The Worldwide At-Home Diagnostic Testing Market to 2027 – Surging Demand for Early Disease Diagnosis, Personalized Medicine & Expanded Technologies Drives Growth –

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 the 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, the importance of disease monitoring, expanded technologies and cost.

The precursor to the 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, the importance of disease monitoring, expanded technologies and cost.

Key Topics Covered:

Chapter 1: Executive Summary

  • Industry at a Glance
  • Scope and Methodology
  • Size and Growth of the Market
  • Key Issues and Trends Affecting the Market
  • Competitive Outlook
  • Conclusion Highlights

Chapter 2: Introduction

  • Overview
  • Issues and Trends
  • COVID-19
  • Insurance for Home Tests
  • Home IVD Testing Drivers and Challenges
  • Genetics
  • Home Collection

Chapter 3: At-Home IVD Tests

  • Introduction
  • Diabetes
  • Pregnancy and Fertility
  • Infectious Disease
  • HIV
  • COVID-19
  • COVID-19 & Flu
  • Coagulation
  • Fecal Occult Blood
  • Cholesterol
  • Drugs of Abuse
  • At-Home IVD Test Market by Test Type
  • At-Home IVD Tests Market by Sample Type
  • Blood Samples
  • Urine Samples
  • Oral/Saliva Samples
  • Nasal Samples
  • Stool Samples
  • Other

Chapter 4: Home Collection IVD Tests

  • Introduction
  • Pregnancy and Fertility
  • Infectious Disease
  • HIV
  • HPV and other STDs
  • COVID-19
  • COVID-19 & Flu
  • Fecal Occult Blood
  • Cholesterol
  • Genetics
  • Home Collection IVD Tests by Test Type
  • Privacy
  • Home Collection Tests by Sample Type
  • Blood Samples
  • Urine Samples
  • Oral/Saliva Samples
  • Nasal Samples
  • Stool Samples
  • Other

Chapter 5: Market Participants

  • 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
  • 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

Chapter 6: Market Analysis

  • Market Overview
  • Market Segment by Test Type
  • Glucose & HbA1c
  • Infectious Disease
  • Other Areas
  • Genetic
  • Market by Distribution
  • Market by Region


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