Central Nervous System Biomarkers Market - By Biomarker Type (Safety, Efficacy, Validation), Application (Disease Diagnosis, Drug Discovery and Development, Personalized Medicine), End-use (Hospitals, Diagnostic Laboratories) – Global Forecast, 2024 – 2032

Central Nervous System Biomarkers Market Size

Central Nervous System Biomarkers Market size was valued at USD 5.6 billion in 2023 and is estimated to grow at a CAGR of 8.1% between 2024 and 2032. Central nervous system (CNS) biomarkers refer to measurable substances or indicators found in biological samples that provide information about the status of the CNS.
 

These biomarkers can include various molecules, proteins, genes, or other characteristics that are associated with normal CNS function or with the presence, progression, or severity of CNS related diseases. The increasing prevalence of neurological disorders have emerged as a significant driver for the market. For instance, according to the World Federation of Neurology, in 2023, over 40% of the global population is currently suffering from some kind of neurological condition, and this burden is projected to nearly double by 2050.
 

Furthermore, advancements in the biomarker discovery outsourcing services industry, which is estimated to reach USD 33.7 billion by 2032, are expected to contribute to the CNS biomarkers market growth. These include technological innovations, government initiatives and policies, increasing use of CNS biomarkers, and growing adoption of neurostimulation devices.
 

Central Nervous System Biomarkers Market Trends

Increasing use of CNS biomarkers is a significant driver for the market. They offer the potential for earlier detection and more accurate diagnosis of neurological diseases such as Alzheimer’s, Parkinson’s, multiple sclerosis, among others.
 

• In the development of new drugs for CNS disorders, biomarkers are essential for patient stratification, monitoring treatment response, and assessing drug efficacy. Biotechnology companies are increasingly using biomarkers as endpoints in clinical trials, speeding up the drug development process and reducing costs.
   
• For instance, according to Springer Nature, in 2020, there were various neurological biomarkers being utilized in the disease screening and interpretation, such as amyloid, tau, and synuclein, in the diagnosis of Alzheimer’s disease.
   
• As research advances, new and more specific biomarkers are being discovered, allowing for more precise identification of these diseases in their early stages. Consequently, leading to increased use by researchers, clinicians, and scientists for improved disease management, drug development, and patient care in the field of neurology.
   

Central Nervous System Biomarkers Market Analysis

Based on biomarker type, the market is classified into safety biomarker, efficacy biomarker, validation biomarker, and other biomarkers. The safety biomarker segment held a market size of USD 2.5 billion in 2023.
 

• Safety biomarkers are essential in clinical trials to monitor and assess the safety profile of new drugs. As CNS drugs often have significant side effects, monitoring biomarkers related to CNS function is critical.
   
• Moreover, conditions like Alzheimer’s, Parkinson’s, and other neurological disorders often require long-term treatment. Thus, safety biomarkers help in understanding how these drugs affect the brain over time, aiding in managing risks and improving patient outcomes.
   
• Further, drugs targeting the CNS can have diverse effects on cognition, mood, behavior, and motor function. Consequently, these biomarkers aid in capturing these varied impacts, ensuring a comprehensive safety assessment to guide decisions on dose adjustments or discontinuation of a drug.

Based on application, the central nervous system biomarkers market is segmented into disease diagnosis, drug discovery and development, personalized medicines, and other applications. The disease diagnosis segment is estimated to account for a market size of USD 4 billion by 2032.
 

• Biomarkers provide valuable information about the diagnosis and severity of CNS diseases. This helps healthcare providers develop appropriate treatment plans and monitor the disease progression over time.
   
• For instance, one significant biomarker for the diagnosis of Parkinson’s disease (PD) is alpha-synuclein, a protein found in the nervous system. The abnormal levels of this biomarker are the indicator of the confirmation of the disease.
   
• Furthermore, biomarkers contribute to better patient outcomes by enabling earlier diagnosis, which leads to personalized treatment plans, adoption of neurotech devices, and more effective monitoring of disease progression.
   
• Additionally, through the process of diagnosis, these biomarkers help identify specific molecular targets for existing or new diseases. This targeted approach leads to the development of more effective and potentially less toxic therapies, thus stimulating the segment growth of the market.
   

Based on end-use, the central nervous system biomarkers market is categorized into hospitals & clinics, diagnostic laboratories, academic & research institutes, and other end-users. The hospitals & clinics segment held a substantial business share of around 44% in 2023.
 

• Hospitals & clinics are primary centers where patients seek diagnosis and treatment for CNS disorders. They rely heavily on biomarkers to aid in the accurate diagnosis of such disorders. It involves the use of the biomarkers to further check the disease progression of patients during their stay and for follow-up care.
   
• These settings often have access to advanced imaging technologies (like MRI systems and PET scans) and other diagnostic facilities, enabling comprehensive biomarker testing for CNS disorders.
   
• Further, these centers often serve as sites for conducting clinical trials of new CNS therapies. Biomarkers are critical in these trials for assessing drug efficacy and safety, leading to increased adoption for the purpose of discovery and repurposing the existing medications.

North America central nervous system biomarkers market accounted for USD 2.3 billion revenue in 2023 and is predicted to witness substantial market growth over the analysis timeline.
 

• The region is home to some of the world's leading research institutions and universities focused on neuroscience and biomarker development. These institutions drive innovation and contribute to the advancement of CNS biomarker technologies.
   
• Furthermore, increasing cases of neurological disorders is a significant factor for the market. For instance, according to the National Brain Tumor Society, in 2021, approximately 85,000 people in the U.S. were diagnosed with a primary brain tumor.
   
• Additionally, North America conducts a large number of clinical trials for CNS disorders, utilizing biomarkers in the early detection and assessment.
   

Central Nervous System Biomarkers Market Share

The central nervous system biomarkers industry is competitive in nature, with several large multinationals and small and mid-sized companies competing in the industry. The development and launch of novel advanced devices based on different technologies is a key market strategy. Some of the leading industry players including F. Hoffmann-La Roche Ltd, Novartis AG, and Thermo Fisher Scientific, Inc, among others have a notable presence in the market.
 

Central Nervous System Biomarkers Market Companies

Some of the eminent market participants operating in the central nervous system biomarkers industry include:

• bioMerieux
• Bio-Rad Laboratories, Inc.
• F. Hoffmann-La Roche Ltd
• G-Biosciences
• Illumina, Inc.                    
• Merck KGaA
• Myriad Genetics, Inc.
• Novartis AG
• PerkinElmer Inc.
• Siemens Healthineers AG
• Sysmex Corporation
• Thermo Fisher Scientific Inc.
   

Central Nervous System Biomarkers Industry News

• In June 2023, F. Hoffmann-La Roche, announced that its Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF assays (tTau), have received U.S. FDA 510(k) clearance. These assays measure two biomarkers of Alzheimer’s pathology, beta-amyloid and tau proteins, in adults ages 55 and older being evaluated for the disease. 
   
• In September 2020, Siemens Healthineers AG collaborated with Novartis AG to develop assays supporting CNS biomarkers. The initial program focused on the development of serum neurofilament light chain (NfL) immunoassay for patients with multiple sclerosis (MS) and other neurological diseases. This collaboration expanded the product portfolio of the company and helped in revenue generation.
   

The central nervous system biomarkers market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 to 2032 for the following segments:

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Market, By Biomarker Type

• Safety biomarker
• Efficacy biomarker
• Validation biomarker
• Other biomarkers

Market, Application

• Disease diagnosis
• Drug discovery and development
• Personalized medicines
• Other applications

Market, By End-use

• Hospitals & clinics
• Diagnostic laboratories
• Academic & research institutes
• Other end-users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East and Africa