Molecular Diagnostics Market

Report Overview

The global molecular diagnostics  market was pegged at US$ 21.1 billion  in 2021 and is expected to witness a CAGR of 5.10%  during the forecast period.

Market Fundamentals

Molecular diagnostics is referred to a collection of techniques used for detection of genomic variants, aiming to facilitate detection, diagnosis, sub classification, prognosis, and monitoring response to therapy. Molecular diagnostics help to understand biological composition on structure and function of nucleic acid and proteins that are found in genetic material or with specific disease. It analyses biological markers in the genome and proteome i.e. the individual's genetic code and how their cells express their genes as proteins by applying molecular biology to medical testing. Molecular diagnostic tests are used in reference labs, diagnostics centers, research institutes, hospitals and blood banks. Molecular diagnostic tests are used to screen donated blood products for infectious diseases like HIV and hepatitis. In hospitals, testing is often performed to identify specific pathogens in patients with infections for qualitative and quantitative diagnosis. The technique is also used to diagnose, monitor and detect disease risk , and in decision making of effective treatment regimen.

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Market Dynamics

The global molecular diagnostics market is mainly driven by increasing prevalence of chronic diseases, infectious diseases, and genetic disorders; technological advancements in PCR; and increasing demand for rapid diagnostic tests. Furthermore, increasing demand for prenatal genetic testing procedures is likely to play a pivotal role in contributing to growth of the market globally. However, stringent regulatory framework, ethical concerns and high cost of the technologies are likely to restrain market growth.

Market Ecosystem

The global molecular diagnostics market has been analyzed from four perspectives: Product & Services, Technology, Application, End User, and Region.

Molecular Diagnostics Market by Product & Services

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Based on product & services, the market has been segmented into systems & instruments, assays, reagents & kits, and software & services. Systems & instruments accounted for the largest share in the market owing to new technologies introduction, increasing infectious diseases, and requirement for fast and accurate diagnosis of diseases.

Molecular Diagnostics Market by Devices for Technology

Based on technology, the market has been segmented into polymerase chain reaction (PCR), DNA sequencing & next-generation sequencing (NGS), in situ hybridization, microarrays and others (transcription mediated amplification, mass spectrometry etc.). Being the most widely used approach, PCR segment accounted for the largest share in the market. Furthermore, advancements in PCR techniques are also expected to boost the market to greater extent. For instance, in June 2020, Stilla Technologies, a provider of digital PCR (dPCR) solutions for high-precision genetic analysis, launched the world's first six-color digital PCR instrument, the six-color Prism. The instrument expands the multiplexing capabilities of the company's digital PCR platform, the Naica™ System. Followed by genome sequencing, diagnostics application also demonstrates potential market growth owing to the rising demand for genome sequencing test in clinical diagnostics and research and development.

Molecular Diagnostics Market by Application

Based on application, the market has been segmented into infectious disease, oncology, pharmacogenomics, genetic testing and others (neurological disease, cardiovascular disease, etc.). The infectious disease segment holds the largest share throughout the forecast period. The growth of the segment in the global market can largely be attributed to the sudden viral epidemics of infectious diseases such as Hepatitis, HIV, H1N1 & COVID-19. The outbreak of these diseases across the globe have raised the demand for effective molecular testing for detection of surging infectious diseases. For instance, in 2022, new outbreak of monkeypox virus had been witnessed in many countries. For diagnosis of this virus, molecular testing techniques like PCR and genome sequencing are more preferred by research institutes, thus boosting the molecular diagnostics market.

Molecular Diagnostics Market by End User

Based on end user, the molecular diagnostics market has been segmented into hospitals, academic institutes & research centers, and clinical & pathology labs. Clinical & pathology labs segment is estimated to be the fastest growing segment during the forecast period owing to the rise in testing for detection of COVID-19 on an enormous scale and increasing application of molecular diagnostics in drug discovery and development efforts.

Molecular Diagnostics Market by Region

Based on region, the global molecular diagnostics market has been segmented into North America, Europe, Asia Pacific, and the Rest of the World (ROW). North America dominated the molecular diagnostics market, followed by Europe. The large share of North America in the global market can largely be attributed to developed healthcare infrastructure, adoption of advanced molecular diagnostics and presence of large number of clinical laboratories in the region. Moreover, high prevalence of infectious diseases & cancers along with growing applications of molecular diagnostics in screening of these diseases is also expected to contribute to the market growth in the region.

Competitive Landscape

Some of the prominent players operating in the molecular diagnostics market are F. Hoffmann-La Roche Ltd., bioMérieux SA, Beckman Coulter Inc., Becton Dickinson & Company, Siemens Healthcare Private Limited, Grifols SA, Abbott Laboratories Inc., Hologic Inc., Danaher Corporation and QIAGEN NV among others.

Strategic Developments

· In September 2020, QIAGEN NV announced completing the acquisition of diagnostics instruments company NeuMoDx Molecular Inc. for $ 248 million. This move rounds out QIAGEN’s portfolio of automated molecular testing solutions based on the proven PCR technology. This transaction was aimed to strengthens QIAGEN’s leadership position in automated molecular testing field.

· In August 2020, OpGen Announces CE-IVD marking and commercial launch in europe of its own developed molecular diagnostic SARS-CoV-2 Kit with PULB for detection of the virus causing COVID-19.

· In October 2019, Sherlock Biosciences and Mologic Ltd., announced a new collaboration to revolutionize molecular diagnostic testing in low-resource settings and within the home. The work is being facilitated by the Bill & Melinda Gates Foundation through an expansion of an existing grant to Mologic.

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