HIV Diagnostics Market Size, Share & Trends Analysis Report By Product (Consumables, Instruments), By Test Type (Antibody Tests, Viral Load Tests), By Mode (Self-Test, Lab-based), By End-use, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global HIV diagnostics market size was estimated at USD 985.7 million in 2022 and is anticipated to grow at a compound annual growth rate (CAGR) of 5.5% over the forecast period owing to the technological development of disease diagnostic tests, and the anticipated development & commercialization of novel, regulatory authorities approved POC and rapid CD4, p24 antigen and EID tests. According to an article published by the World Health Organization in April 2023, by the end of 2021, approximately 38.4 million people were diagnosed with HIV, and two-thirds of these were living in the African region. There is a further need to introduce easily accessible and efficient diagnostics tests in the most affected regions as the limited availability of resources presents difficulties in performing current, complex screening, staging, and monitoring tests.

The lack of enough testing labs and qualified clinical professionals to perform these tests can restrain the market growth in less developed countries. However, these limitations of laboratory-based testing can also prove to be catalysts to the development of portable and easy-to-implement point-of-care, rapid tests. In the present scenario, several POC/rapid tests are being developed by some major market players and are expected to obtain regulatory authorization in a number of regions. This can further increase the number of product offerings and lead to increased accessibility of HIV diagnostics tests across the world. There is no cure for HIV, but the development of new and advanced treatment options and medicines can help in identifying and fighting the disease.

The introduction of HIV self-testing (HIV-ST) is one of the important steps toward improving testing rates across countries. Some rapid diagnostic tests provide same-day results, which can help in the early detection and treatment of the infection. However, for accurate diagnosis and treatment, further confirmatory testing needs to be performed by professionals, which is neglected, especially in low- and medium-income countries. According to a study review published in PubMed in May 2021, the implementation of HIV-ST in Africa was considered acceptable and appropriate, however, there was a lack of further care and counseling. The initiatives focusing on raising awareness in these countries can create further opportunities for the development of the market.

Several national and international organizations are working toward eradicating HIV and AIDS. For instance, in December 2020, the UNAIDS released new targets calling for 95% of all patients suffering from HIV to know their HIV status, 95% of patients with diagnosed HIV infection to receive sustained antiretroviral therapy (ART), and 95% of patients receiving ART to have viral suppression by 2025. Such programs can encourage further innovation in HIV diagnostics and treatment options. Moreover, the increasing need for blood transfusions and the consequent rise in blood donation and diagnostics tests can further increase the demand for HIV diagnostics tests. According to an article published by the World Health Organization in June 2023, approximately 118.5 million blood donations are collected worldwide, 40% of these are from high-income countries and 16% from low-income countries.

Product Insights

On the basis of product, the market is segmented into consumables, instruments, and software & services. The consumables segment accounted for the largest revenue share of 47.7% in 2022 owing to the prevalence of HIV cases and the need to improve the accuracy of the results. Various screening and confirmatory tests are conducted for the diagnosis of HIV-1, HIV-2, and group O incidences. These tests have primary applications to screen and differentiate between the various groups and subtypes of human immunodeficiency virus. Therefore, accurate consumables need to be used to improve the quality of results and treatments.

Moreover, the software & services segment is expected to grow at the fastest CAGR of 6.9% over the forecast period due to technological advancements and increasing awareness regarding HIV and AIDS. Various government campaigns to create awareness and reduce the stigma around these diseases can also be attributed to this growth. For instance, Let’s Stop HIV Together (Together) is a campaign by the Centers for Disease Control and Prevention, which aims to raise awareness regarding HIV, promote diagnostics & testing, and reduce stigma around it.

Mode Insights

On the basis of mode, the market is further segmented into self-testing and lab-based testing. The lab-based testing segment accounted for the largest revenue share of 89.36% in 2022 owing to the accuracy of their results. Lab-based tests are performed in diagnostic laboratories or healthcare facilities by skilled professionals using advanced equipment. It gives accurate results, allows for prolonged monitoring, and is essential for confirmatory testing and complex analysis. Rapid and point-of-care testing technologies also allow for early intervention and reduce the time between testing and the start of the treatment. The market has enormous potential to increase accessibility, accuracy, and efficiency, ultimately leading to better outcomes for HIV patients and global disease-fighting efforts.

The self-testing segment is expected to grow at the fastest CAGR of 10.6% over the forecast period due to their user-friendliness and convenience. Self-testing allows individuals to run diagnostic tests at home using a self-collection kit and interpret the results independently. It offers ease, and anonymity, and facilitates early detection. Self-test kits have become more accessible with higher accuracy and faster turnaround times. It has given people the ability to take control of their health and overcome challenges, such as stigma and inconvenience with traditional testing techniques. Both self-testing and lab-based testing approaches aid in HIV diagnosis by catering to different needs and preferences, promoting awareness, and enabling effective viral control.

Test Type Insights

On the basis of test types, the global market has been further categorized into antibody tests, viral load tests, CD4 tests, and others. The antibody test type segment dominated the industry and accounted for the largest revenue share of 53.3% in 2022. The segment is projected to remain dominant growing at the fastest CAGR of 5.9% during the forecast period. The growth of this segment can be attributed to the presence of several antibody tests.

These tests include HIV-1 screening, confirmatory HIV-2, and Group-O tests, which can be further divided into 3rd- and 4th-generation ELISA tests, POC and non-POC dried blood spot tests, western blot, and line immunoassays. These tests are increasingly being used in disease subtyping, screening, and confirmation. The confirmatory western blot test is regarded as 100% accurate post-antibody screening. The high utilization rates and accuracy of these tests are further expected to drive the antibody testing segment growth.

End-use Insights

On the basis of end-use, the market has been further segmented into diagnostic laboratories, hospitals & clinics, home settings, and others. The diagnostic laboratories segment held the largest revenue share of 36.6% in 2022 as diagnostic laboratories conduct rigorous testing and analysis using advanced technology and qualified personnel, resulting in accurate results. The home settings segment is expected to register the fastest CAGR of 8.3% over the forecast period.

The market is reliant on collaboration among all segments, including diagnostic laboratories, hospitals & clinics, and home settings to work together to ensure that people have access to accurate testing, counseling, and appropriate care to assist in the improvement of public health worldwide. The growth of this segment can be attributed to the privacy and convenience offered by home-based HIV testing kits, which allow individuals to administer tests and receive results in the privacy of their own homes.

Regional Insights

Asia Pacific dominated the market and accounted for the largest revenue share of 35.7% in 2022 owing to technological advancement, an increase in the number of people suffering from HIV and AIDS, and increasing awareness regarding the same in this region. According to an article published by The Indian Express in August 2022, approximately 24.01 lakh people in India are diagnosed with HIV. The increasing health expenditure and efforts by governments in these regions to increase awareness and promote treatment are likely to boost market growth in the years to come.

Latin America is expected to grow at the fastest CAGR of 6.9% during the forecast period owing to the increasing awareness about diagnostic testing in the region. According to the article published by the Pan American Health Organization, in November 2020, HIV infection cases in Latin America have increased by 20% in the last decade. The region has witnessed a significant increase in healthcare expenditure, leading to greater investment in research and development activities.

Key Companies & Market Share Insights

Major market participants are engaging in clinical research and development of CD4, p24 antigen, and viral load testing methodologies to reduce their implementation complexity and boost accessibility and portability. To further solidify its position in the market, Roche Diagnostics, a company renowned for its creative solutions, now provides incredibly sensitive viral load monitoring systems and point-of-care testing platforms. The following are some of the major participants in the global HIV diagnostics market:

• Alere Inc.

• Abbott

• Bristol-Myers Squibb Company

• Janssen Global Services, LLC

• Gilead Sciences, Inc.

• Merck & Co. Inc.

• VIIV Healthcare

• BD

• Beckman Coulter, Inc.

• Sysmex Europe SE

• Apogee Flow Systems

• Point Care

• Zyomtronix, Inc.

• Mylan N.V.

• F. Hoffmann-La Roche Ltd.

• Siemens Healthcare GmbH

• QIAGEN

HIV Diagnostics Market Report Scope

Global HIV Diagnostics Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global HIV diagnostics market report on the basis of product, mode, test type, end-use, and region:

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Consumables

  • Instruments

  • Software and Services

• Mode Outlook (Revenue, USD Million, 2018 - 2030)

  • Self-test

  • Lab-based

• Test Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Antibody Test

    • HIV-1 Screening Tests

      • ELISA/EIA

      • Home Access Dried Blood Spot

      • Rapid Tests (Dot plot, Agglutination Tests)

    • HIV-1 Antibody Confirmatory Tests

      • Western Blot Test

      • Indirect Immunofluorescent Antibody Assay (IFA)

      • Line Immunoassay

      • RadioImmunoPrecipitation Assay (RIPA)

    • HIV-2 & Group O Diagnostic Tests

      • Blood Antibody Tests

      • Dried Blood Spot (DBS) Test

      • Others and (Oral, Urine)

  • Viral Load Test

  • CD4 Test

  • Others

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Diagnostic Laboratories

  • Hospitals & Clinics

  • Home Settings

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Sweden

    • Norway

    • Denmark

  • Asia Pacific

    • China

    • Japan

    • India

    • Australia

    • Thailand

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • Saudi Arabia

    • South Africa

    • UAE

    • Kuwait