South Korea

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The South Korean government has recently announced a new five-year plan that is expected to deliver valuable improvements that will attract even more international biotechnology companies for their clinical trials. The Comprehensive Five-year Plan for the Advancement of Clinical Trials aimed at further establishing the country as a leading research and clinical trial destination in the region and globally

Novotech has built a strong local team to provide CRO and SMO services to biotechnology clients in South Korea. The team has grown by over 30% in 2019 to accommodate the increasing demand for trials in South Korea particularly from biotechnology companies.

In 2019, Novotech has further strengthened its presence in South Korea with two major hospitals joining the Novotech partnership program. The 900 bed Ulsan University Hospital (UUH) and the Hepatology Division in Gastroenterology part of the 1,778 bed Seoul National University Hospital (SNUH), are now in the Novotech CRO partnership program.

Biotechnology companies are increasingly looking to take advantage of the high-quality infrastructure and low trial concentration, to conduct their clinical studies, especially in Oncology, Infectious diseases and Orphan diseases.

Between 2016 and 2018, the clinical activity growth of biotechnology companies in South Korea is estimated at around +10% each year for Oncology trials.

Digestive diseases and Cancers, such as Gastric Cancers, Esophageal Cancer and liver diseases are highly prevalent in South Korea, driving many biotechnology companies to this country to conduct their clinical trials.

Fast Facts

South Korea offers world-class infrastructure in a politically stable environment, right next to one of the world’s largest economies, China. It is fast becoming a hub for clinical trials in Asia.  

  • Homogenous and highly centralized Korean population
  • Strong and efficient regulatory environment
  • Increasing use of English among population
  • World-class technological infrastructure.

Health Trends

With the growth of its economy into an Asian powerhouse, South Korea’s life expectancy has increased dramatically over the past 30 years. This aging population, combined with poor air quality and high smoking rates, has produced a high prevalence of chronic diseases.

High prevalence diseases include:

  • Cancer
  • Respiratory problems
  • Non-communicable diseases
  • Heart disease.

Clinical Trial Landscape

South Korea hosts an increasing number of educated and English proficient medical professionals.

Clinical trials are regulated by the Korean Ministry of Food and Drug Safety (MFDS) and reviewed by local IRBs, who comply with ICH-GCP standards.

The average timeline for regulatory and IRB approval is ~4-5 months.

Market Snapshot

49  million people

83.2% reside in urban centers

97.9% literacy rate

South Korea population age breakdown for pharma companies thinking of using a clinical research organization
  • Novotech opened its first South Korean contract research organization (CRO) office in 2007

Why choose South Korea for clinical research?

There are many compelling reasons to consider contract research organizations in South Korea for your clinical research:

  • Concentrated patient population in and around Seoul
  • Transparent review timelines between IRB and Korean MFDS
  • High standards of GCP
  • Low operational costs (no charge for KFDA submission)   
  • Good IT infrastructure and knowledge of IT
  • High quality medical services.