东南亚和巴基斯坦概述：新兴的临床试验扩大中心

Southeast Asia andPakistan Overview: TheEmerging Hub for ClinicalTrial Scale Up (Southeast Asia: Indonesia, Malaysia, Philippines, Thailand, Vietnam) Table of contents IQVIA Southeast Asia and Pakistan overview4Indonesia8Malaysia11Philippines14Vietnam17Thailand20Pakistan24Conclusion28 IQVIA Southeast Asia and Pakistan overview Southeast Asia and Pakistan represent competitive regions for clinical development, combining large, diverse,treatment-naïve populations with improving healthcare infrastructure. These markets enable efficient patientrecruitment and create vast opportunities to accelerate trial growth and innovation across multiple therapeutic areas.Proactive shift in regulatory frameworks, a maturing clinical trial ecosystem, and strategic national initiativesposition this geography as a key hub for global research. With increasing site readiness and adoption of advancedtechnologies, the region is primed for high-quality, scalable clinical operations. The presence of prime and partner networks in each location enables differentiated clinical trial execution, enhancingpatient recruitment and trial outcomes. Quality IQVIA R&DS site quality and performance in Southeast Asia is on par with mature markets in the keyquality parameters •Effective issue escalation•Proactive risk management•Oversight of audit inspections•Cross functional quality plan•Site inspection readiness•Strong quality culture acrossthe board Clinical trial landscape During 2020-2024, approximately 49% of all trials were local, whereby approximately 45% were phase I and II. Oncology and infectious disease were the top therapeutic areas *Others include Hepatology, Psychiatry, Women's Health/Sexual health, Acute care, Allergy/Immunology, Orthopedics, Transplantation, Medical genetics andother trials are related to safety and efficacy, bioavailability, pharmacokinetic and comparison studies etc. IQVIA footprint In the last 5 years, IQVIA R&DS was involved in ~16% of the global clinical trials in Southeast Asia across alltherapeutic areas Chart 5: Clinical trial performance benchmarkingIQVIA Southeast Asia vs. total Southeast Asiaclinical trials (2020-2024) *Others include Rheumatology, Respiratory, Gastrointestinal, Ophthalmology,Women’s health/Sexual health, Psychiatry, Allergy/Immunolog y, Acute care,Hepatology, Nephrology and other trials are related to safety and efficac y, bioavailability, pharmacokinetic studies etc. Indonesia Indonesia offers one of Southeast Asia’s largest patient pools.Established in 2006, IQVIA has secured full-service CRO license,ensuring streamlined regulatory processes and reliable trialexecution, supported by experienced clinical research team andstrong site networks. COUNTRY OVERVIEW Large Pharma market size(USD 4.2 billion), over 98% ofthe population has access toUniversal Health Care (UHC) Large population oftreatmentnaïve patientsand lower number ofcompeting studies Highest populationin Southeast Asia Relativelylow in cost(as compared toother countries) Limited treatment optionsunder UHC coverage, thustrial will benefit patients Quick turnaround timefor budget negotiation Indonesia clinical trial start-up (drugs, vaccine, biologics) Start-up process flow: *RA submission is made to multiple health authority bodies, depending on type of application: BPOM (for clinical trial application and importation of drug andvaccine) and/or Ministry of Health (for Medical Device Clinical Trial Application, Importation of Medical Device, Ancillary Kits, Lab Kits).**Clinical trial approval is issued within 20 working days after dossier is deemed complete, payment is received, and all queries are answered. EC approval isprerequisite for clinical trial approval. Indonesia clinical regulatory reform Formation of Clinical ResearchUnit (CRU) Reshaping of clinicaltrial ecosystem INA CRC •One stop solution for clinical trialconduct in Indonesia•To facilitate management ofclinical trials •Clinical trial management atkey hospitals•To conduct clinical trial inadherence to ICH GCP •Online application for EC, regulatoryapproval, permits (MTA) — enableeasy progress monitoring•Continuous regulatory restructure toimprove country competitiveness Key therapeutic area Biosimilars Cardiovascularmetabolic Infectious diseasesand vaccine Top indicationincludes: Stroke,Coronaryartery diseases,Heart failure,Hypertension, andDiabetes Mellitus Limited access toadvanced therapycreate high demandsfor affordablealternatives. High prevalentcases include:Breast, Lung,Cervix, Colorectal,and Liver Cancer Most prevalentcases include:Tuberculosis, HIV,Dengue,and Malaria Key indicationsinclude: Oncology,Hematology,Autoimmunediseases, andRespiratory diseases High burdendiseases include:Pneumoniaand Influenza Malaysia Malaysia’s ethnically diverse population and advanced healthcareinfrastructure make it possible to generate multi-ethnic clinicaldata under consistent trial conditions, strengthening scientificvalid