HIV Diagnostics Market By Product Type (Antibody Tests; Viral Load Tests; CD4 Tests; Early Infant Diagnosis (EID) Tests; Others (Nucleic Acid Tests & Rapid Diagnostic Tests)); By Test Type (Laboratory-Based Tests; Point-of-Care (PoC) Tests); By End User (Hospitals; Diagnostic Laboratories; Home Care Settings; Others (Blood Banks, Government & NGO Healthcare Facilities)); By Geography, Segment Revenue Estimation, Forecast, 2024–2032.

HIV Diagnostics Market Size & Overview

The Global HIV Diagnostics Market was valued at USD 4.9 billion in 2024 and is projected to reach around USD 7.3 billion by 2030, growing at a CAGR of 6.8% during the forecast period. This growth is driven by the sustained global efforts to reduce HIV transmission, scale up early diagnosis & improve treatment outcomes. HIV diagnostics play a vital role in both surveillance and clinical management, encompassing technologies such as antibody/antigen tests, nucleic acid amplification tests (NAATs), and rapid point-of-care (POC) tests. With an estimated 39 million people living with HIV worldwide (WHO), the need for reliable, accessible & early diagnostic solutions remains critical especially in low- and middle-income countries where awareness and testing gaps persist. Advancements in self-testing, 4th generation combination assays & decentralized diagnostics are transforming the landscape, enabling quicker detection & broader reach. As global health agencies continue to promote “test & treat” strategies, the HIV diagnostics market is poised for steady expansion across both clinical & community settings.

 

HIV Diagnostics Market Dynamics:

Market Drivers

Increasing Global Burden of HIV Infections & Late Diagnoses

In 2023, an estimated 39.9 Mn individuals worldwide were living with HIV. Out of those, 38.6 Mn were adults aged over 15, while 1.4 Mn were children under 15. Around 5.4 Mn individuals worldwide were unaware of their HIV status & required access to testing services. In 2023, the number of people living with HIV included 20.8 Mn in Eastern & Southern Africa, 5.1 Mn in Western & Central Africa, 6.7 Mn in APAC, and 2.3 Mn in Western & Central Europe as well as North America. HIV testing serves as a crucial entry point to prevention, treatment, care, and support programs. 86% of individuals worldwide living with HIV were aware of their status in 2023. The global goal is to achieve 95% HIV status awareness by 2025. This underlines the urgent need for expanded screening programs & advanced diagnostic tools in both clinical & community settings.

 

Global HIV Statistics and Insights

	2000	2005	2010	2020	2022	2023
People living with HIV	27.2 million [24.6 million– 30.4 million]	29.4 million [26.6 million– 32.9 million]	32 million [29.0 million– 35.8 million]	38.7 million [35.0 million– 43.2 million]	39.5 million [35.8 million– 44.2 million]	39.9 million [36.1 million– 44.6 million]
New HIV Infections	2.8 million [2.3 million– 3.6 million]	2.5 million [2.0 million– 3.2 million]	2.1 million [1.7 million– 2.7 million]	1.5 million [1.2 million–1.9 million]	1.4 million [1.1 million– 1.7 million]	1.3 million [1.0 million– 1.7 million]
AIDS related deaths	1.8 million [1.4 million– 2.3 million]	2 million [1.6 million– 2.6 million]	1.3 million [1.0 million– 1.7 million]	730 000 [570 000– 940 000]	670 000 [530 000– 870 000]	630 000 [500 000– 820 000]
New HIV Infections (Adults, aged 15+)	2.3 million [1.9 million– 3.0 million]	2 million [1.6 million– 2.6 million]	1.8 million [1.5 million– 2.4 million]	1.3 million [1.1 million–1.7 million]	1.2 million [980 000– 1.6 million]	1.2 million [950 000– 1.5 million]
New HIV Infections (Children, aged 0–14)	530 000 [380 000– 760 000]	470 000 [340 000– 680 000]	300 000 [220 000– 440 000]	150 000 [110 000– 210 000]	130 000 [94 000– 190 000]	120 000 [83 000– 170 000]
People accessing antiretroviral therapy	510 000 [450 000– 530 000]	1.9 million [1.7 million– 2.0 million]	7.7 million [6.7 million– 8.0 million]	26.2 million [23.1 million– 27.3 million]	29.3 million [25.7 million– 30.4 million]	30.7 million [27.0 million– 31.9 million]
Resource availability	US$ 5.1 billion	US$ 9.3 billion	US$ 16.7 billion	US$ 21.5 billion	US$ 20.8 billion	US$ 19.8 billion

 

Technological Advancements in Point-of-Care (POC) and Rapid HIV Testing

Modern diagnostic platforms have evolved significantly from lab-based ELISA and Western blot tests to rapid, CLIA-waived, and self-testing kits that provide results in under 30 minutes. The development of fourth- and fifth-generation antigen/antibody combo tests and nucleic acid amplification tests (NAATs) has improved early detection of acute HIV infections. These technologies are expanding accessibility in remote regions & improving linkage to care. In the United States, the FDA has approved eight rapid HIV tests: Alere Determine HIV-1/2 Ag/Ab Combo Test, DPP HIV 1/2 Assay, Clearview HIV 1/2 Stat-Pak, INSTI HIV-1/HIV-2 Rapid Antibody Test, Reveal Rapid HIV-1 Antibody Test, SURE CHECK HIV 1/2 Assay, OraQuick Advance Rapid HIV-1/2 Antibody Test and Uni-Gold Recombigen HIV-1/2 Test.

 

Market Restraints

Stigma, Social Barriers & Testing Hesitancy in Key Populations

Stigma and discrimination associated with HIV have a profound effect on the health, lives, and overall well-being of individuals living with HIV, as well as key populations such as Female Sex Workers, Men who have Sex with Men, Transgender/Hijra individuals, and People who Inject Drugs. According to UNAIDS, more than 50 countries still have laws criminalizing same-sex relationships, which severely impacts testing and care engagement in those regions. The Joint UN Programme on HIV/AIDS (UNAIDS) has introduced an ambitious new strategy to address inequalities hindering progress toward ending AIDS. The "End Inequalities. End AIDS. Global AIDS Strategy 2021–2026" focuses on reducing disparities that fuel the AIDS epidemic and prioritizing individuals who have not yet gained access to life-saving HIV services.

 

Limited Laboratory Infrastructure in Low-Income Regions

In many parts of sub-Saharan Africa & Southeast Asia, lack of laboratory capacity & trained personnel hinders the implementation of advanced diagnostic techniques such as viral load monitoring & genotyping. This leads to over-reliance on outdated antibody-based screening tools, which may miss early or acute infections, thereby delaying treatment decisions & affecting surveillance efforts.

 

Market Opportunities

Rise in Self-Testing & Community-Based Screening Initiatives

HIV self-testing is an effective approach that signifies a transformative shift in testing methods & serves as a crucial component in advancing the objectives of the Ending the HIV Epidemic in the US (EHE) initiative. According to WHO estimates, over 10 million HIV self-tests were procured by major donors and governments in LMICs in 2021. The growing availability of FDA-approved HIV self-test kits (e.g., OraQuick) is empowering individuals to test confidentially, especially in high-risk & underserved populations. Several governments & NGOs are actively promoting community-led testing models, mobile testing vans & home-based kits to improve screening rates & reduce transmission. The WHO prequalified 2 self-test kits in 2023, reflecting regulatory support & growing demand. A partnership between the Clinton Health Access Initiative (CHAI), MedAccess & Wondfo Biotech Company introduced an HIV self-test priced at just $1 for public sector distribution in LMICs, making it the most affordable WHO prequalified HIV self-test to date.

Integration of HIV Diagnostics into Multiplex Platforms

Diagnostic manufacturers are increasingly developing multiplex systems that can detect HIV alongside other infections such as hepatitis B/C and syphilis especially useful in prenatal, emergency, and travel medicine settings. These platforms reduce the cost per test & improve efficiency in healthcare settings with high patient throughput. The Unitaid Multi-disease Diagnostics Landscape for integrated management of HIV, HCV, TB, and other coinfections was created by Cambridge Healthcare Research Limited in partnership with Unitaid.The expansion of integrated care models, particularly in Africa & Latin America, is expected to create demand for such combined testing solutions.

 

HIV Diagnostics Market Segmentation: A Comprehensive Overview

By Product Type

• Antibody Tests

• Viral Load Tests

• CD4 Tests

• Early Infant Diagnosis (EID) Tests

• Others (Nucleic Acid Tests & Rapid Diagnostic Tests)

 

By Test Type

• Laboratory-Based Tests

• Point-of-Care (PoC) Tests

 

By End User

• Hospitals

• Diagnostic Laboratories

• Home Care Settings

• Others (Blood Banks, Government & NGO Healthcare Facilities)

 

By Region

• North America

• Europe

• Asia Pacific

• Latin America

• Middle East & Africa

 

HIV Diagnostics Market Segment Analysis: Growth Trends Across Categories:

By Product Type:

Leading Segment: Antibody Tests

Antibody tests hold the largest market share in the HIV diagnostics market, accounting for approximately 43% of total revenues in 2024. These tests detect the presence of HIV antibodies in blood or oral fluid and are widely used for initial screening due to their high sensitivity, affordability, and ease of use. ELISA-based & rapid antibody tests are most commonly used in both clinical & community healthcare settings for large-scale HIV screening initiatives globally.

Fastest-Growing Segment: Viral Load Tests

Viral load tests are the fastest-growing product type segment, projected to grow at a CAGR of 10.6% from 2024 - 2030. These tests quantify the amount of HIV RNA in a patient’s blood, playing a crucial role in monitoring treatment efficacy & guiding antiretroviral therapy decisions. With increased global efforts toward HIV suppression & personalized treatment regimens, the demand for viral load monitoring is accelerating, especially in LMICs scaling up access to ART.

 

By Test Type:

Leading Segment: Laboratory-Based Tests

Laboratory-based tests dominate the HIV diagnostics market with an estimated 58% share. These include ELISA, Western blot, PCR & other high-complexity tests, which are essential for confirmation, viral load monitoring & early diagnosis. The reliability & accuracy of lab-based tests make them the gold standard in centralized healthcare & reference laboratories.

Fastest-Growing Segment: Point-of-Care (PoC) Tests

Point-of-Care tests are the fastest-growing test type, with a CAGR of 11.4%. These include rapid diagnostic kits used in clinics, outreach programs & home settings, enabling immediate results & linkage to care. The expansion of self-testing and mobile health initiatives in both urban & rural regions, particularly in sub-Saharan Africa & Southeast Asia, is driving growth in this segment.

 

By End User:

Leading Segment: Hospitals

Hospitals accounted for the largest share of the HIV diagnostics market in 2024, holding around 46%. Hospitals serve as primary diagnostic hubs for high-risk populations & patients presenting with HIV-related complications. With access to a broad spectrum of test technologies & specialists, hospitals continue to be the central pillar of HIV testing & disease management.

Fastest-Growing Segment: Home Care Settings

Home care settings are the fastest-growing end-user segment, expected to expand at a CAGR of 12.3%. The rise of over-the-counter HIV self-test kits & telehealth-supported diagnostic programs is fueling this growth. Increased patient privacy, convenience & global advocacy for self-testing are encouraging adoption, especially among younger & at-risk populations who might avoid conventional testing due to stigma.

 

By Region:

Leading Region: North America

North America leads the global HIV diagnostics market with a 38% market share in 2024, driven by well-established healthcare systems, routine HIV screening programs & strong government funding for HIV prevention and care. The U.S. has the largest share, supported by CDC guidelines promoting annual screening for high-risk populations & rapid advancements in PoC and molecular testing technologies.

Fastest-Growing Region: Asia Pacific

Asia Pacific is the fastest-growing regional market, with a projected CAGR of 12.8% through 2030. Rising HIV incidence in countries like India, China, & Thailand, along with expanding public health efforts & funding from global organizations (e.g., PEPFAR, Global Fund), is accelerating the uptake of HIV testing. Growth is also supported by greater awareness, decentralization of testing & scaling up of rapid diagnostics across community-level programs.

 

HIV Diagnostics Market Report Coverage

Report Attribute	Details
Forecast Period	2024 – 2032
Market Size Value in 2024	USD 4.9 Billion
Revenue Forecast in 2030	USD 7.3 Billion
Overall Growth Rate	CAGR of 6.8% (2024 – 2030)
Base Year for Estimation	2023
Historical Data	2017 – 2021
Unit	USD Billion, CAGR (2024 – 2030)
Segmentation	By Product Type, By Test Type, By End User, By Geography
By Product Type	Antibody Tests, Viral Load Tests, CD4 Tests, Early Infant Diagnosis (EID) Tests, Others (Nucleic Acid Tests & Rapid Diagnostic Tests)
By Test Type	Laboratory-Based Tests, Point-of-Care (PoC) Tests
By End User	Hospitals, Diagnostic Laboratories, Home Care Settings, Others (Blood Banks, Government & NGO Healthcare Facilities)
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country Scope	US, Canada, Germany, China, India, etc.
Market Drivers	Rising HIV prevalence, increasing awareness and testing initiatives, advancements in diagnostic technologies
Pricing and Purchase Options	Customized options available

 

Key Players in the HIV Diagnostics Market

• Abbott Laboratories

• Roche Diagnostics

• Siemens Healthineers

• bioMérieux

• Becton, Dickinson and Company (BD)

• Thermo Fisher Scientific

• Bio-Rad Laboratories

• OraSure Technologies

• Hologic, Inc.

• Cepheid (a Danaher company)

 

Future Outlook

The future outlook for the HIV Diagnostics Market remains highly promising, driven by global efforts to eliminate HIV as a public health threat by 2030. Advancements in rapid testing, self-diagnosis kits & next-generation molecular diagnostics are expected to transform HIV screening and monitoring across both high- and low-resource settings. Increasing integration of HIV testing into multiplex diagnostic platforms & digital health systems will further streamline care pathways & improve early detection rates. The growing adoption of decentralized & community-based testing, especially in sub-Saharan Africa, Southeast Asia & Latin America will continue to expand market reach. Additionally, strong governmental and NGO funding, along with public-private partnerships, will support wider implementation of routine testing & surveillance programs. With a pipeline of innovative technologies & a shift toward personalized medicine, the HIV diagnostics market is poised for sustained growth, improved accessibility & enhanced patient outcomes over the coming decade.