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A self-test is a test that can be performed at home by oneself to diagnose or detect various diseases. In the case of the COVID-19, apart from vaccination, masking, and physical distancing, self-tests can be used as one of the many risk-reduction measures that protect individuals by reducing the possibility of viral transmission. Furthermore, self-testing is used to diagnose diabetes by measuring blood sugar levels. A blood sugar test determines the amount of sugar or glucose in the blood. Market 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 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).

Figure 1. Global Self-testing Market in Terms of Value (US$ million), By Region, 2021

Self-testing  | Coherent Market Insights

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.

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).

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Self-testing Market Report Coverage

Report Coverage Details
Base Year: 2020 Market Size in 2021: US$ 18,503.0 Mn
Historical Data for: 2017 to 2020 Forecast Period: 2021 to 2028
Forecast Period 2021 to 2028 CAGR: 8.5% 2028 Value Projection: US$ 32,763.6 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 Testing (Vitamin D, Vitamin B, Others), Mineral Deficiency Testing (Iron, Calcium, Others), COVID Testing, Allergy Testing (Pollen Allergy, Dust Mite Allergy, Others), Gastrointestinal Screening, Hormone Testing (TSH Testing, Menopause Testing, Others), Food Sensitivity Testing (Celiac Disease, Others), Infectious Diseases
  • By Sample Type: Blood Sample, Saliva Sample, Nasal Sample, Stool Sample, Urine Sample
  • By Test Type: Laboratory Tests, Point of Care Tests/Homecare Tests
  • By Distribution Channel: Offline (Hospital Pharmacies, Retail Pharmacies/ Drug Stores, Supermarkets And Hypermarkets), Online (E-commerce, Online Pharmacies, Company’s Own Website)
Companies covered:

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.

Growth Drivers:
  • Increasing prevalence of chronic diseases
  • Increasing supply and demand for self-test kits
Restraints & Challenges:
  • Rising number of product recalls by regulatory authorities

Figure 2. Global Self-testing Market Share in Terms of Value (US$ Mn), By Sample Type, 2021

Self-testing  | Coherent Market Insights

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.

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.

A self-test is a test that can be performed at home for diagnosing or detecting various diseases. It is also known as a ‘home test’, or ‘at-home test’, or ‘over-the-counter (OTC) test’. Self-tests can also be used as one of many risk-reduction strategies, such as vaccination, masking, and physical separation, to protect everyone by lowering the likelihood of viral transmission. These tests are used for various applications such as glucose monitoring, vitamin and mineral deficiency testing, hormone testing, pregnancy testing, and others. Key market players are focusing on developing and launching new self-test kits for emerging diseases and infections such as the COVID-19. For instance, in April 2020, Sanofi, a global healthcare company, and Luminostics, a California-based startup, signed an agreement to evaluate a collaboration on a unique self-testing solution for the COVID-19, leveraging Luminostics' innovative technology and contributing to Sanofi's ongoing efforts to combat the COVID-19 pandemic on multiple fronts.

Market Dynamics

Major companies operating in the global self-testing market are focused on product launches or approvals, which is expected to drive the market growth over the forecast period. For instance, in April 2021, Lucira Health, Inc., a medical technology company focused on the development and commercialization of transformative and innovative infectious disease test kits, announced that Health Canada approved the company's LUCIRA CHECK IT COVID-19 test kit. The LUCIRA CHECK IT COVID-19 test kit is the first Health Canada-approved self-test for people with or without symptoms.

 Key features of the study:

  • This report provides an in-depth analysis of the global self-testing market, market size (US$ Mn), and compound annual growth rate (CAGR%) for the forecast period (2021–2028), considering 2020 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the global self-testing market based on the following parameters – company highlights, products portfolio, key highlights, financial performance, strategies
  • Key companies covered as a part of this study 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.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
  • The global self-testing market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have an ease in decision-making through various strategy matrices used in analyzing the global self-testing market

Detailed Segmentation:

  • Global Self-testing Market, By Product Type
    • Kits
      • Self-testing Kits
      • Self-collection Kits
    • Self-Testing Devices
  • Global Self-testing Market, By Application Type
    • Blood Glucose Testing
    • Pregnancy Testing
    • Pulmonary Function Testing
    • Urinary Tract Infection Testing
    • Sexually transmitted infections (STIs) Testing
    • Genetic Testing
    • Vitamin Testing
      • Vitamin D
      • Vitamin B
      • Others
    • Mineral Deficiency Testing
      • Iron
      • Calcium
      • Others
    • COVID Testing
    • Allergy Testing
      • Pollen Allergy
      • Dust Mite Allergy
      • Others
    • Gastrointestinal Screening
    • Hormone Testing
      • TSH Testing
      • Menopause Testing
      • Others
    • Food Sensitivity Testing
      • Celiac Disease
      • Others
    • Infectious Diseases
  • Global Self-testing Market, By Sample Type
    • Blood Sample
    • Saliva Sample
    • Nasal Sample
    • Stool Sample
    • Urine Sample
  • Global Self-testing Market, By Test Type
    • Laboratory Tests
    • Point of Care Tests/Homecare Tests
  • Global Self-testing Market, By Distribution Channel
    • Offline
      • Hospital Pharmacies
      • Retail Pharmacies/ Drug Stores
      • Supermarkets And Hypermarkets
    • Online
      • E-commerce
      • Online Pharmacies
      • Company’s Own Website
  • Global Self-testing Market, By Region:
    • North America
      • By Country
        • U.S.
        • Canada
    • Latin America
      • By Country
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Country
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Country
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Country
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Country/Region
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • Abbott**
      • Company Highlights
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • Acon Laboratories Inc.
    • ARKRAY Inc.
    • Hoffmann-La Roche AG
    • Siemens Healthineers
    • OraSure Technologies Inc.
    • Quest Diagnostics
    • Bionime Corporation
    • Becton, Dickinson and Company
    • Btnx Inc.
    • JR Biomedical Ltd.

 “*” marked represents similar segmentation in other categories in the respective section.

Frequently Asked Questions

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% between 2021 and 2028.
Factors such as the increasing prevalence of chronic diseases and the development of technologically advanced self-test kits are expected to drive the market growth during the forecast period.
Kits are expected to hold a major market share during the forecast period in the product type segment.
The major factor hampering the market growth is the rising number of product recalls by regulatory authorities
Major players operating in the 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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