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Pipeline Insight: Anxiety Disorders

A decade of declining revenues

Publication Date   March 2006
Publisher   Datamonitor
Product Type   Report
Pages   310
ISBN Number   not applicable
Product Code   DAT507
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Price £6,495.00

approximately: $9,646 | €7,643

Summary


Introduction

The global anxiety disorders market is set to decline from $4.5 billion in 2006 to $2.6 billion by 2015 (CAGR 200615 -6.0%). This will be primarily due to the launch of numerous generic anxiety drugs from 2006 onwards, which will offset the revenue growth derived from existing drugs seeking additional anxiety indications, and the launch of several novel anxiety drugs.

Highlights

  • To maximize drug revenues as a final step before generic incursion, a number of existing market players are seeking approvals in additional anxiety indications. However, sales of $1.6 billion in 2006 will decline over the long-term to $1.2 billion in 2015.
  • Manufacturers with existing branded CNS drugs already approved for indications other than anxiety, are also seeking secondary indications in the anxiety market. Datamonitor forecasts that these drugs will enter the anxiety market from 2007 onwards, and will reach peak anxiety specific revenues of $413m in 2013.
  • Several novel anxiety drugs will be launched over the forecast period from 2006 onwards, including Predix's PRX-00023 (oral non-azapirone 5-HT1A agonist) in Phase III for GAD, and Schering AG/Berlex's YAZ (low dose drospirenone/ethinyl estradiol) and Wyeth's Librel (low dose levonorgestrel/ethinyl estradiol), both in development for PMDD.

Scope

  • Detailed pipeline analysis for key products in development for GAD, SAD, OCD, PTSD, PMDD and panic disorder, plus drug sales forecasts to 2015
  • Overview of patient potential segmentation by indication and unmet needs in anxiety disorders across the US, Japan, France, Germany, Italy, Spain & UK
  • Benchmarking of key clinical and company attractiveness of late-phase pipeline products
  • Detailed clinical trial information and opinions from key thought leaders

Reasons to Purchase

  • Understand unmet needs in the anxiety market based on key opinion leader comments regarding both currently marketed and pipeline products
  • Benchmark key late-stage anxiety compounds against current market leaders
  • Assess the global sales forecasts of late-stage pipeline drugs for anxiety and examine their clinical and commercial potential

Content


  • Chapter 1 Executive Summary
    • Scope of the analysis
    • Insight into the anxiety market
    • Key metrics
  • Chapter 2 Patient Potential
    • Etiology of anxiety disorders
    • Generalized anxiety disorder
    • Panic disorder
    • Social anxiety disorder
    • Obsessive-compulsive disorder
    • Post-traumatic stress disorder
    • Premenstrual dysphoric disorder
    • Agoraphobia
    • Specific phobias
    • Classification of anxiety disorders
    • ICD-10 classification
    • DSM-IV classification
    • Diagnosis algorithm
    • Epidemiology of anxiety
    • Prevalence of anxiety disorder types
    • Generalized anxiety disorder
    • Panic disorder
    • Social anxiety disorder
    • Obsessive-compulsive disorder
    • Post-traumatic stress disorder
    • Premenstrual dysphoric disorder
    • Agoraphobia
    • Specific phobias
    • Other anxiety disorders
    • Key patient segments
    • Acute versus chronic anxiety
    • Gender and age
    • Comorbidities of anxiety disorders
    • Unmet needs in anxiety disorders
    • Improving patient compliance is key
    • Improving the perceived therapeutic efficacy through patient education
    • Patient education and public awareness
    • Faster onset of action on the horizon
    • Limiting side effects is essential
    • Targeting comorbidity expands the prescribing potential of a drug
  • Chapter 3 R&D Approach
    • Classification of marketed and pipeline products
    • Serotonergics
    • Noradrenergics
    • GABAergic drugs
    • Novel therapies
    • Clinical trials and drug development
    • Clinical trial endpoints and anxiety rating scales
    • Hamilton Anxiety (HAM-A)
    • Hospital Anxiety and Depression scale (HADS)
    • Liebowitz Social Anxiety Scale (LSAS)
    • Patient Global Impression of Improvement Scale (PGI)
    • Clinical Global Impression Improvement Scale (CGI-I)
    • Social Phobia and Anxiety Inventory (SPAI)
    • Social Phobia Inventory (SPIN)
    • Clinician Administered PTSD Scale (CAPS)
    • Treatment Outcome PTSD Scale
    • Davidson Trauma Scale (DTS)
    • Short PTSD Rating Interview (SPRINT)
    • Brief Social Phobia Scale fear subscale
    • Panic Disorder Severity Scale (PDSS)
    • Panic and Agoraphobia Scale (PAS)
    • Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
    • The National Institute of Mental Health Obsessive Compulsive Scale (NIMH-OC)
    • Daily Record of Severity of Problems (DRSP)
    • Other scales
    • Clinical trial design guidance
    • Inclusion criteria
    • Exclusion criteria
    • Assessing efficacy
    • Strategy and design of clinical trials
    • Key research recommendations
  • Chapter 4 Marketed And Pipeline Anxiety Drug Overview
    • Marketed anxiety drug overview
    • The market value is calculated using IMS diagnosis value
    • Forecast caveats
    • Pipeline overview
    • Anxiety drugs in Phase III and above
    • Anxiety drugs in Phase II
    • Anxiety drugs in Phase I
    • Key companies involved in the anxiety pipeline
    • GSK
    • Wyeth
    • Lilly
    • Other key companies involved in the anxiety pipeline
    • Sanofi-Aventis
    • Fabre Kramer
    • Methodology of SWOT analysis
    • Gold standard anxiolytic
    • Generalized Anxiety Disorder
    • Obsessive Compulsive Disorder
    • Panic Disorder
    • Social Anxiety Disorder
    • Premenstrual Dysphoric Disorder
    • Post traumatic stress disorder
  • Chapter 5 Gad Pipeline Drug Overview
    • Overview of GAD drugs
    • Launched drugs
    • Pipeline summary
    • Lyrica (pregabalin)
    • Clinical trial data
    • Cymbalta (duloxetine)
    • Clinical trial data
    • Recently completed clinical trials
    • Ongoing clinical trials
    • PRX-00023
    • Clinical trial data
    • Ongoing clinical trials
    • SR-58611
    • Ongoing clinical trials
    • Gabitril (tiagabine)
    • Clinical trial data
    • Ongoing clinical trials
    • Seroquel SR (quetiapine sustained release)
    • Clinical trial data
    • AC-5216
    • Ongoing clinical trials
    • MN-305 (osemozotan / MKC-242)
    • Jazz Pharma
    • Ongoing clinical trials
    • Recently discontinued pipeline drugs
  • Chapter 6 Ocd Pipeline Drug Overview
    • Overview of OCD drugs
    • Launched drugs
    • Pipeline summary
    • Lexapro (escitalopram)
    • Clinical trial data
    • Ongoing clinical trials
    • Luvox CR (fluvoxamine controlled release)
    • Clinical trial data
  • Chapter 7 Sad Pipeline Drug Overview
    • Overview of SAD drugs
    • Launched drugs
    • Pipeline summary
    • Luvox CR (fluvoxamine controlled release)
    • Clinical trial data
    • Lexapro (escitalopram)
    • Clinical trial data
    • Cymbalta (duloxetine)
    • Ongoing clinical trials
    • TGWOOAD/AA
    • LY686017
    • Ongoing clinical trials
    • Gabitril (tiagabine)
    • Clinical trial data
    • Completed clinical trials
    • casopitant (GW679769)
    • Ongoing clinical trials
  • Chapter 8 Pd Pipeline Drug Overview
    • Overview of PD drugs
    • Launched drugs
    • Pipeline summary
    • Lexapro (escitalopram)
    • Clinical trial data
    • TGAR01P
  • Chapter 9 Ptsd Pipeline Drug Overview
    • Overview of PTSD drugs
    • Launched drugs
    • Pipeline summary
    • Risperdal (risperidone)
    • Clinical trial data
    • Ongoing clinical trials
    • Paxil CR (paroxetine controlled release)
    • Ongoing clinical trials
    • Gabitril (tiagabine)
    • Clinical trial data
    • Effexor XR (venlafaxine extended release)
    • Clinical trial data
  • Chapter 10 Pmdd Pipeline Drug Overview
    • Overview of PMDD drugs
    • Launched drugs
    • Pipeline summary
    • YAZ (drospirenone and ethinyl estradiol)
    • Clinical trial data
    • Librel (levonorgestrel / ethinyl estradiol)
    • Ongoing clinical trials
  • Chapter 11 Non-Specified Anxiety Disorders Drug Overview
    • Non-specified anxiety disorders drug overview
    • Launched drugs
    • Pipeline summary
    • alprazolam
    • AP-521
    • ELB139
    • Clinical trial data
    • vestipitant (GW597599) + paroxetine
    • Recently suspended pipeline drugs
  • Chapter 12 Analysis And Forecasts Of Pipeline Anxiety Drugs
    • Analysis and forecasts of pipeline anxiety drugs
    • Lyrica (pregabalin)
    • Lyrica demonstrates a strong safety and efficacy profile, with a fast onset
    • Schedule V may limit patient uptake in the US
    • Lyica will become a first-line treatment for pure GAD
    • Lyrica's anxiety revenues will slow the decline of Pfizer's anxiety franchise
    • Threat from generic gabapentin?
    • Lyrica will be the next new anxiety drug to reach the market
    • Cymbalta (duloxetine)
    • Cymbalta's side effects will limit uptake in anxiety
    • Lack of clear differentiation from venlafaxine in anxiety
    • Global partnerships enhance commercial prospects of Cymbalta
    • Cymbalta's revenue growth in the anxiety market will be short lived
    • PRX-00023
    • Physicians are unconvinced with the therapeutic potential of PRX-00023
    • PRX-00023 will be used to augment SSRI therapy
    • PRX-00023 is unlikely to compete on the same therapeutic plain as the SSRIs
    • SR-58611
    • Efficacy in severe depression may carry over into anxiety
    • Initial off-label usage will support growth in GAD once approved
    • Gabitril (tiagabine)
    • Physicians unimpressed by Gabitril's efficacy in anxiety
    • FDA seizure warning severely threatens Gabitril's patient potential
    • Treatment of comorbid pain in GAD
    • Gabitril's commercial potential is limited
    • Gabitril is unlikey to receive FDA approval for GAD
    • Seroquel SR (quetiapine sustained release)
    • A strong safety and efficacy profile in schizophrenia and BD bodes well for use in anxiety
    • Seroquel will retain patent protection until 2011, protecting the initial uptake of Seroquel SR
    • Targeting community based psychiatric disorders will favor Seroquel SR's growth
    • AC-5216
    • Physicians are skeptical of the therapeutic potential of AC-5216
    • MN-305 (Osemozotan / MKC-242)
    • The record for the 5-HT1A partial agonists has been appallingly bad
    • MediciNova will need to find a marketing partner
    • Jazz Pharma
    • Lexapro (escitalopram)
    • US non-approvals for SAD and PD will limit future revenues
    • Lack of pipeline compounds will limit long-term anxiety revenues for Lundbeck and Forest
    • Lexapro will retain patent protection until 2011
    • Lexapro's anxiety specific revenues will continue to grow through 2009
    • Luvox CR (fluvoxamine controlled release)
    • Luvox will continue to grow in Japan, despite genericization
    • Luvox CR is commercial suicide
    • TGWOOAD/AA
    • TGWOOAD/AA's mode of action is not particularly unique
    • Fabre Kramer will need to find a marketing partner
    • TGAR01P
    • Physicians have serious concerns regarding TGAR01P
    • Datamonitor does not expect that TGAR01P will receive FDA approval
    • LY686017
    • Risperdal (risperidone)
    • Risperdal demonstrates efficacy in reducing the symptoms of PTSD
    • J&J has limited time to gain FDA approval for Risperdal for PTSD before the availability of generic risperidone
    • Paxil CR (paroxetine controlled release)
    • GSK faces several hurdles in terms of establishing Paxil CR as a first-line treatment for PTSD
    • GSK's NK1 antagonists - casopitant (GW679769) and vestipitant (GW597599)
    • Combination of an NK1 antagonist and SSRI shows potential
    • Effexor XR (venlafaxine extended release)
    • Effexor XR's recent approval for PD will certainly boost revenues
    • US and EU patent expiries lead to erosion of Effexor XR revenues from 2008 onwards
    • YAZ (drospirenone and ethinyl estradiol)
    • YAZ will provide an alternative treatment to women who feel that there is a stigma attached to taking an SSRI
    • No PMDD market in the EU limits revenue potential
    • YAZ is expected to continue to grow Schering AG/Berlex's flagship women's health franchise
    • Librel (levonorgestrel / ethinyl estradiol)
    • Librel's continuous regimen may provide a competitive advantage
    • Librel's uptake will be limited by YAZ's first to market status
    • NovaDel's alprazolam oral spray
    • Improved therapeutic potential remains uncertain despite a head-to-head trial with alprazolam tablets
    • NovaDel will have difficulty in gaining FDA approval for the formulation
    • Datamonitor does not expect oral spray alprazolam will receive FDA approval
    • AP-521
    • ELB139
  • Chapter 13 Innovative Early-Stage Projects
    • Overview of innovative early-stage projects
    • NK receptor antagonists
    • ALXZ-002
    • Synthetic human secretin
    • The subcutaneous formulation is unlikely be received well by patients
    • CRF antagonists
    • 5-HT agonists
    • Metabotropic glutamate receptor 5 modulators
    • MAO inhibitors
    • CCK antagonists
    • PDE 2 inhibitor
    • Vasopressin
    • Future treatment of anxiety disorder
  • Appendix A
    • Forecast revenues
    • Anxiety market data
    • Competitive positioning analysis of pipeline anxiety drugs
    • Bibliography
    • Journal articles and conference abstracts
  • Appendix B
    • Report methodology
    • Forecast methodology
    • Sales calculations