The global biomarkers market was valued at USD 23.9 billion in 2015. The increasing use of biomarkers for drug discovery and development coupled with high R&D expenditure is a major propelling factor for the market growth.
Biomarkers are quantifiable molecular alterations used for the development of accurate and effective therapeutic targets. In addition, the rising prevalence of oncology, neurology, and cardiology-based diseases is expected to further drive the growth of this market.
U.S. biomarkers market, by disease, 2013 - 2024 (USD Million)
The market is also estimated to grow owing to the technological advancements in the development of biomarker based-diagnostics and the growing interest of pharmaceutical companies in applying novel technologies for the development of new and improved diagnostics with increased accuracy and sensitivity.
The increasing prevalence of infectious diseases and favorable government initiatives promoting rapid diagnostic platforms in the developing countries are expected to enhance the adoption level of biomarkers. Companies are developing novel kits for the early and timely diagnosis of asymptomatic diseases, such as hemoglobinopathies. For instance, Thermo Fischer Scientific, Inc. has developed the Fetal Hemoglobin mAb test kit for the detection of HbF in infants born to sickle cell carrier parents.
Biomarkers are segmented on the basis of type into safety,efficacy, and validation categories. Safety biomarkers held the largest market share in 2015 at over 40% due to the increasing awareness of routine healthcare checkups, the growing base of the high-risk population for various diseases, the identification of a population subset specific to a certain molecular profile and the associated targeted therapy, and the resultant reduced drug attrition rate that is observed to be associated with biomarker-based therapy.
Several safety biomarkers have been developed and accepted over the years, for instance those, which detect toxicity in the kidney and liver, such as alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
The validation biomarkers segment is expected to witness the fastest growth over the forecast period. These are extensively employed by pharmaceutical companies in applying the pharmacogenomics approach to predict therapeutic failure of the upcoming drugs by identifying non-responder patient subsets with distinct genetic profiles with low therapeutic response. These also ensure that there is enough clinical evidence and analysis with sufficient supportive statistical data for researchers to confidently go ahead with their drug development projects.
The drug discovery segment dominated the market in 2015 with revenue generated over USD 11.0 billion. The pharmaceutical companies are undertaking extensive R&D initiatives for the development of targeted therapeutics. For instance, Halozyme, Inc. is expected to launch a targeted therapy for EGFR mutation in non-small cell lung cancer (NSCLC) patients.
Target or mechanistic biomarkers are used to predict drug failures early in the drug development process by determining their pharmacological effect on patients, which helps the pharmaceutical company obviate additional costs associated with further clinical trials.
The diagnostic segment is estimated to witness the fastest growth owing to the rising prevalence of various diseases, the growing collaborative ties between the diagnostic and drug development companies for the drug-diagnostic co-development, and the rising number of partnerships of pharmaceutical companies with government and private research labs.
The oncology segment held the largest market share in 2015 with a revenue share of around 38.0% owing to the increasing demand for rapid and accurate diagnostic tools, the upsurge in the number of worldwide cancer cases, and the need for more specific, personalized therapeutic targets for oncology patients. Hercep Test by Dako Denmark A/S is a companion diagnostic assay used to determine the HER2 protein over expression in patients suffering from breast cancer.
The cardiovascular segment is projected to be the fastest growing application. Due to the increased understanding of the pathophysiology of cardiac diseases, the diagnostic companies are focusing on the identification of more accurate cardiac biomarkers to target the escalating patient population base.
North America held a significant revenue share of over 39.0% in 2015 owing to the high levels of disposable personal incomes, the presence of sophisticated infrastructure, the high R&D funding in the drug discovery and development sector, and the high patient awareness levels regarding the availability of enhanced diagnostics.
Asia Pacific is expected to exhibit profitable growth over the forecast period owing to factors, such as the increasing target population, the growing economy, and the low cost of clinical trials in this region. Developing countries, such as India, Brazil, South Africa, and China, are expected to offer immense potential for the biomarkers industry with the regulatory bodies slowly adapting to the co-development of drugs and their companion diagnostics, as well as due to the presence of high-unmet needs in these countries.
Some key players in the biomarkers market include Roche Diagnostics Ltd., Abbott Laboratories, Inc., Agilent Technologies, Inc., Epigenomics AG, GE Healthcare, Johnson & Johnson, Thermo Fisher Scientific, Inc., Bio-Rad Laboratories, Inc., Siemens Healthcare GmbH, Qiagen N.V., and Merck& Co., Inc.
The diagnostics biomarker kits are widely used in drug development and clinical research areas. The key players are developing novel kits and therapies or drugs to target population in the areas with high-unmet clinical needs. In 2015, AstraZeneca plc launched BRACAnalysis CDx, a companion diagnostic test developed for the recently FDA approved drug, Olaparib, used in ovarian cancer therapy associated with aberrations in the BRCA1/2 genes.
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