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Commercial Insight: Inflammatory Bowel Disease - Convenience and compliance drive market success

Published by: Datamonitor

Published: Sep. 8, 2008 - 263 Pages


Table of Contents


ABOUT DATAMONITOR HEALTHCARE

About the Immunology & Inflammation pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Strategic scoping and focus

Datamonitor insight into the disease market

Related reports

Upcoming related reports

CHAPTER 2 MARKET DEFINITION

The inflammatory bowel disease market definition

Biologics

TNF inhibitors

Integrin inhibitor

Intestinal anti-inflammatory drugs (5-aminosalicylates)

Immunomodulators

Corticosteroids

ICD-10 codes used to define the inflammatory bowel disease indications

Crohn's disease

Ulcerative colitis

Assumptions and caveats for diagnosis value estimates

Diagnosis value based on retail data only

CHAPTER 3 PATIENT ACQUISITION PROCESS

Introduction

Patient care path

Points of influence in the patient care path

Trigger Point 1: Disease awareness among patients and physicians is critical to increasing diagnosis rates

Trigger Point 2: Tackling patient compliance during maintenance treatment

Trigger Point 3: Physician assessment of disease severity influences treatment choice - using "step-up" or "top-down" strategies

Factors that influence patient flow through the healthcare system

Increased public awareness leading to early presentation to PCP or a specialist

Symptoms of disease can be mild, therefore, patients do not present for treatment

Patients sometimes forget to take medication if they feel symptoms have improved

Self-management limits patient follow-up

CHAPTER 4 MARKET OVERVIEW

Seven major markets

Current market assessment

Impressive historical growth in inflammatory bowel disease sales from 2004 to 2007

Inflammatory bowel disease market volume is increasing, but due to the uptake of biologics, sales growth is outstripping it

Anti-TNFs contributed to half of all sales in the inflammatory bowel disease market in 2007

Spain and France show highest growth in the seven major markets in 2006-07

Future market assessment

Opportunities and threats

Opportunities

Threats

US

Current market assessment

The US was the largest of the seven major markets in 2007

Anti-TNFs held a 55% share of the US inflammatory bowel disease market in 2007

Corticosteroids demonstrated highest CAGR from 2004 to 2007

Abbott's Humira experienced strong US uptake from 2006 to 2007

Rowasa's US sales continue to decrease in light of generic competition

Future market assessment

Opportunities and threats

Opportunities

Threats

Japan

Current market assessment

Japan was the second largest market in terms of sales in 2007

Intestinal anti-inflammatory drug class dominates inflammatory bowel disease market in Japan

Nisshin Kyorin's Pentasa is the leading brand for inflammatory bowel disease in Japan

Mitsubishi Tanabe's Remicade experiences low growth from 2006 to 2007

Future market assessment

Opportunities and threats

Opportunities

Threats

Europe

Current market assessment

Inflammatory bowel disease sales grew by 28% in the 5EU from 2006 to 2007

Anti-TNFs drive growth in the 5EU inflammatory bowel disease market

Intestinal anti-inflammatory drug class sales remain ahead of anti-TNFs in 5EU

Remicade demonstrated the best performance in the 5EU from 2006 to 2007

Future market assessment

Opportunities and threats

Opportunities

Threats

France

Current market assessment

Inflammatory bowel disease market achieved sales of $137m in 2007

Future market assessment

Germany

Current market assessment

Germany is the largest inflammatory bowel disease market in the 5EU

Future market assessment

Italy

Current market assessment

Second smallest inflammatory bowel disease market behind Spain in 2007

Future market assessment

Spain

Current market assessment

Spain showed highest CAGR of all the major markets from 2004 to 2007

Future market assessment

UK

Current market assessment

Although anti-TNF class is growing rapidly, intestinal anti-inflammatory agents retain largest share of the UK market

Future market assessment

Rest of World snapshot

Current market assessment

Rest of World accounts for only 13% of global inflammatory bowel disease market sales

Global inflammatory bowel disease market sales increased with a 14.3% CAGR from 2004 to 2007

Asia-Pacific, particularly China, is the area of highest growth in the Rest of World

Other regions, such as Russia, show promising growth in the inflammatory bowel disease market

Canada is the largest Rest of World market after the rest of Europe.

Remicade is the leading brand in the Rest of World

Opportunities and threats

Opportunities

Threats

CHAPTER 5 BRAND DYNAMICS

Overview of competitive landscape

Drivers of brand choice

Factors driving brand choice in the anti-TNF class

Patient preference, cost and mode of delivery are among drivers of brand choice for anti-TNFs

US formulary status for leading brands

Humira is better positioned than Remicade in most US formularies

Asacol has desirable Tier-2 coverage in most plans

Remicade (infliximab; Centocor/Johnson & Johnson, Schering-Plough and Mitsubishi Tanabe)

Drug profile

Product positioning

Remicade is positioned in multiple Crohn's disease patient populations

Ulcerative colitis approval expands scope for Remicade product positioning

Colectomy avoidance indication will have a small positive impact on Remicade sales

Remicade advances up to second-line therapy for Crohn's disease in the EU

SONIC trial directly evaluates Remicade against immunosuppressants

Marketing mix

Marketing mix for Remicade is varied, but Centocor is promoting the message of evidence and experience

Centocor finds new marketing channel in the form of a documentary

Mitsubishi Tanabe's strengthened promotion of Remicade in Japan is a core marketing strategy

Brand forecast to 2017

Remicade's sales grow in the near term but then decline amid competition from new products and biosimilars

Japan is the only major market where Remicade will experience overall growth to 2017

Infliximab biosimilars will achieve sales of $160m in 2017

Strategic recommendations

Humira (adalimumab; Abbott, Eisai)

Drug profile

Product positioning

The GAIN trial positioned Humira to capture infliximab-failure patients, however, competition now comes from Cimzia and Tysabri

Abbott now has 2-year data for Humira, which will allow better positioning against Remicade

Humira is building up clinical data beyond remission

Remicade will remain choice ahead of Humira for treating fistulizing Crohn's disease

Marketing mix

Abbott has relied on heavy marketing of Humira

Abbott signs up Eisai to co-promote Humira in Japan

Abbott promoted the "sustainable impact" of Humira at the DDW 2008

Brand forecast to 2017

Humira will experience strong uptake for inflammatory bowel disease in the seven major markets and will be market leader by 2014

Strategic recommendations

Cimzia (certolizumab; UCB)

Drug profile

Product positioning

UCB chose a lower price point to position Cimzia in the competitive anti-TNF market

Like Humira, Cimzia will be positioned in the infliximab-failure population, but as third-line choice

Marketing mix

UCB must launch a hard-hitting marketing campaign for Cimzia

'CIMplicity' includes the home health nurse program for Cimzia administration

Crohn's & Me society will increase disease awareness and promote Cimzia

UCB and Otsuka will co-promote Cimzia in Japan

Brand forecast to 2017

Third-line competition will cap Cimzia sales in inflammatory bowel disease

Strategic recommendations

Tysabri (natalizumab; Biogen Idec, Elan)

Drug profile

Product positioning

Tysabri positioned towards Crohn's disease patients who fail anti-TNF therapy

Tysabri reduces hospitalization rates

Elan and Biogen Idec funded study shows Tysabri most cost-effective therapy for anti-TNF-failure patients

Marketing mix

TOUCH program - newly confirmed cases of PML will limit uptake of Tysabri in Crohn's disease

Brand forecast to 2017

Safety concerns dampen Tysabri's sales forecast in Crohn's disease

Strategic recommendations

Asacol (mesalazine, Procter & Gamble)

Drug profile

Product positioning

Procter & Gamble's strong product positioning facilitates Asacol's market leadership

Asacol looking to compete with Pentasa in Japan

Marketing mix

Asacol is the most heavily promoted intestinal anti-inflammatory brand, but Lialda is close behind

Brand forecast to 2017

Competition from Lialda and Salofalk Granustix will diminish Asacol's US and 5EU sales

Strategic recommendations

Pentasa (mesalazine; Shire, Ferring, Nisshin Kyorin)

Drug profile

Product positioning

Pentasa has ulcerative colitis indication, but Crohn's disease generates majority of sales, especially in the US

Pentasa and Lialda co-exist in Shire's gastroenterology franchise without signs of cannibalization

Once-daily Pentasa more effective than twice-daily dosing of Pentasa

Marketing mix

Pentasa's promotional spend falls behind Asacol and Lialda

Brand forecast to 2017

Strategic recommendations

Lialda/Mezavant (MMX mesalazine; Shire, Giuliani, Cosmo)

Target product profile

Product positioning

Shire will roll-out Lialda across the rest of the EU in 2008

Shire markets Lialda as a once-daily tablet in the US, but reduced number of tablets per day does not equate to lower costs

Lialda aims to acquire share from market-leader Asacol

Marketing mix

Shire and Takeda will co-promote Lialda in the US

Drug forecast to 2017

Once-daily dosing and reduced pill burden will propel Lialda to become the market-leading 5-ASA brand

Strategic recommendations

Golimumab (CNTO-148; Centocor/Johnson & Johnson, Schering-Plough, Mitsubishi Tanabe, Janssen Pharmaceutical)

Target product profile

Development overview

Product positioning

Centocor/Johnson & Johnson and Schering-Plough will position golimumab (CNTO-148) in the ulcerative colitis population

Marketing mix

Golimumab's (CNTO-148) marketing will be akin to Remicade's

Drug forecast to 2017

Strategic recommendations

Other marketed brands

Salofalk Granustix (mesalazine; Dr Falk Pharma, Salix Pharmaceuticals)

Salofalk Granustix is a once-daily granule mesalazine formulation and will compete with Lialda in the US

Salix Pharmaceuticals's experienced sales force an advantage to Salofalk Granustix

Entocort (budesonide; Prometheus Laboratories, AstraZeneca)

Abstract

Introduction

Several product launches and indication expansion caused substantial sales growth in the seven major inflammatory bowel disease markets from $1.7 billion in 2004 to $2.7 billion in 2007. Datamonitor forecasts the IBD market will grow with a CAGR (200717) of 4.6% to reach $4 billion in 2017 and success will depend on brands demonstrating patient convenience and improved compliance. Scope
  • In-depth analysis of the current and future inflammatory bowel disease market across the US, 5 EU and Japanese markets, and a rest of world snapshot
  • Crohn's disease and ulcerative colitis specific sales forecasts for key brands to 2017, with total brand figures to benchmark IBD sales against
  • Provides detailed brand dynamics discussion, including analysis of the anti-TNFs Remicade, Humira, Cimzia and impact of new products such as Tysabri
  • Assess the strategies of the key developers in the IBD market
Highlights
  • Anti-TNF sales will peak at over $2 billion in 2012 because of earlier use, extension into ulcerative colitis, uptake of Cimzia (certolizumab) and the launch of golimumab (CNTO-148). Despite competitive pressure from novel agents and biosimilars, the TNF inhibitors will generate $1.8 billion in IBD indications in 2017 and retain market dominance.
  • Cimzia is the third anti-TNF for Crohn's disease, but with few perceived advantages, it will remain a third-line therapy. Time on the market, method of delivery and patient preference will increasingly determine anti-TNF choice. Humira will attain market and class leadership from Remicade by 2014, achieving IBD sales of $0.8 billion by 2017.
  • Patient convenience/compliance will drive brand choice in the homogenous 5-ASA class. Lialda reduces pill burden and data indicate superiority to Asacol. With its favorable once-daily dosing, Lialda is set to head the 5-ASA class and smart marketing will minimize Pentasa cannibalization. Lialda will generate total brand sales of over $400 m in 2017
Reasons to Purchase
  • Quantify the current size of IBD sales in the seven major markets and understand trends in the rest of the world
  • Assess the impact of events, such as biosimilars entry, on sales of over 30 key brand name products
  • Understand the IBD patient acquisition process as well as specific market opportunities and threats


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