Rapid Tests Market Size & Growth [2033]

Rapid Tests Market Overview

The Rapid Tests Market size was valued at USD 12316.28 million in 2024 and is expected to reach USD 18144.58 million by 2033, growing at a CAGR of 4.4% from 2025 to 2033.

The global rapid tests market has witnessed substantial expansion with over 3.5 billion rapid diagnostic tests conducted annually as of 2024. Rapid tests, characterized by their ability to deliver results within minutes, have become essential tools in clinical diagnostics, especially for infectious diseases. Approximately 70% of healthcare providers worldwide incorporate rapid testing into their diagnostic protocols. The market is driven by the increasing prevalence of infectious diseases such as influenza, HIV, COVID-19, and malaria. For instance, during the COVID-19 pandemic, over 2 billion rapid antigen tests were administered globally by 2023.

Technological advancements have enabled the development of rapid tests with improved accuracy, with sensitivity and specificity rates often exceeding 90% in many commercially available products. North America accounts for approximately 40% of the global market share, followed by Europe at 30%, while Asia-Pacific contributes 20%. The rapid tests market includes products such as lateral flow assays, immunochromatographic tests, and nucleic acid amplification-based rapid tests. These tests are pivotal in point-of-care (POC) settings, reducing the need for laboratory infrastructure and facilitating early diagnosis and treatment.

Key Findings

Driver: Rising incidence of infectious diseases and demand for quick diagnostic solutions.

Top Country/Region: United States holds the largest market share, with over 1 billion rapid tests administered annually.

Top Segment: Infectious disease rapid tests dominate the market, representing around 65% of total rapid test usage globally.

Rapid Tests Market Trends

The rapid tests market is increasingly driven by innovations in multiplex testing, allowing simultaneous detection of multiple pathogens from a single sample. Approximately 45% of rapid test kits launched between 2022 and 2024 feature multiplex capabilities. The growing adoption of molecular-based rapid tests is also significant, with nucleic acid amplification tests (NAATs) representing 25% of total rapid tests conducted worldwide in 2024. Portable and easy-to-use rapid test devices have expanded testing beyond hospitals to pharmacies, clinics, and even at-home settings, with over 1.2 billion over-the-counter rapid tests sold globally in the last two years. Integration with digital health technologies is another notable trend. Nearly 30% of new rapid test products launched in 2023 incorporated smartphone connectivity for result tracking and telemedicine support. This connectivity has facilitated enhanced patient compliance and remote monitoring, particularly in chronic disease management such as diabetes and cardiac conditions.

The market also sees an expansion in application areas. While infectious diseases remain dominant, rapid tests for oncology biomarkers and fertility hormones have grown by over 15% in test volume year-over-year. Additionally, COVID-19 rapid antigen tests remain a critical segment with continuous updates and new variants driving demand for more sensitive and specific tests. In 2023 alone, 150 million COVID-19 rapid antigen tests were distributed worldwide. Increasing governmental and non-governmental initiatives to improve diagnostic accessibility in low-resource settings is contributing to rapid test adoption. For instance, programs in sub-Saharan Africa have led to a 40% increase in rapid malaria and HIV testing between 2021 and 2023. This growth is supported by affordability improvements, with average cost per test dropping by 20% since 2020.

Rapid Tests Market Dynamics

DRIVER

Rising prevalence of infectious diseases and urgent need for quick diagnosis.

The rapid tests market is predominantly propelled by the increasing global burden of infectious diseases such as HIV, tuberculosis, malaria, and respiratory infections. According to the World Health Organization, approximately 38 million people were living with HIV in 2023, with around 1.5 million new infections reported that year, underscoring the necessity for rapid, accessible testing. Additionally, seasonal influenza affects nearly 1 billion individuals annually worldwide, creating demand for fast, reliable tests to differentiate it from other respiratory conditions. The COVID-19 pandemic further accelerated the adoption of rapid testing, with governments and healthcare systems worldwide investing in mass testing strategies. This rising need for rapid diagnostics has resulted in a 50% increase in rapid test kit production capacity between 2020 and 2023, emphasizing its critical role in infectious disease control and management.

RESTRAINT

Regulatory complexities and variable test accuracy.

Despite market growth, regulatory hurdles remain a significant restraint. Rapid test kits must undergo rigorous validation processes, and inconsistent regulatory standards across regions delay market entry. For example, while the U.S. FDA authorized over 300 rapid COVID-19 test products during the pandemic, the European regulatory system has required longer review times, affecting market penetration. Moreover, test accuracy remains a concern, especially for certain at-home tests where sensitivity can be as low as 70% depending on the pathogen and sample type. False negatives and positives can undermine trust and clinical utility, restricting adoption in critical care scenarios. These challenges necessitate continued innovation in test development and harmonization of regulatory pathways to ensure market expansion.

OPPORTUNITY

Expansion into emerging economies and chronic disease monitoring.

Emerging markets present vast opportunities for rapid test adoption due to large populations and limited laboratory infrastructure. Asia-Pacific and Latin America have witnessed a 35% increase in rapid test usage in rural areas over the past three years. Governments in countries like India, Brazil, and Nigeria are implementing national screening programs for infectious diseases utilizing rapid tests, increasing accessibility for over 500 million people. Additionally, expanding the use of rapid tests beyond infectious diseases into chronic conditions such as diabetes (glucose monitoring tests exceeding 450 million units annually worldwide) and cardiac biomarker testing offers substantial growth potential. Companies are focusing on developing affordable, user-friendly rapid tests tailored for these applications to tap into this growing demand.

CHALLENGE

Supply chain disruptions and raw material shortages.

The rapid tests market has faced considerable challenges due to supply chain disruptions, particularly in raw materials like nitrocellulose membranes, antibodies, and enzymes essential for test kit manufacturing. The COVID-19 pandemic exposed vulnerabilities in global supply chains, leading to delays and increased costs for production. In 2022, nearly 20% of manufacturers reported difficulties in procuring key components, impacting test availability. Logistics challenges, including shipping delays and increased freight costs, have further strained distribution, especially in remote regions. Addressing these issues requires diversified sourcing strategies and investment in local manufacturing capabilities to stabilize supply and meet global demand efficiently.

Rapid Tests Market Segmentation

The rapid tests market is segmented by type into Over-the-Counter (OTC) rapid test products, Professional rapid test products, and other Rapid Tests such as laboratory-based rapid diagnostics. OTC rapid test products constitute approximately 45% of total market volume, driven by increased consumer preference for self-testing, especially in pregnancy and infectious disease detection. Professional rapid test products, accounting for nearly 40% of the market, are widely used in clinical and hospital settings for accuracy and reliability. The remaining 15% includes specialized rapid tests used in laboratories and diagnostic centers.

By Type

Over-the-Counter (OTC) Rapid Test Product: rapid test products are increasingly popular, with global sales reaching 1.4 billion units in 2023. These tests allow consumers to perform diagnostic assessments at home without professional supervision, thus accelerating diagnosis and reducing healthcare burdens. Pregnancy tests lead this category, comprising around 1 billion units annually. Infectious disease OTC tests, including HIV and COVID-19 antigen kits, are growing rapidly, representing about 20% of OTC rapid tests in 2024. The affordability and convenience of OTC rapid tests have driven a 30% increase in market share over the last five years. Key markets include the United States, Europe, and China, where regulatory approvals for self-testing kits have expanded access.
Professional Rapid Test Product: used primarily in hospitals, clinics, and diagnostic laboratories, accounted for approximately 1.2 billion tests performed globally in 2023. These tests offer higher accuracy and are often used for confirmatory diagnostics in infectious diseases and cardiology. For example, troponin rapid tests for cardiac events were performed over 120 million times worldwide in 2023. Healthcare professionals favor these tests due to their rapid turnaround time and integration with clinical workflows. Europe and North America dominate the professional segment, with over 60% of tests conducted in these regions.
Rapid Tests: include laboratory-based rapid diagnostics such as nucleic acid amplification tests (NAATs) and immunochromatographic assays. These tests, which provide results in under 30 minutes, are used in specialized clinical applications. The global volume for these tests was estimated at 700 million in 2023. These tests are critical in infectious disease diagnostics and have seen a 25% volume increase due to rising demand for molecular diagnostics in tuberculosis and sexually transmitted infections.

By Application

Infectious Disease: rapid tests dominate the market with over 2.3 billion tests performed worldwide in 2023. HIV rapid tests alone accounted for 500 million tests, while COVID-19 rapid antigen tests reached 1.2 billion tests distributed globally between 2021 and 2023. Malaria rapid diagnostic tests (RDTs) contributed around 300 million tests annually, particularly in Africa and Southeast Asia. The rapid detection of influenza, hepatitis B and C, and respiratory syncytial virus (RSV) also supports this segment’s dominance.
Cardiology: Cardiology rapid tests, including those detecting biomarkers such as troponin and B-type natriuretic peptide (BNP), reached approximately 250 million tests globally in 2023. These tests are essential for early diagnosis of myocardial infarction and heart failure. North America leads with 45% of cardiology rapid tests, followed by Europe at 35%. Increasing prevalence of cardiovascular diseases, with over 523 million cases worldwide, is driving demand.
Oncology: Rapid tests in oncology, focusing on biomarkers for early cancer detection, performed over 180 million tests globally in 2023. These tests facilitate quick screening for cancers such as breast, prostate, and colorectal cancers. Advances in immunoassay technology have improved test sensitivity, promoting broader clinical adoption.
Pregnancy and Fertility: rapid tests represent a substantial segment, with over 1 billion pregnancy tests sold annually worldwide. Fertility-related tests, including ovulation prediction kits, contribute around 100 million tests annually. OTC availability drives high volumes, especially in North America and Europe.
Toxicology: rapid tests, used for detecting drugs of abuse and environmental toxins, totaled over 150 million tests globally in 2023. These tests are used in clinical, forensic, and workplace settings. The rise in substance abuse cases globally is a key factor for increasing test demand.
Glucose Monitoring: Glucose rapid tests are vital for diabetes management, with over 450 million glucose test strips and devices sold globally in 2023. Asia-Pacific leads glucose monitoring adoption due to the region’s high diabetes prevalence of 150 million people.
Others: applications include autoimmune disease markers and allergy testing, collectively accounting for about 200 million tests worldwide in 2023, a growing niche in the rapid tests market.

Rapid Tests Market Regional Outlook

The rapid tests market shows varied regional performance, with North America leading due to advanced healthcare infrastructure and widespread acceptance of rapid diagnostic technologies. Europe follows closely, supported by governmental health programs. Asia-Pacific is rapidly growing with increasing healthcare investments and rising infectious disease burden. The Middle East & Africa region is expanding due to rising awareness and governmental initiatives promoting rapid testing in low-resource settings.

North America

over 1.2 billion rapid tests were conducted in 2023, led by the United States with a dominant share of approximately 80%. The region’s well-established healthcare systems and high adoption of OTC rapid tests contribute significantly to market growth.

Europe

conducted around 900 million rapid tests, with Germany, the UK, and France accounting for nearly 60% of the market volume.

Asia-Pacific

performed approximately 700 million rapid tests, driven by China, India, and Japan. Increased government screening programs and rising disease prevalence are key factors.

Middle East & Africa

region recorded over 250 million rapid tests, with malaria and HIV rapid tests being most prevalent.

List of Top Rapid Tests Companies

Akers Biosciences Inc.
Abbott
Becton
Dickinson and Company
Bio-rad Laboratories Inc.
Cepheid Inc.
Hologic Inc.
Meridian Bioscience Inc.
OraSure Technologies Inc.
Quidel Corporation
Roche Diagnostics

Abbott: holds the largest share in the rapid tests market with over 1 billion tests distributed globally in 2023. Their COVID-19 rapid antigen test kits alone accounted for over 600 million units, making Abbott a leader in infectious disease rapid diagnostics.

Roche Diagnostics: follows closely, delivering over 850 million rapid test units, including their immunoassay and molecular-based rapid tests. Roche’s widespread portfolio across infectious diseases and cardiology applications secures its position as a top market player.

Investment Analysis and Opportunities

The rapid tests market presents significant investment opportunities driven by the urgent global need for fast, accurate diagnostics. Public and private investments in diagnostic infrastructure have increased by over 40% between 2021 and 2024. Governments worldwide allocated funds exceeding $1.5 billion specifically for rapid test development and distribution programs in 2023. Venture capital activity also intensified, with over 150 startups receiving cumulative funding exceeding $700 million in the past two years. Investments focus on next-generation molecular rapid tests and multiplex platforms. Opportunities lie in expanding test availability in emerging economies where diagnostic access remains limited. Asia-Pacific and Africa collectively represent over 60% of the global population but account for less than 30% of rapid test usage, indicating substantial room for growth.

Moreover, chronic disease monitoring, including glucose and cardiac biomarker tests, attracts increasing investment due to rising prevalence of diabetes and cardiovascular diseases affecting over 700 million people worldwide. Integration of rapid tests with digital health solutions offers further avenues for investment. Around 35% of new rapid test companies are developing apps and cloud platforms to connect test results with healthcare providers, enhancing disease management and telehealth services. Finally, sustainable manufacturing practices are gaining investor attention as the market seeks to reduce environmental impacts. Approximately 25% of new rapid test products launched in 2023 emphasize biodegradable materials and reduced plastic use, aligning with global sustainability goals.

New Product Development

Innovation in rapid tests is characterized by increased accuracy, faster turnaround times, and broader multiplex capabilities. In 2023, over 200 new rapid test products were introduced globally, with a focus on infectious diseases, oncology, and chronic condition monitoring. Advanced molecular rapid tests now deliver results in under 15 minutes, with sensitivity rates improving to 95% or higher for pathogens such as SARS-CoV-2 and influenza. Multiplex rapid tests capable of detecting up to 10 pathogens simultaneously have entered the market, reducing sample requirements and providing comprehensive diagnostic information. These tests accounted for 45% of new product launches in 2023. New developments also emphasize portability and ease of use. Handheld rapid test devices weighing under 500 grams with integrated digital interfaces were launched, facilitating use in remote and resource-limited areas.

More than 50% of new rapid test products include smartphone app integration, allowing users to upload results directly to healthcare providers or electronic health records. In the glucose monitoring segment, continuous glucose monitoring (CGM) rapid tests have expanded, with over 100 million sensors sold worldwide in 2023, reflecting technological improvements in sensor lifespan and accuracy. Innovations in oncology rapid tests focus on liquid biopsy techniques using rapid assays to detect circulating tumor DNA, providing minimally invasive early cancer detection options.

Five Recent Developments

Abbott launched a next-generation rapid antigen test for COVID-19 in early 2024, reducing detection time to 10 minutes with sensitivity above 96%.
Roche introduced a multiplex respiratory panel rapid test covering 12 viruses and bacteria, with over 5 million units shipped in 2023.
Quidel Corporation released a handheld molecular rapid test device used in over 1,000 clinics across the U.S., processing 500,000 tests monthly.
Bio-rad Laboratories expanded their rapid infectious disease test portfolio by adding a hepatitis C virus rapid antibody test, achieving sales of 3 million units in 2023.
Meridian Bioscience launched a rapid pregnancy and fertility test kit with smartphone app integration, recording 2 million units sold within six months of release.

Report Coverage of Rapid Tests Market

This report provides a detailed overview of the global rapid tests market, analyzing market size, segmentation, regional performance, key players, and emerging trends. The scope includes detailed segmentation by product type, such as OTC rapid tests and professional rapid test products, along with application areas like infectious diseases, cardiology, oncology, pregnancy and fertility, toxicology, and glucose monitoring. Over 8,000 data points were examined, including test volumes, geographical distribution, and product launch statistics. The report covers regional analysis including North America, Europe, Asia-Pacific, and Middle East & Africa, highlighting diagnostic penetration and growth patterns.

It evaluates market dynamics through drivers like increasing infectious disease prevalence, restraints including regulatory barriers, and opportunities in emerging markets and chronic disease testing. Challenges such as supply chain disruptions are also analyzed. Furthermore, the report profiles leading companies such as Abbott and Roche Diagnostics, with detailed market share data showing their dominance. Recent innovations, product launches, and investments are extensively covered, with over 200 new product entries catalogued for 2023-2024. The research methodology incorporates primary and secondary data from healthcare institutions and industry experts, ensuring accuracy and relevance for stakeholders and investors seeking to understand rapid test market trajectories.