HIV Diagnostics Market Size, Share, and Industry Analysis By Product (Instruments and Assay Kits & Reagents), By Type (Qualitative and Quantitative), By Technique (Immunochromatography, Immunoassay, and Polymerase Chain Reaction (PCR)), By Sample Type (Serum, Plasma, and Whole Blood), By Setting (Point-of-Care (POC) Testing and Laboratory Testing), By End-User (Hospitals & Clinics, Clinical Laboratories, and Others), and Regional Forecast, 2026-2034

The global HIV diagnostics market size was valued at USD 1.18 billion in 2025. The market is projected to grow from USD 1.24 billion in 2026 to USD 1.84 billion by 2034, exhibiting a CAGR of 5.07% during the forecast period.

The global HIV diagnostics market is rapidly expanding owing to the spread of HIV worldwide and the exigency of early detection and treatment. There are several testing technologies that comprise HIV diagnostics for detecting HIV infection in persons, such as serological tests, nucleic acid-based assays, and rapid point-of-care-testing of truth-telling that really make sure of timely and accurate diagnosis in clinical and community settings.

• According to the CDC, in 2023 alone, nearly 36 million HIV tests were conducted in the United States; such a number speaks to the far-reaching nature and exigency of these diagnostic services in the fight against the epidemic.

Through timely developments, such as rapid self-testing kits and mobile diagnostics, HIV testing has become very accessible in remote and underserved communities, thereby allowing for treatment and early patient management.

HIV Diagnostics Market Driver

Rising HIV Prevalence Drives Market Growth

Against the backdrop of an increasing global HIV prevalence, HIV diagnosis was pressing on the agenda of the medical world, with 39 million individuals thought to be living with HIV in 2023. As a response, these technologies have been introduced and utilized: rapid point-of-care tests, self-testing kits, etc. In fact, around 3.9 million HIV self-testing kits were distributed just in North America in 2023, according to the National Science Foundation, highlighting the preference for convenient and discreet testing avenues.

HIV Diagnostics Market Restraint

Stigma, Cost, And Access Hinder Market Growth

Despite a technological leap, there remain some restraints for the HIV diagnostics market. Advanced diagnostics, for example, nucleic acid testing, which is of very high accuracy, are in most instances prohibitively expensive for any low-resource setting. In addition, poor logistically positioned infrastructures and non-trained healthcare personnel limit the reach of testing into the rural and underserved. More importantly, social stigma and worries about privacy deter individuals from seeking a diagnosis in time, especially in conservative communities, which in turn hinders the broad adoption of testing.

HIV Diagnostics Market Opportunity

Emerging Innovations Drive HIV Diagnostics Market Growth

In terms of new avenues for development, the HIV diagnostics market stands promising. Developing lands such as the Asia-Pacific region, where investment and healthcare improvement trends are favoring the upgradation of test systems and their availability, should receive particular attention. Triple combination tests for the screening of HIV, hepatitis B, and syphilis can, in fact, reduce diagnostic costs significantly while increasing efficiency. On the other hand, the provision of HIV testing in Pre-exposure Prophylaxis (PrEP) programs could enhance the early detection of HIV cases and thus reinforce preventive health care systems.

Segmentation

Key Insights

The report covers the following key insights:

• HIV Testing Volume and Infrastructure, By Region
• Market Drivers, Restraints, and Opportunities
• Adoption of Self-Testing and POC Solutions
• Key Player Strategies and SWOT Analysis
• Recent Industry Developments
• Overview: Regulatory Scenario for HIV Diagnostic Kits and Devices

Analysis by Product

By product, the market is divided into instruments and assay kits & reagents.

The assay kits & reagents segment is expected to dominate the HIV diagnostics market as they are widely used in clinical labs and point-of-care settings. These products are used specifically to conduct types of tests such as ELISA, rapid antibody, and nucleic acid tests; as such, they drive the steady need across the regions for these products.

The instruments segment would present substantial growth in the upcoming years, supported by the trends of automation and digital platforms in diagnostic settings. Added to this is an even higher increase in adoption by centralized laboratories and research institutions, which would compound this segment's growth.

Analysis by Type

By type, the market is divided into qualitative and quantitative.

The qualitative segment is expected to dominate the HIV diagnostics market, due to its wide use in initial screening and rapid testing formats. These tests, which identify whether HIV antibodies or antigens are present or not, are favored as they are faster and simpler to use in large-scale testing initiatives.

The quantitative segment is expected to log a substantial growth, especially as viral load monitoring in treatment planning gets progressively utilized. Quantitative tests give finer details of the level of viral replication, and they are important in the management of patients who are on antiretroviral therapy.

Analysis by Technique

By technique, the market is divided into immunochromatography, immunoassay, and polymerase chain reaction (PCR).

This segment is dominated by immunoassay techniques that are in use due to their larger sensitivity and ability to detect both antibodies and antigens of HIV. The method itself supports many fourth-generation combination tests that are employed in screening and confirmatory settings worldwide.

Polymerase Chain Reaction (PCR) is expected to show significant growth as it detects viral RNA with perfect sensitivity, even during the early days of infection. This increases the market opportunity in a variety of clinical settings, including neonatal and acute HIV diagnosis.

Analysis by Sample Type

By sample type, the market is divided into serum, plasma, and whole blood.

Serum segment is expected to lead the HIV diagnostics market since it is highly compatible with different immunoassay-based test formats. Its specificity and sensitivity in identifying early and late infection, as well as its consistency and precision, have made it a diagnostic laboratory favorite.

A considerable growth will be registered in the whole blood segment, and this can be attributed to increasing uptake of rapid and point-of-care testing, especially in resource-limited locations. Its increased use is supported by the convenience of applying finger-prick samples that do not require processing.

Analysis by Setting

By setting, the market is divided into point-of-care (POC) testing and laboratory testing.

It is expected that point-of-care (POC) testing will take the lead, as the growth of decentralized testing services and mobile health programs appears. Convenience and fast outcome remain the determining factors in making this segment notable in both the urban and rural settings.

Laboratory testing is expected to increase significantly as well, with more developed areas having centralized laboratories where advanced molecular diagnostic tools are situated. The ability to perform high-throughput testing and accuracy retained over time are the factors leading to the faithful growth of this segment.

Analysis by End-User

By end-user, the market is divided into hospitals & clinics, clinical laboratories, and others.

Hospitals & clinics are expected to dominate the HIV Diagnostic market due to the number of patients served and the integrated care that these settings provide. Typically, such settings offer complete HIV testing services that range from initial screening to confirmatory diagnosis and treatment initiation.

The projection for clinical laboratories is substantial growth, mainly due to increased adoption of sophisticated technology and automated systems. Their ability to handle large volumes of samples while ensuring testing is highly accurate and sensitive tends to support the present market demand.

Regional Analysis

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Based on geography, the market has been studied across North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.

North America is the premier region in HIV diagnostics, backed by a more advanced healthcare infrastructure, routine screening programs for HIV, and more government funding. Due to well-established diagnostic infrastructure and continued investments in preventive healthcare, the region is expected to keep the majority in hand.

Asia-Pacific remains the fastest-growing HIV diagnostics market as HIV incidence grows faster with increasing public health initiatives coming into force. Support from global health organizations and awareness across developing countries further fuel the region's growth potential.

Europe shows steady growth, being driven by targeted policies and health reforms. Emphasis on testing of high-risk populations, including migrants from high-prevalence areas, supports an increasing role of the region in global diagnostics.

Key Players Covered

The report includes the profiles of the following key players:

• Abbott (U.S.)
• Meril Life Sciences Pvt. Ltd. (India)
• bioLytical Laboratories (Canada)
• GeneProof (Czech Republic)
• F. Hoffmann-La Roche Ltd (Switzerland)
• Siemens Healthineers AG (Germany)
• Oscar Medicare Pvt Ltd. (India)
• SD Biosensor, INC. (South Korea)

Key Industry Developments

• In January 2025, MedMira's RevealRapid G4 Test, a rapid HIV-1/2 antibody diagnostic that gives out results in a matter of seconds, got approved by Health Canada. This, hence, considerably improves efficiencies in point-of-care HIV testing in clinical settings.
• In August 2024, PAHO and Unitaid together granted Brazil $5 million for strengthening HIV diagnostics. The program mainly deals with the rollout of new tests, surveillance, and the training of health workers nationwide.
• In June 2024, OraSure Technologies took an active role in organizing events across National HIV Testing Day in the United States. This helped spread testing opportunities while also raising further awareness about prevention.