PUBLISHER: DelveInsight | PRODUCT CODE: 2018977
PUBLISHER: DelveInsight | PRODUCT CODE: 2018977
DelveInsight's "Cervical Dystonia Market Insights, Epidemiology, and Market Forecast - 2036" 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 Treatment Market Report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM cervical dystonia market size from 2022 to 2036. The report also covers Cervical Dystonia treatment market practices/algorithms and Cervical Dystonia unmet needs to curate the best opportunities and assess the market's potential.
Key Factors Driving the Cervical Dystonia Market
Rising Cervical Dystonia Prevalence
According to DelveInsight's estimates, in 2022, there were approximately 106K total diagnosed prevalent cases of cervical dystonia in the 7MM. These cases are expected to increase during the study period (2020 -2034).
Dominance & Expansion of Botulinum Toxin (BoNT) Therapies
BoNT-A injections remain the standard of care for focal cervical dystonia; broader adoption, new formulations/brands, and label expansions are the single largest commercial engine for the market. BoNT market growth underpins cervical dystonia market revenue forecasts.
Cervical Dystonia Treatment Market
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 Cervical Dystonia treatment options include botulinum toxin injections, oral medications, and, in some cases, surgery. These Cervical Dystonia 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.
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 2022 to 2036.
The drug chapter segment of the cervical dystonia treatment market report encloses a detailed analysis of cervical dystonia-marketed drugs and mid to late-stage (Phase III and Phase II) Cervical Dystonia pipeline drugs. It also helps to understand the cervical dystonia clinical trials details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest Cervical Dystonia news and press releases.
Cervical Dystonia Marketed Drugs
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-naive and previously treated patients. In 2011, DYSPORT was approved in Europe for the treatment of cervical dystonia.
DAXXIFY (daxibotulinumtoxinA) (formerly known as RT002) injection is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment of cervical dystonia in adults and the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. Moreover, DAXXIFY is powered by Peptide Exchange Technology, Revance's proprietary, synthetic, 35-amino-acid stabilizing excipient, and is developed free of human serum albumin or animal-based components. DAXXIFY is supplied as a lyophilized powder for reconstitution in single-dose 50 U and 100 U vials. The total recommended dose is 40 U per treatment session divided into five equal intramuscular injections of 8 Units each (two injections in each corrugator muscle and one injection in the procerus muscle).
In August 2023, the US FDA approved DAXXIFY (daxibotulinumtoxinA) for the treatment of cervical dystonia in adults.
BOTOX (onabotulinumtoxinA) is an acetylcholine release inhibitor, and a neuromuscular blocking agent indicated for the treatment of patients with cervical dystonia in adult patients to reduce the severity of abnormal head position and neck pain. It is also being used for other indications, including overactive bladder, urinary incontinence, and prophylaxis of headaches in adult patients with chronic migraine, spasticity, axillary hyperhidrosis, blepharospasm, and strabismus. Botox is marketed by GSK in Japan.
XEOMIN (incobotulinumtoxinA) is an acetylcholine release inhibitor, and neuromuscular blocking agent indicated for the treatment of adults with cervical dystonia to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naive and previously treated patients and for blepharospasm in adults previously treated with onabotulinumtoxinA.
IncobotulinumtoxinA is a highly potent active ingredient. It is a purified neurotoxin type A (150kD) free from complex proteins that prevent the release of the neurotransmitter acetylcholine from nerve endings in muscles and salivary glands. This prescription medicine is used intramuscularly to treat increased muscle stiffness, e.g. in the arm or shoulder of adults with upper limb spasticity, or abnormal head position that happens with cervical dystonia (spasmodic torticollis) in adults.
Additionally, XEOMIN is approved for the treatment of upper and lower limb spasticity, blepharospasm, or hypersalivation.
MYOBLOC is an acetylcholine release inhibitor indicated for the Cervical Dystonia treatment to reduce the severity of abnormal head position and neck pain associated with cervical dystonia in adults and the treatment of chronic sialorrhea in adults. The product is referred to as NERBLOC in Japan by Eisai, MYOBLOC in the US market, and NEUROBLOC in the European market.
Cervical Dystonia Emerging Drugs
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.
ABP-450 completed a Phase II clinical trial in cervical dystonia and is anticipated to initiate a Phase III clinical trial. Recently the company presented its topline results at the TOXINS 2024 conference. Moreover, the drug is also being investigated in multiple indications, including gastroparesis, posttraumatic stress disorder, and chronic and episodic migraine.
IPN10200: Ipsen
IPN10200 is Ipsen's first-in-class recombinant molecule, engineered to combine the active sequence of botulinum toxin type A with the binding domain of botulinum toxin type B. It is designed to enhance receptor affinity and cellular internalization, resulting in a longer and clinically meaningful duration of effect. The molecule has been optimized to improve safety and efficacy and is currently being evaluated in four Phase II clinical trials across both therapeutic and aesthetic indications. It is currently being evaluated in Phase II clinical trial for cervical dystonia.
Cervical Dystonia Drugs Market Insights
In the 21st century, the gold standard for symptomatic Cervical Dystonia treatment 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).
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 (2026-2036).
The current Cervical Dystonia Market Segmentation is based on the therapies prescribed. The Cervical Dystonia 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 Cervical Dystonia Companies 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.
This section focuses on the uptake rate of potential Cervical Dystonia drugs expected to be launched in the market during 2022-2036. 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 Cervical Dystonia therapeutics market provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes Cervical Dystonia Companies involved in developing targeted therapeutics.
Pipeline development activities
The Cervical Dystonia therapeutics market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Cervical Dystonia emerging therapies.
KOL Views
To keep up with current Cervical Dystonia 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.
DelveInsight's 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 Universite, 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 Cervical Dystonia Therapeutics Market and the Cervical Dystonia Unmet Needs.
Physician's View
According to our primary research analysis, despite advancements in the Cervical Dystonia Treatment, 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 Cervical Dystonia Therapeutics 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 Cervical Dystonia treatment landscape.
Cervical Dystonia Therapeutics Market Access and Reimbursement
The high cost of therapies for the Cervical Dystonia 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, Cervical Dystonia 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 Cervical Dystonia Therapeutics Market 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.
Cervical Dystonia Treatment Market Report Scope
Key Cervical Dystonia Treatment Market Assumptions
Cervical Dystonia Treatment Market Insights
Cervical Dystonia Epidemiology Insights
Current Cervical Dystonia Treatment Market Scenario, Marketed Drugs, and Emerging Therapies