REFERENCE CODE GDME1053CFR PUBLICAT ION DATE AUGUST 2013 IN-VITRO COLORECTAL CANCER SCREENING TESTS - US ANALYSIS AND MARKET FORECASTS

Transcription

1 REFERENCE CODE GDME1053CFR PUBLICAT ION DATE AUGUST 2013 IN-VITRO COLORECTAL CANCER SCREENING TESTS -

2 Executive Summary In-vitro CRC Screening Tests: Key Metrics in US Market Screening population (2013) 87,531,980 CRC Incidence Cases 169, In-Vitro CRC Screening Test Market Sales US $74,150,997 Pipeline Assessment Number of early development tests 6 Number of early clinical devices 9 Number of late clinical devices 2 Key Events ( ) Issuing of Premarket Approval for Epi procolon Issuing of Premarket Approval for ColoGuard Publication of DeeP-C trials data Revised USPSTF CRC screening guidelines Myriad Genetics v AMP Supreme Court decision Introduction of ColoGuard Free FOB testing through Affordable Care Act 2019 Market Sales Level of Impact US $1,336,097,414 Source: GlobalData. Market Domination by Fecal Blood Tests The major feature of the in-vitro colorectal cancer (CRC) screening testing market is the current domination of fecal occult blood (FOB) tests, by a large variety of manufacturers, with no clear market leader. Increasingly, immuno-fob tests are preferred over the very dated and obsolete guaiac FOB test. According to GlobalData s forecast, in 2013, FOB tests account for 76% of the market, which is valued at $74m. Despite a lack of any recommendation from published CRC screening guidelines, emerging DNA tests for CRC have gained some ground, accounting for 24% of the market by value. However, this share is distorted by the relatively high price of these tests, compared with FOB tests. In 2012, 8.3 million FOB tests were carried out, compared to 57,600 DNA tests. In-vitro CRC Screening Test Market by Type of Test, 2013 CRC Serum DNA Tests 24% CRC FOB Tests 76% Source: GlobalData. 2

3 Executive Summary While the in-vitro CRC screening market is defined by a large number of fecal occult blood tests, produced by a great number of manufacturers, Beckman Coulter account for 60% of the US fecal occult in-vitro CRC screening market. Significant Unmet Needs Test accuracy remained a significant unmet need, in all markets. FOB tests have a significant false positive result rate, which creates a heavy burden on diagnostic colonoscopy services. Patient aversion to stool samples is another major unmet need. Poor patient compliance with FOB tests is thought by physicians to be due to an inability to comply with specific dietary instructions, cultural aversion and a lack of awareness of the importance of testing. Adoption of new screening tests, which test for DNA biomarkers indicative of early-stage CRC, will increase compliance, because they will be more accessible to patients, via their physician. These tests are expected to be more accurate, resulting in a higher percentage of patients referred for a diagnostic colonoscopy being diagnosed with CRC. Compliance will increase, resulting in more people being screened for CRC. The overall costs of CRC treatment will be driven down, due to increased diagnosis of CRC at an early stage, when it is most easily treatable, and at a lower cost. The number of screening colonoscopies will continue to increase, but will level off over time, since a significant portion of the CRC screening population cannot undergo a screening colonoscopy. Increasingly, the colonoscopy will become regarded as a tool to confirm the diagnosis of CRC indicated by a DNA test. Future Landscape Adoption of new tests will be strongly determined by the administration of the local CRC screening program. In the US, where screening is opportunistic, and typified by a wide range of different screening tests, physicians will continue to prefer the colonoscopy for patients, but will increasingly offer alternative tests to the significant proportion of patients who decline a screening colonoscopy. Overall, within the forecast period, the use of fecal occult blood tests for CRC screening is expected to decline, in particular within mature economies, as physicians continue to increasingly recommend screening colonoscopy, but also adopt new emerging molecular tests. The introduction of an FDA-approved blood test for CRC, coinciding with a revision in the screening guidelines, expected in early 2014, will likely lead to a rapid uptake in DNA CRC screening tests, which will become the preferred alternative to a colonoscopy. 3

4 Executive Summary The fight for market share among DNA test makers is expected to be between Epigenomics and Exact Sciences, as they launch competing DNA screening products. The clear differentiators between them are the type of sample processed and the complexity of the test. GlobalData expects the victor to be the company whose test is most accessible, by answering the key unmet needs, but is also most easily able to be implemented. Tests that are technically superior, but which are technically difficult to implement, will struggle to find favor when compared to the benchmarked immuno-fob test. Tests that at least match the performance of the immuno-fob test, but which answer the key unmet need of patient accessibility, will see a rapid uptake by the population. What do Physicians Think? Physicians have fundamental doubts about the efficacy of present screening tests for CRC. You know, so it s hard to know if somebody, they have been screened two years in a row and then they are all of a sudden diagnosed with colorectal cancer; you don t know whether that was a bad test, or whether it happened to be the biology of that person s tumor. Key Opinion Leader, April, 2013 Patients frequently make mistakes in homecompleted fecal occult blood tests. You know the standard instructions say mail the kit within one week We changed the instructions, we developed our own instructions, with patients and staff, and that says mail immediately. Because they don t forget that way, [it] doesn t sit around for weeks before they mail it in. Fear and inconvenience dissuade people from undergoing screening colonoscopies. People [who refuse a colonoscopy] who have had a cousin, some distant relative, or they know somebody, who had a perforation, or I have had people who were afraid of going under anesthesia, they have fears of that. Some people just don t want their rectums probed half the time it s the patients who totally refuse overtly and the other half are people who refuse covertly. Physicians feel patients are more receptive to colonoscopies if the purpose is to investigate a potential problem. Once the patients know they ve got a fecal occult blood test that s positive, they want to have a colonoscopy; in a whole year, we will only have a couple of patients who won t turn up because they don t want further investigation. 4

5 Executive Summary Some physicians feel that the colonoscopy is not the gold standard for colorectal cancer detection in asymptomatic patients. Everyone always thought that the colonoscopy was like the gold-standard and now with all of the findings about right-sided sessile polyps and you know the mortality associated with that and looking at these interim colorectal cancers that are occurring, you know, two and three years after colonoscopy, which we clearly missed I think people realize now that colonoscopy is far from perfect. A blood test to detect early-stage colorectal cancer would dramatically increase screening rates, because of the greatly improved patient access. Oh, you just have total control, not total control but you know if we order a test and if I see somebody and tell them to get blood drawn on your way out, you know, 98%...95% [of] people would do that. An effective blood test for colorectal cancer could cause an increase in cancer screening compliance last seen with the introduction of PSA testing. The prime example is the screening for prostate cancer, I ve never had anyone say don t get me a PSA, I ve had a lot of people say, I don t want my prostate checked. But they seem to have a great acceptance for a blood test. New tests based on stool sample might face significant resistance from patients, because patients find the stool sample repellant. The majority of people don t make a big stink about it, overwhelming majority, but occasionally you get people who say I m not going to play with my feces [Tests] checking the genes in the stool, might have a little problem catching on, just because people are used to the FOB test, the FIT test, they ve been doing that for years and years, and you are still having to collect stool, so I m not so sure. They re still dirty. Physicians feel that while efficacy is important for any CRC screening test, cost is also a deciding factor. I think we have to reduce the false positives, second, we have to also reduce the false negatives we have to take into account the cost and price of this exam 5

6 Executive Summary Physicians want to see the evidence for new tests before recommending them. I think the gene tests do hold a lot of promise I think there is a lot of potential there, but you need more good evidence. Just because it s available, doesn t mean I m going to use it If you can show me in 10, 15 years the data, that shows a head-tohead comparison, that it performs just as well as colonoscopy; I ll be the first person to jump on the bandwagon. The results of new colorectal screening tests must be easy for physicians to understand, in order to render the correct clinical advice. I think for the busy primary care doctor, a yes-no test has some utility, but doesn t require too much cerebration. If the new colorectal cancer screening tests are complex, test providers will need to include algorithms in the test determination in order to allow physicians to accurately assess their patients for the risk of colorectal cancer. If necessary, this will need engagement with the regulatory authorities. [The FDA] needs to wake up So if you have got that panel and you know somebody has got three genetic defects and you know what the probability is, and that they are independent and then you can say, you know well this person has a 3.2% higher risk, and that s all the clinicians need to see. They don t need to try and interpret that in their brain and here is the three positives and here is what the relative risks are, I mean that s way too complicated. A new screening test, though more expensive than fecal occult blood testing, might lead to overall cost reductions in screening for colorectal cancer because fewer people will be referred needlessly for a colonoscopy. It all depends on how good the test is and how it compares with current tests. Say if it s a little bit more expensive but the bang is worth the bucks, then they would change, probably because, again, it would reduce the number of colonoscopies you d need to do, so that s a cost saving. 6

7 Executive Summary Fecal occult blood tests, although disliked for identifying colorectal cancer, were useful in the detection of other bowel diseases [The FOB test] is going to pick up other pathologies, like inflammatory bowel disease, because I had quite a few patients referred to me because they had a screening colonoscopy, and it s not cancer, its colitis or Crohn s disease. Informed patient consent is of uppermost importance, and patients should be provided information on all the different kinds of screening tests available. New colorectal cancer tests could be included with other screening tests for cancer, improving the economic value of all cancer screening. The panel test will be better; it would also be quite good if it could be combined with looking for other diseases as well, so not just bowel cancer, but breast cancer, prostate cancer, whatever, it s like a one-off test. And then you would decrease the cost of all your screening programs, because it would be one test hits all [of the major cancers]. I think that the variety of tests will expand and the patient has to select an appropriate test for himself. All the diagnostic tests have colonoscopy for confirmation of a CRC diagnosis. 7

8 List of Tables List of Figures Introduction Catalyst Related Reports Disease Overview Colorectal Cancer Anatomy and Physiology Pathophysiology Histology Genetic Basis Etiology of CRC Clinical Presentation Symptoms Screening Overview Status of National CRC Screening Programs Diagnosis Overview Staging Colorectal Cancer Clinical Outcomes Treatment Paradigms

9 3.5.2 Treatment Options Overview Epidemiology Global and Historical Trends US Epidemiology Forecast ( ) Total Incident Cases of Colorectal Cancer Economic Impact Individual Costs Competitive Assessment Overview Fecal Occult Blood Tests Guaiac Fecal Occult Blood Stool Tests Lateral Flow Immuno-Fecal Occult Blood Tests Readers Immuno-FOB Test ELISA Immuno-FOB Agglutination Tests CRC DNA Screening Tests Panel DNA Tests Methylated Gene Testing Other Biomarker Tests Overview Tumor M2-PK Stool Test/2-in-1 Quick Test Transferrin Assays

10 5 Unmet Needs False Negative Results False Positive Results Sample Type Screening Compliance Alternative to Colonoscopy Accurate Early Staging of Colorectal Cancer Screening Test Alternatives Automation Pipeline Products Overview Pipeline by Phases in Development Pipeline Product Profiles BST1 CRC Assay Cologic ColoGuard Colon Cancer BEC Test Colon MarCare Plex Colox CRC Bacterial Signature Assay CRC Breath Test Epi procolon ExiQon MicroRNA Test

11 Gemini CRC Biomarker Assay GenomicTree Methylated DNA Test Measure Fecal Occult Blood Test Metabiomics CRC Test MiR-21 Test Oncolite CR PanC-Dx Industry Overview Colorectal Cancer Screening Test Trends Market Access Reimbursement Trends Regulatory Issues and Recalls Regulatory Issues Recalls Mergers and Acquisitions Current and Future Players Overview Trends in Corporate Strategy Company Profiles Abbott Molecular Alere Beckman Coulter Biomarcare Technologies

12 8.3.5 Companion Dx Eiken Chemical Epigenomics Exact Sciences ExiQon Fujirebio (Miraca Holdings) GeneNews GenomicTree Immunostics Kyowa Medex MDx Health (was OncoMethylome) Merck Millipore Metabiomics Mode Diagnostics Oncocyte (Bio Time) Quest Diagnostics R-Biopharm Randox Laboratories ScheBo Biotech SciMarket Technologies Siemens Healthcare Signature Diagnostics Sysmex

13 Veda Lab Market Drivers, Opportunities and Barriers Market Drivers Uptake of Pipeline Biomarker Tests Increasing Incidence of Colorectal Cancer and Improvements in Treatment Patient Reluctance to Colonoscopies in Opportunistic CRC Screening Increased Pressure on Endoscopy Services Opportunities Blood Tests Increasing CRC Screening Compliance Integration of CRC Screening Tests with Prognostic Tests and Other Screening Programs Market Barriers Cultural and Social Resistance to Stool Tests CRC Screening Awareness and Education Reimbursement Local Requirements Test Complexity Patenting Issues Country Outlooks & Forecasts Overview Market Analysis Appendix

14 11.1 Abbreviations Bibliography Research Methodology Coverage Secondary Research Forecasting Methodology Physicians and Specialists Included in this Study Primary Research About the Authors Analysts Global Head of Healthcare About GlobalData Disclaimer

15 1.1 List of Tables Table 1: Initial Presenting Symptoms of Colorectal Cancer Table 2: Guideline Organization Recommendations for Non-Invasive Tests Table 3: TNM Classification System to Stage CRC Table 4: Stage Grouping for CRC Table 5: Stage II CRC Sub-Divisions Table 6: Stage III CRC Sub-Divisions Table 7: Stage IV CRC Sub-Divisions Table 8: Dukes System of CRC Classification Table 9: Treatment Guidelines for Colorectal Cancer Table 10: Surgical Options for Colorectal Cancer Table 11: Treatment Alternatives for CRC Table 12: Incident Cases of Colorectal Cancer, Ages 40 Years, Men and Women, N, Table 13: Costs of CRC Diagnosis, Treatment and Care Table 14: CRC Screening Test Segmentation Table 15: Guaiac Fecal Occult Blood Tests Product Profile Table 16: Guaiac FOB Test SWOT Analysis, Table 17: Immuno-FOB Tests Table 18: Product Profile Lateral Flow Immunochemical Fecal Occult Blood Tests Table 19: Lateral Flow Immunochemical Fecal Occult Blood Tests SWOT Analysis, Table 20: Table 21: Product Profile Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers) Veda Lab Easy Reader (Lateral Flow Immunochemical Fecal Occult Blood Tests with Readers) SWOT Analysis, Table 22: Fecal Occult Blood ELISA Products

16 Table 23: Product Profile Fecal Occult Blood ELISA Table 24: Immuno-FOB Test ELISA SWOT Analysis, Table 25: Commercially Available Immuno-FOB Agglutination Test Systems Table 26: Product Profile Immuno-FOB Agglutination Tests Table 27: Immuno-FOB Agglutination Tests SWOT Analysis, Table 28: Key Mutations Associated with CRC Table 29: Key Stages of PCR Gene Test Table 30: Product Profile PreGen Plus Table 31: PreGen Plus SWOT Analysis, Table 32: Product Profile K-RAS, B-RAF, PIK3CA Array Table 33: K-RAS, B-RAF, PIK3CA Array SWOT Analysis, Table 34: Product Profile Colonsentry Table 35: Colonsentry SWOT Analysis, Table 36: Product Profile Detector C Table 37: Detector C SWOT Analysis, Table 38: Product Profile ColoSure Table 39: ColoSure SWOT Analysis, Table 40: Product Profile MS Table 41: MS9 SWOT Analysis, Table 42: Septin-9 CRC Screening Marketed Laboratory-Developed Tests Table 43: Product Profile ColoVantage/Septin Table 44: ColoVantage/Septin-9 SWOT Analysis, Table 45: Product Profile Tumor M2-PK Stool Test/2-in-1 Quick Test Table 46: Tumor M2-PK Stool Test/2-in-1 Quick Test SWOT Analysis,

17 Table 47: Product Profile Transferrin Assays Table 48: Transferrin Assays SWOT Analysis, Table 49: Major Reasons for Non-compliance with CRC Screening Table 50: Correlation of Fecal Occult Blood Test with Neoplasia Table 51: CRC Screening Tests Pipeline, Table 52: Product Profile BST1 CRC Assay Table 53: BST1 CRC Assay SWOT Analysis, Table 54: Product Profile Cologic Table 55: Cologic SWOT Analysis, Table 56: Product Profile ColoGuard Table 57: ColoGuard SWOT Analysis, Table 58: Product Profile Colon Cancer BEC Test Table 59: Colon Cancer BEC Test SWOT Analysis, Table 60: Product Profile Colon MarCare Plex Table 61: Colon MarCare Plex SWOT Analysis, Table 62: Product Profile Colox Table 63: Colox SWOT Analysis, Table 64: Product Profile CRC Bacterial Signature Assay Table 65: CRC Bacterial Signature Assay SWOT Analysis, Table 66: Product Profile CRC Breath Test Table 67: CRC Breath Test SWOT Analysis, Table 68: Product Profile Epi procolon Table 69: Epi procolon Clinical Trials Table 70: Epi procolon SWOT Analysis,

18 Table 71: ExiQon MicroRNA Sensitivity and Specificity Table 72: Product Profile ExiQon microrna Test Table 73: ExiQon microrna Test SWOT Analysis, Table 74: Product Profile Gemini CRC Biomarker Assay Table 75: Gemini CRC Biomarker Assay SWOT Analysis, Table 76: Product Profile GenomicTree Methylated DNA Test Table 77: GenomicTree Methylated DNA Test SWOT Analysis, Table 78: Product Profile Measure Table 79: Measure SWOT Analysis, Table 80: Product Profile Metabiomics CRC Test Table 81: Metabiomics CRC Test SWOT Analysis, Table 82: Product Profile mir-21 Test Table 83: mir-21 Test SWOT Analysis, Table 84: Product Profile Oncolite-CR Table 85: Oncolite-CR SWOT Analysis, Table 86: Product Profile PanC-Dx Table 87: PanC-Dx SWOT Analysis, Table 88: Uptake of Colonoscopy, Sigmoidoscopy and FOB Testing in the US Table 89: Projections for Virtual Colonoscopy use for CRC Screening Table 90: Key Mergers and Acquisitions during Table 91: Company Profile Abbott Molecular Table 92: Abbott Molecular SWOT Analysis, Table 93: Company Profile Alere Table 94: Alere SWOT Analysis,

19 Table 95: Company Profile Beckman Coulter Table 96: Beckman Coulter SWOT Analysis, Table 97: Company Profile Biomarcare Technologies Table 98: Biomarcare Technologies SWOT Analysis, Table 99: Company Profile Companion Dx Table 100: Companion Dx SWOT Analysis, Table 101: Company Profile Eiken Chemical Table 102: Eiken Chemical SWOT Analysis, Table 103: Company Profile Epigenomics Table 104: Epigenomics SWOT Analysis, Table 105: Company Profile Exact Sciences Table 106: Exact Sciences SWOT Analysis, Table 107: Company Profile ExiQon Table 108: ExiQon SWOT Analysis, Table 109: Company Profile Fujirebio (Miraca Holdings) Table 110: Fujirebio SWOT Analysis, Table 111: Company Profile GeneNews Table 112: GeneNews SWOT Analysis, Table 113: Company Profile GenomicTree Table 114: GenomicTree SWOT Analysis, Table 115: Company Profile Immunostics Table 116: Immunostics SWOT Analysis, Table 117: Company Profile Kyowa Medex (Kyowa Hakko Kirin Group) Table 118: Kyowa Medex SWOT Analysis,

20 Table 119: Company Profile MDx Health Table 120: MDx Health SWOT Analysis, Table 121: Company Profile Merck Millipore Table 122: Merck Millipore SWOT Analysis, Table 123: Company Profile Metabiomics Table 124: Metabiomics SWOT Analysis, Table 125: Company Profile Mode Diagnostics Table 126: Mode Diagnostics SWOT Analysis, Table 127: Company Profile Oncocyte (Bio Time) Table 128: Oncocyte (Bio Time) SWOT Analysis, Table 129: Company Profile Quest Diagnostics Table 130: Quest Diagnostics SWOT Analysis, Table 131: Company Profile R-Biopharm Table 132: R-Biopharm SWOT Analysis, Table 133: Company Profile Randox Laboratories Table 134: Randox Laboratories SWOT Analysis, Table 135: Company Profile ScheBo Biotech Table 136: Schebo Biotech SWOT Analysis, Table 137: Company Profile SciMarket Technologies Table 138: SciMarket Technologies SWOT Analysis, Table 139: Company Profile Siemens Healthcare Table 140: Siemens Healthcare SWOT Analysis, Table 141: Company Profile Signature Diagnostics Table 142: Signature Diagnostics SWOT Analysis,

21 Table 143: Company Profile Sysmex Table 144: Sysmex SWOT Analysis, Table 145: Company Profile Veda Lab Table 146: Veda Lab SWOT Analysis, Table 147: PreGen Plus Compared to Immuno-FOB Test Table 148: Potential Impacts of Restriction of Gene Patents Table 149: Major Events Affecting the Global In-Vitro CRC Screening Test Market Table 150: Sales Forecasts for In-vitro CRC Screening Tests in the US Market, Table 151: Forecasts for Numbers of In-vitro CRC Screening Tests,

22 1.2 List of Figures Figure 1: Colorectal Cancer Staging Figure 2: US Trends in Colorectal Cancer Incidence, Figure 3: Total Costs of Colorectal Cancer to Society, Figure 4: Example of a Guaiac Fecal Occult Blood Card: Immunostics Hema-Screen Figure 5: Fecal Occult Blood Test Lateral Flow Device Architecture Figure 6: Biohit Colonview (example of immuno-fob test) Figure 7: Beckman Coulter Hemoccult-ICT (example of immuno-fob test) Figure 8: Veda Labs Easy Reader Immuno-FOB Test LFD Reader Figure 9: OC-Hemodia Agglutination FOB Test (manually performed) Figure 10: OC-Sensor/Diana FOB Test Sample Cartridge Figure 11: OC-Sensor/Diana FOB Test Instrument Figure 12: Fujirebio HemSp/MagStream HT Magnetic Agglutination Reaction Figure 13: Sentinel Diagnostic Sentifob Instrument Figure 14: Alere CI5 NS-Plus Instrument Figure 15: Orion Diagnostics Quikread FOB Test and Instrument Figure 16: Basic PCR Process Figure 17: MS9 PCR Response Curve Figure 18: Proposed ColoGuard Patient Stool Sample Collection Kit Figure 19: Exact Sciences Automated Sample Processing WorkStation Figure 20: Colox Kit Contents Figure 21: Measure Fecal Occult Blood Test Figure 22: PanC-Dx Multiplex Detection of CRC-specific Biomarker Figure 23: Uptake of FOB Testing in the US by Income,

23 Figure 24: US Sales Forecast for In-vitro CRC Screening Tests ($m), Figure 25: US Forecast for Numbers of In-vitro CRC Screening Tests, Figure 26: Share of Fecal Occult Blood Tests, by Brand, Figure 27: US Market Segmentation for In-vitro CRC Screening Tests, by Type, 2012 and

24 Introduction 2 Introduction Colorectal cancer (CRC) is the third most commonly diagnosed cancer, and the second most common cause of mortality amongst cancer patients. Prognosis is directly related to early diagnosis, with survival rates dramatically improved by early diagnosis and treatment. Thanks to the introduction of CRC screening programs, mortality in the developed countries is falling; however, incidence continues to rise as a result of diet and increasingly sedentary lifestyles. While historically, colorectal cancer incidence in the developing world is low, in recent years, disease diagnosis rates have dramatically increased, as a result of changing lifestyles, awareness and improved access to medical services. CRC screening can improve survival rates, and reduce the overall cost of patient treatment. This report focuses on the in-vitro CRC screening test markets in the US market, and identifies unmet needs in the market, physician attitudes towards current modalities in in-vitro CRC screening, and the future of CRC screening in the face of rapid technological advancement. 2.1 Catalyst Colorectal cancer screening can be carried out using a number of different methods which are either invasive or non-invasive. Typical approaches include endoscopic examination of the bowel or analysis of fecal samples for evidence of disease. Endoscopic procedures pose challenges, in terms of patient access, cost and risk. Fecal sample analysis poses challenges in patient compliance, disease sensitivity and disease specificity. New in-vitro tests promise improved sensitivity and specificity, while at the same time improving patient compliance. Two new CRC screening tests from Exact Sciences and Epigenomics are expected to receive FDA Premarket Approval in late 2013 or early 2014, and these tests may dramatically change the in-vitro CRC screening test landscape. This report will look at the physiological basis of CRC, and current treatments, in order to illustrate the impact on patients of not being diagnosed with CRC in a timely manner, at an early, and more treatable, stage of the disease. This report will examine the current understanding of CRC, the technological challenges posed and the emerging regulatory landscapes specific to new screening tests. 24

25 Appendix 11.7 About GlobalData GlobalData is a leading global provider of business intelligence in the Healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in medical device research, disease analysis, and clinical research and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports and forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has offices in New York, Boston, London, India and Singapore 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. 320