HIV Diagnostics Market - By Test Type, By End Use - Global Forecast, 2025 - 2034

HIV Diagnostics Market Size

The global HIV diagnostics market was valued at USD 2.5 billion in 2024 and is projected to grow from USD 2.6 billion in 2025 to USD 4 billion by 2034, expanding at a CAGR of 5.2%. The market is growing steadily stimulated by various factors, such as the rising global prevalence of HIV in low- and middle-income countries, the demand for accurate and early testing solutions, increasing awareness campaigns and initiatives led by governments and NGOs, and development of point-of-care (POC) HIV diagnostics testing.

HIV diagnostics refers to the tests and technologies used to detect the presence of the human immunodeficiency virus (HIV) in individuals. These diagnostic tools are crucial for monitoring disease progression, early detection, and determining the appropriate course of treatment for people living with HIV. Major companies in the industry includes Abbott Laboratories, Becton, Dickinson and Company, Biomerieux, Cepheid, and F. Hoffmann-La Roche.
 

The market increased from USD 2.2 billion in 2021 to USD 2.4 billion in 2023, primarily due to the rise in diagnostic testing during this period. For instance, as per the data from the U.S. Centers for Disease Control and Prevention in 2023, approximately 39,000 people were diagnosed with HIV. Moreover, as per the study published in the National Library of Medicine, there was a 3% surge in the rate of HIV diagnosis in India during 2021, compared to the previous year. Therefore, this surge in the rate of disease diagnosis is positively contributing to the market's growth.
 

The rising prevalence of HIV/AIDS is one of the major catalysts for the growth of the HIV diagnostics market. For instance, according to the 2024 data from UNAIDS, around 40.8 million people were living with HIV. Over 1.3 million individuals were newly infected, and around 630,000 people lost their lives to AIDS-related illnesses. Thus, this rising prevalence of HIV infection among individuals across the globe is accelerating the demand for accurate and advanced diagnostic solutions, such as rapid molecular diagnostics kits and point-of-care diagnostic kits for precise diagnosis and timely medical interventions, thereby accelerating the market growth.
 

In addition to the rising prevalence of HIV, large-scale global initiatives such as the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) are significantly supporting the growth of the HIV diagnostics market. For instance, as of September 2023, PEPFAR has provided HIV testing services to over 71.1 million people, supported antiretroviral therapy for nearly 20.5 million individuals, and enabled 5.5 million babies to be born HIV-free to parents living with HIV. Moreover, over 327,000 health workers are directly supported by PEPFAR to deliver and improve HIV care.
 

Additionally, as of June 2024, the Global Fund provided nearly 28% of all international financing for HIV programs and has invested approximately USD 26.6 billion for programs related to treating and preventing HIV and AIDS. Therefore, as such initiatives increase, so does the demand for effective and accurate HIV diagnostic kits, stimulating the market growth.
 

HIV Diagnostics Market Trends

• The rising shift in diagnostic testing from traditional laboratory-based testing to point-of-care testing, which is estimated to reach USD 78.3 billion by 2032 is one of the significant market trends propelling the HIV diagnostic market forward, due to its ease of use, improved privacy management, and rapid delivery of results. Point-of-care testing for HIV diagnostics refers to a test performed outside a central laboratory. Traditional laboratory-based testing methods can take several days to yield results, but POC testing enables immediate results.
   
• In low- and middle-income countries, challenges are faced due to limited economic opportunities and a high burden of transmissible diseases. In such cases, POC HIV diagnostics provide higher convenience and fast disease detection solutions. For example, the OraQuik HIV test is a rapid, OTC test that uses oral swabs to detect HIV antibodies with a time of around 20 minutes.
   
• Further, innovations and technological advancements in HIV testing are helping to increase the adoption of HIV diagnostic kits.
   
• Various research institutions worldwide are undertaking multiple research initiatives to develop technologically advanced HIV diagnostic kits. For example, researchers at the University of Florida are developing an easy-to-use HIV detection kit and have received USD 2.8 million in research funding from the National Institutes of Health as of June 2024. Therefore, as such research initiatives and funding increase, so does the development and regulatory approval of new HIV diagnostics, stimulating the market growth.
   
• Major players in the HIV diagnostics market are actively involved in developing new, innovative POC test kits that are faster, more affordable, and easier to use. For example, Abbott’s Determine HIV-1/2 Ag/Ab Combo 4th Generation Rapid HIV Test provides results in 20 minutes, offers increased accuracy, and features flexible use options. Thus, contributing to the overall market growth.
   

HIV Diagnostics Market Analysis

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The global market was valued at USD 2.2 billion in 2021. The market size reached USD 2.4 billion in 2023, from USD 2.3 billion in 2022.
 

Based on the test type, the HIV diagnostics market is segmented into antibody test, viral load test, and CD4 test. The antibody test segment led this market in 2024, accounting for the highest market share because of their affordability, ease of use, and ability to deliver quick results, making them ideal for large-scale and point-of-care screening. Their compatibility with self-testing kits also supports broader access, especially in low-resource regions.
 

This segment was valued at USD 1.5 billion in 2024 and is projected to reach USD 2.4 billion by 2034, growing at a CAGR of 5.1%. In comparison, the viral load segment, valued at USD 709.7 million in 2024, is expected to grow to USD 1.2 billion by 2034, with a slightly higher CAGR of 5.6%, due to its critical role in monitoring treatment effectiveness and progression of HIV infection.
 

• HIV antibody test checks for antibodies the body makes in response to HIV. It’s usually done with blood or oral fluid and is a fast, reliable method for early HIV screening. HIV antibody tests are readily available, either as a screening procedure at clinics or publicly funded testing centers or as an at-home testing kit. They are cheaper and easier to administer privately at home.
   
• The convenience and cost-efficient nature of HIV antibody tests considerably increases their uptake in segmented populations, particularly individuals hesitant to approach a traditional healthcare system, due to stigma, financial issues, or logistical reasons.
   
• By offering discreet, fast, and accessible testing opportunities, these solutions empower individuals to take control of their health, positively influencing community adoption and ultimately improving public health
   
• For example, the Bioline HIV 1/2 3.0 Antibody Test perfectly aligns with this trend, providing fast and effective testing for HIV-1 and HIV-2 antibodies in all isotypes. This enables early diagnosis and effective screening workflows across various healthcare settings, thereby propelling their adoption in HIV diagnosis.
   

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Based on end use, the HIV diagnostics market is segmented into diagnostic laboratories, hospitals and clinics, home settings, and other end users. The diagnostic laboratories segment accounted for the highest market share of 45.9% in 2024.
 

• The rising prevalence of HIV is accelerating the demand for high-throughput testing, which is one of the significant factors propelling the dominance of diagnostic laboratories. These laboratories are equipped to handle a large volume of sample testing, making them an ideal setting to manage the increasing demand for HIV testing.
   
• These facilities have advanced infrastructure to streamline and automate the processes through technologically advanced instruments and tests, enabling these laboratories to provide rapid and high-volume testing without compromising accuracy.
   
• Moreover, both private and public sector investments play a crucial role in strengthening the infrastructure of the healthcare sector, including diagnostic laboratories, especially in areas with high HIV prevalence.
   
• For example, the UK's Department of Health and Social Care allocated approximately USD 17.4 million from its Official Development Assistance (ODA) budget for the period 2022-2025 to enhance healthcare infrastructure and medical workforce development in countries such as Kenya, Ghana, and Nigeria.
   
• Such investments in healthcare infrastructure are expected to stimulate the adoption of advanced HIV diagnostic technologies in diagnostic laboratories.
   
• Additionally, diagnostic laboratories encompass a large number of skilled professionals, such as pathologists and laboratory technicians, who ensure accurate test execution and interpretation, making them a preferred choice for HIV testing, thereby propelling the segment's growth.
   

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The Middle East and Africa dominated the global HIV diagnostics market with the highest market share of 30.1% in 2024. The region’s rising prevalence of HIV cases is one of the significant factors accelerating the growth of the market.
 

• The South Africa market was valued at 247.1 million and USD 255.6 million in 2021 and 2022, respectively. In 2024, the market size reached USD 279.2 million from USD 266.4 million in 2023.
   
• This growth is largely attributed to the rising prevalence and awareness of HIV in the country. For instance, as per the data from the Government of Africa, approximately 13.9% of the country’s population was suffering from HIV infection in 2022, which is equivalent to approximately 8.45 million individuals.
   
• Therefore, as the prevalence of HIV in the country increases, so does awareness and demand for effective HIV diagnostic tools, fostering market growth.
   

Europe HIV diagnostics market accounted for USD 455.7 million in 2024 and is anticipated to show lucrative growth over the forecast period.
 

• The World Health Organization (WHO) states that HIV remains a major public health threat in the European Region, affecting almost 2.6 million people. The disease burden is particularly distinct in the eastern part of the region, where infection rates remain high.
   
• Europe’s advanced diagnostic infrastructure, particularly in countries such as Germany, France, and the UK, is significantly propelling the market growth in the region. These nations leverage cutting-edge technologies such as rapid antigen/antibody combo tests and molecular assays to enhance early detection and monitoring.
   
• The political commitment by European nations, such as funding, policy support, and integration of HIV testing into national health strategies, is making HIV diagnostics more widely available, further contributing to the growth of the market.
   

Germany HIV diagnostics market is projected to experience steady growth between 2025 and 2034.
 

• Germany has taken significant steps to expand decentralized testing for HIV to reach underserved populations and to improve rates of early diagnosis. National health authorities have encouraged the potential use of self-tests, home-collection kits, and outreach testing (i.e. non-clinical testing), particularly in rural communities with vulnerable sub-populations, including migrants, drug users, and those with limited access to health care.
   
• In 2021, approximately 8,600 people living with HIV in Germany were undiagnosed, representing a substantial public health risk. To mitigate the challenges posed by this undiagnosed population, there has been an increased emphasis on low-threshold testing, for example, point-of-care testing and self -testing. These tests provide rapid results, which don’t require much infrastructure, and can be initiated in the community. Thus, such technological adoption for HIV diagnostics in the country is positively contributing to the growth of the market.
   

The Asia Pacific region is projected to be valued at USD 599.1 million in 2025 and is expected to reach USD 956.7 million by 2034.
 

• Asia Pacific is home to a diverse and large population base, with several countries are combating a high prevalence rate of HIV and growing demand for accurate and technologically advanced HIV diagnostic kits.
   
• For instance, as per the 2023 data, from UNAIDS, approximately 6.7 million people in the region were living with HIV, making the region the world’s largest epidemic after southern and eastern Africa.
   
• Therefore, as the prevalence of HIV increases in the region, so does the requirement for HIV diagnostic test kits, positively contributing to the growth of the market.
   

Japan HIV diagnostics market is poised to witness lucrative growth between 2025 – 2034.
 

• Collaborative efforts among academic institutions, government agencies, and private companies in Japan are significantly enhancing HIV diagnostic capabilities. These partnerships are accelerating innovation in rapid testing and molecular HIV diagnostics, fostering market growth.
   
• Moreover, the rising public awareness regarding early HIV detection in the country is pushing more individuals to seek testing and support. This is contributing to the increased use of HIV diagnostic kits, enabling earlier detection and more effective management of the disease in the country. This trend is further fostering market growth.
   

Brazil is experiencing significant growth in the HIV diagnostics market.
 

• The growth of the market in the country is highly attributed to the rising awareness of HIV diagnosis and the increasing prevalence of HIV in the country.
   
• In 2022, according to a study published in the National Library of Medicine, approximately 990,000 people were suffering from HIV in Brazil. This high prevalence has driven the country to prioritize and adopt widespread HIV diagnostic measures to ensure early detection and effective treatment, thereby fueling the growth of the market.
   

The HIV diagnostics market in U.S. is expected to experience significant and promising growth from 2025 to 2034.
 

• The growth of the market in the country is largely attributed to the well-established healthcare system with extensive access to diagnostic laboratories and large hospitals.
   
• Additionally, growing awareness among people towards timely diagnosis and treatment of STDs is driving a shift in the market towards more convenient and private healthcare solutions such as self-testing kits. This trend is expected to continue contributing to the growth of market in the U.S.
   

HIV Diagnostics Market Share

• Key players, including Abbott Laboratories, Becton, Dickinson and Company (BD), Biomerieux, Cepheid, and F. Hoffmann-La Roche, collectively hold 84.3% of the global market share. These companies maintain their leadership through diverse product portfolios, strategic collaborations, regulatory approvals, and ongoing innovation. Abbott Laboratories stands out due to their comprehensive range of products, widely adopted in various healthcare setting.
   
• Abbott Laboratories and Cepheid have strengthened their market positions through partnership and regulatory approvals. In April 2023, Abbott, partnered with Population Services International (PSI) and Unitaid to expand access to affordable HIV self-testing (HIVST). As part of this initiative, an initial 400,000 tests were to be distributed across Africa to enhance early detection and improve healthcare accessibility. This partnership boosted the company’s growth.
   
• Furthermore, in July 2021, Cepheid, received CE-IVD clearance for Xpert HIV-1 Viral Load XC and Xpert HIV-1 Qual XC tests. This expanded its HIV testing portfolio, boosted access to rapid diagnostics in Europe, and reinforced its leadership in innovative HIV solutions.
   

HIV Diagnostics Market Companies

Few of the prominent players operating in the HIV diagnostics industry include:
 

• Abbott Laboratories
• Becton, Dickinson and Company (BD)
• Biomerieux
• Bioneer
• Cepheid
• ChemBio Diagnostics
• F. Hoffmann-La Roche
• Genlantis Diagnostics
• Hologic
• OraSure Technologies
• Qiagen
• OraSure Technologies
   

OraSure Technologies is a leader in infectious disease diagnostics, with a strong emphasis on making HIV testing both accessible and rapid. Its flagship product, the OraQuick ADVANCE HIV-1/2 Rapid Antibody Test, is FDA-approved and delivers laboratory-accurate results in just 20 minutes using oral fluid, fingerstick, or blood samples.
 

• Abbott Laboratories

Abbott Laboratories offers a comprehensive range of point-of-care diagnostic solutions aimed at improving early disease detection, treatment monitoring, and prevention. Among its key products is the Determine HIV-1/2 Ag/Ab Combo, which enables healthcare providers to identify HIV infections at an earlier stage. This early diagnosis allows individuals to access medical care sooner, supporting timely intervention and better health outcomes.
 

• Hologic

Hologic stands out in the field of molecular diagnostics, with its Aptima Virology portfolio playing a pivotal role in advancing HIV care. The heart of this portfolio is the Aptima HIV-1 Quant Dx Assay, which utilizes Transcription-Mediated Amplification (TMA) technology to deliver highly sensitive and precise viral load measurements. This level of accuracy is crucial not only for initial HIV diagnosis but also for ongoing treatment monitoring, helping clinicians make informed decisions and optimize patient outcomes.
 

HIV Diagnostics Industry News:

• In June 2025, Biomérieux signed an agreement to acquire the key assets of U.S.-based Day Zero Diagnostics. The acquisition included proprietary technologies such as next-generation sequencing (NGS) workflows, reagents, chemistry, and bioinformatics software. By integrating these advanced solutions into its portfolio, bioMérieux aimed to accelerate innovation in rapid testing. The acquisition reflected a broader industry trend toward precision diagnostics.
   
• In January 2025, OraSure Technologies achieved a key regulatory milestone when the FDA’s Center for Biologics Evaluation and Research (CBER) approved a labeling update for the OraQuick HIV Self-Test. This update expanded the test’s approved age range to include individuals 14 years and older, lowering it from the previous minimum age of 17. By enabling access to HIV testing for younger adolescents, the approval enhanced early detection efforts and provided OraSure with a competitive advantage in the market through broader product accessibility.
   

The HIV diagnostics market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million and from 2021 – 2034 for the following segments:

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Market, By Test type

• Antibody test
• Viral load test
• CD4 test

Market, By End use

• Diagnostic laboratories
• Hospitals and clinics
• Home settings
• Other end use

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada 
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Netherlands
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE