The US cancer biomarkers market is expected to register a CAGR 11.7%, during the forecast period, 2018 to 2023. Biomarkers are chemical, physical, or biological parameters, which can be used to indicate disease states. Oncology biomarkers offers high speed, non-invasive cancer diagnosis and believe to enhance cancer detection and screening. Major driving factors for the market are streamlined drug delivery process, noninvasive technology, and increased rates of survival.
The application of biomarkers is not limited to medicine, but it also involves R&D. Drug development is a lengthy, costly, and cumbersome process. It can cost as high as a few USD billion, while the average time required could vary from 7 to 8 years to more than a decade, covering from preclinical to Phase IV (i.e. post marketing). Adding more complexity to it is the low success rate or approval from regulatory bodies. This leaves no option but to look for innovative methods, such as use of biomarker in drug development to decrease the overall period and cost.
The biomarker has the potential to meet the same goal by increasing efficiency of each phase, from preclinical to Phase IV. In preclinical study, the biomarker can be used identifying the drug components that are more likely to be tolerated in humans. In early clinical phase, the biomarker can be used to evaluate the drug-concentration response, and in later phases, stratification approaches (patient with and without biomarker) can be employed for looking at response in subgroups of patients. Predictive biomarkers have their usage in post marketing study too, as they can predict adverse events beforehand.
This ability of contributing to each phase has been successful in attracting the major pharma players to adopt the technology. Moreover, regulatory bodies have played a vital role in increasing the usage of biomarkers for R&D. In 2004, the U.S. Food and Drug Administration issued a white paper titled ‘Innovation or Stagnation, Challenge and Opportunity on the Critical Path to New Medical Products’. The document gives a detailed description of the reason for stagnation in drug development, and highlights the opportunities available. One of these opportunities is the use of biomarkers in drug development. This encouragement from regulatory bodies to use biomarkers has helped in market growth, and is expected to be the prime reason for growth in the future. The other factor, such as paradigm shift in healthcare from disease diagnosis to risk assessment or early diagnosis is driving the US cancer biomarker market.
According to a recent publication, approximately 13% of all deaths across the globe are caused due to cancer. It is estimated that the total cost of cancer in the United States was more than USD 263 billion in a single year. The usage of biomarker for screening, monitoring, diagnosing, and optimizing treatment has the potential to improve patient outcomes. On the contrary, the discovery of cancer biomarkers and the development and validation of assays are both complex and expensive. Because of the critical role that biomarkers play at all stages of disease, it is important that they undergo rigorous evaluation, including analytical validation, clinical validation, and assessment of clinical utility, prior to incorporation into routine clinical care. All these processes add up to the actual cost of cancer biomarkers and make them exorbitant and costly. Due to these reasons, biomarker development and validation costs are very much higher today. This particularly applies to the cancer field with the advent of novel cancer biomarkers. The costs of many of these new-generation technologies, like prognostic or predictive biomarkers, run into thousands of dollars per patient. So, this high cost of diagnosis is hindering the market growth. The other factor, such as reimbursement issues and need for immediate processing is also hindering the growth of the market.
As per the American Cancer Society, lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer) and presence of numerous population with lung cancer in this country has made the lung cancer segment highest.
The major players include - Abbott Laboratories, Affymetrix Inc. (Thermo Fisher Scientific), Agilent Technologies, Hologic Inc., Roche Holding AG, 23andMe, Ambry Genetics, Celera Corporation (Quest Diagnostics) and Illumina Inc., among others.
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