This new Kalorama Information 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.
AT-HOME IVD MARKET SHARE BY MAJOR COMPANY, 2023
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 MARKET BY TYPE, 2023
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.
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 for 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.
Companies Featured in This Report:
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
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
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
