The US Molecular Diagnostics Market, Forecast to 2021

Polymerase Chain Reaction (PCR) Holds Close to 53% Share but Strong Clinical Research will Push NGS to Revolutionize this Space in the Next 5 to 10 Ye

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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?

Table of Contents

1. Executive Summary to the Molecular Diagnostics Market
Scope and Segmentation
Executive Summary—Market Snapshot
Market Drivers
Points to Consider
Executive Summary—Key Questions Addressed in this Study
2. Market Overview
Key Factors Affecting this Market that Could Influence
Market Direction
M&A
Key Technologies
Emerging Technologies
Key Focus Areas
Evolution of Molecular Diagnostics
Molecular Diagnostics Market More Complex Since Origins 20 Years Ago
7 Big Market Directions in Molecular Diagnostics
Personalized Medicine
4 Dominant Technologies
Moving Focus on Key Disease Areas
Regulatory Priority
IVD Leaders in Molecular Diagnostics
Opportunity in Companion Diagnostics
Emerging Technology
Molecular Diagnostics Expanding beyond Laboratory
Trends Driving Molecular Diagnostics in Healthcare
Key Predictions
Shift to value-based systems will spur growth in this market
Business focus is moving outside the US
NGS expanding into other diseases areas will increase competition
Molecular based POCTs are gaining momentum
Personalized medicine initiative drives companion diagnostics forward along with therapy monitoring
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?
US Molecular Diagnostics Market
Disease Segments
Oncology
Infectious Diseases
Women’s Health
HIV/STDs
Technology Segments
PCR
FISH
Microarray
NGS
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
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 Manufactures 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/STDs Segment
9. Technology Overview
Technology Overview
Growth Opportunities for Technology Providers
Market Projection for Overall Molecular Diagnostics
Overall Market Share by Vendor
Roche
Abbott
Cepheid
BD
Thermo Fisher
BioMeireux
Illumina
Others
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
Targeting Niche Areas
Platform Flexibility
FDA or LDT
Targeted Impact
Identifying Synergies for Partnership
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
Disease Areas
Population Analysis
Demand and Technology
Platform Flexibility
Combination Microarrays
12. Technology Segmentation—FISH
FISH Remains 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
Disease Areas
Market Potential
Demand and Technology
Knowing Limitations
Reagent Cost
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 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
Disease Areas
Service Opportunity
Demand and Technology
Platform Flexibility
Regulation
14. Emerging Opportunities—Companion Diagnostics
A 4-step Guideline to Companion Diagnostics (CDx) Projects
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. 236 Systems and Assays
236 FDA Approved Assays and Systems
20. The Frost & Sullivan Story


List of Figures & Charts

1. Molecular Diagnostics Market: Platforms and Assay Availability by Top Manufacturers, US, 2015
2. Molecular Diagnostics Market: Test Volume in Labs, US, 2015
3. Molecular Diagnostics Market: Opportunities in Cancer Screening, Prenatal Testing, and HPV, US, 2015
4. Molecular Diagnostics Market: Detection Rate, US, 2015
5. Molecular Diagnostics Market: Company Market Share Analysis of Top 5 Participants, US, 2015
6. Molecular Diagnostics Market: PCR Technology, US, 2015
7. Total Molecular Diagnostics Market: DTC Offerings, US, 2015


1. Molecular Diagnostics Market: Ecosystem, US, 2015
2. Molecular Diagnostics Market: Market Trends, US, 2016, 2018, 2020
3. Disease Segments: Market Direction, US, 2015
4. Molecular Diagnostics Market: Market Growth/Potential, US, 2015
5. IVD Industry: Segment Breakdown, Global, 2015
6. Molecular Diagnostics Market: Market Segmentation, US, 2015
7. Molecular Diagnostics Market: Test Volume Estimation, US, 2015
8. Molecular Diagnostics Market: NG/CT/HPV Amplification Price per Test, US, 2010–2014
9. Molecular Diagnostics Market: HIV Quant Price per Test, US, 2010–2014
10. Molecular Diagnostics Market: Percent Revenue Breakdown by Disease segment, US, 2015–2021
11. Molecular Diagnostics Market: Percent of Oncology Testing, US, 2015
12. Molecular Diagnostics Market: Tests Count of Oncology, US, 2015
13. Molecular Diagnostics Market: Market Share by Application, US, 2015
14. Infectious Disease Segment: Test Volume MDx vs. Non-MDx Tests, Us, 2010–2015
15. Genetic Disease Segment: Test Volume MDx vs. Non-MDx Tests, Us, 2010–2015
16. Molecular Diagnostic Market: Tests Count of Infectious Diseases, US, 2015
17. Molecular Diagnostics Market: Breast Cancer Opportunity, US, 2015
18. Molecular Diagnostics Market: Prenatal Testing Brands Familiarity (Very Familiar Ratings), United States, 2015
19. Molecular Diagnostics Market: Test Volume of Women’s Health, US, 2015
20. Molecular Diagnostics Market: Prevalence Rate of HIV, US, 2010–2015E
21. Molecular Diagnostics Market: Percent of People Living with HIV Worldwide, Global, 2015
22. Molecular Diagnostics Market: HIV Quant PCR-based Test Prices, 2010–2015 (E)
23. Molecular Diagnostics: FDA Approved Instruments and Assays by Technology, US, 2015
24. Molecular Diagnostics Market: Revenue Forecast, US, 2014–2021
25. Molecular Diagnostics Market: Percent Revenue Breakdown, US, 2015
26. Molecular Diagnostics Market: Current Use of Technologies, US, 2015
27. Molecular Diagnostics Market: Future Use of Technologies, US, 2015
28. Molecular Diagnostics Market: Percent of Multiplexing Platforms/Assays Approved, US, 2015
29. PCR Market: Revenue Forecast, US, 2014–2021
30. PCR Market: Percent Revenue Breakdown, US, 2015
31. Microarray Market: Revenue Forecast, US, 2014–2021
32. Microarray Market: Percent Revenue Breakdown, US, 2015
33. FISH Market: Revenue Forecast, US, 2014–2021
34. FISH Market: Percent Revenue Breakdown, US, 2015
35. Molecular Diagnostics Market: Cost Trend per Raw Megabase and Genome, US, 2010–2015
36. NGS Market: Revenue Forecast, US, 2014–2021
37. NGS Market: Percent Revenue Breakdown, US, 2015
38. Molecular Diagnostics Market: CDx by Technology, US, 2015
39. Molecular Diagnostics Market: Development of Companion Diagnostics in Other Disease Areas, US, 2015
40. Molecular Diagnostics Market: Current and Future of Companion Diagnostics in MDx, US, 2015
41. Molecular Diagnostics Market: Top Predicted Usage of Liquid Biopsy, US, 2015
42. Molecular Diagnostics Market: Timeframe of Liquid Biopsy Replacing Solid Tumor Tissue Biopsy in the Future, US, 2015
43. Molecular Diagnostics Market: Technologies Used to Detect ctDNA, US, 2015
44. Molecular Diagnostics Market: Technologies Used to Detect CTCs, US, 2015
45. Total Molecular Diagnostics Market: Key Conclusions and Future Outlook, US, 2015



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