Published: 2022 June 06
Molecular Diagnostics Market Size, Competitive Landscape and Market Forecast - 2029
180 pages
Report Summary
Table of Contents
List of Tables & Figures

Global Molecular Diagnostics Market is segmented By Product Type (Reagents, Instruments, Software & Services), By Application (Oncology, Cardiovascular Diseases, Infectious Diseases, and Others), By End-User (Research Laboratories, Hospitals, Medical Academics), By Technology (PCR, Hybridization, INAAT, and Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2022-2029


Market Overview

The "Molecular Diagnostics Market" is expected to grow at a CAGR during the forecasting period (2022-2029).

Molecular diagnostics is referred to as the detection of genomic variants, aiming to facilitate detection, diagnosis, sub-classification, prognosis, and monitoring response to therapy. Molecular diagnostics is the outcome of the fruitful interplay among laboratory medicine, genomics knowledge, and technology in the field of molecular genetics, especially with significant discoveries in the field of molecular genomic technologies.


Market Dynamics

The global molecular diagnostics market growth is driven by the increasing burden of various bacterial and viral epidemics, coupled with increasing demand for point-of-care diagnostics and recent advancements in pharmacogenomics, are expected to propel market growth over the forecast period.

Large outbreaks of bacterial and viral epidemics in the world will drive the market growth

As per the report published in 2019, HIV outcomes, Beyond Viral Suppression, around 86,000 people in Germany were living with HIV, whereas around 20% of the diseased population were living in Berlin. Additionally, according to the estimates of the British Heart Foundation, in 2018, around 7 million people were living with heart and circulatory diseases in the United Kingdom, and healthcare costs relating to the heart and circulatory diseases were estimated at GBP 9 billion each year. Thus, the heavy burden of chronic disease is anticipated to increase the adoption of molecular diagnostics.

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.

In addition, in September 2018, Biocartis Group NV, an innovative molecular diagnostics company, and Guangzhou Wondfo Biotech Co. Ltd, a fast-growing diagnostics leader in China, entered a joint venture aimed at the commercialization of the fully automated molecular diagnostics Idylla platform in mainland China, within the field of oncology. Thus, owing to the factors mentioned above, it is expected to drive market growth over the forecast period.

High cost of molecular diagnostics is likely to hamper the market growth

However, molecular diagnostics, while highly advantageous, do contain limitations and certain disadvantages. Molecular diagnostics are usually more expensive than standard traditional methodologies. Equipment and reagent costs could be prohibitive to some laboratories. As molecular methods become more standard, the costs could potentially decrease. Currently, laboratories that consider the cost prohibitive prefer to transport molecular specimens to a reference laboratory. These factors hamper the growth of the market in the forecast period.

COVID-19 Impact Analysis

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.

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.

Segment Analysis

Infectious diseases segment is expected to grow at the fastest CAGR during the forecast period (2021-2028)  

The infectious disease segment is anticipated to hold one of the major market shares over the forecast period. The segment is driven by the huge burden of infectious disease across the world. For instance, sexually transmitted infections (STIs) represent an important public health problem in the United Kingdom. According to the Health Protection Report 2019, 447,694 new STI diagnoses were made at sexual health services (SHSs) in England. Among these, the most commonly diagnosed STIs were chlamydia (218,095; 49% of all new STI diagnoses), first episode genital warts (57,318; 13%), gonorrhoea (56,259; 13%), and genital herpes (33,867; 8%). Therefore, a rise in the prevalence of such infectious disorders is expected to fuel the market growth during the forecast period.

Moreover, players are expanding their regional market position by adopting various strategies, such as mergers and acquisitions, while others are developing new test methods for the diagnosis and introducing new products to retain their market share.

For instance, in May 2021, Swiss pharmaceutical giant, Roche, entered into a definitive merger agreement with GenMark Diagnostics, under which Roche may acquire GenMark’s molecular tests designed to screen patient samples for multiple infections simultaneously. Hence, considering all the factors mentioned above, the market is expected to witness growth over the forecast period.

Geographical Analysis

North America region holds the largest market share of Global Molecular Diagnostics Market

North America is dominating the global molecular diagnostics market and is expected to grow in the forecast period. 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. Additionally, as per the 2018 HIV Surveillance Report, as of 2018, there were around 36.9 million people with HIV in Canada. 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. Thus, considering above mentioned factors, it is expected to drive the market growth in North American region over the forecast period.


Competitive Landscape

The molecular diagnostics market is highly competitive with presence of local as well as global companies. Some of the key players which are contributing to the growth of the market 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, and Bio-Rad Laboratories Inc. among others. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the molecular diagnostics market globally. For instance in December 2020, Co-Diagnostics Inc. announced their sale of more than 10 million of its Logix SmartTM COVID-19 test kits to its domestic and international laboratory, hospital, and supplier network.

Hologic, Inc

Overview: Hologic, Inc. is a developer, manufacturer and supplier of diagnostics products, medical imaging systems, and surgical products focused on women's health and well-being through early detection and treatment. The Company operates through four segments: Diagnostics, Breast Health, GYN Surgical and Skeletal Health.

Product Portfolio:

Direct Load Tube Collection Kit: The Hologic Direct Load Tube Collection Kit is intended to be used for clinician collection of throat and nasal swab specimens and patient collection of nasal swab specimens in a health care setting for testing with the Aptima SARS-CoV-2 assay to detect the presence of RNA for SARS-CoV-2. The Hologic Direct Load Tube Collection Kit has not been evaluated for home use.

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