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The Global Molecular Diagnostics Market

  • June 2015
  • -
  • Medtech Insight

The molecular diagnostic products market is the highest growth segment of the global in vitro diagnostics (IVDs) market valued at an estimated $5.3 billion in 2014 and projected to grow at a compound annual growth rate of 6.6% to $7.3 billion by the year 2019. This growth is forecast to occur in spite of relatively modest growth in the overall worldwide market for IVD products, which is estimated to be expanding at a compound annual rate of 4.2% for the same period. To some extent, growth of the molecular diagnostics market will occur at the expense of certain segments of the conventional diagnostic products market, including cell culture testing, immunoassay products for infectious diseases, immunoassays for cancer diagnosis and screening, and conventional products for genetic testing. Individual product segments covered in this report include molecular diagnostics for infectious disease, blood screening, genetic testing, and cancer diagnosis and screening.

This report will cover:

worldwide procedure and market forecasts for the years 2014 to 2019;
key factors influencing the growth of individual product markets;
estimated market shares and sales among leading suppliers;
major supplier product portfolio analysis in individual product markets;
emerging companies developing novel molecular diagnostic assays;
emerging areas of opportunity in the molecular diagnostic market; and,
innovative technology that could potentially change the way product markets develop.

Table Of Contents

The Global Molecular Diagnostics Market
TABLE OF CONTENTS

EXECUTIVE SUMMARY
i Methodology
Exhibit ES-1: Global Clinical Diagnostics, Combined Market Forecast, 2013-2019

1 MARKET ENVIRONMENT
11 Trends in the Worldwide Molecular Diagnostics Market
12 Factors Driving Adoption of Molecular Diagnostics
121 Advantages of Molecular Testing Versus Immunoassay and Biochemical Methods
122 Companion Diagnostics and Pharmacogenomics
123 Reimbursement and Funding Issues
124 Regulatory Issues
125 Liability Issues
13 Target Market Segments for Molecular Diagnostics
131 Molecular Diagnostics for Infectious Disease Testing
132 Molecular Diagnostics for Blood Screening
133 Molecular Diagnostics for Cancer Screening
134 Genetic Testing Segment

Exhibit 1-1: Comparison of Applicability of Molecular, Immunochemical, and Biochemical Assay Technology in Major Disease Categories
Exhibit 1-2: Worldwide Adoption of Nucleic Acid Testing Technology for Infectious Agent Screening of Donated Blood and Blood Products

2 EPIDEMIOLOGY OF TARGET DISEASES FOR MOLECULAR DIAGNOSTICS
21 Infectious Disease
211 Hepatitis B Virus
212 Hepatitis C Virus
213 Human Immunodeficiency Virus
214 Tuberculosis
215 Chlamydia trachomatis/Neisseria gonorrhea
216 Human Papilloma Virus
217 Methicillin-resistant Staphylococcus aureus
218 Other Infectious Diseases
219 Microbiological Identification and
Susceptibility Testing
22 Oncology
221 Prostate Cancer
222 Breast Cancer
223 Colorectal Cancer
224 Other Cancers
23 Genetic Disease
24 Blood Screening
25 Other Diseases with Molecular Diagnostic Applications
26 Future Applications of Molecular Diagnostics
261 Molecular Diagnostics in Alzheimer's Disease
262 Molecular Diagnostics in Cardiovascular Disease
263 Molecular Diagnostics in Diabetes and Other Metabolic Disorders

Exhibit 2-1: Worldwide Infectious Disease Incidence and Prevalence Estimates
Exhibit 2-2: 2012, Estimated Cancer Incidence by Type and Region
Exhibit 2-3: 2012, Estimated Cancer Prevalence by Type and Region
Exhibit 2-4: Global Trends in Cancer Incidence and Cancer Deaths
Exhibit 2-5: 2012, Projected Trends in Worldwide Incidence of the Major Types of Cancer
Exhibit 2-6: Tumor-Associated Infectious Agents and Related Cancer Incidence for 2012
Exhibit 2-7: Incidence and Risk for Major Types of Genetic Disease
Exhibit 2-8: Trends in Blood Collection in the US
Exhibit 2-9: Trends in Blood Collection in Europe
Exhibit 2-10: Hemostasis Disorders and Prevalence
Exhibit 2-11: US Organ Transplant Procedures, 2008-2014
Exhibit 2-12: Organ Transplant Procedures and Recipient Waiting Lists in Eurotransplant Countries, 2009-2013
Exhibit 2-13: Worldwide Incidence and Prevalence of Cardiovascular Disease by Region
Exhibit 2-14: Global Diabetes Prevalence Trends

3 TECHNOLOGY INSIGHTS
31 Polymerase Chain Reaction
32 Isothermal Nucleic Acid Amplification Technology
33 Hybridization
34 Nucleic Acid Sequencing and Next-Generation Sequencing
35 Microarrays
36 Other Molecular Diagnostic Technologies
37 Testing Methodologies and Instrumentation Technologies
371 Instrument Technologies
372 Reagent Technologies
373 Software and Service
38 Feature Comparison of Automated and Semi-Automated Analyzers

Exhibit 3-1: Characteristics of Nucleic Acid Amplification Technologies
Exhibit 3-2: Next-Generation Sequencing Technologies
Exhibit 3-3: Microarray Technologies for Molecular Diagnostics
Exhibit 3-4: Labeling Technologies for Molecular Diagnostics
Exhibit 3-5: Feature Comparison of Molecular Diagnostic Assay Systems

4 REGIONAL INSIGHTS
41 North America
411 Laboratory Practices
412 Economic Factors
413 Regulatory Factors
414 Demographic and Social Factors
415 Technological Trends
42 Europe (France, Germany, Italy, Spain, the United Kingdom, Rest of Europe)
421 Laboratory Practices
422 Economic Factors
423 Regulatory Factors
424 Demographic and Social Factors
425 Technological Trends
43 Asia Pacific
431 Laboratory Practices
432 Economic Factors
433 Regulatory Factors
434 Demographic and Social Factors
435 Technological Trends
44 Rest of the World
441 Laboratory Practices
442 Economic Factors
442 Regulatory Factors
444 Demographic and Social Factors
445 Technological Trends

Exhibit 4-1: 2015, Molecular Diagnostic Products Market by Region
Exhibit 4-2: Number of Clinical Laboratories in Selected Countries
Exhibit 4-3: Time and Cost for Market Clearance or Approval for In Vitro Diagnostic Products
Exhibit 4-4: United States Population Trend Data, 2014-2020
Exhibit 4-5: Percentage of Molecular Diagnostic Patents and Patent Applications by Applicant Region
Exhibit 4-6: Population Trends in Europe, 2015-2020
Exhibit 4-7: Total healthcare Expenditure as a Percentage of Gross Domestic Product in Major Countries in Asia Versus the United States and Europe
Exhibit 4-8: Population Trends in the Asia-Pacific Region, 2015-2020
Exhibit 4-9: Total healthcare Expenditure as a Percentage of Gross Domestic Product in Major Countries in Asia Versus the United States and Europe
Exhibit 4-10: Population Trends in Latin America and Africa, 2015-2020

5 MOLECULAR DIAGNOSTICS MARKET ANALYSIS AND FORECASTS
51 Market Drivers and Limiters
52 End User Characteristics
53 Markets for Molecular Diagnostics in Infectious Disease Testing
531 Existing Molecular Diagnostics Infectious Disease Testing Applications
532 Applications in Development in Infectious Disease Testing
533 Molecular Diagnostic Infectious Disease Testing Products and Products in Development
534 Infectious Disease Molecular Diagnostics Market Forecast by Region
535 Competitive Analysis
54 Markets for Molecular Diagnostics in Oncology
541 Existing Molecular Diagnostics for Oncology Testing Applications
542 Applications in Development in Oncology
543 Molecular Diagnostic Products for Oncology Testing Currently Available or in Development
544 Molecular Diagnostics Oncology Market Forecast by Region
545 Competitive Analysis
55 Markets for Molecular Diagnostics in Genetic Testing
551 Existing Molecular Genetic Diagnostic Applications
552 Genetic Testing Applications in Development
553 Molecular Genetic Diagnostic Products Currently Available and in Development
554 Molecular Genetic Diagnostic Products Market Forecast by Region
555 Competitive Analysis
56 Markets for Molecular Diangostics in Blood Screening
561 Existing Molecular Blood Screening Applications
562 Applications in Development for Molecular Blood Screening
563 Molecular Blood Screening Products Currently Available and in Development
564 Molecular Blood Screening Markets by Region
565 Competitive Analysis
57 Other Markets for Molecular Diagnostics
571 Emerging Molecular Diagnostics Markets for Neurological Disorders
572 Emerging Molecular Diagnostic Markets in Cardiovascular Disease
573 Emerging Molecular Diagnostic Markets in Diabetes and Metabolic Disease

Exhibit 5-1: Trends in Reported Chlamydia and Gonorrhea Cases
Exhibit 5-2: Number of Target Patients Worldwide for Select Molecular Diagnostic Tests
Exhibit 5-3: Infectious Disease Molecular Diagnostic Products on the Market or in Development
Exhibit 5-4: Worldwide Markets for Infectious Disease Diagnosis and Viral Load Monitoring Products, 2013-2019
Exhibit 5-5: Worldwide Market for Molecular Infectious Disease Diagnosis and Viral Load Monitoring Products by Region, 2013-2019
Exhibit 5-6: Supplier Sales and Market Shares for Molecular Infectious Disease Diagnosis and Viral load Monitoring Products by Region
Exhibit 5-7: Trends in Global Cancer Incidence, 2012-2035
Exhibit 5-8: Select Oncogenes and Tumor Suppressor Genes and Associated Clinical Applications
Exhibit 5-9: New Cancer Cases Attributable to Infectious
Diseases Worldwide
Exhibit 5-10: Molecular Cancer Diagnostic Products on the Market or in Development
Exhibit 5-11: Worldwide Market for Molecular Cancer Testing Products
by Region, 2013-2019
Exhibit 5-12: Worldwide Supplier Sales and Market Shares for Molecular Cancer Testing Products by Region, 2014
Exhibit 5-13: Worldwide Infectious Disease Incidence and Prevalence Estimates
Exhibit 5-14: Pharmacogenomic and Companion Diagnostic Test Applications
Exhibit 5-15: Molecular Diagnostic Products for Genetic Testing Applications
Exhibit 5-16: Worldwide Market for Molecular Genetic Testing Products by Region, 2013-2019
Exhibit 5-17: Worldwide Sales and Market Shares of the Leading Suppliers of Molecular Genetic Testing Products
Exhibit 5-18: Molecular Blood Screening Products
Exhibit 5-19: Worldwide Market for Molecular Blood Screening Products by Region, 2013-2019
Exhibit 5-20: Sales and Market Shares for the Leading Suppliers of Molecular Blood Screening Products by Region
Exhibit 5-21: Major Neurological Diseases Representing Potential Applications
for Molecular Diagnostics
Exhibit 5-22: Major Cardiovascular Disorders Representing Potential
Applications for Molecular Diagnostics
Exhibit 5-23: Major Genes Associated with an Increased Risk of Diabetes

6 COMPETITOR INSIGHTS
61 Sales and Market Shares of Leading Suppliers
62 Market Penetration Strategies
63 Market Entry Barriers and Risks
64 Business Planning Issues and Concerns

Exhibit 6-1: Selected Competitors in the Global Molecular Diagnostics Market
Exhibit 6-2: Market Segment Participation of Leading Competitors in the Molecular Diagnostics Market
Exhibit 6-3: 2014, Worldwide Molecular Diagnostic Product Sales by Region and Global Market Shares for Leading Suppliers
Exhibit 6-4: Major Business Transactions in the Molecular Diagnostics Industry

7 COMPANY PROFILES
71 AdvanDx
72 Asuragen
73 AutoGenomics
74 Bioneer
75 Chronix Biomedical
76 Illumina
77 SeeGene
78 Xagenic

APPENDIX: COMPANY LISTING

BIBLIOGRAPHY

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