Biomarkers: for better patient outcomes
For the past 20 years, rapid technology advancements – particularly in omics – have fundamentally changed the oncology trial landscape with a significant increase in biomarker discovery and development. According to clinicaltrial.gov, 55% of all oncology trials involved using one or more biomarkers in 2018, against approximately 15% in 2000.
Since January 2022, 1,085 studies involving oncology biomarkers for any purposes have started, compared to just 76 trials in 2000 , a ten-fold increase. Moreover, a recent statistical study (Parker JL et al., Cancer Med. 2021 Mar;10(6):1955-1963) where over 1000 trials were screened; using Markov modelling, observed that biomarkers increase the success rates of clinical trials in 3 different indications. Breast cancer, melanoma, and non-small cell lung cancer (NSCLC) studies showed a 12, 8 and 7-fold hazard ratio improvement, respectively. Together, these data highlight the growing importance of biomarkers in oncology clinical development.
Toward precision oncology
With application in diagnosis, prognosis, and selection of targeted therapies and the growing desire for more personalized medicines, biomarkers have become a key in precision oncology. For example, in 2021, Roche received FDA approval for VENTANA ALK (D5F3) CDx Assay aiming to detect the mutated gene ALK (anaplastic lymphoma kinase). This mutation concerns around 72 000 people diagnosed with lung cancer worldwide. By detecting ALK-positive patients more quickly, they can benefit from 4 different targeted treatment options and increase their survival rate.
New technologies are also appearing in the field as Lunit, in collaboration with Guardant Health, announced in 2023 the integration of artificial intelligence to improve the detection of PD-L1 for NSCLC. However, challenges still need to be addressed, such as sample handling, the high cost of research and development activities, and unclear regulations.
Nevertheless, with the rising prevalence of cancer, the biomarker market will continue to expand. In 2020, the International Agency for Research on Cancer estimated 19 million new cancer cases, with a projection of nearly 30 million new cases in 2040.
Lots of cancer biomarkers companies are dedicating time and energy in biomarker discovery and development such as F. Hoffmann-La Roche Ltd., Abbott Laboratories, Thermofisher, Illumina, and Merck Millipore which are among the leading players in the market.
In 2018, the global cancer biomarker size represented 13% ($18.94 billion) of the worldwide cancer market and is projected to reach $48.20 billion by 2026, indicating that the future of biomarker research looks bright and will ultimately lead to better patient outcomes.
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