Tardive Dyskinesia Market

• The approval of VMAT2 inhibitors like INGREZZA (valbenazine) and AUSTEDO (deutetrabenazine) and AUSTEDO XR marks a pivotal advancement in tardive dyskinesia treatment. However, there is still a pressing need for further research into additional pharmacological options that can provide more effective and comprehensive treatment approach of tardive dyskinesia.
• INGREZZA/DYSVAL (valbenazine) is the first drug approved in Japan for the treatment of tardive dyskinesia in 2022.
• Many clinicians continue to face barriers in optimizing care, including apprehension about managing underlying psychiatric symptoms alongside tardive dyskinesia treatment. Furthermore, guidelines for managing tardive dyskinesia are often lacking or insufficiently detailed, particularly in Europe, where treatment practices vary widely 
• The average prevalence of tardive dyskinesia is estimated to be at least 20% of all patients who were treated with first-generation neuroleptics. 
• Tardive dyskinesia is commonly misdiagnosed as mental illness rather than neurologic dysfunction, resulting in the prescription of APDs that can further worsen the condition. Definitive classification of tardive dyskinesia is necessary to prevent such treatment problems from occurring.
• The therapeutic pipeline for tardive dyskinesia remains underdeveloped, with a limited number of emerging pharmacological agents demonstrating substantial clinical promise. The paucity of pharmaceutical companies actively engaged in the development of novel therapies for tardive dyskinesia highlights a significant unmet need in addressing this disorder, resulting in a considerable gap in effective treatment options 
• Only a few companies across the globe are working towards the development of therapies for treating tardive dyskinesia.  SOM Biotech is currently developing its drug SOM3355 for tardive dyskinesia.

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

Tardive dyskinesia 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 tardive dyskinesia market size from 2020 to 2034 in 7MM. The report also covers current tardive dyskinesia treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Geography Covered

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

Tardive Dyskinesia Understanding and Treatment Algorithm

Tardive Dyskinesia Overview 

Tardive dyskinesia is a chronic, involuntary movement disorder that arises primarily from prolonged use of dopamine receptor-blocking medications, commonly prescribed for psychiatric conditions such as schizophrenia or gastrointestinal disorders like nausea and gastroparesis. The term “tardive” means delayed, while “dyskinesia” refers to abnormal, involuntary movements. Tardive dyskinesia typically appears after long-term exposure to first-generation (typical) antipsychotics, with up to 20% of patients developing symptoms. These may include grimacing, lip-smacking, tongue thrusting, blinking, or jerky movements of the limbs, and range in severity from mild to disabling. Other associated movement disorders include akathisia, dystonia, buccolingual stereotypy, chorea, and tics. Individuals with schizophrenia and related neuropsychiatric disorders are particularly at risk, especially after exposure to conventional neuroleptics, anticholinergics, toxic agents, or substances of abuse. Early identification and treatment are critical to improving outcomes and preventing long-term disability.

 Tardive Dyskinesia Diagnosis

Tardive dyskinesia is primarily diagnosed through clinical evaluation, focusing on the presence of involuntary, repetitive movements, particularly in individuals with a history of long-term use of dopamine receptor-blocking medications like antipsychotics or anti-nausea drugs. Diagnosis typically involves a detailed review of the patient’s symptoms, medical background, and medication history. Healthcare providers often use standardized tools, such as the Abnormal Involuntary Movement Scale (AIMS), to assess and track the severity of symptoms. While tardive dyskinesia is largely a clinical diagnosis, additional tests such as blood work or neuroimaging (CT or MRI scans) may be recommended to rule out other conditions with similar presentations, including Huntington’s disease. In most cases, however, a thorough physical exam and medical history are sufficient for diagnosis.

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

Tardive Dyskinesia Treatment

Treatment and management of tardive dyskinesia initially consists of discontinuing the neuroleptic drug as soon as involuntary facial, neck, trunk, or extremity movements are identified in people taking neuroleptic drugs if this is felt to be safe psychiatrically. Thus, switching to second-generation antipsychotic medication like clozapine may help. There are effective FDA-approved treatments for tardive dyskinesia are VMAT2 inhibitors which work by regulating dopamine release in the brain and are safe. GABA-enhancing agents, antioxidants, and in severe or refractory cases, deep brain stimulation (DBS) surgical treatment is considered when medications are ineffective or show significant side effects. Supportive therapies such as physical, occupational, or speech therapy can also improve functional outcomes and quality of life.

Tardive Dyskinesia Epidemiology

The tardive dyskinesia epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total prevalent cases of tardive dyskinesia, total diagnosed prevalent cases of tardive dyskinesia, severity-specific diagnosed prevalent cases of tardive dyskinesia and treatable cases of tardive dyskinesia in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034. 

• Tardive dyskinesia impacted at least 500,000 individuals in the US in 2024.
• About 60% to 70% of cases are mild, and about 3% are extremely severe cases of tardive dyskinesia.
• Prevalence of tardive dyskinesia has increased from 6.88 per 100,000 patients in 2016 to 11.53 per 100,000 in 2020.
• The annual incidence in patients older than 45 years is 15% to 30% after 1 year of treatment; the prevalence rate is about 50% to 60%.
• The average prevalence of tardive dyskinesia is estimated at least 20% of all patients treated with first-generation neuroleptics.
• Women risk developing tardive dyskinesia more than men, especially in middle-aged to senior patients. Post-menopausal women have incidence rates as high as 30% after almost a year of exposure to antipsychotic medications, suggesting estrogen may have an antioxidant effect protecting against tardive dyskinesia. 
• The occurrence of tardive dyskinesia is estimated to be 2–5% annually, and the condition occurs in 15–30% of those who receive long-term treatment with antipsychotic drugs (APDs).

Tardive Dyskinesia Drug Chapters

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

Marketed Drugs

AUSTEDO (deutetrabenazine) and AUSTEDO XR: Teva Pharmaceuticals

AUSTEDO is a VMAT2 inhibitor. The precise mechanism by which deutetrabenazine exerts its effects in the treatment of tardive dyskinesia is unknown but is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals.

• In July 2024, Teva Pharmaceuticals announced that the FDA approved the 18 mg dosage for AUSTEDO XR making it a one pill, once-daily option for all available doses in adults for tardive dyskinesia.
• AUSTEDO XR (deutetrabenazine) extended-release tablets was approved by the FDA on February 2023, in three doses of 6, 12 and 24 mg and became commercially available in the US in May 2023. 
• AUSTEDO was approved by the US FDA in 2017 for the treatment of tardive dyskinesia in adults. It is protected in the United States by 14 Orange Book patents expiring between 2031 and 2038.

INGREZZA/DYSVAL (valbenazine): Neurocrine Biosciences

INGREZZA is also VMAT2 inhibitor that blocks certain chemicals in the body that may be involved with involuntary muscle movement. INGREZZA is taken once daily, is well tolerated by most patients, and represents a targeted treatment option specifically developed for managing movement symptoms in tardive dyskinesia. The mechanism of action of the drug in the treatment of tardive dyskinesia is still unknown.

• In November 2024, Neurocrine Biosciences presented data from patients diagnosed with tardive dyskinesia and treated with INGREZZA (valbenazine) capsules which showed significant improvements in functional, social, emotional and health-related quality of life measures in Phase III and IV studies.
• In March 2022, Neurocrine Biosciences, announced that its collaboration partner, Mitsubishi Tanabe obtained regulatory approval of DYSVAL capsules 40 mg (valbenazine) for the treatment of tardive dyskinesia from the Japanese Ministry of Health, Labour and Welfare.
• It was approved by the US FDA in April 2017 for of tardive dyskinesia in adults.

Emerging Drugs

SOM3355 (bevantolol hydrochloride): SOM Biotech

SOM3355 is a β blocker with a novel mechanism of action representing a different class of molecule. SOM3355 was selected by SOM Biotech through its AI computer system SOMAIPRO, as a potent inhibitor of VMAT2 with distinct chemical structure and distinct interaction with the VMAT2 receptor than existing monoamine depleting agents. It is a medication that has been studied as a potential treatment for tardive dyskinesia. 

It is currently in Phase II trial of clinical development for the treatment tardive dyskinesia as per SOM Biotech’s pipeline. 

Note: Detailed therapy assessment will be provided in the full report of tardive dyskinesia

Drug Class Insights

Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor 

This class of drugs that work by blocking the VMAT2 protein, which is responsible for transporting neurotransmitters like dopamine, norepinephrine, and serotonin into synaptic vesicles for release into the synaptic cleft. By inhibiting VMAT2, these drugs reduce the amount of dopamine available for release, helping to balance abnormal dopamine signalling associated with movement disorders. This mechanism is particularly effective in treating conditions like tardive dyskinesia and Huntington’s disease, where excessive or dysregulated dopamine activity contributes to involuntary, repetitive movements. VMAT2 inhibitors such as INGREZZA (valbenazine) and AUSTEDO (deutetrabenazine) are currently FDA-approved for this indication, offering a targeted approach with fewer systemic side effects compared to traditional dopamine-blocking therapies.

β₁-adrenoceptor blocker 

β₁-adrenoceptor blockers selectively inhibit the beta-1 adrenergic receptors primarily found in the heart. These receptors are normally activated by norepinephrine and epinephrine, leading to increased heart rate, contractility, and cardiac output. By blocking these receptors, beta-1 blockers reduce heart rate, lower blood pressure, and decrease cardiac workload, making them useful in conditions like hypertension, angina, heart failure, and certain arrhythmias. Some β₁-blockers, like bevantolol (used in SOM3355), may also cross the blood–brain barrier and exhibit central nervous system effects, which is particularly relevant in their emerging use for movement disorders. 

Tardive Dyskinesia Market Outlook

Tardive dyskinesia is a syndrome that includes a group of iatrogenic movement disorders caused by the blockade of dopamine receptors. The movement disorders include akathisia, dystonia, buccolingual stereotypy, myoclonus, chorea, tics, and other abnormal involuntary movements, which are commonly caused by the long-term use of typical antipsychotics. 

Treatment of tardive dyskinesia therapeutics is highly individualized. Since, tardive dyskinesia therapeutics is caused by dopamine blockage, initial treatment includes gradual removal of the dopamine blocking agents. Many times, these agents cannot be removed, as these agents are used for a variety of illnesses (such as gastrointestinal and psychiatric). The doctor may switch the patient to a different antipsychotic that may lessen tardive dyskinesia therapeutics. 

 Many available treatments for tardive dyskinesia therapeutics offer some benefit to patients, but response to treatment depends on the patient. INGREZZA/DYSVAL (valbenazine) and AUSTEDO (deutetrabenazine) are FDA approved drugs used for treatment of tardive dyskinesia. Tetrabenazine is often useful for symptomatic treatment of tardive dyskinesia therapeutics and is currently available for use in the US.

Choline, lithium, bromocriptine, baclofen, methyldopa, valproate, clonidine, propranolol, amantadine, clonazepam, and nifedipine have occasionally been helpful but in most cases do not improve dyskinesia. Vitamin E use does not lead to clinically important improvements in tardive dyskinesia once it is established but may protect against deterioration of tardive dyskinesia symptoms. Other experimental drugs are being tested to reduce or eliminate the symptoms of tardive dyskinesia.

Tardive Dyskinesia drug uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025–2034, 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 analysis of emerging therapies' drug uptake in the report…

Tardive Dyskinesia Pipeline Development Activities

The report provides insights into different therapeutic candidates in the marketed and emerging stages. It also analyses key players involved in developing targeted therapeutics. 

Pipeline Development Activities

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

KOL Views

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 Medical/scientific writers, Professors, and Others.

DelveInsight’s analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as University of Glasgow, University of Washington School of Medicine, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or tardive dyskinesia market trends. 

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 analyses multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyse the effectiveness of therapy.

The analyst analyses multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.

In efficacy, the trial’s primary and secondary outcome measures are evaluated.

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.

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 Report

• The report covers a segment of key events, an executive summary, a descriptive overview of tardive dyskinesia, 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 treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborate profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the tardive dyskinesia 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 tardive dyskinesia market.

Tardive Dyskinesia Report Insights

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

Tardive Dyskinesia Report Key Strengths

• Ten-Year Forecast
• 7MM Coverage 
• Tardive dyskinesia Epidemiology Segmentation
• Key Cross Competition 
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Tardive Dyskinesia Report Assessment

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

FAQs

• What was the tardive dyskinesia total market size, the market size by therapies, market share (%) distribution in 2024, and what would it look like in 2034? What are the contributing factors for this growth?
• At what CAGR, the tardive dyskinesia market is expected to grow at the 7MM level during the study period (2020–2034)?
• How many key players are developing therapies for tardive dyskinesia?
• How will upcoming emerging therapies will going to impact the current market share?
• What are the disease risks, burdens, and unmet needs of tardive dyskinesia? 
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to tardive dyskinesia?
• What is the historical and forecasted tardive dyskinesia patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• What are the current options for the treatment of tardive dyskinesia? What are the current treatment guidelines for the treatment of tardive dyskinesia in the US and Europe?
• What are the country-specific accessibility issues of expensive, recently approved therapies? 
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• Which drug is the major contributor of tardive dyskinesia management market by 2034?

Reasons to Buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the tardive dyskinesia market.
• Insights on patient share/disease burden, 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 upcoming players in the market will help devise strategies to help get ahead of competitors.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand KOLs’ 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.