Global Central Nervous System Biomarkers Market Grows Steadily at a CAGR of 8.66%

Introduction

Biomarkers are quantitative indicators used to evaluate and determine pathogenic processes and therapeutic interventions and predict treatment response. Biomarkers provide information regarding a patient throughout virtually all phases of care. Clinically, central nervous system (CNS) biomarkers are utilized to screen, monitor, or diagnose the activity of CNS-related diseases to direct molecularly targeted therapy or assess therapeutic responses. Biomarkers facilitate the understanding of the etiology of chronic diseases and their relationship to environmental compounds, as well as the identification of high-risk subjects for disease development.

Market Dynamics

Rising Investments from Governments and Private Players Drive the Global Market

Increasing government and private investments are driving market expansion. In 2020, the National Institutes of Health provided additional funding for PET scans and other biomarker measurements for the Health and Aging Brain Among Latino Elders (HABLE) study. The additional funding supported the Health and Aging Brain Among Latino Elders-Amyloid, Tau, and Neurodegeneration (HABLE-AT[N]) study, which allowed researchers to collect amyloid and tau PET imaging and other biomarkers.

In addition, Hikma Pharmaceuticals PLC announced in May 2020 that its venture capital subsidiary, Hikma Ventures, had invested in Altoida Inc., following its USD 6.3 million Series-A round in 2019, to assist in the prediction of brain diseases with an accuracy of up to 94%. Such developments are anticipated to stimulate the creation of novel biomarkers, thereby fostering market expansion.

Increasing Research and Development with Successful Clinical Trials of Biomarkers Creates Tremendous Opportunities

Increasing research activities and successful clinical trials drive the demand for biomarkers. This circumstance is driving the market's expansion. The successful conclusion of clinical trials is also anticipated to generate future market expansion opportunities. For instance, in March 2022, LEXEO Therapeutics, a clinical-stage gene therapy company, reported encouraging preliminary expression and biomarker results from the low-dose cohort of their ongoing Phase-1/2 clinical study of LX1001.

LX1001 is an investigational AAV-based gene therapy designed to deliver the protective apolipoprotein E2 (APOE2) gene to the central nervous system (CNS) of APOE4 homozygous Alzheimer's disease patients to halt or delay the progression of the disease. As a result of the factors above, the market is anticipated to develop substantially over the forecast period.

Regional Analysis

North America is the most significant global central nervous system biomarkers market shareholder and is anticipated to exhibit a CAGR of 8.82% during the forecast period. The increasing prevalence of central nervous system (CNS) diseases, the rise in the development of proteomics, genomics, and imaging systems, and the rising adoption of personalized pharmaceuticals and therapy are anticipated to drive the market for CNS biomarkers in the region. The market is also expected to expand over the forecast period due to surging concerns about neurological disorders and rising expenditure on R&D of novel biomarkers. For instance, in May 2021, the Alzheimer's Drug Discovery Foundation (ADDF) announced 11 new investments from October 2020 to March 2021, totaling over USD 11 million, to support innovative Alzheimer's drug discovery and biomarker research.

The introduction of new products also contributes to the expansion of the market. For example, the University of British Columbia launched a new Alzheimer's disease test in Canada in December 2021. The test analyzes biomarker proteins in the cerebrospinal fluid encircling the brain and spinal cord, which could aid in the disease's earlier and more precise diagnosis. Therefore, the market is anticipated to expand over the forecast period because of the factors above.

Key Highlights

• The global central nervous system biomarkers market was valued at USD 4.55 billion in 2022. It is estimated to reach USD 9.60 billionby 2031, growing at a CAGR of 8.66% during the forecast period (2023–2031).
• Based on the type of CNS biomarkers, the global central nervous system biomarkers market is bifurcated into safety biomarkers, efficacy biomarkers, validation biomarkers, and other types of CNS biomarkers. The safety biomarker segment dominates the global market and is projected to exhibit a CAGR of 8.44% over the forecast period.
• Based on application, the global central nervous system biomarkers market is divided into drug discovery and development, personalized medicine, and other applications. The drug discovery and development segment is the highest contributor to the market and is estimated to exhibit a CAGR of 8.55% throughout the forecast period.
• Based on end-users, the global central nervous system biomarkers market is segmented into diagnostic labs, clinics/hospitals, and research centers. The diagnostic labs segment owns the highest market share and is estimated to exhibit a CAGR of 8.55% during the forecast period.
• North America is the most significant global central nervous system biomarkers market shareholder and is anticipated to exhibit a CAGR of 8.82% during the forecast period.

Competitive Players

Competitive Players

The key global central nervous system biomarkers market players are Acumen Pharmaceuticals Inc., Alseres Pharmaceuticals Inc., Thermo Fisher Scientific Inc., Aposense Ltd, Avacta Life Sciences Limited, Bio-Rad Laboratories Inc., DiaGenic ASA, G-Biosciences, Banyan Biomarkers Inc., Merck KGaA, and others.

Recent Developments

Market News

• In May 2023, The FDA approved Biogen and Ionis's tofersen for amyotrophic lateral sclerosis based on the drug's capacity to reduce blood levels of neurofilament light (NfL), establishing a proof of concept for this neuroscience biomarker that could have implications for other brain diseases.
• In February 2023, Roche introduced the ATRX Rabbit Polyclonal Antibody and the IDH1 R132H (MRQ-67) Rabbit Monoclonal Primary Antibody to detect mutation status in brain cancer patients. The IDH1 R132H and ATRX antibodies are the most recent additions to Roche's neuropathology portfolio of 29 biomarkers.

Segmentation

Global Central Nervous System Biomarkers Market: Segmentation

By Type

• Safety Biomarkers
• Efficacy Biomarkers
• Validation Biomarkers
• Other Types of CNS Biomarkers

By Applications

• Drug Discovery and Development
• Personalized Medicine
• Other Applications

By End User

• Diagnostic Labs
• Clinics/Hospitals
• Research Centers

By Regions

• North America
• Europe
• Asia-Pacific
• South America
• The Middle East and Africa