HIV Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Consumables, Instruments, Software and Services), By Test Type (Antibody Tests(HIV-1 Screening Tests, HIV-1 Antibody Confirmatory Tests, HIV-2 & Group O Diagnostic Tests), Viral Load Tests, CD4 Test, Others), By Mode (Self-Test, Lab-based), By End-use (Diagnostic Laboratories, Hospitals & Clinics, Home Settings), By Region and Competition, 2020-2030F

Market Overview

Global HIV Diagnostics Market was valued at USD 4.53 Billion in 2024 and is expected to reach USD 7.47 Billion in the forecast period with a CAGR of 8.68% through 2030. The global HIV diagnostics market has come a long way since the first reported cases of AIDS in the early 1980s. Over the years, significant advancements in diagnostics technologies, increased awareness, and improved accessibility to testing have played a crucial role in the global fight against HIV/AIDS. Today, the HIV diagnostics market is a dynamic and rapidly evolving sector, offering hope for better control and eventual eradication of this global health crisis. HIV (Human Immunodeficiency Virus) is a virus that attacks the body's immune system, specifically targeting CD4 cells, which help the immune system fight off infections. Left untreated, HIV can lead to the disease AIDS (Acquired Immunodeficiency Syndrome), which makes the individual vulnerable to opportunistic infections and cancers. The global HIV epidemic remains a significant public health challenge, with millions of people living with HIV/AIDS worldwide. According to UNAIDS, approximately 38 million people were living with HIV in 2019. While progress has been made in reducing new infections and AIDS-related deaths, challenges persist, making accurate and accessible diagnostics a crucial aspect of the global response.

One of the most significant drivers of the HIV diagnostics market is continuous innovation in testing technologies. Traditional ELISA tests have given way to rapid point-of-care tests (POCTs) that provide quicker results. Advances in nucleic acid testing (NAT) and the development of novel biomarkers have also improved diagnostic accuracy. Increased awareness about HIV/AIDS has led to more individuals seeking testing services. Public health campaigns, educational initiatives, and destigmatization efforts have contributed to a more informed and proactive population. Governments and international organizations have played a pivotal role in expanding access to HIV testing. Funding for HIV diagnostics, especially in low- and middle-income countries, has improved testing infrastructure and accessibility. Early detection of HIV is essential for timely intervention and treatment. Routine testing, especially among high-risk populations, has become a cornerstone of HIV prevention and control strategies. International collaborations, such as the Joint United Nations Programme on HIV/AIDS (UNAIDS), have brought countries together to develop and implement comprehensive HIV/AIDS strategies, including diagnostics.

Key Market Drivers

Rising HIV Prevalence is Driving the Global HIV Diagnostics Market

​The global HIV diagnostics market has experienced notable growth in recent years, primarily driven by the escalating prevalence of HIV/AIDS worldwide. According to the World Health Organization (WHO), approximately 39.9 million individuals were living with HIV at the end of 2023. Sub-Saharan Africa remains the most affected region, accounting for more than two-thirds of the global HIV population. However, the virus continues to impact individuals globally, underscoring the universal need for effective diagnostic solutions.​

Despite advancements in prevention and treatment, new HIV infections persist. In 2023 alone, an estimated 1.3 million people became newly infected with HIV. Factors such as limited access to education, prevention measures, and contraceptives contribute to higher transmission rates. Additionally, the stigmatization of HIV-positive individuals and key populations often hampers efforts to control the virus's spread. As the global population grows, the absolute number of people living with HIV also increases, highlighting the critical need for early detection and management.​

Timely and accurate diagnosis is essential for initiating antiretroviral therapy (ART), which can significantly improve the quality of life for individuals living with HIV and reduce transmission risks. Early detection also helps prevent the progression of the virus to AIDS, thereby reducing mortality rates. In 2023, approximately 630,000 people died from AIDS-related illnesses worldwide. The rising prevalence of HIV has consequently driven the growth of the HIV diagnostics market, emphasizing the importance of early and accurate diagnosis in managing the virus, preventing transmission, and enhancing the quality of life for those affected. As the global healthcare community continues to address the HIV/AIDS pandemic, ongoing innovation in diagnostics will play a pivotal role in achieving the goal of an AIDS-free world.​

Rising Demand for Early Diagnosis and Treatment Fuels Growth in Global HIV Diagnostics

​The global HIV diagnostics market is experiencing significant growth, driven by the increasing demand for early diagnosis and treatment of Human Immunodeficiency Virus (HIV). As of 2023, approximately 39.9 million people worldwide are living with HIV, with 86% aware of their HIV status. Early detection facilitates the prompt initiation of antiretroviral therapy (ART), which can effectively suppress the virus, slow disease progression, and improve the quality of life for those living with HIV.​

Individuals aware of their HIV status are more likely to adopt preventive measures to reduce transmission, such as consistent condom use and safe injection practices. Knowledge of one's status also helps mitigate stigma, encouraging individuals to seek treatment and support. Early treatment not only extends lifespan but also decreases the risk of opportunistic infections and AIDS-related complications. In 2023, 30.7 million people, or 77% of those living with HIV, were receiving antiretroviral therapy globally. Increased awareness through public health campaigns and education has contributed to the rising demand for HIV diagnostics. Governments and international organizations are working to make testing more accessible and affordable, especially in regions with high HIV prevalence. Despite these efforts, approximately 5.4 million people did not know they were living with HIV in 2023, highlighting the ongoing need for expanded testing initiatives. 

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Key Market Challenges

Limited Accessibility and Awareness

Limited accessibility and awareness remain significant challenges for the Global HIV Diagnostics Market, particularly in low- and middle-income countries where healthcare infrastructure is often underdeveloped. In many rural and underserved areas, access to reliable diagnostic facilities is severely restricted due to inadequate transportation, lack of trained healthcare personnel, and insufficient investment in healthcare systems. This geographical disparity limits the reach of HIV testing services, resulting in late diagnoses and delayed initiation of antiretroviral therapy. Even when diagnostic tools are available, the absence of consistent power supply, refrigeration for test kits, and sterile conditions can undermine the accuracy and reliability of testing outcomes, further complicating efforts to control the virus’s spread.

Lack of awareness and education about HIV transmission, prevention, and the importance of early testing also contributes to the challenge. Cultural stigma, fear of discrimination, and misinformation prevent individuals from voluntarily seeking diagnostic services. Many people do not get tested because they do not perceive themselves to be at risk, or they fear the social consequences of a positive diagnosis. In regions where sex education is limited or taboo, there is a substantial gap in knowledge that continues to fuel transmission and hinder testing efforts. Language barriers and lack of culturally tailored outreach further reduce the effectiveness of public health campaigns. Addressing these issues requires comprehensive strategies that combine infrastructure development, community-based awareness programs, and integration of HIV testing into routine medical checkups to ensure widespread acceptance and adoption of diagnostic services. Bridging this accessibility and awareness gap is critical for improving early detection rates and reducing HIV transmission globally.

False Positives and Negatives

One of the most pressing challenges in the Global HIV Diagnostics Market is the occurrence of false positives and false negatives during testing. These diagnostic inaccuracies can significantly impact patient outcomes and hinder efforts to control the spread of the virus. A false positive result occurs when a person who is not infected with HIV is incorrectly diagnosed as positive, leading to unnecessary psychological distress, stigma, and potentially lifelong treatment. This can damage a person’s mental health and social relationships, especially in communities where HIV-related stigma remains high. On the other hand, a false negative result, where an infected individual is incorrectly declared HIV-negative, poses an even greater public health risk. It can lead to a delay in starting antiretroviral therapy, during which time the person may unknowingly transmit the virus to others. Such cases undermine the effectiveness of early detection campaigns and treatment-as-prevention strategies.

False results may arise due to various factors, including poor test sensitivity and specificity, improper handling of samples, and the use of outdated testing kits. Certain conditions such as recent infections (during the “window period”), co-infections, or autoimmune disorders may also interfere with diagnostic accuracy. In resource-limited settings, where rapid tests are widely used due to their affordability and ease of deployment, the risk of diagnostic errors is further exacerbated. Even though confirmatory testing protocols exist, not all regions consistently follow them due to lack of infrastructure, funding, or trained personnel. The psychological, social, and clinical consequences of misdiagnosis not only affect the individual but also reduce trust in public health systems and diagnostic services. Efforts to address this challenge include developing more accurate, robust, and easy-to-use point-of-care testing technologies, increasing awareness about confirmatory testing protocols, and improving quality control standards across laboratories. Minimizing false positives and negatives is essential for ensuring the reliability of HIV testing and reinforcing global strategies aimed at controlling the epidemic.

Key Market Trends

Technological Advancements

One of the most significant advancements in HIV diagnostics is the development of point-of-care testing devices. These portable devices provide rapid results, often in less than 30 minutes, allowing for immediate initiation of treatment and reducing the risk of transmission. POCT devices have been a game-changer in resource-limited settings where access to sophisticated laboratory facilities is limited. NAT technologies have improved the accuracy of HIV diagnostics by directly detecting the virus's genetic material. These tests have a shorter window period, allowing for earlier detection of HIV infection. Additionally, NAT methods are highly sensitive, reducing the likelihood of false-negative results. NGS technologies have enabled researchers to study the genetic diversity of HIV strains. This information is crucial for developing more effective diagnostic tests and treatments, as HIV is known for its rapid mutation rate. Modern serological assays, such as chemiluminescence immunoassays and multiplex bead-based assays, have improved the accuracy and specificity of HIV antibody detection. These assays can distinguish between HIV-1 and HIV-2 and are less prone to false-positive results.

The global HIV diagnostics market has experienced substantial growth due to the demand for advanced testing methods. The market is expected to continue expanding as new technologies become more accessible and affordable. Point-of-care testing devices have made HIV testing more accessible, particularly in remote and underserved areas. This has been instrumental in reaching populations that were previously underserved in terms of HIV diagnosis and treatment. The continuous innovation in HIV diagnostics has spurred research and development efforts in both academia and industry. This has led to the creation of novel diagnostic tools and reagents, further advancing the market. Increased demand and technological advancements have led to fierce competition among diagnostic companies. This competition has driven companies to improve their products, resulting in better diagnostic accuracy and reduced costs.

Segmental Insights

Product Insights

Based on the Product, Consumables emerged as the dominant segment in the Global HIV Diagnostics Market in 2024. The consumables segment includes products like rapid diagnostic test kits, which have gained popularity due to their ease of use and quick results. These tests are often used in resource-limited settings, where access to more sophisticated diagnostic equipment may be limited. The demand for rapid HIV testing has driven the growth of the consumables market. HIV is a global health concern, with a significant burden in developing regions where access to healthcare infrastructure is limited. Consumables are often preferred in such regions due to their cost-effectiveness and suitability for point-of-care testing. As efforts to combat HIV continue to expand in these regions, the demand for consumables remains high. Advances in diagnostic technology have led to the development of more sensitive and specific HIV tests. These newer tests often require specialized consumables to function effectively. As healthcare providers and laboratories upgrade their testing capabilities, they invest in these consumables. Many governments and international organizations run HIV prevention and control programs that involve widespread testing campaigns. These initiatives often involve the procurement of consumables in large quantities, driving market demand. Consumables in the HIV diagnostics market are often competitively priced to cater to a broader customer base. This pricing strategy can stimulate demand and drive the dominance of this segment. The availability of HIV home testing kits has also contributed to the growth of the consumables segment. These kits typically include test strips or other consumables necessary for self-testing.

Mode Insights

Based on the Mode, Lab-based emerged as the dominant segment in the Global HIV Diagnostics Market in 2024. Lab-based tests for HIV diagnosis, such as enzyme immunoassays (EIAs) and nucleic acid tests (NATs), are known for their high accuracy and reliability. They have lower rates of false positives and false negatives compared to some rapid point-of-care tests. Accuracy is crucial in HIV diagnosis to ensure that individuals receive appropriate care and treatment. Lab-based testing allows for a more comprehensive evaluation of HIV infection. It can detect both HIV antibodies and viral RNA or DNA, providing a complete picture of the infection stage and viral load. This information is important for determining the appropriate treatment regimen and monitoring the progression of the disease. In many healthcare settings, lab-based tests are used to confirm positive results from rapid or point-of-care tests. Confirmatory testing helps reduce the chances of misdiagnosis and provides a definitive HIV diagnosis.

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Regional Insights

North America emerged as the dominant region in the Global HIV Diagnostics Market in 2024. This is due to its advanced healthcare infrastructure, high awareness levels, and strong government initiatives aimed at HIV prevention and control. The region benefits from widespread access to cutting-edge diagnostic technologies and robust screening programs that support early detection and management of HIV. The presence of key market players and continuous research and development activities have contributed to the availability of highly sensitive and specific HIV tests, including advanced molecular diagnostics and rapid test kits. Public health agencies such as the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Health and Human Services have implemented comprehensive HIV testing guidelines and national strategies to reduce transmission rates, which have significantly driven market growth.

Asia-Pacific emerged as the fastest growing region in the Global HIV Diagnostics Market during the forecast period. This is due to the rising prevalence of HIV cases across developing nations and the increasing focus on early diagnosis and treatment. Countries like India, China, Thailand, and Indonesia are witnessing a growing number of HIV infections, prompting governments and health organizations to expand testing efforts. National programs, such as India’s National AIDS Control Programme (NACP) and China’s Five-Year Plan for HIV/AIDS prevention, have played a critical role in improving diagnostic coverage and awareness. These initiatives are enhancing access to testing in rural and underserved areas through mobile clinics, community-based testing, and point-of-care diagnostics. The growing involvement of NGOs and international organizations such as UNAIDS and the World Health Organization (WHO) in promoting large-scale testing campaigns and ensuring affordable diagnostic tools has further accelerated regional growth. Additionally, the stigma reduction efforts and public education campaigns have led to increased voluntary testing and regular screening, particularly among high-risk populations.

Recent Developments

• In October 2024, ViiV Healthcare, a global HIV-focused company majority owned by GSK with Pfizer and Shionogi as shareholders, announced new real-world data demonstrating the high effectiveness and patient benefits of Apretude (cabotegravir long-acting) for HIV pre-exposure prophylaxis (PrEP). Presented at IDWeek 2024 in Los Angeles, the OPERA and Trio Health studies reported over 99% effectiveness in nearly 1,300 users. The PILLAR study also highlighted reduced stigma and anxiety among 200 individuals using the injectable PrEP, supporting its role in improving adherence and quality of life.
• In July 2024, MISTR, a leading U.S. telemedicine provider specializing in free STI testing, PrEP, DoxyPEP, and long-term HIV care, announced the availability of free at-home HIV testing kits at select Walmart locations across Georgia. The customers can pick up test kits at the pharmacy sections of seven Walmart Supercenters while supplies last. Users can take the kits home, follow the instructions, and receive their results directly from MISTR. This initiative supports greater access to HIV testing and healthcare services through a convenient, confidential process. Participating stores include locations in Stockbridge, Morrow, Decatur, Atlanta, and Ellenwood.
• In December 2023, Thermo Fisher Scientific Inc., a global leader in scientific services, partnered with Project HOPE to enhance HIV care for adolescents and young people in Nigeria, which has the second largest HIV epidemic globally with nearly two million people affected. The collaboration aims to expand access to community-based HIV testing and link diagnosed individuals to treatment and essential support services in Northwestern Nigeria. Thermo Fisher will also support the initiative through employee volunteer programs to strengthen on-ground efforts led by Project HOPE and local partners.
• In June 2023, Walgreens partnered with Greater Than HIV (a KFF initiative), local health departments, and community organizations to offer free, confidential HIV testing and counseling at over 400 store locations across the U.S. as part of National HIV Testing Day. The initiative aims to increase access to testing, raise awareness about prevention and treatment, and connect individuals with local health services.
• In January 2023, Molbio Diagnostics launched the Truenat HSV 1/2 test for Herpes Simplex Virus detection. Approved by CDSCO, the test delivers results within an hour using Real-Time PCR technology. It runs seamlessly on Molbio’s existing Truelab platform without the need for additional equipment, enabling rapid diagnostics even in resource-limited settings.

Key Market Players

• Thermo Fisher Scientific, Inc.
• Alere Inc.
• Abbott Laboratories inc.
• Bristol-Myers Squibb Company
• Janssen Global Services, LLC
• Gilead Sciences, Inc.
• Merck & Co. Inc.
• VIIV Healthcare
• Beckman Coulter, Inc.
• Sysmex Europe SE
• Zyomtronix, Inc.
• Mylan N.V.
• F. Hoffmann-La Roche Ltd.
• Siemens Healthcare GmbH

 Report Scope:

In this report, the Global HIV Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• HIV Diagnostics Market, By Product:

o   Consumables

o   Instruments

o   Software and Services

• HIV Diagnostics Market, By Test Type:

o   Antibody Tests

o   Viral Load Tests

o   CD4 Test

o   Others

• HIV Diagnostics Market, By Mode:

o   Self-Test

o   Lab-based

• HIV Diagnostics Market, By End-use:

o   Diagnostic Laboratories

o   Hospitals & Clinics

o   Home Settings

• HIV Diagnostics Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global HIV Diagnostics Market.

Available Customizations:

Global HIV Diagnostics market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).