Global Market Outlook on Biomarkers in Clinical Development

The market growth is mainly driven by factors, such as increasing diagnostic applications of biomarkers, rise in R&D funding from the government, growing number of CROs, low cost of clinical trials in the developing countries, high prevalence and incidence of chronic diseases, and new initiatives for biomarker research

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  • Biomarkers are important for predicting prognosis and selecting dose regimes. They are helpful for detecting therapeutic advances and adverse responses as well as for patient stratification, based on efficacy or safety prediction
  • Biomarkers are essential tools for the selection of appropriate patients for treatment with certain drugs, and so enables personalized medicine to a greater extent
  • Biomarker information is also included in labelling, in case of negative selection (i.e., if the biomarker is used to select a population unlikely to respond) or in case of uncertainty about the value of the biomarker, but where a negative selection is suspected, e.g., vandetani
  • Genomics-based biomarker platform is the fastest growing and heavily adopted technology among others. In fact, the genomics biomarker market is expected to grow at a CAGR of ~25–26 percent in the next five years
  • Proteomics biomarker discovery, albeit more complex, is expected to grow at a CAGR of 12–14 percent
  • Imaging biomarkers are expected to grow at a steady rate of 14–15 percent over the next five years
  • The omics family is constantly growing and adding new members, such as genomics, proteomics, peptidomics, and the newer ones, such as epigenomics, transcriptomics, metabolomics, lipidomics, pharmacogenomics, interactomics, and chronemics

Biomarker Market

Cancer

  • The cancer biomarker market is expected to grow at a CAGR of 15 to 15.5 percent
    The market share of cancer biomarkers is expected to reach $ 32,632.11 million by 2024

The growth factors include:

–Increasing rate of cancer patients

–Technological advancement of omics

–Need for personalized cancer treatments

–Rise in the government funding for cancer research

  • Among the regions, Asia–Pacific will continue to grow in the next five years

Cardiovascular

  • Cardiovascular disorders is expected to grow at the highest CAGR of 15.9 percent and is expected to reach $ 25,063.53 million by 2024
  • Cardiac biomarkers are used as risk stratification for various CVDs, such as myocardial infraction, congestive heart failure, ACS, etc.
  • Some of the widely used biomarkers for CVDs as an integrated diagnostic approach include CK-MB, troponin I and T, myoglobin, BNPs, and IMA

Drivers and Restraints

Drivers

  • Increasing diagnostic applications of biomarkers 

−Personalized medicine, an emerging practice of medicine that uses an individual’s enetic profile to guide decisions made, in regard to the diagnosis, prevention, and treatment of diseases.

−Companion diagnostics involves the use of biomarkers that provides biological and/or clinical information that enables better decision making about the development and use of a potential drug therapy

  • Increasing R&D funding for pharma and biotech companies
  • Non-invasive biomarkers can help in decision making during interim analysis in protocols
  • Accuracy in result - Biomarkers can also reflect the entire spectrum of disease from the earliest manifestations to the terminal stages
  • Increasing number of CROs and low cost of clinical trials in developing countries
  • Multi-marker Application: Combination of markers used in the care, along the entire spectrum of disease, by improving screening, simplifying diagnosis, clarifying prognosis, and tailoring treatment
  • Gene-level diagnosis: Cancer diagnosis is becoming more easier with the incorporation of molecular markers, such as DNA, RNA, micro RNAs, and proteins

Restraints

  • High capital investment and low cost-benefit ratio
  • Poorly suited regulatory and reimbursement systems
  • Technical issues related to sample collection and storage
  • Government regulation and ethical problems
  • Complex process