The global HIV Self-testing market size was estimated at USD 211.55 million in 2024 and is expected to reach USD 643.41 million by 2033, growing at a CAGR of 13.55% from 2025 to 2033. This growth is fueled by an increasing emphasis on early HIV detection, rising HIV prevalence, and a global shift toward personal, confidential health solutions.
Over 100 countries have adopted HIVST policies, and more than 20 million kits were distributed globally in 2023 alone. The affordability and scalability of rapid diagnostic kits have made them integral in both developed and developing health systems. As of the most recent estimates, approximately 40.8 million people worldwide are living with HIV, including 1.4 million children between the ages of 0 and 14. In 2024 alone, there were about 1.3 million new HIV infections, with 120,000 cases occurring in children. That same year, an estimated 630,000 people died from HIV-related causes, including 75,000 children. Since the beginning of the HIV epidemic, it is estimated that 44.1 million people have lost their lives due to HIV-related illnesses. Despite the ongoing impact, global progress has been substantial over the past decade and a half. Between 2010 and 2024, the number of new HIV infections decreased by approximately 40%, dropping from 2.2 million to 1.3 million annually. During the same period, HIV-related deaths fell by 54%, declining from 1.4 million to 630,000. These reductions reflect the success of widespread awareness, prevention efforts, antiretroviral therapy scale-up, and increasing adoption of strategies such as HIV self-testing, which have contributed to earlier diagnosis and treatment initiation.
One of the strongest drivers of the HIV self-testing market is the rising demand for discreet, accessible, and user-friendly diagnostic options, particularly in populations facing stigma or barriers to clinic-based testing. According to UNAIDS, nearly 40% of people living with HIV globally remain undiagnosed, a gap largely attributed to fear of discrimination, social stigma, and inconvenient access to health facilities. HIV self-tests provide a private, at-home alternative that empowers individuals to know their status without fear. Saliva-based kits such as OraQuick In-Home HIV Test have become popular for their non-invasive nature, simplicity, and 20-minute result window. In regions such as Sub-Saharan Africa, where HIV prevalence is highest, self-testing has been pivotal: countries like Kenya, Malawi, and South Africa have scaled up national HIVST programs through community and NGO distribution. In high-income countries, rising e-commerce penetration has enabled widespread access to HIV self-tests via online pharmacies. This combination of anonymity, convenience, and technological simplicity is not only improving diagnosis rates but also fundamentally shifting how public health systems approach HIV prevention and treatment linkage.
Technological advancements are transforming HIV self-testing into a more accurate, efficient, and user-centric process. The most common format-lateral flow immunoassays (LFA)-uses a simple strip that detects HIV-1/2 antibodies through a saliva or finger-prick blood sample. These tests deliver results in 15-20 minutes, and newer devices incorporate all-in-one integrated systems, such as Atomo’s HIV Self-Test, which combines lancet, buffer, and strip in a single device. In addition, smartphone-linked digital self-tests are being piloted, allowing users to scan results, receive guided instructions, and access telehealth services-enhancing test reliability and post-test linkage to care. In clinical trials, smartphone-based readers have shown >98% concordance with trained visual interpretation. Furthermore, innovations in microfluidics and nano-based detection promise to make future HIVST kits even more sensitive and early-stage infection-aware. The industry is also shifting toward combination kits (e.g., HIV + syphilis), especially in areas with co-infection burdens. These technological improvements not only reduce human error but also make self-testing viable in low-literacy populations, further expanding its global reach.
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Over 100 countries have adopted HIVST policies, and more than 20 million kits were distributed globally in 2023 alone. The affordability and scalability of rapid diagnostic kits have made them integral in both developed and developing health systems. As of the most recent estimates, approximately 40.8 million people worldwide are living with HIV, including 1.4 million children between the ages of 0 and 14. In 2024 alone, there were about 1.3 million new HIV infections, with 120,000 cases occurring in children. That same year, an estimated 630,000 people died from HIV-related causes, including 75,000 children. Since the beginning of the HIV epidemic, it is estimated that 44.1 million people have lost their lives due to HIV-related illnesses. Despite the ongoing impact, global progress has been substantial over the past decade and a half. Between 2010 and 2024, the number of new HIV infections decreased by approximately 40%, dropping from 2.2 million to 1.3 million annually. During the same period, HIV-related deaths fell by 54%, declining from 1.4 million to 630,000. These reductions reflect the success of widespread awareness, prevention efforts, antiretroviral therapy scale-up, and increasing adoption of strategies such as HIV self-testing, which have contributed to earlier diagnosis and treatment initiation.
One of the strongest drivers of the HIV self-testing market is the rising demand for discreet, accessible, and user-friendly diagnostic options, particularly in populations facing stigma or barriers to clinic-based testing. According to UNAIDS, nearly 40% of people living with HIV globally remain undiagnosed, a gap largely attributed to fear of discrimination, social stigma, and inconvenient access to health facilities. HIV self-tests provide a private, at-home alternative that empowers individuals to know their status without fear. Saliva-based kits such as OraQuick In-Home HIV Test have become popular for their non-invasive nature, simplicity, and 20-minute result window. In regions such as Sub-Saharan Africa, where HIV prevalence is highest, self-testing has been pivotal: countries like Kenya, Malawi, and South Africa have scaled up national HIVST programs through community and NGO distribution. In high-income countries, rising e-commerce penetration has enabled widespread access to HIV self-tests via online pharmacies. This combination of anonymity, convenience, and technological simplicity is not only improving diagnosis rates but also fundamentally shifting how public health systems approach HIV prevention and treatment linkage.
Technological advancements are transforming HIV self-testing into a more accurate, efficient, and user-centric process. The most common format-lateral flow immunoassays (LFA)-uses a simple strip that detects HIV-1/2 antibodies through a saliva or finger-prick blood sample. These tests deliver results in 15-20 minutes, and newer devices incorporate all-in-one integrated systems, such as Atomo’s HIV Self-Test, which combines lancet, buffer, and strip in a single device. In addition, smartphone-linked digital self-tests are being piloted, allowing users to scan results, receive guided instructions, and access telehealth services-enhancing test reliability and post-test linkage to care. In clinical trials, smartphone-based readers have shown >98% concordance with trained visual interpretation. Furthermore, innovations in microfluidics and nano-based detection promise to make future HIVST kits even more sensitive and early-stage infection-aware. The industry is also shifting toward combination kits (e.g., HIV + syphilis), especially in areas with co-infection burdens. These technological improvements not only reduce human error but also make self-testing viable in low-literacy populations, further expanding its global reach.
Global HIV Self-testing Market Report Segmentation
This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. The analyst has segmented the global HIV self-testing market based on type, technology, distribution channel, and region:Type Outlook (Revenue, USD Million, 2021-2033)
- Blood-based Kits
- Saliva-based Kits
Technology Outlook (Revenue, USD Million, 2021-2033)
- Immunofiltration Assays
- Lateral Flow Assays (LFA)
- Other Rapid Diagnostic Technologies
Distribution Channel Outlook (Revenue, USD Million, 2021-2033)
- Retail and Online Pharmacies
- Hospitals and Diagnostics Laboratories
- NGO/ Community-based Distribution
Regional Outlook (Revenue, USD Million, 2021-2033)
- North America
- U.S.
- Canada
- Mexico
- Europe
- UK
- Germany
- France
- Italy
- Spain
- Denmark
- Sweden
- Norway
- Asia-Pacific
- Japan
- China
- India
- Australia
- South Korea
- Thailand
- Latin America
- Brazil
- Argentina
- Middle East & Africa
- South Africa
- Saudi Arabia
- UAE
- Kuwait
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- Comprehensive Market Analysis: Gain detailed insights into the industry across major regions and segments.
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This report addresses:
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segmental and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
- Product innovation listings for you to stay ahead of the curve
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Table of Contents
Chapter 1. HIV Self-testing Market: Methodology and Scope
Chapter 2. HIV Self-testing Market: Executive Summary
Chapter 3. HIV Self-testing Market Variables, Trends, & Scope
Chapter 4. HIV Self-testing Market: Type Estimates & Trend Analysis
Chapter 5. HIV Self-testing Market: Technology Estimates & Trend Analysis
Chapter 6. HIV Self-testing Market: Distribution Channel Estimates & Trend Analysis
Chapter 7. HIV Self-testing Market: Regional Business Analysis
Chapter 8. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
The major companies profiled in this HIV Self-testing market report include:- OraSure Technologies, Inc.
- BioSURE HIVST
- Atomo Diagnostics
- Chembio Diagnostics, Inc.
- SD Biosensor, INC.
- CTK Biotech, Inc.
- genedrive plc
- Hydrex Diagnostics Sp.
- Trinity Biotech
- Abbott
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 150 |
| Published | August 2025 |
| Forecast Period | 2024 - 2033 |
| Estimated Market Value ( USD | $ 211.55 Million |
| Forecasted Market Value ( USD | $ 643.41 Million |
| Compound Annual Growth Rate | 13.5% |
| Regions Covered | Global |
| No. of Companies Mentioned | 11 |
