Austin, May 10, 2025 (GLOBE NEWSWIRE) — HIV Diagnostics Market Size Analysis:
According to SNS Insider, the HIV Diagnostics Market was valued at USD 1.15 billion in 2023 and is set to reach USD 1.80 billion by 2032, growing at a CAGR of 5.10% during the forecast period of 2024–2032
The need for more rapid and readily accessible diagnostic tests has significantly increased as the global HIV count continues to rise. Advances in technology, improved healthcare facilities, and an increased focus on early diagnosis and prevention are largely responsible for this growth. As public support for healthcare grows, the market for HIV diagnostics will evolve substantially in most nations, especially in Asia-Pacific and North America.
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The U.S. HIV diagnostics market was valued at USD 0.20 billion in 2023 and is expected to reach USD 0.27 billion by the year 2032. This reflects a 3.36% CAGR. Increased diagnosis rates of HIV, increased awareness, and the embrace of improved diagnostic technology are largely to be blamed for this phenomenon. Innovations like in-home HIV diagnostic kits and point-of-care testing facilities keep the United States’ market ahead of others in this regard.
Major Players Analysis Listed in this Report are:
- Alere Inc.: Determine HIV-1/2 Ag/Ab Combo
- Abbott: ARCHITECT HIV Ag/Ab Combo Assay
- Bristol-Myers Squibb Company: Sustiva (efavirenz)
- Janssen Global Services, LLC: Prezista (darunavir)
- Gilead Sciences, Inc.: Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), Sunlenca (lenacapavir)
- Merck & Co., Inc.: Isentress (raltegravir)
- ViiV Healthcare: Tivicay (dolutegravir), Triumeq (abacavir/dolutegravir/lamivudine)
- BD (Becton, Dickinson and Company): BD FACSPresto System
- Beckman Coulter, Inc.: Access HIV Combo Assay
- PointCare: PointCare NOW System
- F. Hoffmann-La Roche Ltd.: COBAS AmpliPrep/COBAS TaqMan HIV-1 Test
- Siemens Healthcare GmbH: ADVIA Centaur HIV Ag/Ab Combo Assay
- QIAGEN: artus HIV-1 QS-RGQ Kit
- OraSure Technologies: OraQuick In-Home HIV Test
- DiaSorin: LIAISON XL murex HIV Ab/Ag
HIV Diagnostics Market Report Scope
| Report Attributes | Details |
| Market Size in 2023 | US$ 1.15 billion |
| Market Size by 2032 | US$ 1.80 billion |
| CAGR | CAGR of 5.10% From 2024 to 2032 |
| Base Year | 2023 |
| Forecast Period | 2024-2032 |
| Historical Data | 2020-2022 |
| Key Regional Coverage | North America (US, Canada, Mexico), Europe (Eastern Europe [Poland, Romania, Hungary, Turkey, Rest of Eastern Europe] Western Europe] Germany, France, UK, Italy, Spain, Netherlands, Switzerland, Austria, Rest of Western Europe]), Asia Pacific (China, India, Japan, South Korea, Vietnam, Singapore, Australia, Rest of Asia Pacific), Middle East & Africa (Middle East [UAE, Egypt, Saudi Arabia, Qatar, Rest of Middle East]), Africa [Nigeria, South Africa, Rest of Africa], Latin America (Brazil, Argentina, Colombia Rest of Latin America) |
Segment Analysis
By Product:
Comprising a market share of 45.5%, the consumables sector led the HIV diagnostics market in 2023. The great demand for consumable items, reagents, and diagnostic kits used in HIV testing accounts for the predominance of this category. Consumables remain the main source of income, even with the rising number of diagnostic treatments carried out. Conversely, the sector of software and services is predicted to increase the most since the increasing acceptance of digital platforms and AI-based diagnostic tools enhances patient management and testing accuracy, thereby improving the segment.
By Mode:
With 90.9% of the market share in 2023, the category of laboratory-based testing kept its leading place. Given that laboratory-based tests—which are regarded as the gold standard for HIV diagnosis—have great accuracy and dependability, their supremacy results mostly from their On the other hand, the segment of self-testing is predicted to rise most since need for privacy and convenience lets people test for HIV in the comfort of their homes. The broad availability of at-home testing kits and a move toward decentralization in healthcare services promote this trend.
By Test Type:
With a 53.6% share of income, the segment of the antibody tests dominated the test category in 2023. The most often used HIV diagnostic test, the antibody tests, are the reason behind this supremacy since they produce consistent and accurate findings in HIV infection detection. Given its rising use in both clinical environments and at-home testing options, where it is considered the first line of HIV detection, the antibody test segment is also expected to increase the most.
By End Use:
The biggest end-use category in the HIV diagnostics market, the diagnostic labs segment, produced 50.4% of market revenue in 2023. HIV testing is mostly dependent on diagnostic labs since they can offer accurate, high-throughput testing. Driven by the growing availability and simplicity of home testing kits, the sector in home settings is predicted to develop fastest. In areas with high HIV prevalence and restricted access to healthcare infrastructure, this trend is especially noteworthy.
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HIV Diagnostics Market Segmentation
By Product
- Consumables
- Instruments
- Software and Services
By Mode
By Test type
- Antibody Test
- HIV-1 Screening Tests
- HIV-1 Antibody Confirmatory Tests
- HIV-2 & Group O Diagnostic Tests
- Viral load test
- CD4 test
- Others
By End Use
- Diagnostic Laboratories
- Hospitals & Clinics
- Home Settings
Recent Developments in HIV Diagnostics
- In November 2024, Egypt and the Global Fund signed a Framework Agreement aimed at strengthening health systems and improving HIV and tuberculosis response efforts while addressing the ongoing impact of COVID-19. UNDP will coordinate efforts with the Ministry of Health and civil society organizations to enhance HIV prevention and diagnostic services.
- In April 2024, Cepheid received WHO prequalification for its Xpert HIV-1 Qual XC test. This point-of-care diagnostic test enables early HIV detection in infants using dried blood spots and whole blood samples, thus enhancing accessibility and accuracy in HIV diagnostics, especially in resource-limited settings.
- In January 2024, Abbott launched the ARCHITECT HIV Ag/Ab Combo test, which provides reliable and rapid detection of HIV infection by identifying both HIV antibodies and antigens. This test aims to improve diagnostic accuracy and accelerate HIV detection in clinical settings.
- In March 2024, Mylan announced the launch of its generic HIV self-testing kit, which is designed to provide users with a simple, accurate, and confidential method to test for HIV at home. The launch is part of Mylan’s broader effort to improve access to affordable HIV diagnostics globally.
- In February 2024, Roche introduced a new fully automated system for HIV diagnostics, combining antigen and antibody testing for faster and more accurate results. This innovation is expected to improve efficiency in high-throughput testing labs.
Regional Analysis
North America dominated the HIV diagnostics market in 2023 due to the presence of leading healthcare providers and the high demand for advanced diagnostic solutions. Government initiatives, such as increased funding for HIV awareness and testing programs, have contributed to the market’s dominance in the region. Furthermore, the region’s well-established healthcare infrastructure and adoption of cutting-edge diagnostic technologies, including self-testing kits and at-home diagnostic tools, continue to drive market growth.
Asia Pacific is expected to experience the highest growth from 2024 to 2032. The region has a large HIV-infected population, and increasing government and private sector efforts to combat the disease. Growing awareness, improved access to healthcare services, and the increasing adoption of advanced HIV diagnostics are driving this rapid growth.
Statistical Insights and Trends Reporting
- In 2023, the global incidence of new HIV cases was approximately 1.5 million, with Sub-Saharan Africa accounting for the majority of new infections.
- North America accounted for the highest share of HIV testing prescriptions, with a growing shift toward self-testing and rapid diagnostic tests.
- North America and Europe dominated the HIV diagnostics device volume in 2023, while Asia Pacific is expected to show the highest volume growth due to increased testing and awareness.
- In 2023, government-funded HIV diagnostic programs accounted for 60% of global HIV testing efforts, with the remaining share split between commercial healthcare providers and out-of-pocket expenditures in low-income regions.
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Table of Contents – Major Key Points
1. Introduction
2. Executive Summary
3. Research Methodology
4. Market Dynamics Impact Analysis
5. Statistical Insights and Trends Reporting
5.1 Incidence and Prevalence of HIV (2023)
5.2 HIV Testing and Diagnosis Rates (2023), by Region
5.3 HIV Diagnostic Test Volume, by Region (2020-2032)
5.4 Healthcare Spending on HIV Diagnostics, by Region (Government, Commercial, Private, Out-of-Pocket), 2023
5.5 Adoption of Advanced HIV Diagnostic Technologies (2023-2032)
5.6 Regulatory Approvals and Policy Impact on HIV Diagnostics (2023-2032)
6. Competitive Landscape
7. HIV Diagnostics Market by Product
8. HIV Diagnostics Market by Mode
9. HIV Diagnostics Market by Test type
10. HIV Diagnostics Market by End Use
11. Regional Analysis
12. Company Profiles
13. Use Cases and Best Practices
14. Conclusion
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