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At-Home Diagnostic Testing Markets and Trends (COVID-19, FOB, Glucose, HIV and Other Tests) 2023

  • Report

  • 142 Pages
  • June 2023
  • Region: Global
  • Kalorama Information
  • ID: 5315031

This new report, At-Home Diagnostic Testing Markets and Trends (COVID-19, FOB, Glucose, HIV and Other Tests), 2023, examines a range of both at-home tests and home collection tests. The At-Home in vitro diagnostic (IVD) testing market is comprised of IVD tests that can be purchased at the local store or on the Internet where the patient gathers the specimen and results are displayed usually within minutes. Generally, these are lateral flow technology or dip stick methods.

Meanwhile, the global Home IVD testing market is a growing market with much potential. The Home Collection IVD testing market is comprised of testing kits that are obtained from the local pharmacy or internet and sent to the patient’s home. The patient collects the specimen, puts it into a collection container and sends it to the laboratory for testing. Results are sent back to the patient and/or referring physician.

Detailed Market Estimates by Specialty 

This report covers the At-Home and Home testing markets by segmenting them into several broad areas including:

  • Cholesterol
  • Drugs of Abuse
  • Fecal Occult Blood
  • Glucose/HbA1c including CGM
  • Infectious Disease
    • COVID-19 /+ Flu + RSV
    • HIV
  • Pregnancy and Fertility
  • Rapid Coagulation
  • Genetic (excluding ancestry genetic testing)

The report also breaks out the market by venue:

  • At-Home Test (Patient Gets Result At Home)
  • Home Collection Test (Sent to Lab for Results Later)

A Long-standing Trend That Has Seen Renewed Focus

At-Home IVD tests designed for home use are generally available in the form of strips, cassettes, dip cards and digital monitoring devices. The most widely used patient self-tests are for pregnancy and ovulation and glucose. Manufacturers anticipated consumer acceptance of tests for occult blood, cholesterol, HIV, coagulation/PT and H. pylori. Worldwide, these tests have had minimal appeal. The need for a blood sample has limited the use of self-tests for cholesterol. Tests such as H. pylori have just not yet captured the interest of consumers. Outside United States, consumers will find OTC tests for a wider range of analytes including allergens, TSH, and FSH.  The latest trend to overcome reticence for self-testing is direct to consumer marketing of lab tests in public venues such as malls and supermarkets and home testing kits via the Internet.

At Home Market by Type 2023

The forecasted market analysis for 2022-2027 was largely based on demographic trends, new developments, innovative technology and global expansion.

The growth of the Home IVD testing market is born out of a paradigm shift among consumers who are seeking greater control over their own healthcare. Since the 1980s, consumers have pushed for access to their laboratory tests, but it has been slow to evolve due to concerns that consumers may try to diagnose themselves without understanding how diagnoses information all fits together.

With the increased use of the Internet for medical information, consumers have become medical consumers not just patients. This has created a change in the doctor/patient relationship as individuals become more knowledgeable about their own health and want more control over their personal information and treatment decisions. Consumers are more cost-conscious and the increase in high-deductible insurance plans requires that individuals ask more questions, do their own research and collaborate with their doctor about medical decisions, tests, and treatments.

Drivers include the growing demand for early disease detection and diagnosis, personalized medicine, importance of disease monitoring, expanded technologies and cost.

The precursor to Home IVD testing market rests with the rise of genetic testing which began in the 1970s and has grown to include tests for cancer and other illnesses that there may be a genetic susceptibility in the family. Ancestral testing provided clues as to what may be in the ancestral pool prompting consumers to discover more about their own predisposition for certain diseases. The passage of the 2008 Genetic Information Nondiscrimination Act (GINA) has opened the door for consumer awareness of genetic make-up without the fear of discrimination by health insurers and employers.

Companies that provide such testing offer a broad range of services, such as predicting adverse reactions to specific medications, estimating susceptibility to various complex diseases, and diagnosing predominantly genetic disorders.

Several trends are continuing to shape the home laboratory testing market including the growing demand for early disease detection and diagnosis, personalized medicine, importance of disease monitoring, expanded technologies and cost.

Table of Contents

Chapter 1: Executive Summary
  • Industry at a Glance
  • Scope and Methodology
  • Size and Growth of the Market
  • Figure 1-1: Global Home IVD Market, by Key Segment (Glucose/HbA1c, COVID-19, Other, Genetic), 2019-2022
  • Key Issues and Trends Affecting the Market
  • Competitive Outlook
  • Conclusion Highlights
Chapter 2: Introduction
  • Overview
  • Issues and Trends
  • COVID-19
  • Figure 2-1: Home COVID-19 Test Distribution of Sales by Vendor (Abbott Diagnostics, Becton Dickinson, OraSure Technologies, Siemens Healthineers, Quidel, Others)
  • Insurance for Home Tests
  • Figure 2-2: Diabetes State Mandates - State-Level Insurance Mandates for Benefits, ACA Marketplace Coverage
  • Home IVD Testing Drivers and Challenges
  • Figure 2-3: Benefits to Home Testing vs. Challenges in Home Testing
  • Genetics
  • Table 2-1: Home Genetic Laboratory Testing, Market Drivers and Barriers
  • Home Collection
Chapter 3: At-Home IVD Tests
  • Introduction
  • Diabetes
  • Table 3-1: Selected Glucose At-Home Testing Meter Innovations
  • Pregnancy and Fertility
  • Infectious Disease
  • HIV
  • COVID-19
  • COVID-19 & Flu
  • Table 3-2: Selected COVID-19 and COVID-19 & Flu A/B At-Home Tests for SARS-CoV-2
  • Coagulation
  • Fecal Occult Blood
  • Cholesterol
  • Drugs of Abuse
  • At-Home IVD Test Market by Test Type
  • Table 3-3: Global At-Home IVD Market by Test Type (Glucose, Infectious Disease, Other), 2022 ($BN)
  • Figure 3-1: Global At-Home IVD Market by Distribution of Sales by Segment (Glucose, COVID-19+, HIV, Other Infections, Cholesterol, Drug of Abuse, Coagulation, FOB, Pregnancy & Fertility, Other), 2022
  • At-Home IVD Tests Market by Sample Type
  • Table 3-4: Global At-Home IVD Market by Sample Type (Blood, Nasal, Oral/Saliva, Stool, Urine, Other), 2022 ($BN)
  • Figure 3-2: Global At-Home IVD Market by Distribution of Sales by Sample Type (Blood, Urine, Oral/Saliva, Nasal, Stool, Other), 2019 and 2022
  • Figure 3-3: Year-over-Year Growth for At-Home IVD Markets (Cholesterol, Coagulation, COVID-19, Drugs of Abuse, FOB, Glucose, HIV, Other Infections, Pregnancy & Fertility, Other), 2020-2021 and 2021-2022 (%)
  • Blood Samples
  • Figure 3-4: Estimated Distribution of Blood Sample Sales by Test Type (Cholesterol, Coagulation, Glucose, Other), 2022 (%)
  • Urine Samples
  • Figure 3-5: Estimated Distribution of Urine Sample Sales, by Test Type (Drug of Abuse, Infectious Disease, Pregnancy, Other), 2022 (%)
  • Oral/Saliva Samples
  • Figure 3-6: Estimated Distribution of Oral/Saliva Sample Sales by Test Type (COVID-19, Drug of Abuse, HIV, Other), 2022 (%)
  • Nasal Samples
  • Figure 3-7: Estimated Distribution of Nasal Sample Sales by Test Type (COVID-19, Other), 2022 (%)
  • Stool Samples
  • Figure 3-8: Estimated Distribution of Stool Sample Sales by Test Type (FOB, Other), 2022 (%)
  • Other
Chapter 4: Home Collection IVD Tests
  • Introduction
  • Pregnancy and Fertility
  • Infectious Disease
  • HIV
  • HPV and other STDs
  • COVID-19
  • COVID-19 & Flu
  • Table 4-1: Selected Molecular EUA Tests for COVID-19
  • Fecal Occult Blood
  • Cholesterol
  • Genetics
  • Home Collection  IVD Tests by Test Type
  • Table 4-2: Global Home Collection IVD Market by Test Type (Genetics, Infectious Disease, Other Areas), 2022 ($BN)
  • Figure 4-1: Global Home IVD Market by Distribution of Sales by Segment (Cholesterol, Coagulation, COVID-19, Drug of Abuse, Genetic, HbA1c, HIV, Other Infections, Pregnancy & Fertility, Other), 2022 (%)
  • Privacy
  • Home Collection Tests by Sample Type
  • Table 4-3: Global Home Collection IVD Market by Sample Type (Blood, Nasal, Oral/Saliva, Stool, Urine, Other), 2022 ($BN)
  • Figure 4-2: Global Home Collection IVD Market by Distribution of Sales by Sample Type (Blood, Urine, Oral/Saliva, Nasal, Stool, Other), 2019 and 2022
  • Figure 4-3: Year-over-Year Growth for Home Collection IVD Markets, by Type (Cholesterol, Coagulation, COVID-19, Drug of Abuse, FOB, Genetic, HbA1c, HIV, Other Infections, Pregnancy & Fertility, Other), 2020-2021 and 2021-2022 (%)
  • Blood Samples
  • Figure 4-4: Estimated Distribution of Blood Sample Sales by Test Type (Cholesterol, Fertility, Genetic, Glucose/HbA1c, Infectious Disease - STD blood spot, Tumor Market - PSA blood spot, Other - hormone), 2022 (%)
  • Urine Samples
  • Figure 4-5: Estimated Distribution of Urine Sample Sales by Test Type (Infectious Disease - STD, Pregnancy/Fertility, Other - Heavy metals, hormone, nutrition), 2022 (%)
  • Oral/Saliva Samples
  • Figure 4-6: Estimated Distribution of Oral/Saliva Sample Sales by Test Type (COVID-19, Drug of Abuse, Fertility, Genetic, HIV, Other - hormone, nutrition, medication match), 2022 (%)
  • Nasal Samples
  • Figure 4-7: Estimated Distribution of Nasal Sample Sales by Test Type (COVID-19, Other), 2022 (%)
  • Stool Samples
  • Figure 4-8: Estimated Distribution of Stool Sample Sales by Test Type (FOB, Infectious Disease - pathogen ID, Other - Heavy metals), 2022 (%)
  • Other
Chapter 5: Market Participants
  • 23andMe, Inc
  • Table 5-1:  23andMe Corporate Summary
  • Company Overview
  • Table 5-2:  23andMe Genetic Tests with FDA Marketing Authorization
  • Performance Review
  • Table 5-3: 23andMe Revenue, 2020-2022 ($ millions)
  • Abbott Diagnostics
  • Table 5-4: Corporate Summary
  • Company Overview
  • Performance Review
  • Table 5-5: Abbott Revenues, 2020-2022 (in millions $)
  • AccessBio, Inc.
  • Table 5-6: AccessBio Corporate Summary
  • Company Overview
  • ACON Laboratories, Inc.
  • Table 5-7:  ACON Laboratories Corporate Summary
  • Company Overview
  • ARKRAY, Inc.
  • Table 5-8: ARKRAY Corporate Summary
  • Company Overview
  • Ascensia Diabetes Care Holdings AG
  • Table 5-9: Ascensia Diabetes Care Corporate Summary
  • Company Overview
  • Atomo Diagnostics
  • Table 5-10:  Atomo Corporate Summary
  • Company Overview
  • Performance Review
  • Table 5-11: Atomo Revenues, 2021-2022 (in millions $)
  • Becton-Dickinson
  • Table 5-12:  Becton-Dickinson Corporate Summary
  • Company Overview
  • Performance Review
  • Table 5-13: BD Corporation Revenue, 2020-2022 ($ millions)
  • binx health
  • Table 5-14: binx health Corporate Summary
  • Company Overview
  • Biomerica, Inc.
  • Table 5-15: Biomerica Corporate Summary
  • Company Overview
  • Company Financials
  • Table 5-16: Biomerica Corporation Revenue, 2020-2022 ($ millions)
  • Biosynex SA
  • Table 5-17:  Biosynex Corporate Summary
  • Company Overview
  • Performance Review
  • Table 5-18: Biosynex Revenues 2021-2022 (in millions $)
  • BTNX Inc.
  • Table 5-19: BTNX Corporate Summary
  • Company Overview
  • Church & Dwight Co. Inc
  • Table 5-20: Church & Dwight Corporate Summary
  • Company Overview
  • Performance Review
  • Table 5-21: Church and Dwight Revenues, 2020-2022 ($ millions)
  • Color Health, Inc.
  • Table 5-22:  Color Health Corporate Summary
  • Company Overview
  • Cue Health
  • Table 5-23:  Cue Health Corporate Summary
  • Company Overview
  • Dexcom, Inc.
  • Table 5-24:  Dexcom Corporation Corporate Summary
  • Company Overview
  • Performance Review
  • Table 5-25:  Dexcom Revenues, 2020-2022 ($ millions)
  • EasyDNA
  • Table 5-26:  EasyDNA Corporate Summary
  • Company Overview
  • Everlywell
  • Table 5-27: Everlywell Corporate Summary
  • Company Overview
  • Exact Sciences
  • Table 5-28: Exact Sciences Corporate Summary
  • Company Overview
  • Performance Review
  • Table 5-29:  Exact Sciences Revenues, 2020-2022 ($ millions)
  • First Check Diagnostics LLC
  • Table 5-30:  First Check Diagnostics Corporate Summary
  • Company Overview
  • GlysBy diagnostics
  • Table 5-31: GlysBy Corporate Summary
  • Company Overview
  • Helena Laboratories
  • Table 5-32: Helena Laboratories Corporate Summary
  • Company Overview
  • Hemosure, Inc.
  • Table 5-33: Hemosure Corporate Summary
  • Company Overview
  • LifeScan, Inc
  • Table 5-34: LifeScan Corporate Summary
  • Company Overview
  • Medichecks.com Ltd.
  • Table 5-35:  Medichecks Corporate Summary
  • Company Overview
  • Myriad Genetics, Inc.
  • Table 5-36:  Myriad Genetics Corporate Summary
  • Company Overview
  • Performance Review
  • Table 5-37:  Myriad Diagnostics Revenue, 2020-2022 ($ millions)
  • OraSure Technologies, Inc.
  • Table 5-38:  OraSure Technologies Summary
  • Company Overview
  • Performance Review
  • Table 5-39:  OraSure Revenues, 2020-2022 ($ millions)
  • Polymedco, Inc
  • Table 5-40: Polymedco Corporate Summary
  • Company Overview
  • Preventis GmbH
  • Table 5-41: Preventis Corporate Summary
  • Company Overview
  • Prima Lab SA
  • Table 5-42:  Prima Corporate Summary
  • Company Overview
  • QuidelOrtho Corporation
  • Table 5-43:  QuidelOrtho Corporate Summary
  • Company Overview
  • Performance Review
  • Table 5-44:  QuidelOrtho Revenues, 2020-2022 ($ millions)
  • Roche Diagnostic Corporation
  • Table 5-45:  Roche Diagnostic Corporate Summary
  • Company Overview
  • Performance Review
  • Table 5-46:  Roche Diagnostics, 2020-2022 ($ millions)
  • Siemens Healthineers GmbH
  • Table 5-47: Siemens Healthineers Corporate Summary
  • Company Overview
  • Performance Review
  • Table 5-48:  Siemens Healthineers, 2020-2022 ($ millions)
  • Swiss Precision Diagnostics GmbH
  • Table 5-49:  Swiss Precision Diagnostics Corporate Summary
  • Company Overview
  • Trividia Health
  • Table 5-50: Trividia Health Corporate Summary
  • Company Overview
  • VedaLab
  • Table 5-51: VedaLab Corporate Summary
  • Company Overview
Chapter 6: Market Analysis
  • Market Overview
  • Figure 6-1: Global Home IVD Market, 2022-2027, 5% CAGR, ($MN)
  • Market Segment by Test Type
  • Figure 6-2: Global Home IVD Market by Test Type (Genetic, Glucose/HbA1c, Infectious Disease, Other Areas), 2019-2022 ($MN)
  • Figure 6-3: Global Home IVD Market, by General Test Segment (Genetic, Glucose/HbA1c, Infectious Disease, Other Areas), 2022
  • Glucose & HbA1c
  • Table 6-1: Estimated Global Home IVD Glucose & HbA1c Testing Market, 2022-2027 $MN; CAGR 22-27
  • Infectious Disease
  • Table 6-2: Estimated Global Home IVD Infectious Disease Testing Market, 2022-2027 $MN; CAGR 22-27
  • Other Areas
  • Table 6-3: Estimated Global Home IVD Other Testing Market, 2022-2027 $MN; CAGR 22-27
  • Genetic
  • Table 6-4: Estimated Global Home IVD Genetic Testing Market, 2022-2027 $MN; CAGR 22-27
  • Market by Distribution
  • Market by Region
  • Figure 6-4: Estimated Global Home IVD Testing Market, by Region (APAC, EMEA, United States, Rest of World), 2019-2022
  • Competitive Analysis
  • Figure 6-5: Estimated Global Home IVD Testing Market, Vendor Market Share, by Top Five Market Vendors (Abbott, Dexcom, QuidelOrtho, Roche, Siemens Healthineers, Other), 2022

Samples

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Companies Mentioned

  • 23andMe, Inc
  • Abbott Diagnostics
  • AccessBio, Inc.
  • ACON Laboratories, Inc.
  • ARKRAY, Inc.
  • Ascensia Diabetes Care Holdings AG
  • Atomo Diagnostics
  • Becton-Dickinson
  • binx health
  • Biomerica, Inc.
  • Biosynex SA
  • BTNX Inc.
  • Church & Dwight Co. Inc
  • Color Health, Inc.
  • Cue Health
  • Dexcom, Inc.
  • EasyDNA
  • Everlywell
  • Exact Sciences
  • First Check Diagnostics LLC
  • GlysBy diagnostics
  • Helena Laboratories
  • Hemosure, Inc.
  • LifeScan, Inc
  • Medichecks.com Ltd.
  • Myriad Genetics, Inc.
  • OraSure Technologies, Inc.
  • Polymedco, Inc
  • Preventis GmbH
  • Prima Lab SA
  • QuidelOrtho Corporation
  • Roche Diagnostic Corporation
  • Siemens Healthineers GmbH
  • Swiss Precision Diagnostics GmbH
  • Trividia Health
  • VedaLab