Contents:

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

Companies Mentioned

- ALK-Abelló - Allergopharma - Allergy Therapeutics - CMP Therapeutics - Cobalis - Curalogic - Cytos Biotechnology - Dynavax - Fornix Biosciences - GlaxoSmithKline - Greer Laboratories - HAL Allergy - Merck & Co - Pfizer - Sanofi-Aventis - Schering-Plough - Sepracor - Stallergènes - UCB