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1、HEALTHCARE The Gastrointestinal Market Outlook to 2012 By Melissa Zebrowski ii Melissa Zebrowski Melissa Zebrowski is a pharmaceutical industry analyst with over seven years of experience in healthcare and biopharma policy. During this time she has worked for four years as a consultant providing mar
2、ket research and analysis services, with a therapeutic focus spanning Oncology, Central Nervous System, Gastrointestinal, and Infectious Disease areas. Copyright 2007 Business Insights Ltd This Management Report is published by Business Insights Ltd. All rights reserved. Reproduction or redistributi
3、on of this Management Report in any form for any purpose is expressly prohibited without the prior consent of Business Insights Ltd. The views expressed in this Management Report are those of the publisher, not of Business Insights. Business Insights Ltd accepts no liability for the accuracy or comp
4、leteness of the information, advice or comment contained in this Management Report nor for any actions taken in reliance thereon. While information, advice or comment is believed to be correct at the time of publication, no responsibility can be accepted by Business Insights Ltd for its completeness
5、 or accuracy. iii Table of Contents The Gastrointestinal Market Outlook to 2012 Executive Summary 12 Patient potential of GIT therapeutic area 12 Global market analysis 13 Pipeline analysis 14 Competitive landscape 15 Chapter 1 Patient potential of GIT therapeutic area 18 Summary 18 Introduction 19
6、Gastroesophageal reflux disorder 21 Overview 21 Diagnosis, treatment and management 22 Epidemiology 23 Forecast epidemiology 25 Peptic ulcer disease 26 Overview 26 Diagnosis, treatment and management 28 Epidemiology 29 Forecast epidemiology 30 Irritable bowel syndrome 32 Overview 32 Diagnosis, treat
7、ment and management 33 Epidemiology 34 Forecast epidemiology 36 Ulcerative colitis 37 Overview 37 Diagnosis, treatment and management 38 Epidemiology 39 Forecast epidemiology 40 Crohns disease 41 Overview 41 Diagnosis, treatment and management 42 Epidemiology 43 Forecast epidemiology 45 iv Chapter 2
8、 Global market analysis 48 Summary 48 Introduction 49 Market analysis by country 49 Licensing trends 50 Market analysis by drug class 51 Leading brand dynamics 54 Key events in the GIT market 56 Gastroesophageal reflux disorder and peptic ulcer disease 57 Leading brands of the GERD/PUD market 60 Pro
9、ton pump inhibitor market analysis 62 Market dynamics 62 Key brands analysis 62 Histamine-2 receptor antagonist market analysis 71 Market dynamics 71 Key brands analysis 72 GERD/PUD sales forecasts to 2012 76 Irritable bowel syndrome 77 Competitive dynamics of IBS subclasses 77 Leading brands of the
10、 IBS market 80 GI sensorimotor modulators market analysis 81 Market dynamics 81 Key brands analysis 82 Antispasmodics/anticholinergics 85 Market dynamics 85 IBS sales forecasts to 2012 87 Inflammatory bowel disease: Crohns disease and ulcerative colitis 88 Competitive dynamics of Crohns disease and
11、ulcerative colitis subclasses 88 Leading brands of IBD subclasses 91 Immunosuppressants market analysis 93 Market dynamics 93 Key brands analysis 94 Anti-rheumatic agents 98 Market dynamics 98 Key brands analysis 98 Intestinal anti-inflammatory agents 101 Market dynamics 101 Key brands analysis 101
12、IBD sales forecasts to 2012 103 Total GIT sales forecasts to 2012 104 Chapter 3 Pipeline analysis 106 Summary 106 v Introduction 107 Key trends in R ? Peptic ulcer disease (PUD); ? Irritable bowel syndrome (IBS); ? Ulcerative colitis (UC); ? Crohns disease (CD). A summary of the main prevalence data
13、 for the chapter is given below in Table 1.1. Table 1.1: Estimated prevalence of major GIT indications in the seven major pharmaceutical markets, 2006 Country GERD/PUD IBS IBD* prev. (000s) prev. (000s) prev. (000s) France 19,790 2,861 115 Germany 36,776 14,839 85 Italy 5,817 7,035 100 Spain 6,507 4
14、,525 97 UK 13,582 10,122 72 EU5 82,472 39,383 469 US 130,766 42,082 942 Japan 24,490 13,640 116 Total 237,728 95,106 1,527 * = Includes Crohns disease and ulcerative colitis Source: Authors research, various epidemiological studies Business Insights Ltd Although there remain many weaknesses in epide
15、miological surveys investigating the prevalence of various GIT related conditions, particularly IBS and ulcerative colitis, there is consensus that GERD/PUD-related conditions are the most common major 21 gastrointestinal disorder. This is followed by IBS, a chronic disorder of the lower gastrointes
16、tinal tract and is primarily associated with abdominal pain and a change in the consistency and/or frequency of bowel movements. These three major indications dominate the GIT market and play a pivotal role in defining market potential. Gastroesophageal reflux disorder Overview GERD is defined as th
17、e failure of the anti-reflux barrier, which allows for the abnormal reflux of gastric contents into the esophagus. Caused by a defective band of muscles known as the lower esophageal sphincter (LES), the resulting gastric reflux can cause damage to the esophagus, pharynx, or respiratory tract and le
18、ad to symptoms that negatively affect an individuals quality of life. The American Gastroenterological Association estimates the direct costs of GERD to be $9.8bn per year in the US alone. GERD is thought to have a multi-factorial etiology, which may include temporary relaxations of the LES, delayed
19、 stomach emptying, and the inability of the esophageal tissue to repair itself. Dietary and lifestyle factors may also exacerbate the symptoms of GERD, which includes diets high in caffeine, chocolate and fatty foods, and smoking. In addition, the presence of a hiatal hernia, most common in people o
20、ver the age of 50, and occurring when the stomach moves into the chest due to a weakening in the diaphragm muscle at the hiatus, increases the likelihood of reflux. The herniated area of the stomach may then form a pocket that traps acid, which is then refluxed into the esophagus. The symptoms of GE
21、RD include heartburn (pyrosis), acid regurgitation, chest pain, sore throat and/or painful swallowing, chronic cough, excessive salivation, and inflammation of the sinuses (sinusitis). With prolonged irritation of the lower part of the esophagus from repeated reflux, the cells lining the esophagus m
22、ay change, potentially causing conditions such as Barretts esophagus to arise. Episodes of normal reflux typically occur after meals, are brief and without symptoms, and rarely occur during sleep. Acid reflux becomes pathological when an individual develops frequent symptoms or when the esophagus be
23、comes damaged. 22 Diagnosis, treatment and management GERD is often confirmed by an endoscopy, which allows for an evaluation of the esophagus and any inflammation or damage. It may also be diagnosed by a barium x- ray to show inflammation of the esophagus or to demonstrate how efficient swallowing
24、is. An esophageal pH test is another diagnostic method, which involves swallowing a thin tube that is left in the esophagus for 24 hours. During this period, the patient keeps a diary of symptoms while the amount of acid reaching the esophagus is measured to determine the frequency of reflux and rel
25、ationship of reflux to symptoms. Esophageal manometry may also be used to measure esophageal muscle contractions in order to determine if the lower esophageal sphincter is functioning properly. A number of complications may arise in the presence of severe GERD. Repeated acid reflux may result in eso
26、phageal ulcers or the narrowing of the esophagus due to scarring. In cases where the acid reaches the throat, inflammation of the vocal cords results, causing a sore throat. If the acid reaches the lungs, the outcome may be asthma, aspiration pneumonia or permanent lung damage. Barretts esophagus is
27、 a complication associated with severe chronic GERD and is a pre-cancerous condition of the esophagus. Barretts esophagus occurs when the normal cell type that lines the lower part of the esophagus (squamous cells) is replaced by a different cell type (intestinal cells). Repetitive damage to the eso
28、phageal lining induces the replacement of the squamous cells of the esophagus by intestinal cells. Although the intestinal cells are more resistant to acid, these cells have a small probability to transform into cancer cells. GERD is a chronic and recurrent disease with treatment largely dependent o
29、n its severity. In the instance of mild symptoms, many individuals adjust their diet (avoiding fats and chocolates) and lifestyle behaviors (refraining from smoking), or take over the counter (OTC) medications such as antacids and histamine2-receptor antagonists (H2RAs). H2RAs that are commonly pres
30、cribed include ranitidine and famotidine. With moderate to severe symptoms, or with mild symptoms that have not been alleviated, treatment often entails the use of proton pump inhibitors (PPIs), which include esomeprazole, pantoprazole and lansoprazole. 23 Because of the effectiveness of medical the
31、rapy, surgery has become a relatively under- utilized option and is suggested for those whose symptoms are unresponsive to drug therapy or for young patients demonstrating the need for permanent medical therapy. Surgery to prevent the pathological reflux of acid typically involves repairing the hiat
32、al hernia and strengthening the lower esophageal sphincter. The long-term effectiveness of this surgery, however, is not fully understood. Epidemiology Table 1.2 shows estimates of the current prevalence of GERD within France, Germany, Italy, Spain, the UK, the US and Japan. Table 1.2: Estimated pre
33、valence of GERD across the seven major markets, 2006 Country Prevalence (000s) Prevalence (%) Share in 2006 (%) France 19,056 31.3% 8.4% Germany 35,449 43.0% 15.6% Italy 5,233 9.0% 2.3% Spain 6,060 15.0% 2.7% UK 12,728 21.0% 5.6% EU5 78,526 26.0% 34.6% US 125,351 42.0% 55.3% Japan 22,819 17.9% 10.1%
34、 Total 226,696 31.1% 100.0% Source: Alimentary Pharmacology while the prevalence of NSAID associated PUD is increasing. The US, with an estimated 5.4m people affected by PUD, is the largest contributor to the prevalence of PUD globally. It is further estimated that 500,000 new cases of PUD occur yea
35、rly in the US, equating to 1.8% one-year point prevalence and a lifetime prevalence of 8%-14%. The estimated prevalence of PUD is tightly grouped among France (1.2%), Italy (1%) and Spain (1.1%). Germany and the UK, however, are estimated to feature slightly higher prevalence rates when compared to
36、other European countries, at 1.6% and 1.4% respectively. The prevalence rate of PUD in Japan was estimated at 1.3% in 2006. 30 Forecast epidemiology The changing epidemiology of PUD can be correlated with factors such as increasing age, changes in smoking prevalence and the increasing use of NSAIDs.
37、 Despite a decreasing prevalence of H. pylori and the increasing use of effective eradication regimens, the prevalence of PUD is forecast to remain largely unchanged, with NSAIDs believed to play a large role in this indications prevalence. Table 1.5 provides the forecast prevalence of PUD in the se
38、ven major markets over the period 2006-2012. 31 Table 1.5: Forecast epidemiology of PUD across the seven major markets, 2006-12 Country 2006 2007(f) 2008(f) 2009(f) 2010(f) 2011(f) 2012(f) France Prevalence (000s) 734 739 743 748 753 757 762 Prevalence rate (%) 1.2% 1.2% 1.2% 1.2% 1.2% 1.2% 1.2% Ger
39、many Prevalence (000s) 1,327 1,331 1,335 1,339 1,343 1,344 1,345 Prevalence rate (%) 1.6% 1.6% 1.6% 1.6% 1.6% 1.6% 1.6% Italy Prevalence (000s) 584 586 588 590 592 593 594 Prevalence rate (%) 1.0% 1.0% 1.0% 1.0% 1.0% 1.0% 1.0% Spain Prevalence (000s) 447 448 450 452 454 455 455 Prevalence rate (%) 1
40、.1% 1.1% 1.1% 1.1% 1.1% 1.1% 1.1% UK Prevalence (000s) 854 859 864 869 874 876 879 Prevalence rate (%) 1.4% 1.4% 1.4% 1.4% 1.4% 1.4% 1.4% EU5 Prevalence (000s) 3,946 3,963 3,980 3,998 4,015 4,024 4,035 Prevalence rate (%) 1.3% 1.3% 1.3% 1.3% 1.3% 1.3% 1.3% US Prevalence (000s) 5,415 5,487 5,560 5,63
41、3 5,708 5,759 5,810 Prevalence rate (%) 1.8% 1.8% 1.8% 1.8% 1.8% 1.8% 1.8% Japan Prevalence (000s) 1,671 1,678 1,686 1,693 1,701 1,702 1,703 Prevalence rate (%) 1.3% 1.3% 1.3% 1.3% 1.3% 1.3% 1.3% Total Prevalence (000s) 11,032 11,128 11,226 11,324 11,424 11,486 11,548 Prevalence rate (%) 1.5% 1.5% 1
42、.5% 1.5% 1.5% 1.5% 1.5% (f) - forecast Source: American Jrnl of Epidemiology, Alimentary Pharmacology onset associated with a change in the frequency of the stool; and/or, onset associated with a change in the form and appearance of stool, in order to deliver a positive diagnosis. In addition, the f
43、ollowing symptoms are not essential for the diagnosis of IBS, but their presence increases the likelihood of diagnosis: abnormal stool frequency (more than three times per day or less than three times per week); abnormal stool form (hard, loose or watery); passage of mucus, and bloating (Drossman DA
44、, et. al, 1999). The majority of individuals with IBS-related symptoms, however, do not seek care, greatly impacting upon their quality of life. Those who do seek care in Western countries are mostly female, with an observed a 2:1 female-to-male ratio. This may be attributed to cultural differences
45、in health-seeking behaviors and/or hormonal differences between genders that may affect the functioning of the gastrointestinal system. A majority of studies around IBS have found an inverse relationship between IBS prevalence and age, with IBS most common in men and women between the ages of 18 and
46、 24. Treatment of IBS is typically a long-term process, underpinned by a combination of dietary modification, lifestyle therapy, and psychological and pharmacological treatment. Currently, there is little conclusive evidence on the role of dietary 34 modification in treating the onset of IBS; rather
47、 it is seen as a key component of therapy in conjunction with the above strategies. Dietary fiber and laxatives are frequently recommended for patients with constipation- predominant IBS. Anti-diarrheal agents, including loperamide, are often prescribed to those suffering from diarrhea-predominant I
48、BS. In addition, anti-spasmodics and anti- cholinergic agents are used for patients presenting with pain and diarrhea. Low doses of antidepressants appear to be useful in alleviating abdominal pain. One of the most promising approaches to IBS treatment involves medications that alter the action of s
49、erotonin in the colon. These drugs act on the serotonin receptors of intestinal nerves, specifically serotonin-3 (5-HT3) and serotonin-4 (5-HT4) receptors. Epidemiology The prevalence of IBS across the seven major pharmaceutical markets in 2006 is detailed in Table 1.6. Table 1.6: Estimated prevalence of IBS in the seven major pharmaceutical markets, 2006 County Prevalence (000s) Prevalence rate (%) Share in 2006 France 2,861 4.7% 3.0% Germany 14,839 18.0% 15