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

The tardive dyskinesia therapeutics market size was valued USD 2.33 billion in 2022 and is projected to grow USD 2.77 billion in 2023 to USD 5.09 billion by 2030, exhibiting a CAGR of 9.1% during 2023-2030. U.S dominated the global market with a share of 96.13% in 2022. Moreover, the U.S. tardive dyskinesia therapeutics market size is projected to grow significantly, reaching an estimated value of USD 4.36 billion by 2030, driven by increasing prevalnence of tardive dyskinesia.

Tardive Dyskinesia (TD) is a drug-induced movement disorder that causes involuntary movements of tongue, face, trunk and extremities. It is a side effect caused by the long-term usage of certain types of psychiatric medications, such as antipsychotics. The condition is most common in patients with schizophrenia, schizoaffective disorder, or bipolar disorder who have been prescribed with the long term use of antipsychotic medications, but they occasionally occur in other patients as well. The disease has no known cure, but its symptoms can be achieved with using two drugs that have been approved for this condition, valbenazine (INGREZZA) and deutetrabenazine (AUSTEDO). These drugs belong to the drug class of VMAT2 inhibitors (vesicular monoamine transporter-2 inhibitors) that are used to treat movement disorders such as Huntington's disease or tardive dyskinesia.

Tardive dyskinesia is widely prevailing in regions, such as Europe and North America, which bid a huge prospective for industry players to introduce and announce new drugs over the study period. According to an article published by John Wiley & Sons, Inc., in August 2022, the prevalence of tardive dyskinesia in Europe is 23.3% amongst psychiatric patients receiving treatment with antipsychotics. Government authorities, associations, and private market players are introducing initiatives to increase awareness regarding supportive measures implemented for this condition. For instance, the HealthWell Foundation is a non-profit organization that offers financial support to adults and children to pay for expenses associated with prescription drugs such as coinsurance, copayments, deductibles, health insurance premiums, and other out-of-pocket health care costs. This will lead to increase in demand for therapeutic measures and growth of the market during the study period.

COVID-19 IMPACT 

Reduction in the Number of Hospital Visitations During Pandemic Led to Reduced Market Growth

At the time of COVID-19, there was a decline in healthcare services and procedures which were non-COVID related and it was witnessed due to the restrictions imposed owing to safety concerns. This was specifically related to rare conditions, such as tardive dyskinesia, which witnessed hindrances in terms of the number of diagnosis and subsequent treatment. Despite the attempt to maintain access to diagnostics, the treatment of some patients who needed appropriate drug therapies was hampered due to lockdown restrictions. The process of approving treatments had slowed down and the overall number of prescriptions for this disease decreased due to the closure of non-emergency business, which was a significant deterrent for pharmaceutical companies.

• For instance, Teva Pharmaceutical Industries Ltd. observed a slower growth for AUSTEDO in terms of sales. AUSTEDO displayed an annual growth with 102.5% for 2018-2019 and 54.6% for 2019-2020.

This growth continued in FY2021, however at a slower rate compared to pre-pandemic level. The steady growth of these products is attributed to the continuous expansion in various regions across the globe by getting regulatory approvals.

• The revenues generated by INGREZZA, a U.S. FDA approved product of Neurocrine Biosciences, Inc., has showcased an incline of 31.9% during FY 2019-2020 whereas the year on year growth was 8.9% in FY 2020-2021.   

However, the increasing telehealth usage in place of ‘in-person’ hospital visits has minimized the adverse impact on key markets during pandemic. This increased use of telehealth services has led to a surge in the sales of products associated with the treatment of rare diseases. For instance, the number of prescriptions for AUSTEDO drug rose significantly, from 156,994 in 2021 to nearly 240,527 in 2022. Such trends showcase that the market is poised to witness steady growth during the forecast period.

LATEST TRENDS

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Surge in Initiatives to Increase Patient Engagement by Innovative Campaigns

A prevailing market trend witnessed in the global market is the rise in initiatives of market players to increase awareness regarding treatment of this condition through various campaigns. Currently, the only two drugs approved for this indication are deutetrabenazine (AUSTEDO) and valbenazine (INGREZZA), which are products of Teva Pharmaceutical Industries Ltd. and Neurocrine Biosciences, Inc., respectively. These market players are increasing their customer base for their drugs by introducing innovative campaigns to guide about the symptoms associated with this condition, which will lead to increase in patient engagement in their treatment process.

• In April 2021, Teva introduced its first consumer campaign and pushed its marketing strategy for AUSTEDO to reach out to more people with TD conditions. The trend of Direct-to-Consumer (DTC) initiatives for limited patient populace suffering from rare diseases, such as tardive dyskinesia, continues to grow with INGREZZA.

These surge in initiatives made by market players as well as public organizations are contributing to increased awareness amongst the patient populace about therapeutic measures available for this condition. This will drive the adoption rate of these drugs leading to the tardive dyskinesia therapeutics market growth.

DRIVING FACTORS

Rising Prevalence of Tardive Dyskinesia to Propel the Market Growth

One of the critical drivers that positively impacts the global market is the extensive increase in global prevalence of this condition. It is a type of movement disorder that can occur as a side effect of long-term usage of certain types of psychiatric medications such as antipsychotics. With the increasing usage of antipsychotic drugs in the treatment of schizophrenia, schizoaffective disorder, and bipolar disorder, the prevalence of this disease is also increasing. 

• According to a press release of Teva Pharmaceutical Industries Ltd., in May 2020, the prevalence of tardive dyskinesia in China is reported to be high, with a rate of 33.7% among individuals with schizophrenia who are receiving long-term treatment with antipsychotics. This means that up to a third of patients with schizophrenia who are treated with these medications may develop this condition as a side effect.

Increase in prevalence will propel the demand for more effective therapeutics measures for this disease, which will drive the market growth during the forecast period.

Rising Government Initiatives to Surge Awareness for the Disorder In order to Boost Market Growth

The rising prevalence of this disease has stimulated many countries to launch government programs to increase awareness with a primary purpose to educate the public and healthcare professionals about the cause of condition, symptoms, and available treatment options.

• For instance, in May 2022, the U.S. government organized the tardive dyskinesia awareness week in the first full week of May. In this awareness program, all 50 states and the District of Columbia of the U.S. have participated to increase the awareness of this orphan disease and often misunderstood condition. During this time, the U.S. government enhanced their collaborative effort to advocate for approximately 600,000 individuals in the U.S. impacted by this condition. The increase in government initiatives is expected to boost the market growth during the forecast period.

RESTRAINING FACTORS

Limited R&D Investment by Pharmaceutical Companies May Hinder the Market Growth

One of the major challenges of rare disease drugs in terms of research and development is the small patient population available for clinical trials. Rare diseases affect a small number of people out of which only a few hundred or a few thousand patients are available for a clinical trial. This can make it difficult to conduct large-scale, randomized, and controlled trials that are typically required to prove the efficacy of a new treatment. Moreover, the pharmaceutical companies may be hesitant to invest in research due to the high costs and uncertain returns on investment. Developing new treatments for this condition is a costly and time-consuming process. The high costs of research and development and regulatory approval for this condition may make it less attractive for investment by the pharmaceutical companies.

• According to the 2021 annual report of Neurocrine Biosciences, Inc., the company allocated USD 328.1 million toward the research and development of products, but only a portion of that, specifically USD 50.5 million, which was invested in the research and discovery process.

Limited focus of market players in R&D investment and introduction of alternatives to these drugs may slow down the market growth in the forecast period.

SEGMENTATION

By Drug Analysis

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Valbenazine Segment Dominates the Market Due to High Adoption Rate in 2022

On the basis of drug, the market is categorized into deutetrabenazine, valbenazine, and others.

Valbenazine segment dominated the global tardive dyskinesia therapeutics market share in 2022. The segment’s growth is mainly driven by its strong presence in the United Satets Moreover, the company is focusing on expanding its customer base by conducting various awareness campaigns. In August 2020, Neurocrine Biosciences launched the education campaign called “Talk about TD”. Through these television campaigns ads, the company is spreading awareness about this rare disease digitally. Such initiatives made by market players for increasing awareness of such unusual diseases will propel a higher adoption, which is expected to back to the market growth during the study period.

The deutetrabenazine segment held the second largest market share in 2022. The drug has received approval in countries such as China and Brazil which has led to a higher adoption rate amongst the patient population. In October 2021, Teva Pharmaceutical Industries Ltd. received marketing approval in Brazil for treatment of Huntington’s disease and tardive dyskinesia therapeutics. Such regulatory approvals are expected to fuel the segment’s growth.

The others segment includes pipeline candidates and tetrabenazine, which will display stable growth over the forecast period, after their potential introductions in the market.

By Distribution Channel Analysis

Higher Obtaining of Therapeutics From Hospital Pharmacies Allowed Segment Dominance in 2022

Based on the distribution channel, the market is categorized into drug stores, online pharmacies, hospital pharmacies, and drug stores & retail pharmacies.

Hospital pharmacies segment had the largest part in the 2022 for the global market as the need for the procuring the prescription therapeutics from hospital pharmacies arose. The governance of the segment is characterized by the fact that the regulatory systems for pharmacies in countries such as the U.S. favor the dominance of hospital pharmacies, which further strengthens their preference among patients.

The segment for drug stores & retail pharmacies held the prevalent market share after hospital pharmacies in 2022 with these settings for the obtaining of prescription refills.

The segment for online pharmacies is set to experience maximum CAGR during the forecast period due to the amplified rate of adoption of digital pharmaceutical platforms, which makes the medication procurement process easy by delivery at the doorstep.

REGIONAL INSIGHTS

Geographically, the global market is studied across the U.S., Asia Pacific, Europe, and the Rest of the World.

The U.S. market was valued at USD 2.24 billion in 2022 and is likely to govern the market at the time of study period due with considerable awareness in the population regarding the disease and increasing support from many public and private establishments using research endowments to fasten the study for this disease. For instance, as per the article published by the National Alliance on Mental Health (NAMI) in August 2022, 42 organizations, including the NAMI Champaign that are part of NAMI Affiliates and NAMI State Organizations, received a grant of USD 2,500 each. This mini grant is used to educate people about TD and how it affects an individual’s daily life. Such initiatives are likely to contribute to the market progress during the forecast period.

The Europe market is expected to grow at the highest CAGR during the forecast period due to rising prevalence of this condition across the region, which will lead to the increase in demand for its treatment. According to a research paper published by the journal Psychiatry and Clinical Neurosciences in August 2022, the prevalence of TD was estimated at 23.3% in Europe. This will offer a lucrative opportunity for the market players to launch novel products during the forecast period.

The Asia Pacific region held the second largest market share in 2022. The growth in this region is primarily attributed to increasing research and development activities to provide effective treatment solutions for this condition. In August 2021, Mitsubishi Tanabe Pharma Corporation received approval from Thailand for valbenazine as tardive dyskinesia therapeutics. Such approvals in Asian countries will increase the adoption rate for these treatment measures across the region.

The rest of the world, which includes the Middle East & Africa and Latin America, demonstrates slower growth in the forecast period due to limited healthcare expenditure and lack of awareness among people about the diagnosis and treatment of this disease.

KEY INDUSTRY PLAYERS

Neurocrine Biosciences, Inc. Dominated the Market in 2022 Due to Strong Product Sales

In terms of the global tardive dyskinesia treatment market competitive landscape, Neurocrine Biosciences, Inc., dominated the market, owing to strong sales exhibited by its approved product INGREZZA (valbenazine) in the U.S. market. The company is also focused on getting regulatory approvals to expand its product presence. Teva Pharmaceutical Industries Ltd., is another dominant player of the market. In 2017, approved by U.S. FDA, AUSTEDO (deutetrabenazine) is the drug which has experienced steady growth. The company is focused on increasing awareness among TD patients regarding its product offering through the introduction of innovative campaigns.

Some other key players of the market include Mitsubishi Tanabe Pharma Corporation, which is focusing on getting regulatory approval for its DYSVAL (valbenazine) product for TD in Asian countries. Furthermore, there are several market players that are conducting clinical trials to develop and introduce novel drugs for tardive dyskinesia therapeutics. Some of them include SOM Biotech (Spain) and Luye Pharma Group (China). The pipeline candidates of these companies will occupy a significant proportion of the market in the future. Hence, cumulatively all these factors are expected to drive the global market.

LIST OF KEY COMPANIES PROFILED:

• SOM BIOTECH (Spain)


• Luye Pharma Group (China)


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


• Teva Pharmaceutical Industries Ltd. (Israel)


• Neurocrine Biosciences, Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• March 2022: The Ministry of Health, Labor and Welfare has granted regulatory approval to Mitsubishi Tanabe Pharma Corporation for the use of DYSVAL capsules 40mg, a vesicular monoamine transporter type 2 (VMAT2) inhibitor, as tardive dyskinesia therapeutics.


• December 2021: Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical K.K. have entered into a co-promotion agreement for MT-5199, a vesicular monoamine transporter type 2 (VMAT2) inhibitor, which is intended for use as tardive dyskinesia therapeutics in Japan.


• November 2021: Mitsubishi Tanabe Pharma Corporation received approval from South Korea for Valbenazine (INGREZZA) as tardive dyskinesia therapeutics.


• September 2021: Luye Pharma Group announced that its next-generation Vesicular Monoamine Transporter 2 (VMAT2) inhibitor drug LY03015 has been granted permission for clinical trials as a Class 1 new drug for the indication in TD by the Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.


• May 2020: Teva Pharmaceutical Industries Ltd. received authorization for AUSTEDO from the China National Medical Product Administration (NMPA) for the treating chorea related to Huntington’s disease and tardive dyskinesia in adults.

REPORT COVERAGE

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The research report provides qualitative and quantitative insights on the global market and a detailed analysis of global market size & growth rate for all possible segments in the market. Along with this, the report provides an elaborative analysis of the market dynamics and competitive landscape of tardive dyskinesia therapeutics. Various key insights presented in the report are the prevalence of the disease, by key countries, key industry developments, pipeline analysis, economic cost burden for the treatment of the disease, regulatory and reimbursement scenario, by key regions, and the impact of COVID-19 on the market.

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