Lower-Limb Spasticity Market Summary

• The Lower-limb Spasticity Market Size is anticipated to grow with a significant CAGR during the study period (2020-2034).
• Spasticity is one of the most common sequalae in stroke patients. It affects 43% of stroke patients 12 months after onset.

Lower-limb Spasticity Market & Epidemiology Insights:

• Lower-limb Spasticity was found to occur in one-third of adults after Neuromyelitis Optica Spectrum Disorder (NMOSD), one-quarter to one-third with multiple sclerosis, one-quarter to half with Parkinson’s disease, and roughly half with stroke. Lower-limb Spasticity reduces mobility and diminishes the quality of life.
• Selective Dorsal Rhozotomy (SDR) is a common and irreversible surgical technique used for spasticity treatment, commonly used in children with spastic cerebral Palsy to improve lower limb spasticity.
• Nonmedical treatments, including physical therapies, occupational therapies, and complementary and alternative medicine, are effective adjuncts to mainstream oral agents and interventional therapies.
• Treatment of lower-limb spasticity is imperative to improve quality of life and minimize medical complications.
• Baclofen is considered the first-line treatment for spasticity, especially in adult SCIs. It works pre- and postsynaptically as a gamma-aminobutyric acid (GABA) B agonist at the spinal level and binds to its receptors, leading to membrane hyperpolarization.
• Botulinum toxin injection is a popular and effective pharmacological method of treating spasticity. At present, two botulinum toxin type A formulations are approved for the management of lower-limb spasticity: DYSPORT (abobotulinumtoxinA), developed by Ipsen Biopharmaceuticals, and XEOMIN (incobotulinumtoxinA), jointly developed by Merz Therapeutics and Teijin Pharma.
• The emerging pipeline for lower-limb spasticity is currently inactive, with no therapies in development. Given the considerable unmet need, there is a strong opportunity for key industry players to initiate research and development efforts to address this therapeutic gap.

DelveInsight's “Lower-limb Spasticity Market Insight, Epidemiology and Market Forecast – 2034” report delivers an in-depth analysis of Lower-limb Spasticity epidemiology, market, and clinical development in Lower-limb Spasticity. In addition to this, the report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the Lower-limb Spasticity therapeutics market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

The Lower-limb Spasticity market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted Lower-limb Spasticity market size from 2020 to 2034 in 7MM. The report also covers current Lower-limb Spasticity treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Lower-limb Spasticity Disease Understanding

Lower-limb Spasticity Overview

Lower limb spasticity refers to increased muscle tone and hyperactive reflexes in the legs and feet. The condition can lead to unusual and uncontrollable muscle movements (spasms) in the leg. Lower limb spasticity can be painful. Individuals with upper limb spasticity can also experience difficulties coordinating with the movement of the lower limbs. Lower extremity spasticity (leg and foot spasticity) is also referred to as leg muscle spasticity, flexion contractures, leg spasms, and lower limb spasticity.

Lower-limb Spasticity Diagnosis

Diagnosis of lower-limb spasticity is primarily based on clinical assessment, involving a detailed physical and neurological examination to evaluate muscle tone, movement limitations, and reflexes. Commonly, the Ashworth Scale or Modified Ashworth Scale is used to measure resistance to passive movement, though these tools have some reliability limitations, particularly for lower limbs. Additional methods, such as biomechanical assessments using isokinetic dynamometers, electrophysiological studies like EMG or H-reflex testing, and functional evaluations like the pendulum test, can offer further insight, though they are less commonly used in routine practice. Imaging studies such as MRI may be performed to detect structural lesions in the brain or spinal cord that could be causing spasticity, but these are considered supplemental tools rather than primary diagnostic methods. Ultimately, accurate diagnosis depends on standardized assessment techniques and skilled examiners to ensure consistency and reliability.

Further details related to country-based variations in diagnosis are provided in the report...

Lower-limb Spasticity Treatment

Lower-limb spasticity is managed using a multidisciplinary approach aimed at reducing muscle tightness, improving mobility, and preventing complications such as contractures. Treatment typically involves physical therapy with regular stretching, strengthening, and range-of-motion exercises, alongside oral medications like baclofen, tizanidine, dantrolene, benzodiazepines, or gabapentin to reduce muscle tone, though these may have side effects. For targeted relief, botulinum toxin or phenol injections can be administered into overactive muscles, with effects lasting a few months. In severe cases unresponsive to oral treatment, an intrathecal baclofen pump can deliver the drug directly to the spinal fluid, offering better control with fewer systemic effects. Surgical options, including selective dorsal rhizotomy or orthopedic interventions, may be necessary for refractory cases to release contractures or correct abnormal limb positions, ensuring optimal function and quality of life.

Lower-limb Spasticity Epidemiology

The Lower-limb Spasticity epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total prevalent cases of lower-limb spasticity, gender-specific prevalent cases of lower-limb spasticity, severity-specific prevalent cases of lower-limb spasticity, etiology-specific prevalent cases of Lower-limb Spasticity, and age-specific prevalent cases of Lower-limb Spasticity in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2020 to 2034.

• Around 60% of lower-limb spasticity patients are male.
• A study found that approximately 25% of patients with cerebral palsy had mild, approximately 56% had moderate, and around 19% had severe spasticity in the lower limbs.

Lower-limb Spasticity Drug Analysis

The drug chapter segment of the Lower-limb Spasticity report encloses a detailed analysis of Lower-limb Spasticity marketed drugs. It also deep dives into Lower-limb Spasticity’s pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Lower-limb Spasticity Marketed Drugs

DYSPORT (abobotulinumtoxinA): Ipsen Biopharmaceuticals

DYSPORT is an injectable form of a botulinum neurotoxin type A product, which is a substance derived from clostridium bacteria producing botulinum toxin type A (BoNT-A) that inhibits the effective transmission of nerve impulses and thereby reduces muscular contractions. In August 2016, the US Food and Drug Administration (FDA) approved its supplemental Biologics License Application (sBLA) for DYSPORT for injection for the treatment of lower limb spasticity in pediatric patients two years of age and older. Later in June 2017, its approval was expanded for the treatment of spasticity in adults.

XEOMIN (incobotulinumtoxinA): Merz Therapeutics and Teijin Pharma

XEOMIN is a botulinum toxin type A produced from fermentation of the Hall strain Clostridium botulinum serotype A. In June 2021, Merz Therapeutics and Teijin Pharma jointly announced that Teijin Pharma received additional approval by Japan’s Ministry of Health, Labor and Welfare (MHLW) to market XEOMIN for intramuscular injection for the treatment of lower limb spasticity.

Note: Detailed current therapies assessment will be provided in the full report of Lower-limb Spasticity….

Lower-limb Spasticity Drug Class Insights

Neurotransmitter inhibition

Botulinum toxin A can block the release of acetylcholine at the neuromuscular junction, thereby alleviating spasticity. It has been widely used in clinical practice to treat spasticity.

DYSPORT treats lower-limb spasticity by acting as a neuromuscular blocking agent that inhibits the release of acetylcholine at the neuromuscular junction. When injected into spastic muscles, DYSPORT enters the nerve terminals and prevents acetylcholine from being released into the synaptic cleft. Since acetylcholine is essential for muscle contraction, its inhibition results in reduced muscle activity and temporary muscle relaxation. This mechanism helps relieve the excessive muscle stiffness and overactivity characteristic of spasticity, improving mobility and reducing pain. The effect is localized to the injected muscles, leading to relaxation and improved function without systemic muscle weakness.

Lower-limb Spasticity Market Outlook

SDR is a common and irreversible surgical technique used for spasticity treatment, commonly used in children with spastic cerebral palsy to improve lower limb spasticity. Non-medical interventions such as physical therapy, occupational therapy, and complementary or alternative medicine serve as effective adjuncts to conventional oral medications and interventional treatments. Current reports suggest that non-surgical treatment methods and intrathecal baclofen do not have long-term efficacy, and there may also be many other drawbacks, such as catheter blockage, infection, repeated medication, and drug withdrawal reactions. Surgery (except intrathecal baclofen treatment), as a permanent treatment method, is more effective in improving spasms, and in the long run, the treatment cost is lower than drug treatment. For example, the treatment cost of SDR may be much lower than the cost of intrathecal baclofen for 1 year. However, it should be noted that the specific surgical plan needs to be determined based on the patient’s age, muscle tone, and other factors.

In recent years, increasing evidence has been collected of Extracorporeal Shock Wave Therapy (ESWT) being a safe and effective alternative for reducing muscle spasticity. Indeed, ESWT is considered a valuable adjuvant modality to standard treatment and rehabilitation. The emerging pipeline for lower-limb spasticity is currently inactive, with no therapies in development. Given the considerable unmet need, there is a strong opportunity for key industry players to initiate research and development efforts to address this therapeutic gap.

Lower-limb Spasticity Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020–2034, which depends on the competitive landscape, safety, and efficacy data, along with the order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Further detailed information will be available in the report…

Lower-limb Spasticity Pipeline Development Activities

The Lower-limb Spasticity pipeline report provides insights into different Lower-limb Spasticity clinical trials within Phase III, Phase I/II, and Phase I stages. It also analyzes key players involved in developing targeted therapeutics.

Lower-limb Spasticity Pipeline Development Activities

The Lower-limb Spasticity clinical trials analysis report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Lower-limb Spasticity therapies.

KOL Views on Lower-limb Spasticity Market Report

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including the Director, a Researcher, Medical/Scientific Writers, Professors, and Others.

DelveInsight’s analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such as Virginia Commonwealth University School of Medicine, Fox Chase Cancer Center, Fred Hutchinson Cancer Center, LUNGevity Foundation, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Lower-limb Spasticity market trends.

Lower-limb Spasticity Report Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT Analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and 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.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies’ safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed, and 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 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.

Lower-limb Spasticity Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Lower-limb Spasticity Market Report

• The report covers a segment of key events, an executive summary, a descriptive overview of Lower-limb Spasticity, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the Lower-limb Spasticity 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 in shaping and driving the 7MM Lower-limb Spasticity market.

Lower-limb Spasticity Market Report Insights

• Lower-limb Spasticity Patient Population
• Lower-limb Spasticity Therapeutic Approaches
• Lower-limb Spasticity Pipeline Analysis
• Lower-limb Spasticity Market Size and Trends
• Existing and future Market Opportunity

Lower-limb Spasticity Market Report Key Strengths

• Ten-Years Forecast
• 7MM Coverage
• Lower-limb Spasticity Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Lower-limb Spasticity Drugs Uptake
• Key Lower-limb Spasticity Market Forecast Assumptions

Lower-limb Spasticity Market Report Assessment

• Current Lower-limb Spasticity Treatment Practices
• Lower-limb Spasticity Unmet Needs
• Lower-limb Spasticity Pipeline Product Profiles
• Lower-limb Spasticity Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)
• Lower-limb Spasticity Market Drivers
• Lower-limb Spasticity Market Barriers

FAQs

• What is the historical and forecasted Lower-limb Spasticity patient pool/patient burden in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Which combination of treatment approaches will have a significant impact on the Lower-limb Spasticity drug treatment market size?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the current and emerging options for the treatment of Lower-limb Spasticity?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?
• How many key players are developing therapies for Lower-limb Spasticity?
• Which drug is the major contributor Lower-limb Spasticity market by 2034?

Reasons to buy Lower-limb Spasticity Market Forecast Report

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Lower-limb Spasticity 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.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming 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 of approved therapies, barriers to accessibility of expensive off-label therapies, 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.