The central nervous system biomarkers market is projected to register a CAGR of 7.5% during the forecast period, with a revenue of approximately USD 4,652 million in 2020 and expected to reach USD 7,160 million by 2026.
The rising COVID-19 cases across the globe are having a profound impact on the CNS biomarkers market. Based on the study "Biomarkers for central nervous system injury in cerebrospinal fluid are elevated in COVID-19 and associated with neurological symptoms and disease severity" published in January 2021, it has been found from various studies that there was frequent reporting of neurological symptoms in hospitalized patients with coronavirus disease 2019 (COVID-19). The researchers thus examined cerebrospinal fluid (CSF) from patients with neurological manifestations of COVID-19 for biomarkers of the central nervous system (CNS) injury and other pathology in relation to neurological symptoms and disease severity. Therefore the future studies in larger samples are thus needed to explore and understand the genesis of neurological injury in COVID-19 patients.
A biomarker is being used to measure the biological state, presence of diseases and effects of treatments. The advancements in the fields of genomics and proteomics during the past decade have improved awareness regarding genetic regulatory pathways related to (central nervous system) CNS biomarkers. The proteomics technologies have advanced in various areas of drug discovery and development through a comparative assessment of normal and diseased tissues. The proteomics research has great potential in the discovery of relevant protein biomarkers in both diagnostics and therapies for the central nervous system. It plays a crucial role in earlier disease diagnosis, prognosis, and in monitoring the central nervous disease development.
There is also an increasing number of pipeline studies for the development of biomarkers in various disease conditions, which is expected to boost the central nervous system biomarkers market growth. According to the study "Biomarkers in tumors of the central nervous system" published in 2019, there are specific diagnostic, prognostic and predictive biomarkers that have been detected and it continues to emerge. Hence, the knowledge about specific biomarkers is of great importance for individualized treatment and follow-up.
Therefore, the advanced imaging systems are aiding the early diagnosis of various diseases, while reducing the mortality rate. The development in related technologies, such as genomics, proteomics, and imaging system, has reflected on the evolution of newer biomarkers. Considering the complexity of the central nervous system (CNS), biomarkers are now expected to play a significant role in the identification of several neurodegenerative diseases at an early stage, provide enhanced diagnosis, and eventually better treatment.
However, with the high cost of CNS biomarker testing and diagnostics and certain issues related to regulatory and reimbursement systems are found to be the hindering factors impacting the growth of the market.
Key Market Trends
Personalized Medicine Segment is Expected to Show Better Growth in the Forecast Period
Precision medicine or personalized medicine is found to be one of the most promising approaches to tackle various diseases. The major factors that are contributing to the growth of the market are the rising number of brain and other nervous system cancers. It has its rising application as a diagnostic tool, which helps in recognizing the precise biological markers. There is an increasing number of companies that are found focusing on developing breakthrough products for the treatment of neurological diseases.
The rising COVID-19 pandemic has impacted the personalized medicine segment. Precision medicine (PM) aims to tailor treatment and interventions to unique individual or population-level traits. Therefore personalized medicine is relevant for addressing COVID-19 illness. The San Antonio Partnership for Precision Therapeutics (SAPPT) has also announced the funding of three projects that will accelerate treatments for COVID-19 using precision medicine principles.
Biomarker research in neurodegenerative disease is a rapidly advancing area in personalized medicine. The role of these markers is not only diagnostic, but they also have prognostic potential or role in the development of new treatment. Therefore, a large number of molecules have been evaluated and associated with different neurodegenerative disorders. Alzheimer's disease and Parkinson's disease are found to be the two most common neurodegenerative disorders.
This evolution within precision medicine has profoundly impacted the biopharmaceutical industry, and multiple players from biopharma to diagnostics companies with multiple functions such as research and development to commercial operations will witness a change. Therefore all these factors has helped in boosting the overall market.
North America Dominates the Central Nervous System Biomarkers Market
The growing burden of chronic diseases, rise in the development in proteomics, genomics, and imaging systems, and increasing adoption in personalized medicines and therapy are expected to drive the central nervous system (CNS) biomarkers market in the United States.
The increasing neurological symptoms have been frequently reported in hospitalized patients with coronavirus disease 2019 (COVID-19), and biomarkers of central nervous system (CNS) injury are reported to be increased in plasma but not extensively studied in cerebrospinal fluid (CSF). Therefore with the rising COVID-19 cases, there are increasing evidence of central nervous system (CNS) damage in COVID-19 patients by using serological biomarkers.
According to the estimates of the GLOBOCAN in 2020, there were an estimated 2,281,658 new cancer cases diagnosed and 612,390 deaths, due to cancer in the United States. The National Institute of Neurological Disorders and Stroke is mainly focusing on approaches that could facilitate the discovery and validation of robust biomarkers, primarily for better diagnosis and treatment of certain conditions. Hence, with the rising concerns regarding neurological disorders and increasing spending on R&D of novel biomarkers, the market is expected to grow over the forecast period.
The molecular biomarkers are used for various purposes, including CNS disease diagnosis, prognosis, prediction, and assessment of treatment response and safety. Almost every pharmaceutical company is formulating a molecular biomarker program, either alone or through partnerships. More molecular biomarkers are expected to be identified and validated in drug development.
In 2019, MC10 Inc. announced the collaboration with the University of Rochester for the development of novel digital biomarkers for central nervous system diseases. Hence, with the rising concerns regarding neurological disorders and increasing spending on R&D of novel biomarkers, the market is expected to grow over the forecast period.
The global players in the central nervous system biomarkers market are: Acumen Pharmaceuticals Inc., Alseres Pharmaceuticals Inc., Aposense Ltd., Avacta Life Sciences Limited, Banyan Biomarkers Inc., Bio-Rad Laboratories, Inc., DiaGenic ASA, G-Biosciences, Merck KGaA and Thermo Fisher Scientific Inc. The players strategically invest in research and development for innovative and technological advancements and focus on partnerships with domestic players to expand their outreach.
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TABLE OF CONTENTS
- 1.1 Study Deliverables
- 1.2 Study Assumptions
- 1.3 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
- 4.1 Market Overview
- 4.2 Market Drivers
- 4.2.1 Rise in the Development in Proteomics, Genomics and Imaging System
- 4.2.2 Rising Investments from Government and Private Players
- 4.2.3 Increasing Research and Development with Successful Clinical Trials of Biomarkers
- 4.3 Market Restraints
- 4.3.1 High Cost of CNS Biomarkers Tests and Diagnostics
- 4.3.2 Reimbursement and Regulatory Issues
- 4.4 Porter's Five Forces Analysis
- 4.4.1 Threat of New Entrants
- 4.4.2 Bargaining Power of Buyers/Consumers
- 4.4.3 Bargaining Power of Suppliers
- 4.4.4 Threat of Substitute Products
- 4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION
- 5.1 By Type of CNS Biomarkers
- 5.1.1 Safety Biomarker
- 5.1.2 Efficacy Biomarker
- 5.1.3 Validation Biomarker
- 5.1.4 Other
- 5.2 By Application
- 5.2.1 Drug Discovery & Development
- 5.2.2 Personalized Medicine
- 5.2.3 Others
- 5.3 By End User
- 5.3.1 Diagnostic Labs
- 5.3.2 Clinics/Hospitals
- 5.3.3 Research Centers
- 5.4 Geography
- 5.4.1 North America
- 22.214.171.124 United States
- 126.96.36.199 Canada
- 188.8.131.52 Mexico
- 5.4.2 Europe
- 184.108.40.206 Germany
- 220.127.116.11 United Kingdom
- 18.104.22.168 France
- 22.214.171.124 Italy
- 126.96.36.199 Spain
- 188.8.131.52 Rest of Europe
- 5.4.3 Asia Pacific
- 184.108.40.206 China
- 220.127.116.11 Japan
- 18.104.22.168 India
- 22.214.171.124 Australia
- 126.96.36.199 South Korea
- 188.8.131.52 Rest of Asia Pacific
- 5.4.4 Middle East and Africa
- 184.108.40.206 GCC
- 220.127.116.11 South Africa
- 18.104.22.168 Rest of Middle East and Africa
- 5.4.5 South America
- 22.214.171.124 Brazil
- 126.96.36.199 Argentina
- 188.8.131.52 Rest of South America
6 COMPETITIVE LANDSCAPE
- 6.1 Company Profiles
- 6.1.1 Acumen Pharmaceuticals Inc.
- 6.1.2 Alseres Pharmaceuticals Inc.
- 6.1.3 Aposense Ltd.
- 6.1.4 Avacta Life Sciences Limited
- 6.1.5 Banyan Biomarkers Inc.
- 6.1.6 Bio-Rad Laboratories, Inc.
- 6.1.7 DiaGenic ASA
- 6.1.8 G-Biosciences
- 6.1.9 Merck KGaA
- 6.1.10 Thermo Fisher Scientific Inc.
- 6.1.11 Abastar MDX Inc
- 6.1.12 Adlyfe Inc.
- 6.1.13 Avid radiopharmaceuticals Inc.
- 6.1.14 Exonhit therapeutics
- 6.1.15 Proteome Sciences Plc.
- 6.1.16 Enzo Biochem Inc.
7 MARKET OPPORTUNITIES AND FUTURE TRENDS