Globally, cancer is the second leading cause of death, every year close to 18.1 million people are newly diagnosed with cancer leading to 9.6 million deaths. As per WHO estimation, about 43.8 million people are living with cancer. The global burden of cancer is mainly dominated by China, North America, and Europe. In 2018, North America reported with 13.3% of new cancer cases (2.4 million) and 0.7 million deaths, China with 19% of the global population accounted for 4.3 million new cases and 2.3 million deaths and European region accounted for 1.9 million deaths though the region has only one-tenth of the global population. The burden of cancer and the mortality can be reduced to a greater extent by early diagnosis.
The management of cancer has transformed by improved understanding of the genetic basis of cancer combined with technological advancement. In this regard, molecular diagnostics is used for the detection and monitoring of genetic variants such as DNA, RNA, and proteins associated with cancer.
Currently, among the most molecular diagnostic assays for profiling of cancer, allele-specific PCR based assays are of great demand due to its simplicity and speed, followed by NGS which provides required information of the whole genome of an individual and these techniques have a prominent role in determining the genetic makeup, gene expressions, mutations and other genetic variations/best avenues of an individual for further information on precision treatment and management of cancer.
Some of the advantages of molecular diagnostics are, up to 70% of the healthcare decisions are influenced by molecular-based tests, improve the quality of personalized care of the patient, potential improvement in the patient outcome and facilitate early detection of cancer with sensitive assays thereby reducing the cost of healthcare of an individual.
Molecular diagnostic tests in the form of companion diagnostics are revolutionizing the management and treatment of cancer thereby providing critical information to patients for the right medical decisions. The global market for companion diagnostics is growing at a CAGR of 11.6% to reach $1,199.8 million by 2026. For the development of precise diagnostic tests, molecular diagnostic companies are collaborating with various pharmaceutical companies for effective drug development thereby increasing the success of diagnostics tests/assay and also the drug. In this regard, Qiagen, a pioneer in precision medicine and to be a leader in companion diagnostics, is working on a collaboration with more than 25 companies to develop and commercialize their companion diagnostics products. For instance, on January 2020, Qiagen collaborated with Amgen (U.S.) to develop tissue-based companion diagnostics therascreen test, paired with investigational treatment AMG 510, to identify patients whose cancers have KRAS G12C mutation and apart from Qiagen many other companies such as Agilent Technologies (U.S.) collaborating with Merck & Co (U.S.), Myriad Genetics (U.S.) with GlaxoSmithKline, U.K., and AstraZeneca (U.S.) are coming up with new approvals from FDA for companion diagnostics thereby increasing a trend towards precision health.
Oncologist strongly believes that early diagnosis can cure cancer and drastically reduce the mortality rate associated with cancer. For reliable screening and while taking critical decisions on precise cancer treatment, there are many number of commercially available molecular-based assays for each type of cancer. Some of them are, BGI SENTIS Hereditary Breast and Ovarian Cancer Test (BGI group, China) for early detection of breast and ovarian cancer, Oncotype DX (Exact Sciences, U.S.) is used for early detection as well as prognosis of breast, prostate and colon cancer, MammaPrint (Agendia inc, U.S.) is used to diagnose recurrence of breast cancer and cobas KRAS Mutation Test (F.Hoffmann-LA Roche AG, Switzerland) is used as a companion diagnostic for colorectal cancer. By making new avenues, these molecular-based assays have a major role in the treatment of advanced cancer.
In the coming years, molecular diagnostics will play a very prominent role which is more superior to symptoms based decisions. Besides, due to transformation towards precision health and also false-positive results in other diagnostic tests (biochemical, immunochemical and histological, etc), there is a huge demand for the advanced technology-based tests/assay, and further, the high demand for such tests will, in turn, make the private companies invest more on novel technologies, in this regard most of the companies are expanding their market with advent of novel technologies from early screening till the treatment. Every day, new molecular diagnostic tests are being released at an average of 14 new genetic tests into the market and also the reimbursement environment of molecular diagnostics is evolving rapidly as the novel technological advancement is being made. Thereby ensuring that the advanced diagnostic assays could be utilized by all the individuals without much financial burden.
Some of the key players driving the global molecular diagnostics market are Abbott Laboratories (U.S.), F.Hoffmann-LA Roche AG (Switzerland), BioMerieux (France), Qiagen (Netherlands) Genomic health (U.S.), Thermo Fisher Scientific (U.S.), Grifols (Spain) and Danaher Corporation (U.S.), Hologic, Inc. (U.S.) and Myriad Genetics, Inc. (U.S.).
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