Last Updated 16 December 2015
Schizophrenia is an often disabling psychiatric disease whose core treatment consists of years up to a lifetime of treatment with antipsychotics (older typical antipsychotics or newer atypical antipsychotics). With at least nine different atypical antipsychotic molecules available in most major markets under study (United States, France, Germany, Italy, Spain, United Kingdom, Japan), as well as typical antipsychotic options, new entrants must differentiate themselves to garner a foothold in the market. Sales of premium-priced emerging therapies and the continued uptake of long-acting depot formulations of atypical antipsychotics will not overcome sales of top-selling antipsychotics lost to generic erosion during our 2014-2024 study period. The schizophrenia market will grow from nearly $6.5 billion in 2014 to over $6.6 billion in 2015 and remain relatively stable at approximately $6.5 billion through 2018, due to the launches and continued uptake of newer-to-market agents; however, in the latter half of the forecast period, major-market sales will decline to $6.0 billion in 2021 and remain at that level through 2024, owing to the generic erosion of key players across the major markets. Emerging therapies in development include two new atypical antipsychotics, Otsuka/Lundbeck’s brexpiprazole (Rexulti) and Allergan (formerly Forest Laboratories)/Gedeon Richter/Mitsubishi Tanabe Pharma’s cariprazine (Vraylar), and two new depot formulations of current antipsychotics, Janssen’s paliperidone palmitate (three-month formulation; Invega Trinza) and Alkermes’s aripiprazole lauroxil (Aristada).
Questions Answered in This Report:
- The schizophrenia market comprises up to 15 atypical antipsychotic molecules, at least nine of which are available in most major markets. As of 2014, the four most highly prescribed molecules (risperidone [Janssen’s Risperdal/Risperdal M-Tabs, generics], olanzapine [Eli Lilly’s Zyprexa/Zyprexa Zydis/Zyprexa Velotab, generics], quetiapine IR [AstraZeneca/Astellas’s Seroquel, generics], and aripiprazole [Bristol-Myers Squibb/Otsuka Pharmaceutical’s Abilify/Abilify Discmelt, generics]) are generically available in at least several markets under study, and most of the remainder will experience generics competition during our forecast period. How do interviewed experts differentiate among the numerous currently available options? What drives their choice of antipsychotic therapy? How has the recent generic availability of aripiprazole affected their prescribing habits? To what extent will the extensive—and growing—presence of generics affect the commercial potential of emerging branded antipsychotic therapies?
- Four long-acting injectable depot atypical antipsychotics were available in the base year of our study and are available in most major markets. We expect three new atypical antipsychotic depots to launch during the 2014-2024 forecast period: Janssen’s paliperidone palmitate three-month formulation (Invega Trinza), Alkermes’s aripiprazole lauroxil (Aristada), and Indivior’s risperidone depot (RBP-7000). What factors drive and what factors constrain the use of long-acting injectable depot antipsychotics? How will the overall use of depots be affected by emerging depot therapies? Which depot formulation will experience the greatest commercial success during the forecast period?
- The majority of schizophrenia patients suffer from some degree of cognitive impairment, and no current treatments improve these symptoms. Owing to a large number of late-stage failures, experts are skeptical that new therapies in development for the treatment of cognitive impairment associated with schizophrenia (CIAS) will be successful. What are interviewed experts’ opinions of the existing pipeline of therapies targeting CIAS? If a therapy were to gain approval in this indication, how do psychiatrists anticipate prescribing such a therapy? What hurdles remain, and will these obstacles be overcome in the near term?
- Interviewed experts continue to call for treatments to address the highly disabling negative symptoms of schizophrenia. However, the pipeline for therapies targeting the negative symptoms of schizophrenia is thin. What percentage of patients experience negative symptoms? How are patients’ negative symptoms managed today? What are interviewed thought leaders’ expectations for the future treatment of negative symptoms?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 32 country-specific interviews with psychiatrists, thought leaders, and experts on schizophrenia.
Epidemiology: Diagnosed prevalent cases of schizophrenia; diagnosed prevalent cases of schizophrenia with negative symptoms (“any” and “significant”); diagnosed prevalent cases of schizophrenia with residual positive symptoms (“any” and “significant”); diagnosed prevalent cases of schizophrenia with comorbid depression; diagnosed prevalent cases of schizophrenia with cognitive impairment.
Population segments in market forecast: Drug-treated schizophrenia patients.
Emerging therapies: Phase II: 15 drugs; Phase III: 3 drugs; registered: 1 drug; currently launched, but outside of base year: 3 drugs. Coverage of 11 select preclinical and Phase I products.
Joyce M. Spadafora, AML
Alana K. Simorellis, Ph.D.
Kristin Dorfman, M.P.H., M.S.