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Table of Contents:
EXECUTIVE SUMMARY
Scope of the analysis
Contributing experts
Datamonitor insight into the anxiety disorders market
Related reports
Upcoming reports
PATIENT POTENTIAL
Definition of anxiety disorders
Classification of anxiety disorders
Etiology of anxiety disorders
Generalized anxiety disorder
Panic disorder
Social anxiety disorder
Obsessive-compulsive disorder
Post-traumatic stress disorder
Agoraphobia
Specific phobias
Acute stress disorder
Epidemiology of anxiety disorders
Anxiety disorders are the most prevalent psychiatric conditions
Key patient segments
Acute versus chronic anxiety
Anxiety disorders are twice as prevalent among women
Anxiety disorders are characterized by an early age of onset
Co-morbidity is a fundamental feature of anxiety disorders
Depression is the most common co-morbid condition of anxiety
Clinical unmet needs in anxiety disorders
Improvement in response and remission rates
Limiting side effects is essential
Improving patient compliance
Diagnostic unmet needs in anxiety disorders
Need to increase low diagnosis rates
MARKET OVERVIEW
Current treatment classes and mechanisms
Most treatment guidelines recommend SSRIs as first-line treatment for anxiety disorders
Current market assessment
The anxiety disorders market was worth $4.1 billion in 2007
Future market assessment
The anxiety disorders market is set to experience modest growth over the forecast period 2008–2017
BRAND DYNAMICS
Marketed brands overview
Lexapro (escitalopram, Lundbeck/Forest)
Drug overview
Forecasts to 2017
SWOT analysis
Clinical trial data
Effexor/Effexor XR (venlafaxine, Wyeth)
Drug overview
Forecasts to 2017
SWOT analysis
Clinical trial data
Cymbalta (duloxetine, Eli Lilly)
Drug overview
Forecasts to 2017
SWOT analysis
Clinical trial data
Paxil/Paxil CR (paroxetine, GlaxoSmithKline)
Paxil/Paxil CR drug overview
Forecasts to 2017
SWOT analysis
Clinical trial data
Xanax/Xanax XR (alprazolam, Pfizer)
Drug overview
Forecasts to 2017
SWOT analysis
Clinical trial data
Lyrica (pregabalin, Pfizer)
Drug overview
Forecasts to 2017
SWOT analysis
Clinical trial data
PIPELINE OVERVIEW – R&D DYNAMICS AND APPROACH
Pipeline overview
GlaxoSmithKline has a strong presence in the late-stage anxiety disorders pipeline
Gamma-aminobutyric acid (GABA) modulators represent the most prevalent drug class in early-stage development
Classification of pipeline products
Corticotrophin releasing factor antagonists
Neurokinin receptor antagonists
NMDA receptor modulators
Other drug classes
Discontinued and suspended projects
Pexacerfont (BMS-562086)
Amibegron (SR-58611A)
Clinical trial design in anxiety disorders
Key considerations in clinical trial design of anxiety disorder trials
Clinical trial design guidance
Key research recommendations
Primary clinical trial endpoints and anxiety rating scales
Secondary clinical trial endpoints in anxiety disorders
LATE-STAGE DRUG ANALYSIS AND FORECASTS
Key late-stage pipeline summary
Comparative forecasts
Comparative drug assessment
Definition of current comparator therapy
Forest/Lundbeck’s Lexapro is Datamonitor’s comparator therapy
Forecasted late-stage pipeline drugs
Seroquel XR (quetiapine fumarate extended release, Astrazeneca)
LuAA21004 (Lundbeck, Takeda)
TIK-101 (Tikvah Therapeutics)
PD-332334 (Pfizer)
Unforecasted late-stage drugs
Saredutant (SR-48968, Sanofi-Aventis)
Osemozotan (MN-305, MediciniNova)
TGWOOAA (Fabre-Kramer)
ABIO-08-01 (BTG-1640, Abiogen)
Casopitant (679769, GlaxoSmithKline)
BCI-540 (BrainCells)
GW-876008 (Neurocrine, GlaxoSmithKline)
GSK-561679 (Neurocrine, GlaxoSmithKline)
PH-94B (Pherin)
NPL-2003 (Neuropharm)
Rufinamide (SYN-111, Synosia)
Nepicastat (SYN-117, Synosia Therapeutics)
SEP-225441 (Sepracor)
LuAA24530 (Takeda, Lundbeck)
SPN-805 (Supernus)
AZ-002 (alprazolam, Alexza, Symphony Allegro)
BIBLIOGRAPHY
Journal papers, books, and conference abstracts
Websites
Datamonitor reports
APPENDIX A –MARKET ASSUMPTIONS
New product launches
Patent expiries
Data definitions, limitations and assumptions
Standard units
Japanese market data
Derivation of sales forecasts and pricing trends
Indication-specific sales methodology
Report methodology
APPENDIX B
Contributing experts
TABLES
Table: ICD-10 classification codes for anxiety disorders
Table: DSM-IV classification codes for anxiety disorders
Table: Prevalence of anxiety disorder subtypes across the seven major markets, 2008
Table: Prevalence rates of generalized anxiety disorder
Table: Prevalence of generalized anxiety disorder in the seven major markets, 2008
Table: Prevalence rates of panic disorder in the seven major markets, 2008
Table: Prevalence of panic disorder in the seven major markets, 2008
Table: Prevalence rates of social anxiety disorder
Table: Prevalence of social anxiety disorder in the seven major markets, 2008
Table: Prevalence rates of obsessive-compulsive disorder
Table: Prevalence of obsessive-compulsive disorder in the seven major markets, 2008
Table: Prevalence rates of post-traumatic stress disorder
Table: Prevalence of post-traumatic stress disorder (PTSD) in the seven major markets, 2008
Table: Prevalence rates of agoraphobia across the seven major markets
Table: Prevalence of agoraphobia in the seven major markets, 2008
Table: Prevalence rates of specific phobias
Table: Prevalence of specific phobias in the seven major markets, 2008
Table: Prevalence of a co-morbid psychiatric condition with anxiety disorders across the seven major markets
Table: Sales of the top six drugs indicated for anxiety disorders, seven major markets, 2006–07
Table: Seven major market sales forecast for key branded drugs within the anxiety disorders market ($m), 2007–2017
Table: Leading branded drug sales revenue ($m) for anxiety disorders in the seven major markets, 2007 and 2017
Table: Lexapro: key facts, 2008
Table: Key clinical trials of Lexapro in the treatment of generalized anxiety disorder
Table: Key clinical trial results of Lexapro in the treatment of panic disorder
Table: Key clinical trial results of Lexapro in the treatment of social anxiety disorder (SAD)
Table: Key clinical trials of Lexapro in the treatment of obsessive-compulsive disorder
Table: Effexor/Effexor XR: key facts, 2008
Table: Key clinical trials of Effexor XR in the treatment of generalized anxiety disorder
Table: Key clinical trials of Effexor XR in the treatment of social anxiety disorder
Table: Key clinical trials of Effexor XR in the treatment of panic disorder
Table: Cymbalta: key facts, 2008
Table: Key clinical trials of Cymbalta in the treatment of generalized anxiety disorder
Table: Paxil/Paxil CR: key facts, 2008
Table: Key clinical trial results of Paxil CR in the treatment of social anxiety disorder (SAD)
Table: Key clinical trial results of Paxil CR in the treatment of panic disorder
Table: Xanax franchise: key facts
Table: Key clinical trials of Xanax XR in the treatment of panic disorder
Table: Lyrica: key facts
Table: Key clinical trials of Lyrica in the treatment of generalized anxiety disorder (GAD)
Table: Key pipeline drugs in late-stage development for anxiety disorders, 2008
Table: Drugs in early-stage development for anxiety disorders, 2008
Table: Number of key anxiolytics by class and Phase of development, 2008
Table: Forecasted late stage pipeline drugs, 2008
Table: Lexapro: key clinical trial results
Table: Factors impacting on the revenues of Seroquel XR, 2008–2017
Table: Factors impacting on the revenues of LuAA21004, 2008–2017
Table: Phase III trials of LuAA21004 in generalized anxiety disorder, 2008
Table: Factors impacting the revenues of TIK-101, 2008–2017
Table: Factors impacting on the revenues of PD-332334, 2008–2017
Table: Pfizer’s anxiety disorders portfolio, 2008
Table: Phase III trials of PD-332334 generalized anxiety disorder, 2008
Table: Phase III trials of saredutant in generalized anxiety disorder
Table: Key facts: Phase II trial of casopitant in social anxiety disorder
Table: Key facts: Phase II trial of BCI-540 in depression and anxiety
Table: Key facts: Phase II trial of NLP-2003 in obsessive-compulsive disorder
Table: Key facts: Phase II trial of rufinamide in generalized anxiety disorder
Table: Key facts: Phase II trial of nepicastat in post-traumatic stress disorder
Table: Key facts: Second Phase II trial of nepicastat in post-traumatic stress disorder
Table: Key facts: Phase II trial of SEP-225441 in generalized anxiety disorder
Table: Datamonitor’s launch dates for anxiety disorder products across the US, 5EU and Japan, 2008–2017
Table: Patent expiries of key branded anxiolytics across the US, the 5EU and Japan
Table: Patent expiries of key branded drugs prescribed off-label for anxiety disorders across the US, the 5EU and Japan
Table: Anxiety diagnosis values (%) for key brands sales ($) in the US, 2005–07
Table: Datamonitor drug assessment parameters
FIGURES
Figure: Datamonitor drug competitive positioning analysis of pipeline drugs in development for anxiety disorders in the seven major markets over the forecast period, 2008–2017
Figure: Historical (2004–2007) and forecast (2008–2017) anxiety-specific sales revenue for key marketed and pipeline drugs across the 7MM
Figure: Prevalence of anxiety disorder subtypes across the seven major markets, 2008
Figure: Patient distribution: acute versus chronic anxiety
Figure: Key unmet needs in the treatment of anxiety disorders, 2008
Figure: Value ($) and volume (SU) sales of anxiety disorder therapies across the seven major markets, 2004–07
Figure: Key events affecting the anxiety disorders market, 2004–08
Figure: Anxiety disorder-specific sales by country in the seven major markets, 2006–07
Figure: Share of key drug classes used to treat anxiety disorders in the seven major market, 2007
Figure: Seven major market sales revenue of the leading branded anxiety disorder drugs, 2004–07
Figure: Total non-direct to consumer promotional spend of key brands, 2005–2007
Figure: Seven major market anxiety disorder sales revenue by indication, 2007
Figure: Anxiety disorder-specific sales revenue across the US, Japan and 5EU, ($m), 2004–2017
Figure: Key events impacting the anxiety disorders market, 2008–2017
Figure: Lexapro (escitalopram)– clinical and commercial attractiveness, 2008
Figure: Key marketed drugs approved for specific anxiety disorders in the US, 5EU and Japan, 2008
Figure: Lexapro: proportion of branded anxiety disorder sales across the seven major markets, 2004–07
Figure: Lexapro anxiety-specific sales revenue ($m) across the seven major markets, 2004–07 historical, 2008–2017 forecasts
Figure: Lexapro (escitalopram): SWOT analysis for the anxiety disorders market, 2008
Figure: Effexor/Effexor XR: proportion of branded anxiety disorder sales across the seven major markets, 2004–07
Figure: Effexor/Effexor XR anxiety-specific sales revenue ($m) across the seven major markets, 2004–07 historical, 2008–2017 forecasts
Figure: Effexor XR(venlafaxine extended release): SWOT analysis for the anxiety disorders market, 2008
Figure: Cymbalta: proportion of branded anxiety disorder sales across the seven major markets, 2004–07
Figure: Cymbalta anxiety-specific sales revenue ($m) across the seven major markets, 2004–07 historical, 2008–2017 forecasts
Figure: Cymbalta (duloxtine): SWOT analysis for the anxiety disorders market, 2008
Figure: Paxil/Paxil CR: proportion of branded anxiety disorder sales across the seven major markets, 2004–07
Figure: Paxil franchise anxiety-specific sales revenue ($m) across the seven major markets, 2004–07 historical, 2008–2017 forecasts
Figure: Paxil CR (paroxetine controlled release): SWOT analysis for the anxiety disorders market, 2008
Figure: Xanax/Xanax XR: proportion of branded anxiety disorder sales across the seven major markets, 2004–07
Figure: Xanax franchise anxiety-specific sales ($m) across the seven major markets, 2004–07 historical, 2008–17 forecasts
Figure: Xanax XR (alprazolam extended release): SWOT analysis for the anxiety disorders market, 2008
Figure: Lyrica anxiety-specific sales ($m) across the seven major markets, 2004–07 historical, 2008–17 forecasts
Figure: Lyrica (pregabalin): SWOT analysis for the anxiety disorders market, 2008
Figure: Drugs in development for anxiety disorders by class and development stage, 2008
Figure: Comparative late-stage pipeline anxiety disorder drug sales revenue forecast, 2008–2017
Figure: Datamonitor drug assessment summary of pipeline drugs in development for anxiety disorders across the seven major markets, 2008–2017
Figure: Anxiety-specific sales forecast of Seroquel XR in the seven major markets, 2008–2017
Figure: Datamonitor’s competitive positioning analysis of Seroquel XR in anxiety disorders across the seven major markets, 2008–2017
Figure: Anxiety specific sales ($m) in the seven major markets of Seroquel/Seroquel XR and key drugs approved for anxiety disorders, 2004–07
Figure: Anxiety-specific sales forecast of LuAA21004 in the seven major markets, 2007–2017
Figure: Datamonitor’s competitive positioning analysis of LuAA21004 in anxiety disorders across the seven major markets, 2008–2017
Figure: Anxiety-specific sales forecast of TIK-101 in the seven major markets, 2008–2017
Figure: Datamonitor’s competitive positioning analysis of TIK-101 in anxiety disorders across the seven major markets, 2008–2017
Figure: Anxiety-specific sales forecast of PD-332334 in the seven major markets, 2008–2017
Figure: Datamonitor’s competitive positioning analysis of PD-332334 in anxiety disorders across the seven major markets, 2008–2017
Figure: Phase II results: PD-332334 in generalized anxiety disorder
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