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Molecular Diagnostics Market Size By Product (Instruments, Reagents & Kits), By Technology (Polymerase Chain Reaction [PCR], Hybridization, Sequencing, Isothermal Nucleic Acid Amplification Technology [INAAT], Microarrays), By Application (Infectious Disease Diagnostics {COVID-19, HIV, CT/NG, Hepatitis B, Hepatitis C, RSV, Flu, Tuberculosis}, Oncology Testing, Genetic Disease Testing), By End-use (Diagnostics Laboratories, Hospitals & Clinics), Industry Analysis Report, Regional Outlook, COVID-19 Impact Analysis, Growth Potential, Competitive Market Share & Forecast, 2022 – 2028

  • Report ID: GMI434
  • Published Date: Feb 2022
  • Report Format: PDF

Industry Overview

Molecular Diagnostics Market size was valued at around USD 53.6 billion in 2021 and is expected to witness around -4.1% CAGR from 2022 to 2028 due to the rising geriatric population, unhealthy lifestyle, and outbreaks of bacterial and viral epidemics worldwide. Rising incidence of cancer worldwide and growing demand for point-of-care (POC) diagnostics in developing countries is anticipated to drive the molecular diagnostics market progression over the forecast period.

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Surging prevalence of infectious disease include COVID-19, influenza, hepatitis, and HIV coupled with rise in demand for point-of-care diagnostic testing will drive the molecular diagnostics market share. For instance, according to the Centers for Disease Control and Prevention (CDC), every year around 1.7 million hospital-acquired infection (HIAs) and 99,000 deaths occur in American hospitals alone. HAIs occur in all settings of care, such as ambulatory clinics, hospitals as well as nursing homes and rehabilitation facilities. Furthermore, rising product launch and increasing funding from private & government organizations for diagnostic centers is expected propel the market growth.

The impact of COVID-19 on the industry is observed to be positive due to surging demand for polymerase chain reaction tests (PCR), serology-based rapid-test products, and next-generation sequencing (NGS). Also, increasing adoption of immunoassays and molecular assays diagnostics tests for COVID-19 along with major market player ramping up their R&D activities to curb the COVID-19 pandemic will positively impact the molecular diagnostics market trends.

Molecular diagnostics is the most effective method for identifying and characterizing microorganisms. This test must be precise, quick, and capable of identifying the organism's strain and drug susceptibility more quickly. Molecular diagnostics tools have benefited the clinical setting by allowing for the rapid and sensitive detection, and monitoring of a wide range of infectious diseases, cancers, and other chronic diseases.

The popularity of molecular diagnostics is increasing continuously in life sciences industry due to its wide application for disease diagnosis on molecular level. However, high cost of instruments and molecular diagnostics test will hamper the overall molecular diagnostics market growth.

Rising number of cancer patients worldwide will boost the market growth over the analysis timeframe

The surging prevalence of cancer across the globe is one of the major factors that is driving the growth of molecular diagnostics market leaders. For instance, according to the World Cancer Research Fund, in 2020, there were 18.1 million cancer cases and is expected to rise to 29.5 million by 2040 across the globe. Such a drastic increase in cancer cases, increases the demand for molecular diagnostics.

Furthermore, rise in aging population, unhealthy lifestyle, lack of physical activity led to physiological changes triggering cancer. Thus, rise in cases of various types of cancer, growing use of various biomarkers, and technological innovations in diagnosis will propel the market growth. Additionally, blood cancer molecular diagnostics test is usually performed on PCR systems.

Increasing diagnostic instrument development will propel the molecular diagnostics market over the projected timeline

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Based on product, the molecular diagnostics market is divided into instruments, reagents, and kits. The instruments segment accounted for 28.6% market share in 2021 owing to rising number of product approval by various regulatory bodies along with rising focus towards development of advanced products. Furthermore, increasing research and development activities by major market players will positively promote the business growth during the forecast period.

For instance, in July 2020, Roche Diagnostics launched Cobas 8800 instrument at National Institute of Cholera and Enteric Diseases, Kolkata to detect COVID-19. Similarly, in January 2020, Illumina has received product approval from Pharmaceuticals and Medical Devices Agency (PMDA) for the MiSeqDx instrument in Japan. This registration allows for the distribution of the MiSeqDx as a Class I medical device in Japan.

Growing usage of PCR in diagnostics will boost the market revenue over projected timeline

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Based on technology, the market is segmented into polymerase chain reaction (PCR), hybridization, sequencing, isothermal nucleic acid amplification technology (INAAT), microarrays, and others. Among these, the PCR segment accounted for around USD 47.2 billion in 2021. Factors such as increasing use of PCR technology to detect coronavirus coupled with rising launch of molecular diagnostics instruments is anticipated to drive the molecular diagnostics market growth.

For instance, in June 2021, Thermo Fisher Scientific Inc. launched TaqPath, a PCR combo kit 2.0 to detect active SARS-CoV-2 infection. Furthermore, surging cases of COVID-19 increased the demand for sensitive and rapid detection systems, such as qPCR for detecting the novel coronavirus. Moreover, the development of RT-qPCR kits capable of detecting SARS-CoV-2a and their widespread acceptance across the globe, is a major factor that is likely to fuel the molecular diagnostics market revenue.

Rising infectious diseases globally will upsurge the market growth over the coming years

By application, the market is fragmented into infectious disease diagnostics, genetic disease testing, oncology testing, and others. Among them, the infectious disease diagnostics segment accounted for around USD 46.9 billion in 2021 owing to increasing prevalence of infectious disease among adults along with rising mortality rate due to infectious disease across the globe. Additionally, rising launch of point-of-care testing products is expected to fuel the segmental growth. For instance, in March 2020, Abbott, launched molecular point-of-care test such as Abbott ID NOW COVID-19 test. This is used to detect COVID-19 in five minutes.

Increasing hospital visits for disease diagnosis and treatment will boost the overall industry progression

The molecular diagnostics market based on the end-use is classified as diagnostic laboratories, hospitals and clinics, and others. The hospitals and clinics segment accounted for around USD 24.5 billion in 2021 owing to the increasing healthcare expenditure to provide proper treatment and improved patient care in hospitals.

For instance, as per the Centers for Disease Control and Prevention (CDC), every year in the U.S. around 7.2 million people visit physicians, and approximately 3.5 million visit emergency rooms for diagnosis of infectious diseases. Moreover, the onset of COVID-19 has also positively impacted the market. Thousands of people are testing positive for COVID-19 every day, due to this people are opting for early diagnosis and proper treatment at hospitals. Such scenario will increase the demand for molecular diagnostic instruments in hospitals.

Increasing awareness about molecular diagnostics in North America will enhance the market progression

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North America molecular diagnostics market captured over 20.4% market share in 2021 and is poised to grow substantially during the forthcoming years due to the presence of well-developed healthcare facilities in the U.S. and the availability of proper diagnosis and several treatment options. Also, the growing interactions between government, hospitals, and research institutes will lead to improvements in the market.

Moreover, the rising prevalence of chronic infections across the U.S. coupled with increasing healthcare spending is also expected to propel molecular diagnostics market. For instance, according to the CDC, in 2018, approximately 9,025 new tuberculosis cases were observed. This number is increasing every year and may lead to rise in hospitalization.

The molecular diagnostics industry is flooded with several global companies offering similar products

Some of the prominent key players operating in the molecular diagnostics industry include Abbott Laboratories, Agilent Technologies Inc., Becton, Dickinson and Company, Biocartis, Biomerieux SA, Bio-Rad Laboratories Inc., Danaher Corporation, F. Hoffmann-La Roche AG, Hologic, Inc., Illumina, Inc., Qiagen, Quidel Corporation, Siemens Healthineers AG, Sysmex Corporation, and Thermo Fisher Scientific among others. These market participants are implementing various growth strategies, collaborations, mergers, and acquisitions to enhance product capabilities to sustain market competition.

Some of the recent industry developments:

  • In March 2021, Roche announced merger and acquisition with GenMark Diagnostics to gain access to cutting-edge technology of molecular diagnostics. This partnership allows it to screen for a wide spectrum of pathogens with just one patient sample. This partnership helped the company to accelerate their business growth and improve territorial coverage.
  • In March 2020, Abbott announced that they had received FDA approval for their COVID-19 detection kit. This helped Abbott to increase their business revenue during the pandemic.

The molecular diagnostics market report includes in-depth coverage of the industry with estimates & forecasts in terms of revenue in USD from 2022 to 2028, for the following segments:

By Product

  • Instruments
  • Reagents & Kits

By Technology

  • Polymerase Chain Reaction (PCR)
  • Hybridization
  • Sequencing
  • Isothermal Nucleic Acid Amplification Technology (INAAT)
  • Microarrays
  • Others

By Application

  • Infectious Disease Diagnostics 
    • COVID-19
    • HIV
    • CT/NG
    • Hepatitis B
    • Hepatitis C
    • RSV
    • Flu
    • Tuberculosis
    • Others 
  • Oncology Testing
  • Genetic Disease Testing
  • Others

By End-use

  • Hospitals & Clinics
  • Diagnostic Laboratories
  • Others

The above information is provided for the following regions and countries:

By Region

  • North America 
    • U.S.
    • Canada 
  • Europe 
    • Germany
    • UK
    • France
    • Italy
    • Spain 
  • Asia Pacific 
    • Japan
    • China
    • India
    • Australia
  • Latin America 
    • Brazil
    • Mexico
  • Middle East Asia 
    • Saudi Arabia
    • UAE
    • Israel 
  • Africa 
    • South Africa
    • Nigeria
    • Morocco
    • Egypt


Authors: Sumant Ugalmugle, Rupali Swain

Frequently Asked Questions (FAQ) :

Global market for molecular diagnostics was valued at $53.6 billion in 2021 and is anticipated to observe around -4.1% CAGR during the forecast period of 2022-2028.
The instruments segment captured 28.6% share of the global molecular diagnostics industry in 2021 as notable research and development activities are being conducted by leading companies to create advanced diagnostic equipment, which has positively impacted their approval rate.
The Polymerase Chain Reaction (PCR) technology accounted for $47.2 billion in the overall market in 2021 as this technology is being increasingly used to detect the presence of coronavirus in patients.
The infectious disease applications reported $46.9 billion in the global molecular diagnostics industry in 2021 as the mortality rate is rising due to the growing prevalence of infectious diseases across the world.

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Premium Report Details

  • Base Year: 2021
  • Companies covered: 15
  • Tables & Figures: 348
  • Countries covered: 20
  • Pages: 220
  • Upcoming Report: Details can be customized to meet your information and data needs. Feel free to share your detailed research requirements via this form.

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