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Commercial And Pipeline Insight: Allergic Rhinitis

Published by: Datamonitor

Published: Oct. 8, 2007 - 319 Pages


Table of Contents


ABOUT DATAMONITOR HEALTHCARE

About the Respiratory and Infectious Disease pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor 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

Datamonitor 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

Abstract

Introduction

The allergic rhinitis market will continue to decline over the next few years, after which it will resume limited growth due to the introduction of new compounds and combination products. These will drive the expansion of sales in existing classes as they exhibit safety and convenience advantages. Meanwhile, immunotherapy is expected to move from its niche position into mainstream therapy.

Scope

Indication-based forecasts for allergic rhinitis products and significant pipeline drugs Assessment of country-specific drivers and resistors likely to impact the market Future market outlook for individual products taking into account key market events, in particular patent expiry and competitor launch dates Assessment of the remaining unmet clinical needs in allergic rhinitis, analyzing the potential of new targeted therapies

Highlights

The allergic rhinitis market was worth about $10 billion in 2006 and has been decreasing in value over the last few years due to patent expiries and limited levels of innovation. The top 2 drug classes prescribed for the treatment of allergic rhinitisoral antihistamines and nasal corticosteroidsaccounted for 77% of the total sales in this market. At least 3 major allergic rhinitis players have developed and launched an oral antihistamine/decongestant fixed dose combination. However, several practical concerns have limited the use of these treatments and none of the products have reached sales as high as their single antihistamine component. The immunotherapy market is moving from a niche position towards baseline therapy. Datamonitor expects a sublingual tablet for the treatment of grass allergy (such as Grazax) to be able to reach annual sales of $780m to $1.3 billion, depending on the patient population targeted, the length of administration and price of the product.

Reasons to Purchase

Identify key opportunities and threats that will impact the use and uptake of new and existing products Quantify the future size and scope of the allergic rhinitis market and predict the future performance of key compounds Understand and capitalize on clinical unmet needs in the market, either through lifecycle management of marketed drugs or new product development

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