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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)
AbstractIntroduction
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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