The Role of Biomarkers in Clinical Trials: Enhancing Drug Development and Safety

16 Feb 2024

In the landscape of modern medicine, the quest for safer and more efficacious drugs has been a perpetual challenge. Clinical trials serve as the cornerstone of this pursuit, offering a systematic approach to evaluating the safety and efficacy of potential therapeutics.

However, traditional clinical trial paradigms often rely solely on clinical endpoints and subjective assessments, which may not fully capture the intricate biological mechanisms underlying disease progression or treatment response. Enter biomarkers – the molecular signatures, indicators, or characteristics that can objectively measure and evaluate biological processes.

Furthermore, biomarkers play a pivotal role in personalized medicine, enabling tailored therapeutic approaches that account for individual variability in disease susceptibility and treatment response.

Clinical Biomarkers and their Applications in Healthcare

Clinical biomarkers are quantifiable biological parameters that aid in comprehending disease progression and early diagnosis. Specifically, they encompass molecular biomarkers, offering novel targets for characterizing diseases, discovering drugs, and advancing development. This report centers on manufacturers producing various tests based on biomarkers, including prognostic, predictive, and diagnostic biomarkers, along with associated services.

As per the report of BIS Research, the global clinical biomarkers market was valued at $24.80 billion in 2023 and is expected to reach $53.20 billion by 2033, growing at a CAGR of 7.93% between 2023 and 2033.

Clinical biomarkers are measurable biological parameters that aid in understanding disease progression and early diagnosis. More precisely, they encompass molecular biomarkers, providing fresh targets for characterizing diseases, discovering drugs, and advancing development.

The substantial ongoing investments by healthcare companies to meet industry demands, coupled with the increasing adoption of drug discovery and development, disease risk assessment, and other applications among major end-users, are the primary drivers fueling the growth of the global clinical biomarkers market.

Drug Development and Safety through Clinical Biomarkers

As cancer cases continue to increase, there is a growing demand for improved products. Numerous significant industry players are adjusting their technologies to meet market needs, offering advanced products and services through strategies like product launches, in response to market demands.

Clinical biomarkers play a crucial role in drug development and safety by providing valuable insights at various stages of the process:

1. Early Drug Discovery: Biomarkers help identify potential drug targets and understand disease mechanisms, facilitating the development of more effective and targeted therapies.

2. Patient Stratification: Biomarkers enable the identification of patient subpopulations likely to respond favorably to a particular treatment, allowing for personalized medicine approaches and enhancing clinical trial outcomes.

3. Efficacy Assessment: Biomarkers serve as objective measures of treatment response, allowing researchers to assess the effectiveness of drugs more accurately and efficiently.

4. Safety Assessment: Biomarkers can indicate potential adverse effects or toxicity early in the drug development process, helping to mitigate safety risks and improve patient safety profiles.

5. Predictive Modeling: Biomarkers contribute to predictive modeling, allowing researchers to anticipate drug responses and adverse reactions more accurately, leading to better-informed decisions in clinical trial design and patient care.

Recent Development in the Clinical Biomarkers Market

Significant progress has been made in biomarker detection technologies, resulting in the creation of diverse methods utilizing highly specific recognition biomarkers.
Some of the recent developments in the global clinical biomarkers market are:

  • In August 2023, Quest Diagnostics introduced the AD-Detect test for Alzheimer’s disease in the U.S., marking the first availability of a blood-based biomarker test for evaluating the potential risks of developing AD to consumers.
  • By September 2023, Becton, Dickinson and Company had formed a partnership with Navigate BioPharma Services, Inc. to develop and market flow cytometry-based companion diagnostics and clinical decision tools. The collaboration capitalized on Navigate BioPharma's proficiency in biomarker assay design for clinical trials, complemented by BD's extensive array of flow cytometry instruments, reagents, software, and in vitro diagnostics (IVD) development services.
  • In November 2023, Abbott Laboratories obtained FDA clearance for the Alinity i Lab-Based Blood Test, aimed at assessing mild traumatic brain injury (TBI) or concussion using two biomarkers.
  • In November 2023, Illumina Inc., a prominent provider of DNA sequencing and array-based technologies, rolled out the enhanced TruSight Oncology 500 ctDNA v2 (TSO 500 ctDNA v2). This research assay enables noninvasive comprehensive genomic profiling (CGP) of circulating tumor DNA (ctDNA) from blood, serving as an alternative to tissue testing or complementing tissue-based analysis.
  • In May 2023, Thermo Fisher Scientific Inc. announced FDA clearance for its BRAHMS PlGF plus KRYPTOR and BRAHMS sFlt-1 KRYPTOR biomarker immunoassays, designed for assessing and managing the risk of preeclampsia.


As per the analyst, BIS Research, "The increasing desire for precision medicine and targeted therapies is driving the demand for the clinical biomarkers market. This trend is anticipated to persist in the foreseeable future, propelled by rising awareness globally, encompassing emerging economies."