VOMITING INTESTINAL GAS CONSTIPATION DIARRHEA TABLE 1 CAUSES OF DIARRHEA GASTROINTESTINAL TRACT WALL DISORDERS...

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1 CHAPTER ONE: INTRODUCTION.1 STUDY GOALS AND OBJECTIVES... 1 REASONS FOR DOING THE STUDY... 1 INTENDED AUDIENCE... 1 SCOPE OF REPORT... 2 METHODOLOGY AND INFORMATION SOURCES... 2 ANALYST CREDENTIALS... 3 RELATED BCC REPORTS... 3 BCC ONLINE SERVICES... 4 DISCLAIMER... 4 CHAPTER TWO: EXECUTIVE SUMMARY... 5 EXECUTIVE SUMMARY... 5 SUMMARY TABLE GLOBAL PRESCRIPTION AND OTC GASTROINTESTINAL DISORDER TREATMENT MARKET, THROUGH 2014 ($ MILLIONS)... 6 SUMMARY FIGURE GLOBAL PRESCRIPTION AND OTC GASTROINTESTINAL DISORDER TREATMENT MARKET, ($ MILLIONS)... 6 CHAPTER THREE: INDUSTRY OVERVIEW... 7 STRUCTURE AND FUNCTION OF THE GASTROINTESTINAL SYSTEM... 7 STRUCTURE AND FUNCTION (CONTINUED)... 8 INGESTION AND PROPULSION OF FOOD... 9 Mouth... 9 Pharynx... 9 Esophagus DIGESTION AND ABSORPTION Mouth Stomach Small Intestines Physiology of Digestion Physiology of Digestion (Continued) ELIMINATION Large Intestine LIVER, BILIARY TRACT AND PANCREAS LIVER BILIARY TRACT Bilirubin Metabolism PANCREAS GASTROINTESTINAL TRACT DISORDERS DYSPHAGIA Dysphagia (Continued) ESOPHAGEAL AND ABDOMINAL PAIN... 17

2 VOMITING INTESTINAL GAS CONSTIPATION DIARRHEA TABLE 1 CAUSES OF DIARRHEA GASTROINTESTINAL TRACT WALL DISORDERS GASTRITIS TABLE 2 COMMON CAUSES OF GASTRITIS GASTROENTERITIS PEPTIC ULCER DISEASE Peptic Ulcer Disease (Continued) GASTRIC ULCERS DUODENAL ULCERS INFLAMMATORY BOWEL DISEASE ULCERATIVE COLITIS CROHN S DISEASE ENTEROCOLITIS DIVERTICULAR DISEASE GASTROINTESTINAL TRACT MOTILITY DISORDERS IRRITABLE BOWEL SYNDROME INTESTINAL OBSTRUCTION GASTROINTESTINAL MALABSORPTION DISORDERS CELIAC DISEASE TROPICAL SPRUE CANCERS OF THE GASTROINTESTINAL TRACT ESOPHAGEAL CANCER GASTRIC CANCER LIVER CANCER PANCREATIC CANCER SMALL INTESTINAL CANCER COLONIC POLYPS AND COLON CANCER Colonic Polyps and (Continued) U.S. DEMOGRAPHICS TABLE 3 U.S. ESTIMATED INCIDENCE/PREVALENCE/MORTALITY OF SELECTED GASTROINTESTINAL CONDITIONS TABLE 4 U.S. POPULATION BY SELECTED AGE GROUPS, 2009 AND 2014 (THOUSANDS) FIGURE 1 U.S. POPULATION BY SELECTED AGE GROUPS, 2009 AND 2014 (THOUSANDS) FIGURE 2 U.S. POPULATION SELECTED AGE GROUPS BY PERCENT OF TOTAL POPULATION, 2009 AND 2014 (%) PILL-SIZED VIDEO CAMERA PILLCAM ESO SMARTPILL... 42

3 RADIO FREQUENCY IDENTIFICATION TECHNOLOGY IPHONE APPLICATION ENTERIC NERVOUS SYSTEM INSURANCE COVERAGE MONOCLONAL ANTIBODIES WYETH IN SUIT WITH STATES GENERIC INFLUENCE BRANDED VS OTC PROTON PUMP INHIBITORS MAIL ORDER TRENDS MAIL ORDER TRENDS (CONTINUED) CHAPTER FOUR: PRESCRIPTION PRODUCT SEGMENTS BY TYPE ANTIDIARRHEALS SYSTEMICALLY ACTING ANTIDIARRHEALS OPIUM PRODUCTS TABLE 5 MARKETED ANTIDIARRHEAL PRODUCTS MARKET SIZE AND GROWTH TABLE 6 GLOBAL PRESCRIPTION ANTIDIARRHEAL MARKET, BY REGION, THROUGH 2014 ($ MILLIONS) FIGURE 3 GLOBAL PRESCRIPTION ANTIDIARRHEAL MARKET, BY REGION, THROUGH 2014 ($ MILLIONS) COMPETITIVE STRUCTURE AND MARKET SHARE TABLE 7 GLOBAL PRESCRIPTION ANTIDIARRHEAL REVENUES AND MARKET SHARE LEVELS, BY MANUFACTURER, 2009 ($ MILLIONS/%) FIGURE 4 GLOBAL PRESCRIPTION ANTIDIARRHEAL REVENUES, 2009 ($ MILLIONS) ANTIEMETICS LOCALLY ACTING ANTIEMETICS CENTRALLY ACTING ANTIEMETICS ANTIDOPAMINERGICS Antidopaminergics (Continued) ANTICHOLINERGICS MISCELLANEOUS ANTIEMETICS Miscellaneous Antiemetics (Continued) Miscellaneous Antiemetics (Continued) TABLE 8 MARKETED ANTIEMETIC PRODUCTS TABLE 8 (CONTINUED) MARKET SIZE AND GROWTH TABLE 9 GLOBAL PRESCRIPTION ANTIEMETIC MARKET BY REGION, THROUGH 2014 ($ MILLIONS) FIGURE 5 GLOBAL PRESCRIPTION ANTIEMETIC MARKET BY REGION, ($ MILLIONS) COMPETITIVE STRUCTURE AND MARKET SHARE... 62

4 TABLE 10 GLOBAL PRESCRIPTION ANTIEMETIC REVENUES AND MARKET SHARE BY MANUFACTURER, 2009 ($ MILLIONS/%) FIGURE 6 GLOBAL PRESCRIPTION ANTIEMETICS REVENUES BY MANUFACTURER, 2009 ($ MILLIONS) GASTROINTESTINAL CANCER TREATMENTS GASTROINTESTINAL CANCER (CONTINUED) GASTROINTESTINAL CANCER (CONTINUED) TABLE 11 MARKETED GASTROINTESTINAL CANCER PRODUCTS MARKET SIZE AND GROWTH TABLE 12 GLOBAL PRESCRIPTION GASTROINTESTINAL CANCER DRUG MARKET BY REGION, THROUGH 2014 ($ MILLIONS) FIGURE 7 GLOBAL PRESCRIPTION GASTROINTESTINAL CANCER DRUG MARKET BY REGION, ($ MILLIONS) COMPETITIVE STRUCTURE AND MARKET SHARE TABLE 13 GLOBAL PRESCRIPTION GASTROINTESTINAL CANCER DRUG REVENUES AND MARKET SHARE, 2009 ($ MILLIONS/%) FIGURE 8 GLOBAL PRESCRIPTION GASTROINTESTINAL CANCER DRUG REVENUES, 2009 ($ MILLIONS) H2 INHIBITORS H2 INHIBITORS (CONTINUED) H2 INHIBITORS (CONTINUED) H2 INHIBITORS (CONTINUED) TABLE 14 MARKETED H2 INHIBITORS PRODUCTS MARKET SIZE AND GROWTH TABLE 15 GLOBAL PRESCRIPTION H2 INHIBITOR MARKET BY REGION, THROUGH 2014 ($ MILLIONS) FIGURE 9 GLOBAL PRESCRIPTION H2 INHIBITOR MARKET BY REGION, ($ MILLIONS) COMPETITIVE STRUCTURE AND MARKET SHARE TABLE 16 GLOBAL PRESCRIPTION H2 INHIBITOR REVENUES AND MARKET SHARE, 2009 ($ MILLIONS/%) FIGURE 10 GLOBAL PRESCRIPTION H2 INHIBITOR REVENUES, 2009 ($ MILLIONS) LAXATIVES LAXATIVES (CONTINUED) TABLE 17 MARKETED LAXATIVE PRODUCTS MARKET SIZE AND GROWTH TABLE 18 GLOBAL PRESCRIPTION LAXATIVE MARKET BY REGION, THROUGH 2014 ($ MILLIONS) FIGURE 11 GLOBAL PRESCRIPTION LAXATIVE MARKET BY REGION, ($ MILLIONS) COMPETITIVE STRUCTURE AND MARKET SHARE TABLE 19 GLOBAL PRESCRIPTION LAXATIVE REVENUES AND MARKET SHARE, 2009 ($ MILLIONS/%)... 78

5 FIGURE 12 GLOBAL PRESCRIPTION LAXATIVE REVENUES, 2009 ($ MILLIONS) PROTON PUMP INHIBITORS PROTON PUMP INHIBITORS (CONTINUED) PROTON PUMP INHIBITORS (CONTINUED) TABLE 20 MARKETED PROTON PUMP INHIBITOR PRODUCTS MARKET SIZE AND GROWTH TABLE 21 GLOBAL PRESCRIPTION PROTON PUMP INHIBITOR MARKET BY REGION, THROUGH 2014 ($ MILLIONS) FIGURE 13 GLOBAL PRESCRIPTION PROTON PUMP INHIBITOR MARKET BY REGION, ($ MILLIONS) COMPETITIVE STRUCTURE AND MARKET SHARE TABLE 22 GLOBAL PRESCRIPTION PROTON PUMP INHIBITOR REVENUES AND MARKET SHARE BY MANUFACTURER, 2009 ($ MILLIONS/%) FIGURE 14 GLOBAL PRESCRIPTION PROTON PUMP INHIBITOR REVENUES BY MANUFACTURER, 2009 ($ MILLIONS) BOWEL ANTI-INFLAMMATORY BOWEL ANTI-INFLAMMATORY (CONTINUED) BOWEL ANTI-INFLAMMATORY (CONTINUED) TABLE 23 MARKETED BOWEL ANTI-INFLAMMATORY PRODUCTS MARKET SIZE AND GROWTH TABLE 24 GLOBAL PRESCRIPTION BOWEL INFLAMMATORY AGENT MARKET BY REGION, THROUGH 2014 ($ MILLIONS) FIGURE 15 GLOBAL PRESCRIPTION BOWEL INFLAMMATORY AGENT MARKET BY REGION, ($ MILLIONS) COMPETITIVE STRUCTURE AND MARKET SHARE TABLE 25 GLOBAL PRESCRIPTION BOWEL INFLAMMATORY AGENT REVENUES AND MARKET SHARE, 2009 ($ MILLIONS/%) FIGURE 16 GLOBAL PRESCRIPTION BOWEL INFLAMMATORY AGENT REVENUES BY MANUFACTURER, 2009 ($ MILLIONS) OTHER GASTROINTESTINAL PRODUCTS ANTISPASMODICS TABLE 26 MARKETED ANTISPASMODIC PRODUCTS DIGESTANTS GASTRIC ACIDIFIERS PANCREATIC ENZYMES TABLE 27 MARKETED DIGESTANT PRODUCTS EVACUANTS TABLE 28 MARKETED EVACUANTS PRODUCTS MUCOSAL PROTECTANTS TABLE 29 MARKETED MUCOSAL PROTECTANT PRODUCTS PROSTAGLANDINS TABLE 30 MARKETED PROSTAGLANDIN PRODUCTS... 94

6 STIMULANTS TABLE 31 MARKETED STIMULANT PRODUCTS MARKET SIZE AND GROWTH TABLE 32 GLOBAL PRESCRIPTION OTHER GASTROINTESTINAL DRUG MARKET BY REGION, THROUGH 2014 ($ MILLIONS) FIGURE 17 GLOBAL PRESCRIPTION OTHER GASTROINTESTINAL DRUG MARKET BY REGION, ($ MILLIONS) COMPETITIVE STRUCTURE TOTAL GLOBAL PRESCRIPTION GASTROINTESTINAL MARKET SIZE AND GROWTH TABLE 33 GLOBAL PRESCRIPTION GASTROINTESTINAL DISORDER TREATMENT REVENUES BY CATEGORY, THROUGH 2014 ($ MILLIONS) FIGURE 18 GLOBAL PRESCRIPTION GASTROINTESTINAL DISORDER TREATMENT REVENUES BY CATEGORY, ($ MILLIONS) TOTAL U.S. PRESCRIPTION GASTROINTESTINAL COMPETITIVE ANALYSIS TABLE 34 MANUFACTURERS MARKET SHARE OF PRESCRIPTION GASTROINTESTINAL DISORDER TREATMENT REVENUES, (ESTIMATED 2009) FIGURE 19 MANUFACTURERS MARKET SHARE OF PRESCRIPTION GASTROINTESTINAL DISORDER TREATMENT REVENUES, 2009 ESTIMATED (%) CHAPTER FIVE: OTC PRODUCT SEGMENTS BY TYPE ANTACIDS SYSTEMIC ANTACIDS Sodium Bicarbonate NONSYSTEMIC ANTACIDS Calcium Carbonate Aluminum Products Magnesium Products Combination Products TABLE 35 MARKETED OTC ANTACID PRODUCTS TABLE 35 (CONTINUED) MARKET SIZE AND GROWTH TABLE 36 GLOBAL OTC ANTACID MARKET BY REGION, THROUGH 2014 ($ MILLIONS) FIGURE 20 GLOBAL OTC ANTACID MARKET BY REGION, ($ MILLIONS) COMPETITIVE STRUCTURE AND MARKET SHARE TABLE 37 GLOBAL OTC ANTACID REVENUES AND MARKET SHARE BY MANUFACTURER, 2009 ($ MILLIONS/%)

7 FIGURE 21 GLOBAL OTC ANTACID MARKET SHARE BY MANUFACTURER, 2009 (%) LOCALLY ACTING ANTIDIARRHEALS ADSORBENTS INTESTINAL FLORA MODIFIERS TABLE 38 MARKETED OTC ANTIDIARRHEAL PRODUCTS MARKET SIZE AND GROWTH TABLE 39 GLOBAL OTC ANTIDIARRHEALS MARKET BY REGION, THROUGH 2014 ($ MILLIONS) FIGURE 22 GLOBAL OTC ANTIDIARRHEALS MARKET BY REGION, ($ MILLIONS) COMPETITIVE STRUCTURE AND MARKET SHARE TABLE 40 GLOBAL OTC ANTIDIARRHEALS REVENUES BY MANUFACTURER, 2009 ($ MILLIONS/%) FIGURE 23 GLOBAL OTC ANTIDIARRHEALS MARKET SHARE BY MANUFACTURER, 2009 (%) H2 INHIBITORS H2 INHIBITORS (CONTINUED) H2 INHIBITORS (CONTINUED) TABLE 41 MARKETED OTC H2 INHIBITORS PRODUCTS MARKET SIZE AND GROWTH TABLE 42 GLOBAL OTC H2 INHIBITOR MARKET BY REGION, THROUGH 2014 ($ MILLIONS) FIGURE 24 GLOBAL OTC H2 INHIBITOR MARKET BY REGION, ($ MILLIONS) COMPETITIVE STRUCTURE AND MARKET SHARE TABLE 43 GLOBAL OTC H2 INHIBITOR REVENUES AND MARKET SHARE BY MANUFACTURER, 2009 ($ MILLIONS/%) FIGURE 25 GLOBAL OTC H2 INHIBITOR MARKET SHARE BY MANUFACTURER, 2009 (%) PROTON PUMP INHIBITORS OMEPRAZOLE (PRILOSEC, PROCTER & GAMBLE) TABLE 44 MARKETED OTC PROTON PUMP INHIBITOR PRODUCTS MARKET SIZE AND GROWTH TABLE 45 GLOBAL OTC PROTON PUMP INHIBITOR MARKET BY REGION, THROUGH 2014 ($ MILLIONS) FIGURE 26 GLOBAL OTC PROTON PUMP INHIBITOR MARKET BY REGION, ($ MILLIONS) COMPETITIVE STRUCTURE AND MARKET SHARE TABLE 46 GLOBAL OTC PROTON PUMP INHIBITOR REVENUES AND MARKET SHARE BY MANUFACTURER, 2009 ($ MILLIONS/%) FIGURE 27 GLOBAL OTC PROTON PUMP INHIBITOR MARKET SHARE BY MANUFACTURER, 2009 (%)

8 LAXATIVES TABLE 47 MARKETED OTC LAXATIVE PRODUCTS TABLE 47 (CONTINUED) MARKET SIZE AND GROWTH TABLE 48 GLOBAL OTC LAXATIVES MARKET BY REGION, THROUGH 2014 ($ MILLIONS) FIGURE 28 GLOBAL OTC LAXATIVE MARKET BY REGION, ($ MILLIONS) COMPETITIVE STRUCTURE AND MARKET SHARE TABLE 49 GLOBAL OTC LAXATIVE REVENUES AND MARKET SHARE BY MANUFACTURER, 2009 ($ MILLIONS/%) FIGURE 29 GLOBAL OTC LAXATIVE MARKET SHARE BY MANUFACTURER, 2009 (%) TOTAL OTC GASTROINTESTINAL DRUG MARKET SIZE AND GROWTH TABLE 50 GLOBAL OTC GASTROINTESTINAL DISORDER TREATMENT MARKET BY PRODUCT CATEGORY, THROUGH 2014 ($ MILLIONS) FIGURE 30 GLOBAL OTC GASTROINTESTINAL DISORDER TREATMENT MARKET BY PRODUCT CATEGORY, ($ MILLIONS) TOTAL OTC GASTROINTESTINAL DRUG COMPETITIVE ANALYSIS TABLE 51 TOTAL MANUFACTURERS REVENUES AND MARKET SHARE OF OTC GASTROINTESTINAL DISORDER TREATMENTS, ESTIMATED 2009 ($ MILLIONS/%) FIGURE 31 TOTAL MANUFACTURERS MARKET SHARE OF OTC GASTROINTESTINAL DISORDER TREATMENTS, ESTIMATED 2009 (%) RESEARCH AND DEVELOPMENT METOSOLV ODT NEXIUM LOW-DOSE ASPIRIN COMBINATION REZONIC SANVAR TAK-390MR (KAPIDEX) ZENPEP AB ALICAFORSEN APF CROFELEMER HUMIRA LINACLOTIDE METHYLNALTREXONE (MNTX) (RELSTAR) MLN 0002 (VEDOLIZUMAB)

9 ORBEC PROCHYMAL RENZAPRIDE REMICADE REZULAR RIFAXIMAN (XIFAXAN) SUTENT ALICAFORSEN ENEMA DEXTOFISOPAM EKB GTI PUMOSETRAG RDP SORAPRAZAN TALNETANT BL BL TABLE 52 GASTROINTESTINAL DISORDER TREATMENTS IN DEVELOPMENT TABLE 52 (CONTINUED) TABLE 52 (CONTINUED) TABLE 52 (CONTINUED) TABLE 52 (CONTINUED) TABLE 52 (CONTINUED) TABLE 52 (CONTINUED) TOTAL MARKET ANALYSIS TABLE 53 GLOBAL PRESCRIPTION AND OTC GASTROINTESTINAL DISORDER MARKET BY CATEGORY, THROUGH 2014 ($ MILLIONS) FIGURE 32 GLOBAL PRESCRIPTION AND OTC GASTROINTESTINAL DISORDER TREATMENT MARKET BY CATEGORY, ($ MILLIONS) CHAPTER SIX: INDUSTRY PARTICIPANTS BY PRODUCT TYPE TABLE 54 GASTROINTESTINAL DISORDER TREATMENT MANUFACTURERS REVENUES AND MARKET SHARE BY TYPE, 2009 ($ MILLIONS/%) FIGURE 33 GASTROINTESTINAL DISORDER TREATMENT MANUFACTURERS MARKET SHARE BY TYPE, 2009 (%) COMPANY PROFILES ASTRAZENECA History AXCAN PHARMA, INC History CENTOCOR, INC

10 History EISAI, INC History GENENTECH, INC History GLAXOSMITHKLINE Glaxosmithkline (Continued) Glaxosmithkline (Continued) History JOHNSON & JOHNSON History MCNEIL CONSUMER HEALTHCARE History MERCK & CO., INC History NOVARTIS INTERNATIONAL AG History PFIZER, INC History PROCTER & GAMBLE CO History ROCHE History SANOFI-AVENTIS History SALIX PHARMACEUTICALS, LTD History SOLVAY PHARMACEUTICALS History TAKEDA PHARMACEUTICALS NORTH AMERICA History WYETH History APPENDIX: CONTACT INFORMATION FOR GASTROINTESTINAL MARKET PARTICIPANTS M CORP ABBOTT LABORATORIES ABEILLE PHARMA, INC ACAMBIS, PLC ACE BIOSCIENCES A/S AGI THERAPEUTICS, INC ALCHEMIA, LTD ALIZYME, PLC ALLERGAN, INC

11 ALLSCRIPTS HEALTHCARE SOLUTIONS, INC ALTANA PHARMA AG ALVINE PHARMACEUTICALS, INC AMARIN CORP AMGEN, INC ANTIGENICS, INC APOTHECON B.V AP PHARMA, INC ARCO PHARMACEUTICALS ASPHELIA PHARMACEUTICALS, INC ARYX THERAPEUTICS, INC ASTELLAS PHARMA, INC ASTRAZENECA, PLC AXCAN PHARMA, INC BERTEK (MYLAN LABORATORIES INC.) BIOBALANCE, INC BIOGEN IDEC, INC BIOLINERX, LTD BRAINTREE LABORATORIES, INC BRISTOL-MYERS SQUIBB CO CELLDEX THERAPEUTICS, INC CENTOCOR ORTHO BIOTECH, INC CEPHALON, INC CERIMON PHARMA, INC CHEMOCENTRYX, INC CLAVIS PHARMA ASA COSMO PHARMACEUTICALS SPA CYTOKINE PHARMASCIENCES, INC DEBIOPHARM S.A DOR BIOPHARMA, INC EISAI CO., LTD ELAN CORPORATION, PLC EMD SERONO, INC ENZO EURAND PHARMACEUTICALS, INC EVOKE PHARMA FRESENIUS KABI AG GENENTECH, INC GENZYME GENERAL GLAXOSMITHKLINE, PLC GLAXOSMITHKLINE CONSUMER HEALTHCARE GLENMARK PHARMACEUTICALS, LTD H3 PHARMA, INC HELSINN HEALTHCARE

12 HOFFMAN-LAROCHE, LTD. (ROCHE) HYPERION THERAPEUTICS, INC IMMUCELL CORP ISIS PHARMACEUTICALS. INC JANSSEN PHARMACEUTICA PRODUCTS, LP (JOHNSON & JOHNSON) JOHNSON & JOHNSON LORUS THERAPEUTICS, INC MCNEIL CONSUMER & SPECIALTY PHARMACEUTICALS MEDISCA, INC MERCK & CO., INC MONARCH LABS NABI BIOPHARMACEUTICALS NOVARTIS CORP NPS PHARMACEUTICALS, INC OTSUKA AMERICA PHARMACEUTICAL, INC PFIZER, INC THE PROCTER & GAMBLE CO PRODIGENE, INC PROGENICS PHARMACEUTICALS, INC RAVEN BIOTECHNOLOGIES, INC RELIANT PHARMACEUTICALS, INC ROXANE LABORATORIES, INC SALIX PHARMACEUTICALS, LTD SANOFI-AVENTIS SANTARUS, INC SCHERING AG SCHWARZ PHARMA AG SERONO S.A SHIRE PHARMACEUTICALS GROUP, PLC SOLVAY S.A SUCAMPO PHARMACEUTICALS, INC SWISS AGENCY FOR THERAPEUTIC PRODUCTS (SWISSMEDIC) TAKEDA PHARMACEUTICAL NORTH AMERICA TARGACEPT, INC THERAVANCE, INC UCB PHARMA, INC UNIMED PHARMACEUTICALS, INC PHARMOS PHARMACEUTICALS, INC WATSON PHARMACEUTICALS, INC WYETH (WHITEHALL-ROBINS HEALTHCARE, INC.)

THERAPIES AND BIOMARKERS FOR INFLAMMATORY BOWEL DISEASE

THERAPIES AND BIOMARKERS FOR INFLAMMATORY BOWEL DISEASE PHM125A January 2013 Willem Westra Project Analyst ISBN: 0-89336-715-X BCC Research 49 Walnut Park, Building 2 Wellesley, MA 02481 866-285-7215,