Rapid Medical Diagnostic Kits Market

Rapid Medical Diagnostic Kits Market Analysis By Test (Cholesterol Monitoring, Infectious Diseases Testing), By Application (Hospitals & Clinics, Homecare Settings, Fertility & Pregnancy Testing, Blood Glucose Testing, Substance Abuse Testing), By Region - Global Insights 2021-2031

Analysis of Rapid Medical Diagnostic Kits market covering 30+ countries including analysis of US, Canada, UK, Germany, France, Nordics, GCC countries, Japan, Korea and many more

Rapid Medical Diagnostic Kits Market Growth Outlook

The global rapid medical diagnostic kits market size was valued at US$ 15.6 Billion in 2021, and is projected to reach US$ 23.1 Billion by 2031, with a compound annual growth rate (CAGR) of 4% from 2021 to 2031.

Global market is segmented into various application, including Hospitals & Clinics, Homecare Settings, Fertility & Pregnancy Testing, Blood Glucose Testing and Substance Abuse Testing. Among all the application, blood glucose testing will emerge as a key driver of growth, with a projected growth rate of 2x over the forecast period.

 Report Attributes


Market Size Value in 2021 USD 15.6 Billion
Market Value Forecast in 2031 USD 23.1 Billion
Growth Rate CAGR of 4% from 2021 to 2031 
Forecast Period 2021-2031
Historical Data Available for 2016-2020
Key Regions Covered
  • North America 
  • Latin America 
  • Europe 
  • East Asia 
  • South Asia 
  • Oceania 
  • Middle East & Africa 
Key Companies Profiled
  • ACON Laboratories Inc. 
  • Abbott Laboratories 
  • Artron Laboratories Inc. 
  • Alfa Scientific Designs, Inc. 
  • Becton, Dickinson, and Company 
  • BTNX, Inc. 
  • bioMérieux SA 
  • Cardinal Health 
  • Bio-Rad Laboratories, Inc. 
  • Danaher Corporation 
  • Creative Diagnostics 
  • Meridian Bioscience, Inc. 
  • F. Hoffmann-La Roche AG 
  • McKesson Medical-Surgical, Inc. 
  • Sight Diagnostics Ltd. 
  • Trinity Biotech 
  • Zoetis 

Revenue Analysis 2016-2020 Vs Future Outlook 2021-2031

According to Fact.MR, market research and competitive intelligence provider, from 2016 to 2020, the global market for rapid medical diagnostic kits expanded at a CAGR of 3%. Increasing prevalence of infectious diseases has spurred demand in recent years. 

Prospects further broadened with the outbreak of the COVID-19 pandemic, with patients and non-infected people opting for diagnostic tests with faster turnaround times. Moreover, reluctance in visiting healthcare facilities, either due to absence of one in the vicinity, or apprehension of contracting an infection during the visit, have broadened their popularity. 

Future market demand is reliant on the application of rapid tests in detecting, treating and diagnosing chronic ailments, most notably elevated blood sugar levels. This would help medical professional chart a treatment course for diabetic patients. From 2021 to 2031, the market is poised to expand 1.5x.  

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How is Increasing Prevalence Rates of Infectious Diseases Stimulating Adoption?

A high incidence rate of infections both inside and outside the home has increased the need for people to use rapid testing kits at home. Diagnostic results can be delivered at the point of care thereby decreasing the need for multiple visits to obtain the results of diagnostic tests and thereby improving the specificity of the diagnosis.  

As a result, the chances of the patient receiving treatment increase, and the likelihood of presumptive treatment is reduced, where the patient will more likely become ill in the interim. In response to the growing need to detect pathogens and to know the infection source, rapid diagnostic have been gaining popularity in the market. The increasing use of technologies on the market has yielded a nationwide increase in the demand for these tests on the market.  

It has been estimated that the growth in disposable income and government programs over the past few decades has created a significant market for these tests. Government regulations regarding quarantine and COVID-19 tests have led to a greater demand for rapid tests in both the commercial and residential sectors.  

Will Resumption of Work Premises Bolster Rapid Medical Diagnostic Kits Demand?

With more people traveling and rejoining workplaces, rapid tests are becoming more popular in the markets. Airports, hospitals, offices, etc., are some of the places where such tests are highly in demand. Funding from both the government and private entities has made these tests more popular.  

The number of assays that are compatible with POC testing will surely increase in the years to come, and testing outside of the standard clinical diagnostic laboratories will surely expand in the future. With returning travelers being exposed to a greater variety of contaminating pathogens, POC testing for nondomestic infectious diseases might not be feasible for most centers.  

The test may facilitate a quick diagnosis, provide important information for early intervention, and limit the amount of unnecessary laboratory testing for common syndromes such as respiratory tract and gastrointestinal infections. 

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How are Technological Advancements for Rapid Diagnoses Generating Growth Potential?

Using advanced medical technologies, researchers develop or modify rapid medical test kits to use in home health care settings, hospitals, clinics, and health care centers, ensuring they provide accurate test results. Highly qualified specialists design rapid medical diagnostic kits based on market demands. 

For instance, molecular assays developed by Israeli researchers enables high sensitivity detection of pathogens in clinical samples. To detect RNA, a modified double-quenched hydrolysis probe was combined with an RNA detection system combining both magnetic modulation bio sensing and rapid thermal cycling. 

In June 2021, Scientists at SANKEN at Osaka University demonstrated that machine learning is accurate enough to identify one virus particle passing through a nanopore. Test platforms they developed were so sensitive that they were able to discern between coronaviruses responsible for SARS, common cold, MERS, and COVID. The outcome of this study could lead to rapid, easy-to-use, and highly accurate diagnostic tests for COVID-19 and other viral diseases

Scientists conduct numerous studies and perform various trials before developing these tests. Despite the adverse effects of the COVID-19 outbreak, many manufacturers have developed rapid tests for the detection of pathogens and faster and better treatment globally. However, these tests have not yet been proved to be as accurate by all medical professionals, despite their high demand in the market.  

Country-wise Analysis

How big is the Opportunity in the U.S. for Rapid Medical Diagnostic Kits? 

The market for rapid medical diagnostic kits in the U.S. is estimated to grow at a fast pace in the year 2021. The U.S. was the leading country in 2020, with a share of above 30%, and is expected to maintain its supremacy from 2021 to 2031.  

After the world was hit by the COVID-19 pandemic, cases of people suffering from chronic diseases have increased, which has raised the demand for effective rapid medical diagnostic kits in the country. Several companies got involved in the development of rapid diagnostic tests for novel coronavirus, and are aiming to gain approval from the FDA to launch these tests in the U.S. 

For example, in May 2020, an American diagnostic healthcare company named Quidel Corporation received Emergency Use Authorization (EUA) from the FDA for its new Sofia 2 SARS Antigen FIA for rapid diagnosis of COVID-19. 

Will Japan’s Advanced Healthcare Sector Drive Demand? 

Japan is the world’s third-largest economy, with a great standard of living. Healthcare facilities in Japan are provided free of cost to its citizens. In October 2020, Japan’s Ministry of Health, Labour and Welfare granted the usage of Quick Navi ™ -Flu2, which is a rapid diagnostic kit for the detection of influenza virus antigen, manufactured and marketed by Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Denka Company Limited. 

It also announced that a change in manufacturing and marketing approval for influenza virus antigen rapid diagnostic kits was granted by the Ministry of Health, Labour and Welfare in Japan. 

Japan has taken rapid strides as far as rapid medical diagnostic kits are concerned, with high revenue in the year 2020, which is expected to remain the same through 2031. Japan is expected to register growth of over 5% from 2021-2031, which would be the highest cumulative growth as per the Centers for Disease Control and Prevention (CDC). 

What are the Trends in China for Rapid Medical Diagnostic Kits? 

Rapid medical diagnostic kits involve many players in China as it is considered as one of the fastest-growing areas in the country. The Chinese government is also expanding the types of kits that can be used for the diagnosis of several diseases, rapidly and accurately. 

China has made advances in several major areas, including multiplexing, which is used for simultaneous determination of multiple analyses. Profile test kits are being used for differential monitoring and diagnosis of patients. 

These advances have made China one of the leading countries in rapid medical diagnostic kits, and it is expected to maintain this trend over the next 10 years. China, which is the second-largest economy in the world, is estimated to progress at an impressive CAGR of around 7% through 2031. 

Rapid medical diagnostic kits market forecast analysis by Fact.MR

Category-wise Insights

Will Blood Glucose Testing Generate New Avenues for Growth? 

The increasing number of diabetic patients globally has resulted in an increased demand for glucometers on the market. Self-monitoring of glucose levels at home has grown the market for rapid blood glucose tests. As the population ages, rapid tests are in greater demand. 

According to health experts, diabetes, in combination with COVID-19, may be contributing to the sudden increase in mucormycosis infections. Based on these aforementioned developments, the segment will likely experience 2x growth until 2031 

What is Stimulating Demand for Rapid Medical Diagnostic Kits for Homecare Settings? 

Although rapid home-based COVID-19 tests have lower sensitivity, its results may increase the likelihood of reducing the spread of disease. Furthermore, inadequate access to proper healthcare facilities, especially in remote areas, has emphasized need for these medical diagnostic kits. 

Kits for home testing can save money and provide a secure and private procedure for assessing vital signs, while others can alert patients to potential health hazards. Hence, Fact.MR expects demand for this segment to account for 30% demand in forthcoming years. 

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Competitive Landscape

Manufacturers benefit from strategic collaborations by increasing production and meeting consumer demand. Notable developments concerning deployment of rapid medical diagnostic kits are as follows: 

  • On January 26th, 2021, Innova Medical Group, Inc., announced the production of INNOVA SARS-CoV-2 Antigen Rapid Qualitative Test Kit for the U.S market, designed to provide 5 million test kit production per day by the end of the month and also expanding to 50 million rapid test kits per day in its expanded Orange County facility 

  • Likewise, in June 2021, Hoffmann-La Roche obtained the CE mark for its SARS-CoV-2 Antigen Self Nasal testing kit across home settings. After this development, the company hopes to extend its outreach across various countries through pharmacies and other distribution channels, in packs of five 

Key Segments Covered

  • By Test 

    • Cholesterol Monitoring 
    • Infectious Diseases Testing 
  • By Application 

    • Hospitals & Clinics 
    • Homecare Settings 
    • Veterinary Settings 
    • Fertility & Pregnancy Testing 
    • Blood Glucose Testing 
    • Other Tests 
    • Substance Abuse Testing 
  • By Region

    • North America
    • Latin America
    • Europe
    • East Asia
    • South Asia & Oceania
    • MEA

- FAQs -

From 2016 to 2020, rapid medical diagnostic kits sales surged at around 3% CAGR

From 2021-2031, rapid medical diagnostic kits demand will likely surge at a CAGR of 4%

By 2031, rapid medical diagnostic kits sales will likely reach US$ 23.1 Bn

The growing number of diabetic tests and COVID-19 tests are fueling the demand for rapid medical diagnostic kits

Around 30% of the global rapid medical diagnostic kits demand will be stimulated by the U.S

According to Fact.MR, Japan is likely to register a CAGR of 5% in the rapid medical diagnostic kits domain

China is the fastest growing market, registering a CAGR worth 7% from 2021 to 2031


Testing for blood glucose levels is anticipated to rise, experiencing 2x growth until 2031

Rapid medical diagnostic kits for homecare settings will generate credible opportunities, accounting for 30% revenue

Rapid Medical Diagnostic Kits Market

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