Molecular Diagnostics - An Overview
Molecular diagnostics is technically defined as a class of diagnostic test that analyzes proteins or nucleic acids at a higher molecular level. The nucleic acids and proteins that belong to individual patients or foreign organisms help in identifying a specific therapy, health condition, or risk of developing a specific disease.
In medical terms, molecular diagnostics is better known as (MDx) evaluating the new class of diagnostic tests to test the status and health condition of a specific disease. Today, MDx is included amongst the fastest growing market segment within the in-vitro diagnostic (IVD) sector. It is mainly driven by high sensitivity, accuracy, quick turnaround time, cost-effective testing, and easy workflow.
How has molecular diagnostics evolved?
The molecular diagnostics market has been an epidemic since 1990, and since then, this market has expanded and evolved tremendously. Commencing with the introduction of PCR test for HIV and Chlamydia Trachomatis/Neisseria Gonorrhoeae (CT/NG), today, the market stands effective to a wide-range of clinical applications, particularly in infectious disease molecular testing, microbiology, genetic testing, blood screening, oncology, DNA fingerprinting (e.g., paternity testing, forensic testing), tissue typing, and food pathogen detection testing.
Earlier, the usage of molecular diagnostics was limited because of expensive tests and need of skilled professionals to fill up the job spots. However, this was surmounted by the introduction of cost per sample analysis, reduction in labor cost, and enhanced introduction and development in the advanced technologies and automation systems.
As compared to the nascent molecular diagnostics industry, the present market development and eminence comes across as a science-oriented and bio-technically transforming medical field. The market of molecular diagnostics is now considered as a well-established market for clinical applications.
Factors comprising the Molecular Diagnostics Market
The first-generation amplification, fluorescent in situ hybridization (FISH), DNA probes, and second-generation biochips and micro fluidics are the various technologies that comprise molecular diagnostics. In addition, the next-generation signal detection, biosensors, and molecular labels are other influencing factors that define therapeutic molecules, optimization of drug therapy, and the screening and diagnosis of patients. The next-generation sequencing is developing rapidly in the market due to which the PCR market that was once observed for a maximum share of the total molecular diagnostics market is now declining due to the new-evolution of efficient sequencing techniques.
Nowadays, the molecular diagnostics tests are extensively used for testing infectious diseases such as (HIV, HCV, HPV HAI and others), cancer testing, genetic diseases, HLA testing, and many others. Also, there are specific molecular diagnostic kits available for conducting blood donor screening and pharmacogenetics testing procedures.
Market Status of Molecular Diagnostic Test
According to the global statistics, the U.S market has over 600 laboratories (of which 200 function independently) performing molecular diagnostics test to accelerate and simplify the overall molecular testing process. Currently, the molecular diagnostics revenue is dominated by infectious diseases acquiring (60%) of the market share. However, the overall molecular diagnostic market is valued at 8657.3 million USD for 2019, and is expected to further grow at a CAGR of 11.1% from the forecast period 2013 to 2019. Considering the geographical share of molecular diagnostics market, North America (42.68%) and Europe (29.79%) capture the majority of the market share. This is due to rising awareness and usage of personalized medicines, and economic investments in genomics and proteomics in these regions. Nevertheless, Asia-Pacific (17.47%) and RoW (Rest of the World) (10.06%) part their contribution towards the growth and development of this market too.
Most of the additionally factors are observed through the rising incidences of hospital acquired infections (HAI). The (HAI).market within infectious diseases is anticipated to grow at a CAGR rate of 15.1% in the forecast period of 2013-2019. Similarly, HLA typing testing and oncology testing are also projected to grow at a rapid rate, and the constantly increasing incidence of cervical cancer caused due to Human Papilloma Virus (HPV) is predicted to rise at a CAGR of 14.8% during the same forecast period.
According to the study report, the growth of the molecular diagnostics market will be mainly propelled by rising incidences of hospital acquired infections (HAI), and therefore HAI testing market is expected to secure the fastest growth rate in the coming years.
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