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1、Asia Pacific as a Clinical Trials PowerhouseThe Clinical Trial LandscapeDr Annie Siu,PhD,MBA,APAC Content Director,CitelineAndy Benson,MSc,Senior Director,TrialtrovePatient availability is a critical component for clinical trials,and so it stands to reason that clinical development should match the
2、epidemiology of diseases.Of course,this is often not the case,with longstanding biases towards studies in the US and Europe,where healthcare infrastructure and the pharmaceutical market are generally more mature.However,change is underway.This whitepaper takes a deep dive into the clinical trial lan
3、dscape in the Asia-Pacific(APAC)region over the past decade,from 2012 to 2021.It shows that during this time period,APAC has become a hotspot for clinical trials,with trial activity trending upwards and eventually contributing almost half of the entire global clinical trial activity in 2021.Interest
4、ingly,each APAC location has its own driving forces and unique differentiators.Utilizing the gold-standard clinical trial intelligence database Trialtrove,this new analysis delves into the sponsors,diseases,and types of trials across the APAC region,and considers the factors shaping the present-day
5、landscape in those APAC locations with the highest overall trial activity.As we navigate through the data,it is important to note three things.Firstly,Trialtrove is focused on drug clinical trials with a prospective time perspective.Other types of studies,for example those evaluating devices,surgica
6、l,or behavioral interventions,or based on retrospective data,are not part of this analysis.Secondly,trial start numbers are limited to those for which an actual start date is provided in the public domain(i.e.we excluded trials listed as planned and never confirmed to have started,or for which a spe
7、cific actual start date was never disclosed).The numbers for recent years may also be impacted by delayed reporting of trial activity.Thirdly,we are considering the APAC region to consist of the locations classified into the“Asia”and“Australia/Oceania”Trial Regions in Trialtrove.It is often said tha
8、t“disease knows no borders,”but is the same true for clinical development?IntroductionAsia Pacific as a Clinical Trials Powerhouse2|October 202250%The Rise of APACAlmost half of clinical trials include a trial location in APACClinical trial activity in APAC has increased considerably over the past d
9、ecade(Figure 1a).The total number of Phase IIV trial starts in APAC increased from 4,562 trials in 2012 to 7,718 trials in 2021,with a compound annual growth rate(CAGR)of 5.4%.This growth is most prominent in recent years,in particular since 2016.In contrast,the total number of trial starts in the r
10、est of the world(RoW)decreased from 8,080 trials in 2012 to 7,801 trials in 2021,with a CAGR of-0.4%(data not shown).RoW trials are defined as studies that do not contain a clinical site in an APAC country,although it is worth noting that a portion of APAC trials will also have sites in other region
11、s.As shown in Figure 1b,if this trend continues,APAC will surpass RoW as soon as next year.For a region that has historically trailed behind the US and Europe,this recent transformation is remarkable and shows that APAC is very much on the cutting edge of clinical research.Source:Trialtrove,August 2
12、022Source:Trialtrove,August 2022Figure 1a:Phase IIV trial starts in APAC,201221Figure 1b:Percentage of Phase IIV trial starts in APAC and RoW,by start year,203200020202002020219,000Trial countPercentage of trialsTrial start yearTrial
13、start year7,0004,0001,0004,5624,6284,6265,0364,6565,6616,3006,3357,1817,71850.3%49.7%46%54%44%56%43%57%40%60%37%63%35%35%65%65%36%36%64%64%8,0005,0002,0006,0003,00000%100%APACRoW3|October 2022Asia Pacific as a Clinical Trials PowerhouseChina,Japan,South Korea,Australia,and India are leading APAC loc
14、ationsWhere exactly is this growth in APAC happening?As shown in Figure 2,China has taken the lions share of the clinical activity over the past decade.45%of APAC trials included a Chinese site,and therefore the country takes the top spot by a clear margin.China is followed by Japan in second place,
15、with 21%of trials including a site there,and South Korea rounds out the top three with 13%of trials.Fourth place is taken by Australia,just slightly ahead of India in fifth,with 11%and 10%of APAC trials,respectively.Notably,only 10%of APAC trials included sites in the remaining 32 APAC trial locatio
16、ns where at least one study had been recorded in Trialtrove.These top five countries and China in particular dictate the overall dynamic within APAC.THE RISE OF APACNote:Combined percentages total more than 100%due to trials taking place in more than one location.Source:Trialtrove,August 2022Figure
17、2:APAC trial locations and their percentage share of APAC trials,201221ChinaJapanSouth KoreaAustraliaIndiaOthers50%Percentage of APAC trialsAPAC trial locations40%10%45%11%21%10%13%10%20%30%04|October 2022Asia Pacific as a Clinical Trials PowerhouseTHE RISE OF APACGrowth in early stage clinical tria
18、ls in APACAs shown in Figure 3,late-stage(Phase III or Phase IV)trials dominated in APAC from 2012 to 2016,but since then early-stage(Phase I or Phase II)trials have increased their share of the total trial landscape.Notably,Phase I trials increased from 627 trials(14%of APAC trials)in 2012 to 2,464
19、 trials(33%)in 2021,with a CAGR of 14.7%,surpassing the CAGR of overall APAC trials(5.4%;Figure 1a).Phase II trials increased from 1,301 trials in 2012 to 2,211 trials in 2021,at a CAGR of 5.4%,although the percentage of Phase II trials in APAC remains constant at around 28%.Phase III and Phase IV t
20、rials increased with CAGRs of just 2.6%and 0.5%,respectively.To conclude,the overall growth in APAC clinical trials is attributed to the increasing importance of early-stage clinical trials.This is a result of higher levels of innovation within APAC,with more drugs than ever being discovered by comp
21、anies based in this region.Our whitepaper on the clinical trial landscape in China published last year also showed how Phase I trials are dominant in China specifically.1 This corresponds to China solidifying its position as the second leading location for R&D globally,with South Korea,Japan,and Aus
22、tralia also in the top 10,as per analysis in the latest Pharma R&D Annual Review.21 China Clinical Trials Landscape(2021)Available from:https:/ Accessed September 7 2022.2 Pharma R&D Annual Review(2022)Available from:https:/ Accessed September 7 2022.Note:Phase II includes Phase II and Phase I/II tr
23、ials;Phase III includes Phase III and Phase II/III trials;Phase IV includes Phase IV and Phase III/IV trials.Trials that cannot be associated to any specific phase are excluded from the analysis.Source:Trialtrove,August 2022Figure 3:Clinical trial starts in APAC,by phase,201221Percentage of APAC tri
24、alsTrial start yearPhase IPhase IIPhase IIIPhase IV20000215|October 2022Asia Pacific as a Clinical Trials Powerhouse14%21%35%30%16%20%36%28%17%21%34%28%19%19%34%29%25%17%30%28%31%16%27%25%31%16%26%28%30%16%23%31%33%16%21%30%15%21%35%29%THE RISE OF APACTrials in China
25、,Australia,and India on the rise,but in Japan and South Korea the numbers have declinedAs we have shown,trial activity across the APAC region as a whole has grown over the past decade.However,there are regional differences,and this is not uniform.Figure 4 shows the number of clinical trial starts in
26、 the top five locations.In China these increased from 1,138 trials in 2012 to an impressive 4,751 trials in 2021,with a CAGR of 15.4%.China surpassed Japan to become the leading trial location in APAC since 2014.Although trials in Japan have decreased from 1,561 in 2012 to 875 in 2021,with a CAGR of
27、-5.6%,the country has retained second place since 2014,apart from a brief drop to third in 2020.The number of trials in South Korea also decreased with a CAGR of-1.1%,from 804 trials(in third place)in 2012 to 721 trials in 2021(fifth place).Australia and India both saw an increase in trials,albeit w
28、ith CAGRs of only 4.1%and 2.9%,respectively,in the same reporting period.Notably,India briefly replaced Japan in second place in 2020,primarily due to the large glut of trials for COVID-19 treatments which were initiated there.Source:Trialtrove,August 2022Figure 4:Phase IIV trial starts in top five
29、APAC trial locations,20320002020215,000Trial countTrial start year4,0001,0002,0003,0000ChinaSouth KoreaJapanAustraliaIndia6|October 2022Asia Pacific as a Clinical Trials Powerhouse Autoimmune/Inflammation Genitourinary Oncology Cardiovascular Infectious Disease Ophth
30、almology CNS Metabolic/Endocinology Vaccines(Infectious Disease)Oncology and infectious disease trials have both doubled in numberConsidering trial starts in different therapeutic areas over the last decade,as shown in Figure 5,oncology is the clear winner,increasing from 1,184 trials(26%of APAC tri
31、als)in 2012 to 2,390 trials(31%)in 2021,with a CAGR of 7.3%.This is unsurprising and mirrors the concentration and growth of pharma R&D for cancer observed globally.The number of clinical trials for infectious diseases doubled in the past decade,increasing from 536 trials(12%)in 2012 to 1,384 trials
32、(19%)in 2020,although there was then a slight decrease to 1,259 trials(16%)in 2021.Trials for infectious disease vaccines increased by nearly four-fold in the same reporting period.However,it should be noted that the COVID-19 pandemic triggered a rapid rise in the number of infectious disease trials
33、(both drug and vaccine trials)in 2020.In 202021,over 55%of infectious disease trials for both treatments and vaccines in APAC were targeting COVID-19,with about one-third of them conducted in China(32%)and one-third in India(31%).We will discuss COVID-19 in more detail later in this paper.2012201320
34、002020212,500Trial countTrial start year2,0005001,0001,5000Source:Trialtrove,August 2022Figure 5:Clinical trial starts in APAC,by therapeutic area,201221THE RISE OF APAC7|October 2022Asia Pacific as a Clinical Trials PowerhouseTrends Within APAC LocationsMost studied diseases v
35、ary according to location and epidemiologyA closer look into the top three diseases for each of the therapeutic areas uncovers some interesting differences.In India,five of the nine therapeutic areas included diseases not making the top three in the other locations,with trials for schizophrenia,seps
36、is,anemia,head and neck cancer,and hepatitis vaccines all making an appearance only in this location.Australia had three unique diseases,China had two,while South Korea and Japan had only one apiece.The intensity of trial activity for some of these diseases reflects regional epidemiology;for example
37、,head and neck cancer is very common in India,as is the burden of hepatitis.Table 1:Most studied diseases for each therapeutic area in each of the top five APAC locationsNote:Indications that are unique among the five trial locations are in bold purple text.AMD=age-related macular degeneration;BPH=b
38、enign prostatic hyperplasia;Diabetic compl.=diabetic complications;GERD=gastroesophageal reflux disease;NHL=non-Hodgkins lymphoma;NSCLC=non-small cell lung cancer;RA=rheumatoid arthritis;Respiratory inf.=respiratory infections;UC=ulcerative colitis;Bacterial skin inf.=Bacterial skin infectionChinaJa
39、panSouth KoreaAustraliaIndiaCNSPain(nociceptive)DepressionPain(neuropathic)Alzheimers diseasePain(nociceptive)Pain(neuropathic)Pain(nociceptive)Pain(neuropathic)Alzheimers diseasePain(nociceptive)Alzheimers diseaseMultiple sclerosisPain(nociceptive)Pain(neuropathic)SchizophreniaInfectious DiseaseRes
40、piratory inf.HBVBacterial skin inf.Respiratory inf.HCVCOVID-19Respiratory inf.HBVCOVID-19Respiratory inf.HCVCOVID-19COVID-19Respiratory inf.SepsisMetabolic/EndocrinologyType 2 diabetesDiabetic compl.Renal diseaseType 2 diabetesRenal diseaseDiabetic complType 2 diabetesGERDObesityType 2 diabetesRenal
41、 diseaseDiabetic compl.Type 2 diabetesDiabetic compl.AnemiaAutoimmune/InflammationRAAsthmaOsteoarthritisRAUCAsthmaRAUCAsthmaUCRAPsoriasisAsthmaOsteoarthritisRAOncologyNSCLCNHLBreastNSCLCColorectalBreastNSCLCBreastGastricNSCLCBreastNHLBreastNSCLCHead/NeckCardiovascularHypertensionThrombotic disorders
42、Coronary artery diseaseThrombotic disordersHypertensionCongestive heart failureHypertensionDyslipidemiaThrombotic disordersThrombotic disordersDyslipidaemiaHemeostasisHemophiliaHypertensionDyslipidemiaThrombotic disordersVaccines(Infectious Disease)Respiratory vaccinesOther viral vaccinesInfluenza v
43、accinesRespiratory vaccinesInfluenza vaccinesOther viral vaccinesRespiratory vaccinesInfluenza vaccinesOther viral vaccinesRespiratory vaccinesInfluenza vaccinesOther bacterial vaccinesRespiratory vaccinesOther viral vaccinesHepatitis vaccinesGenitourinaryInfertility BPHOveractive bladderOveractive
44、bladderInfertility BPHBPHOveractive bladderInfertility InfertilityOveractive bladderEndometriosisInfertilityBPHOveractive bladderOphthalmologyDiabetic retinopathyAMDDry eye syndromeGlaucomaDiabetic retinopathyAMDAMDDry eye syndromeDiabetic retinopathyAMDDiabetic retinopathyDry eye syndromeDiabetic r
45、etinopathyGlaucomaAMD8|October 2022Asia Pacific as a Clinical Trials PowerhouseTRENDS WITHIN APAC LOCATIONSChina bucks the trend with a strong domestic bias for clinical trials Figure 6a shows the percentage of industry-sponsored trials in each of the top five APAC locations which were sponsored by
46、domestic or foreign entities over the past decade.In Japan,South Korea,and India we see between 56%and 67%of trials being initiated by foreign sponsors.Australias split is striking,with 95%of the trials initiated by foreign companies.This high number of foreign-sponsored trials speaks to the compara
47、tive lack of domestically domiciled companies and the attractiveness of Australia as a location for foreign companies.Schemes to attract investment include a generous R&D tax incentive,government supportive measures,experienced English-speaking clinical investigators,and acceptance of Australian cli
48、nical data by the major regulatory agencies.China stands out as the only major APAC location where domestically sponsored trials make up the majority.More than three-quarters of trials in China were sponsored by local Chinese companies.Digging deeper into the data,trials in China sponsored by domest
49、ic industry sponsors increased year-on-year at a faster rate than those initiated by foreign multinationals.The two groups showed CAGRs of 28.5%and 7.1%,respectively,over the past decade(Figure 6b).Source:Trialtrove,August 2022Figure 6a:Percentage of industry-sponsored trials sponsored by domestic a
50、nd foreign pharma/biotech companies,201221ChinaJapanSouth KoreaAustraliaIndia100%Percentage of industry-sponsored trialsAPAC trial locations80%20%76%24%40%60%0DomesticForeign44%56%33%67%41%59%5%95%2,0001,000500Source:Trialtrove,August 2022Figure 6b:Industry-sponsored trials in China sponsored by dom
51、estic and foreign entities,2032000202021Trial countTrial start year2,2651,7671,5971,4839573523093246423942653026602,5001,500DomesticForeign9|October 2022Asia Pacific as a Clinical Trials PowerhouseTRENDS WITHIN APAC LOCATIONSA combination of fac
52、tors is nurturing Chinas explosive domestic growth in the pharma and biotech space.Firstly,the availability of capital and talent.With the largest population in the world,of more than 1.4 billion people,the country provides not just huge market opportunities but also a massive(and sometimes previous
53、ly untapped)set of potential patients to enroll into clinical trials.Recent regulatory reforms and policy changes have also helped to facilitate the development of innovative products.Chinas National Medical Products Administration(NMPA),formerly the China FDA,has streamlined the clinical trial and
54、drug approval process,including priority and special reviews as well as breakthrough therapy designations for innovative products that target unmet medical needs in China.The National Reimbursement Drug List(NRDL)is being updated more frequently and prioritizes the entry of newly approved novel drug
55、s.Lastly,listing rule changes allow pre-revenue/pre-profit biotech companies to be listed in the Hong Kong Stock Exchange(HKEX)or Shanghai Stock Exchanges Science and Technology Innovative Board(STAR).Combined together,all of these factors can be seen as the rocket propellant for growth.Japan is the
56、 most popular trial location in APAC for the Top 20 PharmaIn Citeline,each year we categorize a set of companies as“Top 20 Pharma”using Scrip 100 rankings which are based on drug sales.The Top 20 Pharma peer set currently includes Novartis,Roche,AbbVie,Johnson&Johnson,Merck&Co,Bristol Myers Squibb,P
57、fizer,Sanofi,GSK,Takeda,AstraZeneca,Amgen,Gilead Sciences,Eli Lilly,Bayer,Novo Nordisk,Teva,Boehringer Ingelheim,Biogen,and Astellas.Figure 7a charts the total number of trials sponsored by these Top 20 Pharma companies in APAC against the CAGR over the 2012 to 2021 period.As can be quickly determin
58、ed by these metrics,Japan is in prime position,with 3,645 trials and a CAGR of 1.6%.While Australia has historically had a higher number of Top 20-sponsored trials,the number is in slow decline.This is in contrast to China,where the Top 20 are growing the number of trials(CAGR of 5.2%),although the
59、overall numbers are still way behind those in Japan.At 1,811 trials,this constitutes just 7%of overall trial activities in China(data not shown).It will be interesting to follow these trends over the next few years to see whether they continue in the same direction.Note:The number of trials sponsore
60、d by the Top 20 Pharma and the CAGR in the past decade in each trial location are labeled accordingly.Source:Trialtrove,August 2022Figure 7a:Top 20 Pharma-sponsored trials in APAC,201221JapanAustraliaSouth KoreaChinaIndia4,0006%Number of trials sponsored by Top 20 PharmaCAGR3,0004%-4%3,6451.6%2,860-
61、0.6%2,610-0.4%1,8115.2%765-5.1%1,000-2%0%2,0002%0-6%Trial countsCAGR10|October 2022Asia Pacific as a Clinical Trials PowerhouseTRENDS WITHIN APAC LOCATIONSThe Top 20 Pharma sponsored 933 trials in APAC in 2012,the highest amount in the past decade,but by 2020,this number had reduced to just 698(Figu
62、re 7b).However,the decline in trial numbers from 201220 across APAC was not mirrored in Japan,where the Top 20 pharmas utilization of Japanese sites remained steady.On average over this period,46%of the Top 20 Pharma-sponsored APAC trials were conducted in Japan.Japans leading position is perhaps al
63、so unsurprising given two of the Top 20 pharma are headquartered in that country namely Takeda and Astella.However,by excluding trials sponsored by these Japanese companies,the remaining top 18 Pharma still conduct 45%of APAC trials in Japan(data not shown).This reinforces the fact that Japan is an
64、attractive APAC trial location for Big Pharma in general,which can be attributed to Japans excellent reputation and long history in the field.In addition to being the home of many long-established global pharmaceutical companies,Japan is also the only trial location in APAC that acts as a founding r
65、egulatory member(MHLW/PMDA)and a founding industry member(JPMA)of the International Conference on Harmonization(ICH).Source:Trialtrove,August 2022Figure 7b:Top 20 Pharma-sponsored trials in APAC and Japan,by start year,20320002020211,00080%Top 20 Pharma-sponsored tri
66、als in APAC/JapanPercentage of trials in Japan80020%40020040%60%60000%Trial count in APACTrial Count in JapanStart year%in Japan93385386283975776075971869883136%41%45%47%48%48%47%49%48%18%356736735635033539511|October 2022Asia Pacific as a Clinical Trials PowerhouseTRENDS WITHIN APAC LOCA
67、TIONSAustralia is a hub for multi-regional trials and first-in-human trialsAcross the APAC region,Australia is the leading location for multi-regional clinical trials(MRCTs).Over 4,000 MRCTs have been conducted in Australia,representing almost 70%of trials in the country,and with a CAGR of 3.1%over
68、201221(Figure 8a).As a trial location,Australia is particularly attractive due to a streamlined regulatory framework,such as the Clinical Trial Notification(CTN)scheme,and data generated in Australian studies are accepted by the major regulatory agencies.This,coupled with the obvious close cultural
69、and economic ties between Australia and Western countries,has led Australia to be an attractive location to include in global MRCTs for Western sponsors.Note:The number of MRCTs and the CAGR over the past decade for each trial location are labeled.Source:Trialtrove,August 2022Note:The number of FIH
70、trials and the CAGR over the past decade for each trial location are labeled.Source:Trialtrove,August 2022Figure 8a:APAC trial locations for MRCTs,201221Figure 8b:APAC trial locations for FIH trials,201221AustraliaSouth KoreaJapanChinaIndiaAustraliaChinaSouth KoreaJapanIndia5,0004,5004505004,0004003
71、,50035010%6%30%8%40%Number of MRCTsFIH countCAGRCAGR3,0003002,5002504%20%-8%-30%-4%-10%4,1784333.1%15.5%2,9202263.2%34.7%2,3002008.3%2.9%1,5141699.1%7.8%1,0128-2.6%-6.7%1,00010050050-6%-20%-2%0%0%2,0002001,5001502%10%00-10%-40%CountsCountsCAGRCAGRAustralias reputation as a leading global destination
72、 for early-phase clinical trials is also well established,with a robust network of experienced specialized Phase I sites.As shown in Figure 8b,Australia leads the APAC region in the number of first-in-human(FIH)trials,constituting 7%of total trials in Australia(data not shown)and increasing at a CAG
73、R of 15%.China is in second place and its number of FIH studies shows an impressive CAGR of 35%,although such FIH trials are still just a minority at 1%of the overall Chinese trial landscape(data not shown).Interestingly,Australia has also become a location of choice for certain domestic Chinese com
74、panies looking to develop their drugs internationally,to take their drugs into FIH trials and to help accelerate global clinical development timelines.Companies including BeiGene,Zai Lab,Akeso Biopharma,and Jiangsu Hengrui,among others,have used this strategy for some of their FIH trials.12|October
75、2022Asia Pacific as a Clinical Trials PowerhouseTRENDS WITHIN APAC LOCATIONSSouth Korea leads the way in novel trial designsIn more recent years,given the enormous cost of clinical development programs,sponsors have been understandably focused on finding ways to run clinical trials more efficiently
76、and quickly.One common method for innovation is in clinical trial design,allowing multiple hypotheses to be tested concurrently or sequentially,all within a single study.Such trials are created with a master protocol framework,allowing a single trial to achieve the objectives that may otherwise requ
77、ire multiple separate trials and protocols.Figure 9 evaluates the percentage of trials in the major APAC locations which utilized various types of innovative design namely those described as using a“Master Protocol”or being“Adaptive,”as well as those explicitly described by the sponsor as being an“U
78、mbrella”or“Basket”trial.These innovative trial designs are most commonly used in oncology,where basket trials test a drug against multiple different tumor types with a common molecular biomarker,while umbrella trials test multiple different targeted drugs against a single disease.Across the top five
79、 APAC locations,we see that South Korea has the highest percentage of umbrella and basket trials,as well as the second highest percentage of trials described as adaptive or using a master protocol.Clearly this speaks to the attractiveness of South Korea as a trial location for sponsors running these
80、 trials who have confidence in the ability of sites and investigators to perform well with these types of trials.These designs are challenging from the fact that genotypic and phenotypic clinical data and genotype-phenotype associations for the population can be hard to obtain in advance at the tria
81、l-planning stage.South Korea benefits from the Korean Genome Project(KGP),a joint project by the Personal Genome Project at Harvard Medical School,the National Center for Standard Reference Data of Korea,Clinomics Inc,and the Korean Genomics Center of Ulsan National Institute of Science and Technolo
82、gy(UNIST).It provides access to a dataset comprising 1,094 Korean whole genomes,of which 1,007 genomes were newly generated in combination with systematically acquired clinical and biochemical measurement information from the blood and urine of the participants.According to Sitetrove,50 out of 94(53
83、%)umbrella or basket trials in Korea were conducted by the University of Ulsan College of Medicine during the reporting period.Across APAC as a whole,Roche was the sponsor with the most of these types of trials,with 24 umbrella/basket trials;19 of those were conducted in Korea and 17 of those were c
84、onducted in UNIST/Ulsan-associated sites.Source:Trialtrove,August 2022Figure 9:Percentage of APAC clinical trials with adaptive,basket,or umbrella designs conducted in each trial locationAdaptiveUmbrellaBasket0%10%20%30%40%50%60%AustraliaSouth KoreaJapanChinaIndia13|October 2022Asia Pacific as a Cli
85、nical Trials Powerhouse39%55%13%31%35%35%9%2%13%5%0%6%5%0%5%TRENDS WITHIN APAC LOCATIONSIndia top location for COVID-19 treatment trials;China top location for vaccine trialsAlthough our analysis has looked back over a decade,it would be remiss to not briefly mention the profound impact that the COV
86、ID-19 pandemic had on global clinical development in the last few years.If we look at the number of clinical trials initiated across APAC for COVID-19,including both treatment and vaccine trials,we see China and India are almost neck-and-neck for the top spot in terms of the percentage of APACs COVI
87、D-19 trials.Both are ahead of all other APAC locations by a significant margin,with Japan in third place,followed by South Korea and Australia which each contributed about 5%of COVID-19 trials in APAC(Figure 10a).Looking more closely into these trials,Figure 10b shows that India led the way for COVI
88、D-19 treatment trials,with 39%of APAC COVID-19 trials,while China had the most vaccine trial starts(35%).Both countries invested significant resources into the development of vaccines and have world-class domestic vaccine research and production capabilities,so seeing them leading the way for vaccin
89、es in APAC is unsurprising.Additionally,in both locations,there are ancient medical systems using natural products,in the form of Ayurveda in India and traditional Chinese medicine(TCM)in China,and when the pandemic occurred sponsors rapidly began testing natural products to see if they would be eff
90、ective.For those natural-product COVID-19 trials,55%and 35%were conducted in India and China,respectively,and they account for a significant portion of the COVID-19 treatment trials initiated in those countries.Source:Trialtrove,August 2022Source:Trialtrove,August 2022Figure 10a:APAC trial locations
91、 for COVID-19 trials,201221Figure 10b:APAC trial locations for COVID-19 trials,by selected drug types,201221ChinaIndia JapanSouth KoreaAustraliaIndia China JapanAustraliaSouth Korea40%60%Percentage of COVID-19 trials in APACPercentage of APAC trials by drug typeAPAC trial locationsAPAC trial locatio
92、ns10%30%10%32%5%31%5%10%20%40%20%30%50%00TreatmentNatural productVaccine14|October 2022Asia Pacific as a Clinical Trials PowerhouseWhat Does the Future Hold for APAC?How do we think each of the top five APAC locations clinical trial landscapes might change in the coming years?While we cannot predict
93、 the future,we are happy to offer some informed guesses about where things may be headed,with the usual caveat that unexpected global events could easily lead to very different outcomes.In China,we expect that the trend we have seen for growth will continue unabated in the next few years,as both the
94、 domestic Chinese pharma/biotech space continues to expand and mature,and foreign interest in running trials including Chinese sites increases.The size of the opportunity in China is simply too great for sponsors to ignore,and only uncontrollable external factors could put a dampener on the stratosp
95、heric upward trajectory of clinical research.Turning to Japan,the picture is perhaps a little more uncertain,given that the number of trials has actually been falling.One factor to consider is that after decades of development,several Japanese companies have grown into truly large global pharmaceuti
96、cal companies.As such,they are often focused on multinational trials with broad geographical footprints to support drug registration in multiple locations.Additionally,they are well established in running early-stage trials in Western locations.This global outlook may well have contributed to what p
97、resents as a downturn in domestic activity.Secondly,foreign sponsors will naturally spread their APAC trial programs across various locations,and the rise of China may have diverted some clinical activity away from Japan.Clearly though,Japan will continue to be a key location for clinical developmen
98、t,and we look forward to seeing what the statistics for 2022 and beyond reveal.In South Korea,the growth rate of clinical trials may have been negative over the past decade,but the reduction was minor.This remains a dynamic and attractive location for clinical R&D,with world-class medical institutes
99、 and strong support,including the Korea National Enterprise for Clinical Trials(KoNECT)organization which promotes the advancement of clinical trials.Additionally,the domestic South Korean biotech industry continues to thrive,particularly in areas such as cell therapy.We would be surprised if clinic
100、al R&D did not grow in this marketplace in the coming years,particularly for early-phase trials.Regarding Australia,we believe it will continue to be a location of choice for MRCTs.With the expected continued growth of Chinese clinical R&D and Australia being ideally placed geographically for Chines
101、e sponsors,we particularly expect to see growth in the number of Chinese-sponsored trials in Australia.What is less clear is whether we will see an expansion of domestic Australian trial activity,which is of course directly tied to the amount of domestic pharma and biotech research as well as the ca
102、pital funding available.Efforts are underway to expand the industry,such as through the Medical Research Future Fund(MRFF),which we watch with interest.Finally,we look to India,a location where the make-up of clinical trials differs from its geographic peers.Historically,domestic drug development in
103、 India has been mostly concentrated in the generic,biosimilar,and vaccine spaces,as well as natural products,where the country has long-established experience.However,India has many of the same characteristics as China when it comes to attractiveness for clinical development.Regulatory reforms were
104、introduced to address past issues with clinical trial standards,and India has a large potential patient pool for sponsors to tap into.In Pharmaprojects,which tracks all drug development globally(including preclinical),it is interesting to note the first appearance of Indian companies working in cutt
105、ing-edge areas such as immuno-oncology and CAR-T therapy.With a renewed focus from government on the sector,including the right incentives for investment,we might just be on the cusp of seeing a shift towards more innovative novel drug and biotech R&D.If so,in a few years time we could see the clini
106、cal trial landscape in India shift dramatically.As we have shown,the volume of clinical development is generally increasing across APAC,although there are location-specific differences.15|October 2022Asia Pacific as a Clinical Trials PowerhouseAbout the AuthorsWe have focused our analyses on the top
107、 five APAC locations by overall trial volume,but in Trialtrove there are more than 35 different APAC locations which are tracked,including some with very advanced healthcare systems as well as large populations.The authors are of the opinion that APAC will continue to take an increasingly large shar
108、e of global clinical activity,driven by the top locations in the near term but also with the potential if we look further out into the future for other APAC locations to rise in prominence on the global stage.The data presented in this paper show the growth in importance of APAC for clinical develop
109、ment,as well as some of the regional differences between the key locations.Andy Benson is the Senior Director of Trialtrove,overseeing both the content collection and curation of Citelines Trialtrove database,as well as the best-in-class Trialtrove analyst team supporting clients with their business
110、-critical questions via the Ask The Analyst service.Andy has held a variety of roles at Citeline,formerly Pharma Intelligence,over the years,including Director of Citelines CNS and Autoimmune/Inflammation therapeutic area,as well as analyst and editorial roles at Pharmaprojects.He holds a bachelors
111、degree in Biochemistry from the University of Leeds and a masters degree in Neuroscience from Kings College London.Dr Annie Siu(PhD,MBA)is the Director of APAC content for Citeline,overseeing the content collection and curation from this region and its integration into the various services,including
112、 Trialtrove,Sitetrove,Pharmaprojects,Biomedtracker,and Datamonitor Healthcare.Annie previously held roles at Citeline,formerly Pharma Intelligence,as a Principal Analyst and Principal Consultant.She was an Associate Professor at the Chinese Academy of Sciences,and a Visiting Scientist at the Nationa
113、l Cancer Institute of the National Institutes of Health.After receiving first-class honors bachelor and Ph.D.degrees,she carried out postdoctoral fellow research and was promoted to Research Assistant Professor at the University of Hong Kong,and later obtained an MBA from the Hong Kong University of Science and Technology Business School.Annie SiuDirector,APAC Content,CitelineAndy BensonSenior Director,TrialtroveWHAT DOES THE FUTURE HOLD FOR APAC?16|October 2022Asia Pacific as a Clinical Trials Powerhouse