Table of Contents
Overview
New York, NY – May 30, 2025 – Global HIV Diagnostics Market size is expected to be worth around US$ 7.3 billion by 2034 from US$ 3.5 billion in 2024, growing at a CAGR of 7.6% during the forecast period 2025 to 2034.
In 2024, the global HIV diagnostics market witnessed sustained growth, driven by increased awareness, early detection initiatives, and expanding access to healthcare services. HIV (Human Immunodeficiency Virus) remains a critical global public health concern, and timely diagnosis continues to play a vital role in controlling transmission and improving patient outcomes. According to the World Health Organization (WHO), an estimated 39 million people were living with HIV globally in 2022, emphasizing the continued demand for reliable and accessible diagnostic tools.
The market is supported by government-led screening programs, non-governmental health initiatives, and increasing adoption of point-of-care (POC) testing devices. Rapid diagnostic tests, fourth-generation ELISA tests, and nucleic acid-based assays have become widely utilized across hospitals, clinics, and community health settings due to their high sensitivity and quicker turnaround times.
Advancements in molecular diagnostics and home-based self-testing kits have also expanded the reach of HIV screening, particularly in remote and underserved regions. In addition, partnerships between global organizations such as UNAIDS, PEPFAR, and national health ministries have accelerated funding and resource allocation for HIV testing services.
As diagnostic technologies continue to evolve and healthcare infrastructure improves, the HIV diagnostics market is expected to maintain upward momentum. Early diagnosis remains crucial for initiating antiretroviral therapy (ART), reducing transmission rates, and achieving global health targets to end the HIV epidemic.
Key Takeaways
- In 2023, the HIV diagnostics market generated revenue of USD 5 billion. It is projected to reach USD 7.3 billion by 2033, growing at a CAGR of 7.6%.
- By product type, consumables led the market with a 45.8% share in 2023. Instruments and software & services followed in this category.
- Based on test type, antibody tests accounted for the largest segment, holding 38.6% of the market share. Other segments include viral load tests, CD4 tests, early infant diagnosis, and viral identification.
- Among end users, diagnostic laboratories dominated with a 52.4% share in 2023. Hospitals and other healthcare facilities followed.
- Regionally, North America held the leading position, capturing 39.6% of the global market share in 2023.
Segmentation Analysis
- Product Type Analysis: In 2023, consumables dominated the HIV diagnostics market with a 45.8% share, driven by rising demand for reliable test kits, reagents, and sample collection tools. These items are essential in large-scale screening efforts, especially in resource-limited settings. Enhanced sensitivity, improved usability, and stability of consumables have made diagnostics more accessible. Increased awareness and the growing need for rapid, early HIV detection further support the strong growth of this segment.
- Test Type Analysis: Antibody tests accounted for 38.6% of the market share in 2023, owing to their wide use in initial HIV screening and monitoring. These tests are favored for their simplicity, affordability, and quick turnaround time. With greater emphasis on early detection, their use is expanding across hospitals, clinics, and mobile testing units. The increasing availability of point-of-care antibody tests is expected to further strengthen this segment’s position in the HIV diagnostics market.
- End-user Analysis: Diagnostic laboratories held the largest market share at 52.4% in 2023 due to their pivotal role in accurate HIV detection and patient monitoring. These facilities conduct confirmatory tests, viral load assessments, and CD4 count analyses. With rising HIV prevalence and focus on timely intervention, the demand for lab-based diagnostics is growing. The integration of advanced testing platforms and automated systems continues to reinforce the dominance of diagnostic laboratories in this segment.
Market Segments
Product Type
- Instruments
- Consumables
- Software & Services
Test Type
- Viral Load Tests
- Antibody Tests
- CD4 Tests
- Early Infant Diagnosis
- Viral Identification
End-user
- Diagnostic Laboratories
- Hospitals
- Others
Regional Analysis
In 2023, North America led the HIV diagnostics market, accounting for 39.6% of global revenue. This dominance was driven by continuous advancements in diagnostic technologies, growing awareness about early detection, and proactive measures to reduce HIV transmission rates. The widespread implementation of routine testing in high-risk populations and the availability of rapid point-of-care tests have significantly enhanced diagnostic efficiency and accessibility.
Strategic collaborations, such as Roche’s partnership with The Global Fund under the Global Access Program, have played a critical role in improving diagnostic infrastructure, particularly in underserved areas. These efforts have strengthened local healthcare systems and expanded access to quality HIV testing services across the region.
Meanwhile, the Asia Pacific region is projected to record the highest compound annual growth rate (CAGR) during the forecast period. This growth is supported by the rising prevalence of HIV, notably in countries such as India, China, and Thailand. Government-led initiatives aimed at expanding HIV screening and treatment programs, coupled with public awareness campaigns, are driving demand for diagnostic tools. The increasing availability of rapid tests and the improvement of healthcare infrastructure are expected to boost market expansion, supporting more effective HIV detection and management across the region.
Emerging Trends
- Expansion of HIV Self-Testing (HIVST) Policies: The adoption of HIV self-testing policies has been accelerated by global guidance. A total of 102 countries have reported national policies supporting HIVST, and 63 of those have implemented routine self-testing programs to reach hard-to-test populations.
- Surge in Rapid Diagnostic Test (RDT) Procurement: The procurement of HIV rapid diagnostic tests in low- and middle-income countries is being scaled up. Between 2022 and 2027, annual volumes of HIV RDTs are projected to range from 592 million to 838 million kits, reflecting sustained demand and market growth.
- Improved Status Awareness Among People Living with HIV: Testing coverage has been strengthened through community and facility-based initiatives. In 2023, approximately 86 percent of people living with HIV worldwide were aware of their status, up from earlier levels, indicating broader reach of testing services.
- Integration of Testing with Prevention Services: HIV testing has been increasingly integrated into prevention programs. Self-testing is now routinely offered for initiation, continuation, and re-start of pre-exposure prophylaxis (PrEP), which has supported both prevention and linkage to care.
Use Cases
- Community-Based RDT Programs in LMICs: Large-scale procurement of rapid diagnostic tests has been deployed in community settings. Over the next five years, 592 million to 838 million HIV RDT kits are planned for distribution to clinics and outreach teams, enabling widespread access in underserved areas.
- Adolescent Girl Testing Initiatives: Targeted programs have been launched to reach young women. In fiscal year 2023, PEPFAR reached more than 7 million adolescent girls with HIV testing services and supported distribution of over 650 000 HIV self-test kits to improve early diagnosis in this high-risk group.
- Multi-Modality Testing in Tanzania: Diverse testing approaches have been applied to maximize uptake. During October 2021–March 2023, PEPFAR Tanzania facilitated 5 856 460 HIV tests through facility-based, mobile, and index outreach modalities, demonstrating the impact of blended delivery models.
- Pediatric HIV Screening by CDC: Pediatric testing campaigns have been scaled up to identify early infections. In 2023, the CDC conducted over 3.5 million HIV tests among children under 15 years of age, linking more than 300 000 young patients to treatment and care services.
Conclusion
The global HIV diagnostics market is experiencing steady growth, supported by technological advancements, increased awareness, and global health initiatives. High demand for rapid, reliable testing especially in underserved regions—continues to drive innovation and funding. Strategic collaborations, expanded self-testing policies, and integrated prevention programs are improving early diagnosis and care linkage.
The dominance of North America and the rapid expansion in Asia Pacific reflect regional strengths and emerging opportunities. With growing adoption of point-of-care and community-based diagnostics, the market is expected to sustain upward momentum, aligning with global goals to reduce HIV transmission and achieve universal access to testing and treatment.
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