Gastrointestinal Therapeutics in Asia-Pacific Markets to 2019 Strong Potential for Pipeline Biologics on Account of High Regional Unmet Need GBI Research Report Guidance GBI Research Report Guidance The second chapter provides an introduction to the GI therapeutic indications of IBS, UC and CD, including epidemiology, symptoms, etiology, pathophysiology, diagnosis, disease classification and determination of disease severity, and treatment. The third chapter provides an overview of the product profiles for six key marketed products for the treatment of IBS, UC, and CD. The fourth chapter analyses the IBS, UC, and CD pipeline, providing details of, among other parameters, drug distribution by phase, molecule type, and mechanism of action. The chapter also profiles three promising drug candidates in the pipeline. The fifth chapter provides a market forecast to 2019 for the APAC markets of Australia, India, China, and Japan, and includes prevalence population, Annual Cost of Therapy (ACoT) and market size forecast, along with details of drivers and barriers affecting the GI market. Chapter six provides a strategic consolidation analysis, including details of major co-development and licensing deals. © GBI Research. This is a licensed product and is not to be photocopied GBIHC320MR / Published JAN 2014 Page 2 Executive Summary The gastrointestinal market Executive Summary is expected to grow in Asia- Gastrointestinal Therapeutics Market in Asia-Pacific to Grow by XX% to Reach $XX Billion in 2019 Pacific region due to new product launches The Gastrointestinal (GI) therapeutics market for Irritable Bowel Syndrome (IBS), Ulcerative Colitis (UC), and Crohn’s Disease (CD) in the Asia-Pacific (APAC) region, comprising Australia, India, China, and Japan, had an estimated value of $XXm in 2012, which is expected to increase at a Compound Annual Growth Rate (CAGR) of XX% during the forecast period to reach $XXm in 2019. India registers the fastest growth rate at a CAGR of XX%, followed by China, which is expected to register growth at a CAGR of XX%. Japan is the market leader in the APAC region, accounting for $XXm in 2012, equivalent to almost XX% of the total GI market in the region. The market is expected to grow due to new product launches and substantial growth in the size of the diseased population during the forecast period. Gastrointestinal Therapeutics Market, Asia-Pacific, Market Size ($m), 2012–2019 Revenue Revenue ($m) 2012 2019 Australia India China Japan Source: GBI Research Proprietary Products Database [accessed October 16, 2013] © GBI Research. This is a licensed product and is not to be photocopied GBIHC320MR / Published JAN 2014 Page 3 Table of Contents 1 Table of Contents 1 Table of Contents ................................................................................................................................. 6 1.1 List of Tables ............................................................................................................................. 9 1.2 List of Figures...........................................................................................................................10 2 Gastrointestinal Therapeutics in Asia-Pacific Market – Introduction .....................................................11 2.1 Irritable Bowel Syndrome .........................................................................................................11 2.1.1 Classification ....................................................................................................................11 2.1.2 Symptoms ........................................................................................................................11 2.1.3 Etiology ...........................................................................................................................11 2.1.4 Pathophysiology...............................................................................................................12 2.1.5 Diagnosis .........................................................................................................................12 2.1.6 Epidemiology ...................................................................................................................14 2.1.7 Prognosis .........................................................................................................................14 2.1.8 Treatment Options ...........................................................................................................14 2.2 Ulcerative Colitis ......................................................................................................................15 2.2.1 Classification ....................................................................................................................15 2.2.2 Symptoms ........................................................................................................................17 2.2.3 Etiology ...........................................................................................................................17 2.2.4 Pathophysiology...............................................................................................................17 2.2.5 Diagnosis .........................................................................................................................18 2.2.6 Epidemiology ...................................................................................................................19 2.2.7 Prognosis .........................................................................................................................19 2.2.8 Treatment Options ...........................................................................................................19 2.3 Crohn’s Disease .......................................................................................................................21 2.3.1 Classification ....................................................................................................................21 2.3.2 Symptoms ........................................................................................................................22 2.3.3 Etiology ...........................................................................................................................22 2.3.4 Pathophysiology...............................................................................................................23 2.3.5 Diagnosis .........................................................................................................................23 2.3.6 Epidemiology ...................................................................................................................24 2.3.7 Prognosis .........................................................................................................................24 2.3.8 Treatment Options ...........................................................................................................25 3 Gastrointestinal Therapeutics in Asia-Pacific Market – Marketed Products (Global) ..............................26 3.1 Irritable Bowel Syndrome .........................................................................................................26 3.2 Ulcerative Colitis ......................................................................................................................26 3.3 Crohn’s Disease .......................................................................................................................26 3.4 Key Marketed Products ............................................................................................................27 3.4.1 Amitiza ............................................................................................................................27 3.4.2 Humira ............................................................................................................................28 3.4.3 Remicade .........................................................................................................................29 3.4.4 Simponi ...........................................................................................................................30 3.4.5 Cimzia..............................................................................................................................31 3.4.6 Tysabri .............................................................................................................................32 4 Gastrointestinal Therapeutics in Asia-Pacific Market – Pipeline Analysis ...............................................34 4.1 Irritable Bowel Syndrome .........................................................................................................34 4.1.1 Overall Pipeline ................................................................................................................34 4.1.2 Pipeline Analysis by Molecule Type ...................................................................................36 4.1.3 Pipeline Analysis by Mechanism of Action .........................................................................37 4.2 Ulcerative Colitis Pipeline .........................................................................................................39 4.2.1 Overall Pipeline ................................................................................................................39 4.2.2 Pipeline Analysis by Molecule Type ...................................................................................41