The cancer biomarker market size is projected to grow from $ 28.6 billion in 2024 to $ 46.7 billion by 2035, representing a CAGR of 5% during the forecast period from 2024 to 2035.
Over the last couple of decades, the healthcare market has witnessed the entry of several advanced and effective treatment options for cancer; these include a variety of targeted therapies, immunotherapies and certain anti-cancer vaccines as well. However, clinical cancer research is still plagued by high failure rates, various drug / therapy-related limitations, and treatment-based adverse effects, some of which have been proven to be fatal. A prominent concern is associated with deciding the type of treatment option to be used for a specific cancer. Patients suffering from a singular type of cancer, who may be at the same stage of the disease, have been demonstrated to exhibit different molecular profiles, and thereby, may respond differently to recommended drug / therapy types. In order to address this concern, pharmaceutical developers and healthcare professionals have adopted a more personalized approach to disease diagnosis and treatment. This personalized approach has also been referred to as oncology precision medicine. Over time, several molecular markers have been identified and characterized, and many have been validated for use in making important treatment-related decisions.
The role of single analyte biomarkers, such as PD-L1, BRAF, and EGFR, has been well-established across multiple cancer indications. However, owing to the subtle differences in genomic makeup of individual patients, these biomarkers alone have been shown to be insufficient in determining how patients are likely to respond to various drug / therapy types. Advances in biotechnology have enabled the development of several high throughput tools, which have led to the establishment of better biomarkers, based on genome / exome profiles. Novel biomarkers, such as tumor mutation burden (TMB), microsatellite instability (MSI) / mismatch repair (MMR) deficiency, tumor infiltrating lymphocytes (TILs), Single Nucleotide Variants (SNV), Copy Number Variants (CNV) and certain others, are presently being investigated across numerous clinical studies.
Presently, several diagnostics-focused companies have developed / are developing analytical tests for these biomarkers, which are intended to assist physicians in making personalized treatment-related decisions. It is worth highlighting that many big pharmaceutical players have demonstrated interest in this domain and have launched clinical research initiatives to investigate the relevance and applications of multiple novel biomarkers. Having captured the interest of both established companies and start-ups, the cancer biomarker market is poised to grow at a healthy CAGR in the forecast period.
Close to 685 clinical trials (with more than 75,000 enrolled patients) are currently ongoing in order to investigate novel cancer biomarkers, across different geographies. During our research, we came across 680 clinical trials focused on novel cancer biomarkers that have been completed / ongoing in this domain.
The majority of the patients (32,202) were observed to be enrolled in trials conducted in Europe, accounting for more than 40% of the overall enrolled patient population. Within Europe, more than 25% patients were enrolled at different sites in France (8,488), followed by Germany (7,419) and Belgium (3,113). Further, in North America, the maximum number of patients were enrolled in the US (15,916), followed by Canada (1,086).
Majority (418) of registered trials focused on cancer biomarkers are in phase II, followed by those in phase I (165). With 52 trials being evaluated in phase III and phase IV collectively, it can be concluded that there have been continuous advancements in cancer biomarkers domain.
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