Spinal Cord Injury (SCI) - Market Insights, Epidemiology, and Market Forecast-2034

Key Highlights:

• According to DelveInsight's estimates, in 2023, there were approximately 959 thousand diagnosed prevalent cases of SCI in the 7MM. Of these, the United States accounted for 32% of the cases, while EU4 and the UK accounted for nearly 56% and Japan represented 12% of the cases, respectively.
• The SCI market is expected to experience steady growth, with a strong compound annual growth rate (CAGR) forecasted 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. Furthermore, the rising prevalence of SCI, driven by increasing awareness and risk factors like traumatic injuries, aging populations, and advancements in diagnostic tools, the spinal cord Injury market is poised for significant growth. Increasing focus on novel therapies and rehabilitation technologies further supports market expansion.
• According to DelveInsight's analysis, the SCI market in the 7MM was valued at approximately USD 345 million in 2023. Over the forecast period from 2024 to 2034, this market is projected to grow at a CAGR of 15.4%.
• The treatment landscape for SCI remains underdeveloped, with limited approved therapies. Currently, STEMIRAC is the only approved therapy, available in Japan. There is a critical need for targeted therapies to improve outcomes and promote functional recovery.
• Kringle Pharma, Neuroplast, AbbVie, and Mitsubishi Tanabe Pharma America are advancing their assets through various stages of development, driving innovation in the SCI market. Their efforts are shaping a dynamic landscape and opening up significant opportunities for market growth and expansion.
• Kringle Pharma (KP-100IT), an innovative therapy in advanced development, is in Phase III clinical trials and is anticipated to launch by 2025 in Japan for the treatment of SCI.

DelveInsight's "Spinal Cord Injury (SCI) - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of SCI, historical and forecasted epidemiology, as well as the SCI market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The SCI market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM SCI market size from 2020 to 2034. The report also covers SCI treatment practices and unmet medical needs to curate the best opportunities and assess the market's potential.

Spinal Cord Injury Understanding and Treatment Algorithm

SCI overview

Spinal Cord Injury (SCI) refers to a sudden disruption of the spinal cord's neuronal tissue within the spinal canal resulting from trauma, disease, or degeneration. This complex injury varies widely in its impact, with each case presenting unique challenges. Depending on the level and type of damage, SCI can manifest as upper or lower motor neuron lesions, leading to varying degrees of motor, sensory, and autonomic dysfunction. These effects may be temporary or permanent.

The underlying causes of SCI are arise from traumatic events such as motor vehicle accidents, falls, violence, sports injuries, and workplace accidents, as well as non-traumatic causes like vascular disorders. Key risk factors include age, gender, risky behaviors, pre-existing health conditions, and socioeconomic challenges, highlighting the importance of awareness for prevention and management.

Early symptoms of SCI may include partial or complete paralysis, loss of sensation, bladder and bowel incontinence, breathing difficulties, and chronic neuropathic pain. Secondary symptoms may involve spasticity, autonomic dysreflexia, pressure sores, respiratory infections, and circulatory issues such as blood clots and low blood pressure. These symptoms significantly impact daily life, affecting mobility, self-care, employment, social interactions, and emotional well-being, often leading to decreased independence and quality of life.

SCI diagnosis

The diagnosis of SCI involves a comprehensive assessment, including medical history, physical examination, and imaging tests like X-rays, CT scans, and MRIs to evaluate bone and soft tissue damage. Additional tests, such as somatosensory and motor evoked potentials, assess spinal cord function. The severity of the Injury is classified using the ASIA Impairment Scale, ranging from complete loss of function to normal function. Regular follow-ups are crucial to monitor recovery, guide rehabilitation, and adjust treatment plans based on changes in sensory and motor function.

SCI treatment

Currently, treatment approaches include immediate medical intervention, surgery, pharmacological therapies, and rehabilitation. Early interventions like immobilization and breathing support prevent further damage, while surgical treatments such as decompression and stabilization help relieve pressure on the spinal cord. Pharmacological treatments, including glucocorticoids (e.g., methylprednisolone), and pregabalin for neuropathic pain, manage inflammation and pain. Rehabilitation focuses on physical and occupational therapy, assistive technologies, and psychosocial support to enhance recovery.

Spinal Cord Injury Epidemiology

As the market is derived using a patient-based model, the SCI epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by 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, and etiology-specific diagnosed prevalent cases of traumatic SCI in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In 2023, there were an estimated 959 thousand total diagnosed prevalent cases of SCI across the 7MM, with the number expected to rise by 2034.
• According to DelveInsight's estimates, there were approximately 19 thousand acute (incidence) cases of SCI across the US in 2023, with the number expected to rise by 2034.
• According to DelveInsight's estimates, there were approximately 308 thousand diagnosed prevalent cases of SCI across the US in 2023, with the number expected to rise by 2034.
• In 2023, the US reported approximately 247 thousand male and 62 thousand female cases of SCI, with these numbers expected to increase by 2034.
• According to DelveInsight's estimates, there were approximately 537 thousand diagnosed prevalent cases of SCI across EU4 and the UK in 2023, with the number expected to rise by 2034.
• In 2023, in the UK, there were approximately 92 thousand diagnosed prevalent cases of traumatic SCI and 14 thousand cases of non-traumatic SCI. These numbers are expected to rise to 99 thousand and 15 thousand cases, respectively, by 2034.
• In 2023, Japan recorded approximately 20% of traumatic SCI cases due to vehicular accidents, 55% due to falls, 5% each due to violence, sports-related injuries, and medical/surgical causes, and 10% due to other factors.

Spinal Cord Injury Drug Chapters

The drug chapter segment of the SCI report encloses a detailed analysis of SCI-marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the SCI clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed SCI Drugs

STEMIRAC: Nipro Corporation

STEMIRAC, developed by Nipro Corporation, is an autologous mesenchymal stem cell (MSC) therapy designed to treat traumatic SCI. It involves isolating MSCs from the patient's bone marrow, culturing them in vitro, and cryopreserving them for future use. Administered via intravenous infusion, these MSCs home to the site of injury, where they exert therapeutic effects through immunomodulation, anti-inflammatory actions, and secretion of trophic factors, promoting tissue repair and functional recovery.

STEMIRAC received conditional market approval from Japan's Pharmaceutical and Medical Devices Agency (PMDA) in 2018, requiring ongoing data collection to confirm long-term efficacy and safety. Initially approved for subacute SCI, a corporate clinical trial for chronic SCI was initiated in July 2023 to expand its indications. Designated as a breakthrough product under Japan's SAKIGAKE system in 2016, STEMIRAC represents an innovative therapy in regenerative medicine. Developed through collaborations with Sapporo Medical University, it is anticipated to receive full approval by December 2025, advancing treatment options for SCI patients.

Emerging Drugs

KP-100IT: Kringle Pharma

KP-100IT, developed by Kringle Pharma, is being investigated for the treatment of acute SCI. The drug aims to support nerve cell protection and enhance axonal extension, potentially aiding in motor function recovery after SCI. Positive Phase I/II results demonstrated a promising safety and efficacy profile in patients with severe acute cervical SCI. The completed Phase III study, which began in July 2020, evaluated KP-100IT's efficacy in improving recovery outcomes, with the primary endpoint focused on 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, announced in February 2024, indicate continued progress in advancing treatment options for acute SCI. In addition, KP-100IT received Orphan Drug Designation for acute-phase SCI from the (MHLW) in Japan in September 2019. Kringle Pharma is preparing its marketing application and aims for manufacturing and marketing approval by March 2025, with the goal of obtaining marketing authorization by February 2025.

Neuro-Cells: Neuroplast

Neuro-Cells, developed by Neuroplast, is an innovative stem cell therapy designed for treating TSCI, to reduce inflammation and promote nerve regeneration within the central nervous system. By aiming to preserve and restore function, mobility, and independence, Neuro-Cells represents a significant advancement in TSCI treatment.

Clinical development of Neuro-Cells has shown promising results. Neuroplast initiated Phase II trials in March 2022 and successfully completed patient inclusion by September 2023. The trial, conducted under the approval of Spanish regulatory authorities, confirmed an excellent safety profile with no product-related adverse events and positive patient feedback. Currently, Neuro-Cells is in Phase II/III clinical trials for TSCI. Notably, Neuroplast received a European Orphan Designation in May 2019 and a GMP license in November 2021, underscoring its commitment to fast-track development and addressing unmet needs in TSCI care.

MT-3921: Mitsubishi Tanabe Pharma Corporation

MT-3921, developed by Mitsubishi Tanabe Pharma Corporation (MTPC) in collaboration with Osaka University, aimed at treating SCI. By targeting repulsive guidance molecule A (RGMa), which inhibits neuronal survival and regeneration, MT-3921 seeks to promote neuroregeneration and improve motor function in SCI patients. The US FDA granted Fast Track Designation (FTD) in July 2021.

A Phase II Proof-of-Concept study, initiated in September 2021, involves 72 SCI patients across clinical sites in the United States and Japan. This trial evaluates the therapy's efficacy, focusing on changes in Upper Extremity Motor Score (UEMS) over six months of treatment. Administered via intravenous infusion, MT-3921 represents a promising therapeutic candidate for addressing SCI-associated motor impairments.

Drug Class Insights

Currently, there are limited approved therapies specifically for SCI. STEMIRAC, approved in Japan, is one of the few available options, advances in translational biomarkers are accelerating SCI research, focusing on neural regeneration, inflammation, and recovery pathways. These efforts are shaping biomarker-driven strategies for drug discovery and precision therapies to improve outcomes.

SCI aims to stabilize the injury, prevent further damage, and maximize recovery. Treatment involves a combination of medical care, surgical interventions, and intensive rehabilitation, with a focus on restoring motor and sensory functions. Key goals include managing pain, enhancing mobility, improving daily functioning, and promoting independence. Rehabilitation therapies, such as physical and occupational therapy, play a vital role in helping patients regain skills and adapt to new challenges. Although there is no cure for SCI, ongoing research is focused on developing treatments to improve long-term outcomes and prevent complications.

Market Outlook

A Spinal Cord Injury (SCI) occurs when the spinal cord is damaged, disrupting communication between the brain and body. It can result from trauma, such as accidents, falls, or violence. Risk factors include high-risk activities, being male, and age, with individuals aged 16-30 particularly vulnerable. Symptoms vary based on severity and location, often causing loss of movement, sensation, and autonomic function, potentially leading to paralysis.

The treatment landscape for SCI centres on immediate medical intervention, surgical procedures, and rehabilitation. In the acute phase, treatment typically involves surgical decompression to alleviate spinal cord pressure, which may include removing bone fragments or herniated discs. Pharmacological treatments are essential, with intravenous methylprednisolone administered shortly after injury to reduce inflammation and nerve damage, though its routine use is debated due to potential side effects. Additional pharmacological options, such as anti-inflammatory and neuroprotective drugs, aim to limit secondary injury. During rehabilitation, physical therapy enhances mobility and strength, while assistive devices like wheelchairs and braces improve daily functioning. Chronic pain management involves therapies like tramadol, gabapentin, and cannabinoids. Despite these interventions, no definitive cure for SCI currently exists.

LYRICA (pregabalin) is the sole FDA-approved medication for neuropathic pain related to SCI, with generic versions also available. In 2018, STEMIRAC received conditional approval from Japan's PMDA for addressing neurological symptoms associated with SCI. This approval required a seven-year period for collecting additional data to validate its long-term safety and efficacy. Post-marketing evaluations are ongoing to ensure sustained clinical benefits. Efforts are underway to expedite STEMIRAC'S practical application, with full approval expected by December 2025, consistent with the original timeline.

The development pipeline for SCI treatment is limited, with KP-100IT, Neuro-Cells, MT-392 and Elezanumab (ABT-555) 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.

• The total market size of SCI in the 7MM was approximately USD 345 million in 2023 and is projected to increase during the forecast period (2024-2034).
• The market size for SCI in the US was approximately USD 146 million in 2023 and is anticipated to increase due to the launch of emerging therapies.
• The total market size of EU4 and the UK was calculated to be approximately USD 152 million in 2023, which was nearly 44% of the total market revenue for the 7MM.
• In 2023, Germany led the market among the EU4 countries and the UK, generating approximately USD 51 million, followed by France, contributing around USD 40 million.
• In 2023, the total market size of SCI was approximately USD 47 million in Japan which is anticipated to increase during the forecast period (2024-2034).
• Estimates suggest that KP-100IT is expected to generate approximately USD 28 million by 2034 in the 7MM.

Spinal Cord Injury Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034.

Spinal Cord Injury Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline development activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for SCI.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on SCI evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the University Health Network, US, University of Louisville, Kentucky, US, University Hospital Balgrist, Germany, Raymond Poincare University Hospital, France, Santa Lucia Foundation Scientific Institute, Italy, National Hospital for Paraplegics, Spain, University College London, UK, and Keio University School of Medicine, Japan, among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or SCI market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician's View

As per the KOLs from the US, the focus is on neuroprotective strategies and advancing acute care for SCI patients. Therapies targeting secondary injury mechanisms, such as inflammation and apoptosis, are critical for improving long-term outcomes. Combination approaches involving pharmacological agents and rehabilitative strategies are emerging as effective paradigms for enhancing recovery.

As per the KOLs from UK, SCI can happen to any body at any time. When it does your whole life changes in an instant. A positive future is possible but it's imperative that anyone sustaining a spinal cord injury and their families receive the right support. Back Up bought the sectors charities together in coalition to shine a light on this issue and get a better understanding of the scale of the challenge. It is shocking that almost 80% of people with spinal cord injury are not getting to NHS specialist spinal cord injury centres. This needs to change.

As per the KOLs from Japan, the aging population presents unique challenges in SCI management, with falls becoming a leading cause of injury among the elderly. Preventative measures and specialized rehabilitation programs tailored to this demographic are critical to address this growing concern.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.

Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

DelveInsight's 'SCI- Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of SCI.

LYRICA Co-Pay Savings Card

The LYRICA Co-Pay Savings Card offers eligible patients the opportunity to save on their prescription costs. With this card, patients may pay as little as USD 4 per prescription and save up to USD 3,000 annually. It is important to note that the savings card is applicable exclusively for brand-name LYRICA.

This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of SCI, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the SCI market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM SCI market.

Spinal Cord Injury report insights

• Patient Population
• Therapeutic Approaches
• SCI Pipeline Analysis
• SCI Market Size and Trends
• Existing and Future Market Opportunity

Spinal Cord Injury report key strengths

• 11 years Forecast
• The 7MM Coverage
• SCI Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Market Forecast Assumptions

Spinal Cord Injury report assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Attribute Analysis)

Key Questions:

Market Insights

• What was the total market size of SCI, the market size of SCI by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• How will KP-100IT affect the treatment paradigm of SCI?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and marketed therapies?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of SCI? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to SCI?
• What is the historical and forecasted SCI patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• Out of the countries mentioned above, which country would have the highest diagnosed prevalent SCI population during the forecast period (2024-2034)?
• What factors are contributing to the growth of SCI cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of SCI? What are the current clinical and treatment guidelines for treating SCI?
• How many companies are developing therapies for the treatment of SCI?
• How many emerging therapies are in the mid-stage and late stage of development for treating SCI?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in the US?
• What is the 7MM historical and forecasted market of SCI?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the SCI market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• The distribution of historical and current patient share is based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying upcoming solid players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies for SCI, barriers to accessibility of approved therapy, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.