Rapid Medical Diagnostic Kits Market Size, Share & Trends Report

Rapid Medical Diagnostic Kits Market Size, Share & Trends Analysis Report By Product, By Technology (Lateral Flow, Agglutination, Solid Phase), By End Use (Blood Glucose Testing, Coagulation Testing), By Region, And Segment Forecasts, 2020 - 2027

  • Published Date: Aug, 2020
  • Base Year for Estimate: 2019
  • Report ID: GVR-4-68038-987-6
  • Format: Electronic (PDF)
  • Historical Data: 2016 - 2018
  • Number of Pages: 150

Report Overview

The global rapid medical diagnostic kits market size was valued at USD 16.7 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 4.2% from 2020 to 2027. Rapid medical diagnostic kits aid in the speedy etiologic diagnosis of various chronic diseases. These test kits are easy to use and require limited training, facilitating effective analysis. The target audience in the market includes the general population suffering from chronic diseases. Increasing the prevalence of chronic diseases such as cancer, infectious diseases, and diabetes is expected to drive the growth of the market for rapid medical diagnostic kits. Rising need and awareness for rapid detection of chronic diseases is also expected to boost the adoption of these medical kits. In addition, the growing trend of point-of-care diagnostics is further driving the market for rapid medical diagnostic kits. Ancillary markets of rapid medical diagnostic kits are expected to exhibit a similar growth rate during the forecast period.

Germany rapid medical diagnostic kits market size

This can be attributed to the high demand for portable and rapid medical testing kits, a rise in the number of infectious disease cases, and an increase in geriatric population. Besides, rising investments and awareness campaigns by the government, new product approvals, and the growing incidence of communicable diseases are some of the factors driving the market. The presence of several market players and intense competition among players are impacting the buying behavior of consumers. External factors influencing consumers’ buying behavior include culture, social class, family, personal influence, and reference groups. The growing prevalence of chronic diseases is leading to an increase in the need for rapid disease diagnosis, which is positively impacting the buying behavior process of rapid medical diagnostic kits.

Increasing incidence of chronic diseases, infectious diseases, and noninfectious diseases such as diabetes, cardiovascular diseases, cancer, and gastrointestinal diseases, is a major factor driving the growth of the market for rapid medical diagnostic kits. Factors such as unhealthy and sedentary lifestyle, alcohol abuse, smoking, and antimicrobial resistance are contributing to the rising prevalence of these diseases.

Government bodies are also investing heavily to curb the high prevalence of various infectious diseases such as malaria and the novel coronavirus. For instance, as per WHO, in 2017, government authorities and private international investors of endemic nations invested around USD 3.1 billion to control and eliminate the disease. In March 2020, Mesa Biotech, Inc., a U.S.-based molecular diagnostic company, received USD 561,000 contract from the U.S. Department of Health and Human Services (HHS) for the development of a novel rapid molecular diagnostic test kits for COVID-19.

Product Insights

In 2019, the OTC kits segment accounted for the largest revenue share of 61.8% in the market for rapid medical diagnostic kits. The segment is anticipated to maintain its dominance during the forecast period. This dominance can be attributed to the fact that these tests are easy to use in the “near-patient setting” and are a cost-effective alternative to expensive laboratory testing. Over-the-Counter (OTC) kits are the most common rapid medical diagnostic kits available in the market, which facilitate quick and easy disease diagnosis. These tests are typically used in homecare settings, providing an easy and cost-effective alternative to laboratory testing.

Professional kits consist of laboratory tests typically performed in hospitals and diagnostic laboratories. These tests most often make use of techniques such as PCR and molecular diagnostics, providing higher test sensitivity and specificity. Professional laboratory tests are typically performed after a positive RDT has been obtained to confirm disease diagnosis. As RDTs have low sensitivity, they often provide false negatives, thus the use of professional tests is the gold standard in diagnostic settings.

Technology Insights

In 2019, the lateral flow technology segment accounted for the largest revenue share of 32.2% in the market for rapid medical diagnostic kits. This is attributed to several advantages offered by the lateral flow technology over other techniques, such as cost-effectiveness, ease of use, and portability. Furthermore, an increase in initiatives by key players for the development of novel lateral flow tests for COVID-19 diagnosis is anticipated to further support segment growth during the forecast period.

Lateral flow immunoassay or immunochromatography assay is among the most used technology across rapid medical diagnostic kits. Lateral Flow Assays (LFAs) are rapid, low cost, and portable, which is crucial in the effective diagnosis of infectious diseases. The two types of lateral flow tests are sandwich and competitive assays. These tests can also be combined to form multiplexed LFAs such as nucleic acid lateral flow immunoassay. These tests are used to detect multiple targets in a single test, maximizing the use of the patient’s sample. The presence of a broad spectrum of biomarkers, pathogens, and environmental contaminants is detected by lateral flow testing, resulting in increasing demand for these products.

Solid-phase tests are assays in which at least one molecule being analyzed is attached to a solid surface, such as sides of a tube or microplate wall, whereas the other reactants are free in solution. Some of the common examples of these tests are solid-phase Radioimmunoassay (RIA) and Enzyme-Linked Immunosorbent Assay (ELISA). Some common variants of ELISA are sandwich, competitive, reverse, and direct ELISA. Due to its high sensitivity, ELISA was one of the first screening tests used for HIV diagnosis. ELISA is used to detect microorganisms such as mycobacterium, rotavirus, coronavirus, hepatitis B and C, and enterotoxin.

Application Insights

The blood glucose testing segment accounted for the largest revenue share of 13.6% in 2019 in the market for rapid medical diagnostic kits. This is owing to the high prevalence of diabetes and increasing awareness about the management of the disease. The infectious disease testing segment accounted for the second-largest market share in 2019, owing to the growing prevalence of various infectious diseases, including the outbreak of novel coronavirus (COVID-19) in 2020.

The rising global prevalence of diabetes has led to a rise in the demand for blood glucose diagnostic kits and devices. In most cases, patients suffering from type I diabetes are advised to monitor glucose levels about 4 to 10 times a day. Patients suffering from type II diabetes are advised to monitor glucose levels a few times during the day based on the type of insulin is being used to manage the disease.

Patients affected with diabetes are thus required to frequently undergo blood glucose (oral or blood-based) and HbA1C tests to maintain optimal glucose levels. Rising incidence of obesity and other lifestyle-associated disorders are among the factors boosting the need for A1C tests for prediabetes and type 2 diabetes. An outbreak of the novel coronavirus (COVID-19) has created an urgent demand for its rapid medical diagnostic kits, as it is a cornerstone of the management of the COVID-19 pandemic. According to data published by the WHO, as of June 10, 2020, around 7,127,753 confirmed cases of COVID-19 have been reported globally, resulting in around 407,159 deaths.

Countries, including the U.S., Brazil, Russia, the U.K., Spain, Italy, India, Germany, Peru, Turkey, Iran, and France have reported the highest number of COVID-19 cases. Mass testing has increased to manage this pandemic. To fulfill this growing need, numerous diagnostics companies are focusing on R&D activities for the development of novel COVID-19 rapid medical diagnostic kits and gaining approval from different regulatory bodies.

End-use Insights

In 2019, the hospitals and clinics segment represented the largest share of 45.4% in the market for rapid medical diagnostic kits, as they serve as primary care settings for diagnosis and treatment of all diseases. Furthermore, increasing hospitalization due to the outbreak of COVID-19 is expected to further support segment growth. The home care segment is expected to show the fastest growth in the end-use segment, owing to the increasing use of the point-of-care tests at home care settings.

Hospitals and clinics are primary care settings for the diagnosis and treatment of medical conditions. The majority of the population relies on these long-term facilities for diagnosis, treatment, and management of diseases. Thus, hospitals and clinics segment held the largest market share in 2019. Constant changes in the healthcare industry have led to an increase in the need for hospitals with enhanced diagnostic services. The rise in healthcare expenditure globally has also significantly contributed to the growth of the rapid medical diagnostic kits market.

Global rapid medical diagnostic kits market share

With the advent of point of care diagnostics or at-home diagnosis, there has been a steady rise in the number of rapid medical diagnostic tests being performed globally. Most rapid influenza diagnostic kits that are Clinical Laboratory Improvement Amendments (CLIA) waived are typically used in POC settings. Lateral flow rapid antigen assay that helps detect pregnancy at home is widely used, thus driving the demand for rapid medical diagnostic kits that can be used at home. Blood glucose testing strips are also commonly used at home, which are a safe, easy, and affordable way to check diabetes.

Regional Insights

North America held the largest market share of 31.2% among all the regions in 2019 and is expected to dominate the market for rapid medical diagnostic kits throughout the study period. Key factors contributing to its dominance include the presence of developed healthcare infrastructure, favorable reimbursement scenario, and high accessibility of rapid medical diagnostic tests due to the presence of key players in the region.

Furthermore, the high prevalence of chronic diseases as well as the outbreak of COVID-19 in 2020 has drastically boosted the demand for novel rapid medical diagnostic kits in the region. In Asia Pacific, the market is expected to grow at the fastest rate during the forecast period. This growth is attributed to the emergence of local players and the increasing penetration of key players in the region.

For instance, in February 2018, Meridian Bioscience, a U.S. based developer of medical diagnostic tests launched its new TruQuick rapid test in the Asia Pacific. TruQuick is a rapid test for the diagnosis of tropical, infectious, respiratory, sexually transmitted, gastrointestinal, and cardiac diseases as well as cancer. Furthermore, the increasing prevalence of infectious diseases and high cases of COVID-19 in parts of Asia Pacific has driven the demand for rapid medical diagnostic kits in the region.

Key Companies & Market Share Insights

Key companies are keen on adopting strategic moves that assist them in sustaining competition in the market for rapid medical diagnostic kits. For instance, in November 2019, ACON Laboratories launched it's On Call Extra Mobile Glucose Monitoring Systems in Latin America and Europe. With this launch, the company has improved access to its new product in Europe and Latin America. Some of the prominent players in the rapid medical diagnostic kits market include:

  • 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

Rapid Medical Diagnostic Kits Market Report Scope

Report Attribute

Details

Market size value in 2020

USD 17.8 billion

Revenue forecast in 2027

USD 23.6 billion

Growth rate

CAGR of 4.2% from 2020 to 2027

Base year for estimation

2019

Historical data

2016 - 2018

Forecast period

2020 - 2027

Quantitative units

Revenue in USD million and CAGR from 2020 to 2027

Report coverage

Revenue forecast, company share, competitive landscape, growth factors and trends

Segments covered

Product, technology, application, end-use, region

Regional scope

North America; Europe; Asia Pacific; Latin America; Middle East & Africa

Country scope

The U.S.; Canada; Germany; The U.K.; France; Spain; Italy; Russia; Japan; China; India; South Korea; Australia; Singapore; Brazil; Mexico; Argentina; South Africa; Saudi Arabia; UAE

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

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Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global rapid medical diagnostic kits market report on the basis of product, technology, application, end-use, and region:

  • Product Outlook (Revenue, USD Million, 2016 - 2027)

    • Over-The-Counter (OTC) Kits

    • Professional Kits

  • Technology Outlook (Revenue, USD Million, 2016 - 2027)

    • Lateral Flow

    • Agglutination

    • Solid Phase

    • Other Technologies

  • Application Outlook (Revenue, USD Million, 2016 - 2027)

    • Blood Glucose Testing

    • Infectious Disease Testing

    • Cardiometabolic Testing

    • Pregnancy and Fertility Testing

    • Fecal Occult Blood Testing

    • Coagulation Testing

    • Toxicology Testing

    • Lipid Profile Testing

    • Other Applications

  • End-use Outlook (Revenue, USD Million, 2016 - 2027)

    • Hospitals & Clinics

    • Home Care

    • Diagnostic Laboratories

  • Regional Outlook (Revenue, USD Million, 2016 - 2027)

    • North America

      • The U.S.

      • Canada

    • Europe

      • Germany

      • The U.K.

      • France

      • Italy

      • Spain

      • Russia

    • Asia Pacific

      • Japan

      • China

      • India

      • South Korea

      • Australia

      • Singapore

    • Latin America

      • Brazil

      • Mexico

      • Argentina

    • Middle East Africa (MEA)

      • South Africa

      • Saudi Arabia

      • UAE

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