21.06.2008 Sleep Disorders Market Analysis 2008-2018

More than 80 sleep disorders have been identified. They affect over 200 million people worldwide. The report focuses on the market for following sleep disorders:

The market penetration for insomnia drugs has not reached saturation point. Opportunities remain. But with the introduction of several new products the market is set to see changes, but expansion. This expansion is based on increased general awareness physicians better comprehension of the significance of this disease and the positive role that a sleep medication prescription plays.

At present time there are several prescription sleeping medications available to treat insomnia. The market-focus has been driven by the production of sleep medications with less side-effects and danger of overdose. Prescription benzodiazepines and newer non-benzodiazepine hypnotics developed in the 1990s, such as Imovane, Ambien and Sonata will continue to be the most prescribed. Benzodiazepines are widely used to treat an underlying neurological disorder which is often the underlying cause of insomnia, e.g. anxiety and depression.

Visiongain predicts that market share by volume for insomnia in the US will change significantly from 2008 to 2018. Ambien IR lost its patent protection in April 2007, which opened to generic competition for Zolpidem. Ambien will remain the market leader for the short term, but what will over take it? A generic version of Ambien is expected to achieve strong market share by volume as there is a great demand for zolpidem tartrate for insomnia.

The market share for insomnia treatment will gradually rise after 2012, which will be due to:

Modafinil (Provigil) is the first in a new class of wake-promoting drugs and is currently approved in more than 20 countries for the treatment of excessive daytime sleepiness associated with narcolepsy. Provigil is quickly replacing Ritalin, and other CNS stimulants, as the medication of choice for treating daytime sleepiness in narcolepsy. The FDA granted modafinil (Provigil) orphan drug status in 1993. Modafinil was initially launched in the US in 1999 for the treatment of narcolepsy. In 2004, modafinil became FDA-approved prescription medicine for the treatment of excessive sleepiness associated with Obstructive Sleep Apnoea/Hypopnea Syndrome (OSAHS) and Shift Workers Sleep Disorder (SWSD).

Requip (ropinirole) became the first and only FDA-approved drug treatment for moderate to severe primary Restless Legs Syndrome (RLS) in 2005.

The FDA has requested that all manufacturers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labelling to include stronger warnings concerning potential risks.

The Committee for Medicinal Products in Human Use (CHMP) of the European Medicines Agency (EMEA) approved Neurim's Circadin a prolonged-release melatonin as monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients aged 55 or over. Neurim is actively seeking strategic alliances for the major European markets.

Which current or future therapies will drive the sleep disorders market from 2008 to 2018?
The key companies involved in the market and their analysis?
What is the patient identification rate for each of the therapeutic areas?
What is the present state of the disease awareness?
What R&D opportunities exist for ‘new comers’?

The report describes world market situation for sleep disorders, namely insomnia, narcolepsy, RLS and OSAHS, with forecasts made for all key products. It also describes the insomnia market situation in the seven major world markets for sleep medications: the US, Japan, France, Germany, Italy, Spain and the UK, with forecasts for key products.

The report provides transcripts of visiongain’s interviews with experts in the field of sleep disorders, which reviews the future direction of the sleep disorders treatment market.

1 Executive Summary: Pharmaceutical Treatment of Sleep Disorders 2008-2018

1.1 Current Prospects of Sleep Disorders Market

1.1.1 Market Growth Estimate

1.1.2 Generic Pharmaceutical Market

1.1.3 Market Expansion

1.1.4 Market Demand for Short Elimination Half-Life

1.1.5 Medications Targeting M1 and M2 Receptors

1.1.6 Medications Targeting 5HT2A Receptor Receptors

1.1.7 Product Line Extension Activities

1.1.8 Effect of Direct-To-Consumer Advertising (DTCA)

1.1.9 Safety Measures for Online Consumers

1.2 Aim, Scope, and Format Of This Report

2 Introduction to Sleep Disorders and their Pharmaceutical Treatment

2.1 Introduction to Sleep Disorders

2.2 Overview of Chapter

2.3 Introduction to Insomnia

2.4 Discovery of Barbiturates

2.5 Market Entry for Non-Barbiturates

2.6 Arrival of Benzodiazepines

2.7 Non-benzodiazepines the Revolutionary Compound

2.7.1 Prescription Medicines and OTCs

2.8 Pharmacodynamics of Hypnotics

2.9 Introducing New Scope for Insomnia

2.10 Many Forms of Sleep Disturbances

2.10.1 Sleep Deprivation

2.11 Shift Workers Sleep Disorder (SWSD)

2.11.1 Melatonin

2.11.2 Valerian

2.12 Treatment for insomnia in Depression

2.13 Restless Legs Syndrome

2.13.1 Off-label Prescription for Restless Legs Syndrome

2.14 Other Medical Conditions

2.15 Narcolepsy

2.15.1 Xyrem for Cataplexy

2.15.2 Orphan Disease Status

2.15.3 Other Medications for Cataplexy

2.16 Obstructive Sleep Apnea / Hypopnea Syndrome (OSAHS)

2.17 Insomnia - A Common Disease

2.18 Patient Identification Rate

3 Analysis of Current Market for Insomnia

3.1 Market Share for World Insomnia Market

3.2 Market Dominance Continues for Ambien

3.3 Lunesta as Ambien's Contender

3.4 Sonata Continues to Form Niche Market

3.5 Imovane / Amoban Go Down in Insomnia Market

3.6 Benzodiazepines Survived as Low Priced Sleep Aid

3.6.1 Lendormin (brotizolam)

3.6.2 Halcion (triazolam)

3.6.3 Noctamid (Lormetazepam)

3.6.4 Doral (quazepam)

3.6.5 Dalmane (flurazepam)

3.6.6 Rohypnol (flunitrazepam)

3.6.7 Restoril (temazepam)

3.6.8 Eurodin or ProSom (estazolam)

3.6.9 Rhythmy (rilmazafone)

3.6.10 Rhythmy (rilmazafone)

3.6.10 Valium (diazepam)

3.7 Rozerem Market Up-and-Coming

4 Insomnia Market Analysis by World Regions

4.1 US has the Highest Market Share for Insomnia Treatments

4.2 Europe as a Significant Market for Insomnia Treatments

4.3 The Japanese Market for Insomnia is Expanding

5 Market Developments for Narcolepsy, Shift Work Sleep Disorder, and Restless Legs Syndrome

5.1 Provigil Wins Label Extension

5.2 Adrafinil is a Isomer of Provigil

5.3 Ritalin/ Ritalin SR

5.4 Concerta is an Extension Version of Ritalin

5.5 Adderall as Stimulant

5.6 Xyrem for Cataplexy and Excessive Daytime Sleepiness

5.7 Recent FDA Activities for Restless Legs Syndrome

6 Products in Development for Sleep Disorders

6.1 FDA Approves Generic Ambien

6.2 Circadin a Prolonged-Release Melatonin

6.3 GHB analogue Generally Regarded as Safe

6.4 Clinical Trial Product List for Insomnia

6.5 Indiplon for Insomnia in Pre-Registration Stage

6.6 Caraco’s Prospect in Narcolepsy Market

6.7 Lundbeck Faces Setback in Insomnia Market

6.8 Phase III Trial Begins on Posidorm for Insomnia

6.9 Hope for Physiological Sleep with Almorexant

6.10 5HT2A Antagonist for Insomnia

6.11 Agonist at the Serotonin 5-HT1A Receptor

6.12 VEC-162 Future Contender for Rozerem

6.13 Zolpidem as Oral Spray

6.14 Cephalon Adds Nuvigil Alongside Provigil

6.15 Dopamine Patch for RLS

6.16 Transported Prodrug of Gabapentin

7 Recommendations for Ideal Pharmaceutical Treatment for Sleep Disorders

7.1 Firsthand Interview for Expert Opinion 1

7.1.1 Prospect for Sleep Disorders Market

7.1.2 Prospect for Generic Market

7.1.3 Product Line Extension

7.1.4 Prospect for Niche Market

7.1.5 Future of Benzodiazepines Market

7.1.6 Future of Controlled Drug Market

7.1.7 Effect of Direct-to-Consumer Market

7.1.8 Future of Non-Hypnotics Medications

7.1.9 Future Medications for Sleep Apnoea

7.1.10 Prospect for Hypnotics as OTCs

7.1.12 Unmet Needs for Sleep Disorders Market

7.2 Firsthand Interview for Expert Opinion 2

7.2.1 Drug Therapies for the Future

7.2.2 Technological Advance in Sleep Disorders Treatment

7.2.3 New Effective Sleep Medications

7.2.4 Future of Sleep Disorders Market in the Developed Nations

7.2.5 Unmet Needs for Sleep Disorders Treatment

7.2.6 Favourable Medication for the Coming Decade

7.2.7 Side-Effect Profile for Future Drug Development

7.2.8 Sleep Disorders Market in Developing Nations

8 Market Force and Limitation of Sleep Disorders Market

8.1 Table for SWOT Analysis of Sleep Disorders Market

8.2 Market Analysis of Products Unapproved for Sleep Disorders by Regulatory Bodies and Niche Market

8.2.1 Unapproved Insomnia Medications: Benadryl,

Unisom, Tylenol PM, Nytol

8.2.3 Purchase of Prescription Medications Online

8.3 Drug Safety Issues and Side-Effects of Drugs

8.3.1 Hypnotics are not Without Side-Effects

8.3.2 Labelling to include Potential Risks

8.3.3 Rohypnol and Xyrem have Potential for Abuse

8.4.4 Consumer Led Campaign

8.4 Unmet needs of Pharmaceutical Treatment for Sleep Disorders

8.5 Non-product Related Drivers and Restraints

8.5.1 National Policies Recommendations

8.5.2 National Policies Advising Prescription of Particular Drugs

8.5.3 Agreed Guidelines

8.5.4 Market Status Quo

8.6 Success of Direct-to-Consumer Advertising

9 Conclusions

9.1 Insomnia Market Will Show High Growth

9.2 Other Sleep Disorders of Interest

9.3 Life-Cycle Management

9.4 New Markets

More Details

Organisations mentioned in the report

Abbott

Actelion

Alliance

American Insomnia Association

Andx

Apotex

Arena

Astellas

Avant

Aventis

Bayer

Boehringer Ingelheim

Caraco

Carlsbad

Cephalon

Dr. Reddy's

Elan

Eli Lilly

Drug Enforcement Administration (DEA)

European Patent Office

FDA

Genpharm

GlaxoSmithKline

Hoffman-Roche

Hypnion

Ipsen

Johnson & Johnson

King

Lek

Lundbeck

Mallinckrodt

Merck

Mutual

MHRA

Mylan

National Sleep Foundation

NCSDR

Neurim

Neurocrine

Neurogen

NHLBI

NICE

NIH

NovaDel

Novartis

Orphan

Pfizer

Pharmaceutical Researchers and Manufacturers of America (PhRMA)

Questcor

Ranbaxy

Roche

Rhone-Poulenc Rorer

Roxane

Royal Pharmaceutical Society of Great Britain (RPSGB)

Sanofi-Aventis

Schering-Plough

Sepracor

Shionogi

Shire

Skye

Synthon

Takeda

Teva

Tikvah

UCB

Valeant

Vanda

Watson

Wyeth

XenoPort