HIV Diagnostics Market Trends

ID: MRFR/MED/8279-HCR

200 Pages

Rahul Gotadki

October 2025

Global HIV Diagnostics Market Research Report By Test Type (Antibody Tests, Antigen Tests, Nucleic Acid Tests), By End User (Hospitals, Diagnostic Laboratories, Home Care Settings), By Product Type (Tests Kits, Instruments, Software), By Technology (Elisa, Rapid Testing, Polymerase Chain Reaction) and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa)-Forecast to 2035

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Market Trends

Introduction

In 2025, the global market for HIV diagnostics is experiencing a major transformation, driven by a confluence of macro-economic factors. Technological developments, particularly in the field of point-of-care testing and molecular diagnostics, are enabling a rapid and accurate detection of HIV, which will improve patient outcomes. Regulators are putting greater emphasis on the speed of diagnosis and the integration of diagnostics into public health strategies. The rise in public awareness and education about the disease is leading to a demand for more accessible and easy-to-use testing solutions. These trends are strategically important to companies, not only because they will influence their product development and market access strategies, but also because they align with the public health goals of eradicating the transmission of HIV.

Top Trends

Increased Adoption of Point-of-Care Testing
Point-of-care testing (POCT) is gaining ground because of its rapid results and ease of use. In the case of HIV testing, the World Health Organization (WHO) has endorsed POCT, and in resource-poor settings this has led to a 30 percent increase in the rate of testing. Companies like Abbott Laboratories are developing portable devices to make the tests more accessible. This trend promises to make testing more efficient and to ease the burden on centralized laboratories.
Integration of AI and Machine Learning
The accuracy and speed of HIV diagnosis is being improved by combining it with artificial intelligence. Roche has already developed an AI system for analyzing test results, which has reduced the number of false positives by 20 percent. It is likely that this development will lead to a greater diagnostic precision and greater efficiency, and thus to more individual treatment plans.
Expansion of Home Testing Kits
Home testing for sex is a growing business, driven by a desire for privacy and convenience. Home-testing sales rose by 40 per cent in the past year. OraSure is one of the market leaders. Home testing is said to give individuals a greater sense of power and reduce the stigma of testing, thereby increasing the number of people diagnosed.
Focus on Rapid Testing Solutions
Testing is being prioritised to enable immediate diagnosis and treatment. Several rapid tests have already been approved by the Food and Drug Administration that can give results in less than half an hour. This is vital for reducing transmission and improving the survival of infected people.
Enhanced Regulatory Support for Innovative Diagnostics
Regulatory agencies are increasingly supporting new diagnostics through fast-track approvals. The FDA’s Breakthrough Devices Program, for example, has accelerated the approval of new HIV diagnostics, thereby facilitating innovation. In this regulatory environment, more investment in research and development may result in more effective diagnostic tools.
Emphasis on Multi-Disease Testing Platforms
There is a growing tendency towards a combined diagnostic platform that can simultaneously detect HIV and other STIs. Cepheid and other companies are developing such platforms, which will simplify testing and reduce costs. It is hoped that this will improve public health strategies by addressing co-infections and ultimately improve patient management.
Increased Collaboration Between Public and Private Sectors
Public-private partnerships are becoming essential in advancing HIV diagnostics. The World Health Organization and the Global Fund, for example, work with companies to develop testing capacity in developing countries. This approach is likely to increase access to diagnostics and stimulate innovation, thereby contributing to the achievement of global health goals.
Growing Demand for Molecular Diagnostics
Molecular diagnostics are becoming more and more popular because of their high sensitivity and specificity in the detection of the virus. The market for these tests is growing and Hologic is the leading company. This development is expected to greatly improve the early diagnosis and monitoring of HIV and thus to significantly influence treatment strategies and patient outcomes.
Integration of Telehealth Services
Telemedicine is being integrated into the HIV diagnostic process to facilitate remote consultations and follow-ups. The pandemic has accelerated this trend. A 50% increase in the use of telemedicine in the care of patients with HIV has been reported. This integration is likely to improve patient participation and adherence to treatment, and to change the delivery of health services.
Sustainability in Diagnostic Manufacturing
Sustainability is a growing priority in the manufacture of diagnostic devices for HIV. Companies are adopting eco-friendly practices such as reducing waste and using sustainable materials. The trend is expected to be noticed by consumers and other stakeholders who are conscious of the environment, and it could influence purchasing decisions and corporate social responsibility initiatives.

Conclusion: Navigating the Competitive HIV Diagnostics Landscape

The HIV diagnostics market will be characterized by intense competition and significant fragmentation. The market will be contested by both old and new players. Regional trends show a growing emphasis on localized solutions as suppliers adjust to the different health care systems and patient needs. The old players can rely on their established reputation and extensive distribution network, while the newcomers are concentrating on their technological innovations and agile business models. Artificial intelligence, automation, and sustainability will be critical to success. Strategically aligning products with regulatory requirements and enhancing patient outcomes and streamlining diagnostics will be essential to stay ahead of the game in a rapidly changing environment.

Market Highlights

Author

Rahul Gotadki

Assistant Manager

He holds an experience of about 7+ years in Market Research and Business Consulting, working under the spectrum of Life Sciences and Healthcare domains. Rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. His expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. In addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives

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FAQs

What is the projected market valuation of the HIV Diagnostics Market by 2035?

The HIV Diagnostics Market is projected to reach a valuation of 5.089 USD Billion by 2035.

What was the market valuation of the HIV Diagnostics Market in 2024?

In 2024, the overall market valuation was 3.288 USD Billion.

What is the expected CAGR for the HIV Diagnostics Market during the forecast period 2025 - 2035?

The expected CAGR for the HIV Diagnostics Market during the forecast period 2025 - 2035 is 4.05%.

Which companies are considered key players in the HIV Diagnostics Market?

Key players in the HIV Diagnostics Market include Abbott Laboratories, Roche Diagnostics, and Thermo Fisher Scientific, among others.

What are the main segments of the HIV Diagnostics Market?

The main segments of the HIV Diagnostics Market include Test Type, End User, Product Type, and Technology.

How did the Antibody Tests segment perform in 2024?

The Antibody Tests segment was valued at 1.5 USD Billion in 2024 and is projected to grow to 2.3 USD Billion.

What is the projected growth for the Nucleic Acid Tests segment by 2035?

The Nucleic Acid Tests segment is expected to grow from 0.888 USD Billion in 2024 to 1.389 USD Billion by 2035.

Which end user segment is anticipated to have the highest growth?

The Hospitals segment is anticipated to grow from 1.5 USD Billion in 2024 to 2.3 USD Billion by 2035.

What is the expected valuation for the Software product type by 2035?

The Software product type is projected to reach a valuation of 0.989 USD Billion by 2035.

How does the market for Rapid Testing technology compare to other technologies?

The Rapid Testing technology segment is expected to grow from 1.2 USD Billion in 2024 to 1.8 USD Billion by 2035, indicating robust demand.

1. Market Overview

2. Market Trends

3. Market Segment Insights

4. Key Players and Competitive Insights

5. Industry Developments

6. Market Segmentation

7. Report Scope

8. Market Highlights

9. FAQs

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Market Summary

As per MRFR analysis, the HIV Diagnostics Market was estimated at 3.288 USD Billion in 2024. The HIV Diagnostics industry is projected to grow from 3.421 USD Billion in 2025 to 5.089 USD Billion by 2035, exhibiting a compound annual growth rate (CAGR) of 4.05 during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The HIV Diagnostics Market is experiencing robust growth driven by technological advancements and increasing awareness.

Technological advancements in diagnostics are enhancing the accuracy and speed of HIV testing. North America remains the largest market, while the Asia-Pacific region is emerging as the fastest-growing area for HIV diagnostics. Antibody tests continue to dominate the market, whereas nucleic acid tests are witnessing the highest growth rates. The rising prevalence of HIV and government initiatives are key drivers propelling market expansion.

HIV Diagnostics Market

CAGR

4.05%

Market Size & Forecast

2024 Market Size	3.288 (USD Billion)
2035 Market Size	5.089 (USD Billion)
CAGR (2025 - 2035)	4.05%
Largest Regional Market Share in 2024	North America

Major Players

<a href="https://www.abbott.com/product-list.html">Abbott Laboratories</a> (US), Roche Diagnostics (CH), Thermo Fisher Scientific (US), Siemens Healthineers (DE), Becton Dickinson and Company (US), Hologic, Inc. (US), Cepheid (US), Bio-Rad Laboratories (US), Ortho Clinical Diagnostics (US)

Market Trends

The HIV Diagnostics Market is currently experiencing a transformative phase, driven by advancements in technology and an increasing awareness of the disease. The integration of innovative diagnostic tools, such as rapid tests and point-of-care devices, appears to enhance accessibility and efficiency in testing. Furthermore, the growing emphasis on early detection and treatment is likely to propel demand for these diagnostic solutions. As healthcare systems worldwide adapt to the evolving landscape of HIV management, the market is poised for substantial growth, reflecting a commitment to improving patient outcomes and reducing transmission rates. In addition, the rising prevalence of HIV in various regions underscores the necessity for effective diagnostic measures. Public health initiatives and government support seem to play a crucial role in promoting testing and awareness campaigns. This environment fosters collaboration among stakeholders, including healthcare providers, researchers, and policymakers, to develop comprehensive strategies for combating the epidemic. The HIV Diagnostics Market, therefore, stands at a pivotal juncture, where innovation and collaboration may significantly influence its trajectory in the coming years.

Technological Advancements in Diagnostics

The HIV Diagnostics Market is witnessing a surge in technological innovations, particularly in the development of rapid testing methods. These advancements facilitate quicker results, enabling timely interventions and treatment. Moreover, the emergence of digital health solutions, such as mobile applications for monitoring and managing HIV, indicates a shift towards more integrated healthcare approaches.

Increased Focus on Preventive Healthcare

There is a growing emphasis on preventive healthcare strategies within the HIV Diagnostics Market. This trend reflects a broader understanding of the importance of early detection and regular testing. Public health campaigns are increasingly promoting routine screenings, which may lead to higher testing rates and improved health outcomes for individuals at risk.

Expansion of Point-of-Care Testing

The expansion of point-of-care testing is reshaping the HIV Diagnostics Market by making testing more accessible, especially in remote or underserved areas. This trend suggests a move towards decentralized healthcare, where patients can receive immediate results and care, thereby enhancing the overall efficiency of HIV management.

HIV Diagnostics Market Market Drivers

Rising Prevalence of HIV

The increasing prevalence of HIV infections worldwide is a primary driver of the HIV Diagnostics Market. According to recent estimates, approximately 38 million people are living with HIV, with a significant number unaware of their status. This underscores the urgent need for effective diagnostic tools to identify and manage the disease. The rising number of new infections, particularly in regions with limited access to healthcare, further amplifies the demand for innovative diagnostic solutions. As awareness campaigns and testing initiatives expand, the market for HIV diagnostics is likely to experience substantial growth. The need for timely and accurate testing is critical in controlling the spread of HIV, thereby propelling the HIV Diagnostics Market forward.

Growing Awareness and Education

The growing awareness and education surrounding HIV/AIDS are pivotal in driving the HIV Diagnostics Market. Increased public knowledge about the importance of early detection and treatment has led to a rise in testing rates. Educational campaigns, often spearheaded by health organizations, aim to destigmatize HIV testing and encourage individuals to know their status. This shift in perception is crucial, as it fosters a culture of proactive health management. In recent years, the number of individuals seeking testing has surged, indicating a positive trend towards early diagnosis. As awareness continues to spread, the demand for HIV diagnostic tools is expected to rise, thereby enhancing the market landscape.

Emerging Markets and Accessibility

Emerging markets are becoming increasingly important in the HIV Diagnostics Market. As economies develop, there is a growing focus on improving healthcare infrastructure, which includes enhancing access to HIV testing. Countries in regions such as sub-Saharan Africa and parts of Asia are witnessing a surge in demand for affordable and effective diagnostic solutions. The expansion of healthcare services in these areas is likely to drive the adoption of innovative testing methods. Furthermore, partnerships between governments and private sectors are facilitating the distribution of diagnostic tools, making them more accessible to underserved populations. This trend suggests a promising future for the HIV Diagnostics Market as it adapts to meet the needs of diverse populations.

Government Initiatives and Funding

Government initiatives aimed at combating HIV/AIDS play a crucial role in shaping the HIV Diagnostics Market. Many countries have implemented national strategies to increase testing and treatment accessibility, often backed by substantial funding. For instance, public health campaigns and partnerships with non-governmental organizations have been established to promote awareness and facilitate testing. In 2023, funding for HIV-related programs reached billions of dollars, reflecting a commitment to reducing the incidence of HIV. Such investments not only enhance the availability of diagnostic tools but also encourage research and development in the field. As governments continue to prioritize HIV prevention and treatment, the market for diagnostics is expected to expand significantly.

Technological Innovations in Testing

Technological advancements in diagnostic testing are transforming the HIV Diagnostics Market. Innovations such as rapid testing kits, molecular diagnostics, and point-of-care testing devices are enhancing the speed and accuracy of HIV detection. The introduction of these technologies has led to a notable increase in testing rates, as they provide results within minutes and can be used in various settings, including remote areas. The market for rapid HIV tests alone is projected to grow significantly, driven by the demand for user-friendly and efficient testing solutions. As technology continues to evolve, it is likely that new diagnostic methods will emerge, further propelling the growth of the HIV Diagnostics Market.

Market Segment Insights

By Test Type: Antibody Tests (Largest) vs. Nucleic Acid Tests (Fastest-Growing)

The HIV Diagnostics Market consists of various test types, notably Antibody Tests, Antigen Tests, and Nucleic Acid Tests. Antibody Tests dominate the market due to their widespread usage, accounting for a significant share. These tests are crucial for their cost-effectiveness and simplicity in point-of-care settings, making them the preferred choice for initial screening. Antigen Tests follow in popularity, offering quicker results but are less widely used, while Nucleic Acid Tests, although representing a smaller share, are gaining traction for their high sensitivity and specificity, which are vital in early detection and treatment initiation.

Nucleic Acid Tests (Emerging) vs. Antibody Tests (Dominant)

Antibody Tests have long been established as the dominant testing method in the HIV Diagnostics Market, primarily due to their ease of use and effectiveness in initial screenings. These tests are typically used in various healthcare settings, from laboratories to remote clinics. In contrast, Nucleic Acid Tests, while currently an emerging segment, are recognized for their capacity to detect HIV earlier than other testing methods, which is particularly important in controlling the spread of the virus. Their ability to provide quicker and more accurate diagnoses, especially in high-risk populations, positions them for substantial growth. As technology advances, Nucleic Acid Tests are likely to become more accessible, further enhancing their market share.

By End User: Hospitals (Largest) vs. Diagnostic Laboratories (Fastest-Growing)

Within the HIV diagnostics market, the distribution of market share among end users is predominantly led by hospitals, which hold a significant share due to their extensive testing capabilities and resources. Following hospitals, diagnostic laboratories are emerging rapidly, drawing attention for their specialized services and efficiency in processing HIV tests. Home care settings, while growing, currently represent a smaller portion of the market as they capitalize on the convenience of testing at home. Overall, <a href="https://www.marketresearchfuture.com/reports/hospital-information-system-market-10732">hospitals </a>dominate the landscape as comprehensive healthcare providers.

End User Segment: Hospitals (Dominant) vs. Home Care Settings (Emerging)

Hospitals are the dominant force in the HIV diagnostics market, leveraging advanced technology, skilled personnel, and integrated healthcare services to drive effective HIV testing and management. They benefit from established relationships with patients and healthcare providers, ensuring high patient turnover and access to diverse diagnostic tools. On the contrary, home care settings are emerging as a popular choice among patients seeking convenience and privacy in their testing processes. While these settings facilitate a shift toward decentralized healthcare, they face challenges such as compliance, regulatory considerations, and the need for reliable technology to ensure accurate and timely results.

By Product Type: Test Kits (Largest) vs. Instruments (Fastest-Growing)

In the HIV Diagnostics Market, the segment of Test Kits holds a substantial share, making it the largest contributor to the market. This segment is comprised of various types of diagnostic tests, including rapid tests and laboratory-based tests, showcasing a robust demand driven by increasing testing initiatives globally. On the other hand, the <a href="https://www.marketresearchfuture.com/reports/cardiac-surgery-instruments-market-2856">Instruments </a>segment, while currently smaller in market share, is experiencing rapid growth due to advancements in technology and automation in testing processes, driving efficiency and accuracy in HIV diagnostics.

Test Kits: Dominant vs. Instruments: Emerging

Test Kits are the dominant force in the HIV Diagnostics Market, characterized by their widespread use and accessibility. They offer rapid results, which is essential for timely diagnosis and treatment initiation. The versatility and adaptability of test kits to various settings, including at-home testing, make them highly preferable among healthcare providers. In contrast, the Instruments segment is emerging, fueled by innovation in diagnostic technology that enhances the precision and speed of testing. This segment includes advanced diagnostic machinery that is becoming increasingly crucial in laboratory settings, contributing to a more organized and reliable testing environment.

By Technology: ELISA (Largest) vs. Rapid Testing (Fastest-Growing)

In the HIV Diagnostics Market, the technology segment showcases a diverse distribution of methods, with ELISA leading in market share due to its reliability and established presence in laboratories for HIV detection. Rapid Testing, while having a smaller current share, is rapidly gaining traction owing to its convenience and immediate results, appealing significantly to both healthcare providers and patients looking for swift diagnosis. Polymerase Chain Reaction (PCR) technology also plays a vital role, particularly in confirming infections during early stages and for quantifying viral load, but its adoption is comparatively niche. As advancements in diagnostic technologies continue, the market is witnessing robust growth driven by factors such as increasing awareness about HIV/AIDS, rising prevalence of the disease, and the need for early diagnosis. The shift towards home-based testing and point-of-care testing is reshaping patient access to timely diagnostics, leading to a decline in conventional testing methods, such as PCR. Furthermore, innovations in technology, including digital health integration, are expected to enhance patient engagement and streamline testing processes, ultimately expanding the overall market reach of the HIV diagnostics segment.

HIV Testing Technology: ELISA (Dominant) vs. Rapid Testing (Emerging)

Within the HIV diagnostics technology landscape, ELISA remains the dominant force, celebrated for its high sensitivity and specificity, making it a preferred choice for large-scale screenings. The process involves multiple steps and requires laboratory settings, which align well with regular health check-ups and preventive healthcare measures. Meanwhile, Rapid Testing is emerging significantly, providing results in as little as 20 minutes and thus catering to a growing demand for immediate feedback on HIV status. While ELISA is preferred for its accuracy in clinical settings, Rapid Testing, with its user-friendly approach and ability to reach underserved populations, marks a necessary evolution in HIV diagnostics, ensuring broader access. The convergence of these technologies showcases a comprehensive approach to managing HIV diagnoses effectively.

Get more detailed insights about HIV Diagnostics Market Research Report-Forecast to 2035

Regional Insights

The Regional analysis of the Global HIV Diagnostics Market reveals significant market valuations and growth trends across various regions. In 2024, North America is projected to hold a valuation of 1.32 USD Billion, demonstrating majority holding in the overall market and underscoring its importance with advanced healthcare infrastructure and high awareness levels.

Europe follows closely with a valuation of 0.88 USD Billion and is significant due to its robust research capabilities and healthcare policies. The APAC region, valued at 0.82 USD Billion, is rapidly emerging due to increased screening initiatives and population awareness, while South America and MEA, with valuations of 0.15 USD Billion and 0.12 USD Billion respectively, present opportunities for growth driven by improving healthcare access and education.

The collective Global HIV Diagnostics Market revenue is expected to reach 3.29 USD Billion in 2024, reflecting the industry's adaptation to local needs and the varying prevalence of HIV across these regions. As such, market segmentation across these regions is critical for understanding regional dynamics and the tailored approaches required for effectively managing HIV diagnostics.

Source: Primary Research, Secondary Research, Market Research Future Database and Analyst Review

Key Players and Competitive Insights

The Global HIV Diagnostics Market is characterized by a diverse and competitive landscape, driven by a growing emphasis on early diagnosis, increased funding for HIV-related initiatives, and rising awareness of the importance of HIV testing. The market comprises a range of players, including large multinational corporations, mid-sized companies, and specialized firms focusing on innovative diagnostic solutions.

The competitive dynamics are influenced by advancements in technology, regulatory pathways, and evolving healthcare policies in various regions. This market landscape becomes further complicated with the emergence of new players and partnerships aimed at delivering more accurate, rapid, and cost-effective testing options. Companies are increasingly investing in research and development to enhance their product portfolios and meet the unique needs of diverse populations around the globe.

Abbott Laboratories is a significant player in the Global HIV Diagnostics Market, showcasing a strong market presence with a wide range of diagnostic solutions. The company is recognized for its robust portfolio that offers both rapid and laboratory-based testing options. Abbott Laboratories has achieved a notable reputation for innovation, particularly with its advanced testing technologies that not only ensure accuracy but also cater to different testing environments.

The company’s established brand equity and extensive distribution networks contribute to its competitive advantage in reaching healthcare facilities worldwide. Furthermore, its commitment to continuous improvement in product quality and adhering to regulatory standards reflects Abbott's strengths within the global context, positioning it as a leader in the HIV diagnostics sector. Thermo Fisher Scientific has made significant strides in the Global HIV Diagnostics Market through its comprehensive suite of diagnostic products and services.

The company is known for its high-quality assays and testing kits, which are essential tools in HIV research and clinical diagnostics. Thermo Fisher has garnered a strong market presence due to its innovative approaches and commitment to developing advanced technologies that improve detection and monitoring of HIV. The company's strengths lie in its extensive research capabilities, strong collaborative efforts, and strategic mergers and acquisitions, allowing it to broaden its product offerings and enhance its market footprint.

By continually evolving its solutions and investing in cutting-edge technology, Thermo Fisher Scientific reinforces its position as a key player in the global arena focused on providing reliable and efficient HIV diagnostic solutions.

Key Companies in the HIV Diagnostics Market market include

Industry Developments

Q2 2024: Chembio Diagnostics Announces FDA 510(k) Clearance for DPP HIV-Syphilis System Chembio Diagnostics received FDA 510(k) clearance for its DPP HIV-Syphilis System, a point-of-care test designed to simultaneously detect HIV and syphilis antibodies, expanding its diagnostic portfolio in the U.S. market.
Q2 2024: OraSure Technologies Announces Launch of OraQuick HIV Self-Test in the United Kingdom OraSure Technologies launched its OraQuick HIV Self-Test in the UK, providing consumers with a rapid, at-home HIV testing option and expanding the company's international reach.
Q3 2024: bioLytical Laboratories Receives CE Mark for INSTI Multiplex HIV-1/2 Syphilis Antibody Test bioLytical Laboratories received CE Mark approval for its INSTI Multiplex HIV-1/2 Syphilis Antibody Test, allowing commercialization of the rapid diagnostic test across the European Economic Area.
Q3 2024: Abbott launches new Alinity m HIV-1 test in Europe Abbott announced the European launch of its Alinity m HIV-1 test, a molecular diagnostic assay designed for high-throughput HIV-1 viral load monitoring, enhancing its molecular diagnostics portfolio.
Q4 2024: MedMira Receives Health Canada Approval for Multiplo Rapid HIV/HCV Antibody Test MedMira received Health Canada approval for its Multiplo Rapid HIV/HCV Antibody Test, enabling the company to market its dual rapid test for HIV and hepatitis C in Canada.
Q4 2024: Cepheid and FIND Announce Partnership to Expand Access to HIV Viral Load Testing in Africa Cepheid and the Foundation for Innovative New Diagnostics (FIND) entered a partnership to increase access to Cepheid's Xpert HIV-1 Viral Load test in sub-Saharan Africa, aiming to improve HIV management in resource-limited settings.
Q1 2025: Chembio Diagnostics Announces $10 Million Private Placement Financing Chembio Diagnostics completed a $10 million private placement financing round to support the commercialization and development of its rapid diagnostic tests, including those for HIV.
Q1 2025: bioLytical Laboratories Expands Manufacturing Facility to Meet Growing Demand for HIV Rapid Tests bioLytical Laboratories announced the expansion of its manufacturing facility in Canada to increase production capacity for its HIV rapid diagnostic tests, responding to rising global demand.
Q2 2025: Roche receives WHO prequalification for cobas HIV-1/2 Qualitative Test Roche received World Health Organization (WHO) prequalification for its cobas HIV-1/2 Qualitative Test, supporting broader adoption of the test in low- and middle-income countries.
Q2 2025: OraSure Technologies Appoints New Chief Commercial Officer OraSure Technologies appointed a new Chief Commercial Officer to lead the company's global commercial strategy, including the expansion of its HIV diagnostics business.
Q2 2025: MedMira Signs Distribution Agreement with Major U.S. Healthcare Provider for HIV Rapid Tests MedMira signed a distribution agreement with a major U.S. healthcare provider to supply its rapid HIV tests, expanding the company's presence in the U.S. diagnostics market.
Q3 2025: bioLytical Laboratories Receives FDA Clearance for INSTI HIV-1/2 Antibody Test bioLytical Laboratories received FDA clearance for its INSTI HIV-1/2 Antibody Test, enabling the company to market its rapid HIV test in the United States.

Future Outlook

HIV Diagnostics Market Future Outlook

The HIV Diagnostics Market is projected to grow at a 4.05% CAGR from 2024 to 2035, driven by technological advancements, increasing awareness, and rising healthcare investments.

New opportunities lie in:

Development of rapid point-of-care testing kits for remote areas.Integration of AI-driven analytics for personalized treatment plans.Expansion of telehealth services for remote patient monitoring and consultations.

By 2035, the market is expected to achieve substantial growth, enhancing global access to HIV diagnostics.

Market Segmentation

HIV Diagnostics Market End User Outlook

Hospitals
Diagnostic Laboratories
Home Care Settings

HIV Diagnostics Market Test Type Outlook

Antibody Tests
Antigen Tests
Nucleic Acid Tests

HIV Diagnostics Market Technology Outlook

Elisa
Rapid Testing
Polymerase Chain Reaction

HIV Diagnostics Market Product Type Outlook

Tests Kits
Instruments
Software

Report Scope

MARKET SIZE 2024	3.288(USD Billion)
MARKET SIZE 2025	3.421(USD Billion)
MARKET SIZE 2035	5.089(USD Billion)
COMPOUND ANNUAL GROWTH RATE (CAGR)	4.05% (2024 - 2035)
REPORT COVERAGE	Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR	2024
Market Forecast Period	2025 - 2035
Historical Data	2019 - 2024
Market Forecast Units	USD Billion
Key Companies Profiled	Market analysis in progress
Segments Covered	Market segmentation analysis in progress
Key Market Opportunities	Integration of point-of-care testing technologies enhances accessibility in the HIV Diagnostics Market.
Key Market Dynamics	Technological advancements and regulatory changes drive innovation and competition in the HIV diagnostics market.
Countries Covered	North America, Europe, APAC, South America, MEA