Global Schizophrenia Disease Analysis and Market Report 2020-2027: Uptake of LAIs will Flourish and Drug Developers will Reap the Rewards - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Schizophrenia Disease Coverage" report has been added to ResearchAndMarkets.com's offering.

Schizophrenia is a serious mental illness characterized by incoherent thoughts, bizarre behavior, and delusions or hallucinations. The American Psychiatric Association (APA) defines schizophrenia as a chronic brain disorder which actively presents with delusions, hallucinations, lack of motivation, and issues with thinking and concentration

The report estimates that in 2018, there were 23.6 million 12-month prevalent cases of schizophrenia in those aged 15 years and older worldwide, and forecasts that number to increase to 26.8 million cases by 2027.

There have been a number of recent impactful clinical trial data announcements in the schizophrenia space. One of these was the revival of the Nuplazid's hopes in schizophrenia with promising results from a Phase II trial focused on the negative symptoms of the disease. Conversely, Minerva released mixed results for its negative symptom prospect, MIN-101, that have plunged the drug's potential into uncertainty. In addition, impressive pivotal trial results from Alkermes' ALKS 3831 in late 2018 have provided a strong case for approval of the drug, and the FDA's advisory committee agreed with these benefits, though the FDA's issuance of a complete response letter (based on a manufacturing issue) has postponed likely approval.

The current dynamics of the antipsychotic market show domination by atypical antipsychotics, typically oral agents, but there is an increasing uptake of long-acting injectable (LAI) neuroleptics, which will continue. Oral atypical antipsychotics that were historical blockbusters are now facing intense generic erosion. The highest-selling oral antipsychotic is Latuda, one of the newer atypical drugs, but its market exclusivity is only set to last until 2023.

Other newly marketed and pipeline antipsychotics look likely to maintain growth of the oral antipsychotic segment. The demand for both Rexulti and Vraylar, patent protected until 2029 and 2028, respectively, looks set to continually increase over this decade. Considering the approaching genericization of oral market leader Latuda, Rexulti and Vraylar are anticipated to take over as key branded products. Vraylar could even become an unprecedented treatment option for the negative symptoms of schizophrenia.

Interestingly, the most advanced pipeline neuroleptics - ALKS 3831, MIN-101, and Nuplazid - are all orally administered therapies. However, their respective drug developers differentiate them from the highly genericized oral antipsychotic market by positioning them as drugs directed at the unmet needs of the indication, namely increased tolerability (reduced weight gain) and targeting the underserved negative symptom domain.

Invega Sustenna and Trinza remain highly competitive, with patent expiry and loss of exclusivity not destined to occur for over another decade. In addition to succeeding Invega with a combined wealth of real-world data, these LAI formulations are highly appealing in the schizophrenia market since poor medication compliance rates are seen all too commonly.

Furthermore, Johnson & Johnson plans to introduce a longer six-monthly formulation to the market next year, which would be a first of its kind in schizophrenia, further tackling non-compliance for longer periods and reducing the burden of frequent healthcare visits for patients.

Key Topics Covered:

OVERVIEW

DISEASE BACKGROUND

• Definition
• Patient segmentation
• Risk factors
• Diagnosis

TREATMENT

• Pharmacological versus non-pharmacological therapy
• Drug approaches

EPIDEMIOLOGY

• Prevalence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

• Blame It On COVID: Alkermes CRL Tied To Remote Site Inspections
• Submission Of sNDA For Paliperidone Palmitate 6-Month To Treat Schizophrenia
• Alkermes' Antipsychotic Clears US FDA Panel Amid Calls For Broader Professional Education Plan
• CHMP Recommends Paliperidone for Schizophrenia

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

• BI Finds Right Fit For Digital Therapeutic Partnership With Click
• Autifony Regains Kv3 Modulator Program From BI
• Reviva Merges With Tenzing For Approximately $119m
• Neurocrine Takes Over Neuropsychiatric Assets From Takeda
• Vanderbilt Gets $10m Up Front In Neurology Deal With Acadia

CLINICAL TRIAL LANDSCAPE

• Sponsors by status
• Sponsors by phase
• Recent events

DRUG ASSESSMENT MODEL

• Oral antipsychotics
• LAI antipsychotics
• Pipeline drugs

MARKET DYNAMICS

FUTURE TRENDS

• Uptake of LAIs will flourish and drug developers will reap the rewards
• Fresh uptake of atypicals will return the oral market to growth
• Widespread genericization will erode numerous key brands' market shares

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

• MIN-101 (Minerva) for Schizophrenia (December 1, 2020)
• ALKS 3831 for Schizophrenia (October 9, 2020)
• ALKS 3831 for Schizophrenia (October 7, 2020)
• BI-425809 for Schizophrenia (September 14, 2020)
• BXCL501 for Schizophrenia (July 20, 2020)
• ALKS 3831 for Schizophrenia (May 31, 2020)
• MIN-101 (Minerva) for Schizophrenia (May 29, 2020)
• Basmisanil for Schizophrenia (December 31, 2019)
• Nuplazid for Schizophrenia (November 25, 2019)
• KarXT for Schizophrenia (November 18, 2019)
• Geodon (Oral and IM) for Schizophrenia (September 6, 2019)
• Caplyta for Schizophrenia (July 25, 2019)
• Caplyta for Schizophrenia (July 23, 2019)
• Nuplazid for Schizophrenia (July 22, 2019)
• Multiple Drugs for Schizophrenia (June 25, 2019)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

• While patients may be slow to accept LAIs, KOLs would like to increase adoption
• ALKS 3831 could be prescribed over olanzapine due to the reduced weight gain profile reported for the drug
• Antipsychotics still fall short in various areas of schizophrenia treatment

UNMET NEEDS

• Drugs that effectively treat the negative symptoms of schizophrenia
• Drugs with enhanced tolerability profiles
• Improved options for treatment-resistant schizophrenia
• Treatments targeting the cognitive deficits associated with schizophrenia
• Drugs that address non-compliance

BIBLIOGRAPHY

• Prescription information

APPENDIX

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