The tumor profiling market is projected to reach USD 12.47 billion by 2024 from USD 7.56 billion in 2019, at a CAGR of 10.5% during the forecast period. The increasing incidence of cancer across the globe and the increasing use of biomarkers in tumor profiling are the primary growth drivers for this market. In addition, the increase in cancer research and funding initiatives and technological advancements in profiling technologies are also propelling the growth of the cancer/tumor profiling market.
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Increasing demand for personalized medicine
Personalized medicine, which has become a core area of research in the healthcare industry, has entered mainstream clinical practice and is changing the way many diseases are identified, classified, and treated. These advancements are particularly evident in the area of oncology. According to the Personalized Medicine Coalition report (2017), the number of personalized drugs, treatments, and diagnostic products has increased since 2006, and this trend is expected to continue in the coming years. Moreover, biopharmaceutical companies have nearly doubled their R&D investments in personalized medicine over the last five years; this is further expected to increase by 33% over the next five years.
Tumor behavior is often guided by more than a single genetic or molecular marker. Rapid advances in genomic profiling of tumors have profoundly expanded knowledge of tumor behavior and guided tailored chemotherapeutic regimens for patients. The result has been a societal and clinical push toward treatment guided by personalized medicine or precision oncology. However, the progress of genomics in achieving personalized therapy is limited, owing to the inability of genetics to predict the diversity of protein expression patterns, modifications, or protein interactions following translation. Therefore, studying the proteomes of tumors and incorporating this information with genetic data has aided the advancement of personalized medicine.
Tumor profiling also helps decipher which treatments are more likely to be effective, as well as those that may not be effective, which can further help identify important treatment options that might not have otherwise been considered. Thus, the growing demand for effective personalized medicine is expected to increase the adoption of tumor profiling techniques as diagnostic tools and in the drug development process, propelling the growth of the overall market.
Low biomarker discovery-to-approval ratio
The past two decades have witnessed significant advances in the technologies used to identify new biomarkers. Research has resulted in the identification of thousands of candidate biomarkers. Despite the advances in biomarkers in the last few years, lack of clarity regarding several basic elements restricts biomarkers from reaching their full potential in human medicine. Insufficient acceptance of robust clinical biomarker tests is one of the major challenges. Too often, biomarkers identified in initial discovery studies have not shown reproducible activity during subsequent validation. Existing biomarkers are far from comprehensive and often lack specificity, while new biomarkers are being developed at a very slow rate. This leads to the need for better biomarkers to improve diagnosis, guide molecularly targeted therapy, and monitor activity and therapeutic response for various cancer types.
The high cost involved in biomarker validation is a major concern for companies, especially small organizations. Furthermore, factors such as the inherent variability in biomarker levels (due to high diversity across the human population) and molecular heterogeneity pose additional challenges in the biomarker validation process. Another challenge is the long duration required for assay development, due to which the ability to develop assays is not keeping pace with the ability to generate biomarkers.
Uptake of biomarker-based tests in the clinical settings will require evidence of the biomarker’s clinical validity and utility. This is important not just to help physicians in their decision-making process within the practice of evidence-based medicine but also to achieve regulatory approval and appropriate reimbursement for the test. A better understanding of the overall process of biomarker discovery and validation and of the challenges and strategies inherent in each phase could improve the experimental study design and, in turn, increase the efficiency of biomarker development and facilitate the delivery of novel clinical tests.
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