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U.S. Self-Testing Market

U.S. Self-Testing Market Size, Share & Trends Analysis Report

U.S. Self-Testing Market By Type (Blood Glucose Testing, Pregnancy & Fertility Testing, Cholesterol Testing, COVID Testing, Others), By Distribution Channel (Retail Pharmacies, Supermarket/ Hypermarket, E-Commerce) Analysis Report, Regional Outlook, Growth Potential, Competitive Market Share & Forecast, 2021 – 2027

Published
Report ID : BMRC 1475
Number of pages : 300
Published Date : Nov 2022
Category : Medical Device
Delivery Timeline : 48 hrs

The U.S. self-testing Market was worth of USD 9.47 Billion in 2020 and is expected to reach USD 11.03 Billion in 2027, growing at a CAGR of -1.85% from 2021 to 2027. From 2020 to 2021, the market is growing with CAGR of 14.30%. The U.S. self-testing Market is expected to grow at significant growth rate due to number of driving factors.

Brandessence Market Research is working on a new report title ""U.S. self-testing Market: Global Size, Trends, Competitive, Historical & Forecast Analysis, 2021-2027""

Scope of U.S. Self-testing Market

Self-test kits are used for rapid diagnosis of various diseases. This test does not require a medical expert. Self-tests are convenient because they can be taken at any time and require a small procedure. It is a quick diagnostic product used for testing in a private environment by oral fluid, urine, or collected samples. Self-test kits are used in a variety of conditions such as pregnancy self-testing, HIV self-testing, self-testing kits for infertility, STI, and self-testing equipment for others. Home testing with pregnancy kits has been on the rise since the 1970s. There are a variety of self-testing kits available in the market in recent years. Now, these kits are quick and easy tests for ovulation. 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.

The U.S. Self Testing market research reports segments as follows:

The study provides a crucial view of U.S. self-testing market by segmenting the market based on product, usage, application, sample and end- user. Based upon product, U.S. self-testing market is segmented into diagnostic kits, diagnostic device and diagnostic strips. Based upon usage, the market is segmented into disposable and reusable. Based upon application, U.S. self-testing market is segmented into cholesterol and triglycerides tests, diabetes and glucose tests, blood pressure test, diabetes and glucose test, pregnancy test, urinary tract infection test, STD /STI test fertility test, ovulation test cancer test, transaminase test, thyroid test menopause test, intolerance or celiac disease test, allergy test and anemia test. Based upon sample, the market is segmented into urine, blood, stools, oral swabs and others. Based upon end- user, U.S. self-testing market is segmented into hospital pharmacies, pharmacies and e-commerce.

U.S. Self Testing Market: By Type

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

U.S. Self Testing Market: By Distribution Channel

  • Retail Pharmacies
  • Supermarket/ Hypermarket
  • E-commerce

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. In addition, increasing prevalence of Covid-19 cases in this country is also supplementing the self-testing market growth. For example; as per Worldometer; as of march 15th, 2021; total number of active cases in U.S are 7,367,055. In addition, increasing number of product approvals is also supplementing the market growth in this country. 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.

The test will cost around $50 but roll-out will take time. It will be available to patients in Northern California and the Miami-Fort Lauderdale region of Florida in the near future, but US-wide availability is likely to take until early spring 2021. Furthermore, as HIV & diabetes is affecting specific populations in United States especially ethnic and racial minorities & people of all ages are diabetics which are also driving the self-testing market in United States. 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. An estimated 36,400 new HIV infections were reported in the United States in 2018. However, CDC figures show that this progress has slowed down in recent years, with about 38,000 new HIV infections each year in 2014 and 2018. The market for HIV self-testing is evolving rapidly in the U.S. region. Furthermore, 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.

Moreover, The HIV self-test procurement forecast anticipates steady growth in volumes through 2020. Such growth is expected to continue beyond 2020, as some countries in the U.S. implement HIV self-testing for the first time and others scale up existing programs. Limited HIV self-test procurement to date in several high-burden countries and the fact that HIV self-tests currently make up a small proportion of the total RDT (Rural Development Trust) market also create major opportunities for self-testing market growth in United States and public health impact if the implementation of self-testing is prioritized in such settings.

However, non-existent, time-consuming, or unclear national registration and regulatory processes for IVDs make it difficult to introduce and scale-up HIV self-testing in both public and private sector markets. In addition, the lack of policies and/or product registration in the U.S. where the test kit is manufactured or assembled is also a barrier, like certificates of free sale are needed to export and import self-tests in the U.S.

Some major key players for U.S. Self Testing market are,

  • Abbott Laboratories
  • Acon Laboratories Inc.
  • Btnx Inc.
  • Bionime Corporation
  • Roche Holding AG
  • Quidel Corporation
  • True Diagnostics Inc.
  • Thermo Fisher Scientific
  • Arkaray Inc
  • Others

The type segment of U.S. self-testing market is dominated by Blood Glucose Testing with a largest market share of 42.85% in 2020. The distribution channel segment of U.S. self-testing market is dominated by Retail Pharmacies with the largest market share of 51.20% in 2020.

Market Trends of U.S. self-testing Market Report:

Self-testing is sometimes called home testing because people often do it at home. Due to less time to visit the hospital and easy availability the self-testing kits are trending for the shorter result. Following are some trending self-tests that are boosting the market:

a) Covid 19 Test Kits:

From the last year, the corona was spread massively due to this the number of companies have stepped foot forward towards the research and development and manufacturing of covid 19 kits. The U.S government is approving the innovative feature added self-testing kits. 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. It is fully self-administered self-test kit it provides results at home in 30 minutes or less. The Lucira test works by swirling the self-collected sample swab in a vial and placed in the test unit. The results can be read directly from the test unit’s light-up display. In addition to home use, the product is also authorized for use in doctor’s offices, hospitals, and emergency rooms. 

b) Pregnancy Test Kit:

In the U.S., an increasing number of women have preferred the pregnancy tests at home by themselves due to this several companies are entering this pregnancy self-kit market and they were added new features. In 2021, some pregnancy kits which are trending include; digital test kits and pregnancy strip self-test.

  • Digital Test Kit: Digital pregnancy test with smart countdown gives reassurance while waiting for the result and accurate digital reading even in early pregnancy. In the digital pregnancy kit result shown in words as well as the test is over 99% accurate at detecting pregnancy from the day of the expected period.
  • Pregnancy Strip Self-Test: These strips are trending in the U.S market due to their various features like accurate and highly reliable pregnancy test strips. These strips are used for, earliest detection, greatest sensitivity level, it will work 5 days before a missed period, each test is sealed in individual pouch and results are over 99.8% accurate. Additionally, users are impressed by the accuracy, high-quality materials, and affordable price of these strips. Plus, they come in discreet packaging with fairly little waste, making them a slightly eco-friendlier choice. These strips are a great option for those who are actively trying to conceive since might go through a lot of tests over some time, which can be costly.

c) Ovulation Test Kits:

It is helpful to know when body is ovulating. Many people assume that women ovulate on a particular day of their cycle, but in reality, it often shifts around a little. That is why plenty of couples rely on the Pregmate LH Ovulation test to be sure. It works just like a regular pregnancy test it needs to pee on it and then wait three minutes. If the result is positive, it means likely ovulate within the next 24 to 48 hours.

D) HIV Self-Test Kits:

in recent years, the numbers of HIV patients are increasing day by day and the demand for HIV tests is trending. For example; there are currently 1.1 million people living with HIV in the United States. Nearly 39,000 people are newly diagnosed with HIV each year. Additionally, around 1 in 7 Americans who are living with HIV according to U.S. Department of Health & Human Services.

  • INSTI HIV Self-Test: This kit is 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. It has some important features which are helpful for the product trending. For example; the kit detects HIV infection up to two weeks sooner than leading brands, detects IgM and IgG Antibodies, and others.

  Report Coverage

Report Analysis Details
Historical data 2015 - 2020
Forecast Period 2021 - 2027
Market Size in 2020: USD 9.47 Billion 
Base year considered 2020
Forecast Period CAGR %: -1.85 %
Market Size Expected in 2027: USD 11.03 Billion 
Tables, Charts & Figures: 175
Pages 200
Key Players/Companies Abbott Laboratories,Acon Laboratories Inc.,Btnx Inc.,Bionime Corporation,Roche Holding AG,Quidel Corporation,True Diagnostics Inc.,Thermo Fisher Scientific,Arkaray Inc,Others
Segments Covered By Type, By Application
Regional Analysis North America, U.S., Mexico, Canada, Europe, UK, France, Germany, Italy, Asia Pacific, China, Japan, India, Southeast Asia, South America, Brazil, Argentina, Columbia, The Middle East and Africa, GCC, Africa, Rest of the Middle East and Africa

The U.S. Self Testing market research reports segments as follows:

U.S. Self Testing Market By Regional & Country Level:

North America

  • U.S.
  • Canada

Europe

  • U.K.
  • France
  • Germany
  • Italy

Asia Pacific

  • China
  • Japan
  • India
  • Southeast Asia

Latin America

  • Brazil
  • Mexico

Middle East and Africa

  • GCC
  • Africa
  • Rest of Middle East and Africa

 

SUMMARY
VishalSawant
Vishal Sawant
Business Development
vishal@brandessenceresearch.com
+91 8830 254 358
Segmentation
Segments

U.S. Self Testing Market: By Type

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

U.S. Self Testing Market: By Distribution Channel

  • Retail Pharmacies
  • Supermarket/ Hypermarket
  • E-commerce
Country
Regions and Country

North America

  • U.S.
    U.S.
  • Canada
    Canada

Europe

  • Germany
    Germany
  • France
    France
  • U.K.
    U.K.
  • Italy
    Italy
  • Spain
    Spain
  • Sweden
    Sweden
  • Netherlands
    Netherlands
  • Turkey
    Turkey
  • Switzerland
    Switzerland
  • Belgium
    Belgium
  • Rest of Europe

Asia-Pacific

  • South Korea
    South Korea
  • Japan
    Japan
  • China
    China
  • India
    India
  • Australia
    Australia
  • Philippines
    Philippines
  • Singapore
    Singapore
  • Malaysia
    Malaysia
  • Thailand
    Thailand
  • Indonesia
    Indonesia
  • Rest of APAC

Latin America

  • Mexico
    Mexico
  • Colombia
    Colombia
  • Brazil
    Brazil
  • Argentina
    Argentina
  • Peru
    Peru
  • Rest of South America

Middle East and Africa

  • Saudi Arabia
    Saudi Arabia
  • UAE
    UAE
  • Egypt
    Egypt
  • South Africa
    South Africa
  • Rest of MEA
Company
Key Players
  • Abbott Laboratories
  • Acon Laboratories Inc.
  • Btnx Inc.
  • Bionime Corporation
  • Roche Holding AG
  • Quidel Corporation
  • True Diagnostics Inc.
  • Thermo Fisher Scientific
  • Arkaray Inc
  • Others

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