There are more than 40 FDA-authorized home tests, but some may have age restrictions.Some state health departments do accept the results of a self-test, but not all. Some accept only suspect or probable results and require a confirmation nucleic acid amplification test. While data reporting is not required for self-tests, it can improve their effectiveness and aid surveillance. Moreover, it may inform public health policies and programs. Self-tests have been the subject of several debates. However, many experts agree that this method is not without its drawbacks.
In addition to being free, the self-test is available to people who have Medicare. In some cases, enrollees may need to show their Medicare cards. In the case of the BinaxNOW COVID-19 Antigen Self-Test, the detection rate was 95%. The result was positive in 19 of 20 replicates. In addition, it was confirmed as having 140.6 TCID50/mL. A negative result would have meant that the agent detected was not the causative agent of the disease.
The global self-testing market is estimated to be valued at US$ 18,503.0 million in 2021 and is expected to exhibit a CAGR of 8.5% during the forecast period (2021-2028).
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Growing adoption of business development strategies such as agreement, collaboration, and acquisition by key market players is anticipated to drive the global self-testing market growth during the forecast period.
Key market players are engaged in business development strategies to increase their product availability which is expected to drive the self-testing market growth over the forecast period. For instance, in April 2021, Viatris Inc., a global pharmaceutical company, and Atomo Diagnostics Limited, a global leader in the development of user-friendly rapid diagnostic test products, announced a multi-year agreement with the global health agency Unitaid to increase access to HIV self-testing in low- and middle-income countries (LMICs).
Moreover, key players are focusing on various strategies such as investments and funding, which is expected to drive the market growth over the forecast period. For instance, in December 2020, Kenota Health Inc., a Canadian medical technology company, raised US$ 8 million in funding with the goal of providing physicians with rapid and reliable allergy testing, allowing them to test and treat more patients in a single clinic visit.
The development of technologically advanced self-test kits is projected to propel the market growth over the forecast period.
Key market players are focusing on developing advanced technologies in self-testing kits for diagnosing severe chronic diseases such as diabetes and pregnancy detection. For instance, in September 2021, the US Patent and Trademark Office granted a U.S. patent to Gelteq Pty Ltd, a global leader in ingestible gel technology for healthcare, nutrition, and sports. It is Gelteq’s first U.S. patent and it covers product technology and methods for testing human response to oral glucose loads using a proprietary gel-based delivery system. The novel diabetes diagnostic system is intended for use in pathology labs and at home.
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Global Self-testing Market– Impact of Coronavirus (COVID-19) Pandemic
Identifying individuals infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been a focal point throughout the coronavirus disease (COVID-19) pandemic. This has thus created a public health need for COVID-19 testing that is timely, reliable, and widely available. Testing is critical to limiting the spread of the virus that causes the COVID-19. Regardless of the vaccination status, if a person has symptoms or has had a known exposure to someone with suspected or confirmed COVID-19, the individual should be tested. A self-assessment or self-test is a test that can be done at home or anywhere else. A self-test is also known as a ‘home test’, ‘at-home test’, or ‘over-the-counter (OTC) test’. Self-testing yields quick results. Self-tests can also be used as one of many risk-reduction strategies such as vaccination, masking, and physical distancing to protect everyone by lowering the likelihood of viral transmission.
Market players are focused on strategies such as distribution agreements for COVID-19 self-test kits. This is expected to drive the global self-testing market growth. For instance, in April 2021, Quidel Corporation, a leading provider of rapid diagnostic testing solutions, cellular-based virology assays, and molecular diagnostic systems, announced the completion of a distribution and fulfilment agreement with McKesson Corporation, a global leader in healthcare supply chain management solutions and retail pharmacy, to improve consumer access to Quidel’s non-prescription QuickVue At-Home OTC (over-the-counter) COVID-19 Test.
Global Self-testing Market: Restraints
The increasing number of product recalls of self-testing kits by regulatory authorities is expected to hinder the global self-testing market growth over the forecast period. For instance, in November 2021, the U.S. Food and Drug Administration (FDA) issued a recall of approximately 2 million at-home COVID-19 test kits manufactured by the Australian-based biotech company Ellume. Due to a manufacturing flaw, the test kits may produce ‘false positives’, according to the federal regulatory agency. In October 2021, the company notified the FDA about the defect in some lots. The FDA classified the Ellume test recall as ‘the most serious type’, known as a Class I recall.
Key Players
Major players operating in the global self-testing market include Abbott, Acon Laboratories Inc., ARKRAY Inc., F. Hoffmann-La Roche AG, Siemens Healthineers, OraSure Technologies Inc., Quest Diagnostics, Bionime Corporation, Becton, Dickinson and Company, Btnx Inc., and JR Biomedical Ltd.
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Table of Contents
- Research Objectives and Assumptions
- Research Objectives
- Assumptions
- Abbreviations
- Market Purview
- Report Description
- Market Definition and Scope
- Executive Summary
- Market Snapshot, By Product Type
- Market Snapshot, By Application Type
- Market Snapshot, By Sample Type
- Market Snapshot, By Test Type
- Market Snapshot, By Distribution Channel
- Market Snapshot, By Region
- Coherent Opportunity Map (COM)
- Report Description
- Market Dynamics, Regulations, and Trends Analysis
- Market Dynamics
- Drivers
- Restraints
- Opportunity
- Impact Analysis
- Key developments
- New Product Launches or Approvals
- Acquisitions, Collaborations and Agreements
- Market Trends
- Regulatory Scenario
- PEST Analysis
- PORTER’s Five Forces Analysis
- Brand Analysis
- Pricing Analysis
- Market Dynamics
- Global Self-testing Market– Impact of Coronavirus (COVID-19) Pandemic
- Economic Impact
- Impact on Self-Testing Kits
- COVID-19 Epidemiology
- Global Self-testing Market, By Product Type, 2017 – 2028, (US$ Mn)
- Introduction
- Market Share Analysis, 2021 and 2028 (%)
- Y-o-Y Growth Analysis, 2018 – 2028
- Segment Trends
- Kits
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Self-testing Kits
- Self-collection Kits
- Self-Testing Devices
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Introduction
- Global Self-testing Market, By Application Type, 2017 – 2028, (US$ Mn)
- Introduction
- Market Share Analysis, 2021 and 2028 (%)
- Y-o-Y Growth Analysis, 2018 – 2028
- Segment Trends
- Blood Glucose Testing
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Pregnancy Testing
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Pulmonary Function Testing
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Urinary Tract Infection Testing
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Sexually transmitted infections (STIs) Testing
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Genetic Testing
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Vitamin Testing
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Vitamin D
- Vitamin B
- Others
- Mineral Deficiency Testing
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Iron
- Calcium
- Others
- COVID Testing
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Allergy Testing
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Pollen Allergy
- Dust Mite Allergy
- Others
- Gastrointestinal Screening
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Hormone Testing
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- TSH Testing
- Menopause Testing
- Others
- Food Sensitivity Testing
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Celiac Disease
- Others
- Infectious Diseases
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Introduction
- Global Self-testing Market, By Sample Type, 2017 – 2028, (US$ Mn)
- Introduction
- Market Share Analysis, 2021 and 2028 (%)
- Y-o-Y Growth Analysis, 2018 – 2028
- Segment Trends
- Blood Sample
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Saliva Sample
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Nasal Sample
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Stool Sample
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Urine Sample
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Introduction
- Global Self-testing Market, By Test Type, 2017 – 2028, (US$ Mn)
- Introduction
- Market Share Analysis, 2021 and 2028 (%)
- Y-o-Y Growth Analysis, 2018 – 2028
- Segment Trends
- Laboratory Tests
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Point of Care Tests/Homecare Tests
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Introduction
- Global Self-testing Market, By Distribution Channel, 2017 – 2028, (US$ Mn)
- Introduction
- Market Share Analysis, 2021 and 2028 (%)
- Y-o-Y Growth Analysis, 2018 – 2028
- Segment Trends
- Offline
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- Hospital Pharmacies
- Retail Pharmacies/ Drug Stores
- Supermarkets And Hypermarkets
- Online
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2017 – 2028, (US$ Mn)
- E-commerce
- Online Pharmacies
- Company’s Own Website
- Introduction
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