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:
- Insomnia
- Restless legs syndrome (RLS)
- Narcolepsy and
- Obstructive Sleep Apnoea / Hypopnea Syndrome (OSAHS)
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.
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:
- Market expansion of existing expensive medications into Europe and Japan in particular
- Market penetration of new medications currently in pipeline.
Other drugs dealt with in this report include:
- 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.
Key findings that will broaden the scope of the sleep disorders market:
- Over the next decade, the development and improvement of sleep disorders therapies will primarily depend on the success of burgeoning technology and innovative approaches.
- It is possible to purchase prescription medications online without producing a prescription. Purchase of online sleep medications has increased and will continue to evolve over the next years.
- The impact of DTC advertising has created an improved awareness of available insomnia treatment. This is likely to increase as DTC advertising continues to prosper and the culture becomes more accepting towards insomnia treatment. Visiongain expects the market for sleep disorders to increase, driven by a growing awareness of sleep disorders and by campaigns to promote sleep medications, both by DTC advertising and consumer education. The relaxation of DTC marketing restrictions in the 1990s in the US set the stage for a flow for both branded and unbranded advertising and promotional programmes. Those regulations are prompting more responsible DTC advertising on the industry's part.
- 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.
What questions does the report answer?
- 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’?
Why should you buy this report?
- This report focuses on the marketed medications and the pipeline development for sleep disorders from 2008 to 2018. It also discusses the strength and weakness of products, along with the opportunities and threats facing the market.
- 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.
Table of Contents
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
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
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