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Rapid Diagnostics Market

ID: MRFR/HC/10167-HCR
128 Pages
Kinjoll Dey
October 2025

Rapid Diagnostics Market Research Report Information By Product (Over the Counter (OTC) Kits and Professional Kits), By Application (Blood Glucose Testing, Infectious Disease Testing, Cardiometabolic Testing, Pregnancy & Fertility Testing, Fecal Occult Blood Testing, Coagulation Testing, and Toxicology Testing), And By Region (North America, Europe, Asia-Pacific, and Rest Of The World) –Market Forecast Till 2035

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Rapid Diagnostics Market Summary

As per MRFR analysis, The Global Rapid Diagnostics Market was estimated at 31.44 USD Billion in 2024. The rapid diagnostics industry is projected to grow from 34.21 USD Billion in 2025 to 79.51 USD Billion by 2035, exhibiting a compound annual growth rate (CAGR) of 8.8 during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The Global Rapid Diagnostics Market is poised for substantial growth driven by technological advancements and a shift towards point-of-care testing.

  • North America remains the largest market for rapid diagnostics, reflecting a robust demand for innovative testing solutions.
  • The Asia-Pacific region is emerging as the fastest-growing market, fueled by increasing healthcare investments and rising disease prevalence.
  • Over-the-Counter (OTC) kits dominate the market, while professional kits are experiencing the fastest growth due to their enhanced accuracy and reliability.
  • Technological advancements and a rising incidence of infectious diseases are key drivers propelling the market forward.

Market Size & Forecast

2024 Market Size 31.44 (USD Billion)
2035 Market Size 79.51 (USD Billion)
CAGR (2025 - 2035) 8.8%

Major Players

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

Rapid Diagnostics Market Trends

The Global Rapid Diagnostics Market is currently experiencing a transformative phase, characterized by advancements in technology and an increasing demand for timely diagnostic solutions. This market encompasses a wide array of testing methods, including molecular diagnostics, immunoassays, and point-of-care testing. The growing emphasis on early disease detection and management is driving innovation, as healthcare providers seek to enhance patient outcomes through rapid testing capabilities. Furthermore, the integration of digital health technologies is reshaping the landscape, enabling more efficient data management and analysis. In addition, The Global Rapid Diagnostics Market is witnessing a shift towards personalized medicine, where diagnostic tools are tailored to individual patient needs. This trend is likely to foster collaboration between diagnostic manufacturers and healthcare professionals, ensuring that tests are not only accurate but also relevant to specific patient populations. As the market evolves, regulatory frameworks are adapting to accommodate new technologies, which may further accelerate the development and adoption of rapid diagnostic solutions. Overall, the future of this market appears promising, with potential for significant growth driven by innovation and a focus on patient-centered care.

Technological Advancements

The Global Rapid Diagnostics Market is seeing rapid technological innovations that enhance the accuracy and speed of diagnostic tests. New methodologies, such as microfluidics and lab-on-a-chip technologies, are emerging, allowing for more efficient testing processes. These advancements are likely to improve the overall reliability of results, thereby fostering greater trust among healthcare providers and patients alike.

Shift Towards Point-of-Care Testing

There is a noticeable trend towards point-of-care testing within The Global Rapid Diagnostics Market. This approach allows for immediate results at the site of care, reducing the need for laboratory visits. Such convenience is appealing to both patients and healthcare providers, as it streamlines the diagnostic process and facilitates quicker clinical decision-making.

Focus on Personalized Medicine

The emphasis on personalized medicine is becoming increasingly prominent in The Global Rapid Diagnostics Market. Diagnostic tools are being developed to cater to the unique needs of individual patients, which may enhance treatment efficacy. This trend suggests a growing collaboration between diagnostic companies and healthcare professionals to ensure that tests are not only precise but also tailored to specific patient demographics.

Rapid Diagnostics Market Drivers

Focus on Personalized Medicine

The trend towards personalized medicine is reshaping The Global Rapid Diagnostics Industry by emphasizing tailored treatment approaches based on individual patient profiles. This paradigm shift necessitates the development of diagnostic tools that can provide specific insights into a patient's genetic makeup, lifestyle, and environmental factors. As a result, there is a growing demand for rapid diagnostic tests that can deliver precise information to guide treatment decisions. Market analysis suggests that the personalized medicine segment is poised for significant growth, with projections indicating a potential increase in market size by over 15% in the next few years. This focus on customization not only enhances treatment efficacy but also fosters patient engagement, thereby driving the adoption of rapid diagnostics that align with personalized healthcare strategies.

Government Initiatives and Funding

Government initiatives and funding are instrumental in propelling The Global Rapid Diagnostics Industry forward. Various governments are increasingly recognizing the importance of rapid diagnostics in enhancing healthcare delivery and are allocating resources to support research and development in this field. Initiatives aimed at improving healthcare infrastructure, particularly in low- and middle-income countries, are expected to drive demand for rapid diagnostic solutions. Furthermore, public-private partnerships are emerging as a viable strategy to foster innovation and expedite the commercialization of new diagnostic technologies. Market data suggests that government funding in the healthcare sector is projected to increase, which could further stimulate growth in the rapid diagnostics market. This supportive environment is likely to encourage the development of novel diagnostic tools that address pressing healthcare challenges.

Shift Towards Point-of-Care Testing

The increasing preference for point-of-care testing (POCT) is significantly influencing The Global Rapid Diagnostics Industry. POCT allows for immediate results, which is crucial in emergency situations and for chronic disease management. The convenience of conducting tests at the patient's location reduces the need for laboratory visits, thereby streamlining the diagnostic process. Market data indicates that the POCT segment is expected to account for a substantial share of the overall market, driven by the rising demand for rapid and accurate testing solutions. This shift is particularly evident in areas such as infectious disease testing and glucose monitoring, where timely results can lead to better patient outcomes. Consequently, the growth of POCT is likely to propel the market forward, as healthcare systems increasingly adopt these technologies to enhance patient care.

Rising Incidence of Infectious Diseases

The escalating incidence of infectious diseases is a critical driver of The Global Rapid Diagnostics Industry. With the emergence of new pathogens and the resurgence of existing ones, there is an urgent need for rapid diagnostic solutions that can facilitate timely detection and management. Data from health organizations indicate that infectious diseases account for a substantial burden on global health systems, leading to increased healthcare expenditures. This scenario creates a favorable environment for the development and adoption of rapid diagnostic tests, particularly in regions with limited access to traditional laboratory facilities. The market is likely to expand as healthcare providers seek efficient tools to combat infectious diseases, thereby enhancing public health responses and improving patient outcomes.

Technological Advancements in Diagnostics

The rapid evolution of technology plays a pivotal role in shaping The Global Rapid Diagnostics Industry. Innovations such as microfluidics, biosensors, and artificial intelligence are enhancing the accuracy and speed of diagnostic tests. For instance, the integration of AI algorithms in diagnostic tools has been shown to improve the detection rates of various diseases, potentially increasing market demand. Furthermore, advancements in mobile health technologies are facilitating remote diagnostics, thereby expanding access to healthcare services. As a result, the market is projected to witness substantial growth, with estimates suggesting a compound annual growth rate of over 10% in the coming years. This technological momentum is likely to drive the development of more sophisticated diagnostic solutions, ultimately benefiting patients and healthcare providers alike.

Market Segment Insights

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

The Global Rapid Diagnostics Market is significantly influenced by the product segment, with Over-the-Counter (OTC) Kits leading in market share. This dominance is primarily attributed to their widespread availability and the increasing preference for home testing among consumers. In contrast, Professional Kits are gaining traction, reflecting a robust growth trajectory as healthcare settings increasingly adopt rapid testing solutions for various applications, from infectious diseases to chronic conditions.

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

Over-the-Counter (OTC) Kits dominate The Global Rapid Diagnostics Market, appealing to consumers due to their convenience and immediate results. They are widely used for conditions such as COVID-19, flu, and sexually transmitted infections, making them a favored choice among the general populace. In contrast, Professional Kits are emerging rapidly, driven by the need for accurate diagnostics in clinical settings. They are designed for healthcare professionals, offering advanced testing capabilities and higher reliability for critical decision-making, thereby contributing to their accelerated adoption across hospitals and clinics.

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

Within The Global Rapid Diagnostics Market, the application segment is diverse, with blood glucose testing being the most significant contributor. This segment accounts for a substantial share, primarily driven by the rising prevalence of diabetes worldwide. Infectious disease testing, while smaller in comparison, showcases rapid expansion due to increasing demand for quick diagnostic solutions, particularly in a post-pandemic environment. Both segments are crucial, but their market dynamics differ significantly, reflecting varying consumer needs and healthcare trends. The growth trends in the application segment are influenced by technological advancements and the rising demand for point-of-care testing. Blood glucose testing continues to gain traction, supported by an aging population and increasing health awareness. On the other hand, infectious disease testing is witnessing a surge as health authorities push for improved disease surveillance and quick turnaround times in testing. This shift is largely driven by advancements in diagnostic technologies, such as innovative test kits and portable devices, allowing for enhanced accuracy and ease of use in both clinical and home settings.

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

Blood glucose testing stands as the dominant application in The Global Rapid Diagnostics Market, reflecting the growing concerns regarding diabetes management and preventive healthcare. Its established presence is rooted in a long history of adoption by healthcare professionals and patients alike, aided by the development of user-friendly monitoring devices. As diabetes prevalence increases globally, the demand for effective blood glucose diagnostics continues to rise. Conversely, infectious disease testing emerges as a significant player, fueled by increased awareness and the need for rapid response to outbreaks. This segment is characterized by its innovative testing solutions, which offer quick results and efficient disease management. The rise of new pathogens and the urgency for rapid diagnostic procedures are propelling infectious disease testing into a prominent position in the market, making it an area of keen interest for future investments.

Get more detailed insights about Rapid Diagnostics Market

Regional Insights

By region, the report provides market insights into Europe, North America, Asia-Pacific, and the Rest of the World. The North American rapid diagnostics market will likely exhibit a significant CAGR growth in the study period. The North American region is the largest market for rapid diagnostics due to well-established healthcare infrastructure, the increasing prevalence of infectious diseases, and the rising demand for point-of-care testing. 

The United States dominates the market in this region due to the high demand for early diagnosis and treatment. In the United States, chronic diseases are the primary cause of death and disability. As per the Centers for Disease Control & Prevention (CDC), 6 in 10 Americans have at least one chronic illness as of February 2021. These and other chronic diseases are the leading causes of death and disability in the United States and the major cause of healthcare costs.

Also, the major countries studied in the market report are the U.S., German, Canada, France, the U.K., Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 2: RAPID DIAGNOSTICS MARKET SHARE BY REGION 2022 (%)RAPID DIAGNOSTICS MARKET SHARE BY REGION 2022Source: Secondary Research, Primary Research, Market Research Future Database, and Analyst Review

The European rapid diagnostics market accounts for the second-largest global market share. Europe is a key market for rapid diagnostics owing to the rising incidence of chronic diseases, the expanding need for personalized medication, and the growing understanding of the value of early diagnosis. 

The region also sees the introduction of novel technologies such as lab-on-a-chip and microfluidics, boosting market growth. Further, the German market of rapid diagnostics held the largest market share, and the U.K. market of rapid diagnostics was the fastest-growing market in the European region.

The Asia Pacific Rapid Diagnostics Market is expected to grow at the fastest CAGR from 2023 to 2032 due to the increasing burden of infectious diseases, rising healthcare expenditure, and growing demand for affordable and accessible diagnostic testing. Emerging economies such as China and India are driving market growth in this region due to their large patient pool and increasing healthcare spending. 

The region also offers significant opportunities for market players owing to a large untapped market. Moreover, the China market of rapid diagnostics held the largest market share, and the Indian market of rapid diagnostics was the fastest-growing market in the Asia-Pacific region.

Rapid Diagnostics Market Regional Image

Key Players and Competitive Insights

Leading market players, such as Abbott Laboratories, Roche Diagnostics, and Danaher Corporation, invest heavily in R&D to expand their product portfolios and gain a competitive advantage. With the increasing demand for rapid diagnostics due to the COVID-19 pandemic, global rapid diagnostics industry players are investing in capacity expansion and production scale-up to meet the rising demand. New product releases, strategic alliances, collaborations, and mergers and acquisitions among leading competitors are key market developments in the rapid diagnostics sector.

Major players in the rapid diagnostics market, such as Bio-Rad Laboratories Inc, Becton, Dickinson & Company, Bio-Rad Laboratories, and Quidel Corporation, also focus on expanding their global presence through acquisitions and collaborations with local players in emerging markets. Moreover, the trend towards personalized medicine and point-of-care testing propels the rapid diagnostics industry forward, with companies focusing on developing innovative and cutting-edge products to fulfill increasing demands.

Roche Diagnostics is a branch of F. Hoffmann-La Roche Ltd, a Swiss multinational healthcare firm. The firm is a market leader in in vitro diagnostics and medical imaging equipment. Roche Diagnostics employs about 120,000 people worldwide and operates in over 150 countries. Roche Diagnostics provides a wide range of products, including point-of-care testing solutions, fast antigen tests, and molecular assays for infectious disease detection. Roche introduced its Cobas Pulse System in certain countries that accept the CE Mark in January 2022. This is the latest generation of integrated point-of-care solutions for professional blood glucose management.

ACON Laboratories Inc. is a privately held firm in San Diego, California. The company was created in 1996 to develop reliable, high-quality, cost-effective medical diagnostic and healthcare solutions. ACON produces and distributes medical diagnostic devices such as rapid diagnostic tests for infectious diseases, fertility, illicit drugs, hematology instruments, and reagents. 

ACON Laboratories has increased its global presence, opening offices and subsidiaries in China, Canada, Mexico, and Germany. ACON Laboratories announced the release of their new rapid test, the Flowflex SARS-CoV-2 Antigen Rapid Test, in 2021. This test is intended to detect the presence of the SARS-CoV-2 virus in patients with COVID-19 symptoms, and it offers results in as little as 15 minutes.

Key Companies in the Rapid Diagnostics Market market include

Industry Developments

  • Q2 2024: Abbott launches new rapid COVID-19 and flu test in Europe Abbott announced the launch of a new rapid diagnostic test that simultaneously detects COVID-19 and influenza A/B in Europe, expanding its portfolio of point-of-care infectious disease diagnostics.
  • Q2 2024: QuidelOrtho Receives FDA Clearance for Sofia 2 SARS Antigen+ FIA Rapid Test QuidelOrtho received FDA clearance for its Sofia 2 SARS Antigen+ FIA, a rapid diagnostic test designed for point-of-care detection of SARS-CoV-2, further strengthening its U.S. diagnostics portfolio.
  • Q2 2024: BD Launches New Rapid Antimicrobial Susceptibility Test in Europe Becton, Dickinson and Company (BD) launched a new rapid antimicrobial susceptibility test in Europe, enabling clinicians to quickly determine the most effective antibiotics for patients with bloodstream infections.
  • Q2 2024: LumiraDx Announces CE Mark for New RSV Rapid Antigen Test LumiraDx received CE Mark approval for its new rapid antigen test for respiratory syncytial virus (RSV), allowing the company to market the test across the European Economic Area.
  • Q2 2024: Cue Health wins $28M contract from U.S. Department of Health and Human Services for rapid flu test Cue Health secured a $28 million contract from the U.S. Department of Health and Human Services to develop and supply a rapid flu diagnostic test for use in public health settings.
  • Q2 2024: Visby Medical raises $100M Series E to expand rapid diagnostics platform Visby Medical closed a $100 million Series E funding round to accelerate the development and commercialization of its rapid, single-use molecular diagnostic platform.
  • Q3 2024: Siemens Healthineers acquires rapid diagnostics startup CorDx for $350 million Siemens Healthineers announced the acquisition of CorDx, a U.S.-based rapid diagnostics company, for $350 million to strengthen its point-of-care testing capabilities.
  • Q3 2024: bioMérieux launches new rapid sepsis diagnostic test in the U.S. bioMérieux launched a new rapid diagnostic test for sepsis in the United States, aiming to improve early detection and treatment outcomes for critically ill patients.
  • Q3 2024: OraSure Technologies Appoints New CEO to Lead Rapid Diagnostics Market Growth OraSure Technologies announced the appointment of a new Chief Executive Officer, signaling a strategic focus on expanding its rapid diagnostics business.
  • Q3 2024: Ellume opens new U.S. manufacturing facility for rapid COVID-19 and flu tests Ellume inaugurated a new manufacturing facility in the United States dedicated to producing rapid COVID-19 and influenza diagnostic tests, increasing domestic supply capacity.
  • Q4 2024: Roche launches new rapid molecular test for sexually transmitted infections Roche introduced a new rapid molecular diagnostic test for sexually transmitted infections, expanding its portfolio of point-of-care solutions for infectious diseases.
  • Q1 2025: Abbott receives FDA approval for new rapid dengue test Abbott received FDA approval for its new rapid diagnostic test for dengue, enabling faster detection and management of the disease in endemic regions.

Future Outlook

Rapid Diagnostics Market Future Outlook

The Global Rapid Diagnostics Market is projected to grow at an 8.8% CAGR from 2024 to 2035, driven by technological advancements, increasing demand for point-of-care testing, and rising healthcare expenditures.

New opportunities lie in:

  • Development of portable diagnostic devices for remote areas
  • Integration of AI for enhanced diagnostic accuracy
  • Expansion of telehealth services incorporating rapid diagnostics

By 2035, the market is expected to be robust, driven by innovation and increased accessibility.

Market Segmentation

Rapid Diagnostics Market Product Outlook

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

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 202431.44(USD Billion)
MARKET SIZE 202534.21(USD Billion)
MARKET SIZE 203579.51(USD Billion)
COMPOUND ANNUAL GROWTH RATE (CAGR)8.8% (2024 - 2035)
REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR2024
Market Forecast Period2025 - 2035
Historical Data2019 - 2024
Market Forecast UnitsUSD Billion
Key Companies ProfiledMarket analysis in progress
Segments CoveredMarket segmentation analysis in progress
Key Market OpportunitiesIntegration of artificial intelligence in rapid diagnostics enhances accuracy and efficiency in disease detection.
Key Market DynamicsTechnological advancements drive rapid diagnostics, enhancing accuracy and speed in disease detection and management.
Countries CoveredNorth America, Europe, APAC, South America, MEA

Market Highlights

Author
Kinjoll Dey
Research Analyst Level I

He is an extremely curious individual currently working in Healthcare and Medical Devices Domain. Kinjoll is comfortably versed in data centric research backed by healthcare educational background. He leverages extensive data mining and analytics tools such as Primary and Secondary Research, Statistical Analysis, Machine Learning, Data Modelling. His key role also involves Technical Sales Support, Client Interaction and Project management within the Healthcare team. Lastly, he showcases extensive affinity towards learning new skills and remain fascinated in implementing them.

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FAQs

What is the projected market valuation of The Global Rapid Diagnostics by 2035?

The projected market valuation for The Global Rapid Diagnostics is expected to reach 79.51 USD Billion by 2035.

What was the market valuation of The Global Rapid Diagnostics in 2024?

The overall market valuation of The Global Rapid Diagnostics was 31.44 USD Billion in 2024.

What is the expected CAGR for The Global Rapid Diagnostics during the forecast period 2025 - 2035?

The expected CAGR for The Global Rapid Diagnostics during the forecast period 2025 - 2035 is 8.8%.

Which companies are considered key players in The Global Rapid Diagnostics?

Key players in The Global Rapid Diagnostics include Abbott Laboratories, Roche Diagnostics, Siemens Healthineers, and Thermo Fisher Scientific.

What are the projected revenues for Over-the-Counter (OTC) Kits by 2035?

The projected revenues for Over-the-Counter (OTC) Kits are expected to reach 30.0 USD Billion by 2035.

How much is the Infectious Disease Testing segment projected to generate by 2035?

The Infectious Disease Testing segment is projected to generate 25.0 USD Billion by 2035.

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