Biomarkers

Global Market Outlook on Biomarkers

• The global demand for biomarkers is expected to grow at approx. 14–16 percent CAGR through 2022–2028

• Pharmaceutical companies are outsourcing manufacturing and development services, due to the nature of business being capital intensive and the growing demand of biologics and generic medicines

• North America is the preferred region, followed by Asia Pacific, mainly due to the low cost of operations and continuous evolving nature of regulations

Biomarker Market

• Cancer had the biggest market share of USD 16.07 billion in 2022 and is expected to grow at a CAGR of 15-17 percent during the forecast period.

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

• 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 approx. 12–15 percent in the next five years

• Proteomics biomarker discovery, albeit more complex, is expected to grow at a CAGR of 14–16 percent

• Imaging biomarkers, on the other hand, are expected to grow at a steady rate of 14–15 percent, over the next five years

• 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

• Secondary End Point Biomarkers is expected to grow at a CAGR of 14.7 percent from 2022 to 2026 and is expected to reach $4.9 billion in 2026 

• The North American sub-continent constitutes the biggest market share to the global biomarkers market. The major growth in this continent is because of the modern healthcare infrastructure facility, new product launches, entry of new industry players in the business/market sector, wide utilization of biomarkers, and strong development trends in contract research organizations and pharmaceutical firms in this continent, dynamic government initiatives and increase in the disease prevalence

Cancer

• The cancer biomarker market is expected to grow at a CAGR of 15–17 percent

• The market share of cancer biomarkers is forecasted to reach $46 billion by 2028

• The growth factors include:

–Increasing rate of cancer patients

–Technological advancement of Omics

–Need for personalized cancer treatments

–Rise in government funding for cancer research

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

Cardiovascular

• Cardiovascular disorders are expected to grow at the highest CAGR of 14–16 percent and is expected to reach $20,450 million by 2026

• 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 : Biomarkers

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