Global HIV Self-test Kits Market Size By Technology (Immunofiltration, Lateral Flow Immunoassay), By Specimen Type (Blood, Urine), By Tests Generation (2nd, 3rd), By End-User (Hospitals, Diagnostic Laboratories), By Geographic Scope And Forecast

HIV Self-test Kits Market Size And Forecast

HIV Self-test Kits Market size was valued at USD 2.87 Billion in 2024 and is projected to reach USD 19.97 Billion by 2031, growing at a CAGR of 30.29% from 2024 to 2031.

The key drivers for the Global HIV Self-test Kits Market are the increasing need for early diagnosis and treatment, the convenience and privacy offered by the self-testing kits, and the availability of over-the-counter testing kits. Additionally, growing initiatives taken by governments and organizations to promote HIV testing, particularly in high-risk populations, along with technological advancements undertaken by the key players to develop user-friendly and accurate testing kits, are expected to boost market growth. The Global HIV Self-test Kits Market report provides a holistic evaluation of the market. The report offers a comprehensive analysis of key segments, trends, drivers, restraints, competitive landscape, and factors that are playing a substantial role in the market.

Global HIV Self-test Kits Market Definition

HIV self-test kits are diagnostic tools designed for individuals to test for the presence of HIV antibodies or antigens in their own homes or private settings. These kits allow the individuals to collect samples, typically through oral fluid, blood, or urine, to conduct the test themselves, without the involvement of a healthcare professional.

The kits usually include all the necessary components, such as instructions, test devices, and sample collection materials. The tests utilize various testing methods, such as molecular-based techniques or rapid immunoassays, to detect HIV infection. The results are typically provided within a specified period, allowing individuals to determine their HIV status confidentially and quickly.

HIV self-test kits offer several advantages, such as increased accessibility to testing, particularly for individuals facing barriers seeking traditional healthcare services, and enhanced privacy, as these kits allow individuals to take control of the testing process and obtain results from the comfort of their homes. Additionally, self-test kits can help facilitate early detection of HIV infection, leading to timely linkage to care and treatment initiation, ultimately contributing to better health outcomes and reduced transmission rates.

Global HIV Self-test Kits Market Overview

HIV self-test kits are a convenient and accessible testing option, especially for patients with barriers to accessing traditional healthcare services. These kits also allow individuals to test for HIV in their homes, increasing privacy. This eliminates the need for clinic visits and reduces the stigma associated with HIV testing. Improved access to these tests encourages more individuals to test for HIV, facilitating early detection and timely linkage to care and treatment.

Despite efforts to combat HIV/AIDS, the global HIV prevalence remains significant. For instance, according to HIV.gov, as of 2021, more than 38 million people globally have HIV, of which 36.7 million are adults and 1.7 million are children. The article also states that an estimated 1.5 million people are expected to acquire the condition globally. The high burden of the disease, especially in regions with limited healthcare infrastructure, is fueling the demand for HIV self-test kits.

Several governments and public health organizations have recognized the potential of HIV self-test kits in detecting HIV. The public and private institutions have partnered with manufacturers, NGOs, and international organizations that are expected to drive the demand for these kits. For instance, in July 2022, MedAccess, Clinton Health Access Initiative (CHAI), and Wondfo Biotech Company announced a partnership wherein the companies will provide HIV self-kits for 1 USD to the public sectors in the low and middle-income countries, which is the lowest price for kits prequalified by HIV.

Technology advancements have led to the development of highly accurate and user-friendly HIV self-test kits, which use innovative testing methods, such as finger-prick blood or oral fluid samples, to provide results within minutes. Additionally, integrating telemedicine services and smartphone applications further enhances the usability and interpretation of test results.

The HIV self-test kits also align with global HIV prevention strategies, such as the “90-90-90” set by UNAIDS that aim to diagnose 90% of all HIV-positive individuals, provide antiretroviral therapy to 90% of diagnosed patients, and achieve viral suppression in 90% of treated patients. HIV self-test kits complement existing testing approaches, facilitating early detection and increased testing frequency, which is critical for effective prevention efforts.

Global HIV Self-test Kits Market Segmentation Analysis

The Global HIV Self-test Kits Market is Segmented on the basis of Technology, Specimen Type, Tests Generation, End-User, and Geography.

HIV Self-test Kits Market, By Technology

• Immunofiltration
• Lateral Flow Immunoassay
• Fluorescent Chromatography

Based on Technology, the market is segmented into Immunofiltration, Lateral Flow Immunoassay, and Fluorescent Chromatography. The Lateral Flow Immunoassay segment accounted for the largest market share in 2022. The lateral immunoassay offers several advantages, such as rapid results, simplicity, convenience, and portability. The technology also features a user-friendly design and provides quick and easy testing, which makes it suitable for remote care and point-of-care settings. The rapid turnaround time also allows timely decision-making, enhancing workflow efficiency and patient management.

HIV Self-test Kits Market, By Specimen Type

• Blood
• Urine
• Oral Fluid

Based on Specimen Type, the market is segmented into Blood, Urine, and Oral Fluid. The Blood segment accounted for the largest market share in 2022. Blood sample-based HIV tests are more common for HIV tests due to the presence of higher concentrations of HIV antibodies than the other samples, such as oral fluids and urine. The tests also offer high accuracy, reliable results, and early detection of HIV infection, which is expected to further drive the demand for these kits. These kits are user-friendly, convenient, and provide rapid results within minutes, which enables timely intervention and linkage for patients diagnosed with HIV.

HIV Self-test Kits Market, By Tests Generation

• 2nd
• 3rd
• 4th

Based on Tests Generation, the market is segmented into 2nd, 3rd, and 4th. The 2nd generation segment accounted for the largest market share in 2022. The 2nd test kits have higher accuracy in detecting chronic HIV infection, which is a key factor driving the segment growth. Additionally, the kits are widely available and are used in clinics, healthcare settings, and laboratories globally, which is expected to further drive the segment growth. The 2nd-generation HIV testing kits are also cost-effective, which makes them suitable for widespread screening programs and resource-limited settings.

HIV Self-test Kits Market, By End-User

• Hospitals
• Diagnostic Laboratories
• Specialty Clinics
• Research Institutes
• Others

Based on End-User, the market is segmented into Hospitals, Diagnostic Laboratories, Specialty Clinics, Research Institutes, and Others. The Hospital segment contributed the largest market share in 2022. The increasing number of people undergoing testing in hospital settings is the key factor driving the segment’s growth. HIV testing kits are an essential component of the diagnostic infrastructure in hospitals to identify and diagnose HIV infections. These kits are used to screen patients that are at risk of suffering from HIV or have consistent symptoms of the infection. In hospital settings, different types of HIV testing kits are employed, such as enzyme immunoassays (EIAs), rapid tests, and nucleic acid amplification tests (NAATs).

HIV Self-test Kits Market, By Geography

• North America
• Europe
• Asia Pacific
• Middle East and Africa
• Latin America

Based on regional analysis, the Global HIV Self-test Kits Market is classified into North America, Europe, Middle East & Africa, Latin America, and Asia Pacific. North America contributed the highest share in 2022. The high prevalence of HIV in the region is a crucial factor driving the market growth in the region. For instance, according to data published by HIV.org, approximately 1.2 million people in the U.S. have HIV. Additionally, the growing prevalence of the condition is expected to further drive the demand for these kits. For instance, as per cdc.gov, as of 2021, more than 36,000 new patients were diagnosed with HIV in the U.S.

Key Players

The “Global HIV Self-test Kits Market” study report will provide a valuable insight with an emphasis on the global market including some of the major players such as OraSure Technologies Inc., Atomo Diagnostics, Chembio Diagnostic Systems Inc., Biosynex Group, BioSURE United Kingdom Ltd., ECO Diagnostica, bioLytical Laboratories, Sedia Biosciences Corporation, Orangelife Comércio e Indústria LTDA, and WAMA Diagnostica.

Our market analysis also entails a section solely dedicated for such major players wherein our analysts provide an insight to the financial statements of all the major players, along with its product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share and market ranking analysis of the above-mentioned players globally.

Key Developments

• In September 2022, OraSure Technologies Inc. announced it would provide the OraQuick In-Home HIV test kits under the “Together Take Me Home” program started by the Centers for Disease Control & Prevention. The CDC will provide USD 14.5 million to support the program.
• In May 2022, Chembio Diagnostics, Inc. announced it had partnered with Reszon Diagnostics International Sdn, wherein Reszon will leverage Chembio’s manufacturing capabilities to produce Chembio’s HIV 1/2 STAT-PAK Assay products in its production facility in Malaysia.

Ace Matrix Analysis

The Ace Matrix provided in the report would help to understand how the major key players involved in this industry are performing as we provide a ranking for these companies based on various factors such as service features & innovations, scalability, innovation of services, industry coverage, industry reach, and growth roadmap. Based on these factors, we rank the companies into four categories as Active, Cutting Edge, Emerging, and Innovators.

Market Attractiveness

The image of market attractiveness provided would further help to get information about the region that is majorly leading in the Global HIV Self-test Kits Market. We cover the major impacting factors that are responsible for driving the industry growth in the given region.