BURLINGTON, Mass.--()--Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that sales for schizophrenia therapies will drop from $7.4 billion in 2011 to $6.5 billion in 2014 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Thereafter, the launch of premium-priced emerging therapies, coupled with an increase in the prevalent population (as a result of population growth), will drive the market to $8 billion by 2021. Polypharmacy rates will increase with the launch of a treatment for negative symptoms that will be used as an adjunctive to antipsychotics. Also, three of the most highly prescribed atypical antipsychotics—olanzapine (Eli Lilly’s Zyprexa/Zyprexa Zydis/Zyprexa Velotab, generics), quetiapine (AstraZeneca/Astellas’s Seroquel, generics) and aripiprazole (Bristol-Myers Squibb/Otsuka Pharmaceutical’s Abilify/Abilify Discmelt)—will have lost patent protection early in the forecast period, resulting in substantial sales losses through 2016.
“Interviewed experts are most interested in drugs with novel mechanisms of action, which include Roche/Chugai’s bitopertin, that have the potential to treat symptoms that are not well controlled by current therapies, such as negative symptoms.”
The Pharmacor advisory service entitled Schizophrenia also finds that, following Eli Lilly’s recent decision to discontinue development of pomaglumetad methionil, substantial need remains for a therapy to treat patients who experience suboptimal response to current therapies. Development of pomaglumetad methionil was discontinued after clinical trials failed to show efficacy for monotherapy treatment of schizophrenia and for adjunctive treatment of negative symptoms.
According to the findings, atypical antipsychotic depot sales will more than double from $1.4 billion in 2011 to $3 billion in 2021. This growth will be driven primarily by the launches of Otsuka/Lundbeck’s aripiprazole depot—which offers a better tolerated option to the depot market—and Janssen’s three-month formulation of paliperidone palmitate, which offers meaningful delivery advantages to physicians and patients. These new depot formulations will command premium pricing, and Decision Resources forecasts peak-year sales of at least $500 million in schizophrenia for aripiprazole depot and at least $1 billion in post-2021 peak-year sales for paliperidone palmitate three-month depot. Patient share for depot therapies is expected to grow slightly as new, more favorable options become available. However, psychiatrists’ and patients’ resistance to injections remains a substantial barrier to growth of depot patient share.
The findings also reveal that, owing to a plethora of available antipsychotics—most of which will become generically available in the next five years—new entrants to the schizophrenia market must effectively differentiate themselves to establish a foothold.
“While the unpredictability of patients’ individual responses to drugs drives frequent switching, a crowded market provides less opportunity for late-to-market entrants and greater barriers to market access as generics become increasingly entrenched on favorable formulary tiers,” said Decision Resources Analyst Anne-Elise Tobin, Ph.D. “Interviewed experts are most interested in drugs with novel mechanisms of action, which include Roche/Chugai’s bitopertin, that have the potential to treat symptoms that are not well controlled by current therapies, such as negative symptoms.”
Decision Resources expects bitopertin, a glycine transporter 1 inhibitor, to be the first approved treatment for negative symptoms of schizophrenia. Given that approximately two-thirds of schizophrenia patients experience significant negative symptoms and interviewed experts welcome a treatment for these symptoms, bitopertin is forecasted to achieve blockbuster status. However, opportunity will remain for additional treatments providing a variety of mechanisms of action to sufficiently address this top unmet need in this large and diverse patient population.
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