OVERVIEW:
Rapid at home testing opens up new market.
Genetic DTC testing led the way. Now diagnostic testing is moving directly to the consumer. New technology has changed the picture on how and where testing is done. This report explores the outlook for all manner of At Home Diagnostics. Find out where the action is and the learn about the players.
Exciting technical developments especially in the seesaw between different analytic technology, hold the promise of a dynamic, growing and evolving world market that holds the promise of diagnostics taking the lead in infectious disease eradication. Even newer technology is on the horizon.
The report has hundreds of pages of information.
The report includes detailed breakouts for 15 Countries and 4 Regions. A detailed breakout for any country in the world is available to purchasers of the report.
All report data is available in Excel format on request.
Make investment decisions and valuations with confidence using the latest data.
ABOUT THE LEAD AUTHOR:
Mr. Greg Powell, B.SC., M.B.A is the President of Howe Sound Research. He is an experienced business and clinical professional. He is co-author of the paper "The Radioimmunoassay of Angiotensinogen by Antibody Trapping." He has worked in laboratory testing and management for over 20 years. Mr. Powell's education includes:
- B.Sc. (Chemistry) University of BC
- M.B.A. (Finance and Policy) University of BC
- Market Research Seminar - Burke Institute
- Finance for Senior Executives - Harvard Business School
Table of Contents
1. Market Guides
- 1.1. Situation Analysis
- 1.2. Guide for Executives and Marketing Staff
- 1.3. Guide for Investment Analysts and Management Consultants
2. Introduction and Market Definition
- 2.1. What are Home Diagnostics?
- 2.2. Home Testing - the quiet revolution in diagnostics
- 2.3. Self vs. Send vs. In House - Who knew?
- 2.3.1. Self
- 2.3.2. Send
- 2.3.3. In-House
- 2.4. Market Definition
- 2.4.1. Retail vs. Wholesale
- 2.5. Application Segments
- 2.5.1. Channel Segments
- 2.5.2. Technology Segments
- 2.5.3. Currency
- 2.5.4. Years
- 2.6. Methodology
- 2.6.1. Methodology
- 2.6.2. Sources
- 2.6.3. Authors
- 2.7. Perspective: Healthcare and the IVD Industry
- 2.7.1. Global Healthcare Spending
- 2.7.2. Spending on Diagnostics
- 2.7.3. Important Role of Insurance for Diagnostics
3. Industry Overview
- 3.1. Players in a Dynamic Market
- 3.1.1. Academic Research Lab
- 3.1.2. Diagnostic Test Developer
- 3.1.3. Instrumentation Supplier
- 3.1.4. Chemical/Reagent Supplier
- 3.1.5. Pathology Supplier
- 3.1.6. Independent Clinical Laboratory
- 3.1.7. Public National/regional Laboratory
- 3.1.8. Hospital Laboratory
- 3.1.9. Physicians Office Lab (POLS)
- 3.1.10. Audit Body
- 3.1.11. Certification Body
- 3.2. Diagnostic Market Segments
- 3.2.1. Traditional Market Segmentation
- 3.2.2. Laboratory Focus and Segmentation
- 3.2.3. Segmenting the Home Diagnostics Market
- 3.3. Industry Structure
- 3.3.1. Hospital Testing Share
- 3.3.2. Economies of Scale
- 3.3.3. Hospital vs. Central Lab
- 3.3.4. Physician Office Lab's
- 3.3.4.1. The Problem with POLS
- 3.3.5. Physician's and Home Diagnostics
- 3.3.6. Pharmacies and Home Diagnostics
- 3.3.6.1. The Diagnostic Plight of Pharmacies - Trying to do good
- 3.3.6.2. The Theranos Legacy
4. Market Trends
- 4.1. Factors Driving Growth
- 4.1.1. Privacy and Anonymity
- 4.1.2. The Internet Effect
- 4.1.3. Rapid Result
- 4.1.4. The Wellness Movement
- 4.1.5. The COVID-19 Impact
- 4.2. Factors Limiting Growth
- 4.2.1. Trust Factor
- 4.2.2. Infectious Disease is Declining But...
- 4.2.3. Wellness Hurts
- 4.2.4. Economic Growth improves Living Standards
- 4.3. Diagnostic Technology Development
- 4.3.1. The Multiplex Paradigm Shift
- 4.3.2. NAT vs. Lateral Flow
- 4.3.3. The Unusual Role of GPS
- 4.3.4. Self and Send Competition
- 4.3.5. The Relationship to DTC Genetic
- 4.3.6. The Relationship to TeleHealth
- 4.3.7. Sample Collection - Who Knew?
5. Home Diagnostics Recent Developments
- 5.1. Recent Developments - Importance and How to Use This Section
- 5.1.1. Importance of These Developments
- 5.1.2. How to Use This Section
- 5.2. Watmind Get Two EUAs
- 5.3. Capitainer, Life Genomics Partner on Self-Sampling Diagnostics
- 5.4. MyGeneticScreen Home Test Launched
- 5.5. Demand for OTC Self-Tests Tempered by Lack of Reimbursement
- 5.6. DiaCarta OTC Fecal Occult Blood Test Receives FDA Approval
- 5.7. LetsGetChecked Nabs FDA Authorization for Chlamydia, Gonorrhea Test
- 5.8. DiagMetrics Developing Breath Assays
- 5.9. Co-Diagnostics Awarded $2.3M for TB, HPV Tests
- 5.10. POC Developers Nuclein and Minute Molecular Dx Merge
- 5.11. ReadyGo Dx to Make MDx Testing a 'Snap'
- 5.12. Altratech Enters POC Testing Space by Supplanting PCR
- 5.13. Sherlock Biosciences to Acquire Sense Biodetection
- 5.14. Scripps Research, Cue Health to Offer Home Based Test-to-Treat Program
- 5.15. KSL Pulse Scientific to Distribute Home Molecular Test in Canada
- 5.16. Juno Diagnostics Offers NIPT With At-Home Sample Collection
- 5.17. Sherlock Biosciences Adds to Diagnostic Toolkit
- 5.18. Morgan Health Invests in LetsGetChecked
- 5.19. Prenetics ColoClear by Circle
- 5.20. Detect to Roll Out Next-Gen Molecular Instrument
- 5.21. Diagnostics for the Real World Third-Generation POC Platform
- 5.22. Labcorp Partnering With Getlabs for Home Collection
- 5.23. Salignostics Closes Funding Round
- 5.24. Cue Health Targets DTC Market in 2022
- 5.25. Grip Molecular Developing Home Respiratory Panel
- 5.26. Mainz Biomed Developing Home ColoAlert Assay
- 5.27. MFB Fertility Closes Series A Financing Round
- 5.28. Continued Demand for SARS-CoV-2 Rapid Tests
- 5.29. Rapid Covid-19 Test Results Risk Going Uncounted
- 5.30. FDA Grants EUAs for Direct-to-Consumer Coronavirus Kit
- 5.31. Researchers Develop 15-Minute PCR System
- 5.32. Stanford Developing Low-Cost, At-Home, COVID-19 Saliva Test
- 5.33. Lucira Health Files for $115M IPO
- 5.34. Spectrum Solutions Gets CE Mark for Saliva Collection Devices
6. Profiles of Key Home Diagnostics Companies
- 6.1 1DropDiagnostics
- 6.2 23andME Inc.
- 6.3. Abbott Laboratories
- 6.4. Accel Diagnostics
- 6.5. ADT Biotech
- 6.6. Akonni Biosystems
- 6.7. AlphaBiolabs
- 6.8. Alveo Technologies
- 6.9. Anitoa
- 6.10. Applied BioCode
- 6.11. Atomo Diagnostics
- 6.12. Aureum Diagnostics
- 6.13. Aus Diagnostics
- 6.14. Becton, Dickinson and Company
- 6.15. Binx Health
- 6.16. Biocartis
- 6.17. BioFire Diagnostics (bioMerieux)
- 6.18. bioMerieux Diagnostics
- 6.19. Bio-Rad Laboratories, Inc
- 6.20. Bosch Healthcare Solutions GmbH
- 6.21. Cepheid (Danaher)
- 6.22. Cue Health
- 6.23. Curetis (OpGen)
- 6.24. DBS Systems
- 6.25. Detect
- 6.26. Diagenode Diagnostics (Hologic)
- 6.27. Diasorin S.p.A.
- 6.28. Domus Diagnostics
- 6.29. Ellume
- 6.30. Everywell
- 6.31. Genomadix
- 6.32. Getlabs
- 6.33. Grip Molecular Technologies
- 6.34. Healthy.io
- 6.35. Hologic
- 6.36. Inflammatix
- 6.37. Invetech
- 6.38. Iollo
- 6.39. J&J Innovative Medicine
- 6.40. Karius
- 6.41. Laboratory Corporation of America
- 6.42. Letsgetchecked
- 6.43. LightDeck Diagnostics
- 6.44. Lucira Health (Pfizer)
- 6.45. LumiraDx
- 6.46. Meep
- 6.47. MFB Fertility
- 6.48. myLabBox
- 6.49. NanoDx
- 6.50. Nanomix
- 6.51. OraSure Technologies
- 6.52. Oxford Nanopore Technologies
- 6.53. Panagene
- 6.54. Prenetics
- 6.55. Primerdesign (Novacyt)
- 6.56. Prominex
- 6.57. Proof Diagnostics
- 6.58. Qiagen
- 6.59. QuantuMDx
- 6.60. Quest Diagnostics
- 6.61. QuidelOrtho
- 6.62. Randox Toxicology
- 6.63. Roche Diagnostics
- 6.64. Salignostics
- 6.65. SD Biosensor
- 6.66. Seegene
- 6.67. Siemens Healthineers
- 6.68. T2 Biosystems
- 6.69. TestCard
- 6.70. Thermo Fisher Scientific
- 6.71. Thriva
- 6.72. Visby Medical
- 6.73. XCR Diagnostics
- 6.74. YourBio Health
7. Global Market Size
- 7.1. Home Diagnostics Global Market Size by Country
- 7.1.1. Home Diagnostics Global Market Size by Country Table
- 7.1.2. Home Diagnostics Global Market Size by Country Chart
- 7.2. Home Diagnostics Global Market Size by Application
- 7.2.1. Home Diagnostics Global Market Size by Application Table
- 7.2.2. Home Diagnostics Global Market Size by Application Share by Year
- 7.2.3. Home Diagnostics Global Market Size by Application Base vs Final
- 7.2.4. Home Diagnostics Global Market Size by Application Base Year
- 7.2.5. Home Diagnostics Global Market Size by Application Final Year
- 7.2.6. Home Diagnostics Global Market Size by Application Segment Growth
- 7.3. Home Diagnostics Global Market Size by Channel
- 7.3.1. Home Diagnostics Global Market Size by Channel Table
- 7.3.2. Home Diagnostics Global Market Size by Channel Share by Year
- 7.3.3. Home Diagnostics Global Market Size by Channel Base vs Final
- 7.3.4. Home Diagnostics Global Market Size by Channel Base Year
- 7.3.5. Home Diagnostics Global Market Size by Channel Final Year
- 7.3.6. Home Diagnostics Global Market Size by Channel Segment Growth
- 7.4. Home Diagnostics Global Market Size by Technology
- 7.4.1. Home Diagnostics Global Market Size by Technology Table
- 7.4.2. Home Diagnostics Global Market Size by Technology Share by Year
- 7.4.3. Home Diagnostics Global Market Size by Technology Base vs Final
- 7.4.4. Home Diagnostics Global Market Size by Technology Base Year
- 7.4.5. Home Diagnostics Global Market Size by Technology Final Year
- 7.4.6. Home Diagnostics Global Market Size by Technology Segment Growth
8. Global Market by Application
- 8.1. Respiratory Market
- 8.1.1. Respiratory Market by Country Table
- 8.1.2. Respiratory Market Chart
- 8.2. STD Market
- 8.2.1. STD Market by Country Table
- 8.2.2. STD Market Chart
- 8.3. UTI Market
- 8.3.1. UTI Market by Country Table
- 8.3.2. UTI Market Chart
- 8.4. Pregnancy Market
- 8.4.1. Pregnancy Market by Country Table
- 8.4.2. Pregnancy Market by Chart
- 8.5. Ovulation Market
- 8.5.1. Ovulation Market by Country Table
- 8.5.2. Ovulation Market by Chart
- 8.6. DNA Market
- 8.6.1. DNA Market by Country Table
- 8.6.2. DNA Market Chart
- 8.7. Other Market
- 8.7.1. Other Market by Country Table
- 8.7.2. Other Market Chart
9. Global Market by Channel
- 9.1. Store Market
- 9.1.1. Store Market by Country Table
- 9.1.2. Store Market Chart
- 9.2. Online Market
- 9.2.1. Online Market by Country Table
- 9.2.2. Online Market Chart
- 9.3. Other Channel Market
- 9.3.1. Other Channel by Country Table
- 9.3.2. Other Channel Market Chart
10. Global Market by Technology
- 10.1. Immunoassay Market
- 10.1.1. Immunoassay Market by Country Table
- 10.1.2. Immunoassay Market Chart
- 10.2. Chemistry Market
- 10.2.1. Chemistry Market by Country Table
- 10.2.2. Chemistry Market Chart
- 10.3. Nucleic Acid Market
- 10.3.1. Nucleic Acid Market by Country Table
- 10.3.2. Nucleic Acid Market Chart
- 10.4. Other Technology Market
- 10.4.1. Other Technology Market by Country Table
- 10.4.2. Other Technology Market Chart
11. Appendices
- 11.1. United States Medicare System: Clinical Laboratory Fees Schedule
- 11.2. The Most Used IVD Assays
- 11.3. The Highest Grossing Assays