Central Nervous System Biomarkers Market Trends

Central Nervous System Biomarkers Market Overview

Central Nervous System Biomarkers Market Size was valued at USD 6.01 Billion in 2023. The Global Central Nervous System Biomarkers industry is projected to grow from USD 6.50 Billion in 2024 to USD 12.24 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 8.67% during the forecast period (2024 - 2032). 

The Central Nervous System (CNS) biomarkers support new drug discovery and development, further helping indecision-making regarding drug treatment and its effectiveness. Moreover, biomarkers also help in the understanding of the disease mechanism and improve the quality of patient care.The major factors driving the CNS biomarkers market include new technological advancements and their increased use in the diagnosis of neurodegenerative diseases. Moreover, an increase in R&D for new CNS biomarkers and successful clinical trials further contribute to the central nervous system biomarkers market growth.

However, changing government regulations and policies pose a restraint to the central nervous system biomarkers market growth since reimbursements do not cover the biomarker mediated therapies that are not standard of care. Even though biomarkers provide high value for tests, there is a limited number of reimbursements. For instance, Medicare—a leading provider of healthcare coverage in the US with over 50 million beneficiaries—does not reimburse for experimental treatments or most screening and biomarker tests.Test developers require adequate reimbursement levels to ensure sufficient return on their investment.

Eisai Co. Ltd and Biogen Inc. made the announcement in November 2021 about the use of plasma biomarkers in a presentation during phase 3 ahead 3-45 study of lecanemab (BAN2401), an experimental anti-amyloid beta (Aβ) protofibril antibody intended to be used in Alzheimer's disease treatment.

Diadem announced clinical data publication in October 2021, showing that the AlzoSure biomarker test predicts years prior to clinical symptoms onset of a patient's progress with Alzheimer's disease.

Hoffmann-La Roche's Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF assays (tTau) has cleared US FDA 510(k) approval as of June 2023. These two tests measure levels of two markers for Alzheimer's pathology such as beta amyloid and tau proteins among people aged ≥55 years who are being evaluated for the condition.

In September 2020, Siemens Healthineers AG collaborated with Novartis AG to develop assays supporting CNS biomarkers. The first program was aimed at serum neurofilament light chain (NFL) immunoassay development for patients suffering from multiple sclerosis(MS) or other neurological conditions. The company expanded its product mix through this partnership thus boosting its sales revenue.

COVID-19 Analysis:

COVID-19 has severely impacted the world with disruptions in the supply chain, research and development, and central nervous system biomarkers market growth. According to our database, in May 2021, it is estimated that the global GDP was at a loss of 4.5%, amounting to about USD 3.94 trillion is lost in economic output. The effects were also felt in the global CNS biomarkers market. The rate of patients screening and diagnosis was severely impacted in the initial phase of the pandemic since governments across the globe implemented restrictions such as lockdowns to curb the spread of the disease. According to the American Cancer Society’s report in 2021, due to restricted healthcare coverage, delays in cancer screening, diagnosis, and treatment would almost certainly result in a short-term decrease in cancer diagnoses, followed by an increase in late-stage diagnoses and unnecessary cancer deaths.

Some studies also suggested a correlation between COVID-19 and CNS biomarkers. According to a research study published in December 2020, neurological symptoms were found commonly in hospitalized COVID patients with CNS biomarkers directly correlating with the disease severity, time in intensive care, and level of consciousness. Further research is underway in this aspect; however, this would lead to some interest building upon more research into CNS biomarkers.

Central Nervous System Biomarkers Market Dynamics

Drivers

• Technological advancements in CNS biomarkers

Identifying new biomarkers will facilitate the research for novel diagnostic and prognostic indicators that might be used to monitor the efficacy of a novel therapeutic or provide a new target for disease treatment.Technological advancements such as high throughput scanning of the human genome and its encoded proteins have allowed systematic analysis of human disease. The use of these technologies is proving to be a more effective method of determining the biological basis of genetically complicated neurological illnesses.According to a report published in June 2019 by the Department of Neurosciences, Cleveland Clinic, US, the recent developments in proteomics have helped identify biomarkers such as CHI3L1, Tymosin β4, and SCGsrelated to multiple sclerosis, a neurodegenerative disease. 

Furthermore, assay technologies are advancing, which will provide a more accessible and efficient means to test many biomarkers;this will become more relevant as more targeted medicines are approved, and the presence of biomarkers has a greater impact on clinical decision-making. Also, advances in imaging systems have helped develop biomarkers derived from images and aid decision-making tools in clinical trials, according to the European Society of Radiology. These new advancements also make CNS biomarkers use accessible and feasible to be performed even in small laboratories. Therefore, the recent technological advancements are expected to impact the central nervous system biomarkers market growth in the forecast period positively.

• Increase in use of CNS biomarkers in the diagnosis of neurodegenerative diseases

In the past decade, tremendous efforts were put into the discovery of biomarkers and their validation for neurodegenerative disorders. Several different sources and types of biomarkers have been discovered and continue to grow, such as biofluid-based biomarkers (blood or cerebrospinal fluid (CSF)), nucleic acids, tissue, and imaging. According to a report published in Springer Nature in February 2020, there are now key neurodegenerative pathology biomarkers (e.g., amyloid, tau, and -synuclein), a disease strength biomarker (e.g.,NFL), synaptic activity (e.g., neurogranin), and a variety of novel analytical platforms (e.g.,Simoa and MSp). Also, a shift in the diagnosis of disease in an early stage has increased the demand for novel biomarkers. For instance, in Alzheimer’s, biopsies were the definitive step for diagnosis, but now with the help of biomarkers, Alzheimer’s can be detected in the asymptomatic stage itself.

While DNA remains the predominant biomarker used for the identification of familial neurodegenerative disease, several new forms of biomarkers have been developed, including blood biomarkers, RNA-based biomarkers, and imaging-based biomarkers that facilitate the early diagnosis of neurodegenerative disorders. Furthermore, the incorporation of biomarkers into the drug development and clinical trials of neurodegenerative diseases will aid in the drug development and assessment of target engagement and drug efficacy in neurological disorders. Furthermore, the increasing cases of neurological disorders,with stroke being the second leading cause of death, according to WHO’s report in December 2020, is expected to drive the central nervous system biomarkers market growth in the forecast period. 

Opportunities

• The untapped Asia-Pacific region have significant opportunities for the central nervous system biomarkers market

The Asia-Pacific region possesses tremendous growth prospects in the forecast period; this is owing to the presence of emerging economies such as India, China, South Korea, and the Philippines. Other factors include the rising cases of chronic disordersand increasing healthcare expenditurein the region. According to a report published by China Stroke Statistics in 2019, China had the greatest number of cases of stroke in the world, accounting for 1.57 million deaths in 2018.

With increasingneurological disorders, healthcare expenditure, and improving healthcare infrastructure, the demand for CNS biomarkers is expected to facilitate drug development and early diagnosis of such diseases.

Restraints

• Expensive CNS biomarker tests and diagnostics

Diagnosis of a disease is the first step for disease treatment and care. With biomarkers, diagnosis has become easier with the recent developments in the field. But such diagnostics and tests are expensive in nature which tends to restrain the central nervous system biomarkers market growth. For instance, for diagnosing Alzheimer’s, biomarkers like tau protein are detected through imaging (i.e., PET scan) and spinal fluid tests, which are expensive in nature.

Several neurological disorders are very complex and need special conditions for disease assessment or treatment efficacy checks. Hence, there is a need to use a combination of biomarkers to diagnose a disease for accurateresults, hence increasing the expenses. For instance, according to a report published in December 2019 by the American University of Beirut, Lebanon, it is well established for complex diseases such as Alzheimer’s. A combination of biomarkers is required todiagnose the disease accurately.

• Regulatory implications for CNS biomarkers

Qualified biomarkers have the potential to give useful information that could help regulators make more informed judgments during the drug development process.When a biomarker is qualified, it has gone through a rigorous regulatory process to verify that it has a defined interpretation and application in the development of medical products and regulatory assessment.

According to the FDA, the Biomarker Qualification Program works with the requestor(s) to guide biomarker development through a collaborative method. To create a biomarker for qualifying, multiple interested parties frequently collaborate in working groups or consortia. There are three steps for biomarker qualification:

• Letter of Intent (LOI): the requestor submits the LOI with information regarding the biomarker like purpose and mode of measurement


• Qualification Plan (QP): This has information necessary information that will qualify the biomarker


• Full Qualification Package (FQP): FQP is a comprehensive compilation of supporting evidence based on which the FDA makes its decision

Central Nervous System Biomarkers Market Segmentation

By type

• Safety Biomarker

As companies strive to develop drugs for challenging targets and novel disease indications in a risk-averse setting, the detection, implementation, and certification of safety biomarkers is becoming increasingly important to effective drug discovery and production.

According to a report published in December 2020 by a consortium of pharmaceutical companies, out of the 24 companies in the survey, 83% of them used safety biomarkers in the clinical trials phase. Furthermore, significant efforts are being put to qualify biomarkers such that they can be used in preclinical studies and clinical trials to accelerate drug development

• Efficacy Biomarker

Efficacy biomarkers are used to detect early events in disease progression, toxic changes, or pharmacological events. They are of more significance in the preclinical stage of drug development to establish proof of mechanism.

For CNS drugs, the ability to show pharmacologically driven biological activity in the brain as a result of a drug’s association with its intended target ensures that proof-of-concept studies sufficiently assess the therapeutic effectiveness hypothesis and that patients are not subjected to inactive medications

• Validation Biomarker

Validation biomarkers can be defined as a biomarker assessed in an analytical test method with well-established performance characteristics. There is a well-established theoretical context or body of evidence that elucidates the test results’ physiologic, toxicologic pharmacologic, or clinical significance.

Validation of a biomarker is a necessary component to the delivery of high-quality research data necessary for the effective use of biomarkers. Biomarkers pass through three evidentiary stages towards full acceptance under regulatory guidance: exploratory, probable valid, and known valid.

By Application

• Drug Discovery & Development

To improve and broaden the therapeutic options available to improve patient outcomes, the researchers need to find and develop medicinal products. There is a huge investment of time and money in order to develop and bring a product into the market, which is around 10-12 years of time with investments of around USD 50 million. Even so, attrition remains the major challenge, and very few molecules make it to the market.

In terms of CNS-related drug development, neurotoxicity remains a major reason for attrition. With the development ofimaging and fluidic biomarkers, efforts are being made to increase the success of drug development. According to a report published in September 2018 by the University of Glasgow, UK, non-invasive biomarkers of neurotoxicity help in the early prediction of likely neurotoxicity, facilitating clinical trials of new therapies for neurodegenerative conditions such as Parkinson’s Disease (PD) and Multiple Sclerosis (MS).

• Personalized Medicine

In neurodegenerative and neuropsychiatric illnesses, the genetic complexity, clinical unpredictability, and inaccessibility of afflicted tissue have primarily hampered the discovery of effective treatments. Personalized medicine, also known as precision medicine, is a very potent approach to curing such diseases.

This segment is growing rapidly due to factors such as increasing brain and other nervous system cancers. Government organizations are also supporting research of personalized medicine to find a specific cure for patients. For instance, the All of Us Research Program started in 2015 to support development in personalized medicine with over USD 150 million funding. Hence, with wide applications of biomarkers in personalized medicine, the growth of this segment will positively impact the central nervous system biomarkers market growth

By End User

• Diagnostic Labs

Biomarkers, whether genetic attributes, biochemical changes, or structural or functional changes, are requiredto aid in the diagnosis of various neurological disorders and the detection of illness progression.The development of new technologies for early diagnoses such as imaging biomarkers and genomics and proteomics is anticipated to boost the demand for CNS biomarkers in diagnostic labs.

The rise in neurological disorders and nervous system cancers is also expected to contribute to the market growth during the study period. According to a report by Cancer.net, in January 2021, an estimated 24,530 adults and 3,460 children under 15 years of age were diagnosed with a primary brain or spinal cord tumor in the US in 2020. Moreover, approximately 85,000 more cases of brain tumor will be diagnosed in 2021, according to the National Brain Tumor Society.

• Hospitals and Clinics

As the number of neurological disorders and cancers increases, the demand for CNS biomarkers in hospitals and clinics is also positively impacted. The adoption of CNS biomarkers for diagnosis and therapeutic application of various diseases complements the central nervous system biomarkers market.

The healthcare expenditure is also increasing significantly,which is anticipated to drive growth for this segment. According to a report published by the University of Michigan in May 2019, the annual costs of treating neurological disorders in the US are more than USD 500 billion. Furthermore, the costs of drugs for diseases like Multiple Sclerosis have also increased 20 times from 2004 to 2016. 

• Research Centers

Research and development of new biomarkers are essential for the development and validation of new CNS biomarkers. Such new biomarkers canthen be employed in new drug development programs, diagnosis, prognosis, and predictive analysis of CNS disorders.

Furthermore, increased research funding is expected to be a key driver for the growth of this central nervous system biomarkers market segment. For instance, the American Academy of Neurology has funded more than USD 5 billion till 2020 for neuroscience research to the NIH and BRAIN initiatives in the US and further funded more than USD 2.5 billion in the year 2020.

Central Nervous System Biomarkers Market Regional Analysis

• North America

RisingCNS cancer cases and increasing R&D expenditure are likely to drive central nervous system biomarkers market growth duringthe forecast period for this region.According to the American Cancer Society, in 2021,brain cancer is estimated to be the second most diagnosed cancer, with an estimated 27% and 21% share in children and adolescents, respectively, where CNS biomarkers are used.

Furthermore, companies and research institutes are constantly innovating and discovering new technologies and biomarkers; this is supported by the presence of leading key players within the region as well as increasing R&D expenditure. For instance, as of August 2020, USD 23.1 million was funded for brain-related clinical and cancer control research in the US, according to the American Cancer Society. Hence, due to these factors, North America is expected to hold the largest share in the central nervous system biomarkers market throughout the forecast period.

• Europe

An increase in the demand for personalized/precision medicine and the rising prevalence of neurological diseases in Europe are driving the central nervous system biomarkers market in the region. According to a report published in October 2020, in Europe, neurological disorders ranked third after cardiovascular diseases and cancer. Furthermore, another report published in July 2020, by 2047, there will be 2.5 million cases of stroke in Europe, which is a 23% increase from 2017 data.

The European regulatory network is assisting in the advancement of personalized medicinefor CNS conditions, such as pharmacogenomics, biomarkers, companion diagnostics, and rare diseases, as well as new methodologies and clinical trial designs (e.g., gene therapies, somatic cell therapies, and tissue-engineered medicines), according to Synchrogenix in June 2019.

• Asia-Pacific

Asia-Pacific region is projected to be the fastest-growing regional market during the forecast period due to factors such as a large customer base, high prevalence of CNS disorders, and improving healthcare infrastructure. China accounts for the highest number of stroke cases in the world with 354 cases per 100,000 people in 2016, according to a report published in The Lancet in March 2019.

Furthermore, improving healthcare infrastructure and advancing research capabilities will help develop novel CNS biomarkers. For instance, according to a report published in April 2021 in the Journal of Translational Psychiatry, a new electroencephalography (EEG)-mediated process to discover biomarkers for neuropsychiatric conditions was discovered in China.

• Rest of the World

The rest of the world includes the Middle East, Africa, and Latin America. These regions are also facing an increase in the cases of neurological disorders, which is driving the central nervous system biomarkers market. For instance, according to a report from Alzheimer’s Disease International 2020, an estimated 6% of the 15 million older people (above the age of 50 years) in Brazil.

Central Nervous System Biomarkers Market Competitive Landscape

Thermo Fisher Scientific is one of the key players in the central nervous system biomarkers market. Some of the neurological biomarkers provided by the company include carbamazepine, lamotrigine, phenytoin, topiramate, valproic acid, and nonivamide. The company also provides biomarker discovery and development programs that help discover new effective biomarkers for use. One such example is the ProtoArray Human Protein Microarray.

The industry players are coming up with various business strategies to increase their market presence. The companies are investing in R&D activities to expand their product portfolio, further driving the central nervous system biomarkers market. In addition, the market players are engaged inmergers and acquisitions, contractual agreements, new product launches, increasing investments, and partnering with other players to expand their global footprint.

List of Key Companies Covered in this Report

• Thermo Fisher Scientific (US)


• Merck & Co. (US)


• AbaStarMDx Inc. (US)


• Abiant, Inc. (US)


• Avacta Group plc (UK)


• Diagenic Asa (Norway)


• Banyan Biomarkers (US)


• Avid Radiopharmaceuticals Inc. (US)


• Acumen pharmaceuticals Inc. (US)


• Siemens AG (Germany)


• Novartis (Switzerland)

Recent Developments

• InSeptember 2020, Siemens Healthineersannounced a strategic collaboration with Novartis Pharma AG for biomarker development for Multiple Sclerosis.


• In May 2019, N170 CNS biomarker letter of intent submitted by Roche (Switzerland) was accepted by FDA for autism spectrum disorder.


• In March 2020, Oculomotor Index was accepted by FDA as a valid biomarker for the diagnosis of autism spectrum disorder, submitted by The Autism Biomarkers Consortium for Clinical Trials (ABC-CT).

Report Overview:

The study covers the existing short-term and long-term market effect, as well as helping decision-makers to draught short-term and long-term plans for businesses by region. The report covers major regions in North America, Europe, Asia-Pacific, and Rest of the World. The report analyzes market drivers, restraints, opportunities, challenges, Porters Five Forces, Value Chain, and impact of COVID-19 on the market.

Market Segments:

By Type        

• Safety Biomarker


• Efficacy Biomarker


• Validation Biomarker


• Other

By Application  

• Drug Discovery & Development


• Personalized Medicine


• Others

By End User    

• Diagnostic Labs


• Hospitals& Clinics


• Research Centers

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