In the antipsychotic market, companies promoting the leading brands have found ways to differentiate their benefits, allowing them to compete successfully against both generics and other brands. Some of the most successful products have multiple indications, expanding the population of potential patients and extending patent protection.
PREVALENCE AND PERFORMANCE
While the conditions that each antipsychotic is approved to treat differ, the majority of these drugs are cleared for schizophrenia and/or bipolar disorder. The National Institute of Mental Health estimates that 1.1% of the U.S. adult population suffers from schizophrenia, and 2.6% of U.S. adults have bipolar disorder.
During the 12 months ending October 2011, more than 54 million prescriptions were filled for antipsychotics, generating approximately $12.6 billion in sales. While the majority (68%) of antipsychotic prescriptions were filled at retail pharmacies, a significant portion, 29%, was dispensed by long-term care pharmacies (Figure 1). As a comparison, only 9% of all prescriptions industry-wide were filled by long-term care pharmacies.
Most prescriptions for antipsychotics are filled by patients continuing on their current therapy. During the 12 months ending September 2011, 91% of prescriptions were filled by patients already taking the particular product. Six percent of prescriptions were filled by patients new to antipsychotic therapy; 3% were filled by patients switching to or adding a new antipsychotic medication.
FIRST-AND SECOND-GENERATION MEDICATIONS
The antipsychotic market consists of two groups of drugs, often referred to as typicals and atypicals, or first-generation and second-generation. Initially, the new atypical antipsychotics gained popularity because they were touted as causing fewer side effects—particularly tardive dyskinesia, marked by involuntary, tic-like movements of the facial muscles—than the first-generation products. Although some doubt now exists about that benefit, the newer-generation drugs continue to lead the market.
The first atypical, Clozaril, was introduced in the 1970s; Zyprexa, Risperdal and Seroquel followed in the 1990s. Geodon and Abilify were introduced in the early 2000s. The most recent launches in the market were Invega, in early 2007; Saphris, at the end of 2009; and Latuda, in the beginning of 2011. Although these medications have been grouped together as “atypicals,” their mechanisms of action differ.
In the 12 months ending October 2011, Seroquel* led the antipsychotic market with more than 17 million prescriptions, or almost 32% of the market total. Risperidone (the generic version of Risperdal) and Abilify followed with 23% and 16%, respectively, of all antipsychotic prescriptions. Zyprexa and Geodon rounded out the top five with prescription shares of 11% and 5%.
Haloperidol, or generic Haldol, the most popular first-generation antipsychotic, accounted for 5% of the market’s prescriptions. The newest atypicals—Invega, Saphris and Latuda—accounted for 1.7%, 0.5% and 0.2%, respectively.
In terms of sales, Seroquel led the market and Abilify followed closely, with each accounting for 32% of the market, or more than $4 billion, during the 12 months ending October 2011. Zyprexa, Geodon and Invega followed with 18%, 8% and 3%, respectively, of antipsychotic sales.
Seroquel has led the market in prescriptions for years, with Risperdal running a close second until its generic equivalent, risperidone, was introduced in mid-2008 (Figure 2). Interestingly, generic risperidone cannibalized Risperdal’s business but took longer to reach the brand’s typical monthly volume than new generics in other markets and has not negatively impacted the growth of other popular antipsychotics. Some of this can be explained by physicians’ tendencies in this market to hesitate to change a therapy if it is working for a patient. Even the small difference between a brand and its generic equivalent may be enough to give providers pause before altering therapy.
Since the introduction of risperidone, monthly Seroquel prescriptions have remained fairly consistent at around 1.3 million to 1.5 million. Abilify has grown steadily over the years—even after the arrival of risperidone. Abilify prescriptions in October 2011 were 29% higher than in July 2008, the month risperidone entered the market.
Zyprexa prescriptions have been declining for a while. Olanzapine, the generic equivalent, was introduced in October 2011.
REASONS FOR SUCCESS
Beyond the market dynamics that may hinder switching to a generic, actions taken by AstraZeneca and Otsuka/Bristol-Myers Squibb have boosted Seroquel and Abilify. First, and perhaps most important, both drugs have received approval to treat multiple diagnoses.
Seroquel is cleared to treat schizophrenia, a number of conditions related to bipolar disorder, manifestations of psychotic disorders, and major depressive disorder as an adjunct to antidepressants. Its most recent approval, at the end of 2009, expanded its indication for acute manic episodes associated with bipolar disorder to include pediatric patients.
Abilify has a number of the same indications as Seroquel and also is cleared for bipolar disorder as monotherapy, irritability associated with autistic disorders, and expanded uses for pediatric patients. The most recent indications for Abilify were obtained in February 2011, when different forms of the drug were approved to treat bipolar disorder as an adjunct to mood stabilizers.
By increasing uses for these products, the manufacturers expanded the number of patients who could be treated, in some cases extended patent protection, and provided more materials and messages for marketing.
Regarding marketing, Abilify and Seroquel are backed by the most promotion in this category. Overall, in the 12 months ending August 2011, more than $453 million was spent promoting antipsychotics through physician details, direct-to-consumer advertising, and professional advertising. Abilify led with over $174 million, or 38% of the market total (Figure 3). Most Abilify promotion was sponsored by Otsuka (77%); the rest was handled by Bristol-Myers Squibb (23%).
Thirty-four percent of promotion expenditures in this market, or almost $156 million, were for Seroquel. Saphris and Geodon followed with 7% and 5% shares, respectively, of spending to market antipsychotics.
Clearly, Seroquel and Abilify have performed well— even with the introduction of generic risperidone—in part because of the investments their marketers have made, both in promotion and to acquire expanded indications.
*Please note: Drug mentions include all forms of the product