The global molecular diagnostics market was valued at US$ xx million in the year 2019. This market is estimated to be valued at US$ xx million in the year 2020, and is expected to reach US$ xx million by the year 2025, with an estimated CAGR of xx% during the forecast period (2020-2025). Molecular diagnostics field involves the detection of genomic variants, in order to facilitate diagnosis, subclassification, prognosis, of the various application including oncology, genetic testing, microbiology, STDs, blood screening, virology, tissue typing, and prenatal diagnostics.

Table 1. Global molecular diagnostics market Synopsis

Market Dynamics

Nowadays, molecular diagnostics has become the leading diagnostic platform for the research and treatment purpose for most of the chronic disease conditions. This has provided a robust opportunity for key players operating in the diagnostics industries to launch innovative molecular diagnostics test, assay, instruments/equipment to enhance and strengthen their molecular diagnostics product portfolio. This is one of the major factors driving the growth of the molecular diagnostics market. For instance, recently in March 2020, Sense Biodetection Limited (Sense) launched the world’s first instrument-free, point-of-care molecular diagnostic test for SARS-CoV-2. 

Moreover, prevalence of chronic diseases such as cancer, infectious disease, and others disease, has increased the demand for the molecular diagnostics test. For instance, according to the National Cancer Institute (NCI), in 2018, an estimated 1,735,350 new cases of cancer have been registered in the U.S.

However, product recall has been considered as one the major restraining factors for the molecular diagnostics market. Mechanical defects and false results associated with molecular diagnostics instruments may result into product recalls. For instance, in August 2019, the U.S. Food and Drug Administration (FDA) issued a class I product recall for QiaSymphony SP/AS (sample prep/assay setup) instruments, developed by Qiagen N.V. due to potential leaking issues that may lead to delayed or inaccurate results. Such product recalls also hamper the manufacturers’ production and distribution capabilities. 

Figure 1. PORTER’S Analysis

Note: Above figure shown for illustrative purpose only, the actual data may vary and will be incorporated in the report.

North America is anticipated to hold a leading position in the global molecular diagnostics market owing to the high prevalence of the cancer and infections in the U.S; this further leads to rise in the demand for molecular diagnostics tests. For instance, according to Centers for Disease Control and Prevention estimation, in 2018, around 37,832 people have been diagnosed with HIV in the U.S. Moreover, recent outbreak of the coronavirus (COVID-19) infection, has driven the demand of the molecular diagnostic test in the U.S.

Figure 2. Regional Analysis

Note: Above figure shown for illustrative purpose only, the actual data may vary and will be incorporated in the report.

Competitive Landscape

Key players involved in global molecular diagnostics market include: Thermo Fisher Scientific, Becton Dickinson, Abbott Laboratories, Roche Diagnostics, Novartis, Diasorin S.P.A., Johnson and Johnson, bioMerieux, Bio-Rad Laboratories, Qiagen NV, Sysmex Corporation, Siemens Healthcare, Danaher Corporation, and Hologic., among others

These players are increasingly focusing on the adoption of inorganic growth strategies such as acquisition and mergers, in order to strengthen their molecular diagnostics product portfolio. For instance, in May 2016, DiaSorin S.p.A. acquired Focus Diagnostics' immunodiagnostic and molecular diagnostic products business from Quest Diagnostics. Also, bioMérieux, a player in the field of in vitro diagnostics, acquired the BioFire Diagnostics Inc., a privately held U.S.-based company specialized in molecular biology, in September 2014. Thus, such initiatives by the major players are contributing to the growth of the molecular diagnostics market.

Figure 3. Market Share of Key Players, 2019

Note: Above figure shown for illustrative purpose only, the actual data may vary and will be incorporated in the report.