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Commercial and Pipeline Insight: Allergic Rhinitis
Datamonitor, Oct 2007, Pages: 319
CHAPTER 1 EXECUTIVE SUMMARY
Objective of the analysis
Our insight into the allergic rhinitis market
Contributing experts
Related reports
Upcoming related reports
CHAPTER 2 MARKET DEFINITION AND OVERVIEW
Market definition for this report
Allergic rhinitis disease background
Asthma is main and most important co-morbidity
Segmentation
Allergic rhinitis prevalence
Allergic rhinitis prevalence in children
Current market situation
Unmet needs in allergic rhinitis
- Clinical unmet needs
- Lack of a cure
- Uncontrolled disease
- Drugs do not impact co-morbidities sufficiently
Environmental unmet needs
- Compliance is relatively low
Pipeline overview
Key companies involved in the allergic rhinitis market
Schering-Plough
Pfizer
Sanofi-Aventis
GlaxoSmithKline
Merck & Co
UCB
Sepracor
Companies involved in immunotherapy
Clinical trial design in allergic rhinitis
Endpoints
- Symptom scores are most often used in clinical trials
- Specific safety measures remain essential
- Objective inflammatory endpoints are key for new anti-inflammatory therapies
Study population
- Pediatric trials need some adaptation
Comparator drug
CHAPTER 3 COUNTRY MARKET ASSESSMENTS
Summary of environmental issues affecting the allergic rhinitis market
Seven major market opportunities and threats
Opportunities
- Over-the-counter (OTC) status may extend revenue after patent expiry
- Increasing prevalence of allergic rhinitis
- Allergy seasons start earlier, last longer and are more intense
- EMEA harmonizes drug approval process
- Smaller companies helped by European regulators
Threats
- Governments try to stop increasing healthcare expenditure by controlling pricing and reimbursement
- Parallel trading threatens return on investment
US: opportunities and threats
Allergic rhinitis market overview
Opportunities
- The OTC market is becoming more important in the US
- FDA initiatives to decrease product development times
- US is the only country to allow direct-to-consumer (DTC) advertising of prescription medicines
Threats
-
- Reimbursement controls decrease healthcare expenditure in the US
- Implementation of Medicare Part D influences US healthcare market
- Parallel trading could increase due to Medicare D's 'donut hole'
- Prescription Drug User Fee Act (PDUFA) likely to increase fees
Japan: opportunities and threats
Allergic rhinitis market overview
Opportunities
- Separation of manufacturing and marketing entities benefits both Japanese and foreign companies
- Japan shows initiatives to open its market
Threats
- Price cuts still dominate pricing and reimbursement in Japan
- Increasing uptake of generics
- Lengthy approval process slows down access to the Japanese market
France: opportunities and threats
Allergic rhinitis market overview
Opportunities
- Generics use is still relatively low in France
- Pricing and reimbursement negotiations to be shortened by new agency
Threats
- France increases its pricing and reimbursement efforts
Germany: opportunities and threats
Allergic rhinitis market overview
Opportunities
- Encouraging environment for novel drug development
- ePharmacy and mail-order drugs legalized
Threats
- Reimbursement controls are important in decreasing healthcare expenditure in Germany
- Generic penetration in Germany is relatively high
Italy: opportunities and threats
Allergic rhinitis market overview
Opportunities
- Generic drugs play a small role in Italy
- Reimbursement negotiations are less restrictive
Threats
- Italy increases its pricing and reimbursement efforts
Spain: opportunities and threats
Allergic rhinitis market overview
Opportunities
- The pharmaceutical industry implements strategies to reduce parallel exportation
- Health ministry introduces 'Spanish national formulary'
Threats
- The introduction of a new medicines bill increases the focus on cost containment in Spain
- The profile of generics is being raised in Spain
UK: opportunities and threats
Allergic rhinitis market overview
Opportunities
- The UK offers an attractive market
- The pricing and reimbursement environment in the UK is relatively non-restrictive
Threats
- Lack of allergy knowledge in primary care setting
- Lack of allergy specialists
- The UK enjoys a strong generics market
- The post-guidance and pre-guidance effects of NICE are a significant concern
CHAPTER 4 DRUG ANALYSIS & FORECASTS
Overview for oral antihistamines
Patient potential
Comparative forecasts
Pipeline summary
Zyrtec
- Zyrtec forecast assumptions
- Trial data
Xyzal
- Xyzal forecast assumptions
- Trial data
Telfast/Allegra
- Telfast/Allegra forecast assumptions
- Trial data
Claritin
- Claritin forecast assumptions
- Trial data
Aerius/Clarinex
- Aerius/Clarinex forecast assumptions
- Trial data
Pipeline drugs in the antihistamines class
- Bilastine
- CP-118
- Late-stage development compounds recently discontinued
Overview for nasal corticosteroids
Patient potential
Comparative forecasts
Pipeline summary
Nasonex
- Nasonex forecast assumptions
- Trial data
Flixonase/Flonase
- Flixonase/Flonase forecast assumptions
- Trial data
Nasacort
Nasacort forecast assumptions
Trial data
Rhinocort
Rhinocort forecast assumptions
Trial data
Pipeline drugs in the nasal corticosteroid class
- Veramyst
- Omnair
- Nasal steroid/antihistamine combination
- Innovative anti-inflammatory projects
- Late-stage development compounds recently discontinued
Overview for oral antihistamine/decongestant combinations
Patient potential
Comparative forecasts
Zyrtec-D
- Zyrtec-D forecast assumptions
- Trial data
Allegra-D
- Allegra-D forecast assumptions
- Trial data
Clarinex-D
- Clarinex-D forecast assumptions
- Trial data
Overview for nasal antihistamines
Patient potential
Pipeline summary
Astelin
- Astelin forecast assumptions
- Trial data
Pipeline drugs in the nasal antihistamine class
- Patanase
- Other pipeline drugs in the nasal antihistamine class
Overview for antileukotrienes
Patient potential
Pipeline summary
Singulair
- Singulair forecast assumptions
- Trial data
Onon
- Onon forecast assumptions
- Trial data
Pipeline drugs in the antileukotrienes class
- Loratadine/montelukast combination
Overview for nasal decongestants
Overview for immunotherapy
Current market overview
Patient potential
Moving towards baseline therapy
- Immunotherapy is shown to be effective and safe
- Studies show long-term relief after discontinuation of immunotherapy
- Immunotherapy is thought to prevent new sensitizations
- Studies suggest role for immunotherapy in the prevention of asthma
- More studies needed to evaluate the safety of immunotherapy in asthma
- Showing safety of immunotherapy in children is an important step for expanding the market
- Immunotherapy can be cost-effective
Significant commercial opportunity
Pipeline summary
Companies involved in immunotherapy
- ALK-Abelló
- Stallergènes
- Allergy Therapeutics
- Dynavax
- Fornix Biosciences
- Curalogic
- Greer Laboratories
- Allergopharma
- HAL Allergy
Non allergen-based immunotherapy
- Cytos Biotechnology
- CMP Therapeutics
- Cobalis
Data definitions, limitations and assumptions
Over-the-counter (OTC) sales
Standard units
Japanese market data
Derivation of sales forecasts and pricing trends
Regional launch dates for new products
Generic erosion and pricing assumptions
Forecasts
Forecast methodology
Strategic scoping and focus
BIBLIOGRAPHY
Papers
Websites
Our reports
APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS
Summary allergic rhinitis market data
Antihistamines market data
Nasal corticosteroids market data
Antihistamine/decongestant combination market data
Antileukotrienes market data
Nasal anti-allergic agents market data
APPENDIX B - MARKET FORECAST DATA
Seven major markets
M5EU
US
Japan
France
Germany
Italy
Spain
UK
APPENDIX C
Contributing experts
Report methodology
Disclaimer
List of Tables
Table 1: The diagnosed AR population aged over 20 years old according to severity and allergen in the seven major markets (million), 2006 and 2016
Table 2: The diagnosed AR population aged over 20 years old according to severity and allergen in the US (million), 2006 and 2016
Table 3: The diagnosed AR population aged over 20 years old according to severity and allergen in Europe (million), 2006 and 2016
Table 4: The diagnosed AR population aged over 20 years old according to severity and allergen in Japan (million), 2006 and 2016
Table 5: Prevalence of allergic rhinitis symptoms and hay fever in patients aged 6-7 and 13-14 in the seven major markets, 2007
Table 6: Prevalence of allergic rhinitis symptoms and hay fever in patients aged 0-19 in the seven major markets, millions, 2007
Table 7: Key products in late-stage R&D pipeline for the treatment of allergic rhinitis, 2007
Table 8: Overview of types of immunotherapy products on the market, 2007
Table 9: Time trends in hay fever or allergic rhinitis in school-age children in the UK, Finland, and Germany, 1973-1996
Table 10: Effect of oral antihistamines on allergic rhinitis symptoms
Table 11: Overview of the top five oral antihistamines, 2006
Table 12: Sales forecasts of oral antihistamines, seven major markets ($m), 2006-2016
Table 13: Key products in the late-stage R&D pipeline for oral antihistamines in AR, 2007
Table 14: Clinical trial summary cetirizine versus fexofenadine
Table 15: Comparative safety data for bilastine, 2007
Table 16: Effect of nasal corticosteroids on allergic rhinitis symptoms
Table 17: Overview of the top four nasal corticosteroids, 2006
Table 18: Sales forecasts of nasal corticosteroids across the seven major markets ($m), 2006-2016
Table 19: Key products in the late-stage R&D pipeline for nasal corticosteroids in AR, 2007
Table 20: Clinical trial data of Veramyst versus placebo, 2007
Table 21: Clinical trial data of Omnair versus placebo in PAR and SAR, 2007
Table 22: Overview of the top oral antihistamine/decongestant combinations, 2006
Table 23: Sales forecasts of nasal corticosteroids across the seven major markets ($m) 2006-2016
Table 24: Effect of nasal antihistamines on allergic rhinitis symptoms
Table 25: Key products in the late-stage R&D pipeline for nasal antihistamines in AR, 2007
Table 26: Clinical trial summary of the safety and efficacy of olopatadine, 2007
Table 27: Effect of antileukotrienes on allergic rhinitis symptoms
Table 28: Key products in the late-stage R&D pipeline for antileukotrienes in AR, 2007
Table 29: Effect of nasal decongestants on allergic rhinitis symptoms
Table 30: Overview of immunotherapy products in development, 2007
Table 31: Launch forecast assumptions used in the asthma/COPD market, 2007
Table 32: Generic erosion in the seven major markets over 3 years (%)
Table 33: Generic price discounts in the seven major markets (%)
Table 34: US summary market data, 2006
Table 35: Japan summary market data 2006
Table 36: France summary market data, 2006
Table 37: Germany summary market data, 2006
Table 38: Italy summary market data, 2006
Table 39: Spain summary market data, 2006
Table 40: UK summary market data, 2006
Table 41: Zyrtec: key facts
Table 42: Telfast/Allegra: key facts
Table 43: Claritin: key facts
Table 44: Aerius/Clarinex: key facts
Table 45: Xyzal: key facts
Table 46: Nasonex: key facts
Table 47: Flixonase/Flonase: key facts
Table 48: Nasacort: key facts
Table 49: Rhinocort: key facts
Table 50: Zyrtec-D: key facts
Table 51: Allegra-D: key facts
Table 52: Clarinex-D: key facts
Table 53: Singulair: key facts
Table 54: Onon: key facts
Table 55: Astelin: key facts
Table 56: Seven major markets allergic rhinitis drug sales ($m) forecasts, 2006-2016
Table 57: 5EU allergic rhinitis drug sales ($m) forecasts, 2006-2016
Table 58: US allergic rhinitis drug sales ($m) forecasts, 2006-2016
Table 59: Japan allergic rhinitis drug sales ($m) forecasts, 2006-2016
Table 60: France allergic rhinitis drug sales ($000) forecasts, 2006-2016
Table 61: Germany allergic rhinitis drug sales ($000) forecasts, 2006-2016
Table 62: Italy allergic rhinitis drug sales ($000) forecasts, 2006-2016
Table 63: Spain allergic rhinitis drug sales ($000) forecasts, 2006-2016
Table 64: UK allergic rhinitis drug sales ($000) forecasts, 2006-2016
List of Figures
Figure 1: Concept of minimal persistent inflammation
Figure 2: Classification of allergic rhinitis based on duration and severity of symptoms
Figure 3: Distribution of severity of diagnosed allergic rhinitis patients, 2006
Figure 4: Total sales in the seven major markets by class ($ billion), 2003-06
Figure 5: Allergic rhinitis market by class and value in the seven major markets, 2006 and 2016
Figure 6: Top five brands by sales in seven major markets ($ billion), 2006
Figure 7: Allergic rhinitis market sales split by country, CAGR 2003-2006 (%), sales ($m) and market share (%), 2006
Figure 8: Key players in the allergic rhinitis market, 2002-06
Figure 9: Sales of top five companies involved in immunotherapy, 2006
Figure 10: Advantages and disadvantages of objective inflammatory endpoints
Figure 11: Opportunities and threats in the seven major markets, 2007
Figure 12: Drivers and resistors of prescription-to-OTC switching
Figure 13: Sales in Japan during a high pollen season ($ billion), 2004-06
Figure 14: Healthcare spending as a proportion of GDP in the seven major markets, 2004
Figure 15: Key pharmaceutical pricing controls used globally, 2006
Figure 16: US: total sales in the AR market, by class ($ billion), 2003-06
Figure 17: US: prescriptions of AR treatment per sex and age group, 2006
Figure 18: Differences and similarities of NDAs and monographs
Figure 19: Decrease of FDA's mean total approval time, 1995-2005
Figure 20: Japan: total sales in the AR market, by class ($ billion), 2003-2006
Figure 21: Japan: prescriptions of AR treatment per sex and age group, 2006
Figure 22: France: total sales in the AR market, by class ($m), 2003-06
Figure 23: France: prescriptions of AR treatment per sex and age group, 2006
Figure 24: Germany: total sales in the AR market, by class ($m), 2003-06
Figure 25: Germany: prescriptions of AR treatment per sex and age group, 2006
Figure 26: Italy: total sales in the AR market by class ($m), 2003-06
Figure 27: Italy: prescriptions of AR treatment per sex and age group, 2006
Figure 28: Spain: total sales in the AR market, by class ($m), 2003-06
Figure 29: Spanish prescriptions of AR treatment per sex and age group, 2006
Figure 30: UK: total sales in the AR market by class ($m), 2003-06
Figure 31: UK: prescriptions of AR treatment per sex and age group, 2006
Figure 32: ARIA treatment guidelines for allergic rhinitis, 2001
Figure 33: Sales forecasts of oral antihistamines, seven major markets ($m), 2006-2016
Figure 34: Sales of Zyrtec in allergic rhinitis per age group, 2006
Figure 35: Sales forecasts for Zyrtec, generic cetirizine and Xyzal , seven major markets ($m), 2006-2016
Figure 36: Sales of Xyzal in allergic rhinitis per age group, 2006
Figure 37: Sales forecasts for Xyzal, generic levocetirizine and Zyrtec in the seven major markets ($m), 2006-2016
Figure 38: Sales of Telfast/Allegra in allergic rhinitis per age group, 2006
Figure 39: Impact of patent expiry on sales of Telfast/Allegra in the US, 2003-06
Figure 40: Sales forecasts of Telfast/Allegra and generic fexofenadine, seven major markets ($m), 2006-2016
Figure 41: Sales of Claritin in allergic rhinitis per age group, 2006
Figure 42: Impact of patent expiry on sales of Claritin in the US, 2002-06
Figure 43: Sales forecasts of Claritin and generic loratadine, seven major markets ($m), 2006-2016
Figure 44: Sales of Aerius/Clarinex in allergic rhinitis per age group, 2006
Figure 45: Sales forecasts of Aerius/Clarinex and generic desloratadine, seven major markets ($m), 2006-2016
Figure 46: Sales forecasts of nasal corticosteroids across the seven major markets ($m), 2006-2016
Figure 47: Sales of Nasonex in allergic rhinitis per age group, 2006
Figure 48: Sales forecasts of Nasonex and generic mometasone in the seven major markets ($m), 2006-2016
Figure 49: Sales of Flixonase/Flonase in allergic rhinitis per age group, 2006
Figure 50: Impact of patent expiry on sales of Flixonase/Flonase in the seven major markets, 2003-06
Figure 51: Sales forecasts of Flixonase/Flonase, generic fluticasone propionate and Veramyst across the seven major markets ($m), 2006-2016
Figure 52: Sales of Nasacort in allergic rhinitis per age group, 2006
Figure 53: Sales forecasts of Nasacort and generic triamcinolone across the seven major markets ($m), 2006-2016
Figure 54: Sales of Rhinocort in allergic rhinitis per age group, 2006
Figure 55: Sales forecasts of Rhinocort and generic budesonide across the six major markets ($m), 2006-2016
Figure 56: GSK's Veramyst device (fluticasone furoate)
Figure 57: Sales forecasts of Veramyst, Flixonase/Flonase and generic fluticasone across the seven major markets ($m), 2006-2016
Figure 58: Sales forecasts of Omnair across the seven major markets ($m), 2006-2016
Figure 59: Sales forecasts of a nasal steroid/antihistamine combination across the six major markets ($m), 2006-2016
Figure 60: Sales of oral antihistamine/decongestant combinations in Europe and the US (%), 2006
Figure 61: Sales forecasts of oral antihistamine/decongestant combinations across the seven major markets ($m), 2006-2016
Figure 62: Sales of Zyrtec-D in allergic rhinitis per age group, 2006
Figure 63: Sales forecasts of Zyrtec-D, Zyrtec and generic cetirizine across the seven major markets ($m), 2006-2016
Figure 64: Sales of Allegra-D in allergic rhinitis per age group, 2006
Figure 65: Sales forecasts of Allegra-D, Telfast/Allegra and generic fexofenadine across the seven major markets ($m), 2006-2016
Figure 66: Sales of Clarinex-D in allergic rhinitis per age group, 2006
Figure 67: Sales forecasts of Clarinex-D, Aerius/Clarinex and generic desloratadine, 7MM ($m), 2006-2016
Figure 68: Sales of Astelin in allergic rhinitis per age group, 2006
Figure 69: Sales forecasts of Astelin and generic azelastine across the seven major markets ($m), 2006-2016
Figure 70: Sales forecasts of Patanase in the US and Japan ($m), 2006-2016
Figure 71: Sales of Singulair in allergic rhinitis per age group, 2006
Figure 72: Sales forecasts of Singulair and generic montelukast across the seven major markets ($m), 2006-2016
Figure 73: Sales of Onon in allergic rhinitis per age group, 2006
Figure 74: Sales forecasts of Onon and generic pranlukast, across the seven major markets ($m), 2006-2016
Figure 75: Sales forecasts of loratadine/montelukast fixed dose combination in the US ($m), 2006-2016
Figure 76: Sales forecasts of the nasal decongestant class, US ($m), 2006-2016
Figure 77: Key players in the immunotherapy market, 2007
Figure 78: Sales of immunotherapy per type of administration, 2006
Figure 79: Current limitations of immunotherapy in allergic rhinitis
Figure 80: The allergic march
Figure 81: Minimum and maximum cost of treatment with immunotherapy per patient per year
Figure 82: Patient potential for a tablet-based grass allergen immunotherapy in the seven major markets, 2007
Figure 83: Immunotherapy market in the treatment of allergic rhinitis has opportunities to expand
Figure 84: Distribution of pipeline products according to allergen, 2007
Figure 85: Overview of non-subcutaneous immunotherapy products in development, 2007
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