Vaccine Independence
As worries over pandemics of diseases such as the Ebola virus are increasing, achieving “vaccine independence” is becoming an essential criteria to assess the national economy and security.
In Korea, however, only ten out of a total of 27 vaccines are produced, and 80 percent, by amount, of vaccines are imported. The degree of self-sufficiency in Korea, in terms of vaccine, is very low, compared to the 59 percent of Japan and the 100 percent of the US and Europe. But Korean pharmaceutical companies are expanding vaccine development and production, which is a positive signal under the current circumstances.
SK Chemical has completed preparations for commercial production for “L House,” a vaccine factory located in Andong, Gyeongsangbuk-do, with the permission of the Good Manufacturing Practice (GMP). This factory is the largest vaccine manufacturing facility in Korea, capable of producing vaccines for 140 million people annually. Over 200 billion won (US$195 million) has been spent in the construction and R&D of this factory for the last three years.
SK Chemical plans to produce the first cell culture influenza vaccine, which is currently under review for approval at the Ministry of Food and Drug Safety. A cell culture influenza vaccine is manufactured in three months, definitely shorter than the traditional fertile egg method which takes six months to produce vaccine, and is strongly resistant to external stresses such as avian influenza (AI). This is why the government supports the cell culture vaccine. The United States Department of Health and Human Services built a cell culture vaccine factory in North Carolina by investing US$1 billion with Novartis in 2010.
SK Chemical is also focusing on developing premium vaccine for pneumococcus, shingles, and uterine cervical cancer. Green Cross, the first organization to develop a vaccine for influenza in Korea, is performing well in exports. Its influenza vaccine is pre-qualified (PA) by the World Health Organization (WHO), which means that quality of the vaccine is guaranteed worldwide and grants permission to supply the vaccine to international organizations.
Green Cross is rapidly increasing exports by bidding for international organizations since 2010, when the company first started to export the influenza vaccine. Green Cross won US$23 million in orders by bidding for medicine and the medical supplies of the Pan American Health Organization, which is under the WHO. The company also won about US$15 million at the northern hemisphere medicine and medical supplies bidding. The total exports amount is expected to reach US$40 million this year, over 50 percent increase from the last year.
Green Gross aims to finish clinical testing of H5N1 type AI vaccines within this year, and has embarked on developing four influenza vaccines. Clinical tests for the fertile egg method influenza vaccine has recently started, and one for a cell culture method vaccine will start within this year.
Ilyang Pharmaceutical, which built a vaccine factory capable of producing vaccines for 60 million people at Eumseong, Chungcheongnam-do, aims to produce its own influenza vaccine permitted, which was by the Ministry of Food and Drug Safety last year. This company is also preparing a vaccine for measles and hepatitis, and planning to export vaccines to underdeveloped countries that do not have sufficient supplies of vaccines and vaccine production facilities. The company started joint research with Korea University College of Medicine for the development of new anti-virus drugs and globalization of the vaccine as well.
According to the Korea Health Industry Development Institute (KHIDI), the global vaccine market will grow by 11.5 percent for the next six years to US$56.7 billion by 2017, from US$31.7 billion in 2011. Growth of emerging vaccine markets such as China and India as well as expensive premium vaccines, improved vaccines, and combined vaccines are leading this expansion. Especially when the development of premium vaccines is successful, a lot of profits are expected. In the case of Pfizer’s pneumococcus vaccine ‘”Prevenar,” which is the most sold vaccine in the world, annual sales revenues were US$3.6 billion in 2011.
The government started to support the pharmaceutical industry by announcing the globalization of the vaccine business, which entails a national goal to become the world’s fifth vaccine country by 2020. Considering the technical capabilities and development stages in Korea, vaccine businesses are expected to grow the fastest in the biotech industry. The Ministry of Food and Drug Safety presented a plan to expand varieties of domestically-produced vaccines from 10 to 22 by 2020, in order to enhance the self-sufficiency of vaccine.