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The US Molecular Diagnostics Market, Forecast to 2021

  • ID: 4009624
  • Report
  • November 2016
  • Region: Global
  • 144 pages
  • Frost & Sullivan
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High Interest Towards Multiplexing Molecular Technologies Will Create Opportunities for the Vendor Community
The US molecular diagnostics market is growing at 12.5% CAGR and is set to reach close to $6.5 billion by 2021. PCR, next-generation sequencing (NGS), microarray, and fluorescent in situ-hybridization (FISH) are the dominant technologies in this space with PCR holding more than 75% of the market. Roche, Cepheid, Qiagen, Abbott, and Thermo Fisher dominate in this field and are expected to maintain their positions in the market through mergers and acquisitions of smaller start-ups. Illumina maintains its monopoly in the NGS market followed by Thermo Fisher, which is likely to remain unchanged during the forecast years. The market continues to grow despite strict guidelines. Molecular diagnostics is expected to at least partially replace microbiology testing and other ELISA/ immunoassay based tests during the forecast years. This study discusses growth opportunities and trends and offers predictions for the 4 technology segments discussed above. Trends across therapeutic areas such as oncology, women's health, HIV/STDs, and infectious disease testing areas are also covered in this research. The study period is 2014 to 2021.

Key questions this study answers:

Will the molecular diagnostics market disrupt your current business or create growth opportunities?
What do you need to know? Where are the hottest segments in this market?
Where is the most interest in terms of funding and innovation?
What are some of the most disruptive products by disease indication in this space?
What are the gaps in the market that encourage penetration and provide opportunities to new entrants?
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1. Executive Summary to the Molecular Diagnostics Market
  • Scope and Segmentation
  • Executive Summary-Market Snapshot
  • Executive Summary-Key Questions Addressed in this Study
2. Market Overview
  • Key Factors Affecting this Market that Could Influence Decision Makers
  • Evolution of Molecular Diagnostics
  • Molecular Diagnostics Market More Complex Since Origins 20 Years Ago
  • 7 Big Market Directions in Molecular Diagnostics
  • Trends Driving Molecular Diagnostics in Healthcare
  • Key Predictions
  • Future of Molecular Diagnostics Market
  • Molecular Technologies in IVD-Growth Trends by Segment
  • Key Companies to Watch
  • Molecular Diagnostics Growing Fastest within the IVD Industry
  • How is this Market Segmented?
  • Molecular Diagnostics Test Volume Estimation
  • Molecular Diagnostics Cross the Patient Care Continuum
  • Reimbursement of Molecular Tests
  • FDA versus LDT-Opportunity Expectations
3. Competitive Landscape
  • Comparison of Molecular Diagnostic Techniques
  • Key Mergers, Acquisitions, and Partnerships
4. Disease Segments-Overview
  • Largest Revenue Contributors to the Molecular Diagnostics Market by Disease
  • Platforms and Assay Availability by Top Manufacturers
5. Oncology
  • Key Opportunities and Trends-Oncology Segment
  • Precision Medicine in Oncology
  • Rise of Computational Genomics
  • Value Proposition of MDx in Cancer to be Correlated with Reducing Price or Reimbursing Tests
  • Current Scenario in the Oncology Segment
  • Oncology Opportunities Through the Patient Continuum
  • US Competitive Landscape for Oncology Tests by Technology
  • Top Predictions for the Oncology Segment
6. Infectious Disease
  • Key Opportunities and Trends-Infectious Disease Segment
  • The Culture of Culture Technology and ACA
  • HAI Diagnostics Penetrating Testing Sites
  • Infectious Disease Highest Growth Segment by Volume
  • Need-based Opportunities High in Infectious Diseases, Especially in Niche Markets
  • Competitive Landscape for Infectious Disease Tests by Technology
  • Top Predictions for the Infectious Disease Segment
7. Women’s Health
  • Key Opportunities and Trends-Women’s Health Segment
  • Opportunities in Cancer Screening, Prenatal Testing, and HPV
  • Breast Cancer-Opportunities Lie in Parallel Diagnosis and Screening Along with Imaging Technologies
  • Noninvasive Prenatal Testing (NIPT)-With Average Maternal Age Increasing, Opportunity Grows in the US
  • Prenatal Testing Brands Familiarity by End-user Type
  • Molecular Tests Becoming a Part of Routine Healthcare Visits for Women’s Health
  • Reimbursements-CPT Code List and Volume
  • Competitive Landscape for Women’s Health Tests by Technology
  • Top Predictions for the Women’s Health Segment
8. HIV and STDs
  • Key Opportunities and Trends-HIV Segment
  • HIV MDx Manufacturers Focusing Away from the US, Seeking Opportunities Overseas
  • Reimbursement and Pricing Pressures Significantly Dropping Price of HIV Quant Tests
  • Immunodiagnostic Tests Have Similar HIV Tests for a Lower Cost and Simpler Workflow
  • Competitive Landscape HIV and STDs Tests by Technology
  • Top Predictions for the HIV/STD Segment
9. Technology Overview
  • Technology Overview
  • Growth Opportunities for Technology Providers
  • Market Projection for Overall Molecular Diagnostics
  • Overall Market Share by Vendor
  • Current Use of Technologies
  • Future Use of Technologies
10. Technology Segmentation-PCR
  • PCR-An Array of Options
  • New Age of PCR-Multiplexing PCR Systems
  • FDA-approved Multiplex Tests on the Rise
  • PCR (Despite Being a Mature Technique) Growing as a Market Due to Technical Unmet Needs
  • Market Projection for PCR Market
  • Market Share Analysis for PCR
  • Selected Vendor Profiles-PCR
  • Top Predictions for the US PCR Market
  • 5 Competitive Keys for Success in the PCR Space
11. Technology Segmentation-Microarray
  • Microarray Becoming a Flexible and Customizable Technology, Important for Genomic Research
  • Market Projection for Microarray Market
  • Market Share Analysis for Microarray
  • Select Vendor Profiles-Microarray
  • Top Predictions for the US Microarray Market
  • 5 Competitive Keys for Success in the Microarray Space
12. Technology Segmentation-FISH
  • FISH Remains a Progressive Field, but Necessary to Confirm and Refine Results Before the Technology Can Come to Fruition
  • Market Projection for FISH Market
  • Market Share Analysis for FISH
  • Select Vendor Profiles-FISH
  • Top Predictions for the US FISH Market
  • 5 Competitive Keys for Success in the FISH Space
13. Technology Segmentation-NGS
  • NGS Systems Have High Capabilities, but Still Need to Meet Fundamental Needs to Sustain Growth
  • Evidence of Cost per Raw Megabase and Cost per Genome Dropping Significantly and Driving Market Adoption
  • Recent FDA Guideline to NGS in Infectious Disease to Offer Structure to a Rapidly Evolving Market
  • Market Projection for NGS Market
  • Market Share Analysis for NGS
  • Select Vendor Profiles-NGS
  • Top Predictions for the US NGS Market
  • 5 Competitive Keys for Success in the NGS Space
14. Emerging Opportunities-Companion Diagnostics
  • A 4-step Guideline to Companion Diagnostics (CDx) Projects
  • A 4-step Guideline to Companion Diagnostics (CDx) Projects (continued)
  • What Has Changed in FDA Regulation of CDx in the Molecular Market?
  • Companion Diagnostics by Disease and Technology-PCR is Highly Prevalent in CDx
  • CNS, Infectious Diseases, and CV-The Next Big Opportunities for Molecular Diagnostics in CDx
  • Current and Future of Companion Diagnostics in MDx
15. Emerging Opportunities-Liquid Biopsy
  • Liquid Biopsy to Revolutionize the Therapeutic, Monitoring, and Drug Resistance Landscape for Genotyping
  • Liquid Biopsy to Become Mainstream within 1 to 4 Years in the United States
  • Technologies Used to Detect ctDNA
  • Technologies Used to Detect CTC
  • Large IVD Participants Expanding Product Portfolio to Include Liquid Biopsy
16. Emerging Opportunities-Direct-to-Consumer Testing
  • DTC Market Value Chain
  • DTC Offerings in the United States
17. Conclusion
  • Future Perspectives-3 Big Predictions
  • Key Conclusions and Future Outlook
18. Appendix
  • List of Others
19. Systems and Assays
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