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  • Published On : Sep 2022
  • Code : CMI4902
  • Pages :197
  • Formats :
      Excel and PDF
  • Industry : Clinical Diagnostic

A self-test is a test that one can carry out independently at home to identify or diagnose various diseases. Self-tests can be used as one of the many risk-reduction strategies that protect people by lowering the likelihood of viral transmission in the case of the COVID-19, in addition to vaccination, masking, and physical separation. Additionally, diabetes is diagnosed through self-testing by monitoring blood sugar levels. The quantity of sugar or glucose in the blood can be measured using a blood sugar test. Market participants are concentrating on a variety of strategies, including funding and investments, which is expected to drive market growth over the forecast period. For instance, on 22 October 2021, the U.S. Department of Health and Human Services had announced that is has invested almost half a billion dollars in dozen of the U.S. companies to expand manufacturing of COVID-19 self-test kits. In continuation, OraSure Technologies, a Pennsylvania-based company in the medical device industry was awarded US$109 million to increase domestic manufacturing capability of rapid antigen self-tests for home care testing.

Global self-testing market is estimated to be valued at US$ 20,117.5 Million in 2022 and expected to reach US$ 39,175.0 million by 2030, witnessing a CAGR of 8.7 % over the forecast period (2022-2030).

Figure 1. Global Self-Testing Market Share (%), By Region, 2022

SELF-TESTING MARKET

Increasing 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.

Due to the increase in business development strategies such collaboration and acquisition by major market players is expected to drive the self-testing market growth over the forecast period.

For instance, on 22 February 2021, Becton, Dickinson and Company a leading global medical technology company, and Scanwell Health, a leader in smartphone-enabled at-home medical tests, announced a collaboration to create an at-home rapid test for SARS-CoV-2 using a Becton, Dickinson and Company’s antigen test and the Scanwell Health mobile app.

Moreover, 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, Unit aid to increase access to HIV self-testing in low- and middle-income countries (LMICs).

Self-Testing Market Report Coverage

Report Coverage Details
Base Year: 2021 Market Size in 2022: US$ 20,117.5 Mn
Historical Data for: 2017 to 2020 Forecast Period: 2022 to 2030
Forecast Period 2022 to 2030 CAGR: 8.7% 2030 Value Projection: US$ 39,175.0 Mn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Product Type: Kits (Self-testing kits, Self-collection kits), Self-testing Devices
  • By Application Type: Blood Glucose Testing, Pregnancy Testing, Pulmonary Function Testing, Urinary Tract Infection Testing, Sexually transmitted infections (STIs) Testing, Genetic Testing, Vitamin and Mineral Deficiency Testing, COVID Testing, Allergy Testing, Gastrointestinal Screening, Hormone Testing, Food Sensitivity Testing, Others (Infectious Disease Testing, etc.)
  • By Sample Type: Blood Sample, Saliva Sample, Nasal Sample, Stool Sample, Urine Sample, Other Sample (Vaginal Swab Sample and Breathe Sample)
  • By Test Type: Laboratory Tests, Point of Care Tests/Homecare Tests
  • By Distribution Channel: Offline (Hospital Pharmacies, Retail Pharmacies/ Drug Stores, Supermarkets and Hypermarket), Online
Companies covered:

Becton, Dickinson and Company, Abbott, ACCESS BIO, CELLTRION INC., Siemens Healthcare GmbH, ACON Laboratories Inc., ARKRAY, Inc, F. Hoffmann-La Roche Ltd., OraSure Technologies Inc., Quest Diagnostics, Bionime Corporation, Btnx Inc., iHealth Labs Inc., InBios International, Inc. USA. And True Diagnostics Inc.

Growth Drivers:
  • Increasing adoption of business development strategies such as agreement, collaboration, and acquisition by key market players
  • Development of technologically advanced self-test kits
Restraints & Challenges:
  • Product recalls

Figure 2. Global Self-Testing Market Share (%) Analysis, By Test Type, 2022

SELF-TESTING MARKET

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 U.S. 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.

Global Self-Testing Market – Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 outbreak in December 2019, the disease has spread to over 100 countries across the globe. The coronavirus (COVID 19) pandemic and consequent lockdown in various countries across the globe have impacted the financial status of businesses in all sectors. Supply chain and manufacturing activities have been disrupted globally, due to lockdowns implemented by governments of countries, restricted movement, and other COVID-19 safety precautions.

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.

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.

The U.S. Food and Drug Administration (FDA) continues to monitor the supply chain. The Center for Drug Evaluation and Research (CDER) Drug Shortage Staff in 2020 asked manufacturers to evaluate their entire supply chain of various products, ethanol, EDTA and vaccines manufacturing equipment’s etc.  Which in future is expected to improve the supply chain of healthcare products.

Global Self-Testing Market: Restraint

The increasing number of product recalls of self-testing kits by regulatory authorities such as the U. S. FDA, 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.

Frequently Asked Questions

Global self-testing market is estimated to be valued at US$ 20,117.5 Million in 2022 and expected to exhibit a CAGR of 8.7% between 2022 and 2030.

Increasing adoption of business development strategies such as agreement, collaboration, and acquisition by key market players and the development of technologically advanced self-test kits are the major driving factor market.

Kits are the major product type in the market, owing to the increase in products launches by key market players.

Increase in number of product recalls is a major factor restraining the market growth.

Major players operating in the market include Becton, Dickinson and Company, Abbott, ACCESS BIO, CELLTRION INC., Siemens Healthcare GmbH, ACON Laboratories Inc., ARKRAY, Inc, F. Hoffmann-La Roche Ltd., OraSure, Technologies Inc., Quest Diagnostics, Bionime Corporation, Btnx Inc., iHealth Labs Inc., InBios International, Inc. USA. And True Diagnostics Inc.

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