Global Clinical Biomarkers Market Report (2020-2026)

Market Overview

Biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Also called molecular marker and signature molecule.

Biomarkers have played an increasingly prominent role in drug development and the broader cancer patient journey over the past 15–20 years. Biomarkers are used across all stages of drug development, ranging from enrichment, stratification, and patient selection to safety, efficacy, and performance assessment.

For instance, the number and percentage of oncology clinical trials that include biomarkers have grown substantially to 55 percent of all oncology trials in 2018 involved the use of biomarkers, as compared with 15 percent in 2000.

COVID-19 Impact

Currently hospital resources have been diverted to fight the pandemic, and many government agencies in conjunction with healthcare systems have made decisions to defer many elective and semi-elective procedures that use the medical device and diagnostic products. In addition, some people are avoiding seeking treatment for non-COVID-19 emergency procedures, resulting in an impact to those emergent product lines. Capital equipment purchases, outside of ventilators and patient monitoring equipment, are also being deferred by hospitals in the current environment.

Segmentation by End-Users

End-users segment includes research and academic laboratories, Biopharmaceutical and Biotech Companies, Diagnostic Centers and others  

Biopharmaceutical companies have incorporated biomarker strategies to drive their research and commercial operations. Biomarkers are used to optimize their targeted therapy portfolios, make clinical development decisions, access and preserve bio-specimens, build and mine scaled clinico-genomic datasets, segment commercial markets, develop market access and pricing strategies for biomarker driven targeted therapies, and pursue broader collaborations with academic and diagnostic partners.

In biopharmaceutical and biotech companies clinical biomarkers are used in research and commercial decision-making. The biopharmaceutical companies that pursued the most biomarker trials during 2000–2018 are Roche, Novartis, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer. Bio-pharma companies’ focus on biomarkers during this time period was likely driven by their targeted therapy and immunotherapy portfolios and disease area focus.

Segmentation by Geography

Geographically, the global clinical biomarkers market has been classified into Europe, Asia Pacific, North America, Latin America, and Middle East & Africa.

North America is one of the major region for clinical biomarkers market with major medical research happening in U.S and Canada. Research teams in the U.S. publish significantly more biomedical research discoveries than teams from other countries, as well as lead the world in research and development expenditures

The United States is the largest market for biopharmaceuticals, accounting for around a third of the global market, and is the world leader in biopharmaceutical R&D. According to the Pharmaceutical Research and Manufacturers Association (PhRMA), U.S. firms conduct over half the world's R&D in pharmaceuticals ($75 billion) and hold the intellectual property rights on most new medicines.

In the United States alone, and nearly 4 out of 10 people in the United States will develop cancer during their lifetimes. More cancer cases in the United States are expected in large population centers or in places where the population tends to be older. But even so, for the most part, cancer cases in the United States are spread randomly across the country.

Furthermore, U.S. food and drug administration is encourages the integration of biomarkers in medical product development and approval, to facilitate the monitoring of FDA-regulated products, and their appropriate use in clinical practice.

Therefore the range of medical research, presence of well-established biopharmaceutical industry and cancer diagnosis in the region showcases North America as potential leading market for clinical biomarkers.