Cervical Dystonia Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• The prevalence of cervical dystonia is projected to increase during the forecast period (2023-2034). This increase is attributed to heightened awareness among healthcare professionals and the general public regarding cervical dystonia, alongside the aging population.
• The diagnosis of cervical dystonia relies on clinical examination, thorough patient history assessment, and a deep understanding of the disorder. No specific laboratory or imaging test definitively confirms cervical dystonia, as there are no abnormal findings in such tests associated with the condition.
• The current market for cervical dystonia is dominated by the use of botulinum toxin injections, oral medications like benzodiazepines, anticholinergics, muscle relaxants, etc. Among the present treatment options, botulinum toxin injections are the gold standard of treatment and capture the maximum market share.
• The US FDA has approved five therapies - DYSPORT (abobotulinumtoxinA), DAXXIFY (daxibotulinumtoxinA), BOTOX (onabotulinumtoxinA), XEOMIN (incobotulinumtoxinA), MYOBLOC (rimabotulinumtoxinB)/NERBLOC, and others for the treatment of cervical dystonia.
• Botulinum toxin injections are recommended as first-line therapy for most patients, as they provide excellent symptom relief with minimal side effects. The effects are temporary, and injections are repeated quarterly for sustained benefit. Moreover, not all patients respond adequately to this therapy, as some may develop resistance to botulinum toxin over time, leading to decreased effectiveness.
• In 2022, the US had the largest market size of cervical dystonia among the 7MM, accounting for approximately USD 222.2 million. This is expected to increase further by 2034.

The “Cervical Dystonia - Market Insights, Epidemiology, and Market Forecast - 2034” report delivers an in-depth understanding of cervical dystonia, historical and forecasted epidemiology, as well as the cervical dystonia market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

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

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Cervical Dystonia Understanding and Treatment Algorithm

Cervical Dystonia Overview

Dystonia is a complex neurological condition characterized by involuntary muscle contractions that lead to abnormal movements and posture. It is often classified depending on which parts of the body are affected. Such as focal dystonia, segmental dystonia, generalized dystonia, multifocal dystonia, and others.

Cervical dystonia, also known as spasmodic torticollis, is the most common form of focal dystonia. It is a rare neurological movement disorder characterized by sustained or intermittent muscle contractions in the neck, resulting in functional impairment, sensory symptoms, muscle spasms, abnormal movements, and posture.

Cervical Dystonia diagnosis

A diagnosis of cervical dystonia is based on clinical examination, a detailed patient history, and knowledge of the disorder. No specific laboratory or imaging test confirms a diagnosis of cervical dystonia. There are no abnormalities in laboratory or imaging tests. Magnetic resonance imaging (MRI) of the brain is normal, and MRI of the neck does not help with the diagnosis unless compression of the spinal cord is suspected. Electromyography is not indicated unless there are additional signs of nerve irritation.

Cervical Dystonia treatment

The major treatment options include botulinum toxin injections, oral medications, and, in some cases, surgery. These treatment approaches focus on alleviating symptoms and improving functional abilities in cervical dystonia patients.

The US FDA-approved botulinum toxin therapies includes DYSPORT (abobotulinumtoxinA), DAXXIFY (daxibotulinumtoxinA), BOTOX (onabotulinumtoxinA), XEOMIN (incobotulinumtoxinA), and MYOBLOC (rimabotulinumtoxinB). Botulinum toxin is the primary treatment modality for cervical dystonia.

Cervical Dystonia Epidemiology

As the market is derived using a patient-based model, the cervical dystonia epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of cervical dystonia, gender-specific diagnosed prevalent cases of cervical dystonia, and type-specific diagnosed prevalent cases of cervical dystonia 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 the 7MM, the total diagnosed prevalent cases of cervical dystonia were estimated to be approximately 106,252 in 2022, of which the US accounted for around 57.40%, while EU4 and the UK accounted for nearly 39.32%, and Japan accounted for approximately 3.27% of the total diagnosed prevalent cases.
• Among the 7MM, the UK accounted for nearly 7.46% of the total diagnosed prevalent cases of cervical dystonia, with nearly 7,932 cases in 2022. These cases are expected to increase during the study period (2020-2034).
• As per the analysis, EU4 and the UK accounted for around 41,783 diagnosed prevalent cases of cervical dystonia in 2022. These cases are expected to change during the study period (2020-2034).
• Among the EU4 and the UK, Germany accounted for the highest prevalent cases of cervical dystonia, representing nearly 51% of the cases, followed by the UK, and Italy, while Spain had the least cases in 2022.
• According to estimates based on the epidemiology model, cervical dystonia exhibits a higher female preponderance than males in the US. Of the total diagnosed prevalent cases in the US, nearly 21% were males and 79% were females, in 2022.
• As per the epidemiology model, in the US, cervical dystonia is classified into torticollis, laterocollis, retrocollis, and anterocollis. In 2022, of the total diagnosed cervical dystonia cases, there were nearly 33,563, 22,015, 2,526, and 2,887 cases of torticollis, laterocollis, retrocollis, and anterocollis, respectively.
• According to these estimates, males accounted for nearly 1,623 cases in Japan, while females accounted for around 1,855 cases of cervical dystonia in 2022. These cases are expected to change during the forecast period.

Cervical Dystonia Drug Chapters

The drug chapter segment of the cervical dystonia report encloses a detailed analysis of cervical dystonia-marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps to understand the cervical dystonia 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 Drugs

DYSPORT (abobotulinumtoxinA): Ipsen

DYSPORT is an injectable form of botulinum toxin type A (BoNT-A), which is isolated and purified from clostridium bacteria producing BoNT-A. The drug is being supplied as a lyophilized powder. It has been approved in the US for the treatment of adults with cervical dystonia and other movement disorders, including blepharospasm, hemifacial spasms, and spasticity affecting the upper and/or lower limbs in adults and children aged 2 years or older. Furthermore, DYSPORT has marketing authorizations in more than 90 countries worldwide. The product is referred to by different names like RELOXIN (US), AZZALURE (EU), ALLUZIENCE (UK), etc in aesthetic markets.

In April 2009, the US FDA approved DYSPORT (abobotulinumtoxinA) for the treatment of cervical dystonia in adults to reduce the severity of abnormal head position and neck pain in both toxin-naïve and previously treated patients. In 2011, DYSPORT was approved in Europe for the treatment of cervical dystonia.

Emerging Drugs

ABP-450 (prabotulinumtoxinA): AEON Biopharma

ABP-450 is a prabotulinumtoxinA that inhibits the release of acetylcholine, relieving muscle contraction and spasms associated with many conditions, such as incontinence and cervical dystonia. ABP-450 contains a 900-kDa botulinum toxin type-A complex produced by the bacterium Clostridium botulinum. The active part of the botulinum toxin is the 150-kDa component, and the remaining 750 kDa of the complex is made up of accessory proteins that are believed to help with the function of the active portion of the botulinum toxin. When injected at therapeutic levels, ABP-450 blocks peripheral acetylcholine release at presynaptic cholinergic nerve terminals by cleaving SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within the nerve endings leading to denervation and relaxation of the muscle.

Additionally, ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name JEUVEAU.

Note: Further emerging therapies and their detailed assessment will be provided in the final report.

Drug Class Insights

In the 21st century, the gold standard for symptomatic treatment of cervical dystonia is botulinum toxin injections, which are administered into target neck muscles to cause selective denervation and relaxation of the abnormal neck posture. For cervical dystonia, because the muscles pulling or twisting the neck to one side are overactive, botulinum toxin injections work to calm those specific muscles and allow for the neutral head position by disrupting the nerve and the muscle, thereby weakening the muscle that it is injected into.

It inhibits the release of acetylcholine (ACh) at the neuromuscular junction, thereby blocking neuromuscular conduction and muscle contraction. The normal release of ACh at the neuromuscular junction occurs through the formation of the synaptic fusion complex of ACh vesicles bound to the presynaptic membrane by soluble N-ethylmaleimide-sensitive factor attachment protein receptor (SNARE) proteins. SNARE proteins form a trans complex of three proteins, including syntaxin 1, synaptosomal-associated protein 25 (SNAP-25), and synaptobrevin, which mediate the docking and exocytosis of ACh vesicles at the presynaptic nerve terminal. The mechanism of action of the various serotypes of botulinum toxins are similar, as all cleave the SNARE proteins; however, BoNT A, C, and E cleave SNAP-25, and BoNT B, D, F, and G cleave synaptobrevin.

Botulinum toxin injections are recommended as first-line therapy for most patients, as they provide excellent symptom relief with minimal side effects. The effects are temporary, and injections are repeated quarterly for sustained benefit.

In the US, five botulinum toxin injections are approved by the US FDA for the treatment of cervical dystonia. Among these, four are type A toxins, Ipsen’s DYSPORT (abobotulinumtoxinA), Revance Therapeutics’ DAXXIFY (daxibotulinumtoxinA), Merz Pharmaceutical and Teijin Pharma’s XEOMIN (incobotulinumtoxinA), and AbbVie’s BOTOX (onabotulinumtoxinA), while one type B toxin, Supernus Pharmaceuticals and Eisai’s MYOBLOC (rimabotulinumtoxinB).

Cervical Dystonia Market Outlook

The approach to treating cervical dystonia focuses on managing symptoms and is considered optional, with therapy aimed at improving neck alignment, reducing pain, addressing cosmetic concerns, and minimizing treatment-related side effects. While some individuals with mild symptoms may opt not to pursue treatment unless the abnormal head posture or movement significantly impacts their appearance, those experiencing disabling pain or severe neck movements that interfere with daily activities typically require intervention.

Treatment can be both pharmacological and neurosurgical. Pharmacological treatment includes botulinum toxin injections, oral medications like baclofen, benzodiazepine derivatives, analgesics, anticholinergics, and antidopaminergics.

In some patients, botulinum toxin injections are not sufficient to control the symptoms, and oral medications may be useful as additional treatment. These include benzodiazepines such as clonazepam, anticholinergics such as trihexyphenidyl, and muscle relaxants such as baclofen. However, useful adjuncts in patients are often of limited benefit due to systemic side effects and relatively modest anti-dystonia effects.

However, none of these are curative therapies and are often associated with side effects. All of these medications can be associated with muscle weakness, somnolence (sleepiness), dizziness, imbalance, and fogginess. In addition, trihexyphenidyl can cause dry mouth, nausea, constipation, urinary retention (inability to urinate), and confusion. Surgical treatments for dystonia refractory to medications and BoNT therapies include deep brain stimulation and selective peripheral denervation. DBS with electrodes placed in the globus pallidus interna has been effective in the treatment of generalized dystonia; however, there have been inconsistent results with the use of DBS for cervical dystonia. DBS is like a pacemaker for the brain and results in non-permanent suppression of a deep part of the brain.

The pipeline is limited, with no major product in development except ABP-450 (prabotulinumtoxinA). Thus, it is anticipated that the cervical dystonia market will largely be driven by the products already in the market, and there is a need to increase disease awareness and improve the efficacy and durability of the current regime to further expand the market in the forecast period (2023-2034).

The current market segmentation is based on the therapies prescribed. The drugs that are being used in the present market include DYSPORT (abobotulinumtoxinA), DAXXIFY (daxibotulinumtoxinA), BOTOX (onabotulinumtoxinA), XEOMIN (incobotulinumtoxinA), and others are included. These are the major segments covered in the forecast model.

Very few key players are evaluating their lead candidates in different stages of clinical development like ABP-450 (prabotulinumtoxinA) by AEON Biopharma. The market for Cervical Dystonia is expected to experience positive growth.

• The total market size of cervical dystonia in the 7MM was approximately USD 303.4 million in 2022 and is projected to increase during the forecast period (2023-2034).
• The market size of cervical dystonia in the US was approximately USD 222.2 million in 2022, which is anticipated to increase due to the increasing awareness of the disease and the launch of the emerging therapy.
• The total market size of EU4 and the UK was calculated to be approximately USD 73.2 million in 2022, which was nearly 24.1% of the total market revenue for the 7MM.
• According to these estimates, among EU4 and the UK, Germany accounted for the highest market with approximately USD 37.1 million in 2022, followed by the UK with approximately USD 13.9 million in the respective year, while Spain accounted for the lowest market in 2022.
• According to the analysis, in the US, among the currently used therapies, the majority of the market share was of BOTOX (onabotulinumtoxinA) with a revenue of approximately USD 135.7 million, in 2022, followed by other therapies.
• In 2022, Japan with a revenue of approximately USD 8.1 million, which was nearly 2.7% of the total market revenue for the 7MM, which is expected to increase significantly by 2034.

Cervical Dystonia Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. For example, AEON Biopharma’s ABP-450, a prabotulinumtoxinA, which functions by inhibiting the release of acetylcholine, thereby alleviating muscle contraction and spasms commonly observed in various conditions including incontinence and cervical dystonia, is expected to enter the US market in 2027 with a “fast” uptake.

Cervical Dystonia 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 cervical dystonia.

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 cervical dystonia 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.

The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like Cedars Sinai Medical Center, Los Angeles, US, University of California, San Francisco, US, Massachusetts General Hospital, Boston, US, Hannover Medical School, Hannover, Germany, Sorbonne Université, Paris, France, Lancaster University, England, UK, and Fukuoka University, Japan were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or cervical dystonia 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

According to our primary research analysis, despite advancements in the treatment of cervical dystonia, significant unmet needs persist in effectively managing the condition. One such challenge lies in the variability of patient responses to existing therapies, particularly botulinum toxin injections, which serve as the primary treatment. Not all patients respond optimally to this intervention, and some may develop resistance over time, necessitating alternative approaches. Additionally, while botulinum toxin injections effectively target muscle contractions, they may not fully address associated non-motor symptoms such as pain, depression, and impaired quality of life. Furthermore, there remains a lack of standardized protocols for long-term management, leading to uncertainty regarding the optimal treatment duration and frequency.

According to a KOL in the US, the disease is often misdiagnosed, and because cervical dystonia is not as well-known as many other neurologic conditions, the journey to a diagnosis can be long. Cervical dystonia symptoms can mimic neck sprain, slipped disk in the neck, tremor, and Parkinson’s disease. We believe raising awareness about cervical dystonia and its symptoms among healthcare providers and the general public can contribute to early detection and appropriate disease management.

As per another KOL, management typically involves a combination of treatments such as botulinum toxin injections, oral medications, physical therapy, and in some cases, surgery. Despite this, they are not very effective in treating cervical dystonia. Therefore, we need a new generation of therapies that is curative or can help slow the progression of the disease.

Another KOL found that the BoNT injections are typically administered every 3-4 months to maintain symptom control in cervical dystonia. For some people, having to get injections regularly can be a hassle. For others, the cost of BoNT injections can also be a major factor, particularly if there are out-of-pocket costs or if insurance does not cover the full cost.

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.

Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The reimbursement challenges related to medical care and treatment for individuals with cervical dystonia can be significant as it often requires specialized medical attention, covering the costs of diagnosis, treatment, and ongoing care. Health insurance plans may not fully cover limited coverage of some medical treatments, and therapies specific to cervical dystonia. This can result in high out-of-pocket expenses for families seeking the best care for their loved ones. Moreover, it requires specialized care from healthcare providers with expertise. Finding and accessing such specialists may be challenging, and the associated costs may not always be fully reimbursed by insurance.

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, 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 Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of cervical dystonia, 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 cervical dystonia, 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 cervical dystonia market.

Cervical Dystonia Report Insights

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

Cervical Dystonia Report Key Strengths

• 12 years Forecast
• The 7MM Coverage
• Cervical Dystonia Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Market Forecast Assumptions

Cervical Dystonia Report Assessment

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

Key Questions

Market Insights

• What was the total market size of cervical dystonia, the market size of cervical dystonia 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 DYSPORT, DAXXIFY, and others affect the treatment paradigm of cervical dystonia?
• How will ABP-450 (prabotulinumtoxinA) compete with upcoming products and marketed therapies?
• 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 cervical dystonia? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Cervical Dystonia?
• What is the historical and forecasted cervical dystonia 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 cervical dystonia population during the forecast period (2023-2034)?
• What are the contributing factors to the evolving trends in cervical dystonia prevalence?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of cervical dystonia? What are the current clinical and treatment guidelines for treating cervical dystonia?
• How many companies are developing therapies for the treatment of cervical dystonia?
• How many emerging therapies are in the mid-stage and late stage of development for treating cervical dystonia?
• 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 cervical dystonia?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the cervical dystonia 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 cervical dystonia, 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.