The molecular diagnostic is the technique for identifying alterations in DNA or RNA sequence, associated with any medical condition.
The molecular diagnostic is a technique used to analyze biological markers in an individuals genetic code and to analyze how their cells express their genes as proteins.
Among the technology, the polymerase chain reaction (PCR) is the most widely used method for DNA amplification for the detection and identification of infectious diseases, genetic disorders, and other research purposes.
The large share of this segment is attributed to the growing use of PCR in proteomics and genomics, the automation of PCR instruments, and the emergence of advanced technologies like qRT-PCR.
PCR can be used for the diagnosis of various diseases such as sickle cell anemia, malaria, cancer, inherited diseases and other bacterial & infectious diseases and shed light on variants of PCR.
Among all the molecular diagnostics technologies, PCR is one of the most developed molecular techniques which has a wide range of applications in the field of medicine, broad-spectrum pathogen detection and evaluation of emerging novel infections, surveillance. Also, PCR-based methods are cost-effective relative to other molecular diagnostic technologies.
Based on Application, the market is segmented into Oncology, Cardiovascular Diseases (CVDs), Infectious Diseases, Blood Screening, Microbiology, and Others.
Infectious Diseases segment accounted for the most substantial chunk of global molecular diagnostics market share with over 50% of the total molecular diagnostics market followed by Blood Screening.
The primary factors leading to a growth of the market include the rising prevalence of HIV and the introduction of novel molecular diagnostic test kits for HIV and hepatitis screening.
The oncology segment is projected to grow over the forecasting period because the U.S. has a broad base of a non-targeted population for cancer diagnosis, which is expected to rise to around 19 million in 2024, based on statistics reported by the National Cancer Institute.
In 2017, around 80,000 new cases of HIV infections were found in India. Recent outbreaks of the Ebola virus in West Africa and the zika virus in Brazil have resulted in several deaths.
With the emerging new infectious disease, there is a rising demand for molecular diagnostics techniques.
Also, increasing geriatric population is impacting industry growth as the vulnerability to such infections significantly increases with the increasing age.
Market Trends and Opportunities
The increasing prevalence of infectious diseases and increasing incidences of cancer are expected to be among the major factors boosting the molecular diagnostics market growth over the forecast period.
For instance, according to the Centers for Disease Control and Prevention (CDC), in 2015, around 5,251 deaths were reported due to influenza infection in the U.S. Furthermore, according to a National Cancer Institute, 2016, an estimated 16.8 million new cases of cancer were diagnosed in the U.S. with an estimated 595,690 deaths from the disease.
The number of people with cancer is expected to rise to 19 million by 2024. Additionally, cancer is also a significant cause molecular diagnostic market.
For instance, according to cancer.gov, in 2018, an estimated 1,735,350 new cases of cancer were diagnosed in the U.S. and 609,640 people died from cancer.
Major cancer in descending order is breast cancer, lung and bronchus cancer, prostate cancer, colon and rectum cancer, melanoma of the skin, bladder cancer, non-Hodgkin lymphoma, kidney and renal pelvis cancer, endometrial cancer, leukemia, pancreatic cancer, thyroid cancer, and liver cancer.
Breast cancer is the most common type of cancer and can occur both in men and women.
However, it is mostly found among females and the male occurrence of breast cancer is very rare.
The other factors influencing the growth of molecular diagnostic marker are research and development for identification of biomarkers have led to the development of new molecular diagnostic tests. For instance, in February 2018, the FDA granted marketing approval to Banyan Biomarkers, Inc. for the first diagnostic blood test.
Market Challenges
However, stringent regulation by FDA to regulate molecular diagnostic tests is expected to be a major factor restraining the growth of the market.
Framework regarding the regulatory approval process is been one of the major setbacks for the molecular diagnostics market.
Emerging countries, such as India and China, lack standard structured regulatory framework and guidelines on diagnostics, which certainly had a negative impact on the growth regional molecular diagnostic market irrespective of the presence of a large population.
Regulatory uncertainties in the approval process of molecular diagnostics lead to a low profiled profit scenario among the manufacturers.
Product Launch, Merger, and acquisition and technological advancement paving way for a robust increase in the global molecular diagnostic market.
For instance, Abbott Laboratories in August 2016 launched Alinity, a next-generation system, which is advanced in the segments such as immunoassay, clinical chemistry, point-of-care, hematology, blood and plasma screening, and molecular diagnostics.
HTG Molecular Diagnostics, Inc. in 2017, is expected to launch HTG EdgeSeq PATH Assay, which is used for retrospective gene expression profiling to complement traditional immunohistochemistry (IHC) testing in the second quarter.
Alton Diagnostic, 2018, launched its new CE-IVD marked AltoStar Molecular Diagnostic Workflow, which automates the entire workflow from sample preparation to analysis.
In 2016, Debiopharm Group acquired a majority holding in GenePOC, Inc., the Canadian developer of affordable, rapid molecular tests that identify infectious agents at the point-of-care.
Market Key Companies
Key companies operating in the global molecular diagnostics market are Hologic, Inc., Grifols, S.A., Abbott Laboratories, Qiagen N.V., F. Hoffmann-La Roche Ltd., Siemens Healthineers, Becton, Dickinson and Company, and Beckman Coulter, Inc., among others.
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