The total worldwide market for antipsychotic drugs is expected to reach $19.6 billion in 2010. With continued market penetration into new diseases and price increases for currently marketed antipsychotics, this market is expected to grow to a high of $20.8 billion in 2011 and then hit a low of $14.4 billion in 2013, before resuming growth again to $14.8 billion in worldwide sales for 2014. This represents a total compound annual growth rate (CAGR) of -4.6%.
Most atypical antipsychotics will lose patent exclusivity through the study period, resulting in a compound annual growth rate (CAGR) of -3.7%. This market will be worth an estimated $18.5 billion by the end of 2010, but decrease to $14.5 billion in 2014.
Antipsychotic drug sales are expected to remain strong in long-acting injectable (depot) formulations. Long-acting injectables are forecast to record a 16.6% compound annual growth rate (CAGR) during this time period, increasing from $1.5 billion in 2009 to $3.2 billion in 2014.
STUDY GOALS AND OBJECTIVES
BCC’s goal in conducting this study was to determine the current status of the antipsychotic drug market and to assess its growth potential over a 5-year period, from 2010 through the end of 2014.
Antipsychotic drugs all share the common trait that they able to reduce the symptoms of psychosis. They are most generally differentiated from one another by their mechanisms of action and side effect profiles. The first “typical” antipsychotic drugs were developed for schizophrenia in the 1950s and work primarily by strongly binding to and antagonizing dopamine receptors in the brain. The following 60 years up to today have seen multiple first-generation and then second-generation antipsychotics (known as atypical antipsychotics and characterized by binding to and antagonizing dopamine D2 receptors and serotonin 5-HT2A receptors) get approved for marketing throughout the world. Third-generation antipsychotics are only now just entering the market or in late stages of clinical development. Third-generation antipsychotics have a range of mechanisms of action such as dopamine D2 partial agonism, serotonergic modulation, or glutamatergic modulation, for examples.
Patent protection and marketing exclusivity for all typical antipsychotics has long-since passed and generic drug competition currently affects all typical antipsychotics and some atypical antipsychotics as well. In the 2011 to 2014 timeframe, competition from generic drugs will begin against almost all of the remaining atypical antipsychotics that haven’t yet lost marketing exclusivity.
There are many follow-on second-generation and novel third-generation antipsychotics currently in clinical and preclinical development for indications such as schizophrenia, bipolar disorder, depression, dementia-related psychosis, and agitation. If some of these agents make it to market, they could potentially fill in for lost sales when the atypical antipsychotics face further generic competition.
We have examined for each antipsychotic drug on the market, all antipsychotic drug candidates in mid- to late stages of development, and some in earlier stages of development (if the drug has a unique target). Where these compounds stand in the development process, the major challenges to their regulatory approval or market success, their competitive profile, and, if applicable, their projected sales through 2014 are presented.
We were particularly interested in profiling antipsychotics in phase II or III clinical studies or those with unique mechanisms of action. We also identify the leading antipsychotics by disease application, by formulation, and by geographic location. In some cases, we discuss notable antipsychotics that failed in clinical testing or were pulled from the market due to adverse event or other issues.
Our main objective is to present a comprehensive analysis of the current antipsychotic drugs market and its future direction.
REASONS FOR DOING THIS STUDY
Antipsychotic drugs are currently the largest class of pharmaceuticals by sales in the U.S. This may not last for much longer, though. A period of dynamic change in the antipsychotics market is expected with more than eight currently marketed atypical antipsychotics set to begin facing generic competition in the 2011–2015 timeframe. At the same time, several unique new molecular entities or formulations of already approved antipsychotics will be entering the market. New approaches to treating all the psychosis-related indications are being pursued by pharmaceutical companies, as many of them look to move beyond first- and second-generation antipsychotics. These potential new antipsychotics with novel mechanisms of action or improved delivery systems will provide powerful new options to currently prescribed antipsychotic drugs.
We have compiled detailed profiles of all the branded atypical and some typical antipsychotic drugs on the market in the U.S. and around the world. We also cover all antipsychotics in phase I, II, and III stages of clinical development and some unique antipsychotics in preclinical stage development. This study includes technical descriptions of antipsychotic drugs, discussion of their individual efficacy and side-effect profiles when possible, the diseases they treat, the major companies focusing on their development, and international aspects. We provide sales forecasts and the reasoning behind our forecasts for branded antipsychotics that are on the market already or that may enter the market through 2014.
This study will be of interest to members of the pharmaceutical, health care, and biotechnology industries. It will also be a valuable resource for investors in the pharmaceutical sector. It is written in such a way as to be accessible to an investor or business person while maintaining a high level of technical detail.
SCOPE OF REPORT
At the beginning of 2010, there were more than 18 atypical antipsychotics and at least 13 typical antipsychotics (and their derivatives) actively being sold on the worldwide market. The emphasis of this report is on these drugs and the more than 47 antipsychotics in various stages of development.
Special focus is placed on how new products and technologies will affect market leaders in the antipsychotic drug sector. Profiles are provided of companies projected to have antipsychotics on the market during the forecast period and on companies with rich antipsychotics pipelines.
Included in this report are forecasts for sales by product, company, geographic region, formulation, and indication (if possible) from 2010 through 2014, including supporting analyses for projections.
Market trends are assessed based on projected sales of new products being introduced, competitive advantages of emerging drug as well as other factors, such as increases in the prevalence of certain diseases.
The study is arranged to offer an overview of the antipsychotic drug market, including regulatory issues, and accompanied by detailed analyses and forecasts by product. Profiles of the many emerging competitors in this sector provide a comprehensive assessment of the various products and technologies entering this market as well as marketing strategies being used to gain a competitive edge.
The market assessments in this report have been assembled based on publicly available information through 20010-03-15. The base year for the report is 2008 and forecast data is provided through 2014. Market figures are based on current dollars, and inflation is not computed into the projection figures. Interviews were also used to adjust market size estimates as well as to formulate market projections.
The field of antipsychotic drug development is still evolving as new therapy targets are discovered and other targets prove futile in development. The reader is cautioned to use the report data as a guide to assess trends, developments, and challenges that the industry faces.
The information contained in this report has been assembled from both primary and secondary data. Primary research was conducted via in-person, telephone, and e-mail correspondences with selected industry professionals, research scientists, and laboratory heads to discover the most recent developments in their fields of interest. Secondary data was collected via a comprehensive search of the scientific, peer-reviewed literature, clinical trial reports, databases such as PubMed, industry trade media, company websites, annual reports, and industry press releases.
Brian Lawler has more than 4 years of experience working as an analyst covering the pharmaceutical and biotechnology industries. Trained at the University of Southern California, he holds a B.A. degree in economics.
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The information developed in this report is intended to be as reliable as possible at the time of publication and of a professional nature. This information does not constitute managerial, legal, or accounting advice; nor should it serve as a corporate policy guide, laboratory manual, or an endorsement of any product, as much of the information is speculative in nature. The author assumes no responsibility for any loss or damage that might result from reliance on the reported information or its use.
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