HIV Diagnostics Market Analysis

Global HIV Diagnostics Market Overview

HIV diagnostics market is expected to reach USD 4.88 Billion by 2032 and is projected to register a CAGR of 9.2% from 2023 to 2032. Human immunodeficiency virus (HIV) is an autoimmune disease which affects the immune system similar to other autoimmune diseases and leaves the body susceptible to other diseases and infections. HIV diagnostics are majorly used to test the HIV diseases.

There are large number of different market player for HIV diagnostics that dominates the HIV diagnostics market, which includes Siemens Healthiness, Roche Diagnostics, Abbott Laboratories, Beckman Coulter, Inc. and many more. The companies are involved in launching new products, technologies, and are undergo strategic collaboration to develop healthcare produces. For instance, on January 2019, Hologic Inc. has received US Food and Drug Administration (FDA) for its Aptima Mycoplasma genitalium assay, used to detect common sexually transmitted infection (STI).

In January 2024, A license agreement was announced by WHO and the MPP with SD Biosensor Inc., a global in-vitro diagnostic company, so as to give sublicensees the right, know-how, and material required for manufacturing SDB’s rapid diagnostic testing (RDT) technology. It is a transparent, non-exclusive license agreement that has been negotiated with C-TAP under the COVID-19 Technology Access Pool (C-TAP). In this regard, it can be observed that the C-TAP initiative has reached a significant milestone because the license allows diagnostics for COVID-19 but also permits other diseases like HIV, malaria, and syphilis. The objectives of WHA Resolution 76.5 on strengthening diagnostics capacity are well aligned with the technology transfer support that this agreement can offer, including calling on countries to commit resources towards investing in research and product development as well as promoting local production capacity for diagnostics, especially in developing countries.

In June 2023, INVEX Health said that it had successfully created an Oral Fluid-Based HIV Self-Test, an innovative product that is currently undergoing validation in India. To dramatically expand its therapeutic offerings, INVEX Health recently acquired the global licensing rights for a patented product targeting Psoriasis. By manufacturing this product in India and gradually making it available in various markets at an affordable price, they have completely disrupted the landscape of treatment Psoriasis patients experience. It was claimed that this strategic move demonstrates INVEX Health’s commitment to innovation in patient care.

In August 17, 2022, Aurobindo Pharma Ltd announced its launch of an HIV triple combination product for children living with HIV/AIDS across low –and middle-income countries. Aurobindo Pharma shares were flat ahead of opening before trading at Rs 872.65 around 9:31 am on August 17 after announcing that it will launch a tablet for treating HIV/AIDS across low-to-middle-income nations. The drug maker granted Aurobindo a pediatric dolutegravir voluntary license, according to media reports. Consequently, the company’s product is developed and supplied to 123 low and middle-income countries, including India.

HIV Diagnostics Market Trends

The increasing innovation and research activity to develop innovative HIV diagnostic kits boosts the market growth.

Market Drivers

• Growing prevalence of HIV/Aids across the globe. According to The Joint United Nations Programme on HIV/AIDS (UNAIDS) there were approximately 37.9 million people across the globe with HIV/AIDS in 2018. Also reported that around 1.7 million people became newly infected with HIV across the world.

• Not following safety procedure while blood transfusions and blood donations also increases the infection cases

• Availability of point-of-care instruments & kits. There are large number of companies involved in development of HIV diagnostic kits. The companies such as Becton, Dickinson & Company, Hologic Inc., Alere Inc., Bio-Rad Laboratories and many more offers HIV diagnostic products.

• Increasing government initiatives to create awareness about the precaution and treatment method for HIV disease. In the beginning, HIV prevention programs were primarily focused on preventing the sexual transmission of HIV through behavior change. For many years, the ABC approach ("Abstinence, Be faithful, Use a Condom") was used to control the increasing epidemic in sub-Saharan Africa.

• Rising fund for research activity to develop innovative drugs to treat AIDs. At the end of 2018, USD 19,000 million was available for the AIDS response.

Market Restraints

• Social stigma and embarrassment faced by patients affected AIDS leads to a negative impact on HIV diagnostics market growth avoiding of diagnosis for the disease.

• Lack of developmental and technological innovations in low middle-income countries (LMICs).

HIV Diagnostics Market Segment Insights

By Product

• Consumables: It is the fastest growing HIV diagnostics market as there is demand for consumable product for every test. The consumables include assays and kits & reagents and other consumables. These products are used to collect, prepare, and examine the patients’ body samples such as blood, tissues, and others. Furthermore, reagents and kits are the most fundamental and critical components used in diagnostic assays and are required in almost every diagnostic assay.

• Instruments: It is the largest segment by product in the HIV diagnostics market. The instruments used in HIV diagnosis includes spectroscopy, microscope, cleaning and sterilization and many more instruments for the analysis of the sample.

• Software & Services: As more and more researchers entered this new field of study, the need for power tools and software became apparent and therefore led to the development of such tools. The growth of the services segment is attributed to factors such as the increasing focus of key HIV diagnostics market players on providing efficient diagnostics services to researchers and rising research activities in genomics.

By Test Type

• Antibody Tests: It is the most common performed test to detect the presence of HIV antigen. There are different antibody tests which includes HIV-1 screening test, HIV-1 antibody confirmatory tests and HIV-2 & Group O diagnostic tests. The HIV-1 screening test includes Elisa, rapid tests and home access dried blood spots. 




• HIV-1 Screening Test: It is performed to confirm HIV and also to find out whether the person have HIV-1 or HIV-2.


• HIV-1 Antibody Confirmatory Tests: This test is performed to confirms the HIV-1 infection if the person is positive on the first antigen/antibody combination immunoassay test.


• HIV-2 & Group O Diagnostic Tests: It is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to HIV-1 (anti-HIV-1) Groups O and M or antibodies to HIV-2 in human plasma and serum specimens. The company like Abbott offers ABBOTT PRISM HIV O Plus assay for this test.




• Viral Load Tests: Viral load test are performed to know the amount of HIV genetic material (RNA) in the blood and reports how many copies of the virus are present. Knowing the viral load helps to decrease an infected person's risk of progressing to HIV and also helps to improves long-term health.

• CD4 Tests: CD4 are the type of white cells also known as T cells, that helps to treat HIV and AIDs. HIV damages immune system as it targets CD4 cells. The virus attacks the CD4 cells and releases more HIV copies. The normal CD4 count should be from 500 to 1,400 cells per cubic millimeter of blood. To know the amount of CD4 cell in patient this test is performed.

• Tests for Early Infant Diagnosis: Dried blood spot (DBS) sample is collected from infants for early infant diagnosis (EID). This test requires only a small amount of blood, the dried sample is easy to store and transport which increases its preference for the diagnosis of HIV.

By End-User

• Diagnostic Laboratories: Diagnostic labs are the fastest growing segment by end users. There are number of diagnostic centers specific for the diagnosis of HIV infection. Additionally, during pregnancy HIV test it is mandate to performed HIV test which increase the market growth. The diagnostic laboratories is anticipated the fastest market owing to the presence of advance diagnostic instruments to ensure accuracy of results.                                


• Hospitals: The hospitals accounted for the largest HIV diagnostics market share by end user and expected to register a healthy CAGR during the forecast period. The growth of this segment is attributed to a growth in hospital visits for the diagnosis and treatment of HIV.

• Blood Banks: The increasing surgical procedures requires blood. Before collecting blood from the donor there are number of tests to be performed to ensure the safety that increases the demand for the product.

• Others: The other end users includes HIV/AIDs campaigns and research institutes.

By Region

• Americas: Holds the largest market share in the HIV diagnostics market. HIV and AIDS is considered as one of the continuing problems for the US and countries around the world. America accounted for the largest market owing to the rising cases of HIV, presence of skilled physicians and established healthcare infrastructure. It was estimated that around 1.1 million people in the US had HIV at the end of 2018. The increasing new cases of HIV in this region rises the demand for HIBV diagnosis market.

• Europe: Europe is the second-largest market for HIV diagnostics. Growing innovation in the healthcare industry, increasing focus on developing new diagnostic kits, presence of large number of research laboratories and healthcare companies in this region enhances the European market growth. In 2017, nearly 160,000 people were newly diagnosed with HIV in the European Region.

• Asia-Pacific: The Asia-Pacific region is anticipated to be the fastest-growing region in the HIV diagnostics market. This region has been witnessing the increasing market growth owing to the increase in research on sexually transmitted diseases and rising medical research in countries like China, Japan, India and others increases the market growth. Additionally, the lack of precaution during blood transformation or having unprotected sex with someone who has HIV increases the cases of patient population in the developing countries. There are around 5.9 million population living with HIV in Asia-Pacific and treatment coverage is low at 54%.

• Middle East & Africa: The Middle East & Africa holds the least market share owing to the limited healthcare infrastructure, lack of awareness and limited resources in this region slows down the market growth. The majority of people living with HIV are situated in low- and middle- income countries, with an estimated 68% living in sub-Saharan Africa. Among this group 20.6 million are living in East and Southern Africa which witnessed 800,000 new HIV infections in 2018.

HIV Diagnostics Market Key Players

• Siemens Healthineers (A Division of Siemens AG) (Erlangen, Germany.)


• Roche Diagnostics (Division of Hoffman La Roche Ltd.) (Basel, Switzerland)


• Abbott Laboratories (Chicago, US)


• Beckman Coulter, Inc. (Subsidiary of Danaher Corporation) (California, US)


• Thermo-Fisher Scientific Inc. (Massachusetts, US)


• Merck KGaA (Darmstadt, Germany)


• Becton, Dickinson & Company (New Jersey, US)


• Hologic Inc. (Massachusetts, US)


• Alere Inc. (Massachusetts, US)


• Bio-Rad Laboratorie (California, US)