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Introduction
HOME > Introduction > Background and Necessity
Background and Necessity
Background
Rapid change of the global clinical trial market
and insufficient capability in clinical trial
Shrinking global R&D and advancement of competitors like China
- Continuous reduction of registration of clinical trial research since 2008
  · average of 11.8% per year since 2008 (clinicaltrials.gov, 2013)
- Rapid emergence of powerful competitors owing to the change of circumstances of
clinical trials
  ※ Competitors like China, Japan, India, Russia, and Brazil have ventured into clinical trials
       based on government support for R&D and infrastructure.
      · In particular, Japan has spent more than 3 billion yen of its budget every year since 2011 on activating clinical trials.
Compared to the skyrocketing R&D costs, the success rate in new medicine development is very low in the world pharmaceutical industry including Korea; hence the growing demand for new technologies to guarantee high efficiency
The cost of clinical trial in Korea has increased
to the level of advanced countries, which is
causing difficulty in attracting multinational
clinical trials.
※ Costs of clinical trials in major countries (UK=100): Korea 95, Brazil 80, Russia 75, India 39,
    China 37, Poland 75, Taiwan 88, Australia 138, US 127 (as of 2013, Parexel sourcebook)
※ Percentage of costs incurred for clinical trial while developing new medicine: 60~70%
Necessity
Need to strengthen the capability of clinical trial and
discover new areas for the future of the clinical trial industry
Need to develop early clinical trial and niche market areas due to the relative saturation of
late-phase clinical trials in Korea

Need for the capability to foster an environment for the performance of global clinical trials
and spearhead new medicine development

  ※ Smaller population, global network, and CRO capability than competitor nations
Need to maximize the value of existing infrastructure for clinical trials and develop business
on its basis
Need to develop new technologies based on clinical
trials using hi-tech convergence technologies like IT, BT,
and NT, which can reduce the time and cost of clinical
trial to secure Korea’s competitiveness in clinical trials