CNS (Central Nervous System Biomarkers) Market Revenue to Hit US$11.00Bn by 2033

“Next-Generation Biomarkers Revolutionize Early Diagnosis in Central Nervous System Disorders”

AUSTIN, CA, UNITED STATES, October 7, 2025 /EINPresswire.com/ -- Market Size:

According to DataM Intelligence, the central nervous system (CNS) biomarkers market reached US$ 5.00 billion in 2023, with a rise to US$ 5.41 billion in 2024, and is expected to reach US$ 11.00 billion by 2033, growing at a CAGR of 8.2% during the forecast period 2025–2033.

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The global central nervous system (CNS) biomarkers market is witnessing dynamic growth, fueled by the rising prevalence of neurological disorders, increasing demand for early and precise diagnosis, and rapid advancements in biomarker discovery technologies. CNS biomarkers are playing a pivotal role in detecting, monitoring, and managing conditions such as Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, and epilepsy, enabling personalized treatment strategies and improving patient outcomes. Innovations in molecular diagnostics, imaging, and bioinformatics are further accelerating their adoption in clinical and research settings. With growing investments from pharmaceutical companies and expanding awareness among healthcare providers, the CNS biomarkers market is poised to transform the landscape of neurological healthcare, offering significant opportunities for early intervention, drug development, and precision medicine.

Latest FDA Approvals

In October 2025, the FDA granted Fast Track designation to BMS-986446, an anti-tau antibody targeting early Alzheimer’s; biomarker data from this trial include tau and amyloid-beta.

Eisai's LEQEMBI^® (lecanemab-irmb) received FDA approval for intravenous maintenance dosing for early Alzheimer’s Disease in January 2025, reinforcing the growing role of fluid biomarkers in therapy monitoring and patient selection.

Capricor Therapeutics received an FDA Complete Response Letter for its cell-based CNS candidate deramiocel; re-submission is expected after further biomarker and clinical data from ongoing phase 3 trials.

Major Companies:

1. Acumen Pharmaceuticals Inc.
2. Biogen Inc.
3. Alseres Pharmaceuticals Inc.
4. Aposense Ltd.
5. Avacta Life Sciences Ltd.
6. Banyan Biomarkers Inc.
7. Bio-Rad Laboratories Inc.
8. DiaGenic ASA
9. G-Biosciences
10. Thermo Fisher Scientific Inc.

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Regional Analysis

North America is projected to capture about 42.7% of the market.

The global CNS biomarkers market is projected to reach over $6 billion in 2025, with a CAGR of about 7-8% through 2032; North America remains dominant, while Europe and Asia grow rapidly through innovations and collaborative ventures.

Success in the CNS biomarker space is increasingly driven by personalized medicine, proprietary platform development, and strategic regional partnerships.

M&A Activity

Johnson & Johnson’s $14.6 billion acquisition of Intra-Cellular Therapies (August 2025), focused on CNS diagnostics and therapeutics, remains the largest pharma M&A deal this year and adds a major biomarker-driven neurology brand to J&J’s portfolio.

AbbVie acquired Aliada Therapeutics for $1.4 billion, gaining access to an antibody therapeutic for Alzheimer’s, potentially tied to new CNS biomarker strategies.

Lilly licensed Sangamo’s neurotropic gene therapy platform (AAV capsid technology) for CNS biomarkers in a deal worth up to $1.4 billion.
Syndeio Biosciences secured $90 million in funding, advancing biomarker-driven synapse-targeted therapies for CNS disorders and launching biomarker trials for Alzheimer’s and MDD.

Market Segments

By Type: (Safety Biomarker, Efficacy Biomarker, Validation Biomarker, Others)

By Application: (Drug Discovery & Development, Drug Discovery & Development, Personalized Medicines, Disease Risk Assessment, Diagnostics, Others)

By Disease: (Multiple Sclerosis, Alzheimer's disease, Parkinson's Disease, Traumatic Brain Injury, Others)

By End-user: (Diagnostic Labs, Clinics, Hospitals, Research Centers, Others)

By Region: (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa)

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