272 Pages | 59 Exhibits | 2015 Analysis | Forecasts Through 2020 Product Family: Market Reports

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 covers:

•    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.


i. Methodology

Exhibit ES-1: Global Clinical Diagnostics, Combined Market Forecast, 2013-2019


1.1 Trends in the Worldwide Molecular Diagnostics Market
1.2 Factors Driving Adoption of Molecular Diagnostics
	1.2.1 Advantages of Molecular Testing Versus Immunoassay and Biochemical Methods
	1.2.2 Companion Diagnostics and Pharmacogenomics
	1.2.3 Reimbursement and Funding Issues
	1.2.4 Regulatory Issues
	1.2.5 Liability Issues
1.3 Target Market Segments for Molecular Diagnostics
	1.3.1 Molecular Diagnostics for Infectious Disease Testing
	1.3.2 Molecular Diagnostics for Blood Screening
	1.3.3 Molecular Diagnostics for Cancer Screening
	1.3.4 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


2.1 Infectious Disease
	2.1.1 Hepatitis B Virus
	2.1.2 Hepatitis C Virus
	2.1.3 Human Immunodeficiency Virus
	2.1.4 Tuberculosis
	2.1.5 Chlamydia trachomatis/Neisseria gonorrhea
	2.1.6 Human Papilloma Virus
	2.1.7 Methicillin-resistant Staphylococcus aureus
	2.1.8 Other Infectious Diseases
	2.1.9 Microbiological Identification and Susceptibility Testing
2.2 Oncology
	2.2.1 Prostate Cancer
	2.2.2 Breast Cancer
	2.2.3 Colorectal Cancer
	2.2.4 Other Cancers
2.3 Genetic Disease
2.4 Blood Screening
2.5 Other Diseases with Molecular Diagnostic Applications
2.6 Future Applications of Molecular Diagnostics
	2.6.1 Molecular Diagnostics in Alzheimer's Disease
	2.6.2 Molecular Diagnostics in Cardiovascular Disease
	2.6.3 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 U.S.
Exhibit 2-9: Trends in Blood Collection in Europe
Exhibit 2-10: Hemostasis Disorders and Prevalence
Exhibit 2-11: U.S. 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


3.1 Polymerase Chain Reaction
3.2 Isothermal Nucleic Acid Amplification Technology
3.3 Hybridization
3.4 Nucleic Acid Sequencing and Next-Generation Sequencing
3.5 Microarrays
3.6 Other Molecular Diagnostic Technologies
3.7 Testing Methodologies and Instrumentation Technologies
	3.7.1 Instrument Technologies
	3.7.2 Reagent Technologies
	3.7.3 Software and Service
3.8 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


4.1 North America
	4.1.1 Laboratory Practices
	4.1.2 Economic Factors
	4.1.3 Regulatory Factors
	4.1.4 Demographic and Social Factors
	4.1.5 Technological Trends
4.2 Europe (France, Germany, Italy, Spain, the United Kingdom, Rest of Europe)
	4.2.1 Laboratory Practices
	4.2.2 Economic Factors
	4.2.3 Regulatory Factors
	4.2.4 Demographic and Social Factors
	4.2.5 Technological Trends
4.3 Asia Pacific
	4.3.1 Laboratory Practices
	4.3.2 Economic Factors
	4.3.3 Regulatory Factors
	4.3.4 Demographic and Social Factors
	4.3.5 Technological Trends
4.4 Rest of the World
	4.4.1 Laboratory Practices
	4.4.2 Economic Factors
	4.4.3 Regulatory Factors
	4.4.4 Demographic and Social Factors
	4.4.5 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


5.1 Market Drivers and Limiters
5.2 End User Characteristics
5.3 Markets for Molecular Diagnostics in Infectious Disease Testing
	5.3.1 Existing Molecular Diagnostics Infectious Disease Testing Applications
	5.3.2 Applications in Development in Infectious Disease Testing
	5.3.3 Molecular Diagnostic Infectious Disease Testing Products and Products in Development
	5.3.4 Infectious Disease Molecular Diagnostics Market Forecast by Region
	5.3.5 Competitive Analysis
5.4 Markets for Molecular Diagnostics in Oncology
	5.4.1 Existing Molecular Diagnostics for Oncology Testing Applications
	5.4.2 Applications in Development in Oncology
	5.4.3 Molecular Diagnostic Products for Oncology Testing Currently Available or in Development
	5.4.4 Molecular Diagnostics Oncology Market Forecast by Region
	5.4.5 Competitive Analysis
5.5 Markets for Molecular Diagnostics in Genetic Testing
	5.5.1 Existing Molecular Genetic Diagnostic Applications
	5.5.2 Genetic Testing Applications in Development 
	5.5.3 Molecular Genetic Diagnostic Products Currently Available and in Development
	5.5.4 Molecular Genetic Diagnostic Products Market Forecast by Region
	5.5.5 Competitive Analysis
5.6 Markets for Molecular Diangostics in Blood Screening
	5.6.1 Existing Molecular Blood Screening Applications
	5.6.2 Applications in Development for Molecular Blood Screening
	5.6.3 Molecular Blood Screening Products Currently Available and in Development
	5.6.4 Molecular Blood Screening Markets by Region
	5.6.5 Competitive Analysis
5.7 Other Markets for Molecular Diagnostics
	5.7.1 Emerging Molecular Diagnostics Markets for Neurological Disorders
	5.7.2 Emerging Molecular Diagnostic Markets in Cardiovascular Disease
	5.7.3 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


6.1 Sales and Market Shares of Leading Suppliers
6.2 Market Penetration Strategies
6.3 Market Entry Barriers and Risks
6.4 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


7.1 AdvanDx
7.2 Asuragen
7.3 AutoGenomics
7.4 Bioneer
7.5 Chronix Biomedical
7.6 Illumina
7.7 SeeGene
7.8 Xagenic




  1. Abbott Laboratories Inc
  2. AdvanDX
  3. Affymetrix
  4. Agena Bioscience
  5. Agilent Technologies
  6. Alere
  7. American Association of Blood Banks
  8. American Board of Clinical Chemistry
  9. American Cancer Society
  10. American Heart Association
  11. American Red Cross
  12. Amplexa Genetics
  13. Applied Spectral Imaging
  14. Ariosa Diagnostics
  15. Asuragen
  16. Athena Diagnostics
  17. Atharva Biosciences
  18. AutoGenomics
  19. Bayer AG
  20. BD
  21. BGI
  22. Biodesix
  23. BioFire Diagnostics/bioMerieux
  24. Bioneer
  25. bioMerieux SA
  26. Blue Cross Blue Shield
  27. CareDx
  28. CardioDx
  29. Celera Diagnostics
  30. Central Drugs Standard Control Organization
  31. Cepheid Inc.
  32. Cetus Corporation
  33. Chiron/Novartis
  34. Chronix Biomedical
  35. Cigna
  36. Complete Genomics
  37. Dako
  38. DiaCarta
  39. DiagnoCure
  40. Elitech Group
  41. Enterix/Quest Diagnostics
  42. Epistem Ltd
  43. Exosome Diagnostics, Inc.
  44. F. Hoffmann-La Roche Ltd
  45. Focus Diagnostics
  46. Foundation for Innovative New Diagnostics
  47. Foundation Medicine
  48. Fujjirebio Diagnostics
  49. GeneDx
  50. Genia
  51. GenMark Diagnostics
  52. Genomic Health
  53. Gen-Probe
  54. Great Basin Scientific
  55. Grifols S.A.
  56. Hologic
  57. IBIS Biosciences
  58. Ikonisys
  59. Illumina
  60. Immucor
  62. Iquum
  63. IRIS Molecular Diagnostics
  64. Laboratory Corporation of America
  65. Luminex
  66. 3M
  67. Medicare/Medicaid
  68. Meridian Bioscience
  69. MetaSystems
  70. Microarrays Inc.
  71. Miraca Holdings
  72. Molecular Staging
  73. Myriad Genetics
  74. Nanobiosym Diagnostics
  75. Nanosphere
  76. Nanostring
  77. Novartis
  78. Orchid Biosciences and Dianon Cellmark Forensics
  79. Oxford Nanopore Technologies
  80. Pacific Biosciences
  81. Palmetto GBA
  82. PrimeraDx
  83. Quest Diagnostics
  84. Qiagen
  85. Quidel, Inc.
  86. Randox Laboratories
  87. Roche Diagnostics
  88. Savyon Diagnostics
  89. SeeGene
  90. Sequella
  91. Siemens Healthcare Diagnostics
  92. Signature Diagnostics
  93. Spartan Bioscience
  94. Thermo Fisher Scientific Inc.
  95. Trimgen
  96. U.S. Center for Medicare and Medicaid Services
  97. U.S. Centers for Disease Control and Prevention
  98. U.S. Food and Drug Administration
  99. U.S. National Cancer Institute
  100. Ustar Biotechnologies
  101. Verinata Health
  102. Vysis/Abbott
  103. Xagenic
Contact Us

Need help finding medtech research? Let us help you!