GlobalData-干细胞生命医学应用临床报告（英文）-2017.6正式版.doc

Global Trends in Stem Cell Therapy Clinical TrialsA 10-Year Retrospective, 20072016HealthcareReport Code:Published:GDHC1299EIJune 2017Global Trends in Stem Cell Therapy Clinical Trials A 10-Year Retrospective, 20072016Reference Code: GDHC1299EIPublished: June 2017Healthcare1Table of Contents1Table of Contents .21.1List of Figures .32Introduction .42.1Report Scope .42.2Methodology .42.3Organizations Mentioned.43Stem Cell Therapy Trial Landscape .53.1Introduction .53.2Stem Cell Therapy Clinical Trials by Phase and Sponsor Type, 20072016 .53.3Single-Country and Multinational Stem Cell Therapy Trials, 20072016 .83.4Average Size of Stem Cell Therapy Clinical Trials, 20072016 .93.5Stem Cell Therapy Clinical Trials by Therapy Area, 20072016 .113.6Top Indications for Stem Cell Therapy Clinical Trials, 20072016.123.7Stem Cell Therapy Clinical Trials by Status, 20072016 .143.8Top Sponsors for Stem Cell Therapy Clinical Trials, 20072016 .153.9Top Interventions Investigated in Stem Cell Therapy Clinical Trials, 20072016 .173.10Stem Cell Therapy Clinical Trials by Country, 20072016 .184Summary .195About the Authors .205.1Associate Analyst, Clinical Trials Database .205.2Global Director of Databases and Analytics .206About the Pharmaceutical Clinical Trials Team .217About GlobalData.227.1Contact Us .227.2Disclaimer .232© GlobalData 2017. This product is licensed and is not to be photocopied.Global Trends in Stem Cell Therapy Clinical Trials A 10-Year Retrospective, 20072016Reference Code: GDHC1299EIPublished: June 2017Healthcare1.1List of FiguresFigure 1: Stem Cell Therapy Clinical Trials by Phase , 200720166Figure 2: Stem Cell Therapy Clinical Trials by Sponsor Type, 200720167Figure 3: Stem Cell Therapy Single-Country and Multinational Trials, 200720168Figure 4: Average Size of Stem Cell Therapy Clinical Trials, 200720169Figure 5: Stem Cell Therapy Clinical Trials by Average Number of Locations, 2007201610Figure 6: Stem Cell Therapy Clinical Trials by Therapy Area and Sponsor Type, 2007-201611Figure 7: Stem Cell Therapy Clinical Trials for the Top Five Indications by Sponsor Type, 2007201612Figure 8: Stem Cell Therapy Clinical Trials for the Top Five Indications by Phase, 2007201613Figure 9: Status of Stem Cell Therapy Clinical Trials by Sponsor Type, 2007201614Figure 10: Top Industry Sponsors for Stem Cell Therapy Clinical Trials, 2007201615Figure 11: Top Non-Industry Sponsors for Stem Cell Therapy Clinical Trials, 2007201616Figure 12: Top Drugs Investigated in Stem Cell Therapy Clinical Trials, 2007201617Figure 13: Stem Cell Therapy Clinical Trials by Country, 20072016183© GlobalData 2017. This product is licensed and is not to be photocopied.Global Trends in Stem Cell Therapy Clinical Trials A 10-Year Retrospective, 20072016Reference Code: GDHC1299EIPublished: June 2017Healthcare2Introduction2.1Report ScopeThis whitepaper provides a review of global clinical trials for stem cell therapy initiated between 2007 and 2016. The data for this review were derived from the Clinical Trials Database of GlobalDatas Pharma Intelligence Center. The aim of this paper is to provide analyses of the main features of these trials according to 10-year trends, where relevant.2.2MethodologyThe clinical trials data used for these analyses were extracted from the Clinical Trials Database of GlobalDatas Pharma Intelligence Center. The data included global interventional trials (94.9%), observational trials (5.0%), and one expanded access clinical trial, all of which had an initiation between January 1, 2007 and December 31, 2016. The Clinical Trials Database of the Pharma Intelligence Center recorded 584 trials that satisfied the above criteria. The data were analyzed and segmented by sponsor type, trial phases, single or multinational location, size, therapy area, top indications, status, leading industry drugs, and trial locations investigated in the trials. Further analyses were carried out on the dataset to identify the top sponsors, and the top Contract Research Organizations (CROs) involved.2.3Organizations MentionedThe companies mentioned in this whitepaper include Aderans Research Institute, Anterogen, Celgene, City of Hope, Great Ormond Steet Hospital, MediPost, Mesoblast, Microbot Medical, Nanfang Hospital, Neuralstem, Pluristem Therapeutics, Samsung Medical Center, Stempeutics Research, TiGenix, University of California and Los Angeles, Universiti of Kebangsaan Malaysia, University of Miami, University of Texas, and US Stem Cell.4© GlobalData 2017. This product is licensed and is not to be photocopied.Global Trends in Stem Cell Therapy Clinical Trials A 10-Year Retrospective, 20072016Reference Code: GDHC1299EIPublished: June 2017Healthcare3Stem Cell Therapy Trial Landscape3.1IntroductionGlobalData analyzed the number of trials carried out by industry and non-industry sponsors to determine the top sponsors involved in these clinical trials, as well as the top investigational drugs. Global Data also looked at the locations that hosted the most clinical trials, and studied the most popular therapy areas and the characteristics of the populations involved in the clinical trials.GlobalData identified 584 stem cell therapy clinical trials with a start date between 2007 and 2016. The total number of stem cell therapy trials featured a steady year-on-year increase from 2007 to 2012, from 31 to 70 clinical trials globally, followed by a small decrease to 67 in 2013. There was then a continuous increase until 2015, which saw the highest number of stem cell therapy trials at 74 globally. The 10 year period ended in 2016 with 69 trials.Stem cell therapy trials experienced their highest growth in 2015, with 74 trials being initiated in that year.3.2Stem Cell Therapy Clinical Trials by Phase and Sponsor Type, 20072016In this report, a small number of Phase 0, Phase I/II, Phase II/III, and Phase III/IV trials were combined with Phase I, Phase II, Phase III, and Phase IV trials, respectively. Overall, there was a predominance of Phase I and Phase II trials as compared to Phase III and Phase IV trials, except for 2007 when Phase III trials took second place instead of those in Phase II. The yearly contribution of Phase I stem cell therapy trials saw an increase from 16% in 2007 to 35% in 2009, followed by a decrease to 17% in 2012, as shown in Figure 1. The following five years saw continuous increases in contribution of Phase I trials to a 10-year peak of 38% in 2016. Phase II had the highest contribution in 2012 and 2013 at 71% and 75%, respectively. From 2013 onwards there was a year-on-year decrease until 2016, which had the lowest contribution of Phase II trials at 48%. Phase III trials started off very strong at a peak of 32% of in 2007, then had a continual decrease and hit an all-time low of 6% in 2010. From this year onwards there were fluctuations between 7% and 12% until 2016. The contribution of Phase IV trials presented the lowest contribution numbers overall. The highest contribution of Phase IV trials was 3% in 2016; between 2007 and 2010 there was no trial registered at Phase IV.5© GlobalData 2017. This product is licensed and is not to be photocopied.Global Trends in Stem Cell Therapy Clinical Trials A 10-Year Retrospective, 20072016Reference Code: GDHC1299EIPublished: June 2017HealthcareFigure 1: Stem Cell Therapy Clinical Trials by Phase , 20072016Number of Trials807060504030201002007200820092010201120122013201420152016Phase IPhase IIPhase IIIPhase IVSource: GlobalData Pharmaceutical Intelligence Center, Clinical Trials Database Accessed May 22, 20176© GlobalData 2017. This product is licensed and is not to be photocopied.Global Trends in Stem Cell Therapy Clinical Trials A 10-Year Retrospective, 20072016Reference Code: GDHC1299EIPublished: June 2017HealthcareOver this period and across all stages of development, there were more trials sponsored by industry sponsors than non-industry sponsors. Non-industry sponsored trials saw an increase from 13 to 29 trials from 2007 to 2012, which was the highest amount of non-industry trials over the 10-year period. Industry trials saw an increase from 18 trials in 2007 to their highest level at 53 trials in 2014, as shown in Figure 2.Figure 2: Stem Cell Therapy Clinical Trials by Sponsor Type, 20072016Number of Trials60504030201002007200820092010201120122013201420152016Industry SponsorNon-Industry SponsorSource: GlobalData Pharmaceutical Intelligence Center, Clinical Trials Database Accessed May 22, 20177© GlobalData 2017. This product is licensed and is not to be photocopied.Global Trends in Stem Cell Therapy Clinical Trials A 10-Year Retrospective, 20072016Reference Code: GDHC1299EIPublished: June 2017Healthcare3.3Single-Country and Multinational Stem Cell Therapy Trials, 20072016There were, on average, 7.1 times as many single-country trials as multinational trials over the 10-year period. As shown in Figure 3, the total number of multinational trials was at its largest in 2014 at 12 trials, and was at an all-time low in 2009 at two trials. Single-country trials saw an increase between 2007 and 2012, from 22 trials to 61 trials, their highest level in the 10-year period. The biggest decrease of single-country trials was seen from 2015 to 2016, where it fell by 22%, as shown in Figure 3.Figure 3: Stem Cell Therapy Single-Country and Multinational Trials, 200720167060504030201002007200820092010201120122013201420152016Single CountryMultinationalSource: GlobalData Pharmaceutical Intelligence Center, Clinical Trials Database Accessed May 22, 20178© GlobalData 2017. This product is licensed and is not to be photocopied.Global Trends in Stem Cell Therapy Clinical Trials A 10-Year Retrospective, 20072016Reference Code: GDHC1299EIPublished: June 2017Healthcare3.4Average Size of Stem Cell Therapy Clinical Trials, 20072016The average size of clinical trials in terms of number of subjects planned across both multinational and single-country trials saw a decrease of 59%, from 92 to 38 for patient subject trials between 2007 and 2016. In contrast, the average size of clinical trials involving healthy subjects increased by 429%, from 17 to 90 between 2007 and 2016. The largest number of average healthy participants was seen in 2015. This was primarily due to a multinational trial sponsored by Mesoblast and carri