Biomarker Validation & Testing Market Report Based on Technology (Transcriptomics, Imaging Biomarker(MRI, PET, PECT, Ultrasound Devices), NGS), By Indications(Cancer, Coronary Artery, Alzheimer’s, Parkinson’s Disease, Multiple Sclerosis, chizophrenia)

Biomarker Validation and Testing Market in the Global Industry Landscape

Biomarker validation is a process to test the biomarkers for their accuracy and consistency, and also about their ability to signify important aspects related to the health or disease. As known there is no one single measure to validate all the biomarkers, thus they are required to meet a general criteria in order to be useful. In cancer medicine today, often protein are used as biomarkers, which are used as per the stage of development of the cancer. This is identified through validation process that determines how well a process or test measures or predicts. The numerous cases of critical diseases primarily drives the development in biomarker validation and testing market.

Further, laboratory validates biomarkers can either be commercialized or made available for only clinical use. This is largely dependent upon the compliance of strict regulatory requirements. Regulatory approval for biomarkers is much different from the process for approval of drugs and therapeutics. The intended use of the biomarker test leads towards the regulatory approval.

Our Global Biomarker Validation and Testing Market can be segmented on the following basis:

Based on Technology

• Transcriptomics
• Imaging Biomarker
  • MRI
  • PET
  • SPECT
  • Ultrasound Devices
• NGS Platforms/Consumables/Services

Based on Indications

• Cancer
• Coronary Artery Disease
• Alzheimer’s Disease
• Parkinson’s Disease
• Multiple Sclerosis
• Schizophrenia
• Others

Based on Geography

• North America (U.S. & Canada)  Biomarker Validation & Testing  Market {Market Share (%), Market Size (USD Billion)}
• Latin America (Brazil, Mexico, Argentina & Rest Of Latin America)  Biomarker Validation & Testing  Market {Market Share (%), Market Size (USD Billion)}
• Europe (The U.K., Germany, France, Italy, Hungary, Spain, Poland, Sweden & Roe)  Biomarker Validation & Testing  Market {Market Share (%), Market Size (USD Billion)}
• Asia-Pacific (China, India, Japan, Singapore, South Korea, Australia, New Zealand, Rest Of Asia)  Biomarker Validation & Testing  Market {Market Share (%), Market Size (USD Billion)}
• Middle East & Africa (GCC, South Africa, North Africa, Romea) Biomarker Validation & Testing  Market {Market Share (%), Market Size (USD Billion)}

Global Biomarker Validation and Testing Market Outlook comprises of the following data:

• Biomarker validation and testing market size and market compounded annual growth rate, 2017-2025
• Drug Discovery Outlook, 2017
• New FDA approved biomarkers outlook, 2017

North America biomarker validation and testing market is the leading the way in terms of revenue generation. The high healthcare investments in the region and positive regulatory framework coupled with widespread acceptance of personalized medicine are the major driving factors for the growth of biomarker validation and testing market in North America.

Biomarkers have huge impact on the success rate of drug discovery under clinical trials. NeoGenomics, Inc. in 2017 announced the expansion of Immuno-Oncology profiling tests. It includes Tumor Mutation Burden (TMB) and microsatellite instability (MSI) testing. TMB is a recent genomic biomarker designed to foresee response to checkpoint inhibitor immunotherapies by targeting the PD-1 and PD-L1 proteins. This expansion of testing services is expected to help the physicians to identify different response of patients to new advanced immunotherapies.

FDA Approval to Biomarker: The FDA has given its first approval to treat the cancer patients having their biomarker. This approval has set a milestone in the history of biomarker FDA approval. Tumor biomarker based drug is now approved which is not limited by the tumor’s original position.     

Expert Analysis: The use of biomarkers in clinical research is finally growing up, with an increased importance of biomarkers in clinical studies, diagnosis and therapeutic monitoring, patient stratification, and all this amounts to a ‘fit-for-purpose’ validation approach. Though the validation guidance is evolving to become more transparent and unified with time, the practice of fit-for-purpose validation is becoming even more dynamic with the broadening of biomarkers utilization.