Multiple Sclerosis Diagnostics Market Revenue to Attain USD 12.88 Bn by 2035

Multiple Sclerosis Diagnostics Market Revenue and Trends 2026 to 2035

The global multiple sclerosis diagnostics market revenue reached USD 5.70 billion in 2025 and is predicted to attain around USD 12.88 billion by 2035 with a CAGR of 8.80%. The market is driven by the rising incidence of multiple sclerosis (MS) worldwide and the increasing requirement for early and accurate diagnosis to distinguish MS from other nervous system diseases.

Understanding the Intricacies of Neurological Disorders

The multiple sclerosis diagnostics market consists of medical devices and diagnostic procedures that are used for diagnosing, confirming, and managing multiple sclerosis. It is an autoimmune disease wherein the body’s defense system attacks the myelin sheaths of nerve fibers in the brain and spinal cord. This market involves the use of magnetic resonance imaging (MRI) for detecting lesions in the brain and spinal cord.

This market also includes the use of optical coherence tomography for detecting thinning of retinal nerve fibers, and blood tests that help differentiate MS from other disorders. Various diagnostic methods are used in the market, such as the software for analyzing images and quantifying lesions, automated report generation software, and diagnostic algorithms based on the McDonald Criteria.

NfL Blood Test for Neuroinflammation in Multiple Sclerosis Diagnosis

The emerging trend in the market is the use of blood tests based on neurofilament light chain (NfL) markers, which diagnose neuroinflammation in relapsing-remitting multiple sclerosis. This innovation allows for standardized monitoring of neuroaxonal injury through the convenience of a blood sample, reducing the frequency and risks related to lumbar puncture procedures. In 2026, Roche Diagnostics acquired the CE mark for its Elecsys NfL blood test that detects neuroinflammation in relapsing-remitting multiple sclerosis using commonly available cobas equipment.

Implementing Blood-Based Multiple Sclerosis Disease Activity Assessment

The multiple sclerosis diagnostics market is benefiting from the adoption of blood-based multi-biomarker tests that calculate quantitative scores for disease activity. This testing represents an alternative to imaging as a non-invasive test for monitoring and evaluating disease and treatment outcomes. The usage of these tests has been increasing rapidly as doctors are using them for disease monitoring, baseline assessments, and treatment efficacy evaluations. In 2025, Octave Bioscience announced a collaboration agreement with Quest Diagnostics, allowing the latter to offer Octave’s MSDA Test at its chain of about 7,000 patient service centers across the U.S.

Government Initiatives to Boost MS Testing and Research

Governments across the globe have set up several financial programs that aim to increase the availability of biomarker tests and minimize the waiting period for diagnosis. Governments have introduced funding for research studies aimed at exploring the progression and reaction of the condition to medications. In 2025, the Canadian province of New Brunswick initiated an unprecedented province-wide NfL biomarker test program for MS patients through a joint venture between the Horizon Health Network, the Vitalite Health Network, and Roche Canada. The program, which caters to around 2,000 MS patients in the province, cuts down the cost per test by over 60 percent and delivers results within days, giving neurologists an opportunity to track disease progression regularly and make informed decisions.

Octave MSDA Test Received 21,138 Orders by September 2025

During the time period between 2022 and September 2025, 21,138 tests were performed by Octave MSDA Test for 15,040 multiple sclerosis patients through 359 health care providers from 198 facilities. Out of the patients whose disease-modifying treatment details were available, 44.4% were receiving high-efficacy treatments, while 34.2% did not receive any treatment at all.

Market Segmentation Overview

• By diagnostic type, the magnetic resonance imaging (MRI) segment led the multiple sclerosis diagnostics market with 42% share in 2025, due to its high sensitivity and specificity, which can offer excellent visualization of lesions in the brain and spine caused by myelin degeneration and allow both diagnosis of acute inflammation and chronic changes.
• By diagnostic type, the blood-based biomarker testing segment is expected to expand at the highest CAGR of 15.5% during the forecast period, because it provides a less-invasive and economical substitute for lumbar punctures and serial MRI scans, which can help measure the progression of the disease in MS patients.
• By biomarker type, the neurofilament light chain (NfL) segment dominated the market with 34% share in 2025, and is expected to expand at the fastest CAGR of 14.5% from 2026 to 2035, because it is one of the most extensively researched and validated blood markers of axonal injury in multiple sclerosis, showing a high association with disease activity.
• By biomarker type, the oligoclonal bands (OCBs) segment held the second-largest market share of 28% in 2025, because testing for oligoclonal bands in cerebrospinal fluid is considered a gold standard for diagnostics, due to their specific presence in cerebrospinal fluid as a sign of intrathecal synthesis of immunoglobulin G in MS patients.
• By disease type, the relapsing-remitting multiple sclerosis (RRMS) segment led the multiple sclerosis diagnostics market with 62% share in 2025, owing to its high prevalence as the initial form of the disease, and the patients suffering from RRMS undergo regular MRI, lumbar puncture, and blood tests for detecting relapses, lesions, and treatment response.
• By disease type, the primary progressive multiple sclerosis segment is expected to grow at the fastest CAGR of 11.2% from 2026 to 2035, since it lacks distinct relapses and needs evidence that the disability status will progress over at least a year before a patient can be diagnosed. 
• By end-use, the hospitals segment dominated the market with 44% share in 2025, due to the availability of neurology departments, MRI equipment, and laboratories in hospitals, which are crucial for diagnosing and treating multiple sclerosis.
• By end-use, the specialty neurology clinics segment is expected to expand at the highest CAGR of 12.2% during the forecast period, because of its ability to provide more convenient and faster follow-up visits than hospitals, and the availability of MRI facilities within the specialty clinics, which facilitate initial diagnostics and assessments.

Regional Analysis

North America led the multiple sclerosis diagnostics market with 40% share in 2025, due to the high prevalence of multiple sclerosis cases, which created consistent demand for diagnostic imaging services, cerebrospinal fluid examination, and blood testing. The U.S dominated the market in North America because of the availability of high-field MRIs, commercial reference laboratories conducting tests on NfL chains, and Medicare and private insurance companies covering the costs of diagnostic testing under the medical necessity criteria. Canada witnessed notable market growth owing to its universal healthcare system, guaranteeing free testing of all multiple sclerosis patients, and province-wide biomarker testing conducted by Roche Canada in the province of New Brunswick.

Asia-Pacific is expected to grow at the fastest CAGR of 13.2% from 2026 to 2035, due to a large population, growing awareness about multiple sclerosis amongst healthcare professionals, access to advanced diagnostic tests, and significant investments in diagnostic infrastructure. China led the market in Asia-Pacific because of high healthcare expenditure and active government efforts towards increasing neurological diagnostic facilities in urban and rural areas. India is a significant contributor to the market increase in the number of neurological awareness initiatives and the rapid development of diagnostic laboratories and imaging centers in cities.

Multiple Sclerosis Diagnostics Market Coverage

Top Companies in the Multiple Sclerosis Diagnostics Market

Siemens Healthineers, GE Healthcare, Philips Healthcare, and Canon Medical Systems are some of the key players that provide MRI technology for MS diagnostics using lesion identification. Bio-Rad Laboratories, Thermo Fisher Scientific, and Qiagen N.V. offer immunology testing solutions for identifying markers of MS. Abbott Laboratories, Danaher Corporation, and Quanterix Corporation provide ultrasensitive assays based on blood collection and chemiluminescence. Agilent Technologies and Merck KGaA provide mass spectrometry solutions for MS diagnostics.

Segments Covered in This Report

By Diagnostic Type

• Magnetic Resonance Imaging (MRI)
• Cerebrospinal Fluid (CSF) Analysis
• Evoked Potential Testing
• Blood-based Biomarker Testing
• Optical Coherence Tomography (OCT)
• Molecular & Genetic Diagnostics

By Biomarker Type

• Neurofilament Light Chain (NfL)
• Oligoclonal Bands (OCBs)
• Glial Fibrillary Acidic Protein (GFAP)
• Cytokine Biomarkers
• Other Neurological Biomarkers

By Disease Type

• Relapsing-Remitting Multiple Sclerosis (RRMS)
• Secondary Progressive Multiple Sclerosis (SPMS)
• Primary Progressive Multiple Sclerosis (PPMS)
• Progressive-Relapsing Multiple Sclerosis (PRMS)

By End-use

• Hospitals
• Diagnostic Laboratories
• Specialty Neurology Clinics
• Academic & Research Institutes

By Technology

• Imaging Technologies
• Immunoassays
• Molecular Diagnostics
• AI-based Diagnostic Analytics

By Region

• North America
• Latin America
• Europe
• Asia-pacific
• Middle and East Africa

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