HIV Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Consumables, Instruments, Software and Services), By Test Type (Antibody Tests(HIV-1 Screening Tests, HIV-1 Antibody Confirmatory Tests, HIV-2 & Group O Diagnostic Tests), Viral Load Tests, CD4 Test, Others), By Mode (Self-Test, Lab-based), By End-use (Diagnostic Laboratories, Hospitals & Clinics, Home Settings), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 4.73 Billion
CAGR (2026-2031)	9.02%
Fastest Growing Segment	Hospitals & Clinics
Largest Market	North America
Market Size (2031)	USD 7.94 Billion

Market Overview

The Global HIV Diagnostics Market will grow from USD 4.73 Billion in 2025 to USD 7.94 Billion by 2031 at a 9.02% CAGR. The Global HIV Diagnostics Market encompasses the reagents, assays, and instruments utilized for the detection of Human Immunodeficiency Virus antibodies, antigens, and viral nucleic acids in biological samples. A primary driver facilitating market growth is the sustained global prevalence of the infection combined with international funding mandates aiming to achieve universal testing targets. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), in 2024, approximately 40.8 million people were living with HIV globally. This substantial disease burden necessitates rigorous surveillance and frequent screening initiatives, thereby generating consistent demand for diagnostic solutions across both clinical and community settings.

Despite these favorable conditions, the market encounters a significant challenge regarding the high cost and logistical complexity of deploying molecular diagnostics in resource-limited regions. Inadequate healthcare infrastructure and a shortage of trained laboratory personnel in low-income nations often restrict the widespread adoption of essential viral load monitoring and early infant diagnosis tools. These economic and operational barriers limit market penetration in high-burden geographies, hindering the broader expansion of the global diagnostics industry.

Key Market Drivers

The expansion of government initiatives and public health funding serves as a primary catalyst for the Global HIV Diagnostics Market. International bodies and national health departments are aggressively scaling up testing programs to meet eradication targets, resulting in massive procurement volumes for diagnostic supplies. These initiatives subsidize the cost of assays in high-burden regions, ensuring consistent demand for screening services. According to The Global Fund, September 2025, in the 'Results Report 2025', the organization’s investment partners conducted 46.6 million HIV tests across supported countries in 2024. This sustained public investment is yielding tangible results; according to UNAIDS, in 2025, data indicated that 87% of all people living with HIV globally knew their status in 2024, highlighting the efficacy of funded campaigns.

The increasing adoption of HIV self-testing kits is further driving market growth by decentralizing access and reaching undiagnosed populations. By enabling individuals to perform screening in private settings, self-testing technologies overcome barriers related to stigma and clinic capacity, particularly for key demographics hard to reach through traditional facilities. This shift towards user-centric diagnostics is supported by substantial procurement from major health programs. According to the U.S. Department of State, December 2024, in the 'PEPFAR Latest Global Results & Projections Factsheet', the program supported the distribution of 8.8 million HIV self-test kits during the 2024 fiscal year. Such wide-scale deployment of rapid solutions demonstrates the growing reliance on self-administration to close global diagnostic gaps.

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Key Market Challenges

The primary challenge hampering the growth of the Global HIV Diagnostics Market is the prohibitive cost and logistical complexity associated with deploying molecular diagnostics in resource-limited settings. While the demand for testing is highest in low-income regions, the financial burden of procuring instruments and the technical requirements for maintaining reagents create a barrier to entry. This disconnect prevents the market from expanding into decentralized community settings, confining revenue generation to centralized laboratories and limiting the overall volume of diagnostic kits that can be effectively sold and utilized.

Furthermore, the inadequacy of healthcare infrastructure and the shortage of trained personnel directly impede the adoption of critical testing segments, such as early infant diagnosis. This operational bottleneck results in a significant portion of the potential market remaining unserved. According to UNAIDS, in 2024, only 55% of children aged 0–14 years living with HIV had access to treatment, a disparity largely driven by the inability to implement timely diagnostic testing in high-burden areas. Consequently, these systemic economic and operational constraints cap the industry's growth potential, preventing manufacturers from fully capitalizing on the global disease burden.

Key Market Trends

The adoption of Dual HIV/Syphilis Rapid Diagnostic Tests is emerging as a critical trend in the Global HIV Diagnostics Market, driven by the need to streamline antenatal care and improve efficiency in high-burden settings. These multiplex assays allow healthcare providers to screen for both infections simultaneously using a single specimen, significantly reducing the logistical burden and cost associated with separate testing workflows. This integration is particularly vital for preventing mother-to-child transmission, as it ensures that pregnant women receive immediate and comprehensive screening during routine visits. The market impact of this consolidation is evident in the rapid uptake of these devices within national health programs aiming for triple elimination targets. According to the Clinton Health Access Initiative, October 2025, in the 'Dual HIV/Syphilis Rapid Tests: Lessons from Scale-Up Across Six Countries' brief, the strategic implementation of these tools enabled syphilis testing coverage to nearly match HIV testing rates, with three of the six monitored countries achieving over 90% coverage for both infections by 2024.

Concurrently, there is a distinct shift towards Decentralized Point-of-Care Viral Load Monitoring, designed to address the limitations of centralized laboratory networks in resource-limited geographies. By moving molecular testing closer to the patient, this trend reduces the turnaround time for results, facilitating faster clinical decision-making and improved adherence to antiretroviral therapy. This transition is essential for closing the gap in treatment efficacy, as delayed feedback from distant central labs often leads to patient loss to follow-up and unmanaged drug resistance. The urgency of this market evolution is underscored by the current disparity in treatment outcomes; according to The Global Fund, September 2025, in the 'Results Report 2025', only 74% of people living with HIV in supported countries had a suppressed viral load in 2024, highlighting the substantial market opportunity for point-of-care solutions to enhance monitoring frequency and patient suppression rates.

Segmental Insights

The Hospitals and Clinics segment is anticipated to experience the most rapid growth within the Global HIV Diagnostics Market. This expansion is primarily driven by the increasing adoption of routine screening protocols recommended by regulatory authorities such as the Centers for Disease Control and Prevention. Hospitals remain the primary access point for patient care, handling a significant volume of initial screenings and essential confirmatory tests. Additionally, the continuous development of healthcare infrastructure ensures that these facilities maintain a central role in managing HIV testing and treatment monitoring worldwide.

Regional Insights

North America maintains a leading position in the global HIV diagnostics market, supported by established healthcare infrastructure and proactive government initiatives. High disease awareness and the widespread implementation of routine screening programs, recommended by the U.S. Centers for Disease Control and Prevention, drive regional market activity. Furthermore, the U.S. Food and Drug Administration plays a vital role in approving diagnostic tests, ensuring their availability to the public. Favorable reimbursement frameworks and the presence of major industry participants also contribute to the region's dominance by facilitating broad access to testing services.

Recent Developments

• In January 2025, OraSure Technologies announced that the U.S. Food and Drug Administration granted approval for a labeling change to its OraQuick HIV Self-Test, expanding the authorized use to individuals aged 14 and older. This regulatory decision represented the first approval of an over-the-counter HIV test specifically for adolescents in this age bracket, addressing a significant barrier to testing access. The expanded indication was designed to empower a younger demographic to determine their HIV status in private. By facilitating earlier detection and connection to care, this development aimed to support public health efforts in reducing transmission rates and improving long-term outcomes.
• In December 2024, the World Health Organization approved a packaging and shipping site in Nigeria for the STANDARD Q HIV 1/2 Ab 3-Line Test, developed by SD Biosensor. This milestone, realized through a collaboration with a local partner, marked a significant advancement in strengthening regional diagnostic capacity and supply chain resilience within Africa. The regulatory approval permitted the rapid diagnostic test to be procured by major international organizations for widespread distribution. This initiative supported global strategies to increase access to essential health tools, ensuring that reliable HIV diagnostics are more readily available to populations in high-burden regions.
• In July 2024, Roche Diagnostics highlighted the development of its new generation Elecsys HIV Duo Test during the 25th International AIDS Conference in Munich. The company emphasized its strategic commitment to enhancing the sensitivity and specificity of serological testing to address the evolving landscape of HIV diagnostics, including challenges associated with pre-exposure prophylaxis. This advancement aimed to support earlier detection of the virus and meet changing requirements for seroconversion performance. The presentation underscored the critical importance of continuous innovation in diagnostic solutions to support laboratories and healthcare systems in achieving global targets for disease elimination.
• In April 2024, Cepheid announced that its Xpert HIV-1 Qual XC test achieved prequalification from the World Health Organization, signifying compliance with global standards for quality, safety, and performance. This point-of-care molecular diagnostic test was designed to facilitate the early diagnosis of HIV-1 infection in infants, adolescents, and adults, particularly in resource-limited settings. By utilizing a dual-target approach, the test ensures broader coverage of HIV strains and provides rapid results, which are essential for initiating timely treatment. The prequalification status enables international procurement agencies to distribute the test, thereby improving access to critical diagnostics and supporting efforts to reduce mortality rates among infected infants.

Key Market Players

• Thermo Fisher Scientific, Inc.
• Alere Inc.
• Abbott Laboratories inc.
• Bristol-Myers Squibb Company
• Janssen Global Services, LLC
• Gilead Sciences, Inc.
• Merck & Co. Inc.
• VIIV Healthcare
• Beckman Coulter, Inc.
• Sysmex Europe SE
• Zyomtronix, Inc.
• Mylan N.V.
• F. Hoffmann-La Roche Ltd.
• Siemens Healthcare GmbH

By Product	By Test Type	By Mode	By End-use	By Region
Consumables Instruments Software Services	Antibody Tests(HIV-1 Screening Tests HIV-1 Antibody Confirmatory Tests HIV-2 & Group O Diagnostic Tests) Viral Load Tests CD4 Test Others	Self-Test Lab-based	Diagnostic Laboratories Hospitals & Clinics Home Settings	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global HIV Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• HIV Diagnostics Market, By Product:

• Consumables
• Instruments
• Software
• Services

• HIV Diagnostics Market, By Test Type:

• Antibody Tests(HIV-1 Screening Tests
• HIV-1 Antibody Confirmatory Tests
• HIV-2 & Group O Diagnostic Tests)
• Viral Load Tests
• CD4 Test
• Others

• HIV Diagnostics Market, By Mode:

• Self-Test
• Lab-based

• HIV Diagnostics Market, By End-use:

• Diagnostic Laboratories
• Hospitals & Clinics
• Home Settings

• HIV Diagnostics Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE