Bariatric Surgery Devices - Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2018

Bariatric Surgery Devices - Global Pipeline Analysis, Competitive Reference Code: GDME0152MAR Publication Date: July 2012 The Global Bariatric Surgery Devices Market is Forecast to Reach $XX Billion by 2018 Bariatric Surgery Devices Market, Global, Revenue ($bn), 2011-2018 Revenue ($bn) CAGR (2011-2018): XX% There are marked differences in the trends related to gastric bypass and gastric banding procedures in the US and European countries. In the US, the number of gastric banding procedures being conducted is on the rise whereas in European countries the number is declining. In the US, gastric banding procedures started about 10 years later than in Europe and were performed using modern efficient devices. Surgeons therefore had a better first experience with the surgery and quickly adopted it. Factors such as gastric banding being less invasive, less risky and resulting in shorter hospital stays also favored the growth of these procedures in the US. Sleeve gastrectomy procedures are also on the rise in the US due to their safety and efficacy. Ethicon Endo-Surgery Remains the Leading Player in the Global Bariatric Surgery Devices Market 2011 2018 Source: GlobalData analysis based on primary research with 17 marketing and product development managers and bariatric surgeons in Asian, European and North American markets Bariatric Surgery Devices Market, Global, Company Share (%), 2011 Ethicon Endo-Surgery The global bariatric surgery devices market was valued at $XX billion in 2011 and is forecast to grow at a Compound Annual Growth Rate (CAGR) of XX% to reach $XX billion in 2018. The market is expected to be driven by the increasing prevalence of obesity, failure of medicines to treat obesity, availability of reimbursement, increasing awareness about the risks associated with obesity and advantages of bariatric surgery, increasing number of bariatric surgery procedures among adolescents, and the cost-effectiveness of bariatric surgery in the long term. The US Remains the Largest Bariatric Surgery Devices Market, Driven by the Increase in the Prevalence of Obesity The US bariatric surgery devices market was valued at $XXm in 2011 and is expected to grow at a CAGR of XX% to reach $XX billion in 2018. This growth is expected to be driven by the increasing prevalence of obesity and increasing number of gastric banding and sleeve gastrectomy procedures in the US. According to the results of 2007-2008 National Health and Nutrition Examination Survey (NHANES), published by the Centers for Disease Control and Prevention (CDC) in June 2010, about XX% of US adults aged 20 years and over are overweight, while XX% are obese and XX% are extremely obese. Covidien Plc Allergan Inc. Applied Medical Resources Corporation Synovis Life Technologies, Inc. Silimed Source: GlobalData analysis based on primary research with 17 marketing and product development managers and bariatric surgeons in Asian, European and North American markets In 2011, Ethicon Endo-Surgery Inc. was the leading player in the global bariatric surgery devices market with a share of XX%. The leadership of Ethicon Endo Surgery in the global bariatric surgery devices market can be attributed to its technological innovation capabilities, diversified global presence, extensive bariatric surgery devices portfolio and a strong financial performance. The company s business strategy involves building its position in the marketplace through internal development, in-licensing of technology and products, acquisitions and strategic alliances. Page 1

1 Table of Contents 1 Table of Contents... 3 1.1 List of Tables... 5 1.2 List of Figures... 6 2 Introduction... 7 2.1 GlobalData Report Guidance... 7 3 Disease Overview... 8 3.1 Overweight and Obesity - Introduction... 8 3.1.1 Morbid/Extreme Obesity... 8 3.2 Prevalence of Obesity... 9 3.2.1 Prevalence in the US... 9 3.2.2 Prevalence in the UK... 10 3.2.3 Prevalence in France... 11 3.2.4 Prevalence in Spain... 12 3.2.5 Prevalence in Japan... 13 3.3 Treatment of Obesity... 14 3.4 Types of Bariatric Surgery... 15 3.4.1 Gastric Bypass Surgery... 15 3.4.2 Gastric Banding Surgery... 15 3.4.3 Sleeve Gastrectomy... 15 4 Bariatric Surgery Devices - Overview... 16 4.1 Gastric Bands... 16 4.2 Stapling Devices... 16 4.3 Trocars... 16 5 Bariatric Surgery Devices - Global Market Characterization... 17 5.1 Bariatric Surgery Devices Market, Global, Revenue ($m), Historic, 2004-2011... 17 5.2 Bariatric Surgery Devices Market, Global, Revenue ($m), Forecast, 2011-2018... 18 5.3 Global Bariatric Surgery Devices Market, Key Trends... 19 5.3.1 Laparoscopic Surgery is a Current Trend in the Bariatric Surgery Devices Market... 19 5.3.2 Number of Bariatric Surgery Procedures is Increasing among Adolescents... 20 5.3.3 Gastric Banding Procedures are Increasing in North America Unlike in Europe where Gastric Bypass Procedures are Increasing... 21 5.3.4 Intragastric Balloons to be a Future Trend in the Bariatric Surgery Devices Market... 23 5.4 Global Bariatric Surgery Devices, Market Dynamics... 24 5.4.1 Market Drivers... 24 5.4.2 Market Restraints... 29 6 Bariatric Surgery Devices Market, Analysis by Country, Revenue ($m), 2004-2018... 31 6.1 Bariatric Surgery Devices Market, The US, Revenue ($m), Historic, 2004-2011... 31 6.2 Bariatric Surgery Devices Market, The US, Revenue ($m), Forecast, 2011-2018... 32 6.3 Bariatric Surgery Devices Market, Canada, Revenue ($m), Historic, 2004-2011... 33 6.4 Bariatric Surgery Devices Market, Canada, Revenue ($m), Forecast, 2011-2018... 34 6.5 Bariatric Surgery Devices Market, The UK, Revenue ($m), Historic, 2004-2011... 35 6.6 Bariatric Surgery Devices Market, The UK, Revenue ($m), Forecast, 2011-2018... 36 6.7 Bariatric Surgery Devices Market, Germany, Revenue ($m), Historic, 2004-2011... 37 6.8 Bariatric Surgery Devices Market, Germany, Revenue ($m), Forecast, 2011-2018... 38 6.9 Bariatric Surgery Devices Market, France, Revenue ($m), Historic, 2004-2011... 39 6.10 Bariatric Surgery Devices Market, France, Revenue ($m), Forecast, 2011-2018... 40 6.11 Bariatric Surgery Devices Market, Italy, Revenue ($m), Historic, 2004-2011... 41 6.12 Bariatric Surgery Devices Market, Italy, Revenue ($m), Forecast, 2011-2018... 42 6.13 Bariatric Surgery Devices Market, Spain, Revenue ($m), Historic, 2004-2011... 43 6.14 Bariatric Surgery Devices Market, Spain, Revenue ($m), Forecast, 2011-2018... 44 6.15 Bariatric Surgery Devices Market, Japan, Revenue ($000 s), Historic, 2004-2011... 45 6.16 Bariatric Surgery Devices Market, Japan, Revenue ($000 s), Forecast, 2011-2018... 46 6.17 Bariatric Surgery Devices Market, India, Revenue ($m), Historic, 2004-2011... 47 6.18 Bariatric Surgery Devices Market, India, Revenue ($m), Forecast, 2011-2018... 48 6.19 Bariatric Surgery Devices Market, Australia, Revenue ($m), Historic, 2004-2011... 49 6.20 Bariatric Surgery Devices Market, Australia, Revenue ($m), Forecast, 2011-2018... 50 6.21 Bariatric Surgery Devices Market, Brazil, Revenue ($m), Historic, 2004-2011... 51 6.22 Bariatric Surgery Devices Market, Brazil, Revenue ($m), Forecast, 2011-2018... 52 7 Global Bariatric Surgery Devices Market - Competitive Assessment... 53 Page 3

7.1 Bariatric Surgery Devices Market, Global, Key Market Participants... 54 7.1.1 Ethicon Endo-Surgery, Inc. (Subsidiary of Johnson & Johnson)... 54 7.1.2 Covidien Plc... 57 7.1.3 Allergan Inc.... 60 7.1.4 Applied Medical Resources Corporation... 63 8 Global Bariatric Surgery Devices Market - Pipeline Assessment... 66 8.1 Bariatric Surgery Devices, Key Pipeline Products... 69 8.1.1 AspireAssist (Aspire Bariatrics, Inc.)... 69 8.1.2 Deep Brain Stimulation System - Obesity (NeuroSigma, Inc.)... 69 8.1.3 EndoBarrier Flow Restrictor (GI Dynamics, Inc.)... 69 8.1.4 EndoBarrier Gastrointestinal Liner (GI Dynamics, Inc.)... 69 8.1.5 Endoretics Device (EndoRetics Inc.)... 69 8.1.6 GelesisMD (Gelesis Inc.)... 70 8.1.7 Intra Gastric Implant (Slimedics Ltd)... 70 8.1.8 Maestro RC System (EnteroMedics Inc.)... 70 8.1.9 nobese Device (Silhouette Medical, Inc.)... 71 8.1.10 SatiSphere (EndoSphere, Inc.)... 71 8.1.11 ValenTx Endo Bypass System (ValenTx, Inc.)... 72 9 Appendix... 73 9.1 Market Definitions... 73 9.1.1 Bariatric Surgery Devices... 73 9.2 Abbreviations... 74 9.3 Sources... 74 9.4 Research Methodology... 77 9.4.1 Secondary Research... 77 9.4.2 Primary Research... 78 9.4.3 Models... 78 9.4.4 Forecasts... 78 9.4.5 Expert Panel... 79 9.5 GlobalData Consulting... 79 9.6 Contact Us... 79 9.7 Disclaimer... 79 Page 4

1.1 List of Tables Table 1: Body Mass Index for Adults... 8 Table 2: Body Mass Index for Children and Adolescents... 8 Table 3: Prevalence of Overweight, Obesity and Extreme Obesity Among US Adults Aged 20 Years and Over, 1999-2008... 9 Table 4: Prevalence of Obesity Among UK Adults Aged 16 Years and Over, 2001-2010... 10 Table 5: Prevalence of Obesity Among Adults in France Aged 16 Years and Over, 2000-2008... 11 Table 6: Prevalence of Obesity Among Adults in Spain Aged 16 Years and Over, 2003-2009... 12 Table 7: Prevalence of Obesity Among Adults in Japan Aged 16 Years and Over, 2001-2008... 13 Table 8: Bariatric Surgery Devices Market, Global, Revenue ($m), 2004-2011... 17 Table 9: Bariatric Surgery Devices Market, Global, Revenue ($m), 2011-2018... 18 Table 10: Prevalence of Obesity among US Children and Adolescents Aged 2-19 Years, 1999-2010... 20 Table 11: Bariatric Surgery Procedures in North America, 2003 and 2008... 22 Table 12: Bariatric Surgery Procedures in Europe, 2003 and 2008... 22 Table 13: Studies Indicating Short-term Safety and Efficacy of Intragastric Balloons, 2008-2009... 23 Table 14: Public Notifications Issued by the FDA Against Obesity Drugs, The US, 2010-2012... 24 Table 15: Obesity Drug Recalls, The US, 2010-2012... 25 Table 16: Studies Indicating Safety and Efficacy of Bariatric Surgery in Treatment of Type 2 Diabetes, 2010-2011... 26 Table 17: Studies Indicating Cost-effectiveness of Bariatric Surgery, 2010-2011... 27 Table 18: Bariatric Surgery Devices Market, The US, Revenue ($m), 2004-2011... 31 Table 19: Bariatric Surgery Devices Market, The US, Revenue ($m), 2011-2018... 32 Table 20: Bariatric Surgery Devices Market, Canada, Revenue ($m), 2004-2011... 33 Table 21: Bariatric Surgery Devices Market, Canada, Revenue ($m), 2011-2018... 34 Table 22: Bariatric Surgery Devices Market, The UK, Revenue ($m), 2004-2011... 35 Table 23: Bariatric Surgery Devices Market, The UK, Revenue ($m), 2011-2018... 36 Table 24: Bariatric Surgery Devices Market, Germany, Revenue ($m), 2004-2011... 37 Table 25: Bariatric Surgery Devices Market, Germany, Revenue ($m), 2011-2018... 38 Table 26: Bariatric Surgery Devices Market, France, Revenue ($m), 2004-2011... 39 Table 27: Bariatric Surgery Devices Market, France, Revenue ($m), 2011-2018... 40 Table 28: Bariatric Surgery Devices Market, Italy, Revenue ($m), 2004-2011... 41 Table 29: Bariatric Surgery Devices Market, Italy, Revenue ($m), 2011-2018... 42 Table 30: Bariatric Surgery Devices Market, Spain, Revenue ($m), 2004-2011... 43 Table 31: Bariatric Surgery Devices Market, Spain, Revenue ($m), 2011-2018... 44 Table 32: Bariatric Surgery Devices Market, Japan, Revenue ($000 s), 2004-2011... 45 Table 33: Bariatric Surgery Devices Market, Japan, Revenue ($000 s), 2011-2018... 46 Table 34: Bariatric Surgery Devices Market, India, Revenue ($m), 2004-2011... 47 Table 35: Bariatric Surgery Devices Market, India, Revenue ($m), 2011-2018... 48 Table 36: Bariatric Surgery Devices Market, Australia, Revenue ($m), 2004-2011... 49 Table 37: Bariatric Surgery Devices Market, Australia, Revenue ($m), 2011-2018... 50 Table 38: Bariatric Surgery Devices Market, Brazil, Revenue ($m), 2004-2011... 51 Table 39: Bariatric Surgery Devices Market, Brazil, Revenue ($m), 2011-2018... 52 Table 40: Bariatric Surgery Devices Market, Global, Key Company Revenue ($m), 2011... 53 Table 41: Key Products, Ethicon Endo-Surgery, Inc., 2012... 54 Table 42: Key Products, Covidien, 2012... 57 Table 43: Endomechanical Instruments Sales, Covidien, 2009-2011... 58 Table 44: Key Products, Allergan Inc., 2012... 60 Table 45: Obesity Intervention Segment Revenues, Allergan, 2009-2011... 62 Table 46: Key Products, Applied Medical Resources Corporation... 63 Table 47: Bariatric Surgery Devices, Pipeline by Phase of Development... 66 Table 48: Bariatric Surgery Devices Market, Pipeline Products, 2012... 67 Table 49: Maestro RC System, Clinical Trial Details... 71 Table 50: ValenTx Endo Bypass System, Clinical Trial Details... 72 Page 5

1.2 List of Figures Figure 1: Prevalence of Overweight, Obesity and Extreme Obesity Among US Adults Aged 20 Years and Over, 1999-2008... 9 Figure 2: Prevalence of Obesity Among UK Adults Aged 16 Years and Over, 2001-2010... 10 Figure 3: Prevalence of Obesity Among Adults in France Aged 16 Years and Over, 2000-2008... 11 Figure 4: Prevalence of Obesity Among Adults in Spain Aged 16 Years and Over, 2003-2009... 12 Figure 5: Prevalence of Obesity Among Adults in Japan Aged 16 Years and Over, 2001-2008... 13 Figure 6: Treatment of Obesity... 14 Figure 7: Bariatric Surgery Devices, Market Segmentation... 16 Figure 8: Bariatric Surgery Devices Market, Global, Revenue ($m), 2004-2011... 17 Figure 9: Bariatric Surgery Devices Market, Global, Revenue ($m), 2011-2018... 18 Figure 10: Advantages of Laparoscopic Bariatric Surgery over Open Bariatric Surgery... 19 Figure 11: Prevalence of Obesity Among US Children and Adolescents Aged 2-19 Years, 1999-2010... 20 Figure 12: Percentage of Adjustable Gastric Banding Procedures in North America and Europe, 2003 and 2008... 21 Figure 13: Percentage of Gastric Bypass Procedures in North America and Europe, 2003 and 2008... 22 Figure 14: Bariatric Surgery Devices, Market Dynamics... 24 Figure 15: Post-bariatric Surgery Complications... 29 Figure 16: Bariatric Surgery Devices Market, The US, Revenue ($m), 2004-2011... 31 Figure 17: Bariatric Surgery Devices Market, The US, Revenue ($m), 2011-2018... 32 Figure 18: Bariatric Surgery Devices Market, Canada, Revenue ($m), 2004-2011... 33 Figure 19: Bariatric Surgery Devices Market, Canada, Revenue ($m), 2011-2018... 34 Figure 20: Bariatric Surgery Devices Market, The UK, Revenue ($m), 2004-2011... 35 Figure 21: Bariatric Surgery Devices Market, The UK, Revenue ($m), 2011-2018... 36 Figure 22: Bariatric Surgery Devices Market, Germany, Revenue ($m), 2004-2011... 37 Figure 23: Bariatric Surgery Devices Market, Germany, Revenue ($m), 2011-2018... 38 Figure 24: Bariatric Surgery Devices Market, France, Revenue ($m), 2004-2011... 39 Figure 25: Bariatric Surgery Devices Market, France, Revenue ($m), 2011-2018... 40 Figure 26: Bariatric Surgery Devices Market, Italy, Revenue ($m), 2004-2011... 41 Figure 27: Bariatric Surgery Devices Market, Italy, Revenue ($m), 2011-2018... 42 Figure 28: Bariatric Surgery Devices Market, Spain, Revenue ($m), 2004-2011... 43 Figure 29: Bariatric Surgery Devices Market, Spain, Revenue ($m), 2011-2018... 44 Figure 30: Bariatric Surgery Devices Market, Japan, Revenue ($000 s), 2004-2011... 45 Figure 31: Bariatric Surgery Devices Market, Japan, Revenue ($000 s), 2011-2018... 46 Figure 32: Bariatric Surgery Devices Market, India, Revenue ($m), 2004-2011... 47 Figure 33: Bariatric Surgery Devices Market, India, Revenue ($m), 2011-2018... 48 Figure 34: Bariatric Surgery Devices Market, Australia, Revenue ($m), 2004-2011... 49 Figure 35: Bariatric Surgery Devices Market, Australia, Revenue ($m), 2011-2018... 50 Figure 36: Bariatric Surgery Devices Market, Brazil, Revenue ($m), 2004-2011... 51 Figure 37: Bariatric Surgery Devices Market, Brazil, Revenue ($m), 2011-2018... 52 Figure 38: Bariatric Surgery Devices Market, Global, Key Company Share (%), 2011... 53 Figure 39: SWOT Analysis, Ethicon Endo-Surgery, Inc... 54 Figure 40: SWOT Analysis, Covidien Plc... 57 Figure 41: SWOT Analysis, Allergan Inc... 61 Figure 42: SWOT Analysis, Applied Medical Resources Corporation... 64 Figure 43: Bariatric Surgery Devices, Pipeline by Phase of Development... 66 Figure 44: Bariatric Surgery Devices Market, Pipeline Analysis, 2012... 67 Page 6

2 Introduction Obesity can be defined as buildup of excessive fat in the body which poses a risk to the person s health. Body Mass Index (BMI) is a useful measure as it determines whether a person is overweight or obese based on their height and weight. According to the World Health Organization (WHO), an adult with a BMI of XX or more is considered overweight and a person with a BMI of XX or more is considered obese. Bariatric surgery or weight-loss surgery is suggested as a primary treatment for obesity if the patient s BMI is more than or equal to XX, or if it is between XX and XX and the patient is suffering from weightrelated diseases such as diabetes or high blood pressure. Three types of bariatric surgeries are covered under the scope of this report: Gastric bypass Gastric banding Sleeve gastrectomy 2.1 GlobalData Report Guidance The report includes an executive summary detailing the key points in the global bariatric surgery devices market. Chapter three describes obesity, its prevalence across different geographies and the associated methods of treatment. Chapter four details the available types of bariatric surgery devices. Chapter five provides information on the global market from 2004 to 2018 and discusses key trends, drivers and restraints. Chapter six discusses the size of the market in terms of segment, namely gastric bands, stapling devices and trocars, from 2004 and 2018. Chapter seven provides information on market revenues and forecasts by segment for the US, Canada, the UK, Germany, France, Spain, Italy, Japan, Australia, India and Brazil. Chapter eight gives information on key companies, their market shares, marketed products and relevant SWOT analysis. Chapter nine provides information on the profile and development stage of pipeline products in the bariatric surgery devices market with details of clinical trials. Page 7

3.2.2 Prevalence in the UK Figure 2: Prevalence of Obesity Among UK Adults Aged 16 Years and Over, 2001-2010 Obesity Prevalence (%) Among Adults 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Source: GlobalData, NOO - 2010 Table 4: Prevalence of Obesity Among UK Adults Aged 16 Years and Over, 2001-2010 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Obese Source: GlobalData, NOO - 2010 The prevalence of obesity among adults in the UK increased from XX% in 1993 to XX% in 2010. The prevalence of morbid obesity increased from XX% in the 1993-1995 period to XX% in the 2006-2008 period. Results from 2010 s Health Survey for England (HSE) on overweight and obese adults (defined as people aged 16 and over) by the National Obesity Observatory (NOO), showed that about XX% of adults were either overweight or obese. Page 10

6 Bariatric Surgery Devices Market, Analysis by Country, Revenue ($m), 2004-2018 6.1 Bariatric Surgery Devices Market, The US, Revenue ($m), Historic, 2004-2011 Figure 16: Bariatric Surgery Devices Market, The US, Revenue ($m), 2004-2011 Revenue ($m) 2004 2005 2006 2007 2008 2009 2010 2011 Gastric Bands Stapling Devices Trocars Source: GlobalData analysis based on primary research with 17 marketing and product development managers and bariatric surgeons in Asian, European and North American markets Table 18: Bariatric Surgery Devices Market, The US, Revenue ($m), 2004-2011 Gastric bands Stapling devices Trocars Total 2004 2005 2006 2007 2008 2009 2010 2011 CAGR 2004-2011 Source: GlobalData analysis based on primary research with 17 marketing and product development managers and bariatric surgeons in Asian, European and North American markets The market for bariatric surgery devices in the US was valued at $XXm in 2004 and grew at a CAGR of XX% to reach $XXm in 2011. Page 31

9 Appendix The data and analysis within this report is driven by the Medical etrack Medical etrack gives you key information to drive the sales, investment and deal making activity of your business. It includes the following information: 14,000+ Market size data tables across 400 medical equipment segments and 37 countries with historic data from 2000 forecast to 2016 3,000+ Primary expert interviews conducted to ensure data and report quality 1,000+ Conferences on the medical equipment covered 1,000+ Industry leading reports covering growing sectors, market trends, investment opportunities and the competitive landscape 450+ Analysis reports covering market and pipeline product analysis reports by indication, medical equipment trends and issue reports and investment and M&A trend reports worth over $3m 20,000+ Medical equipment companies profiled 1,500+ Private, emerging and technology start-up company profiles 1,000+ Medical equipment manufacturers in China and India 1,500+ Medical equipment companies in Japan 450+ Companies with revenue splits and market shares by category 500+ Quarterly and annual medical equipment company financials 400+ Medical equipment company SWOTs 7,000+ Pipeline product profiles 4,000+ Marketed product profiles 1,500+ Pipeline technologies 10,500+ Clinical trials 12,000+ Trial investigators 9,000+ New product patents 2,500+ Companies with products in development 12,000+ Deals in the medical equipment industry 1,100+ Surgical and diagnostic procedures by therapy area 40+ Key healthcare indicators by country For more information or to receive a free demo of the service visit http://www.medicaletrack.com/contactus.aspx?rd=demo 9.1 Market Definitions 9.1.1 Bariatric Surgery Devices Bariatric surgery devices include those used during obesity surgeries such gastric bypass, gastric banding and sleeve gastrectomy. The devices include gastric bands, stapling devices and trocars. 9.1.1.1 Gastric Bands Gastric bands are used in gastric banding surgeries to reduce the size of the stomach s opening. The band is connected to a port which is placed just under the patient s skin and then used to inflate the band, restricting the size of the stomach s opening. 9.1.1.2 Stapling Devices Stapling devices are used in gastric bypass procedures to create a small pouch, and in sleeve gastrectomy procedures to create a banana-shaped sleeve. Page 73

9.1.1.3 Trocars Trocars are used during laparoscopic bariatric surgeries to gain access to the patient s abdomen. Depending upon the procedure, five to seven trocars are needed. 9.2 Abbreviations ADA: American Diabetes Association ASMBS: American Society for Metabolic and Bariatric Surgery BMI: Body Mass Index CAGR: Compound Annual Growth Rate C.H.O.I.C.E.: Choosing Health over Obesity Inspiring Change through Empowerment CDC: CMS: DBS: FDA: GE: HSE: IFSO: IGB: ILS: Centers for Disease Control and Prevention Centers for Medicare Services Deep-brain Stimulation Food and Drug Administration Gastroesophageal Health Survey for England International Federation for the Surgery of Obesity and Metabolic Disorders Intragastric Balloon Intraluminal Stapler JAMA: Journal of the American Medical Association LABG: Laparoscopic Adjustable Gastric Banding NHANES: National Health and Nutrition Examination Survey NHS: NOO: OSSI: PEG: National Health Service National Obesity Observatory Obesity and Metabolic Surgery Society of India Percutaneous Endoscopic Gastrostomy RYGBP: Roux-en-Y Gastric Bypass SOARD: Surgery for Obesity and Related Diseases WHO: World Health Organization 9.3 Sources American Society for Metabolic & Bariatric Surgery (ASMBS) (2012). Medicare removes CPT code 43770 (placement of gastric band) from the Inpatient-only list. Available from: http://asmbs.org/2012/03/medicare-removes-cpt-code-43770-placement-of-gastric-band-from-the-inpatient-onlylist/ [Accessed Date: March 26, 2012] Avgerinos et al (2010). Incidence and risk factors for the development of anemia following gastric bypass surgery. World Journal of Gastroenterology. Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/pmc2856827/?tool=pubmed [Accessed Date: March 29, 2012] Center for Adolescent Bariatric Surgery - NewYork-Presbyterian Morgan Stanley Children's Hospital. Adolescent Bariatric Surgery Center Passes Surgical Milestone. Available from: http://nyp.org/news/hospital/bariatric-surgery-milestone.html [Accessed Date: March 20, 2012] Page 74

Centers for Disease Control and Prevention (CDC). National Health and Nutrition Examination Survey (NHANES) - 2007-2008. Prevalence of Overweight, Obesity, and Extreme Obesity Among Adults: United States, Trends 1960-1962 Through 2007-2008. Available from: http://www.cdc.gov/nchs/data/hestat/obesity_adult_07_08/obesity_adult_07_08.htm [Accessed Date: March 26, 2012] Centers for Medicare and Services (CMS). Medicare Claims Processing Manual. Available from: https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads//clm104c32.pdf [Accessed Date: March 27, 2012] Chang et al (2011). Cost-effectiveness of bariatric surgery: Should it be universally available? Maturitas Journal. Available from: http://www.maturitas.org/article/s0378-5122%2811%2900143-5/abstract [Accessed Date: April 10, 2012] Cherian et al (2010). Band erosion after laparoscopic gastric banding: a retrospective analysis of 865 patients over 5 years. Surgical Endoscopy. Available from: http://www.springerlink.com/content/1405043476122857/ [Accessed Date: April 5, 2012] Choosing Health over Obesity Inspiring Change through Empowerment. Allergan, Inc. launches public awareness and advocacy campaign to urge greater attention to critical need for both prevention and treatment to effectively address adult obesity. Available from: http://multivu.prnewswire.com/mnr/mychoicecampaign/43609/. [Accessed Date: March 26, 2012] Columbia University Center for Metabolic and Weight Loss Surgery. Center for Adolescent Bariatric Surgery Completes 28th Lap-Band Surgery in September 2007. Available from: http://obesitymd.org/news_ob.html [Accessed Date: March 20, 2012] DeBar et al (2011). Student public commitment in a school-based diabetes prevention project: impact on physical health and health behavior. BMC Public Health. Available from: http://www.biomedcentral.com/bmcpublichealth/ [Accessed Date: March 30, 2012] Deveney (2011). To Band or to Bypass, That Is the Question. Archives of Surgery. Available from: http://archsurg.ama-assn.org/cgi/content/short/archsurg.2011.36 [Accessed Date: March 27, 2012] Frenken et al (2011). Improvement of Type 2 Diabetes Mellitus in Obese and Non-Obese Patients after the Duodenal Switch Operation. Journal of Obesity. Available from: http://www.hindawi.com/journals/jobes/2011/860169/ [Accessed Date: April 2, 2012] Hakky, S. et al (2009). The Provision of Bariatric Surgery in the United Kingdom Past, Present and Future Considerations: the Road to Excellence. Available from: http://bariatrictimes.com/2009/09/23/theprovision-of-bariatric-surgery-in-the-united-kingdom%e2%80%94past-present-and-future-considerations-the-roadto-excellence/. [Accessed Date: March 26, 2012] Buchwald and Oien (2009). Metabolic/Bariatric Surgery Worldwide 2008. Obesity Surgery. Available from: http://wlsvitagarten.com/wp-content/uploads/2009/11/2008-surgery-type-percentage.pdf [Accessed Date: March 29, 2012] Hezelgrave and Oteng-Ntim (2011). Pregnancy after Bariatric Surgery: A Review. Journal of Obesity. Available from: http://www.hindawi.com/journals/jobes/2011/501939/ [Accessed Date: April 3, 2012] Highland Hospital - University of Rochester Medical Center. Bariatric Surgery Center. Available from: http://www.urmc.rochester.edu/hh/services-centers/bariatrics/morbid-obesity.cfm Hinojosa et al (2008). National trends in use and outcome of laparoscopic adjustable gastric banding. Surgery for Obesity and Related Diseases Available from: http://www.soard.org/article/s1550-7289(08)00627-8/abstract [Accessed Date: April 3, 2012] Hoerger et al (2010). Cost-Effectiveness of Bariatric Surgery for Severely Obese Adults With Diabetes. Diabetes Care Journal. Available from: http://care.diabetesjournals.org/content/33/9/1933.abstract [Accessed Date: April 10, 2012] Imaz (2008). Safety and effectiveness of the intragastric balloon for obesity. A meta-analysis. Obesity Surgery. Available from: http://www.springerlink.com/content/993mu31725186219/ [Accessed Date: March 30, 2012] Page 75

Jen et al (2010). Trends and Outcomes of Adolescent Bariatric Surgery in California, 2005-2007. Pediatrics. Available from: http://pediatrics.aappublications.org/content/126/4/e746.abstract?sid=ea40f5ef- 11c3-46cc-975d-c36c9183680b [Accessed Date: March 29, 2012] Los Angeles Times. Study questions Lap-Band's long-term effectiveness. Available from: http://articles.latimes.com/2011/mar/22/business/la-fi-lap-band-study-20110322 [Accessed Date: March 23, 2012] Magdaleno et al (2011). Pregnancy after bariatric surgery: a current view of maternal, obstetrical and perinatal challenges. Archives of gynecology and obstetrics. Available from: http://www.springerlink.com/content/9645p025q3085243/ [Accessed Date: April 9, 2012] Mäklin et al (2011). Cost-utility of bariatric surgery for morbid obesity in Finland. British Journal of Surgery. Available from: http://onlinelibrary.wiley.com/doi/10.1002/bjs.7640/abstract;jsessionid=2dd9da7ded95458916f76b7c98c67d7 C.d02t04 [Accessed Date: April 9, 2012] Mayo Clinic. Bariatric Surgery. Available from: http://www.mayoclinic.org/bariatricsurgery/complications.html. [Accessed Date: March 27, 2012] Mayo Clinic. Obesity Treatment and Drugs. Available from: http://www.mayoclinic.com/health/obesity/ds00314/dsection=treatments-and-drugs [Accessed Date: March 14, 2012] National Obesity Observatory (NOO). Epidemiology of Adult Obesity. Available from: http://www.noo.org.uk/noo_about_obesity/adult_obesity/epidemiology [Accessed Date: March 27, 2012] National Obesity Observatory (NOO). International comparisons of obesity prevalence (June 2009). Available from: http://www.noo.org.uk/uploads/doc799_2_international_comparisons_obesity_prevalence2.pdf [Accessed Date: March 27, 2012] Nguyen et al (2010). Trends in Use of Bariatric Surgery, 2003 2008. Journal of the American College of Surgeons. Available from: http://www.journalacs.org/article/s1072-7515(11)00340-1/abstract [Accessed Date: April 4, 2012] Nguyen et al (2011). Increasing Utilization of Laparoscopic Gastric Banding in the Adolescent: Data from Academic Medical Centers, 2002-2009. The American Surgeon. Available from: http://www.ingentaconnect.com/content/sesc/tas/2011/00000077/00000011/art00042?token=004f1607fef02f6e58 654624317b427c6b655d7e6b67446a5e4e26634a492f2530332976a9ae280 [Accessed Date: April 4, 2012] NYU Medical Center. NYU Medical Center Receives FDA Approval to Study Safety and Efficacy of Gastric Banding Weight Loss Surgery on Teens. Available from: http://thinforlife.med.nyu.edu/success/news-articles/nyu-medical-center-receives-fda-approval-study-safety-andefficacy-gastric-ban [Accessed Date: March 20, 2012] Ogden et al (2012). Prevalence of Obesity and Trends in Body Mass Index Among US Children and Adolescents, 1999-2010. The Journal of the American Medical Association (JAMA). Available from: http://jama.ama-assn.org/content/early/2012/01/11/jama.2012.40.abstract [Accessed Date: March 28, 2012] Padwal et al (2011). Bariatric Surgery: A Systematic Review of the Clinical and Economic Evidence. Journal of General Internal Medicine. Available from: http://www.springerlink.com/content/k48h0686338u7012/ [Accessed Date: April 5, 2012] Ray and Ray (2010). Safety, efficacy, and durability of laparoscopic adjustable gastric banding in a single surgeon U.S. community practice. Surgery for Obesity and Related Diseases. Available from: http://www.soard.org/article/s1550-7289%2810%2900643-x/abstract [Accessed Date: March 30, 2012] Ruz et al (2011). Zinc absorption and zinc status are reduced after Roux-en-Y gastric bypass: a randomized study using 2 supplements. American Journal of Clinical Nutrition. Available from: http://www.ajcn.org/content/94/4/1004.abstract [Accessed Date: April 2, 2012] Sarwer et al (2012). Physicians' attitudes about referring their type 2 diabetes patients for bariatric surgery. Surgery for Obesity and Related Diseases. Available from: http://www.soard.org/article/s1550-7289%2812%2900022-6/abstract [Accessed Date: March 28, 2012] Sciumè et al (2009). Role of intragastric air filled ballon (Heliosphere Bag) in severe obesity. Personal experience. Annali italiani di chirurgia journal. Available from: Page 76

http://www.researchgate.net/publication/26742566_role_of_intragastric_air_filled_ballon_%28heliosphere_bag% 29_in_severe_obesity._Personal_experience [Accessed Date: April 10, 2012] Slater et al (2011). Early Postoperative Outcomes and Medication Cost Savings after Laparoscopic Sleeve Gastrectomy in Morbidly Obese Patients with Type 2 Diabetes. Journal of Obesity. Available from: http://www.hindawi.com/journals/jobes/2011/350523/ [Accessed Date: March 26, 2012] Surgical Review Corporation. The Obesity & Metabolic Surgery Society of India and SRC Launch Center of Excellence Program for Bariatric Surgery. Available from: http://www.surgicalreview.org/news/2011/05/ossi-coe-launch/ [Accessed Date: March 26, 2012] Tamir et al (2011). Downsizing pregnancy complications: a study of paired pregnancy outcomes before and after bariatric surgery. Surgery for Obesity and Related Diseases. Available from: http://www.soard.org/article/s1550-7289%2811%2900850-1/abstract [Accessed Date: March 26, 2012] Tiwari et al (2010). Safety, efficacy, and cost-effectiveness of common laparoscopic procedures. Surgical Endoscopy. Available from: http://www.springerlink.com/content/786843t53q7633x4/ [Accessed Date: April 2, 2012] US Food and Drug Administration (FDA). Tainted Weight Loss Products Available from: http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/medicationhealthfraud/ucm 234592.htm [Accessed Date: March 28, 2012] Villamizar and Pryor (2010). Safety, Effectiveness, and Cost Effectiveness of Metabolic Surgery in the Treatment of Type 2 Diabetes Mellitus. Journal of Obesity. Available from: http://www.hindawi.com/journals/jobes/2011/790683/ [Accessed Date: April 4, 2012] Walk from Obesity. Walk from Obesity Media Kit. Available from: http://walkfromobesity.com/media/2011wfomediakit.pdf. [Accessed Date: March 26, 2012] WebMd. Bariatric Surgery on the Rise in Obese Teens. Available from: http://children.webmd.com/news/20100920/bariatric-surgery-on-the-rise-in-obese-adolescents [Accessed Date: March 20, 2012] World Health Organization (WHO). Nutrition - Facts and Figures (2009). Available from: http://www.euro.who.int/en/what-we-do/health-topics/disease-prevention/nutrition/facts-and-figures [Accessed Date: March 28, 2012] Yoon et al (2011). Early experience with diagnosis and management of eroded gastric bands. Journal of Korean Surgical Society. Available from: http://thesurgery.or.kr/doix.php?id=10.4174/jkss.2012.82.1.18 [Accessed Date: March 26, 2012] 9.4 Research Methodology GlobalData s dedicated research and analysis teams consist of qualified professionals with experience in marketing, market research, consultancy (with a background in the medical devices industry) and advanced statistical expertise. GlobalData adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and the Society of Competitive Intelligence Professionals (www.scip.org). All GlobalData databases are continuously updated and revised. The following research methodology is followed for all databases and reports. 9.4.1 Secondary Research The research process begins with exhaustive secondary research of internal and external sources to provide qualitative and quantitative information relating to each market. The secondary research sources that are typically referred to include, but are not limited to: Company websites, annual reports, financial reports, broker reports, investor presentations and SEC filings Industry trade journals, scientific journals and other technical literature Internal and external proprietary databases Page 77

Relevant patent and regulatory databases National government documents, statistical databases and market reports Procedure registries News articles, press releases and web-casts specific to the companies operating in the market 9.4.2 Primary Research GlobalData conducts hundreds of primary interviews a year with industry participants and commentators in order to validate its data and analysis. A typical research interview fulfills the following functions: Provides first-hand information on the market size, market trends, growth trends, competitive landscape and future outlook Helps in validating and strengthening the secondary research findings Further develops the analysis team s expertise and market understanding. Primary research involves telephone and email interviews as well as face-to-face interviews for each market, category, segment and sub-segment across geographies. The participants who typically take part in the process include, but are not limited to: Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and national sales managers Hospital stores, laboratories, pharmacies, distributors and paramedics Outside experts: investment bankers, valuation experts, and research analysts specializing in specific medical equipment markets Key opinion leaders: physicians and surgeons specializing in different therapeutic areas corresponding to different kinds of medical equipment. 9.4.3 Models Where no hard data is available, GlobalData uses modeling and estimates in order to produce comprehensive data sets. The following rigorous methodology is adopted: Available hard data is cross referenced with the following data types to produce estimates: Demographic data: population, split by segment Macro-economic indicators: such as GDP and inflation rate Healthcare indicators: health expenditure, physicians base, healthcare infrastructure and facilities Selected epidemiological and procedure statistics 9.4.4 Forecasts GlobalData uses proprietary forecast models. The following four factors are utilized in the forecast models: Historic growth rates Macro indicators such as population trends and healthcare spending Forecast epidemiological data Qualitative trend information and assumptions Data is then cross checked by the expert panel. Page 78

9.4.5 Expert Panel GlobalData uses a panel of experts to cross verify its databases and forecasts. GlobalData s expert panel includes marketing managers, product specialists, international sales managers from medical device companies, academics from research universities, KOLs from hospitals, consultants from venture capital firms and distributors/suppliers of medical equipment and supplies. Historic data and forecasts are relayed to GlobalData s expert panel for feedback and adjusted accordingly. 9.5 GlobalData Consulting We hope that the data and analysis in this brief will help you make informed and imaginative business decisions. If you have further requirements, GlobalData s consultancy team may be able to help you. GlobalData offers tailor made analytical and advisory services to drive your key strategic decisions. 9.7 Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData. Page 79