Global Molecular Diagnostics Market Size and Share Analysis 2023-2028

Market Overview

The molecular diagnostics industry has undergone a revolution in recent decades. These tests detect specific sequences in DNA or RNA, which can be associated with diseases. In the current year, the market for molecular diagnostics was valued at USD 13.9 billion, and it is projected to grow at a CAGR of 9.22% during the forecast period.

The global distribution channels in the healthcare sector, which ensure better quality, safety, and innovative approaches, have been significantly impacted by disruptions caused by COVID-19. This has resulted in increased focus on the molecular diagnostics industry worldwide, with rapid development of diagnostics, expedited regulatory clearances, and enhanced distribution efforts in various regions to contain the spread of the virus.

Product Type

Market Research



Release Date

June 2023

Base Year


Forecast Period


Market Size

USD 18.5 Mn incremental growth between 2022 and 2027

Market Segments

Product, Application, End User, Technology, Region



No. of Companies Mentioned


The demand for diagnostic products, particularly related to COVID-19, is expected to rise due to the increased need for polymerase chain reaction tests, next-generation sequencing, serology-based rapid tests, and a surge in the target patient population. For example, Roche expanded its COVID-19 PCR portfolio on the Cobas 5800 System in February 2022, thereby enabling more people to access accurate and reliable diagnostics for combating COVID-19. Such instances are anticipated to drive the adoption of COVID-19 molecular diagnostic testing and contribute to market growth after the pandemic.

Factors contributing to the growth of the molecular diagnostics market include large outbreaks of bacterial and viral epidemics worldwide, increasing demand for point-of-care diagnostics, advancements in pharmacogenomics, and rapid technological developments. The India TB report of 2022 indicated an increase in the number of incident TB patients, highlighting the rising prevalence and patient pool, which is expected to drive the demand for molecular diagnostics in the market.

Additionally, there is a global rise in the incidence of infectious diseases such as HIV. In 2021, approximately 38.4 million people worldwide were living with HIV, including 36.7 million adults and 1.7 million children, according to the UNAIDS update in August 2022. This high incidence of infectious diseases like HIV is expected to boost market growth as molecular diagnostics are increasingly adopted for HIV testing.

Molecular diagnostics is considered the most effective method for identifying and characterizing microorganisms. An effective test must be precise, rapid, and capable of measuring the infectious burden. Advanced technologies, such as polymerase chain reaction (PCR), have made it possible to identify antimicrobial resistance genes and provide public health information through strain characterization via genotyping. Therefore, the market is expected to witness significant growth due to these factors.

However, the market growth may be hindered by limited R&D budgets, economic slowdown, and the need for high-complexity testing centers.

Market Segmentation

The market is segmented based on various factors, including product, application, end user, technology, and region.

Segmentation by Product
Other Products

Segmentation by Application
Infectious Disease
Genetic Disease Screening
Human Leukocyte Antigen Typing
Blood Screening

Segmentation by End User
Other End Users

Segmentation by Technology
In Situ Hybridization
Chips and Microarrays
Mass Spectrometry (MS)
Other Technologies

Segmentation by Region
North America – United States, Canada, and Mexico
Europe – United Kingdom, Germany, France, Spain, Italy, and Rest of Europe
Asia-Pacific – China, Japan, India, South Korea, Australia, and Rest of Asia-Pacific
Latin America – Brazil, Argentina, and Rest of Latin America
Middle East and Africa – South Africa, GCC, and Rest of MEA

The Instruments Segment is projected to hold a significant market share throughout the forecast period. Molecular diagnostics has become crucial in assessing disease prognosis, therapy response, and detecting minimal residual disease. This growth can be attributed to advancements in chemistries and instrumentation, such as automation, integration, throughput, and random-access capabilities.

The impact of COVID-19 on molecular diagnostics instruments has been positive during and post-pandemic. Market players have implemented key strategies to develop and manufacture these instruments. To accelerate the development of affordable point-of-care molecular diagnostic platforms for COVID-19, organizations like FIND have invested in companies like Biomeme, Bioneer, Qlife, and SD Biosensor. These investments are expected to drive market growth through increased adoption of these instruments.

Furthermore, key market players launching new molecular diagnostic instruments have further contributed to market growth. For example, Roche launched the Cobas 5800 system, which offers efficiency, simplicity, and timely results to improve patient care.

Moreover, the instruments segment of the molecular diagnostics market is witnessing growth due to various strategies adopted by market players, including collaborations, acquisitions, new product launches, and expansions. For instance, Mylab Discovery Solutions partnered with Hemex Health to create diagnostic solutions for Point-of-Care (POC) testing. Such initiatives are expected to drive market growth through increased adoption of molecular diagnostic instruments.

Polymerase Chain Reaction (PCR) technology is gaining prominence due to its benefits, including the amplification of tiny quantities of DNA, affordability, and quick results. The PCR segment is anticipated to have the largest market share due to its increasing application in clinical diagnostics and the rising demand for personalized and precision medicines.

In terms of application, infectious diseases are expected to witness the highest compound annual growth rate (CAGR) over the forecast period. The application of molecular diagnostics in infectious disease testing is experiencing rapid innovation and growth. Molecular diagnostic techniques have aided in the timely diagnosis of contagious diseases. The COVID-19 pandemic has also created opportunities for the development of diagnostic procedures and technologies. For example, Minute Molecular Diagnostics received FDA approval for its rapid DASH SARS-CoV-2/S test, which provides results in about 15 minutes.

Hospitals are the major end users of molecular diagnostics instruments, holding a significant market share. The increasing adoption of molecular diagnostics in hospitals is driven by factors such as improved healthcare infrastructure and the rise in infectious diseases and cancer cases.

North America is expected to hold the largest market share in the molecular diagnostics segment. This can be attributed to the region’s high incidence of bacterial and viral epidemics, growing demand for point-of-care diagnostics, rapid technological advancements, and the presence of key market players.

The United States, in particular, has witnessed a shift from traditional diagnostic methods to molecular diagnostics due to factors like increased per capita health expenditures, advancements in healthcare infrastructure, and a higher prevalence of infectious diseases and cancers. Technological advancements, the entry of new players, and the adoption of advanced molecular diagnostics systems further contribute to market growth in the United States.

In conclusion, the molecular diagnostics market, particularly the instruments segment, is expected to experience significant growth. This can be attributed to various factors, including advancements in chemistries and instrumentation, investments in research and development, product launches, collaborations, and the increasing adoption of molecular diagnostics for infectious diseases and cancer diagnosis. North America, especially the United States, is anticipated to hold a prominent market share due to its favorable market conditions and high demand for advanced diagnostic solutions.

Competitive Landscape

The molecular diagnostics market is characterized by intense competition and is composed of various prominent industry players. Nevertheless, smaller to medium-sized companies are seizing opportunities in this market by enhancing their market presence through the introduction of innovative devices at more affordable prices. Notable participants in this market include Abbott Laboratories, F Hoffmann-la Roche Ltd, Hologic Corporation, Danaher Corporation, and Agilent Technology, among other significant players.

Key Companies Profiled in this report include F Hoffmann-la Roche Ltd, Illumina Ltd, Hologic Corporation, Agilent Technologies Inc., Qiagen NV, Myriad Genetics, Becton, Dickinson and Company, Abbott Laboratories, Biomerieux SA, Bio-Rad Laboratories Inc., Sysmex Corporation, Danaher Corporation (Beckman Coulter Inc.), Thermo Fisher Scientific Inc.

Recent Industry Developments

Becton, Dickinson, and Company introduced a new high-throughput molecular diagnostic combination test for SARS-CoV-2 and Influenza A/B in May 2022. The BD SARS-CoV-2/Flu assay for the BD COR™ System is an automated multiplexed real-time RT-PCR test designed to identify and differentiate SARS-CoV-2, influenza A, and influenza B from a single nasal sample. This test is intended for patients exhibiting symptoms of respiratory viral infection, as well as asymptomatic individuals.

In May 2022, miDiagnostics, based in Belgium, launched an ultrafast COVID-19 PCR test that utilizes silicon chip technology. The latest test developed by the company can deliver results in approximately 30 minutes.

Sense Biodetection obtained CE Marking for Veros COVID-19 from the European Authorities in March 2022. Veros COVID-19 is a fully integrated molecular diagnostic test that offers easy-to-use functionality and provides laboratory-quality results in just 15 minutes.

Minute Molecular Diagnostics received Emergency Use Authorization (EUA) from the United States Food and Drug Administration in March 2022 for its rapid DASH SARS-CoV-2/S Test. The DASH SARS-CoV-2/S test, which runs on the DASH Analyzer, consolidates the entire PCR testing process (including sample extraction and PCR), yielding results in approximately 15 minutes.

In January 2021, Eurofins Technologies launched NovaType, an SARS-CoV-2 RT-PCR assay that detects and monitors new variants of COVID-19, namely B.1.1.7 and B.1.351. The company’s previous PCR test, the Eurofins Viracor SARS-CoV-2 RT-PCR diagnostic test, has been recognized as the most sensitive among more than 115 kits evaluated by the FDA SARS-CoV-2 Reference Panel.

In March 2023, Illumina Inc., a US-based company specializing in DNA sequencing and array-based technologies, partnered with GenoScreen to introduce a package combining Illumina products with the GenoScreen Deeplex Myc-TB assay. The Deeplex Myc-TB assay utilizes targeted next-generation sequencing (NGS) technology for a rapid and comprehensive detection of anti-TB drug resistance.

In March 2023, Oxford Gene Technology launched eight CytoCell fluorescence in situ hybridization probes that have received certification for clinical use in accordance with the European In Vitro Diagnostics Regulation (IVDR).

Key Questions Answered

What is the study period for this market?
What is the growth rate of the Molecular Diagnostics Market?
What was the size of the Molecular Diagnostics Market in 2018?
What is the projected size of the Molecular Diagnostics Market in 2028?
Which region has the highest growth rate in the Molecular Diagnostics Market?
Which region has the largest share in the Molecular Diagnostics Market?
Who are the key players in the Molecular Diagnostics Market?

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Global Molecular Diagnostics Market Size and Share Analysis 2023-2028

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Global Molecular Diagnostics Market Size and Share Analysis 2023-2028

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