Difference between revisions of "Gastrointestinal Endoscopy - Landscape Report"

Revision as of 01:16, 29 September 2011

Overview

Introduction

Gastrointestinal Tract

Gastrointestinal Endoscopy deals with the endoscopic examination, therapy or surgery of the gastrointestinal tract. Gastrointestinal Tract generally refers to the digestive structures stretching from the mouth to anus, but does not include the accessory glandular organs such as liver, billary tract, panceras. The gastrointestinal tract is categorized into various sections, these include:

• Intestines: The section of the alimentary canal from the stomach to the anal canal, includes the large intestine and small intestine.
• Lower Gastrointestinal Tract: The segment of gastrointestinal tract that includes the small intestine below the duodenum, and the large intestine.
• Mouth: The oval-shaped oral cavity located at the apex of the digestive tract and consisting of two parts: the vestibule and the oral cavity proper.
• Pharynx: A funnel-shaped fibromuscular tube that conducts food to the esophagus, and air to the larynx and lungs. It is divided into the nasopharynx; oropharynx; and hypopharynx (laryngopharynx).
• Upper Gastrointestinal Tract: The segment of gastrointestinal tract that includes the esophagus, stomach and the duodenum.

(Source: MeSH Database)

Procedures

Currently, the most commonly used imaging methods for detection of gastrointestinal disorders, including disorders of the small intestine, are endoscopy and radiological imaging.
A traditional endoscope is a device consisting of a flexible tube and an optical system. There are several types of endoscopic procedures used to identify disorders in the gastrointestinal tract. The basic endoscopic procedures available include:

Upper Endoscopy

• Upper Endoscopy: In upper endoscopy, the physician inserts an endoscope, which is an approximately 3.5 foot long tube, through the patient’s mouth. In esophagogastroduodenoscopy, or EGD, the gastroscope passes down the esophagus and into the stomach and duodenum for visual examination. In esophagoscopy, only the esophagus is viewed.
• Colonoscopy: In colonoscopy, the physician inserts a colonoscope, which is an approximately 5.5 foot long endoscope, into the patient’s colon through the anus. Colonoscopy is the primary method for detecting disorders of the colon and is the standard screening tool for early detection of colon cancer.
• Push Enteroscopy: Push enteroscopy involves the insertion of an approximately six-foot long push enteroscope into the mouth. Due to the length and curvature of the small intestine, push enteroscopy enables the physician to view only the first one-third of the small intestine. The procedure is time consuming and difficult to perform for the physician and significantly more difficult to bear for the patient compared to traditional endoscopy.
• Double Balloon Endoscopy: The technique involves the use of a balloon at the end of a special enteroscope camera and an overtube, which is a tube that fits over the endoscope, and which is also fitted with a balloon. The procedure is usually done under general anesthesia, but may be done with the use of conscious sedation.

GI Imaging

Gastrointestinal endoscopy is undergoing major improvements, which are driven by new available technologies and substantial refinements of optical features. Detection, characterization and confirmation are essential steps required for proper endoscopic diagnosis. Optical and nonoptical methods can help to improve each step; these improvements are likely to increase the detection rate of neoplasias and reduce unnecessary endoscopic treatments. Furthermore, functional and molecular imaging are emerging as new diagnostic tools that could provide an opportunity for personalized medicine, in which endoscopy will define disease outcome or predict the response to targeted therapy.

Key steps to endoscopic diagnosis

Several new technologies are now available for each step, some of them include:

• Narrow-Band Imaging(NBI) by Olympus America, uses filter to illuminate mucosa at specific wavelength
• Fujinon Intelligent Color Enhancement(FICE) by Fujinon, uses Spectral endoscopic image processing technology which has been developed to estimate spectral information from RGB image data obtained through a routine endoscopy and to better characterize mucosal tissue structures
• I-Scan by Pentax Medical, a next generation technology, is a dynamic, multimodal tool revealing the hidden colors, topography, vascularity, and structure of disease. i-SCAN explores the possibility of the first electronic version of chromoendoscopy (e-Chrome™) through the use of complimentary color filters and enhancements
• Third Eye Retroscope® by Avantis Medical Systems, an additional small-caliber endoscope that can be passed over the working channel of standard colonoscopes with the possibility of retro view—leads to a substantially increased detection of neoplastic changes
• Endoflag by Endopix, is a single filter, single-pass implementation that processes standard or high-definition video sequences after acquisition

Classification of GI Imaging

Product Portfolio Heat Map

Market Size

Source: Kalorama Information Report

Major Players

Detailed Company Profile

Olympus Corporation

Snapshot Profiles

• Boston Scientific
• Conmed
• Covidien
• Ethicon Endo
• Fujinon
• Given Imaging
• Karl Storz
• Hoya Corporation
• Stryker

Source: Kalorama, Company website, Company SEC filings

M&A Activity

Procedure Volumes

The three main areas where GI Endoscopy has considerable applications are Colon/Rectum cancer, Obesity (gastric bypass/gastric banding) and Digestive system disorders.

Colon/Rectum cancer

Stages of Cancer

Tumors or cancer of the colon or the rectum or both. Colorectal cancer starts in the large intestine (colon) or the rectum (end of the colon). Risk factors for colorectal cancer include chronic ulcerative colitis; familial polyposis coli; exposure to asbestos; and irradiation of the cervix uteri. (MeSH) Colorectal cancer is the third most commonly diagnosed cancer in the world, but it is more common in developed countries.
Stages of colon cancer are:

• Stage 0: Very early cancer on the innermost layer of the intestine
• Stage I: Cancer is in the inner layers of the colon
• Stage II: Cancer has spread through the muscle wall of the colon
• Stage III: Cancer has spread to the lymph nodes
• Stage IV: Cancer has spread to other organs

(For more information on colon cancer click here)

Volumes, Prevalence and Incidence

• Overall, the lifetime risk of developing colorectal cancer is about 1 in 20 (5.1%). This risk is slightly lower in women than in men.
• Cases estimated in the US in 2011 are:
  • 101,700 cases of colon cancer
  • 39,510 cases of rectal cancer
• Overall, colorectal cancer is the second-leading cause of cancer death in Canada.
  • In 2011, an estimated 22,200 Canadians (12,500 men - 9,700 women) will be diagnosed with colorectal cancer and 8,900 (5,000 men - 3,900 women) will die from it.
  • One in 14 men is expected to develop colorectal cancer during his lifetime and one in 27 will die from it.
  • One in 15 women is expected to develop colorectal cancer during her lifetime and one in 31 will die from it.
  • On average, 426 Canadians will be diagnosed with colorectal cancer every week and 171 will die from the disease every week.

(Source: Colorectal cancer association of Canada & American cancer society)

Survival Rates

Source:SEERdatabase

Incidence rates

The estimated incidence rate of colorectal cancer in 2007 is expressed geography wise below:

Source: Kalorama Information Report

Obesity (Gastric bypass/Gastric banding)

Laparoscopic Gastric Banding

The two most common weight-loss surgeries are:

• Laparoscopic Gastric Banding(also referred as lap band): The surgeon places a band around the upper part of your stomach, creating a small pouch to hold food. The band helps you limit how much food you eat by making you feel full after eating small amounts.
• Gastric Bypass: This surgery helps you lose weight by changing how your stomach and small intestine handle the food you eat. After the surgery, you will not be able to eat as much as before, and your body will not absorb all the calories and other nutrients from the food you eat.

Volumes, Prevalence and Incidence

• In United States obesity is estimated to cause an excess 111,909 to 365,000 deaths per year
• One million (7.7%) of deaths in the European Union are attributed to excess weight.
• On an average, obesity reduces life expectancy by six to seven years:
  • A BMI of 30–35 reduces life expectancy by two to four years
  • While morbid obesity (BMI > 40) reduces life expectancy by 10 years
• Large-scale American and European studies have found that mortality risk is lowest at a BMI of 20–25 kg/m2, with risk increasing along with changes in either direction. (Source: thelancet & jama-ama-assn)
• Obesity prevalence rate in USA

Percent of Obese (BMI > 30) in U.S. Adults

Digestive system disorders

Diseases in any part of the gastrointestinal tract or the accessory organs (liver; biliary tract; pancreas). The digestive system disorders are categorized as:

• Biliary Tract Diseases
• Digestive System Abnormalities
• Digestive System Fistula
• Digestive System Neoplasms
• Gastrointestinal Diseases
• Liver Diseases
• Pancreatic Diseases
• Peritoneal Diseases

(Source: MeSH)

Volumes, Prevalence and Incidence

• Hospital visits in USA (Digestive disorders as the primary reason)

Source:CDC health statistics report

• Disease wise breakup (Digestive disorders as the primary reason)

Source: CDCsurvey

• USA and Europe Procedure Volumes

Source: Kalorama Information; WHO; US Census Bureau; Centers for Disease Control and Prevention

NOTE: All values for USA and Europe are in 000's. Data includes both in-patient and out-patient surgical procedures in all populations

Reimbursements

Upper GI/ Colonoscopy

Bariatric Surgery

Technology Advancements

Enhanced Imaging Modalities: High-definition and virtual chromoendoscopy; (a) White-light imaging during endoscopy; a lesion beside a diverticular is hardly visible (arrow). (b) Closer inspection and image enhancement reveals tubular surface structures (arrows); (c) Virtual chromoendoscopy leads to pseudocolorization and improved visualization of the flat adenoma (arrows); (d) Chromoendoscopy using methylene blue unmasks the full extent of the lesion (arrows).