[Report] Schizophrenia Market Research, Trends, Analysis TOC

ABOUT DATAMONITOR HEALTHCARE
- About the CNS pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the schizophrenia market
- Key metrics
CHAPTER 2 PATIENT POTENTIAL
- Etiology of schizophrenia
- DSM-IV defined symptoms of schizophrenia
- A - Characteristic symptoms
- B - Social/occupational dysfunction
- C - Duration
- D - Schizoaffective and mood disorder exclusion
- E - Substance/general medical condition exclusion
- F - Relationship to a pervasive developmental disorder
- Classification of schizophrenia
- Epidemiology of schizophrenia
- Schizophrenia affects 1% of the population
- Comorbidities of schizophrenia
- Anxiety is the most prevalent comorbidity of schizophrenia
- Substance and alcohol abuse is frequently observed in schizophrenia
- Depression affects a third of schizophrenia patients
- Diagnosis rates of schizophrenia
- Unmet needs in schizophrenia
- Improving patient compliance is key
- Lack of insight into schizophrenia, and the management thereof, are the most frequent reasons for patient noncompliance
- Increased public and physician awareness and education
- The importance of identifying a market niche before launch
- Greater efficacy with fewer side-effects
- A need for drugs targeting negative and cognitive symptoms, and partial-responders
- Long-acting depots and patch technology are favored to improve patient compliance
CHAPTER 3 R&D APPROACH
- Classification of marketed and pipeline products
- Serotonergic and dopaminergic receptor antipsychotics
- Dopaminergic antipsychotics
- Dopamine antagonists
- Dopamine agonists
- Serotonergic antipsychotics
- Serotonin antagonists
- Serotonin agonists
- Novel antipsychotics
- Alpha 2 adrenoceptor antagonists
- Glutamate (AMPA and NMDA) and glycine receptor modulators
- Cannabinoids
- Cyclooxygenase-2 inhibitors
- Monoaminergic antipsychotics
- Muscarinic M(1) receptor agonists
- Neurokinin 3 (NK3) receptor antagonists
- Nicotinic acetylcholine receptor modulators
- Secretin
- Clinical trials and drug development
- Clinical trial endpoints and schizophrenia rating scales
- Positive and Negative Syndrome Scale
- Brief Psychiatric Rating Scale
- Brief Assessment of Cognition in Schizophrenia
- Neuropsychological Assessment Battery
- Other tests
- A number of other tests are used in the diagnosis and monitoring of patients during general treatment management and for the duration of clinical trials:
- Clinical trial design guidance
- MATRICS recommendations for the clinical trial design for cognition enhancing drugs in schizophrenia
- Key research recommendations
- Increased focus on cost containment
- Improved quality of life
CHAPTER 4 PIPELINE DRUG ANALYSIS
- Pipeline overview
- Approved drugs yet to be launched
- Drugs in pre-registration
- Pipeline drugs in Phase III
- Pipeline drugs in Phase II
- Pipeline drugs in Phase I
- Key companies involved in the development of novel schizophrenia therapeutics
- J&J's schizophrenia franchise will decline from 2008 onwards despite the launch of paliperidone
- Lundbeck's experience with marketing sertindole will provide a strong base from which to launch bifeprunox
- Organon's asenapine will be an exciting entrant to the schizophrenia market
- Pfizer's schizophrenia franchise will continue to grow through 2011
- Dainippon-Sumitomo's blonanserin will first launch in Japan, despite competing with the recently launched Abilify
- GSK's antipsychotic pipeline drugs are unlikely to have a significant impact on the schizophrenia market
- Methodology of Datamonitor's competitive positioning analysis
- Gold standard antipsychotic
- The market value is calculated using IMS diagnosis value
- Forecast caveats
CHAPTER 5 LATE-STAGE PIPELINE DRUG ANALYSIS AND FORECASTS
- Paliperidone
- Clinical trial data
- Study 1
- Study 2
- Study 3
- Study 4
- Study 5
- Study 6
- Completed trials
- Ongoing clinical trials
- Physicians not overly impressed with paliperidone therapeutic profile
- Paliperidone IM - an improvement over Risperdal Consta?
- Risperdal patent expiry and switch to paliperidone over generic risperidone
- How will J&J price paliperidone IM compared to Risperdal Consta
- Paliperidone ER will be the next entrant to the US market in H2 2006
- Intramuscular Zyprexa
- Clinical trial data
- Ongoing clinical trials
- Zyprexa's undesirable side-effect profile will limit the uptake of the long-acting IM formulation
- Intramuscular Abilify
- Clinical trial data
- Study 1
- Study 2
- Study 3
- Study 4
- Study 5
- Completed clinical trials
- Abilify IM may lead to increased use of Abilify as a first-line maintenance therapy
- Abilify needs to demonstrate strong efficacy in a head-to-head study
- Multiple IM doses within a 24-hour period may limit use of Abilify IM compared to other IM formulations
- How will Abilify IM be priced?
- BMS/Otsuka should consider a long-acting IM version of Abilify
- Sertindole
- Clinical trial data
- Study 1
- Study 2
- Study 3
- Study 4
- Study 5
- Other clinical studies
- Physicians not impressed with sertindole's tolerability despite new data
- Sertindole will be the next entrant to the EU market in H2 2006
- Asenapine (Org-5222)
- Clinical trial data
- Study 1
- Study 2
- Study 3
- Study 4
- Ongoing clinical trials
- Asenapine's potential in treating negative symptoms will be a key therapeutic and commercial advantage
- Twice daily dosing of asenapine may limit uptake
- Asenapine will be the leading market entrant in terms of revenue value by 2015
- Bifeprunox
- Clinical trial data
- Study 1
- Additional clinical trial data
- Completed clinical trials
- Ongoing clinical trials
- Bifeprunox's tolerability is a key therapeutic and commercial attribute
- Bifeprunox unlikely to be used for acute psychosis, but may have a niche in first episode psychosis
- Bifeprunox's pharmacokinetic profile is suitable for once-daily dosing, with a potential for numerous reformulation strategies
- Solvay and Wyeth's experience in psychiatry and Lundbeck's launch of sertindole will provide a strong base for the commercialization of bifeprunox
- Bifeprunox will be the second-highest new entrant in terms of cash value to the schizophrenia market by 2015
- Blonanserin
- Clinical trial data
- Study 1
- Study 2
- Blonanserin demonstrates no clear advantages over marketed or pipeline schizophrenia drugs
- Almirall's limited commercial presence in the EU, and lack of presence in the US will limit uptake of blonanserin outside of Japan
- Blonanserin will receive its strongest uptake in the Japanese market
- Seroquel SR
- Clinical trial data
- Ongoing clinical trials
- Seroquel SR unlikely to provide significant differentiation from Seroquel
- Seroquel will retain patent protection until 2011, safeguarding the initial uptake of Seroquel SR from generic quetiapine
- Will US health insurers pay the increased costs for the SR formulation?
- Seroquel SR is not expected to receive a strong uptake, and revenues will decline from 2012 onwards
- Iloperidone
- Clinical trial data
- Ongoing clinical trials
- If approved, QT will limit iloperidone uptake as a first-line therapy
- Iloperidone offers no therapeutic advantage over marketed or pipeline schizophrenia drugs
- Iloperidone will receive limited uptake in the US
CHAPTER 6 PHASE II PIPELINE DRUG ANALYSIS
- Introduction
- ABT-089
- Clinical trial data
- Nicotinic agonists which improve cognitive functioning and smoking cessation would be valuable in the management of schizophrenia
- ACP-103/ACP-104
- ACP-103 clinical trial data
- Study 1
- Study 2
- Study 3
- Other trial data
- Ongoing clinical trials
- There is little need for an adjunct to improve positive symptoms, as marketed drugs already treat this domain of schizophrenia
- ACP-104 clinical trial data
- Study 1
- Other trial data
- Ongoing clinical trials
- ACP-104 would be a significant treatment advance if it can demonstrate cognitive enhancement without the side effects of clozapine
- AVE-1625
- Dihydrexidine
- Idazoxan
- Clinical trial data
- Study 1
- Idazoxan is unlikely to be a standalone therapy, but may have a niche in treatment-resistant schizophrenia
- Lurasidone
- Clinical trial data
- Completed clinical trials
- Ongoing clinical trials
- Lurasidone - another me-too atypical, and therefore of limited therapeutic and commercial potential
- LY2140023
- Ocaperidone
- Clinical trial data
- Study 1
- Other clinical trial data
- J&J may choose to relicense ocaperidone from Neuro3d if ocaperidone performs well in Phase II trials
- Org-24448
- Org-24448 may have potential in treating cognitive functioning
- RG1068
- Clinical trial data
- Study 1
- Other clinical trial data
- Ongoing clinical trials
- The subcutaneous formulation is unlikely be well received by patients
- Sabcomeline
- 773812 (SB-750093A)
- Clinical trial data
- Completed clinical trials
- Ongoing clinical trials
- SCA-136
- Clinical trial data
- Ongoing clinical trials
- SGS518
- Clinical trial data
- Study 1
- Study 2
- Commercial and patient potential
- Talnetant
- Clinical trial data
- Study 1
- Other study data
- Completed clinical trials
- Ongoing clinical trials
- Pharmacokinetic profile may hamper talnetant's clinical development
CHAPTER 7 FUTURE TREATMENT OF SCHIZOPHRENIA
- Future treatment of schizophrenia
APPENDIX A
- Forecast revenues
- Competitive positioning analysis of pipeline schizophrenia drugs
- Bibliography
- Websites
- Journal articles and conference abstracts
APPENDIX B
- Report methodology
- Datamonitor forecast methodology
- Sales calculations
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare's therapy area capabilities
- List of Tables
  - Table 1: Diagnostic criteria for schizophrenia and its subtypes
  - Table 2: Prevalence of patients with schizophrenia exhibiting comorbid psychiatric disorders across the US, EU and Japan (%), 2005
  - Table 3: Risk factors for non-compliance to follow-up appointments and/or antipsychotics in patients with schizophrenia
  - Table 4: Potential strategies for improving compliance in patients with schizophrenia
  - Table 5: Novel antipsychotic drug classes in development for the treatment of schizophrenia,2006
  - Table 6: Approved drugs yet to be launched in the US, EU and Japan for the treatment of psychosis and schizophrenia, 2006
  - Table 7: Pipeline drugs in pre-registration for the treatment of psychosis and schizophrenia, 2006
  - Table 8: Pipeline drugs in Phase III development for psychosis and schizophrenia, 2006
  - Table 9: Pipeline drugs in Phase II development for psychosis and schizophrenia, 2006
  - Table 10: Pipeline drugs in Phase I development for psychosis and schizophrenia, 2006
  - Table 11: J&J's pipeline schizophrenia drugs, 2006
  - Table 12: Lundbeck's pipeline schizophrenia drugs, 2006
  - Table 13: Organon's pipeline schizophrenia drugs, 2006
  - Table 14: Pfizer's pipeline schizophrenia drugs, 2006
  - Table 15: Dainippon-Sumitomo's pipeline schizophrenia drugs, 2006
  - Table 16: GSK's pipeline schizophrenia drugs, 2006
  - Table 17: Commercial strength/weakness factors - weightings and scoring definitions
  - Table 18: Product-specific strength/weakness factors - weightings and scoring definitions
  - Table 19: Proportion of total molecule volume (SU and sales) of antipsychotics, accounted for by schizophrenia diagnoses in the US, EU and Japan, 2005
  - Table 20: Comparison of paliperidone IM versus Risperdal Consta
  - Table 21: Price of different formulations of Risperdal ($), 2001-05
  - Table 22: Revenues of the rapid-acting atypical antipsychotic IMs ($m), 2002-05
  - Table 23: Price points for the rapid-acting atypical antipsychotic IMs ($), 2004-06
  - Table 24: Asenapine can address most of the unmet needs for the treatment of schizophrenia
  - Table 25: Datamonitor's forecast schizophrenia revenues of marketed and pipeline schizophrenia drugs across the US, EU and Japan ($m), 2006-2015
  - Table 26: Datamonitor's competitive positioning analysis of pipeline schizophrenia drugs according to product-specific strength/weakness factors, 2006
  - Table 27: Datamonitor's competitive positioning analysis of pipeline schizophrenia drugs according to commercial strength/weakness factors, 2006
  - Table 28: Schizophrenia market definition by ICD10 code
- List of Figures
  - Figure 1: Forecast schizophrenia revenues of marketed and pipeline schizophrenia drugs across the US, EU and Japan, 2006-2015
  - Figure 2: Datamonitor's competitive positioning analysis of pipeline schizophrenia drugs compared to marketed comparators, 2006
  - Figure 3: Reasons for non-compliance among schizophrenia patients receiving antipsychotic therapy
  - Figure 4: Drug classes in development for the treatment of schizophrenia, 2006
  - Figure 5: NICE measurement of cost-effectiveness of drug treatment
  - Figure 6: Forecast revenues for J&J's schizophrenia franchise (Risperdal and paliperidone), 2006-2015
  - Figure 7: Datamonitor's competitive positioning analysis of J&J's marketed and pipeline schizophrenia drugs, 2006
  - Figure 8: Datamonitor's competitive positioning analysis of Lundbeck's pipeline schizophrenia drugs, 2006
  - Figure 9: Forecast revenues of Lundbeck's schizophrenia franchise(Serdolect and bifeprunox (Lundbeck's share - EU only), 2006-2015
  - Figure 10: Datamonitor's competitive positioning analysis of Pfizer's marketed and pipeline schizophrenia drugs, 2006
  - Figure 11: Forecast revenues of Organon's schizophrenia franchise (asenapine), 2006-2015
  - Figure 12: Datamonitor's competitive positioning analysis of Pfizer's marketed and pipeline schizophrenia drugs, 2006
  - Figure 13: Forecast revenues of Pfizer's schizophrenia franchise (Geodon and asenapine), 2006-2015
  - Figure 14: Paliperidone ER only meets one of the criteria for a therapeutically and commercially successful drug reformulation
  - Figure 15: Datamonitor's competitive positioning analysis of paliperidone ER and IM, 2006
  - Figure 16: Datamonitor's forecast of paliperidone's revenues across the US, EU and Japan ($m), 2006-2015
  - Figure 17: Zyprexa's declining US revenues, and plateauing EU revenues
  - Figure 18: Datamonitor's competitive positioning analysis of Zyprexa IM, 2006
  - Figure 19: Datamonitor's competitive positioning analysis of Abilify IM, 2006
  - Figure 20: Datamonitor's competitive positioning analysis of sertindole, 2006
  - Figure 21: Datamonitor's forecast of sertindole's revenues across the five major EU markets ($m), 2006-2015
  - Figure 22: Datamonitor's competitive positioning analysis of asenapine, 2006
  - Figure 23: Datamonitor's forecast of asenapine's revenues across the US, EU and Japan ($m), 2006-2015
  - Figure 24: Datamonitor's competitive positioning analysis of bifeprunox, 2006
  - Figure 25: Datamonitor's forecast of bifeprunox's revenues across the US, EU and Japan ($m), 2006-2015
  - Figure 26: Datamonitor's competitive positioning analysis of blonanserin, 2006
  - Figure 27: Datamonitor's forecast of blonanserin's revenues across the US, EU and Japan, 2006-2015
  - Figure 28: Seroquel SR meets two out of three criteria for a therapeutically and commercially successful drug reformulation
  - Figure 29: Datamonitor's competitive positioning analysis of Seroquel SR, 2006
  - Figure 30: Datamonitor's forecast of Seroquel SR's revenues across the US, EU and Japan, 2006-2015
  - Figure 31: Datamonitor's competitive positioning analysis of iloperidone, 2006
  - Figure 32: Datamonitor's forecast of iloperidone's revenues across the US, EU and Japan, 2006-2015
  - Figure 33: Polypharmacology affinity of atypical antipsychotics for serotonergic, dopaminergic, adrenergic, muscarinic and histaminergic receptors

Pipeline Insight: Schizophrenia

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