Japan Tardive Dyskinesia Therapeutics Market Size, Share & COVID-19 Impact Analysis, By Drug (Deutetrabenazine, Valbenazine, and Others), By Distribution Channel (Hospital Pharmacies and Retail Pharmacies), and Country Forecast, 2023-2030

The Japan tardive dyskinesia therapeutics market size was valued at USD 24.3 million in 2022. The market is projected to grow from USD 38.6 million in 2023 to USD 162.1 million by 2030, exhibiting a CAGR of 22.7% during the forecast period.

Tardive Dyskinesia (TD) is a movement disorder that occurs as a potentially serious adverse drug reaction to various psychotropic medications, especially antipsychotics. It is more commonly observed in patients treated with first-generation antipsychotics (FGAs) than with second-generation antipsychotics (SGAs), which are used for the treatment of psychiatric disorders.

The symptoms can be managed with the help of two drugs, as there is no known cure. The symptoms are managed through drugs belonging to the VMAT2 inhibitors (vesicular monoamine transporter-2 inhibitors) indicated to treat Huntington's disease or tardive dyskinesia. These two drugs are valbenazine and deutetrabenazine, which received approval from the U.S. Food and Drug Administration (FDA) in 2017 for this disease.

In the case of Japan, only valbenazine had received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of this condition in 2022. The approval status of the VMAT-2 inhibitors for this indication in Europe is inconsistent. Prolonged consumption of these medications increases the risk of tardive dyskinesia as a side effect.

The increasing prevalence of psychiatric disorders is expected to drive the demand for its treatment through medications such as antipsychotics. This is anticipated to drive effective therapeutic measures among psychiatric patients and surge the demand for approved medications indicated to treat this condition. Hence, the surge in demand for these drugs is likely to propel the market growth for tardive dyskinesia therapeutics during the forecast period.

COVID-19 IMPACT 

Drop in Hospital Visits During COVID-19 Led to a Slower Market Growth

The impact of COVID-19 was visible in the healthcare sector as health was at the center of this unprecedented challenge. Due to the lockdowns implemented during the COVID-19 pandemic, a significant decline was witnessed in hospital visits as there was a lack of availability of healthcare services and procedures unrelated to COVID-19 due to safety precautions. This served as an impediment in diagnoses and providing subsequent treatments to psychotic patients.

During the lockdown restrictions, the government authorities attempted to maintain access to psychiatric care. However, the treatment of some patients who needed appropriate drug therapies was hampered.

• For instance, before the pandemic, 3.7% of patients with newly treated major depressive disorder (MDD) in Japan were below the age of 20 in 2019, as opposed to 4.8% during the same period the following year. The prevalence of MDD slightly increased during the COVID-19 pandemic in Japan compared to pre-pandemic, as per the International Society for Pharmacoeconomics and Outcomes Research, Inc.

The pandemic also hampered pharmaceutical companies' business as the process of obtaining critical treatment slowed down due to the closure of healthcare facilities for non-emergency procedures during the pandemic.

However, as the lockdown restrictions were eased, the resumption of healthcare facilities for patients diagnosed with certain psychotic disorders occurred. In terms of drug approval, the regulatory authorities reviewed the pending or delayed clinical data to provide approvals and expand treatment options for movement disorders.

• For instance, in June 2022, Mitsubishi Tanabe Pharma Corporation launched the DYSVAL (valbenazine) capsules 40mg, the first medication approved in Japan for treating tardive dyskinesia.

Japan Tardive Dyskinesia Therapeutics Market Trends

Increased Transition from Off Label Treatments to Approved Treatments

For several decades, tardive dyskinesia was extensively considered as an untreatable drug-induced movement disorder associated with the pharmacotherapy of numerous psychiatric disorders resulting from the deployment of dopamine receptor-blocking agents, such as antipsychotics. The off-label treatments for this disease are dietary supplements, pharmacologic interventions, and non-pharmacologic treatment approaches available in Japan.

Before the approval of any medication for this disease, there was no fixed treatment, and the treatment regime usually involved lowering or reducing antipsychotic dosage or switching medications. However, these treatment approaches possessed a high risk of destabilizing the psychiatric condition of the patient population. Antioxidants and benzodiazepines are examples of some nonspecific interventions which were used.

The use of second-generation antipsychotics for the treatment of underlying mental health conditions reduced the risk of this condition. However, it did not eliminate it, leaving an unmet need for treatment for this disruptive movement disorder. In 2017, the treatment landscape for this disease significantly changed with the approval of vesicular monoamine transporter 2 (VMAT2) inhibitors by the U.S. FDA. The inhibitors offer treatment for involuntary movements and also help the encouragement of earlier intervention and diagnosis.

Japan Tardive Dyskinesia Therapeutics Market Growth Factors

Increasing Patient Population of Mental Disorders to Propel Market Growth

The tardive dyskinesia therapeutics market growth is driven by the increasing prevalence of psychiatric disorders in Japan. Psychiatric disorders such as schizophrenia, bipolar disorder, depression, anxiety, and others are treated with certain drugs such as antipsychotics, and the long term use of these medications leads to this condition as a side effect. 

• In a cross-sectional study published by the Journal of Medical Investigation in 2023, the prevalence of anxiety and depression was 43.9% and 69.4%, respectively, among Japan’s older adults.

The increasing patient population undergoing antipsychotic treatment is likely to increase the prevalence of this disease. This is anticipated to drive the demand for tardive dyskinesia therapeutics across the country during the forecast period.

Increasing Consumption of Antipsychotic Drugs to Drive Market Growth

Another factor responsible for driving the demand for tardive dyskinesia therapeutics is the growing consumption of antipsychotic drugs for the treatment of psychotic disorders. Antipsychotic drugs are commonly prescribed for schizophrenia, attention-deficit hyperactivity disorder (ADHD), epilepsy, and dementia, among others. The increasing prescription rate of antipsychotic medication among this patient population increases their risk of tardive dyskinesia.

• The proportion of Japanese patients receiving second-generation antipsychotics (SGA) has increased from 28.9% to 70.3% over the past 20 years in Japan, as per a study conducted in April 2021 and published in the Neuropsychiatric Disease and Treatment.

The use of antipsychotics is expanding, which may lead to an increased number of tardive dyskinesia patients. This is anticipated to surge the demand for therapeutic measures approved for the treatment of this condition. This will subsequently drive the market growth during the forecast period.

RESTRAINING FACTORS

Lack of Awareness Related to Tardive Dyskinesia to Limit Market Growth

One of the significant hindrances witnessed in the growth of tardive dyskinesia therapeutics is the lack of awareness about this disease and its limited treatment options among patients as well as among healthcare providers in Japan. A lack of awareness related to this condition will increase the burden of this disease and will also result in a restricted number of patients undergoing treatment. Furthermore, the stringent regulatory scenario limits the number of drugs approved for this condition, subsequently restricting the Japan tardive dyskinesia therapeutics market growth.

Moreover, there is a lack of approved drugs indicated for the treatment of this disease in Japan compared to other regions. For instance, valbenazine and deutetrabenazine were approved in the U.S. for the treatment of adults with TD in 2017. In contrast, valbenazine received approval in Japan for the treatment of TD in 2022. These potential barriers related to diagnosis, timely treatment, and monitoring of TD may limit the demand for tardive dyskinesia therapeutics, restricting the market growth.

Japan Tardive Dyskinesia Therapeutics Market Segmentation Analysis

By Drug Analysis

Single Drug Availability Led to Dominance of Valbenazine Segment in 2022

By drug, the market is segmented into valbenazine, deutetrabenazine, and others.

The valbenazine segment dominated the Japan tardive dyskinesia therapeutics market share in 2022. In Japan, only valbenazine is approved for the treatment of this disease. In March 2022, Neurocrine Biosciences, Inc., in collaboration with Mitsubishi Tanabe Pharma Corporation (MTPC), obtained the regulatory approval of DYSVAL capsules 40 mg (valbenazine) for the treatment of tardive dyskinesia from the Japanese Ministry of Health, Labour and Welfare. The growing focus of valbenazine manufacturers on collaborations with domestic players of Japan is majorly driving the growth of the segment. Moreover, its inclusion in the National Health Insurance Drug Price List has contributed to its future growth prospects.

Deutetrabenazine has not received approval in Japan for this disease till date. The use of deutetrabenazine has demonstrated significant improvements in the abnormal involuntary movement of patients suffering from this disease. Patients on deutetrabenazine have also demonstrated a safe and efficacious profile in its long-term use. These factors indicate that there are significant prospects for its approval in the near future.

Pipeline candidates are included in the others segment, which are estimated to be launched at the end of the forecast period. The rising prevalence of this disease is contributing to an increase in investment in the research and development of new drug candidates from established market players. This rising prevalence and growing awareness have brought opportunities for many new entrants to introduce new and innovative treatment options to the market, leading to its growth.

By Distribution Channel Analysis

Higher Distribution through Hospital Pharmacies Contributed to the Segment’s Dominance in 2022

On the basis of distribution channel, the market is classified into retail pharmacies and hospital pharmacies.

The hospital pharmacies segment accounted for the largest share of the market in 2022 due to the need to procure prescription tardive dyskinesia therapeutics from hospital pharmacies. Pharmaceutical drug products in Japan are mainly categorized into OTC drugs and ethical drugs. Most of the ethical drugs in Japan are distributed from pharmaceutical manufacturers to wholesalers and then supplied to hospitals and clinics in the nation. Drugs available for the treatment of this condition are prescription drugs and, hence, are likely to be distributed by hospital pharmacies, subsequently driving the segment growth.

The retail pharmacies segment is projected to grow comparatively at a lower CAGR over the study period. The increasing number of patient footfall seeking the treatment of neurological disorders is primarily driving the growth of the segment in the market. Moreover, an increase in the prescription rate of antipsychotics for the treatment of various psychotic disorders is contributing to the rising prevalence of this disease among the Japanese population. This contributes to an increase in the number of patients visiting their nearest pharmacist for their repeated dose.

List of Key Companies in Japan Tardive Dyskinesia Therapeutics Market

Sole Regulatory Approval Belonging to Mitsubishi Tanabe Pharma Corporation Led to its Market Monopoly in 2022

In terms of the competitive landscape, the market for tardive dyskinesia therapeutics in Japan was dominated by the Mitsubishi Tanabe Pharma Corporation (Mitsubishi Chemical Group Corporation). In the Japanese market, only valbenazine is approved for the treatment of this disease, which has led to its dominance in 2022. The company is focused on expanding its product presence across Asian countries by getting regulatory approvals for this disease.

Teva Pharmaceutical Industries Ltd. is likely to hold some share of the Japan tardive dyskinesia therapeutics market during the forecast period. The company’s product, Austedo (deutetrabenazine), is a deuterated drug, and the guidelines related to these drugs are inconsistent and are at a very nascent stage in the Japanese market. There are limited R&D investments for the treatment of this disease in the market. Some of the market players, such as Luye Pharma Group, which has a geographical presence in Japan, are investing in accelerating the development of its pipeline candidate for this indication, which is expected to capture some share by the end of the forecast period.

LIST OF KEY COMPANIES PROFILED:

• Teva Pharmaceutical Industries Ltd. (Israel)


• Neurocrine Biosciences, Inc. (U.S.)


• Mitsubishi Tanabe Pharma Corporation (Mitsubishi Chemical Group Corporation) (Japan)


• SOM BIOTECH (Spain)


• Luye Pharma Group (China)


• Janssen Pharmaceutical K.K. (Johnson & Johnson Services, Inc.) (Japan)

KEY INDUSTRY DEVELOPMENTS:

• September 2023: Neurocrine Biosciences, Inc. received acceptance for oral granules of INGREZZA from the U.S. FDA.  The company announced plans to introduce INGREZZA in a new sprinkle formulation for the treatment of tardive dyskinesia.


• May 2023: Teva Pharmaceutical Industries Ltd. launched AUSTEDO XR (deutetrabenazine), an extended-release tablet for the treatment of tardive dyskinesia (TD) in the U.S. This availability led to the expansion of the company’s product portfolio.


• January 2023: Mitsubishi Tanabe Pharma Corporation launched REMLEAS in Singapore. It is indicated for the treatment of tardive dyskinesia.


• June 2022: Janssen Pharmaceutical K.K. launched valbenazine, a drug indicated for the treatment of tardive dyskinesia. The drug received approval in Japan through Mitsubishi Tanabe Pharma. Janssen Pharmaceutical K.K. is a distributor and co-promoter of valbenazine in the Japanese market.


• December 2021: Janssen Pharmaceutical K.K. and Mitsubishi Tanabe Pharma Corporation signed a co-promotion agreement for MT-5199. This vesicular monoamine transporter type 2 inhibitor is intended for use as a treatment for tardive dyskinesia in Japan.

REPORT COVERAGE

The Japan tardive dyskinesia therapeutics market research report provides qualitative and quantitative insights into the market and a detailed analysis of the market size and growth rate for all possible segments. In addition to this, the report provides a detailed analysis of the market dynamics and competitive landscape. Various key insights presented in the report are the prevalence of the disease, 2022, pipeline analysis, key industry developments by key players, regulatory and reimbursement scenario, economic cost burden for the treatment of the disease, and the impact of COVID-19 on the market.

Report Scope & Segmentation