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Home Diagnostics Market: Strategies and Trends - Forecasts by Application, by Channel, by Technology and by Country, with Market Analysis and Executive Guides

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    Report

  • 392 Pages
  • July 2024
  • Region: Global
  • Howe Sound Research
  • ID: 5585274

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 of 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 learn about the players.

Exciting technical developments especially in the seesaw between different analytic technologies, 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 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.

This research makes you the expert in your organization.

The report includes five year market forecasts.

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 (bioMérieux)
6.18 bioMérieux 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

List of Tables
Table 1 Application Segment Definitions
Table 2 Channel Segment Definitions
Table 3 Technology Segment Definitions
Table 4 Market Players by Type
Table 5 Clinical Laboratory Departments and Segments
Table 6 Laboratory Management Focus - Different Approaches
Table 7 Key Segmentation Variables Going Forward
Table 8 Possible Market Segments of HOME Market
Table 9 Five Factors Driving Growth
Table 10 Four Factors Limiting Growth
Table 11 Self vs. Send TAT
Table 12 Home Diagnostics Global Market by Country/Region
Table 13 Home Diagnostics Global Market by Application
Table 14 Home Diagnostics Global Market by Channel
Table 15 Home Diagnostics Global Market by Technology
Table 16 Respiratory by Country
Table 17 STD market by country
Table 18 UTI Market by country
Table 19 Pregnancy Market by country
Table 20 Ovulation Market by country
Table 21 DNA Market by country
Table 22 Other Market by country
Table 23 Store Market by Country
Table 24 Online market by country
Table 25 Other Channel Market by country
Table 26 Immunoassay by Country
Table 27 Chemistry Market by country
Table 28 Nucleic Acid Market by country
Table 29 Other Technology Market by country
Table 30 Clinical Lab Fee Schedule
Table 31 The Most Common Assays
Table 32 Largest Revenue Assays

List of Figures
Figure 1 Standard Test Paradigm
Figure 2 The New Test Paradigm
Figure 3 Global Healthcare Spending
Figure 4 The Lab Test Pie
Figure 5 The Road to Diagnostics
Figure 6 Chart Death Rates and Infectious Disease Decline
Figure 6 The Multiplex Paradigm Shift
Figure 8 Market Size by Country - Key Countries
Figure 9 Chart of Global Market by Application by Year
Figure 10 Application Segment Shares Base vs Final
Figure 11 Application Share Base Year
Figure 12 Application Share Final Year
Figure 13 Application Segment Growth Rates
Figure 14 Chart of Global Market by Channel by Year
Figure 15 Channel Segment Shares Base vs Final
Figure 16 Channel Share Base Year
Figure 17 Channel Share Final Year
Figure 18 Channel Segment Growth Rates
Figure 19 Chart of Global Market by Technology by Year
Figure 20 Technology Segment Shares Base vs Final
Figure 21 Technology Share Base Year
Figure 22 Technology Share Final Year
Figure 23 Technology Segment Growth Rates
Figure 24 Chart - Respiratory Market Growth
Figure 25 Chart - STD Market Growth
Figure 26 Chart - UTI Market Growth
Figure 27 Chart - Pregnancy Market Growth
Figure 28 Chart - Ovulation Market Growth
Figure 29 Chart - DNA Market Growth
Figure 30 Chart - Other Market Growth
Figure 31 Chart - Store Market Growth
Figure 32 Chart - Online Market Growth
Figure 33 Chart - Other Channel Market Growth
Figure 34 Chart - Immunoassay Market Growth
Figure 35 Chart - Chemistry Market Growth
Figure 36 Chart - Nucleic Acid Market Growth
Figure 37 Chart - Other Technology Market Growth

Companies Mentioned

  • 1DropDiagnostics
  • 23andME Inc.
  • Abbott Laboratories
  • Accel Diagnostics
  • ADT Biotech
  • Akonni Biosystems
  • AlphaBiolabs
  • Altratech
  • Alveo Technologies
  • Anitoa
  • Applied BioCode
  • Atomo Diagnostics
  • Aureum Diagnostics
  • Aus Diagnostics
  • Becton, Dickinson and Company
  • Binx Health
  • Bio-Rad Laboratories, Inc
  • Biocartis
  • BioFire Diagnostics (bioMérieux)
  • bioMérieux Diagnostics
  • Bosch Healthcare Solutions GmbH
  • Capitainer
  • Cepheid (Danaher)
  • Circle
  • Co-Diagnostics
  • Cue Health
  • Curetis (OpGen)
  • DBS Systems
  • Detect
  • DiaCarta
  • Diagenode Diagnostics (Hologic)
  • DiagMetrics
  • Diasorin S.p.A.
  • Domus Diagnostics
  • Ellume
  • Everywell
  • Genomadix
  • Getlabs
  • Grip Molecular
  • Healthy.io
  • Hologic
  • Inflammatix
  • Invetech
  • Iollo
  • J&J Innovative Medicine
  • Juno Diagnostics
  • Karius
  • KSL Pulse Scientific
  • Labcorp
  • Laboratory Corporation of America
  • Letsgetchecked
  • Life Genomics
  • LightDeck Diagnostics
  • Lucira Health (Pfizer)
  • LumiraDx
  • Mainz Biomed
  • Meep
  • MFB Fertility
  • Morgan Health
  • myLabBox
  • NanoDx
  • Nanomix
  • OraSure Technologies
  • Oxford Nanopore Technologies
  • Panagene
  • Prenetics
  • Primerdesign (Novacyt)
  • Prominex
  • Proof Diagnostics
  • Qiagen
  • QuantuMDx
  • Quest Diagnostics
  • QuidelOrtho
  • Randox Toxicology
  • ReadyGo
  • Roche Diagnostics
  • Salignostics
  • Scripps Research
  • SD Biosensor
  • Seegene
  • Sense Biodetection
  • Sherlock Biosciences
  • Siemens Healthineers
  • Spectrum Solutions
  • Stanford
  • T2 Biosystems
  • TestCard
  • Thermo Fisher Scientific
  • Thriva
  • Visby Medical
  • Watmind
  • XCR Diagnostics
  • YourBio Health