Molecular Diagnostics Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The Molecular Diagnostics Market is Segmented by Technology (In Situ Hybridization, Chips and Microarrays, Mass Spectrometry (MS), Sequencing, PCR, and Other Technologies), Application (Infectious Disease, Oncology, Pharmacogenomics, Microbiology, and Genetic Disease Screening, Human Leukocyte Antigen Typing, and Blood Screening), Product (Instruments, Reagents, and Other Products), End User (Hospitals, Laboratories, and Other End Users), and Geography (North America, Europe, Asia Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the above segments.

Market Snapshot

Molecular Diagnostics Market Summary
Study Period: 2019-2027
Base Year: 2021
Fastest Growing Market: Asia Pacific
Largest Market: North America
CAGR: 8.76 %
Molecular Diagnostics Market Major Players

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Market Overview

The global molecular diagnostics market was valued at USD 17,838.62 million in 2021, and it is expected to reach 29,255.49 million by 2027, registering a CAGR of 9.2% during the forecast period, 2022-2027.

Globally, the integrated supply chains that ensure better quality, safety, and innovative approaches for distribution across the healthcare sector are tremendously impacted due to the disruption in the distribution channels across the world. The COVID-19 pandemic has turned a spotlight on the molecular diagnostics industry across the world, with the rapid development of diagnostics, fast-tracked regulatory clearances, and ramped-up distribution in various regions to help curb the spread of the virus.

The demand for diagnostic products due to COVID-19 in Brazil is expected to increase mainly due to rising demand for polymerase chain reaction tests, next-generation sequencing (NGS), serology-based rapid-test products, and a sharp rise in the target patient population. For instance, in May 2020, Seegene Inc., a leading developer of multiplex PCR technologies, has supplied five million tests of Allplex 2019-nCOV assay to Brazil through subsidiary Seegene do Brasil Diagnosticos Ltda.

Some of the factors responsible for the growth of the market include large outbreaks of bacterial and viral epidemics in the world, increasing demand for point-of-care diagnostics, recent advancements in pharmacogenomics, and rapidly evolving technology. According to the World Health Organization 2020 report, tuberculosis is the world's 13th leading cause of death and the second leading infectious disease, trailing only COVID-19 (but ahead of HIV/AIDS). In 2020, it was estimated that around 10 million people suffered from tuberculosis globally. This includes 5.6 million men, 3.3 million women, and 1.1 million children. Tuberculosis affects people of all ages and from all countries. The 30 most affected countries by tuberculosis accounted for 86% of new cases in 2020. India leads the pack with two-thirds of the total, followed by China, Indonesia, the Philippines, Pakistan, Nigeria, Bangladesh, and South Africa. Thus, increasing the prevalence and rising patient pool increased the demand for molecular diagnosis over the period.

Furthermore, globally, there is an increasing incidence of cancer, which is driving the market growth. For instance, according to GLOBOCAN 2020, there were 19,282,789 new cancer cases worldwide in 2020, with the number expected to rise to 28,887,940 cases by 2040. Therefore, the global incidence of cancer, as well as modern healthcare facilities, have been major drivers of the market's growth

Molecular diagnostics is considered to be the best method to identify and characterize a microorganism. An effective test must be precise, rapid, and also be able to measure the infectious burden. Better testing quickly identifies the organism’s strain and drug susceptibility, thus, reducing the delay in finding the right antibiotic. Technological advancements, like a polymerase chain reaction (PCR), have also made it possible to identify the antimicrobial resistance genes and provide public health information, such as strain characterization by genotyping. Hence, from the factors mentioned above, the market is estimated to witness significant growth over the forecast period.

Scope of the Report

As per the scope of the report, molecular diagnostic tests detect specific sequences in DNA or RNA (including single nucleotide polymorphisms (SNP), deletions, rearrangements, insertions, and others), which may or may not be associated with diseases. Molecular diagnostics has been revolutionized over the past few decades. The global molecular diagnostics market is segmented by technology (in situ hybridization, chips, and microarrays, mass spectrometry (MS), sequencing, PCR, and other technologies), application (infectious disease, oncology, pharmacogenomics, microbiology, genetic disease screening, human leukocyte antigen typing, and blood screening), product (instruments, reagents, and other products), end-user (hospitals, laboratories, and other end-users), and geography (North America, Europe, Asia Pacific, Middle-East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.

By Technology
In Situ Hybridization
Chips and Microarrays
Mass Spectrometry (MS)
Sequencing
PCR
Other Technologies
By Application
Infectious Disease
Oncology
Pharmacogenomics
Microbiology
Genetic Disease Screening
Human Leukocyte Antigen Typing
Blood Screening
By Product
Instruments
Reagents
Other Products
By End User
Hospitals
Laboratories
Other End Users
By Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia Pacific
China
Japan
India
Australia
South Korea
Rest of Asia Pacific
Middle-East and Africa
GCC
South Africa
Rest of Middle-East and Africa
South America
Brazil
Argentina
Rest of South America

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Key Market Trends

Instruments Segment is Expected to Hold Significant Market Share Over the Forecast Period

Molecular diagnostics plays a vital role in the assessment of disease prognosis and therapy response, as well as in the detection of minimal residual disease. In the past decade, molecular diagnostics has grown, due to advances in chemistries and instrumentation, including automation, integration, throughput, and the ability to use the instrumentation in a random-access mode.

The impact of COVID-19 on molecular diagnostics instruments is positive because during the pandemic US FDA has been approved many instruments in the diagnosis of COVID-19. For instance, in July 2020, FDA granted an amendment, to add the Promega Maxwell RSC 48 as an authorized extraction instrument for use with the CDC 2019-nCoV rRT-PCR Diagnostic Panel.

Additionally, in July 2020, Roche Diagnostics India launched the Cobas 8800 instrument at the National Institute of Cholera and Enteric Diseases, Kolkata, and Cobas 6800 at the National Institute for Research in Reproductive Health, Mumbai, to aid with SARS CoV-2 diagnostic testing. Roche’s Cobas 6800/8800 systems provide test results in three and half hours and offer improved operating efficiency, flexibility, and fastest time-to-time results.

Some of the sophisticated instruments used in this market are high-performance liquid chromatography (HPLC), mass spectrometry (MS), and nuclear magnetic resonance (NMR), along with real-time PCR, enzyme-linked immunosorbent assay (ELISA), radioimmunoassay (RIA), lateral flow devices, patient safety syringes, and point-of-care testing devices, among others.

Furthermore, with the tremendous opportunity in in vitro diagnostics, many market players are adopting various strategies, such as collaborations, acquisitions, new products launches, and expansions, into the Asia Pacific Market.

For instance, in January 2020, Illumina received product approval from Pharmaceuticals and Medical Devices Agency (PMDA), Japan for MiSeqDx instrument. This approval allows for the distribution of the MiSeqDx as a Class I medical device in Japan, which shows a positive impact on the market.

 Thus, owing to the factors mentioned above, it is expected to drive market growth over the forecast period.

Molecular Diagnostics Market - Incidence of Lung Cancer in Males (Per 100,00 population), by Region, 2020

North America Dominates the Market and is Expected to do the Same over the Forecast Period

Some of the factors driving the market growth include large outbreaks of bacterial and viral epidemics, increasing demand for point-of-care diagnostics, rapidly evolving technology, and the presence of key market players in the region.

During the COVID-19 pandemic, the United States Centers for Disease Control and Prevention (CDC) used a one-step PCR format to diagnose COVID-19. The assay was carried out by isolating RNA from the sample and adding it to the master mix containing forward and reverse primers, nuclease-free water, the reaction mixture (reverse transcriptase, polymerase, nucleotides, magnesium, and other additives). For instance, as per the Centers for Disease Control and Prevention (CDC), in the United States, antigen tests and nucleic acid amplification tests (NAATs) were used as diagnostic tests to detect infection with SARS-CoV-2. Viral tests were used as screening tests to reduce the transmission of SARS-CoV-2 by identifying infected persons who need to isolate from others.

Molecular diagnostics has played a vital role in changing the face of disease diagnostics and assuring speedy detection and accurate care for critically ill patients. The increase in per capita health expenditures, the advancement in healthcare infrastructure, and the increase in the number of infectious diseases and cancer cases in the United States have led to a shift in trend from the traditional diagnostic methods to molecular diagnostics.

The high burden of chronic diseases in all age groups, especially the aging population, may drive the demand for molecular diagnostic tests in Canada. According to the data provided by the Canadian government, in 2019, 44% of adults aged 20+ years have at least 1 of 10 common chronic conditions, and the prevalence of chronic diseases is rising. 

Furthermore, rising technological advancements, increasing entry of new players, and speedy adoption of advanced molecular diagnostics are helping in the growth of the market in the United States. For Instance, in March 2020, Abbott announced that the US Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the fastest available molecular diagnostics test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes

Thus, considering above mentioned factors, it is expected to fuel the market growth in North American region over the forecast period.

Molecular Diagnostics Market - Growth Rate by Region

Competitive Landscape

The global molecular diagnostics market is highly competitive and consists of several major players. However, with technological advancements and product innovations, mid-size to small companies are increasing their market presence by introducing new devices with fewer prices. Some market players include Abbott Laboratories, F Hoffmann-la Roche Ltd, Hologic Corporation, Danaher Corporation, and Agilent Technology, among others.

Major Players

  1. Abbott Laboratories

  2. Hologic Corporation

  3. Cepheid Inc. (Danaher Corporation)

  4. F Hoffmann-la Roche Ltd

  5. Agilent Technologies Inc.

Molecular Diagnostics Market Concentration

Recent Developments

  • In January 2021, MatMaCorp., a developer of comprehensive molecular diagnostic systems, was granted Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the COVID-19 2SF RNA test for the detection of SARS-CoV-2 on the company’s Solas 8 portable detection system
  • In February 2021, Bio-Rad Laboratories, Inc., received Emergency Use Authorization (EUA) approval from the United States Food and Drug Administration (FDA) for Reliance SARS-CoV-2/FluA/FluB RT-PCR and Reliance SARS-CoV-2 RT-PCR Assay Kits. The multi-target Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit simultaneously detects and differentiates SARS-CoV-2, influenza A, and influenza B in a single multiplex reaction.​
  • In June 2021, Bio-Rad Laboratories Inc. entered a partnership agreement with Seegene Inc., a global leader in multiplex molecular diagnostics, for the clinical development and commercialization of infectious disease molecular diagnostic products in the United States.

Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Large Outbreaks of Bacterial And Viral Epidemics in the World

      2. 4.2.2 Increasing Demand for Point-of-care Diagnostics

      3. 4.2.3 Recent Advancements in Pharmacogenomics

      4. 4.2.4 Rapidly Evolving Technology

    3. 4.3 Market Restraints

      1. 4.3.1 Limited Budgets for R&D and Economic Slowdown

      2. 4.3.2 Need for High-complexity Testing Centers

    4. 4.4 Industry Attractiveness - Porter's Five Forces Analysis

      1. 4.4.1 Bargaining Power of Buyers/Consumers

      2. 4.4.2 Bargaining Power of Suppliers

      3. 4.4.3 Threat of New Entrants

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value – USD million)

    1. 5.1 By Technology

      1. 5.1.1 In Situ Hybridization

      2. 5.1.2 Chips and Microarrays

      3. 5.1.3 Mass Spectrometry (MS)

      4. 5.1.4 Sequencing

      5. 5.1.5 PCR

      6. 5.1.6 Other Technologies

    2. 5.2 By Application

      1. 5.2.1 Infectious Disease

      2. 5.2.2 Oncology

      3. 5.2.3 Pharmacogenomics

      4. 5.2.4 Microbiology

      5. 5.2.5 Genetic Disease Screening

      6. 5.2.6 Human Leukocyte Antigen Typing

      7. 5.2.7 Blood Screening

    3. 5.3 By Product

      1. 5.3.1 Instruments

      2. 5.3.2 Reagents

      3. 5.3.3 Other Products

    4. 5.4 By End User

      1. 5.4.1 Hospitals

      2. 5.4.2 Laboratories

      3. 5.4.3 Other End Users

    5. 5.5 By Geography

      1. 5.5.1 North America

        1. 5.5.1.1 United States

        2. 5.5.1.2 Canada

        3. 5.5.1.3 Mexico

      2. 5.5.2 Europe

        1. 5.5.2.1 Germany

        2. 5.5.2.2 United Kingdom

        3. 5.5.2.3 France

        4. 5.5.2.4 Italy

        5. 5.5.2.5 Spain

        6. 5.5.2.6 Rest of Europe

      3. 5.5.3 Asia Pacific

        1. 5.5.3.1 China

        2. 5.5.3.2 Japan

        3. 5.5.3.3 India

        4. 5.5.3.4 Australia

        5. 5.5.3.5 South Korea

        6. 5.5.3.6 Rest of Asia Pacific

      4. 5.5.4 Middle-East and Africa

        1. 5.5.4.1 GCC

        2. 5.5.4.2 South Africa

        3. 5.5.4.3 Rest of Middle-East and Africa

      5. 5.5.5 South America

        1. 5.5.5.1 Brazil

        2. 5.5.5.2 Argentina

        3. 5.5.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 F Hoffmann-la Roche Ltd

      2. 6.1.2 Illumina Ltd

      3. 6.1.3 Hologic Corporation

      4. 6.1.4 Agilent Technologies Inc.

      5. 6.1.5 Qiagen NV

      6. 6.1.6 Myriad Genetics

      7. 6.1.7 Becton, Dickinson and Company

      8. 6.1.8 Abbott Laboratories

      9. 6.1.9 Biomerieux SA

      10. 6.1.10 Bio-Rad Laboratories Inc.

      11. 6.1.11 Sysmex Corporation

      12. 6.1.12 Beckman Coulter Inc.

      13. 6.1.13 Thermo Fisher Scientific Inc.

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments
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Frequently Asked Questions

The Global Molecular Diagnostics Market market is studied from 2019 - 2027.

The Global Molecular Diagnostics Market is growing at a CAGR of 8.76% over the next 5 years.

The Global Molecular Diagnostics Market is valued at 17838 Million USD in 2019.

The Global Molecular Diagnostics Market is valued at 29255 Million USD in 2027.

Asia Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2021.

Abbott Laboratories, Hologic Corporation, Cepheid Inc. (Danaher Corporation), F Hoffmann-la Roche Ltd, Agilent Technologies Inc. are the major companies operating in Global Molecular Diagnostics Market.

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