The high cost associated with biomarkers research and development can hamper the growth of neurological biomarkers market. Developing novel biomarkers requires massive investments in terms of time, capital and resources. The rigorous and lengthy research activities involved in biomarker validation and qualification inflates the costs substantially. Furthermore, stringent regulatory policies related to clinical trials and approvals makes the process even more capital intensive.
For instance, according to the report published by Organization for Economic Co-operation and Development report in 2021, the average cost of developing a new medical entity and bringing it to market was USD 2.17 billion. This cost has increased nearly three-fold over the past two decades. A significant portion of these costs can be attributed to biomarker validation studies. The extensive and well-controlled clinical studies involving large patient cohorts are necessary to prove the clinical validity and utility of a biomarker but these add considerably to the expenses.
Market Opportunities: Biomarker discovery for rare neurological disorders
Biomarker discovery for rare neurological disorders can presents a major opportunity for neurological biomarkers market. Rare neurological disorders are often hard to diagnose due to the lack of clear symptoms and biomarkers. However, biomarkers can help in early and accurate diagnosis of these conditions. This has become an important area of research as many rare neurological disorders are progressive and early detection along with treatment can help stop or delay progression of the disease.
Researchers are making significant progress in identifying novel biomarkers for rare neurological disorders such as Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, epilepsy, and brain tumours. According to the Orphanet Report Series published by INSERM in 2022, there are over 7,000 known rare diseases affecting over 300 million people worldwide. The report estimates that rare neurological disorders account for about 30% of all rare diseases. With growing diagnosis and prevalence rates, the neurological biomarkers market is likely to grow substantially to address the clinical research and diagnostic needs for these large number of rare diseases.
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