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Biomarkers Validation and Testing Market Size, Share & Industry Analysis, By Technique (Biomarker Immunoassays, Flow Cytometry, Others), By Applications (Oncology, Drug Discovery & Development, Others), By End-user (Pharmaceutical & Biotechnology Companies, Research Institutes & CRO’s, Others) And Regional Forecast, 2024-2032

Region : Global | Report ID: FBI105042 | Status : Ongoing



Biomarkers are used in all areas of medicine to predict, diagnose, characterize, or to treat a disease. A biomarker represents a biological molecule that is used efficiently and precisely to evaluate pharmacologic responses.  Biomarker testing is used prominently in drug discovery and treatment of cancer. Validation of a biomarker is essential in delivery of high-quality research data necessary for effective use of biomarkers.  Once a biomarker is validated, it is then used in drug development for disease identification or disease treatment. NeoGenomics, Inc. in 2017 announced the expansion of Immuno-Oncology profiling tests that includes microsatellite instability (MSI) testing and tumor mutation burden (TMB).

Increasing prevalence of the chronic diseases is leading to higher demand for the biomarkers. This factor is responsible for driving the growth of the global biomarkers validation and testing market. Additionally, increased investment in the drug discovery and development and high input in the research activities on the development of the diagnostics markers are some of the major factors driving the growth of the global biomarkers validation and testing market.

However, numerous challenges faced by pharmaceutical company researchers in biomarker validation and testing is the factor restraining the growth of the global biomarkers validation and testing market. In addition, high-cost of biomarker validation immuno-assays is likely to have negative impact on the growth of the global market.

Key Market Driver -

Increasing R&D for drug discovery and development

Key Market Restraint -

Challenges faced in biomarker validation and testing

Market Segmentation:

By technique, the market is segmented into biomarker immunoassays, flow cytometry and others. Based on applications, the market is segmented into oncology, drug discovery & development and others. Based on end-users, the Biomarkers Validation and Testing Market is segmented into pharmaceutical & biotechnology companies, research institutes & CRO’s and others.

From a geographical standpoint, the market is categorized into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.

Key Players Covered:

The major companies in the global biomarkers validation and testing market report include LGC Limited, SGS SA, BiomarkerBay B. V, Intertek Group plc, Eurofins Central Laboratory, AnyGenes, NeoGenomics Laboratories, Inc., GP-Bio Inc, Covance Inc., and others.

Key Insights:

  • Overview of Regulatory Scenario in the Biomarker Validation and Testing Market

  • Technological Advancements in the Biomarker Validation and Testing Market

  • Key Mergers and Acquisitions

Regional Analysis:

Geographically the global biomarker validation and testing market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. Among the regions, North America accounted for the largest share of the global biomarkers validation and testing market in 2018. The leading position is attributable to the high investments in research and development of the biomarkers, increasing prevalence of cancer, and adoption of personalized medicine by patient pool. Asia Pacific region is anticipated grow at a higher CAGR owing to rise in cancer diagnostic test by patients, need for accurate diagnostics and validation of assays for drug development and discovery as well as strong government backup and funding to launch novel drugs in the market. Latin America and Middle East & Africa are expected to have slower market growth owing to less R&D investments and lack of awareness for technological advancements.

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By Technique

  • Biomarker Immunoassays

  • Flow Cytometry

  • Others

By Applications

  • Oncology

  • Drug Discovery & Development

  • Others

By End-user

  • Pharmaceutical & Biotechnology Companies

  • Research Institutes & CRO’s

  • Others

By Geography

  • c

Biomarker Validation and Testing Industry Developments

  • In November 2019, Biocept Inc. launched a liquid biopsy test TARGET SELECTOR, a pan-TRK assay for the detection of TRK proteins designed to provide physicians with presence of NTRK fusions in patients diagnosed with cancer.

  • In October 2019, Biocartis Group NV announced the launch of IDYLLA ctEGFR Mutation Assay. The liquid biopsy assay provides accurate and highly molecular information of 49 EGFR mutations from blood plasma of a cancer patient.

  • In May 2019, Roche launched VENTANA HER2 Dual ISH DNA Probe Cocktail assay, to detect HER2 biomarker found in the breast and gastric cancers.

  • In May 2019, QIAGEN announced the launch of therascreen PIK3CA RGQ PCR Kit. The USFDA approved kit is useful in detection of activating mutations of PIK3CA gene in any cancer indications.

  • Ongoing
  • 2023
  • 2019-2022


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