HIV Diagnostics Market By Product Type (Consumables, Instruments, Software & Services), By Test Type (Antibody Tests, Viral Load Tests, CD4 Tests, Early Infant Diagnosis (EID) Tests, Others), By Technology Platform (Immunoassays, Molecular Diagnostics, Flow Cytometry, Lateral Flow Assays), By Test Purpose (Screening Tests, Confirmatory Tests, Monitoring Tests, Others), and By End User (Diagnostic Laboratories, Hospitals & Clinics, Home Care Settings, Blood Banks & Government, Others), Global Market Size, Segmental Analysis, Regional Overview, Company Share Analysis, Leading Company Profiles and Market Forecast, 2025 – 2035

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What trends will shape the HIV Diagnostics Market in the coming years?

The HIV Diagnostics Market accounted for USD 2.01 Billion in 2024 and USD 2.12 Billion in 2025 is expected to reach USD 3.53 Billion by 2035, growing at a CAGR of around 5.25% between 2025 and 2035. It is estimated that a number of trends will define the HIV diagnostics market in the following years. The trend toward the increased utilization of point-of-care (PoC) testing and self-testing kits will accelerate the ability to improve access to testing and ensure early detection, especially in remote population centers. Nucleic acid amplification and molecular diagnostic technologies are leading to greater sensitivity and quicker results. AI and automation are becoming part of diagnostics in a way that increases precision and operational efficiency. There is increased focus on the use of viral load and CD4 monitoring to inform antiretroviral therapy under the influence of drugs. Patient-centered testing is facilitated through home care and telehealth solution expansions. Moreover, the government programs and increased HIV awareness are increasing the demand for sophisticated diagnostics in the world.

What do industry experts say about the HIV Diagnostics market trends?

“We are committed to making sure that people around the world can get our new HIV prevention injection, Yeztugo.”

• Daniel O’Day, CEO of Gilead Sciences.

Qiagen aims for 7% annual sales growth until 2028, focusing on lab testing machines for infections and cancers, including HIV diagnostics.

• Thierry Bernard, CEO of Qiagen.

Which segments and geographies does the report analyze?

What are the key drivers and challenges shaping the HIV Diagnostics market?

How is rising global HIV prevalence driving strong demand for advanced diagnostic solutions?

The high demand in the Global HIV Diagnostics Market is witnessed in the increased demand in the use of advanced diagnostic solutions, given the rising rate of HIV worldwide, thus creating a great need to find the infections early and accurately. The World Health Organization estimates put the number of individuals living with HIV in 2022 to be 39 million, thus indicating the extent of the problem. The increasing rates of infection, particularly in resource-deprived areas, are fueling the emergence of novel diagnostic tools. Complex platforms, including molecular diagnostics and 4th-generation immunoassays, are making it possible to identify the virus at earlier stages, quicker, and more precisely.

There is growing interest in point-of-care testing, which is being used where testing facilities are remote to improve access and convenience. Early detection is important in terms of connecting patients with the right remedy and having better long-term health-related outcomes. Heightened social awareness programs and campaigns on health are encouraging more people to participate in testing programs. AI-based technology is being further integrated into the diagnostic process to improve accuracy and automate the process. Increasing government funding and international collaborations are supporting innovative solutions and their wider uptake. On their own, these developments are driving the Global HIV Diagnostics Market to greater heights in handling the HIV epidemic.

Why do government awareness programs enhance accessibility and adoption of HIV testing technologies?

Increasing awareness initiatives run by governments are also an important influencing factor in the Global HIV Diagnostics Market, and this effectively enhances the accessibility and uptake of improved testing technologies all over the world. In 2022, the World Health Organization statistics declared that 29.8 million individuals were under antiretroviral treatment, which reflects firsthand the benefit of increased testing promoted by public programs. These programs minimize social stigma and promote early diagnosis and inclusion of HIV testing in the mainstream healthcare services.

As well, governments are vigorously investing in such areas as diagnostic labs, biomedical testing trucks, and mobile clinical facilities in order to spread accessibility in rural and underserved communities. Cheap or subsidized diagnostic tools also improve the affordability of diagnostics, particularly among vulnerable groups. Educational campaigns provide the communities with power and knowledge in order to bring them to voluntary testing and preventive behavioral habits in healthcare. Public health agencies also cooperate with private firms to secure the guarantee of distribution of innovative diagnostic devices. Incorporation of HIV testing into maternal health programs and blood donation services will increase the rate of testing. Under these initiatives, the training of healthcare workers also serves the purpose of accuracy and standardization in carrying out the testing procedures. Together, these are advancing the adoption of the HIV diagnostics market, increasing its coverage, and fueling its growth.

Why does the high diagnostic test cost limit adoption across low-income and rural populations?

The response to the adoption of the Global HIV Diagnostics Market is in the low-income and rural population, which hinders the adoption of diagnostic tests because the cost difference becomes very high to cater to the low-income and rural community. More advanced tests, such as molecular diagnostics and viral load tests, are characterized by a markedly larger price point and by being far more accurate in comparison to the traditional antibody tests. In resource-scarce areas, most financing is provided through out-of-pocket expenditure, so costly testing is unavailable.

Some rural clinics also do not have a lot of finances to acquire advanced machinery used to perform such tests, which reduces the number of kits available. The indirect costs, like the travel required to travel to the urban centers, form a burden on the patients even in the presence of subsidies. Even low insurance coverage and inadequate government reimbursement contribute to barriers in affordability. Consequently, most of them depend on the late/improper tests, and there is a threat of missing the detection of infections and late treatment. This expenditure-based disparity reduces the chances of early diagnosis and proper treatment of the disease. In addition, it increases health inequities between rural and urban communities. Overall, the prohibitive nature serves as a crucial constraint in the Global HIV Diagnostics Market by hindering access and adoption.

How can expanding point-of-care diagnostics revolutionize HIV testing accessibility in remote areas?

The HIV diagnostics market is undergoing a revolution since, through the rise of point-of-care, it is improving the testing accessibility in distant and underserved regions that have simplified lab infrastructure. These portable and rapid tools give answers within several hours that make the earlier intervention of the treatment and loss of patients easier to follow. In 2022, it was stated by health organizations worldwide that 86% of individuals living with HIV knew that they had it, which testified to the importance of universal and early testing.

Point-of-care technologies are of prime importance to rural and low-resource places where there is usually no access to centralized laboratories. These solutions can enable frontline healthcare workers to complete accurate and prompt tests so that they do not have to rely on sophisticated facilities. They are simple, affordable, and easy to carry around, therefore making them extremely appropriate to deploy in community-based health initiatives. Governments or NGOs are now more widely taking them on to ensure they reach more marginalized groups. These diagnostics are also important in early detection, which is critical to curbing further spread. They reinforce the infrastructures of public health in an environment that is challenging by bridging the gaps in the delivery of healthcare. Altogether, this evolution of point-of-care diagnostics is transforming the Global HIV Diagnostics Market in terms of providing equity, access, and impact.

Why does rising investment in R&D foster innovations in rapid diagnostic device development?

The Global HIV Diagnostics Market is in a fast phase of growth, with growing investment in R&D leading to the development of rapid diagnostic devices. Funding projects makes it possible to create highly sensitive and user-friendly tests, giving a much quicker and more accurate result. In line with the current expenditure in HIV/AIDS research, the U.S. National Institutes of Health (NIH) stated that about 2.9 billion U.S. dollars were spent on it in 2020. These investments are supporting innovation in molecular diagnostics, immunoassays, and point-of-care (POC) testing platforms that enable broader accessibility throughout health systems. Research and development are also being directed towards the cost-effectiveness of devices so that they can be adopted in the low-income and rural areas.

The testing of HIV is improving more with advanced technologies like microfluidics and biosensors. There is greater financial support, which leads to better collaboration between research institutions, diagnostic companies, and health establishments. The collaboration helps in the process of converting the findings of scientific research into viable and commercially viable medical procedures. The improvement in early detection and monitoring of HIV is aided by the presence of such underlying factors on such devices as faster, cheaper, and reliable machines of a high level of reliability. In general, the expansion in R&D budgets is transforming the global HIV diagnostics market by enhancing equality, affordability, and innovation.

What are the key market segments in the HIV Diagnostics industry?

Based on the product type, the HIV Diagnostics Market is classified into Consumables, Instruments, Software & Services. Consumables form a large proportion of the marketplace, as they are repetitive and used by most people, whether in laboratories or point-of-care facilities. These include instruments like diagnostic analyzers and laboratory machinery, and these are the ones needed to perform tests accurately, and are witnessing steady growth due to the advancements in technology.

The software & services business segment, including data management systems and AI-based diagnostic systems, is picking up as healthcare facilities continue to embrace digital systems in search of efficiency and accuracy. The increasing focus on fast testing and early detection is pushing the consumption of consumables and instruments. The connection of AI and automation to the diagnostic workflows is improving the relevance of software and services. Generally, the product type segmentation is balanced in terms of the number and volume of consumables, high-tech instruments, and innovative software solutions.

Based on the technology platform, the HIV Diagnostics Market is classified into immunoassays, molecular diagnostics, flow cytometry, and lateral flow assays (LFAs). One reason is that immunoassays, such as ELISA and Western blot, remain popular in HIV screening because of their low costs and their high reliability. Molecular tests are becoming a reportable trend since they are highly sensitive, with the capability of early detection, which is crucial for confirmatory and monitoring tests. Flow cytometry is essential in determining the number of CD4 cells, which informs a treatment recommendation and monitors the disease progression in HIV-positive patients.

Lateral flow assays are rapidly growing in popularity due to their applicability in the realm of point-of-care and self-testing applications, providing fast and efficient results. The migration in low-resource environments to decentralized testing is creating adoption of LFAs and molecular platforms. Moreover, technological innovations are incorporating AI and automation into them to increase accuracy. This segmentation shows an increase in the balancing of affordability, accessibility, and accuracy in HIV diagnostics.

Which regions are leading the HIV Diagnostics market, and why?

The North America HIV Diagnostics Market is leading due to the well-established healthcare system, marketing, high level of awareness, and government involvement in supporting HIV prevention and testing. The United States occupies the highest market share involved in the extensive use of advanced diagnostic mechanisms, including molecular testing and rapid point-of-care kits. Funding of HIV diagnostics by organizations such as the CDC and the NIH is continuous. The increased cases of HIV, particularly among the high-risk groups, help maintain the demand for both the screening and monitoring tests.

Canada is also a prominent contributor, but the facilitating factors, in this case, include campaigns through public health and access to self-testing solutions. The availability of the global diagnostic leaders, including the likes of Abbott, Bio-Rad, and Thermo Fisher Scientific, also fortifies the market. Favorable regulatory acceptances and rapid product releases increase its availability and use. Overall, North America will retain its position due to the innovation, positive policies, and increased attention to early HIV identification.

The Asia Pacific HIV Diagnostics Market is growing due to the increasing prevalence of HIV and increasing awareness and access to diagnostic solutions. Such countries as India, China, and Thailand are reported to have a highly powerful government push and the support of international programs that encourage mass testing. Rural and low-resource markets are moving rapidly to adopt rapid point-of-care tests, speeding market penetration along. Increasing investments in molecular diagnostic technologies and expanding healthcare infrastructure are two of the factors that are stimulating the demand.

Collaborations between local authorities and international organizations are increasing access to reasonable check kits. The rising importance attached to early detection programs and preventive programs is also adding to it. Moreover, the rising popularity of the self-testing kits is changing patient involvement in HIV care. The large population base and the increasing accessibility of healthcare facilities make the Asia-Pacific region take a lead over other regions in terms of growth in the coming forecast period.

What does the competitive landscape of the HIV Diagnostics market look like?

The expansive HIV diagnostics market is highly competitive, with the key players being in the advanced stages of product development, collaborations, and global expansions that include Abbott Laboratories, Roche Diagnostics, Siemens Healthineers, Bio-Rad Laboratories, and Hologic, among others. Abbott leads the market with its strong share due to a wide range of rapid and laboratory-based diagnostic covers, and Roche has a strong premium molecular diagnostic platform. Siemens Healthineers adheres to the integrated solutions strategy in particular, as far as automation of testing systems is concerned, as a means of promoting the hospital and reference lab business. Bio-Rad boasts of its HIV-1/HIV-2 differentiation test, whereas Hologic celebrates high-throughput molecular systems to speed and enhance the efficiency of detection.

It is spending companies' fortunes on point-of-care testing and self-test kits to satisfy the demands of decentralized diagnostics. One of the factors that further contributes to the competitive edge of the company is strategic alliances and acquisitions, along with the possibility of integrating its digital solutions with mobile health technologies. There are increasing competitive threats with the introduction of innovative technologies, such as CRISPR-based and smartphone-based diagnostic tools, that make such diagnostics less affordable and accessible. Another recent development that is worth mentioning is the opening of a new manufacturing facility in Nigeria by Codix Bio Ltd., in liaison with SD Biosensor, that would produce hundreds of millions of HIV and malaria RDTs annually, not only stabilizing the supplies to that region but also reducing import reliance. The move indicates the changes, like the competition among the players in the global market in HIV diagnostics, as a result of national production, state sponsorship, and international alliances.

HIV Diagnostics Market, Company Shares Analysis, 2024

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Which recent mergers, acquisitions, or product launches are shaping the HIV Diagnostics industry?

• In July 2025, the World Health Organization (WHO) prequalified the first bundled set of three in vitro rapid diagnostic tests (RDTs) capable of simultaneously detecting HIV, hepatitis B virus (HBV), and syphilis, three major infections that pose serious risks to maternal and child health.
• In June 2025, Nigerian health tech company Codix Bio Ltd. partnered with South Korean diagnostics firm SD Biosensor, under a WHO-brokered sublicensing agreement, to begin local production of HIV and malaria rapid diagnostic kits (RDTs). This initiative, supported by the World Health Organization, aims to address donor funding gaps and improve equitable access to diagnostics in Africa by establishing local manufacturing capacity for these vital tools.
• In May 2025, Universal Therapeutics Diagnostics received Malaysia’s Ministry of Health approval for its UT+ Diagnostics 4th Generation HIV-1/2 + p24 Test, enabling highly accurate early HIV detection.

Report Coverage:

By Product Type

• Consumables
• Instruments
• Software & Services

By Test Type

• Antibody Tests
• Viral Load Tests
• CD4 Tests
• Early Infant Diagnosis (EID) Tests
• Others

By Technology Platform

• Immunoassays
• Molecular Diagnostics
• Flow Cytometry
• Lateral Flow Assays

By Test Purpose

• Screening Tests
• Confirmatory Tests
• Monitoring Tests
• Others

By End User

• Diagnostic Laboratories
• Hospitals & Clinics
• Home Care Settings
• Blood Banks & Government
• Others

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of Middle East & Africa

List of Companies:

• Abbott Laboratories
• F. Hoffmann-La Roche Ltd
• Siemens Healthineers AG
• Bio-Rad Laboratories, Inc.
• Hologic, Inc.
• Becton, Dickinson and Company (BD)
• Thermo Fisher Scientific Inc.
• Danaher Corporation
• Orasure Technologies, Inc.
• Chembio Diagnostics, Inc.
• Alere Inc.
• Cepheid, Inc.
• Meridian Bioscience, Inc.
• bioMérieux SA
• Mylan N.V.

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