Central Nervous System Biomarkers Market

Market Overview

The global central nervous system biomarkers market size was valued at USD 4.55 billion in 2022. It is estimated to reach USD 9.60 billion by 2031, growing at a CAGR of 8.66% during the forecast period (2023–2031). The key aspects bolstering the expansion of the CNS biomarkers market are the rise in the development of proteomics, genomics, and imaging systems, rising investments from governments and private players, and increasing R&D activities. Some other factors that could potentially proliferate the market growth are the surging prevalence of chronic disorders, the increasing number of initiatives, and the growing geriatric population.

Biomarkers are quantifiable indicators that are used to evaluate and determine pathogenic processes and therapeutic interventions, as well as to predict treatment response. Biomarkers are utilized in numerous scientific disciplines. Biomarkers are used in drug development and regulatory decision-making processes because they can enhance the efficacy of drug discovery and development. Biomarkers also provide information about a patient during virtually all phases of care.

Clinically, central nervous system (CNS) biomarkers are used to screen, monitor, or diagnose the activity of CNS-related diseases to guide molecularly targeted therapy or evaluate therapeutic responses. Biomarkers aid in comprehending the etiology of chronic diseases and their relationship to environmental compounds, as well as identifying subjects at high risk for developing diseases.

Market Dynamics

Market Drivers

Rising Investments from Governments and Private Players

Rising investments from governments and private players are also boosting the market growth. For instance, the National Institutes of Health provided additional funding for more PET scans and other biomarker measures for the Health and Aging Brain Among Latino Elders (HABLE) study in 2020. The additional funding supported the Health and Aging Brain Among Latino Elders-Amyloid, Tau, and Neurodegeneration (HABLE-AT[N]) study, which enabled researchers to collect amyloid and tau PET imaging and other biomarker measures.

Furthermore, in May 2020, Hikma Pharmaceuticals PLC reported that its venture capital arm, Hikma Ventures, invested in Altoida Inc., following its USD 6.3 million Series-A round in 2019, to help predict brain diseases with up to 94% accuracy. Such developments are anticipated to boost the development of novel biomarkers, proliferating market growth.

Rising Development of Proteomics, Genomics, and Imaging Systems

The development in related technologies, such as genomics, proteomics, and imaging systems, has reflected in the evolution of newer biomarkers. For instance, as per a September 2020 article, a detailed proteomic analysis of cerebrospinal fluid (CSF) reflected significant alterations in signaling molecules related to neurotoxicity. The study stated that a total of 352 proteins were identified, and the trimethyltin (TMT) samples contained 29-237 significantly different proteins.

Similarly, as per the study, such findings provide an opportunity to explore the correlation of these fluid biomarkers with traditional neuropathology and magnetic resonance imaging (MRI), which define TMT-induced neurotoxicity. Hence, due to the advancements in imaging methods, proteomics, and genomics, the market is expected to grow significantly over the forecast period.

Market Restraint

High Cost of CNS Biomarkers and Diagnostic Tests

The high cost of central nervous system (CNS) biomarkers and diagnostic tests is a major factor hindering the demand for CNS biomarker products. The products that are available for the diagnosis of central nervous system (CNS) disorders are expensive. As per a June 2020 article titled "Neurofilament light chain in demyelinating conditions of the central nervous system: a promising biomarker," the combination of clinical and radiological indicators of disease activity have long been used, and they have exhibited high costs and incomplete predictive strength.

As per the same study, to overcome these limitations and boost the outcome prediction, the potential utility of different serums and CSF biomarkers has been explored over the last few years by using high-sensitivity technologies. Therefore, high cost has been a major barrier to the demand for biomarkers for experiments on the central nervous system.

Market Opportunities

Increasing Research and Development with Successful Clinical Trials of Biomarkers

Increasing research activities with successful clinical trials are driving the demand for biomarkers. This situation is fueling the market growth. The focus on research and development has been continuously increasing. Moreover, the successful completion of clinical trials is expected to provide future market growth opportunities. For instance, in March 2022, LEXEO Therapeutics, a gene therapy business in the clinical stages, announced encouraging preliminary expression and biomarker findings from the low-dose cohort of their ongoing Phase-1/2 clinical study of LX1001.

LX1001 is an AAV-based investigational gene therapy that is designed to deliver the protective apolipoprotein E2 (APOE2) gene to the CNS of APOE4 homozygous Alzheimer's disease patients to halt or slow down the disease progression. Hence, the market is expected to substantially expand over the forecast period due to the abovementioned factors.

Regional Analysis

Based on region, the global central nervous system biomarkers market is bifurcated into North America, Europe, Asia Pacific, South America, and Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global market shareholder and is anticipated to exhibit a CAGR of 8.82% during the forecast period. The growing burden of central nervous system (CNS) diseases, the rise in the development of proteomics, genomics, and imaging systems, and the increasing adoption of personalized medicines and therapy are expected to drive the CNS biomarkers market in the region. Likewise, 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. For instance, in May 2021, the Alzheimer's Drug Discovery Foundation (ADDF) announced 11 new investments from October 2020 to March 2021, totaling more than USD 11 million supporting innovative Alzheimer's drug discovery and biomarker research.

Product launches are another factor for the growth of the market. For instance, in December 2021, the University of British Columbia launched a new test for Alzheimer's disease in Canada. The test measures proteins known as biomarkers in the cerebrospinal fluid enveloping the brain and spinal cord, which could assist with the disease's earlier and more accurate diagnosis. Hence, the market is expected to boost over the forecast period due to the above conditions.

Europe is estimated to exhibit a CAGR of 8.25% over the forecast period. Factors such as the rising cases of central nervous system (CNS) diseases, the aging population, the increasing demand for efficient products, and favorable initiatives by the key market players are the driving factors for the market growth. As per the report by the German Alzheimer Society, approximately 1.6 million Germans suffer from dementia, with approximately 300,000 new cases each year. Similarly, according to the report, the number of people affected is anticipated to rise to between 2.4 and 2.8 million by 2050 due to shifting demographics and an aging population. Dementia is expected to rise in the coming years, positively impacting the market.

In Asia-Pacific, the growing burden of CNS diseases like Alzheimer's disease, multiple sclerosis, Parkinson's disease, and others is predicted to contribute to the market growth. For instance, according to data by Dementia in India Report 2020, about 7.6 million people in India will likely be diagnosed with Alzheimer's by 2030. Similarly, the strategic initiatives taken by the key market players, such as partnerships and collaborations in the studied market, are also expected to drive market growth. For instance, in January 2022, Clario and XingImaging, a biomarker imaging company, expanded their partnership to deliver PET imaging clinical trials for testing novel therapeutics for Alzheimer's disease (AD) and other neurodegenerative diseases in China. As PET imaging involves imaging markers, such developments contribute to the market's growth.

In South America, the increasing prevalence of diseases is among the prominent aspects contributing to the market growth. For instance, as per the Pan American Health Organization (PAHO), in 2019, the burden of neurological conditions per 100,000 population in Brazil was 20.50. The same source also reports that the burden of Parkinson's disease in 2019 was 1.91 per 100,000 population. Thus, Brazil's neurological disorders burden fuels the region's demand for central nervous system biomarkers.

Moreover, according to World Population Ageing 2019, the number of people aged above 65 years in 2019 in the Argentina region is 5,035,000 and is expected to reach 9,480,000 by 2050. This increase in the geriatric population is expected to increase the number of individuals affected with neurological disorders in the country, as elderly people are more prone to diseases, thus boosting the market.

Segmental Analysis

The global central nervous system biomarkers market is segmented by type of CNS biomarkers, application, and end-user.

Based on the type of CNS biomarkers, the global 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. A safety biomarker is a biomarker that is assessed before or during exposure to a pharmaceutical or environmental substance to determine the possibility, presence, or severity of toxicity as a negative side effect. The safety biomarkers have become widely accepted and qualified by regulatory agencies, are increasingly implemented in early clinical trials, play a prominent role in decision-making, and promote the progression of promising therapeutics from preclinical through clinical development.

The other types of CNS biomarkers include predictive and prognostic biomarkers, among others. Predictive biomarkers can identify patients most likely to benefit from a given treatment, sparing other patients from the negative effects of failed medications. A prognostic biomarker indicates an increased probability of a specific population's future clinical event, disease recurrence, or disease progression. Biomarkers for prognosis are measured at a defined baseline, which may include a treatment as a background.

Based on application, the global 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. It has been difficult to discover effective treatments for mental disorders. The efficacy of therapeutic interventions can be evaluated using biomarkers that modulate the expression of potential drug targets. Biomarkers can assist in diagnosis, demonstrate target engagement, support disease modification, and monitor for safety. Compared to other areas of drug discovery, the clinical failure rate for new drugs targeting central nervous system (CNS) diseases is even higher. Therefore, these biomarkers that help in drug development are increasing in use, boosting the segment growth.

Precision medicine, commonly called personalized medicine, is among the most promising approaches to tackling diseases. The key aspect contributing to the segment's growth is the rising number of brain and other nervous system cancers. It is one of the emerging fields for CNS biomarkers due to its rising application as a diagnostic tool, which helps recognize the precise biological markers.

Based on end-users, the global 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. The increasing prevalence of neurological diseases, government initiatives, and major market players' strategies are the major factors fueling the increase in diagnostics laboratories, thereby increasing the tests performed in these diagnostic laboratories. With the automation and growing emergence of robotics in diagnostic laboratories, a transformation has resulted in increased productivity and lowered the cost of the tests. The market for CNS biomarkers usage in laboratories is also expected to increase due to the collaboration between the manufacturers and laboratories to produce innovative products.

Hospitals play a vital role in neurological diagnosis tests, as most patients visit hospitals due to these disorders. The startup cost is not prohibitive for most hospitals, given diagnostics' important clinical and financial benefits. Hence, most of the large-scale and middle-scale hospitals have inbuilt laboratories to conduct the diagnosis of CNS diseases. The major advantage of the diagnosis within the hospitals is that the results are easily accessible to the healthcare professionals to make the required decision.

Recent Developments

• 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.
• 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.