The cutting-edge precision oncology revolution in cancer therapy is unlike the antiquated one-size-fits-all model. The patient-centered model is gaining popularity as healthcare systems become more committed to value-based care and personalized medicine. Advances are underway in developments of next-generation technologies in DNA sequencing, AI-driven analysis, and companion diagnostics driving precision oncology growth worldwide.
Growing incidence of cancer, increasing demand for targeted treatments, and increased availability of biomarker testing are driving the growth of the market. Also, co-operation among biotechnology companies and diagnostic laboratories is rationalizing precision-driven treatment pipelines. Payers and regulatory authorities also see the sustained cost-effectiveness of targeted interventions.
For example, the FoundationOne CDx assay provided by Roche delivers an exhaustive genomic profiling solution analyzing 324 genes, enabling oncologists to pair patients with FDA-approved targeted treatments or clinical trials, which is the essence of precision oncology's value proposition-right drug, right patient, right time.
The increased burden of cancer worldwide is one of the leading drivers to the precision oncology market. Cancer caused almost 10 million deaths in the year 2020 alone, with the incidence expected to reach dramatically higher numbers over the coming decades, according to the WHO. Traditional chemotherapy often doesn't cure complicated, genetically diverse tumors, and there is a growing need for accurate methods that take into account the individual's unique molecular signature.
Precision oncology helps oncologists detect oncogenic mutations, fusion genes, and, which are all involved in determining prognosis and treatment. This becomes especially relevant in the cases of aggressive cancers such as TNBC, which do not have favorable response to hormone therapy or HER2-targeted interventions. Personalized medicine is hence essential in treating such cases.
For example, in non-small cell lung cancer (NSCLC), treatments targeted at mutations such as EGFR, ALK, and ROS1 have proven to improve survival dramatically over chemotherapy, an illustration of how molecular subtyping can have direct implications for both treatment efficacy and patient outcome. The efficacy of these targeted treatments is generating both clinical adoption and investment in precision oncology infrastructure.
Advances in technologies in genomics, especially of next-generation sequencing or NGS, have transformed the scalability and practicability of precision oncology. These developments have lowered the cost and turnaround for genome-wide tumor profiling significantly, which makes genomic analysis available in all clinical settings. The use of artificial intelligence and big data analytics is also further improving the interpretation of high-dimensional genomic data.
The concurrent advancement of companion diagnostics further spurred market growth. Companion diagnostics are co-developed with relevant targeted therapies to ascertain their applicability to individual patients in terms of unique biomarkers. Regulators such as the FDA have further approved treatments in conjunction with companion diagnostics, abetting a dual-track model of approval, which strengthens the precision oncology value chain.
For example, Illumina's TruSight Oncology 500 assay enables clinicians to measure tumor mutational burden (TMB), microsatellite instability (MSI), and other biomarkers with one assay. This enables clinicians to choose the best immunotherapies and targeted therapies, and illustrates the crucial role that state-of-the-art genomic diagnostics play in contemporary oncology. Such technologies are not only supporting point-of-care decision-making but are speeding up the identification of new drugs by using biomarker-guided clinical trials.
North America leads the world's precision oncology Industry; thanks to its well-developed healthcare infrastructure, cutting-edge research environment, and favorable regulatory framework for personalized medicine. The region is favored with early embracement of novel technologies, high health expenditure, and presence of leading pharma and biotech industries with active research and development of targeted treatments and diagnostics.
The U.S. is among the major hubs for clinical trials, with both - the National Cancer Institute (NCI) and commercial organizations investing heavily in precision medicine initiatives. Federal programs such as the Cancer Moonshot and All of Us Research Program are further accelerating genomic data creation and application in oncology. In addition, reimbursement models and FDA policies continually favor the application of companion diagnostics and molecular profiling in healthcare.
For example, the FDA's approval of Keytruda (pembrolizumab) for any solid tumor with high microsatellite instability (MSI-H) or with mismatch repair deficiency (dMMR), independent of tissue of origin, has signaled the first site-agnostic oncology therapy approval. This regulatory achievement highlighted the region's pre-eminence in facilitating biomarker-directed treatment approaches, paving the way for global precision oncology.
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Precision Oncology Market
