HIV Rapid Test Kit Market Size, Growth Trends & Insights Analysis Report by Type (Blood Detection, Saliva Detection, Others), by Application (Donating Blood Site, Hospital, Other), by Region, and Competitive Landscape Forecasts, 2024-2033

In 2024, the global HIV Rapid Test Kit market was valued at USD 947.71 million, with a CAGR of 7.1% from 2024 to 2033.

HIV Rapid Test Kits are diagnostic tools designed to quickly detect the presence of HIV-specific proteins, such as antibodies or antigens, in blood or saliva. These kits are crucial for early detection and management of HIV, allowing for timely initiation of treatment and prevention of transmission. Most rapid tests and self-tests are antibody tests, with venous blood tests generally detecting HIV earlier post-infection compared to finger blood or oral fluid tests.

Global HIV Rapid Test Kit Market Size (M USD) and CAGR 2024-2033

The HIV Rapid Test Kit market is experiencing significant growth, driven by several key trends and factors. One of the most notable trends is the intense market competition. The industry has high barriers to entry, requiring substantial capital and advanced technology. This has led to a market dominated by powerful large enterprises and specialized companies. The potential for market demand has intensified competition, prompting companies to focus on efficiency and reliability while also offering more cost-effective products.

Another significant trend is the development of the self-testing market. Self-testing is a vital tool for individuals to discover their HIV status, providing a pathway to treatment and reducing the global HIV burden. This is particularly relevant in low- and middle-income countries (LMICs), where stigma and access to healthcare can be significant barriers. Unitaid’s agreement with Viatris (through its subsidiary Mylan) has led to a significant market expansion and price reduction of around 50%, making blood-based HIV self-tests available for less than $2 each in 135 eligible countries. Over 85 national governments have embedded self-testing protocols in their health policies, further driving the market for HIV rapid test kits.

The importance of rapid detection is a key driver of the market. Knowing one’s HIV status allows individuals to receive antiretroviral therapy (ART), which can keep them healthy for many years. Early treatment initiation provides the most significant benefits, reducing the viral load, preventing HIV-related illnesses, and minimizing transmission risks. Governments worldwide are emphasizing HIV testing, with initiatives such as targeted community-based testing, door-to-door campaigns, and the introduction of self-testing kits. For example, Kenya has adopted innovative approaches to increase HIV testing, and the United States has set bold goals to end the HIV epidemic by 2030 through its National HIV/AIDS Strategy.

Quality risk is a significant concern. Ensuring that rapid diagnostic products provide fast, simple, and accurate test results is crucial. Although most suppliers have strict systems and regulations for safe production, operating procedures, and quality control, the numerous links in the supply chain—from procurement to storage—can introduce quality control risks. The circulation of counterfeit and substandard products can severely damage the market ecosystem, negatively impact market development, and harm the reputation of enterprises and the trust of customers. Maintaining product quality is an ongoing challenge for companies in this sector.

Blood Detection kits are designed to detect antibodies to human immunodeficiency virus (HIV) types 1 and 2 using human fingertip blood. These kits can also test other sample types such as venous whole blood, plasma, and serum. Blood Detection is the most common and widely used method due to its high sensitivity and specificity. In 2024, the Blood Detection segment is expected to account for the largest share of the market, valued at 719.68 million USD. This segment’s dominance is attributed to its ability to provide early detection of HIV, which is crucial for initiating timely treatment and reducing the spread of the virus.

Saliva Detection kits use oral fluid to check for antibodies to HIV Type 1 and HIV Type 2, the viruses that cause AIDS. The user swabs the gums to collect a sample of oral fluid and uses the kit materials to test the oral cavity fluid sample. Saliva Detection offers a non-invasive and convenient alternative to blood testing, making it particularly useful in settings where blood collection may be challenging or undesirable. In 2024, the Saliva Detection segment is forecasted to be valued at 173.72 million USD. The growth of this segment is driven by the increasing demand for non-invasive testing methods and the expansion of self-testing markets, especially in low- and middle-income countries where access to healthcare facilities may be limited.

Type

Market Size (M USD) 2024

Market Share 2024

Blood Detection

719.68

75.94%

Saliva Detection

173.72

18.33%

Others

54.32

5.73%

In 2024, the market size for HIV Rapid Test Kits used at donating blood sites is forecasted to be 164.50 million USD. These sites are crucial for ensuring the safety of the blood supply. They use rapid test kits to screen blood donors for HIV infection, preventing the transmission of the virus through blood transfusions. This application is essential in maintaining the integrity of the blood supply chain and protecting both donors and recipients from potential infection.

The hospital segment is the largest application area, with a market size of 656.58 million USD in 2024. Hospitals use HIV Rapid Test Kits for immediate diagnosis and treatment planning. These kits are vital in emergency departments, outpatient clinics, and inpatient wards to manage patients suspected of HIV infection. Rapid and accurate testing enables hospitals to initiate antiretroviral therapy (ART) as soon as possible, reducing the viral load and improving patient outcomes. Hospitals also rely on these kits for routine screening and confirmatory testing, ensuring that patients receive timely and appropriate care.

Application

Market Size (M USD) 2024

Market Share 2024

Donating Blood Site

164.50

17.36%

Hospital

656.58

69.28%

Other

126.63

13.36%

North America is a well-established market with a strong healthcare infrastructure. The region is characterized by a high demand for advanced diagnostic tools and a focus on early detection and treatment of HIV. In 2024, the market is expected to reach 13,194 K Units.

East Asia is experiencing rapid growth in the HIV Rapid Test Kit market, driven by increasing awareness and government initiatives to improve public health. In 2024, the market is forecasted to reach 15,125 K Units. The region is a significant manufacturer of these kits, with companies like Wantai BioPharm and Wondfo Biotech playing key roles. These companies are expanding their market share both domestically and internationally, benefiting from lower production costs and growing demand.

Europe has a mature market with a strong emphasis on healthcare quality and innovation. The region is known for its rigorous regulatory standards, which ensure the high quality and reliability of HIV Rapid Test Kits. In 2024, the market is expected to reach 21,037 K Units. Companies like bioMérieux and Orasure Technologies have a significant presence, with a focus on research and development to improve testing technologies. The region’s healthcare systems are well-equipped to handle the demand for rapid testing, and the market is driven by the need for accurate and efficient diagnostic tools.

South Asia is a growing market with a high potential for expansion. The region faces challenges such as limited healthcare resources and infrastructure, but is making significant strides in improving access to HIV testing. In 2024, the market is forecasted to reach 19,081 K Units. Local and international companies are investing in the region to meet the increasing demand for affordable and reliable testing kits. The region’s large population and growing awareness of HIV prevention and treatment are driving the market growth.

Africa is the largest market for HIV Rapid Test Kits, driven by the high prevalence of HIV and significant international support for testing and treatment programs. In 2024, the market is expected to reach 86,235 K Units. The region faces challenges such as limited resources and infrastructure, but is making progress in improving access to testing. A mix of international and local companies are active in the market, with a focus on providing affordable and reliable testing solutions. The region’s large population and the high prevalence of HIV make it a critical area for HIV testing and management efforts.

Global HIV Rapid Test Kit Market Size (K Units) by Region in 2024

Company Profile:

Abbott is a Chicago-based medical products company founded in 1888. It is known for its diagnostics, medical devices, nutrition products, and branded generic pharmaceuticals. Abbott’s production sites are mainly located in North America, and it operates globally, serving a wide range of healthcare needs.

Business Overview:

Abbott’s business encompasses a broad spectrum of medical products, with a strong focus on diagnostic solutions. The company is committed to developing innovative technologies that improve healthcare outcomes. In the HIV Rapid Test Kit market, Abbott offers highly sensitive and accurate testing kits that are used in various healthcare settings.

Product Specification:

Abbott’s HIV Rapid Test Kit, the Bioline™ HIV 1/2 3.0, is an immunochromatographic assay designed to detect all isotypes (IgG, IgM, IgA) of antibodies specific to HIV-1, including subtype O, and HIV-2 simultaneously. The test is highly sensitive, even during the early infection stage, and provides differentiated results between HIV type I and II through clear band formation. The kit can be used with serum, plasma, or whole blood and has a shelf life of 24 months at 1-30℃.

Recent Financial Data:

In 2021, Abbott’s HIV Rapid Test Kit sales reached 14,759 K Units, generating a revenue of 148.00 M USD. The gross margin for the year was 64.10%.

Company Profile:

Wantai BioPharm, established in 1991, is a leading biopharmaceutical company based in China. The company is known for its diagnostic tests in the fields of human infectious diseases and blood donor screening. Wantai BioPharm’s production sites are primarily located in China, and it serves a global market.

Business Overview:

Wantai BioPharm operates both domestic and international diagnostic test businesses, focusing on the development, manufacturing, and marketing of diagnostic products. The company is committed to providing high-quality and reliable testing solutions to improve public health.

Product Specification:

Wantai BioPharm’s HIV 1+2 Rapid Test is a single-use device designed for the qualitative detection of antibodies to Human Immunodeficiency Viruses (HIV) in blood, serum, and plasma specimens. The test is intended for use in health facilities by trained staff and provides clear results within 10-30 minutes.

Recent Financial Data:

In 2021, Wantai BioPharm’s HIV Rapid Test Kit sales reached 26,236 K Units, generating a revenue of 72.54 M USD. The gross margin for the year was 63.25%.

Company Profile:

bioLytical Laboratories Inc., founded in 2002, is a privately-owned Canadian company. It is focused on the research, development, and commercialization of rapid in vitro medical diagnostics. The company’s production sites are mainly located in North America, and it serves primarily North American and European markets.

Business Overview:

bioLytical Laboratories Inc. is dedicated to developing innovative diagnostic solutions that improve healthcare outcomes. The company’s products are designed to provide rapid and accurate results, enabling healthcare professionals to make informed decisions quickly.

Product Specification:

bioLytical Laboratories Inc.’s INSTI Multiplex HIV-1 / HIV-2 / Syphilis Antibody Test is a rapid diagnostic tool that screens for both HIV and syphilis infections simultaneously. The test is designed to identify individuals who need treatment, prevent mother-to-child transmission, and reduce the spread of both infections worldwide. The test provides results in just 60 seconds.

Recent Financial Data:

In 2021, bioLytical Laboratories Inc.’s HIV Rapid Test Kit sales reached 5,333 K Units, generating a revenue of 55.52 M USD. The gross margin for the year was 63.68%.

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