The commercialization potential of the esoteric testing market is quite evident from the proliferation of companion diagnostics in the sphere of oncology drug development over the past few years. Significant investments in genomics research over the past couple of years have resulted in remarkable advancements in medical science. Genetic testing is one such direct benefit of the clinical research, which, of late, has been gaining popularity with the increasing occurrences of complex diseases like epilepsy, muscular dystrophy, Alzheimer’s disease etc. In fact, driven by this myriad application scope in disease treatment, the global clinical laboratory services industry has been forecast to surpass a valuation of USD 342 billion by 2024. Overtly, this multi-billion-dollar business space will leave a perpetual impact on the worldwide esoteric testing market dynamics. In this year 2017, this fraternity stood at a valuation of USD 19 billion.
Personalized medicine has of late become clinical reality, a factor that has led to huge investments in proteomics and genomics industry. Increasing sophistication of the laboratory instruments along with growing implementation of advanced technologies like bioinformatics for complex disease treatment have upscaled the demand for esoteric testing market lately. Esoteric testing allows in-depth analysis of molecules that are not routinely performed in a clinical lab, subject to skilled medical technologists’ requirement and the expensive cost associated with these tests. Thus, many commercial laboratories outsource these complex tests to reference laboratories that are specialized in esoteric testing. However, with technology being profoundly penetrating the laboratory service space, many of the medium sized labs nowadays are performing these tests in-house. The massive surge in R&D investments is expected to expand esoteric testing industry periphery in the years ahead.
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Globally, esoteric testing industry is highly regulatory driven, with mandatory roll outs by FDA and CLIA (Clinical Laboratory Improvement Amendments) that these clinical labs are required to comply with. In fact, stringent regulatory framework and uncomplimentary reimbursement scenario hinder the market penetration across some of the domains to some extent. While FDA regulates reagents, test kits, and other instruments that are widely deployed in esoteric laboratories for diagnostic purpose, highly complex testing laboratories require CLIA certification for performing these tests. The requirement of complying with all these regulatory approaches has resulted in an increased burden on small to medium sized laboratories. Amidst this backdrop, business collaboration is emerging as a top-notch strategy in the competitive landscape of esoteric testing market.
The strategic partnership of U.S. based metagenomics firm IDbyDNA with ARUP Laboratories is a testimony to the aforementioned aspect. Reportedly, with this collaboration, the firms aim to develop and commercialize advanced NGS (next generation sequencing) tests that are claimed to be more accurate and comprehensive. The partnership also outlines integration of laboratory medicine with data-driven analytics to exploit the benefits of precision medicine in infectious disease treatment. Market experts claim that similar kinds of collaboration will bring advanced genetic technology into clinical practice more rapidly, subsequently enhancing esoteric testing market outlook. In this regard, it is important to note that market giants have been really optimistic and are betting big on Infectious disease and immunology, which in 2017, procured 28% of the overall esoteric testing industry landscape.
Oncology is yet another vital domain significantly influencing the esoteric testing market augmentation. This can be primarily credited to the increased detection of cancer at terminal stages which has led to a surge in demand for esoteric tests. Not to mention, the oncology application is also intensely characterized by the regulatory trends. An instance validating the aforesaid is the sanction of Merck’s Keytruda drug by the U.S. FDA to be used for cancer treatment that is based on specific genetic defects. This is reportedly the first time any regulatory agency has approved cancer treatment that is solely based on a common bio maker, rather than on the location where the tumor is originated.
Regionally, U.S., China, Germany, U.K, Japan are poised to establish strong foothold in esoteric testing market space. The large patient pool suffering from infectious diseases, a significant development in health care infrastructure, rising demand for customized medication, and the growing prevalence of cancer are some of the factors driving the regional market trends. The U.S. procured 35% of the global esoteric testing market in 2017 and is anticipated to witness lucrative growth trends majorly on grounds of its upper hand in terms of medical advancements. China and Germany are anticipated to register CAGR of 12.5% and 8.5% respectively over 2018-2024.
The laboratory technology has indeed been one of the major focal points of medical advances. There has been a remarkable expansion in the range and complexity of clinical tests and services availability. With these trends gaining further traction and personalized medicine proliferating at a remarkable space, the growth potential of esoteric testing market seems humongous. In terms of revenue, the overall esoteric testing market is set to exceed USD 35 billion by 2024.