Last Updated 25 November 2014
Schizophrenia is an often disabling psychiatric disease whose core treatment consists of antipsychotic therapy lasting from years to a lifetime. With at least nine different atypical antipsychotic molecules available in most of the major markets under study (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) and many more typical antipsychotic options, new entrants must differentiate themselves to garner a foothold in the market. Sales of premium-priced emerging therapies will not overcome sales of top-selling antipsychotics lost to generic erosion during our 2013-2023 study period; however, the continued uptake of long-acting depot formulations of atypical antipsychotics will help stabilize the overall market. The schizophrenia market will grow from $5.9 billion in 2013 to $6.4 billion in 2017 as a result of launches and continual uptake of newer-to-market agents and continued uptake of long-acting depots, followed by a decline in sales to $6.1 billion in 2023 due to generic erosion of key players across the major markets. The most-promising therapies in development include two novel atypical antipsychotics (Otsuka/Lundbeck’s brexpiprazole and Actavis [formerly Forest Laboratories]/Gedeon Richter/Mitsubishi Tanabe Pharma’s cariprazine) and two new depot formulations of current antipsychotics (Janssen’s paliperidone palmitate [three-month formulation] and Alkermes’s aripiprazole lauroxil [ALKS-9070]).
Questions Answered in This Report:
- The schizophrenia market comprises up to 15 atypical antipsychotic molecules, at least nine of which are available in most of the major markets we cover. Three of the four most highly prescribed molecules (risperidone [Janssen’s Risperdal/Risperdal M-Tabs, generics], olanzapine [Eli Lilly’s Zyprexa/Zyprexa Zydis/Zyprexa Velotab, generics] and quetiapine IR [AstraZeneca/Astellas’s Seroquel, generics]) are generically available in most markets, and we expect many more will become generically available in our forecast period. How do interviewed experts differentiate among the numerous currently available options, and what drives their choice of antipsychotic therapy? To what extent will the extensive—and growing—presence of generic drugs affect the commercial potential of emerging antipsychotic therapies?
- Four long-acting injectable depot atypical antipsychotics are available in most major markets, and we expect two new atypical antipsychotic depots will launch during the 2013-2023 forecast period: Janssen’s paliperidone palmitate three-month formulation and Alkermes’s aripiprazole lauroxil (ALKS-9070). What factors currently drive and 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 most commercial success during the forecast period?
- Interviewed experts highlight the need for treatments that address the highly disabling negative symptoms of schizophrenia. However, following the high-profile failure of Roche/Chugai’s bitopertin and the discontinuation of Targacept’s TC-5619 program, the pipeline for therapies targeting the negative symptoms of schizophrenia is thin. How many patients experience negative symptoms? What are interviewed thought leaders’ expectations for the future of therapies targeting negative symptoms? How will companies address the significant unmet need to treat the negative symptoms of schizophrenia?
- The majority of schizophrenia patients suffer from some degree of cognitive impairment, and no treatments are available to 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. Which emerging CIAS therapies do interviewed experts consider the most promising? If a therapy were to gain approval in this indication, how do psychiatrists anticipate prescribing it? What hurdles remain, and will these obstacles be overcome in the near term?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 31 country-specific interviews with psychiatrists, thought leaders, and experts on schizophrenia.
Epidemiology: Diagnosed prevalent cases of schizophrenia; diagnosed prevalent cases of schizophrenia with comorbid depression; diagnosed prevalent cases of schizophrenia by cognitive impairment status; diagnosed prevalent cases of schizophrenia with negative symptoms (“any” and “significant”); diagnosed prevalent cases of schizophrenia with residual positive symptoms (“any” and “significant”).
Population segments in market forecast: Drug-treated schizophrenia patients.
Emerging therapies: Phase II: 12 drugs; Phase III: 4 drugs; preregistration: 3 drugs; coverage of 5 select preclinical and Phase I products.
Kristin Dorfman, M.P.H.