Spinal Cord Injury Drug Treatment Market is Predicted to Reach New Heights with the Anticipated Launch of Emerging Therapies and Breakthroughs by 2034 | DelveInsight

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Feb 19, 2025, 17:31 ET

The spinal cord injury market is expected to experience steady growth, with a strong CAGR of 15.4% forecast from 2024 to 2034. This growth across the 7MM will be propelled by the introduction of innovative therapies such as KP-100IT, Neuro-Cells, Elezanumab (ABT-555), and MT-3921.

LAS VEGAS, Feb. 19, 2025 /PRNewswire/ -- Spinal cord injury (SCI) is a sudden disruption of the spinal cord's neural tissue within the spinal canal, caused by trauma, disease, or degeneration. This complex injury can vary greatly in its effects, with each case presenting distinct challenges. The severity and type of SCI depend on the level and nature of the damage, which can result in upper or lower motor neuron lesions, causing a range of motor, sensory, and autonomic dysfunctions.

In 2023, there were an estimated 959K total diagnosed prevalent cases of SCI across the 7MM, with the number expected to rise by 2034, as per DelveInsight analysis. According to estimates, there were approximately 19K acute (incidence) cases of SCI across the US in 2023, with the number expected to rise by 2034.

A spinal cord injury is a life-changing experience, and adapting to it can be difficult. However, with the help of a committed medical team and strong social support, individuals with spinal cord injuries can discover ways to participate in activities they love and live meaningful lives. Continued research efforts are focused on advancing our understanding of SCI's causes, developing new treatment approaches, and evaluating the effectiveness of interventions. These initiatives include preclinical research, clinical trials, and collaborative partnerships between academia, industry, and government, all aimed at improving treatment options for SCI patients.

The treatment options for SCI are still limited, with few approved therapies. At present, STEMIRAC is the only authorized treatment, available exclusively in Japan. LYRICA (pregabalin) is the only FDA-approved medication for neuropathic pain related to SCI, with generic versions also available.

Learn more about the FDA-approved SCI drugs @ Drugs for Spinal Cord Injury Treatment

STEMIRAC, developed by Nipro Corporation, is an autologous mesenchymal stem cell (MSC) therapy aimed at treating traumatic spinal cord injury. The treatment process involves extracting MSCs from the patient's bone marrow, expanding them in vitro, and cryopreserving them for future administration. Delivered via intravenous infusion, these MSCs migrate to the injury site, where they promote tissue repair and functional recovery through immunomodulatory, anti-inflammatory, and trophic factor-secreting mechanisms.

In 2018, STEMIRAC received conditional market approval from Japan's Pharmaceutical and Medical Devices Agency (PMDA), requiring continued data collection to assess its long-term efficacy and safety. Initially approved for subacute SCI, a corporate clinical trial for chronic SCI was launched in July 2023 to broaden its therapeutic applications. Recognized as a breakthrough product under Japan's SAKIGAKE system in 2016, STEMIRAC represents a significant advancement in regenerative medicine. Developed in collaboration with Sapporo Medical University, it is expected to achieve full approval by December 2025, offering new treatment possibilities for SCI patients.

There is a critical need for targeted therapies to improve outcomes and promote functional recovery. Although there is no cure for SCI, ongoing research is focused on developing treatments to improve long-term outcomes and prevent complications.

To know more about SCI treatment options, visit @ New Treatment for Spinal Cord Injury

The development pipeline for SCI treatment is limited, with KP-100IT (Kringle Pharma), Neuro-Cells (Neuroplast), MT-392 (Mitsubishi Tanabe Pharma America), and Elezanumab (ABT-555) (AbbVie) being the primary candidates. There is a significant unmet need for targeted treatments, as current therapies focus on symptom management rather than addressing the underlying condition.

Discover which therapies are expected to grab major SCI market share @ Spinal Cord Injury Market Report

KP-100IT, developed by Kringle Pharma, is under investigation for treating acute spinal cord injury (SCI). The drug is designed to protect nerve cells and promote axonal growth, potentially aiding motor function recovery. Promising Phase I/II results demonstrated a strong safety and efficacy profile in patients with severe acute cervical SCI. A Phase III trial, initiated in July 2020, assessed KP–100IT's effectiveness in improving recovery, with the primary objective of achieving at least a two-grade improvement in the American Spinal Injury Association (ASIA) score within six months.

Top-line results from the Phase III study, released in February 2024, reinforce progress in acute SCI treatment. Additionally, KP–100IT was granted Orphan Drug Designation for acute-phase SCI by Japan's Ministry of Health, Labour and Welfare (MHLW) in September 2019. Kringle Pharma is now preparing a marketing application, targeting manufacturing and marketing approval by March 2025.

Neuroplast has developed Neuro-Cells, an innovative stem cell therapy designed to treat traumatic spinal cord injury (TSCI) by reducing inflammation and promoting nerve regeneration in the central nervous system. Its goal is to preserve and restore function, mobility, and independence, marking a significant advancement in TSCI treatment.

The clinical development of Neuro-Cells has shown encouraging results. Neuroplast launched Phase II trials in March 2022, successfully completing patient enrollment by September 2023. Conducted with the approval of Spanish regulatory authorities, the trial confirmed a strong safety profile, with no product-related adverse events and positive patient feedback. Currently, Neuro–Cells is progressing through Phase II/III clinical trials for TSCI. Notably, Neuroplast was granted European Orphan Designation in May 2019 and secured a GMP license in November 2021, reinforcing its commitment to accelerating development and addressing unmet needs in TSCI treatment.

MT-3921, developed by Mitsubishi Tanabe Pharma Corporation (MTPC) in partnership with Osaka University, is designed to treat spinal cord injury. By inhibiting repulsive guidance molecule A (RGMa), a key factor that suppresses neuronal survival and regeneration, MT-3921 aims to enhance neuroregeneration and restore motor function in SCI patients. The U.S. FDA granted it Fast Track Designation (FTD) in July 2021.

A Phase II Proof-of-Concept trial, launched in September 2021, is assessing MT-3921's effectiveness in 72 SCI patients across clinical sites in the United States and Japan. The study focuses on changes in Upper Extremity Motor Score (UEMS) over a six-month treatment period. Administered via intravenous infusion, MT-3921 holds promise as a potential therapy for improving motor function in individuals with SCI.

Discover more about drugs for SCI in development @ Spinal Cord Injury Clinical Trials

The anticipated launch of these emerging therapies for SCI are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the SCI market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

DelveInsight estimates that the market size for SCI in the 7MM is expected to grow from USD 345 million in 2023 with a significant CAGR of 15.4% by 2034. This growth is mainly driven by the rising prevalence of SCI, driven by increasing awareness and risk factors like traumatic injuries, aging populations, and advancements in diagnostic tools.

DelveInsight's latest published market report titled as Spinal Cord Injury Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the SCI country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The SCI market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

Acute (Incident) Cases of SCI
Total Diagnosed Prevalent Cases of SCI
Gender-specific Diagnosed Prevalent Cases of SCI
Etiology-specific Diagnosed Prevalent Cases of SCI
Etiology-specific Diagnosed Prevalent Cases of Traumatic SCI

The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM SCI market. Highlights include:

11-year Forecast
7MM Analysis
Epidemiology-based Market Forecasting
Historical and Forecasted Market Analysis upto 2034
Emerging Drug Market Uptake
Peak Sales Analysis
Key Cross Competition Analysis
Industry Expert's Opinion
Access and Reimbursement

Download this SCI market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the SCI market. Also, stay abreast of the mitigating factors to improve your market position in the SCI therapeutic space.

Related Reports

Spinal Cord Injury Pipeline

Spinal Cord Injury Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key SCI companies, including Kringle Pharma, Eusol Biotech, Pharmicell, Pharmazz, AbbVie, Acorda Therapeutics, Geron Corporation, ReNetX Bio, GNT Pharma, AlaMab Therapeutics, Mitsubishi Tanabe Pharma, Kancera, Olatec Therapeutics, Scholar Rock, AXONIS Therapeutics, K-STEMCELL, Nordic Life Science Pipeline, NervGen Pharma, Athersys, Healios, Angiocrine Bioscience, among others.

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SOURCE DelveInsight Business Research, LLP