Rapid Medical Diagnostic Devices Market, by Technology (Lateral Flow, Agglutination Assays, Flow-Through, and Biosensors), By Application (Cardio Metabolic Testing, Infectious Disease Testing, Nephrology Testing, Drugs of Abuse (DoA) Testing, Blood Glucose Testing, Pregnancy Testing, Cancer Biomarker Testing, and Others), By End User (Hospitals, Diagnostic Laboratories, Home-Care Settings, and Others), and by Region - Global Forecast to 2025

Rapid Medical Diagnostic Devices Market - Insights

Rapid medical diagnostic devices provide test results within a minimum amount of time ranging from under a minute to up to a few minutes. Rapid medical diagnosis involves testing of the samples to identify the cause behind a disease and start the treatment. Rapid diagnosis helps in early detection of diseases, which would aid in adopting an optimal treatment plan. Diagnosis using rapid medical diagnosis devices is often a non-invasive approach, which makes frequent testing possible, and treatment can be effectively validated. Rapid diagnosis requires only a small amount of sample and the procedure is quicker. Rapid medical diagnostic devices make use of innovative technologies such as lateral flow and agglutination assays as well as biosensors. Some of the commercially available rapid medical diagnostic devices include Uni-Gold HIV, Accu-Chek Aviva meter, Alere I Influenza A & B, and ICON SC Strep A.

Rising demand for decentralized (point of care) testing

Demand for decentralized testing is rising, owing to factors such as less time consumption, independence from centralized laboratories, and cost-effectiveness. Rapid diagnostic testing aid patients by conducting testing process at the comfort of their homes, which is convenient and helps in early diagnosis and treatment. This is expected to significantly affect treatment outcomes. Manufacturers such as Alere, Inc., Roche, and Danaher Corporation are providing faster operating, easy-to-use, and reliable rapid diagnostic devices, to cater to rising demand for rapid diagnosis from patients and healthcare providers. Large population base in certain rural areas do not have adequate access to laboratory testing facilities, therefore, demand for rapid diagnostic devices from these is increasing. Rapid diagnostic devices aid in improving treatment outcomes by rapid testing and disease monitoring. Furthermore, diseases requiring constant monitoring such as diabetes, wherein, real-time physician counselling is necessary, rapid diagnostic medical devices such as glucometers have proven to be highly effective, which is further boosting growth of the market.

The global rapid medical diagnostic devices market was valued at US$ 17,078.1 million in 2016 and is expected to witness a robust CAGR of 8.2% over the forecast period (2017–2025).

Figure 1. Global Rapid Medical Diagnostic Devices Market Share, by Technology (%) 2017 and 2025

rapid medical diagnostic devices market

Source: Coherent Market Insights Analysis (2017)

Increasing prevalence of chronic diseases is expected to boost the demand for rapid diagnostic devices

Incidence of chronic diseases such as cancer, diabetes, HIV, tuberculosis, and cardiovascular conditions is increasing, which is expected to positively impact growth of the rapid medical diagnostic devices market. For instance, according to American Diabetes Association (ADA) around 30.3 million population in U.S. was suffering from diabetes in 2015 and around 1.5 million people are diagnosed with the disease every year. Moreover, according to the World Health Organization (WHO), an estimated 36.7 million people were suffering from HIV globally, in 2016. According to the World Health Organization (WHO), in 2015, an estimated 32,000 deaths from tuberculosis and around 3, 23,000 new cases of TB cases were reported in the European region. According to Centers for Disease Control and Prevention, 2016, the number of deaths due to heart disease increased from 596,577 in 2011 to 614,348 in 2014, i.e. 3.0% between 2011 and 2014. Moreover, death due to cancer increased by 2.6% during the same time period. Early diagnosis can play a vital role in preventing or curtailing this increasing number of death due to chronic diseases such as heart disease, and cancer. As rapid diagnostic devices are primarily used for early diagnosis, the market for rapid diagnostic devices is expected to witness rapid growth rate over the forecast period.

However, factors such as reliability of the test results, less sensitivity as compared to laboratory testing, and interference in tests resulting in inaccurate final results are expected to hinder growth of the market over the forecast period.

Some major players operating in the rapid medical diagnostic devices market include Danaher Corporation, Abbott Laboratories, Acon Laboratories, Inc., Hoffman-La Roche AG, Becton, Dickinson, and Company, Johnson & Johnson, Trinity Biotech Plc, and Siemens Healthineers.

Prevalence of chronic diseases such as cancer, diabetes, cardiovascular, and infectious diseases (tuberculosis, HIV, malaria, and sexually transmitted diseases) is rising globally, and is expected to lead to high demand for rapid diagnostic techniques and devices. Diseases such as Chikungunya virus infection, neglected infectious diseases (Chagas diseases, Dengue, Leprosy, Schistosomiasis, and others) create extensive unmet needs for rapid diagnostic tests. Though rapid diagnostic tests are available for these diseases such as rapid CHIKV IgM for Chikungunya, the accuracy of these tests is not known. Severe conditions such as multidrug-resistant tuberculosis (MDR-TB) has high prevalence in emerging economies such as India, which requires rapid diagnostic devices. For instance, according to Lancet 2017, by 2040, the percentage of MDR-TB will make up of 12.4% of the TB cases in India. Leading manufacturers with established research and development capacities could aim towards development of rapid diagnostics for such diseases and gain first mover advantage in a potential market.

Market Dynamics

Demand for decentralized testing is rising, owing to factors such as less time consuming, independence from centralized laboratories as the testing can be done on the spot without the need of laboratory facilities, and cost effectiveness, which is expected to create a conducive environment for growth of rapid medical diagnostic devices market. The market is expected to exhibit significant growth, owing to further developments in point-of-care diagnostics aimed towards impacting medical outcomes, increased adoption of rapid medical diagnostic devices, and rising prevalence of chronic diseases such as HIV, infectious diseases, and diabetes. Development of innovative rapid medical diagnostic, and wide number of applications of these ranging from cancer diagnosis to metabolic diseases is expected to fuel growth of the market. Issues associated with reliability of rapid diagnostic devices results, management related issues in remote areas, and result reliability issues are expected to hinder the market growth.

Key features of the study:

  • This report provides in-depth analysis of rapid medical diagnostic devices market and provides market size (US$ Million) and Cumulative Annual Growth Rate (CAGR %) for the forecast period (2017–2025), considering 2016 as the base year
  • It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, regional outlook, and competitive strategy adopted by the leading players
  • It profiles leading players in the global rapid medical diagnostic devices market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments, and strategies
  • Key companies covered as a part of this study include Danaher Corporation, Abbott Laboratories, Acon Laboratories, Inc., Hoffman-La Roche Ltd., Becton, Dickinson, and Company, Johnson & Johnson, Trinity Biotech Plc, and Siemens Healthineers.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decision regarding their future product launches, technology up-gradation, market expansion, and marketing tactics
  • The global rapid medical diagnostic devices market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through the various strategy matrices used in analyzing the rapid medical diagnostic devices market

Detailed Segmentation:

  • Global Rapid Medical Diagnostic Devices Market, By Technology:
    • Lateral Flow
    • Agglutination Assays
    • Flow-Through
    • Biosensors
  • Global Rapid Medical Diagnostic Devices Market, By Application:
    • Cardio Metabolic Testing
    • Infectious Disease Testing
    • Nephrology Testing
    • Drugs of Abuse (DoA) Testing
    • Blood Glucose Testing
    • Pregnancy Testing
    • Cancer Biomarker Testing
    • Others
  • Global Rapid Medical Diagnostic Devices Market, By End User:
    • Hospitals
    • Diagnostic Laboratories
    • Home-Care Settings
    • Others
  • Global Rapid Medical Diagnostic Devices Market, By Region:
    • North America
      • By Technology:
        • Lateral Flow
        • Agglutination Assays
        • Flow-Through
        • Biosensors
      • By Application:
        • Cardio Metabolic Testing
        • Infectious Disease Testing
        • Nephrology Testing
        • Drugs of Abuse (DoA) Testing
        • Blood Glucose Testing
        • Pregnancy Testing
        • Cancer Biomarker Testing
        • Others
      • By End User:
        • Hospitals
        • Diagnostic Laboratories
        • Home-Care Settings
        • Others
      • By Country:
        • U.S.
        • Canada
    • Europe
      • By Technology:
        • Lateral Flow
        • Agglutination Assays
        • Flow-Through
        • Biosensors
      • By Application:
        • Cardio Metabolic Testing
        • Infectious Disease Testing
        • Nephrology Testing
        • Drugs of Abuse (DoA) Testing
        • Blood Glucose Testing
        • Pregnancy Testing
        • Cancer Biomarker Testing
        • Others
      • By End User:
        • Hospitals
        • Diagnostic Laboratories
        • Home-Care Settings
        • Others
      • By Country:
        • U.K.
        • Germany
        • Italy
        • France
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Technology:
        • Lateral Flow
        • Agglutination Assays
        • Flow-Through
        • Biosensors
      • By Application:
        • Cardio Metabolic Testing
        • Infectious Disease Testing
        • Nephrology Testing
        • Drugs of Abuse (DoA) Testing
        • Blood Glucose Testing
        • Pregnancy Testing
        • Cancer Biomarker Testing
        • Others
      • By End User:
        • Hospitals
        • Diagnostic Laboratories
        • Home-Care Settings
        • Others
      • By Country:
        • China
        • India
        • Japan
        • ASEAN
        • Australia
        • South Korea
        • Rest of Asia Pacific
    • Latin America
      • By Technology:
        • Lateral Flow
        • Agglutination Assays
        • Flow-Through
        • Biosensors
      • By Application:
        • Cardio Metabolic Testing
        • Infectious Disease Testing
        • Nephrology Testing
        • Drugs of Abuse (DoA) Testing
        • Blood Glucose Testing
        • Pregnancy Testing
        • Cancer Biomarker Testing
        • Others
      • By End User:
        • Hospitals
        • Diagnostic Laboratories
        • Home-Care Settings
        • Others
      • By Country:
        • Brazil
        • Mexico
        • Rest of Latin America
    • Middle East
      • By Technology:
        • Lateral Flow
        • Agglutination Assays
        • Flow-Through
        • Biosensors
      • By Application:
        • Cardio Metabolic Testing
        • Infectious Disease Testing
        • Nephrology Testing
        • Drugs of Abuse (DoA) Testing
        • Blood Glucose Testing
        • Pregnancy Testing
        • Cancer Biomarker Testing
        • Others
      • By End User:
        • Hospitals
        • Diagnostic Laboratories
        • Home-Care Settings
        • Others
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Technology:
        • Lateral Flow
        • Agglutination Assays
        • Flow-Through
        • Biosensors
      • By Application:
        • Cardio Metabolic Testing
        • Infectious Disease Testing
        • Nephrology Testing
        • Drugs of Abuse (DoA) Testing
        • Blood Glucose Testing
        • Pregnancy Testing
        • Cancer Biomarker Testing
        • Others
      • By End User:
        • Hospitals
        • Diagnostic Laboratories
        • Home-Care Settings
        • Others
      • By Country:
        • Central Africa
        • South Africa
        • North Africa
  • Company Profiles
    • Danaher Corporation*
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Key Strategies
      • Recent Developments
    • Abbott Laboratories
    • Acon Laboratories, Inc.
    • Hoffman-La Roche Ltd.
    • Becton, Dickinson, and Company
    • Johnson & Johnson
    • Trinity Biotech Plc
    • Siemens Healthineers

 “*” marked represents similar segmentation in other categories in the respective section.

Table of Contents

  1. Research Objective and Assumption
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Technology
      • Market Snippet, By Application
      • Market Snippet, By End User
      • Market Snippet, By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Product Launches
  4. Global Rapid Medical Diagnostic Devices Market, By Technology, 2015–2025 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2016 and 2025 (%)
      • Y-o-Y Growth Analysis, 2016–2025
      • Segment Trends
    • Lateral Flow
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015–2025, (US$ Mn)
    • Agglutination Assays
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015–2025, (US$ Mn)
    • Flow-Through
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015–2025, (US$ Mn)
    • Biosensors
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015–2025, (US$ Mn)
  5. Global Rapid Medical Diagnostic Devices Market, By Application, 2015–2025 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2016 and 2025 (%)
      • Y-o-Y Growth Analysis, 2016–2025
      • Segment Trends
    • Cardio Metabolic Testing
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015–2025, (US$ Mn)
    • Infectious Disease Testing
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015–2025, (US$ Mn)
    • Nephrology Testing
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015–2025, (US$ Mn)
    • Drugs of Abuse (DoA) Testing
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015–2025, (US$ Mn)
    • Blood Glucose Testing
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015–2025, (US$ Mn)
    • Pregnancy Testing
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015–2025, (US$ Mn)
    • Cancer Biomarker Testing
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015–2025, (US$ Mn)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015–2025, (US$ Mn)
  6. Global Rapid Medical Diagnostic Devices Market, By End User, 2015–2025 (US$ Mn)
    • Introduction
      • Market Share Analysis, 2016 and 2025 (%)
      • Y-o-Y Growth Analysis, 2016–2025
      • Segment Trends
    • Hospitals
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015–2025, (US$ Mn)
    • Home-Care Settings
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015–2025, (US$ Mn)
    • Diagnostic Laboratories
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015–2025, (US$ Mn)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2015–2025, (US$ Mn)
  7. Global Rapid Medical Diagnostic Devices Market, By Regions, 2015–2025 (US$ Mn)
    • Introduction
      • Market Share Analysis, By Region, 2016 and 2025 (%)
      • Y-o-Y Growth Analysis, For Regions, 2016–2025
    • North America
      • Market Size and Forecast, By Technology, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By Application, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By End User, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By Country, 2015–2025 (US$ Mn)
        • U.S.
        • Canada
    • Europe
      • Market Size and Forecast, By Technology, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By Application, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By End User, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By Country, 2015–2025 (US$ Mn)
        • U.K.
        • Germany
        • Italy
        • France
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • Market Size and Forecast, By Technology, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By Application, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By End User, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By Country, 2015–2025 (US$ Mn)
        • China
        • India
        • Japan
        • ASEAN
        • Australia
        • South Korea
        • Rest of APAC
    • Latin America
      • Market Size and Forecast, By Technology, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By Application, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By End User, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By Country, 2015–2025 (US$ Mn)
        • Brazil
        • Mexico
        • Rest of Latin America
    • Africa
      • Market Size and Forecast, By Technology, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By Application, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By End User, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By Country, 2015–2025 (US$ Mn)
        • Central Africa
        • South Africa
        • North Africa
    • Middle East
      • Market Size and Forecast, By Technology, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By Application, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By End User, 2015–2025 (US$ Mn)
      • Market Size and Forecast, By Country, 2015–2025 (US$ Mn)
        • GCC
        • Israel
        • Rest of Middle East
  8. Competitive Landscape
    • Heat Map Analysis
    • Company Profiles
      • Danaher Corporation
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Abbott Laboratories
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Acon Laboratories, Inc.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Hoffman-La Roche Ltd.
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Becton, Dickinson, and Company
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Johnson & Johnson
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Trinity Biotech Plc
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
      • Siemens Healthineers
        • Company Overview
        • Product Portfolio
        • Key Developments
        • Financial Performance
        • Strategies
  9. Section
    • References
    • Research Methodology
    • About us and Sales Contact

*Browse 41 market data tables and 27 figures on "Rapid Medical Diagnostic Devices Market - Global forecast to 2025”.

Research Methodology

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  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.


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  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

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  • Trade association, National and international media and trade press.
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Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization:

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
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  • Distributors
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