Although Korea’s clinical trials fared well in terms of global share despite the decline from the endemic, the challenge of international clinical growth remained.
At a time when fostering the domestic biopharmaceutical industry has emerged as a hot topic, he believes that international clinical trials are essential during the growth period to strengthen competitiveness, such as access to new drugs and a better understanding of international standards.
If you look at the ‘Korea Clinical Trial Industry Information Statistics 2022’ published on the 15th by the National Clinical Trial Support Organization (hereinafter referred to as KoNETCT), the number of clinical trials approved by the Ministry of Food and Drug Safety last year was 711, down 15.6% from 842 in 2021.
These numbers are similar to the 2019 clinical number of 714 cases, which has decreased in the endemic situation of clinical trials that have been active for the development of corona vaccines and treatments in 2020-2021. Among them, the number of clinical trials led by pharmaceutical companies decreased by 12.4% from the previous year to 595 cases, but the proportion increased by 3.1% from 80.6% in the previous year to 83.7%.
According to Cornet’s analysis, this is due to the increasing share of domestic clinical trials conducted by domestic pharmaceutical companies.
However, last year the number of clinical trials for which global pharmaceutical companies were original developers fell by 15.1% from the previous year to 338, and international clinical trials by global pharmaceutical companies turned to a downward trend .
When examining domestic clinical trials by efficacy group, anticancer drugs accounted for 36.4% (259 cases) of all clinical trials, but the number of clinical trials decreased compared to 321 cases (19.3%c) in 2021.
Conversely, the areas where the proportion of clinical trials increased significantly were endocrine and immunosuppressive drugs. The number of endocrine clinical trials increased by 48.4% from the previous year to 92 cases, and in particular, clinical trials conducted by domestic pharmaceutical companies increased by 37.7%.
“It is understood that domestic pharmaceutical companies are actively developing products for endocrine and metabolic diseases, including diabetes,” said Kornet.
Examining the status of clinical trials by client, it was found that among pharmaceutical companies, MSD Korea conducted the most clinical trials with 20 cases.
Among domestic companies, Chong Kun Dang performed the most clinical trials with 19 cases, followed by ▲Janssen Korea with 19 cases ▲Daewoong Pharmaceutical with 16 cases ▲Roche Korea with 15 cases and ▲ Novatis Korea with 14 cases.
Korea’s clinical competitiveness in the global market … Single country share ↑ Multi-country clinical trial ↓
However, when the Korean clinical trials were looked at from a global perspective, there were mixed joys and sorrows.
First, the positive aspect is that Korea maintained its global one-country clinical share position despite the fact that the global clinical contraction affected most of the top 10 countries last year.
(Source: FDA clinical trial plan approval status, KoNECT reprocessing)
In particular, it increased its influence by rising from 6th to 5th in the ranking of pharmaceutical companies’ clinical trials.
However, in a situation where uncertainty in the global biopharmaceutical and clinical trial markets is increasing due to the economic recession, ‘multinational clinical trials’, an indicator that can confirm a country’s competitiveness, left a disappointment.
Korean international clinical trials continued to rise from 19th in 2011 to 10th in 2020, but looking at the past three years, ▲2020 3.20% (10th) ▲2021 3.13% (10th) ▲2022 3.01%), and etc. (11th, place 3.01%) show a decrease in market share and position.
The reason why international clinical trials are an indicator of global competitiveness is that they can achieve effects such as a better understanding of international standards, technology and technology transfer to the domestic pharmaceutical business, and a change in the perception of developed countries.
In addition, there is the advantage of improving accessibility in that new drug approval can be obtained without a separate transition test when participating in a global clinical trial.
Considering this, the current clinical trial in Korea has a dilemma of maintaining its market share according to the growth of the domestic biopharmaceutical industry and weakening competitiveness due to the decline in clinical trials by global pharmaceutical companies.
In the end, the future task seems to be to balance the domestic single clinical trial by expanding the international clinical trial, which has been reduced to improve the competitiveness of the Korean clinical trial.
“As growth in research and development investment in new drug development slows globally, pharmaceutical companies are struggling to improve cost efficiency and
“There is a possibility that future clinical trials will be conducted in a small number of countries and excellent clinical institutions,” he said.
“For this reason, competition between countries to participate in international clinical trials is expected to intensify,” said Cornet.
