North America Self Testing Market

North America Self Testing Market Size, Share & Trends Analysis Report

North America Self Testing Market Size Share Companies & Trends Analysis Report By Type (Blood Glucose Testing, Pregnancy & Fertility Testing, Cholesterol Testing, COVID Testing), By Distribution Channel (Retail Pharmacies, Supermarket/Hypermarket, E-Commerce), Based On Region, And Segment Forecasts, 2022 - 2029

Report ID : BMRC 2081
Number of pages : 300
Published Date : Jan 2023
Category : Healthcare
Delivery Timeline : 48 hrs

North America Self-Testing Market in terms of revenue was worth of USD 13,621.1 Million in 2021, growing at a CAGR of -2.7% from 2022 to 2029.

Self-testing is the testing that occurred at home. It is paving the way for new approaches to rapid diagnosis in various diseases. These kinds of tests are comfortable and convenient as can take at any time and require a small procedure. These kits are useful into various convenient as they can be taken at any time and required a small various conditions these kits are basically use rather than to visits hospitals. For example, pregnancy self-test, HIV self-test, self-test kit for infertility, self-test kits for STIs and others. Self-test kits are handy and comfortable because they can be used at any time and just need a minor process. People can also check for blood pressure as well as HIV, colon cancer, hepatitis C, impaired vision, and urinary tract infections. Some products provide instant results, while others are sample collection tools that must be mailed to a laboratory for processing. Customers are leaning towards self-testing kits as they are convenient and give quick results.

Covid-19 has positively impacted the North America self-testing market. In the past two years, the Covid-19 has drastically changed the people lives and it negatively impacted on the manufacturing industries due to various factors like, lockdown, disturbance in supply chain and restriction on the transportation. However, self-testing is exception for these factors. Meanwhile, due to medical devices are included in essential services these kits have easily available on online and pharmacies. During pandemic, people were not frequently visited to the hospitals due to fear of infections. For the quick result and restricting infection, number of companies and government invested into the Covid-19 self-kit. For example, on October 6th, 2021; The White House planned to spend an additional $1 billion on rapid at-home Covid tests. As a result, research facilities for self-testing kits have been add technological advancement in self-test kits.

In addition, increasing number of health conditions due to modern lifestyles have led companies to create technology-advanced equipment that can effectively identify various health problems in this country. People are avoiding lengthy process for diagnosis of diseases and to avoid these process people go for self-testing kits diagnosis. There are various self-testing kits available in the market such as; cholesterol and triglycerides tests, diabetes and glucose tests, blood pressure test, diabetes and glucose test, pregnancy test, ovulation test cancer test, transaminase test, and other. Like, 37.3 million people have diabetes (11.3% of the US population) another example is the provisional number of births for the United States in 2021 was 3,659,289.  Furthermore, rising demand of self-testing kits in hospitals is another factor which increasingly supplementing the market growth in this region. In addition, increasing number of product approvals is also supplementing the market growth in this region. For instance; on November 17th, 2020; FDA authorized first COVID-19 test for self-testing at home & it is developed by Lucira Health, formerly known as Diassess. The company has gained EUA for the Lucira Covid-19 All-In-One kit which is a prescription-only test that can be used at home to detect viral RNA on self-collected nasal swabs by people aged 14 and older. And, on November 3rd, 2020; bioLytical Laboratories, received Health Canada Licence to produce and sell its highly accurate, 1-minute INSTI HIV Self Tests in Canada.

And, furthermore, as HIV & diabetes are also affecting specific populations in United States especially ethnic and racial minorities & people of all ages. According to the latest estimates from the Centers for Disease Control and Prevention; an estimated 1.2 million people in the United States are living with HIV today and About 14% (1 in 7) of them do not know this and need testing. The HIV incidence indicates the approximate number of new HIV infections in a given period (such as one year), which is different from the number of people diagnosed with HIV in a given year. According to the National Diabetes Statistics Report, 2020, the estimated number of adults aged 18 or over in the United States, 2018, undiagnosed diabetes, diagnosed with diabetes, and total diabetes. For example, Contrary to the popular belief, HIV infections are still on the rise in Canada. It is estimated that 14 percent of people living with HIV nationwide do not know their status.

United States has dominated the North America self-testing market in terms of revenue in 2021 by accounting more than 90% market share. This is due to ongoing investments in self testing kits from various market players. The Canada is following the United States due to the high incidence of infectious diseases, increasing aging population, and investment from pharmaceutical diseases.

Analyst Comment, “With more sophisticated technology and immense investments in the self-testing will result in promising growth for the North America self-testing market”.

Key Players:

  • Thermo Fisher Scientific
  • ARKRAY Inc.
  • Access Bio
  • Lucira Health Inc.
  • Ellume
  • Ihealth
  • Orasure
  • Bionime Corporation
  • BTNX Inc.
  • ACON Laboratories Inc.
  • Abbott Laboratories
  • BD Medical device company
  • Roche Holding AG
  • True Diagnostics
  • Quidel Corporation
  • Becton
  • Dickinson and Company
  • Siemens Healthcare GmbH
  • F.Hoffmann-La Roche Ltd.
  • Quest Diagnostics
  • others


By Type

  • Blood Glucose Testing
  • Pregnancy & Fertility Testing
  • Cholesterol Testing
  • COVID Testing
  • Others

By Distribution Channel

  • Retail Pharmacies
  • Supermarket/Hypermarket
  • E-Commerce


Digital Testing in the Self-Testing is One of the Major Trends of the North America Self Testing Market

Self-testing itself is one of the trends now-a-days. Huge number of people are promoting diverse self-testing kits due to the latest innovations. Recently, the digitalization is leading to the new age of self-testing. Digital pregnancy test with smart countdown gives reassurance while waiting for the result and accurate digital reading even in early pregnancy. The digital pregnancy kit results over 99% accurate at detecting pregnancy from the day of the expected period. Moreover, HIV self-testing (HIVST) with digital supports is described as the use of digital interventions (e.g., website based, mobile HIVST applications (apps), social media, text messaging (SMS), digital vending machines i.e., digital VMs). These are used to improve the efficiency and impact of HIVST. The deployment and integration of HIVST in health services is an emerging priority. Bluetooth, digital apps, and other connectivity are playing major role in the self-testing. Bluetooth connectivity is already available in the U.S. In the United States, Roche Diagnostics partnered with Qualcomm Life last year to capture patient data from connected devices, starting with anti-coagulation meters. In addition to this, Inverness Medical Innovations has received FDA approval to sell the industry's first digital pregnancy test. Such digitalization in the self-testing has enhanced the demand across the countries in the U.S.

Soaring Demand for Early Detection of Sexually Transmitted Diseases are Developing the Self-Testing Market Growth in North America

Sexually transmitted diseases are on the rise in the United States and are common infections that people unknowingly transmit. As per U.S. Department of Health & Human Services, in 2019, an estimated 34,800 new HIV infections occurred in the United States. And, as of September 14th, 2021; more than 60,000 people are currently living with HIV in Canada, approximately 13% of whom are unaware of their status. HIV remains to have a disproportionate impact on populations, particularly racial and ethnic minorities and bisexual, gay, and other men who have sex with men. To detect these dangerous infections or diseases at early stage, self-testing is largely used among North American people. For example, on November 3rd, 2020; bioLytical Laboratories, received Health Canada Licence to produce and sell its highly accurate, 1-minute INSTI HIV Self Tests in Canada. Contrary to the popular belief, HIV infections are still on the rise in Canada. It is estimated that 14 percent of people living with HIV nationwide do not know their status. Several quick, safe, and easily available tests can help avoid further transmission and health complications. INSTI HIV self-test used to detect HIV-1 and HIV-2 antibodies using human fingerstick blood drops, a simple flow-through technique is used in the test. This test has been used by small untrained general users to diagnose HIV-1 and HIV-2 infection with a small drop of blood obtained through a fingerprint collection procedure. Unique features of this self-test are making it trendy in the market due to which it is widely used in the region. For example, the kit detects HIV infection up to two weeks sooner than leading brands, detects IgM and IgG Antibodies, and others. Technology-based HIV-self testing (HST) interventions have the potential to improve access to HIV testing among gay, bisexual, and other men who have sex with men (MSM), as well as address concerns about HST use, including challenges with linkage to appropriate follow-up services.

Report Analysis Details
Historical data 2016 - 2021
Forecast Period 2022 - 2029
Market Size in 2021: USD 13,621.1 Million 
Base year considered 2021
Forecast Period CAGR %:


Market Size Expected in 2028: USD XX Million 
Tables, Charts & Figures: 175
Pages 200
North America Self Testing Manufacturers Thermo Fisher Scientific, ARKRAY, Inc., Access Bio, Lucira Health,Inc., Ellume, Ihealth, Orasure, Orasure, Bionime Corporation, BTNX Inc., ACON Laboratories, Inc., Abbott Laboratories, BD Medical device company, Roche Holding AG, True Diagnostics, Quidel Corporation, Becton, Dickinson and Company, CELLTRION INC., Siemens Healthcare GmbH,  F.Hoffmann-La Roche Ltd.,Quest Diagnostics, and others.
Segments Covered By Type, By Distribution Channel
Regional Analysis North America