Research Reports

Market Overview

• The Global Biomarkers Market is expected to grow at a CAGR of 12.5% during the forecasting period (2019-2026). Biomarkers are used for the diagnosis health status of an individual. In medical terms, a measurable biomarker is a chemical component which reflects the presence as well as the severity of the disease. Biomarkers have an important function in the early detection of various diseases.

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Market Dynamics

• The Biomarkers market growth is driven by therising ageing population and increasing incidence of chronic diseases such as cancer, cardiovascular diseases and neurological disorders. In addition, increasing regulatory approval for biomarkers, rising demand in drug discovery, growing emphasis on personalized medicine and companion diagnostics are some of the other factors driving the growth of the biomarkers market globally. For instance, according to Globocan, the incidence rate of cancer types is increasing notably for many cancer types globally. The incidence of all cancer types worldwide is anticipated to increase at a CAGR of 2.5% during 2015-2030. Also, approval and product launches of biological and targeted therapies have positively impacted the global biomarker in the past few years and the trend is anticipated to be the same in the forecast period as well. For instance, In May 2018, the FDA approved Loxo application for biomarker-driven cancer drug. In November 2018, the U.S. Food and Drug Administration (FDA) approved the molecularly targeted therapeutic larotrectinib (Vitrakvi) for use based on whether a patient’s tumor tests positive for a specific genetic biomarker and not where in the body the tumor originated. Hence, with rising product launches and approvals, the market is growing rapidly globally.
• However, high investment costs and problems associated such as sample storage & collection is hampering the growth of the biomarker market. Also, unfavorable reimbursement scenarios are expected to hinder the market growth during the forecast period.

Market Segment Analysis

• On the basis of product type, the global biomarkers market is segmented into safety biomarkers, efficacy biomarkers, and validation biomarkers. Among these, Efficacy biomarker segment accounted for the largest market share and growing at a significant CAGR. Wide usage in oncology and antiretroviral treatment coupled with numerous research on identification of efficacy biomarkers should drive segment growth in projected timeframe.
• Among disease indication, cancer segment occupied a significant market share in 2018 due to rising cancer prevalence globally. According to WHO, cancer is the second leading cause of death globally, and is responsible for an estimated 9.6 million deaths in 2018. Globally, about 1 in 6 deaths is due to cancer. Approximately 70% of deaths from cancer occur in low- and middle-income countries. Biomarkers help in differential diagnosis, risk assessment and monitoring of disease progression in oncology field. Availability of several cancer biomarkers for detection of different kinds of cancer including ovarian cancer, breast cancer and leukemia will foster segment growth in recent years.
• The pharmaceutical companies are forming agreements with molecular diagnostic companies to for accelerating results biomarker testing. For instance, in Dec 2017, Biocartis Group NV signed a companion diagnostic development agreement with Amgen for the Idylla RAS biomarker tests. The agreement aims to register the Idylla RAS biomarker tests with the FDA as a companion diagnostic test for Amgen's drug Vectibix. In August 2018, FDA approved Roche’s Cobas EGFR Mutation Test V2 as a companion diagnostic test with AstraZeneca's cancer drug Iressa (gefitinib) for first-line treatment of patients with NSCLC. In July 2018, Nucleix, an Israeli molecular diagnostics firm, received $2.9 million Horizon 2020 grant from the European Commission to continue development of its lung cancer screening test, Lung EpiCheck. With the new funding, Nucleix anticipates to push Lung EpiCheck into US and European clinical trials in early 2019.

Market Geographical Analysis

• North America is dominating the global Biomarkers market in 2018 and estimated to hold largest market size over the forecast period (2019-2026). The U.S. biomarkers market will lead biomarkers market due to favorable healthcare infrastructure as well as availability of technologically advanced products. Rising investment in drug discovery, diagnostics along with rising cancer patient pool will further stimulate the biomarkers market growth. According to the National Cancer Institute, in 2018, an estimated 1,735,350 new cases of cancer are diagnosed in the United States and 609,640 people die from the disease. The most common cancers are breast cancer, lung and bronchus cancer, prostate cancer, endometrial cancer, leukemia, pancreatic cancer, thyroid cancer, and liver cancer. The number of new cases of cancer (cancer incidence) is 439.2 per 100,000 men and women per year (based on 2011–2015 cases). Increased funds and support from government bodies for biomarker discovery, and growing number of FDA approvals for biomarkers is expected to positively influence the market in the future. For instance, in Jun 2018, Halozyme Therapeutics, a biotechnology company developing novel oncology and drug-delivery therapies, presented data evaluating certain biomarkers as potential predictors of survival in patients with previously untreated metastatic pancreatic ductal adenocarcinoma at the American Society of Clinical Oncology (ASCO).

Competitive Analysis

• The Biomarkers market is a highly consolidated market, with major shared obtained by most of the emerging and local players. Some of the major players include Bio-Rad Laboratories Inc., Merck Millipore, Qiagen N.V., Siemens Healthcare, Abbott Laboratories, Affymetrix Inc., (Thermo Fisher Scientific), Signosis, Inc., EKF Diagnostics Holdings, Inc., Biosims Technologies Sas, and Cisbio Bioassays.
• The key players are adopting various key strategies such as product launches, mergers & acquisitions, and collaborations which are contributing to the growth of the biomarkers market globally. For instance,
• In April 2019, Synapse launched a new Innovative Medicines Initiative project, the Translational Safety Biomarker Pipeline (TransBioLine) Project, aims to generate exploratory and confirmatory data supporting regulatory qualification and acceptance of novel safety biomarkers for five target organ systems (kidney, liver, pancreas, vascular, and central nervous system) for application in drug development.
• In March 2019, Summa Equity acquired Olink Proteomics, a Swedish life science company that has developed a unique technology for human biomarker discovery, targeting the global biopharma and academic research and discovery markets.
• In December 2018, Olink Proteomics launched Olink® ONCOLOGY III, a new oncology-focused biomarker panel that complements and expands on Olink’s growing portfolio of thoroughly validated assays, extending the power of the Olink platform for discovery-scale applications to 1164 different human protein biomarkers.

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