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US Rapid Diagnostics Market

ID: MRFR/MED/15211-HCR
200 Pages
Rahul Gotadki
October 2025

US Rapid Diagnostics Market Research Report By Application (Blood Glucose Testing, Infectious Disease Testing, Cardiometabolic Testing, Pregnancy & Fertility Testing, Fecal Occult Blood Testing, Coagulation Testing, Toxicology Testing) and By Product Type (Over the Counter (OTC) Kits, Professional Kits) - Forecast to 2035

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US Rapid Diagnostics Market Summary

As per MRFR analysis, the US rapid diagnostics market Size was estimated at 6.6 USD Billion in 2024. The US rapid diagnostics market is projected to grow from 7.13 USD Billion in 2025 to 15.37 USD Billion by 2035, exhibiting a compound annual growth rate (CAGR) of 7.98% during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The US rapid diagnostics market is experiencing robust growth driven by technological advancements and increasing consumer demand for home testing solutions.

  • Technological advancements are enhancing the accuracy and speed of rapid diagnostic tests.
  • The largest segment in the market is the infectious disease diagnostics, while the fastest-growing segment is home testing solutions.
  • Regulatory support and funding are facilitating the development and approval of innovative diagnostic tools.
  • Key market drivers include the growing prevalence of chronic diseases and rising consumer awareness and demand for preventive healthcare.

Market Size & Forecast

2024 Market Size 6.6 (USD Billion)
2035 Market Size 15.37 (USD Billion)

Major Players

Abbott Laboratories (US), Roche Diagnostics (CH), Siemens Healthineers (DE), Thermo Fisher Scientific (US), Danaher Corporation (US), Becton Dickinson and Company (US), bioMérieux (FR), Cepheid (US), Hologic, Inc. (US), Ortho Clinical Diagnostics (US)

US Rapid Diagnostics Market Trends

The rapid diagnostics market is currently experiencing notable growth, driven by advancements in technology and increasing demand for timely medical testing. Innovations in point-of-care testing and home diagnostics are reshaping how healthcare providers and patients approach disease detection and management. The emphasis on rapid results is becoming more pronounced, as stakeholders recognize the importance of swift decision-making in clinical settings. Furthermore, the integration of digital health solutions is enhancing the accessibility and efficiency of diagnostic services, allowing for improved patient outcomes. In addition, regulatory support and funding initiatives are fostering an environment conducive to innovation within the rapid diagnostics market. The focus on personalized medicine and preventive healthcare is likely to propel the development of novel diagnostic tools. As healthcare systems continue to evolve, the need for rapid, accurate, and cost-effective diagnostics remains paramount. This trend suggests a promising future for the market, with potential for further expansion and diversification of product offerings.

Technological Advancements

Recent innovations in technology are transforming the rapid diagnostics market. The development of portable and user-friendly devices enables healthcare professionals to conduct tests at the point of care. This shift not only enhances the speed of diagnosis but also improves patient engagement and satisfaction. Furthermore, advancements in molecular diagnostics and biosensors are likely to lead to more accurate and reliable results.

Increased Demand for Home Testing

There is a growing trend towards home testing solutions within the rapid diagnostics market. Patients are increasingly seeking convenient options that allow them to conduct tests in the comfort of their homes. This demand is driven by a desire for privacy, ease of use, and immediate results. As a result, manufacturers are focusing on developing user-friendly kits that cater to this emerging consumer preference.

Regulatory Support and Funding

Regulatory bodies are providing support for the rapid diagnostics market through streamlined approval processes and funding initiatives. This environment encourages innovation and the introduction of new diagnostic tools. As healthcare systems prioritize rapid testing capabilities, the backing from government agencies is likely to facilitate the growth of the market, enabling the development of cutting-edge solutions.

US Rapid Diagnostics Market Drivers

Supportive Regulatory Environment

A supportive regulatory environment is crucial for the growth of the rapid diagnostics market. Regulatory bodies in the US are increasingly streamlining the approval processes for diagnostic tests, which facilitates quicker market entry for innovative products. This trend is evident in the FDA's initiatives to expedite the review of diagnostic tools, particularly those that address urgent healthcare needs. The favorable regulatory landscape encourages investment in research and development, fostering innovation within the rapid diagnostics market. As companies navigate the regulatory framework more efficiently, they are better positioned to introduce new and improved diagnostic solutions. This supportive environment is likely to enhance the competitiveness of the rapid diagnostics market, driving growth and expanding access to essential diagnostic services.

Rising Consumer Awareness and Demand

Consumer awareness regarding health and wellness is on the rise, significantly impacting the rapid diagnostics market. As individuals become more informed about their health, there is an increasing demand for accessible and reliable diagnostic tools. This trend is evident in the growing popularity of home testing kits and over-the-counter diagnostic products. The market for home diagnostics is expected to grow at a CAGR of around 12% over the next few years, reflecting the changing consumer preferences. This heightened awareness is driving innovation and competition within the rapid diagnostics market, as companies strive to meet the evolving needs of health-conscious consumers. The emphasis on self-monitoring and preventive care is likely to further propel the growth of the rapid diagnostics market in the coming years.

Growing Prevalence of Chronic Diseases

The rising incidence of chronic diseases in the US is a pivotal driver for the rapid diagnostics market. Conditions such as diabetes, cardiovascular diseases, and infectious diseases necessitate timely diagnosis and management. According to the CDC, approximately 6 in 10 adults in the US have a chronic disease, which underscores the need for efficient diagnostic solutions. Rapid diagnostics enable healthcare providers to make informed decisions quickly, improving patient outcomes. The increasing burden of these diseases is likely to propel the demand for rapid diagnostic tools, as they facilitate early detection and monitoring. This trend indicates a robust growth trajectory for the rapid diagnostics market, as healthcare systems seek to enhance their diagnostic capabilities to address the growing healthcare challenges posed by chronic conditions.

Increased Focus on Preventive Healthcare

The shift towards preventive healthcare is a significant driver for the rapid diagnostics market. As healthcare providers and patients alike recognize the importance of early detection, there is a growing emphasis on screening and monitoring. This trend is supported by initiatives aimed at reducing healthcare costs and improving population health outcomes. The rapid diagnostics market is poised to benefit from this focus, as diagnostic tools play a crucial role in identifying health issues before they escalate. The US healthcare system is increasingly investing in preventive measures, which is likely to enhance the adoption of rapid diagnostic solutions. This proactive approach to health management suggests a promising future for the rapid diagnostics market, as it aligns with the broader goals of improving healthcare efficiency and effectiveness.

Technological Innovations in Diagnostic Tools

Technological advancements are significantly influencing the rapid diagnostics market. Innovations such as point-of-care testing, microfluidics, and artificial intelligence are enhancing the accuracy and speed of diagnostic processes. The integration of these technologies allows for real-time results, which is crucial in clinical settings. For instance, the market for point-of-care testing is projected to reach approximately $50 billion by 2026, reflecting a compound annual growth rate (CAGR) of around 10%. These innovations not only improve diagnostic efficiency but also expand the range of tests available, catering to diverse medical needs. As technology continues to evolve, the rapid diagnostics market is expected to experience substantial growth, driven by the demand for more sophisticated and user-friendly diagnostic solutions.

Market Segment Insights

By Product: Over-the-Counter Kits (Largest) vs. Professional Kits (Fastest-Growing)

The distribution of the product segment in the US rapid diagnostics market reveals that Over-the-Counter (OTC) Kits currently hold the largest share, appealing to consumers looking for convenient testing options from home. In contrast, Professional Kits are rapidly gaining traction among healthcare providers for their accuracy and reliability in clinical settings. The growth of OTC Kits is driven by increased consumer awareness and accessibility, while the rise of Professional Kits is fueled by advancements in technology and procurement by healthcare institutions. As the healthcare landscape evolves, the demand for both OTC and Professional Kits continues to rise. Factors such as the ongoing emphasis on rapid testing solutions, especially in response to health crises, push the market forward. In particular, the integration of digital technologies into Professional Kits enhances their appeal and effectiveness, marking them as a vital component of clinical diagnostics and ensuring they outpace traditional methods in growth rates.

Over-the-Counter Kits (Dominant) vs. Professional Kits (Emerging)

Over-the-Counter (OTC) Kits have established themselves as the dominant force in the product segment, primarily because of their convenience and cost-effectiveness for consumers. They enable individuals to conduct tests at home, thus enhancing accessibility to diagnostic solutions. Conversely, Professional Kits are emerging as a critical segment focused on medical facilities seeking reliable and precise diagnostic tools. As healthcare professionals increasingly adopt these advanced kits, their market presence grows, supported by innovations in testing methodologies. These kits cater to a more specialized demographic, addressing the needs of healthcare providers who rely on detailed and accurate results to inform patient care decisions.

By Application: Blood Glucose Testing (Largest) vs. Infectious Disease Testing (Fastest-Growing)

The US rapid diagnostics market exhibits a diversified application segment, with blood glucose testing holding the largest market share. Other applications like infectious disease testing, cardiometabolic testing, pregnancy & fertility testing, fecal occult blood testing, coagulation testing, and toxicology testing contribute to the overall dynamics of this market. Each category has established its niche, reflecting unique consumer needs and technological advances influencing market preferences. Growth trends in the application segment of the US rapid diagnostics market indicate a robust expansion, particularly for infectious disease testing due to rising incidences of infectious conditions and heightened awareness post-pandemic. Blood glucose testing remains indispensable for diabetes management, while innovations in cardiometabolic and toxicology testing further spur market evolution. The demands for rapid and accurate diagnostics continue to drive growth across various applications.

Blood Glucose Testing (Dominant) vs. Infectious Disease Testing (Emerging)

Blood glucose testing is a dominant force in the US rapid diagnostics market, largely driven by the increasing prevalence of diabetes and the growing need for regular monitoring among patients. This segment benefits from advanced technologies that facilitate quick and reliable results, making it indispensable in both home healthcare and clinical settings. Emerging in contrast, infectious disease testing is rapidly gaining traction, particularly in the wake of recent global health crises. This segment is characterized by its adaptability to new pathogens, enhanced sensitivity, and the integration of molecular diagnostics, positioning it as a critical player in responsive healthcare strategies. Both segments face distinct regulatory challenges and market opportunities that shape their future trajectories.

Get more detailed insights about US Rapid Diagnostics Market

Key Players and Competitive Insights

The rapid diagnostics market is characterized by a dynamic competitive landscape, driven by technological advancements and an increasing demand for timely and accurate diagnostic solutions. Key players such as Abbott Laboratories (US), Roche Diagnostics (CH), and Thermo Fisher Scientific (US) are at the forefront, each adopting distinct strategies to enhance their market positioning. Abbott Laboratories (US) focuses on innovation, particularly in point-of-care testing, which allows for rapid results in various settings. Roche Diagnostics (CH) emphasizes its extensive portfolio and integration of digital solutions, enhancing the efficiency of diagnostic processes. Meanwhile, Thermo Fisher Scientific (US) is leveraging strategic partnerships to expand its reach and capabilities in molecular diagnostics, thereby shaping a competitive environment that prioritizes speed and accuracy in diagnostics.

In terms of business tactics, companies are increasingly localizing manufacturing to mitigate supply chain disruptions and optimize operational efficiency. The market structure appears moderately fragmented, with several key players exerting influence while also facing competition from emerging firms. This fragmentation allows for diverse offerings, yet the collective strength of established companies like Becton Dickinson and Company (US) and Danaher Corporation (US) plays a crucial role in shaping market dynamics through their extensive distribution networks and established reputations.

In October 2025, Roche Diagnostics (CH) announced a significant partnership with a leading telehealth provider to integrate its rapid diagnostic tests into remote healthcare services. This strategic move is likely to enhance patient access to diagnostics, particularly in underserved areas, thereby expanding Roche's market footprint and reinforcing its commitment to digital health solutions. The integration of diagnostics with telehealth services may also streamline patient management, indicating a shift towards more holistic healthcare delivery models.

In September 2025, Abbott Laboratories (US) launched a new rapid test for infectious diseases that utilizes advanced molecular technology. This innovation not only underscores Abbott's commitment to enhancing diagnostic accuracy but also positions the company to capture a larger share of the growing demand for rapid testing solutions. The introduction of this test is expected to bolster Abbott's competitive edge, particularly in emergency and outpatient settings where rapid results are critical.

In August 2025, Thermo Fisher Scientific (US) expanded its manufacturing capabilities by investing in a new facility dedicated to the production of rapid diagnostic kits. This strategic investment is indicative of the company's proactive approach to meeting increasing market demands and ensuring supply chain reliability. By enhancing its production capacity, Thermo Fisher aims to solidify its position as a leader in the rapid diagnostics sector, particularly as healthcare systems continue to prioritize rapid and reliable testing solutions.

As of November 2025, the competitive trends in the rapid diagnostics market are increasingly defined by digitalization, sustainability, and the integration of artificial intelligence (AI) into diagnostic processes. Strategic alliances are becoming more prevalent, as companies recognize the value of collaboration in enhancing innovation and expanding market reach. Looking ahead, competitive differentiation is likely to evolve, with a pronounced shift from price-based competition towards a focus on technological innovation, supply chain reliability, and the ability to deliver rapid, accurate diagnostic solutions. This evolution suggests that companies that prioritize these aspects will be better positioned to thrive in an increasingly competitive landscape.

Key Companies in the US Rapid Diagnostics Market market include

Industry Developments

In recent months, the US Rapid Diagnostics Market has experienced notable advancements and developments. Danaher Corporation has expanded its portfolio by enhancing diagnostic capabilities through strategic partnerships and innovative product launches. Quidel Corporation has introduced new rapid test kits for infectious diseases, reflecting an increasing demand for quick testing solutions post-pandemic.

Hologic continues to innovate in women's health diagnostics, while bioMerieux has strengthened its position with new offerings in infectious disease testing. Roche Diagnostics and Abbott Laboratories have also contributed to market growth with novel diagnostic tools. In terms of mergers and acquisitions, BD (Becton, Dickinson and Company) announced its acquisition of a diagnostics company in July 2023, further solidifying its role in the market.

Recent financial reports indicate substantial growth in market valuation among leading companies, positively impacting overall industry dynamics. Over the past two to three years, the market has seen significant technological progress and an increasing shift towards decentralized testing solutions, with companies like Cepheid and Thermo Fisher Scientific leading the trend.

This evolving landscape is shaping the future of rapid diagnostics, meeting the urgent needs of healthcare providers and patients across the United States.

Future Outlook

US Rapid Diagnostics Market Future Outlook

The rapid diagnostics market is projected to grow at 7.98% CAGR from 2024 to 2035, driven by technological advancements, increasing demand for point-of-care testing, and rising healthcare expenditure.

New opportunities lie in:

  • Development of portable diagnostic devices for remote patient monitoring.
  • Integration of AI-driven analytics in diagnostic platforms.
  • Expansion of telehealth services incorporating rapid testing solutions.

By 2035, the rapid diagnostics market is expected to achieve substantial growth and innovation.

Market Segmentation

US Rapid Diagnostics Market Product Outlook

  • Over-the-Counter (OTC) Kits
  • Professional Kits

US Rapid Diagnostics Market Application Outlook

  • Blood Glucose Testing
  • Infectious Disease Testing
  • Cardiometabolic Testing
  • Pregnancy & Fertility Testing
  • Fecal Occult Blood Testing
  • Coagulation Testing
  • Toxicology Testing

Report Scope

MARKET SIZE 2024 6.6(USD Billion)
MARKET SIZE 2025 7.13(USD Billion)
MARKET SIZE 2035 15.37(USD Billion)
COMPOUND ANNUAL GROWTH RATE (CAGR) 7.98% (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 Abbott Laboratories (US), Roche Diagnostics (CH), Siemens Healthineers (DE), Thermo Fisher Scientific (US), Danaher Corporation (US), Becton Dickinson and Company (US), bioMérieux (FR), Cepheid (US), Hologic, Inc. (US), Ortho Clinical Diagnostics (US)
Segments Covered Product, Application
Key Market Opportunities Integration of artificial intelligence in rapid diagnostics enhances accuracy and efficiency in patient care.
Key Market Dynamics Technological advancements drive rapid diagnostics market growth, enhancing accuracy and speed of disease detection.
Countries Covered US

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FAQs

What was the market size of the US Rapid Diagnostics Market in 2024?

The US Rapid Diagnostics Market was valued at 5.02 billion USD in 2024.

What is the expected market value of the US Rapid Diagnostics Market by 2035?

By 2035, the US Rapid Diagnostics Market is anticipated to reach a valuation of 12.5 billion USD.

What is the expected compound annual growth rate (CAGR) for the US Rapid Diagnostics Market from 2025 to 2035?

The expected CAGR for the US Rapid Diagnostics Market from 2025 to 2035 is 8.639%.

Which application in the US Rapid Diagnostics Market has the highest projected value in 2024?

In 2024, Blood Glucose Testing is projected to have the highest market value at 1.2 billion USD.

What will be the market size of Infectious Disease Testing in the US Rapid Diagnostics Market by 2035?

Infectious Disease Testing is expected to grow to 4.5 billion USD by 2035.

Who are the major players in the US Rapid Diagnostics Market?

Major players include Mylan, Roche Diagnostics, Abbott Laboratories, and Thermo Fisher Scientific, among others.

What is the expected market size for Pregnancy Fertility Testing in 2024?

Pregnancy Fertility Testing is expected to be valued at 0.7 billion USD in 2024.

What challenges does the US Rapid Diagnostics Market face?

Challenges include the need for continuous innovation and navigating regulatory approvals in rapid diagnostics.

What growth drivers are influencing the US Rapid Diagnostics Market?

Key growth drivers include the increasing prevalence of chronic diseases and a growing demand for timely diagnostic results.

What is the market value of Cardiometabolic Testing in 2035?

Cardiometabolic Testing is expected to reach a market size of 2.5 billion USD by 2035.

What is the expected market size of the US Rapid Diagnostics Market in 2024?

The US Rapid Diagnostics Market is expected to be valued at 5.2 billion USD in 2024.

What is the projected value of the US Rapid Diagnostics Market by 2035?

By 2035, the US Rapid Diagnostics Market is projected to be valued at 12.5 billion USD.

What is the CAGR for the US Rapid Diagnostics Market from 2025 to 2035?

The expected CAGR for the US Rapid Diagnostics Market from 2025 to 2035 is 8.3%.

Which application segment is expected to hold the largest market share in 2024?

In 2024, the Blood Glucose Testing segment is expected to hold the largest market share valued at 1.4 billion USD.

What market value is projected for the Infectious Disease Testing application by 2035?

The Infectious Disease Testing application is projected to have a market value of 3.9 billion USD by 2035.

What is the estimated market value for Cardiometabolic Testing in 2024?

The Cardiometabolic Testing segment is estimated to have a market value of 1.2 billion USD in 2024.

How much is the Pregnancy & Fertility Testing application expected to grow by 2035?

The Pregnancy & Fertility Testing application is expected to grow to a market value of 1.9 billion USD by 2035.

What are some key growth drivers for the US Rapid Diagnostics Market?

Key growth drivers for the US Rapid Diagnostics Market include increasing demand for timely diagnostics and advancements in technology.

What is the projected value for Fecal Occult Blood Testing in 2035?

The Fecal Occult Blood Testing application is projected to have a market value of 1.4 billion USD by 2035.

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