HIV Diagnosis Market Size & Share Analysis - Trends, Drivers, Competitive Landscape, and Forecasts (2025 - 2032)
This Report Provides In-Depth Analysis of the HIV Diagnosis Market Report Prepared by P&S Intelligence, Segmented by Product (Consumables, Instruments, Software & Services), Test Type (Antibody Test, Viral Load, CD4, Early Infant Diagnosis, Viral Identification), End User (Diagnostic Laboratories, Hospitals, Homecare Settings), and Geographical Outlook for the Period of 2019 to 2032
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HIV Diagnosis Market Future Prospects
The global HIV diagnosis market size stood at USD 4.8 billion in 2024, which is expected to reach USD 9.8 billion by 2032, advancing at a CAGR of 9.6% during 2025–2032. This is primarily due to the surging prevalence of AIDS, in part, due to the rising number of blood donations and transfusions all over the world. In addition, the advantages offered by point-of-care kits and instruments are expected to burgeon the domain growth during the forecast period.
The AIDS virus can spread through a compromised needle or transfusion of infected blood to a healthy individual. The increasing participation of government associations in educational programs has raised awareness regarding unsafe blood donations and blood transfusions globally. Some of the major associations involved in this include the WHO, International Federation of Red Cross and Red Crescent Societies, and American Red Cross. They support blood donation programs and encourage people to donate blood and blood components in a safe way.
The use of unsterilized needles during blood transfusion leads to a high risk of this infection, thus serving as a major driver for the growth of the sector. Current trends suggest that the growing awareness leading to the increasing volume of blood donations and blood transfusions is expected to contribute to the rising incidence of HIV infection which, in turn, will drive the growth of the domain.
With the advent of point-of-care instruments and kits for the detection of this infection, the rate of diagnosis is expected to increase. Some of the advantages of point-of-care instruments and kits include convenience, time saving, high-confirmatory testing, and affordability. Moreover, these instruments and kits make it easy to perform medical tests at the bedside or point of care. The increasing acceptance of these devices by HIV-infected individuals and cautious people will drive the growth of the sector in the future.
The healthcare expenditure has increased in various countries to alleviate the burden of AIDS over the past few years, especially in low- and middle-income. The rise in the healthcare spending across regions is thought to be related to the relative burden of the disease in that region, which in the case of Sub-Saharan African countries is significantly high. The overall spending on HIV-related activities has increased over the years, which, in turn, is expected to drive the growth of the sector.
HIV Diagnosis Market Trends and Growth Drivers
Rising HIV Incidence Is Central Market Driver
The market is driven by the increasing incidence of HIV/AIDS, as well as the increasing awareness of it and diagnostic methods.
As per the UNAIDS, 39.9 million people had this condition in 2023, compared to 36.7 million in 2015.
HIV can spread through a compromised needle or transfusion of infected blood to a healthy individual.
Increased participation of government associations has raised awareness regarding blood donations and blood transfusions, globally. Some of the major associations involved in this include WHO, International Federation of Red Cross and Red Crescent Societies (IFRC), the American Association of Blood Banks (AABB), and American Red Cross.
These organizations support blood donor programs and encourage people to donate blood and blood components.
Moreover, various government initiatives have also been launched by these associations to increase awareness among people about blood donations. This initiative supports blood transfusion services around the world.
Although these blood donation activities have been advantageous, various hazards and risks are associated with these activities such as compromised use of sterilized needles during blood transfusion and transfusions of HIV-infected blood in healthy individuals.
As per the WHO, 118.5 million units of blood are donated around the globe each year.
However, screening protocols for HIV, syphilis, and hepatitis B & C are either lax or not enforced properly in many low-income countries.
Home-Use HIV Diagnosis Devices Offer Opportunity
In recent years, the USFDA has approved a few home-based diagnosis kits that can provide an HIV test result within 20 to 40 minutes, without needing to send the test sample to a laboratory.
Such home-based diagnostic devices are rising in popularity in countries such as the U.S. and the U.K over the standard laboratory-use devices, since the former are more convenient to use and cost-effective and save time.
A lot of people are reluctant to visit their physician or a healthcare facility to be tested for AIDS even if they have been engaging in behavior that would put them at a risk of being infected.
One of the reasons for their reluctance is believed to be the social stigma around having HIV.
The availability of home-based tests is expected to help a lot more infected people become aware of their status, thereby helping alleviate the lives of patients.
This also provides an opportunity for the players to further strengthen their current and potential markets, by launching low-cost and easy-to-use analytical devices that can be used at home by consumers themselves.
Some of the home-use kits approved by the USFDA are the Home Access HIV-1 Test System and OraQuick In-Home HIV test.
High Cost and Lack of Skilled Professionals Hamper Market Growth
High cost of HIV diagnosis procedure is hampering the growth of the overall market. The NATs are very costly and is not usually used for HIV screening.
Viral load tests and the IFA are considered to be one of the most expensive tests.
The cost of these tests is not affordable by many people in low and middle-income countries.
Moreover, most HIV tests require highly skilled technicians and dedicated laboratory spaces as well as long time to perform them.
For instance, p24 immunoassays needs dedicated equipment and trained staff.
Point-of-care tests require extra skilled staff and consumables to produce accurate results.
Lack of skill and training may lead to false-positive or false-negative, or indeterminate results.
Although the USFDA has approved some home bases HIV tests in recently, it strictly warns consumers to know that positive test results using these home base tests must be confirmed by follow-up laboratory-based testing, which reinforces the importance of skilled professional for HIV diagnosis procedures.
Moreover, there is a high shortage of health workers for HIV and AIDS, especially those in Sub-Saharan Africa and India, Bangladesh, and Indonesia.
The skills of these limited but highly expensive professionals do not match the local health needs, and almost all countries suffer from deficits.
HIV Diagnosis Market Analysis
Product Analysis
The consumables category accounted for the largest HIV diagnosis market share, of 60% in 2024, and it will also witness the highest CAGR during the forecast period. This is mainly attributable to the increasing use of reagents, assays, and kits for laboratory as well as home-based analytical tests. In addition, consumables need to be procured continuously and repetitively by hospitals and labs. Furthermore, the surge in the number of initiatives taken by government organizations to combat the spread of AIDS is expected to drive the category during the forecast period.
These products are part of the research scope:
Consumables (Largest and Fastest-Growing Category)
Instruments
Software & Services
Test Type Analysis
Based on type, the antibody test category garnered the largest market size in 2024, driven by the increasing number of approvals for new antibody tests with higher sensitivity and specificity by various regulatory authorities globally, including the USFDA. In addition, the surging pace of technological advancements and rising awareness regarding the disease are driving the demand for such tests. Further, the increasing adoption of these tests in countries such as Malaysia, India, Thailand, and China is fueling the category’s growth. Moreover, most recent antibody tests, including the confirmatory Western blot test, are considered over 99% precise.
Early infant diagnosis is the fastest-growing category, with a CAGR of 10.5%. This is because of the increasing awareness of the transmission of HIV to the baby from the mother in utero. The WHO says that almost 1.3 million females living with HIV conceive each year across the globe. There is a 15–45% chance that they will pass on the infection to the infant during pregnancy, breastfeeding, delivery, or labor. This is why HIV testing is becoming an important aspect of prenatal care. For instance, New Zealand offers free HIV tests to pregnant women along with other antenatal blood tests for blood group & Rh factor, hepatitis B, TLC/DLC, syphilis, and rubella. Moreover, in countries with high transmission rates, the WHO, UNICEF, and other international agencies are taking initiatives to make people aware of these tests and make them accessible to he masses.
We studied these test types:
Antibody Test (Largest Category)
HIV-1 Screening Test
ELISA
Rapid Test
Home Access Dried Blood Spot
HIV-1 Antibody Confirmatory Test
Western Blot
Indirect Immune Fluorescent Antibody Assay (IFA)
Line Immunoassay (LIA)
Radio-Immunoprecipitation Assay (RIPA)
HIV-2 & Group O Test
Blood Antibody Test
Dried Blood Spot (DBS) Test
Others
Viral Load
CD4
Early Infant Diagnosis (Fastest-Growing Category)
Viral Identification
Diagnostic Laboratories To Witness Highest CAGR
Hospitals dominate the market with 45% share in 2024. Most patients prefer hospitals because these places are all-inclusive centers that offer comprehensive care. Patients can trust hospitals to provide the highest levels of services, inclusive of diagnosis, prognosis, prophylaxis, and palliative care. Tertiary-care hospitals generally house comprehensive diagnostics laboratories with advanced equipment and employ skilled doctors for consultation and treatment.
The diagnostic laboratories category is expected to register the highest CAGR in the forecast period. Diagnostic laboratories are one of the major end users of these analytical instruments and kits. In countries where people do not have access to portable analytical kits, such labs are the mainstay of the virus detection ecosystem.
Furthermore, the advent of new, portable devices for diagnosis has led to the increasing affordability of these products for diagnostic laboratories, which, in turn, is resulting in a greater number of people being diagnosed with the disease. These labs offer the advantage of the latest instruments, as well as skilled professionals who can perform various tests to screen and confirm the presence of the infection.
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HIV Diagnosis Market Geographical Outlook
North America accounted for the largest HIV diagnosis market size in 2024, driven by the high incidence of AIDS in the region and the rising awareness regarding it. In addition, the region is considered the hub for innovations in diagnostic procedures since a majority of the established and upcoming players are either headquartered or have a significant presence here. In addition, the region's growth is expected to be driven by the increasing funding from government bodies for HIV-related activities and rising number of people donating blood.
In the North American region, the U.S. holds the major share, mainly due to the favorable insurance coverage for AIDS testing in the country. In the U.S., AIDS testing that is deemed “medically necessary” is usually covered in insurance, which makes it easy and cost-effective for people to get tested.
Europe held the second-largest share, of more than 25%, in 2024, due to the presence of prominent HIV diagnosis product manufacturers, such as Siemens AG, Hoffman-La Roche Ltd., and Merck KGaA in the region. Additionally, the EU’s CE marking standards with respect to the basic design and engineering are comparatively less stringent than those of the FDA, thus offering favorable development opportunities to key players. Furthermore, the low antiretroviral therapy coverage is considered to be one of the factors driving the incidence of AIDS in the region. The increasing awareness of this disease in this region has helped bring down the social stigma and discrimination toward people living with HIV.
APAC is expected to register the highest CAGR, of XX%, during the forecast period, driven by the expanding middle-class population with an increasing disposable income, low access to antiretroviral therapy, and rising support from the government of many countries in the region for AIDS diagnosis and management. The per capita income of many developing countries in this region, including India and Indonesia, has been on the rise in recent years, which is expected to fuel the demand for these products during the forecast period.
Here is the regional breakdown of the market:
North America (Largest Regional Market)
U.S. (Larger and Faster-Growing Country Market)
Canada
Europe
Germany (Largest and Fastest-Growing Country Market)
Brazil (Largest and Fastest-Growing Country Market)
Mexico
Rest of LATAM
Middle East and Africa (MEA)
Saudi Arabia
South Africa (Largest and Fastest-Growing Country Market)
U.A.E.
Rest of MEA
HIV Diagnosis Market Share
The market is fragmented because a wide range of consumables, testing equipment, and software are required for diagnosing and confirming HIV/AIDS.
Because most consumables are common items, such as gloves, Petri dishes, test tubes, beakers, flasks, droppers, and pipettes, even small, local firms hold significant shares.
Moreover, primary care centers and family practitioners in the rural areas of developing countries often buy from local firms for cost reasons.
Additionally, home-use tests are often less-strictly regulated than those for use by laboratories and hospitals, which also offers opportunities to new companies.
Major Companies in HIV Diagnosis Market:
Siemens Healthineers
F. Hoffmann-La Roche Ltd.
Danaher Corporation
Abbott Laboratories
Thermo Fisher Scientific Inc.
Merck KGaA
Becton, Dickinson & Company
Alere Inc.
Bio-Rad Laboratories Inc.
Hologic Inc.
QIAGEN N.V.
Agilent Technologies Inc.
HIV Diagnosis Market News
In December 2024, the GQ Topology-Targeted Reliable Conformational Polymorphism (GQ-RCP) platform, initially developed by the Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), was approved for HIV testing in India.
In December 2024, Codix Pharma Group received the WHO’s approval to package and ship the STANDARD Q HIV 1/2 Ab 3-Line Test, developed by SD Biosensor, in Nigeria. The approval will allow international organizations, such as President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund, as well as national, state/provincial, and municipal governments across Africa to procure this test.
In December 2024, MedMira received Health Canada’s approval for its Multiplo rapid TP/HIV test.
In November 2024, the Vietnamese government launched a digital health platform for people to test themselves and consulted for HIV, with support from the WHO and the Global Fund.
Frequently Asked Questions About This Report
How much will the HIV diagnosis market value in the future?+
In 2032, the value of the market for HIV diagnosis solutions will be USD 9.8 billion.
What kind of tests leads the HIV diagnosis industry?+
Antibody tests dominate the HIV diagnosis industry.
What are the key drivers for the HIV diagnosis market?+
The market for HIV diagnosis solutions is driven by the high number of people practicing unsafe sex and the increasing number of those donating or receiving blood.
Which are the largest and fastest-growing regions in the HIV diagnosis industry?+
North America is the largest HIV diagnosis industry, followed by Europe; APAC is set to grow the fastest.
What is the competitive landscape of the HIV diagnosis market?+
The market for HIV diagnosis solutions is fragmented.
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