisms7.6 Threats7.6.1 US Medical Device Excise Tax7.6.2 Gene Patents: Controversial Ruling7.7 Porters Five Forces Analysis of the MDx Market7.7.1 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. Expert Opinions8.1 Mike Nugent, Worldwide Market Segment Leader BD MAX, BD Diagnostics8.1.1 Becton Dickinsons Leadership in Infectious Disease Molecular Diagnostics8.1.2 BD MAX System: Becton Diagnostics Leading Product8.1.3 The Changing Landscape of the MDx 8. Contents8.1.4 Cost: A Deterrent of MDx Use#9. Conclusions9.1 The Molecular Diagnostics Market: Growing Market Share9.2 Molecular Diagnostics: Oncology Testing Market Growth9.3 Commercial Drivers of the Molecular Diagnostics Market9.4 Commercial Restraints of the Molecular Diagnostics Market9.5 Emerging Markets9.6 Concluding 9. The Molecular Diagnostics (MDx) Market Forecast2014-2024: Opportunities for Leading CompaniesTable 4.14 Selected List of FDA Approved MDx tests for Prostate Cancer, 2014Test Tumour Type Manufacturer Biomarker(s)The CELLSEARCH Circulating Tumor CellKitBreast, prostate,colorectal Janssen DiagnosticsCD45-, EpCAM+, andcytokeratins 8, 18+, and/or19+ levelsOncotype DXBreast, prostate,colorectal Genomic Health multiple biomarkersProlaris Prostate Myriad Geneticsexpression levels of cellreplication genesPROGENSA PCA3 test Prostate DiagnoCureProstate cancer gene 3(PCA3 or DD3)NADiA ProsVue Prostate Iris Molecular Diagnostics PSA levels in human serumSource: Visiongain20144. Pipeline Biomarker4. TMPRSS2-ERG (OriGene)The TMPRSS2-ERG gene rearrangements are commonly present in prostate cancer. The over-expressionof ERG has been considered as a specific prostate cancer biomarker. OriGene hasdeveloped a powerful tool for detecting ERG over-expression using TissueScan Tissue cDNAArrays which contain panels of first strand cDNAs converted from RNA from cancer and normaltissues. PTENLoss PTEN, known as a tumour suppressor gene, inhibits androgen receptor signalling and causesresistance to androgen receptor-based therapies. PTEN deletion also has been associated withpoor outcomes, suggesting it may be of both prognostic and predictive importance. Colorectal CancerColorectal cancer is the third most common cause of cancer-related death in the US. One strategyto reduce the burden of colorectal cancer is to develop strategies for colorectal cancer screeningthat will result in earlier detection. The CDC estimates that if everyone age 50 or older had regularscreening tests as recommended, at least 60% of colorectal cancer deaths could be avoided. Thecurrent gold standard screening method for colon cancer is a colonoscopy. However, in August2014, 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 Page 66 10. The Molecular Diagnostics (MDx) Market Forecast2014-2024: Opportunities for Leading Companiestraditionally uninsured such as those from low-income backgrounds. As of 2013 nearly everyMexican has healthcare coverage, of which around 50% are covered by public insurance andsocial security through their employer, 3% are privately covered, and practically all of theremainder are covered by Seguro Popular.Coverage of the Mexican population under the Seguro Popular insurance system increased from10 million in 2004 to over 50 million by 2012, representing near-universal enrolment for thepreviously uninsured. There was a corresponding expansion in healthcare infrastructure, includingthe 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 onmedicines has been increasing steadily. These radical expansions of the healthcare system shouldallow for a growing number of MDx tests to be made available for use in the public healthcaresystem.Table 5.19 The Mexican MDx Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2013-20242013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024Mexico ($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 (%) 2013-201818.2 2018-2024 18.6CAGR (%) 2013-202418.4Source: Page 108 11. The Molecular Diagnostics (MDx) Market Forecast2014-2024: Opportunities for Leading Companiesdiagnostic company Ipsogen. After the completion of that deal, Qiagen moved to acquire allremaining shares of the French cancer molecular diagnostic firm. This acquisition has expandedQiagens portfolio of molecular diagnostic tests. From January 1st 2013, Ipsogen has changed itsCompany name to Qiagen Marseille.6.3.1 Sales and Recent Performance Analysis, 2013In 2013, Qiagen achieved sales of $1301.98m, which was a 3.8% increase in sales from theprevious year. However, from 2009-2013, Qiagen have been facing a downward trend in profitmargin from 13.6% in 2009 to 5.3% in 2013. The decline in net income was reported to primarily bedue to the impacts of Qiagens recent restructuring efforts. The company have funded their growththrough internally generated funds, debt, and private and public sales of equity securities.Figure 6.6Qiagen:Revenue ($m), Net Income ($m) and Profit Margin (%), 2009-2013Revenue ($m) Net Income ($m) Profit margin (%)161412108642014001200100080060040020002009 2010 2011 2012 2013Profit Margin (%)Revenue ($m)Fiscal YearSource: Qiagen 2013, Visiongain20146.3.2 Qiagen Sales by Region, 2013The U.S. represented the largest regional share of sales, generating 40.9% of Qiagens revenue,followed closely by Europe with 37.0% of sales. The U.S. revenue sales in 2013 were $ Page 121 </p>