| Study Period | 2019 - 2030 |
| Market Size (2025) | USD 5.02 Billion |
| Market Size (2030) | USD 8.22 Billion |
| CAGR (2025 - 2030) | 10.35 % |
| Fastest Growing Market | Africa |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order |
HIV/AIDS Diagnostics Market Analysis
The Global HIV/AIDS Diagnostics Market size is estimated at USD 5.02 billion in 2025, and is expected to reach USD 8.22 billion by 2030, at a CAGR of 10.35% during the forecast period (2025-2030).
COVID-19 caused a dramatic decline in HIV testing and, as a consequence, a much lower number of new HIV diagnoses. In May 2022, an article published titled "COVID Caused Drop-in HIV Testing, Diagnoses" stated that the Centers for Disease Control and Prevention (CDC) 2020 HIV surveillance report showed COVID disruptions. The COVID-19 pandemic in the United States led to disruptions in HIV testing services and access to clinical services throughout 2020. This disruption resulted in a steep, single-year decline in HIV diagnoses that is mostly attributed to declines in testing caused by less frequent visits to health centers, reduced outreach services, and shifting of public health staff to COVID-19 response activities. Similarly, in December 2021, a report published by the Government of Canada, titled "HIV in Canada: 2020 Surveillance highlights" stated that the COVID-19 pandemic resulted in a decreased demand for, and ability to provide, services related to sexually transmitted and bloodborne infections, including HIV testing. This may have had an impact on observed new diagnosis rates for HIV in 2020. Hence, the COVID-19 pandemic has a negative impact on market growth. However, in the future, the market is likely to grow.
Factors such as the increasing prevalence of HIV along with new initiatives and product launches are the primary reasons for the growth of the market. According to the World Health Organization (WHO) update in November 2021, HIV continues to be a major global public health issue, having claimed 36.3 million lives so far. There were an estimated 37.7 million (30.2-45.1 million) people living with HIV at the end of 2020, over two-thirds of whom (25.4 million) are in the WHO African Region. In 2020, 680,000 (480,000-1.0 million) people died from HIV-related causes and 1.5 million (1.0-2.0 million) people acquired HIV.
The increasing initiatives by public organizations such as United Nations Programme on HIV and AIDS. (UNAIDS) provides awareness and investments to the market. To reach the new proposed global 95-95-95 targets set by UNAIDS, to avoid the worst-case scenario of 7.7 million HIV-related deaths over the next 10 years, increasing HIV infections due to HIV service disruptions during COVID-19, and the slowing public health response to HIV. Such initiatives increase awareness which increases the demand for more diagnostic tests which increases the growth of the market.
Furthermore, the new research and developments, technological innovations, and the launch of technologically advanced products by key players are expected to boost the growth of the market. For instance, in April 2021, Altona Diagnostics launched an in-vitro diagnostic test based on real-time RT-PCR technology that detects and quantifies the human immunodeficiency virus (HIV) specific RNA in human plasma. The test was named as AltoStar HIV RT-PCR Kit 1.5. Therefore, due to the above-stated factors, the studied market is anticipated to witness notable growth during the study period.
However, the lack of mandates for nucleic acid tests in developing countries is likely to hinder market growth.
HIV/AIDS Diagnostics Market Trends
Antibody Test Segment Accounts for the Large Market Share Over the Forecast Period
The Antibody test detects HIV antibodies in blood or saliva. The immune system makes antibodies when bacteria or viruses enter the body. An HIV antibody test can determine if the person is positive after 3-12 weeks after infection. That's because it can take a few weeks or longer for the immune system to make antibodies to HIV. The patient can do an HIV antibody test in privacy at home with the kits.
The dominance in the market growth can be attributed to the increase in the prevalence of HIV/AIDS globally and the efficacy of antigen testing. As per the statistics updated in August 2022 by HIV.gov, an estimated 1.5 million individuals worldwide acquired HIV in 2021. Moreover, there were approximately 38.4 million people across the globe with HIV in 2020. Of these, 36.7 million were adults and 1.7 million were children (<15 years old). In addition, 54% were women and girls. As per the same source, the vast majority of people with HIV are in low- and middle-income countries. In 2021, there were 20.6 million people with HIV (53%) in eastern and southern Africa, 5 million (13%) in western and central Africa, 6 million (15%) in Asia and the Pacific, and 2.3 million (5%) in Western and Central Europe and North America. The high incidence rate of HIV in the country boosts the demand for its diagnostics, thus driving the studied market.
The report 'HIV testing, new HIV diagnoses, outcomes and quality of care for people accessing HIV services: 2021 report' published by the UK Health Security Agency in December 2021, stated that in 2020, an estimated 97,740 people were living with HIV in England and an estimated 4,660 in 2020 were unaware of their infection indicating that diagnostic services are not provided to the larger extent of the people. Therefore, the market in the country has great potential to grow. Furthermore, the rise in government initiatives and programs is boosting the global market. For instance, in December 2021, the Government launched an HIV action plan, supported by over GBP 23 million of funding, which aims to reduce new HIV infections by 80% by 2025 and end infections and deaths in England by 2030. Such rising investments aligned with strategic programs will increase the diagnostic capabilities in the country, thus propelling the market. Product launches are another factor in the market growth. For instance, in September 2020, Roche launched Elecsys HIV Duo immunoassay in the United States. Through separate measurements of the HIV p24 antigen (the virus) and anti-HIV antibodies (caused by immune reaction), this test can detect an acute HIV infection earlier than current methods. Hence, such innovations coupled with increasing HIV cases and government initiatives the market is likely to grow in the future. In January 2022, Vela Diagnostics's Sentosa SQ HIV-1 genotyping assay for HIV received reimbursement from The Centers for Medicare and Medicaid (CMS). This will allow more laboratories to bridge the gap that may have been deterring them from moving onto a newer technology that gives higher sensitivity and possibly better clinical outcomes to HIV patients. Hence, such initiatives would increase the market growth in the region in the upcoming period.
Hence, the above-mentioned factors are expected to increase the market growth.
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North America Dominates the Market and Expected to do Same Over the Forecast Period
North America is expected to dominate the overall market, throughout the forecast period. The market growth is due to factors such as the presence of key players, the high prevalence of HIV/AIDS in the region, and established healthcare infrastructure are some of the key factors accountable for its large share.
According to Statistics published by HIV.gov in June 2021, approximately 1.2 million people in the United States have HIV (Human Immunodeficiency Virus) resulting in a total of 34,800 HIV infections in 2019 with a rate was 12.6 (per 100,000 people). This suggests that HIV incidences are high in the country, therefore increasing the demand for its diagnostics products, which will drive the studied market.
Additionally, in October 2021, an article published by The Borgen Project stated that in 2020, UNAIDS reported 340,000 people living with HIV, a 55% increase from 2018's report of 230,000 in Mexico. The program received Usd26 million in HIV treatment funding to assist '7,500 at-risk people in Mexico, Brazil, and Peru' until 2020. In Mexico, the PrEP program was open to assist up to 3,000 people with free treatments across four Mexican cities including Puerto Vallarta, Mexico City, Merida, and Guadalajara. Additionally, patients received STD testing, counseling, and condoms free of charge. Hence, such initiatives would increase market growth in the region.
Additionally, in December 2021, the Centers for Disease Control and Prevention (CDC) awarded USD 22 million to nearly 30 organizations around the world to combat antimicrobial resistance (AR) and infectious diseases (including HIV), and other healthcare threats through the establishment of two new networks namely the Global Action in Healthcare Network (GAIHN) and the Global AR Laboratory and Response Network (Global AR Lab & Response Network). Thus, increasing investments and the establishment of a global network for supporting diagnostics will drive the market.
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HIV/AIDS Diagnostics Industry Overview
The HIV/AIDS diagnostics market is moderately competitive and consists of several major players. Some of the market players are Siemens Healthineers, F. Hoffmann-La Roche Ltd, Abbott Laboratories, Danaher Corporation, Thermo-Fisher Scientific Inc., Merck KGaA, Becton, Dickinson & Company, Hologic Inc., and Bio-Rad Laboratories among others.
HIV/AIDS Diagnostics Market Leaders
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Siemens Healthineers
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F. Hoffmann-La Roche Ltd
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Abbott Laboratories
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Thermo-Fisher Scientific Inc.
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Danaher Corporation
- *Disclaimer: Major Players sorted in no particular order
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HIV/AIDS Diagnostics Market News
- In May 2022, THE Amref Health Africa-Tanzania launched the 'Afya Kamilifu' project in Mara Region to prevent HIV. The project is sponsored by the Centre for Disease Control and Prevention (CDC). Under this HIV self-test kits were made available at all health centers in the region.
- In May 2022, Roche through its Global Access Program, partnered with The Global Fund to improve the diagnosis of HIV by building local capacity to tackle fundamental infrastructure challenges for generating and delivering diagnostic results and managing healthcare waste. This includes building effective processes to collect, transport, test samples, and return the results to patients for timely clinical interventions, as well as addressing challenges arising from a lack of network infrastructure, workforce capacity, access to roads, and IT systems.
HIV/AIDS Diagnostics Industry Segmentation
As per the scope of the report HIV/AIDS diagnostics are used to investigate the existence of the human immune-deficiency virus, in saliva, serum or urine. HIV/AIDS diagnostics helps to detect antibodies, RNA or antigens. Blood tests are the most regular way to make a diagnosis of HIV. HIV is most commonly diagnosed by doing a urine test and blood test. The HIV/AIDS Diagnostics Market is Segment by Product (Consumables, Instruments, and Software & Services), Test Type (Antibody Tests, Viral Load Tests, CD4 Tests, and Others), End User (Diagnostic Laboratories, Hospitals, and Others), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.
| By Product | Consumables | ||
| Instruments | |||
| Software & Services | |||
| By Test Type | Antibody Tests | ||
| Viral Load Tests | |||
| CD4 Tests | |||
| Others | |||
| By End User | Diagnostic Laboratories | ||
| Hospitals | |||
| Others | |||
| Geography | North America | United States | |
| Canada | |||
| Mexico | |||
| Europe | Germany | ||
| United Kingdom | |||
| France | |||
| Italy | |||
| Spain | |||
| Rest of Europe | |||
| Asia-Pacific | China | ||
| Japan | |||
| India | |||
| Australia | |||
| South Korea | |||
| Rest of Asia-Pacific | |||
| Middle-East and Africa | GCC | ||
| South Africa | |||
| Rest of Middle-East and Africa | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
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HIV/AIDS Diagnostics Market Research FAQs
How big is the Global HIV/AIDS Diagnostics Market?
The Global HIV/AIDS Diagnostics Market size is expected to reach USD 5.02 billion in 2025 and grow at a CAGR of 10.35% to reach USD 8.22 billion by 2030.
What is the current Global HIV/AIDS Diagnostics Market size?
In 2025, the Global HIV/AIDS Diagnostics Market size is expected to reach USD 5.02 billion.
Who are the key players in Global HIV/AIDS Diagnostics Market?
Siemens Healthineers, F. Hoffmann-La Roche Ltd, Abbott Laboratories, Thermo-Fisher Scientific Inc. and Danaher Corporation are the major companies operating in the Global HIV/AIDS Diagnostics Market.
Which is the fastest growing region in Global HIV/AIDS Diagnostics Market?
Africa is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Global HIV/AIDS Diagnostics Market?
In 2025, the North America accounts for the largest market share in Global HIV/AIDS Diagnostics Market.
What years does this Global HIV/AIDS Diagnostics Market cover, and what was the market size in 2024?
In 2024, the Global HIV/AIDS Diagnostics Market size was estimated at USD 4.50 billion. The report covers the Global HIV/AIDS Diagnostics Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Global HIV/AIDS Diagnostics Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
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Statistics for the 2025 Global HIV/AIDS Diagnostics market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Global HIV/AIDS Diagnostics analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
