CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – South Korea
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The South Korean medical device market was valued at $9.95 billion in 2020 and is expected to grow at a CAGR of over 4% during the period 2021-2027. South Korea is the world’s 10th largest pharmaceutical market and considers the pharmaceutical industry a potential growth engine for the country’s future economic growth. South Korea’s pharmaceutical manufacturing industry is accelerating its transformation due to increased support from government policies such as the five-year comprehensive plan and the steadily rising coronavirus-related deals.
In 2020, the Advanced Regenerative Bio Act was passed to encourage biopharma innovation. The Act is a law that relaxes screening criteria in regenerative medicine research when certain conditions are met which allows companies to market products in phase 2 development provided phase 3 clinical trials are conducted. The Ministry of Food and Drug Safety (MFDS) has established a goal of responding to clinical trial applications within 30 days of submission. The emphasis on speed has contributed to a 152-day average time frame for starting a clinical trial in South Korea.
South Korean medical device market overview
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What are the market dynamics in South Korean pharmaceutical market?
South Korea has many domestic pharmaceutical manufacturers with advanced R&D facilities. According to the Korea International Trade Research Institute (KITRI) report, South Korea’s biopharmaceutical exports increased by 139% year on year, and it ranked seventh across the globe during 2020. The aging population will sustain demand for pharmaceuticals given its high burden of non-communicable diseases, such as heart disease, obesity, cancer and diabetes. In May 2020, the government announced a joint medical devices R&D project with a target budget of $0.98 billion between 2020 and 2025. The project aims to support the strengthening of the medical devices industry by taking the opportunity of increased trust in Korean-made medical devices and health services in the fight against COVID-19.
Which are the key segments in the South Korean pharmaceutical market?
The key segments in the South Korea pharmaceutical market are generics, biologics, biosimilars, and OTC.
Generics pharmaceutical market in South Korea: The Korean Ministry of Food and Drug Safety (MFDS) has improved the quality of generic drug products and ensured an efficient and competitive generics market. South Korea’s generics market was expected to increase further due to the government’s significant investment in the generics market. Another contributing factor was that many original drugs were set to lose their patents by 2020, thus opening the market for generics. In July 2021, the KPBMA announced the revision of the Pharmaceutical Affairs Act (PAA) to restrict generic drugs. The act was amended to include a 1+3 restriction regulation, limiting the number of generic drugs that can be approved with a single bioequivalence test set to a maximum of four.
Biologics and Biosimilars pharmaceutical market in South Korea: In 2020, 20 biologics were approved in South Korea, of which 18 were domestically manufactured and two were imported biologics. As of October 2021, MFDS had approved 13 biosimilars within the product classes of HER2-inhibitor, insulin, tumor necrosis factor (TNF)-inhibitor, and monoclonal antibody, for use in South Korea. The top 10 companies producing drugs in South Korea in 2020 were Celltrion, Hanmi Pharmaceutical, Chong Kun Dang, GC Pharma, inno.N, Daewoong Pharmaceutical, Yuhan, LG Chem Dong-A ST, and JW Pharmaceutical. All these companies are involved in the production or distribution of biosimilars.
Over-the-Counter Medicines (OTC) pharmaceutical market in South Korea: The sale of OTC drugs such as cold and digestive medicines, antipyretics, analgesics, and pain relief patches in stores other than a pharmacy has been legal in South Korea. Convenience stores sell around a dozen OTC drugs. Regional associations of Korean pharmacists began boycotting imported Japanese over-the-counter drugs in 2019. Takeda’s Actinium, Kobayashi’s Eyebon, and Nichiban’s Careleaves were among them. This was done in order to protect South Korea’s national interestsfrom Japan’s newly imposed trade restrictions. According to in-house sales data, in 2020, the cumulative over-the-counter drug sales for the past nine months amounted to $1.5 billion, with an increase of 0.2% as compared to a similar time period of 2019.
South Korean pharmaceutical market, by segment type
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Who are the key players in the South Korean healthcare market?
In the South Korean pharmaceutical market, Celltrion is the leading company by net sales followed by Pfizer GSK and Chong Kun Dang Pharmaceutical Corp. Chong Kun Dang Pharmaceutical Corp is expected to grow during the forecast period. Whereas the major players in South Korea’s medical devices market are Abbott, Medtronic, GE Healthcare, Canon Medical Systems Corp, and i-Sens.
South Korean Pharmaceutical Market, by key players
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Market report scope
Market value (Year – 2020) | $9.95 billion (Medical devices) |
Growth rate (CAGR) | >4% |
Base year for estimation | 2020 |
Forecast period | 2021-2027 |
Key Segment | Generics, Biologics, Biosimilars, and OTC |
Key Players | Celltrion, Pfizer GSK and Chong Kun Dang Pharmaceutical Corp. Abbott, Medtronic, GE Healthcare, Canon Medical Systems Corp, and i -Sens |
Scope:
The report provides information on the healthcare, regulatory, and reimbursement landscape in South Korea, and includes:
- An overview of the pharmaceutical and medical device markets, comprising market size, segmentation, and key drivers and barriers.
- Profiles and SWOT analyses of the major players in the pharmaceutical market: Roche, Pfizer, Sanofi, CSL, and Sonic Healthcare.
- Profiles and SWOT analyses of the major players in the medical device market: Medtronic, Stryker, Boston Scientific, Ansell, and Nanosonics.
- An insightful review of the COVID-19 epidemiology, COVID-19 impact and developments in healthcare market, HealthTech landscape, reimbursement and regulatory landscape, with analysis covering details of the country’s healthcare reimbursement process, regulatory agencies and the approval processes for new drugs and medical devices.
- Detailed analysis of the country’s healthcare policy highlights, demographics, healthcare infrastructure and healthcare expenditure.
- An overview of the opportunities for and challenges to growth in the South Korea healthcare market.
Reasons to Buy
This report will enhance your decision-making capability by allowing you to:
- Develop business strategies by understanding the trends shaping and driving the South Korea healthcare market.
- Drive revenues by understanding the key trends, reimbursement and regulatory policies, pharmaceutical market segments and companies likely to impact the South Korea healthcare market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing competitors’ performance.
- Organize your sales and marketing efforts by identifying the market categories and segments that present the most opportunities for consolidation, investment and strategic partnership.
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Frequently asked questions
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What was size of the South Korean medical devices market in 2020?
The South Korea medical devices market was valued at $9.95 billion in 2020.
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What is the growth rate of the South Korean medical devices market?
The South Korean medical devices market is expected to grow at a CAGR of over 4% during the period 2021 to 2027.
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Which are the key segments in the South Korean pharmaceutical market?
The key segments in the South Korean Pharmaceutical market include generics, biologics, biosimilars, and OTC.
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Who are the key players in the South Korean pharmaceutical market?
Celltrion is the leading company by net sales followed by Pfizer GSK and Chong Kun Dang Pharmaceutical Corp.
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Who are the key players in the South Korean medical devices market?
In the medical device market, major players are Abbott, Medtronic, GE Healthcare, Canon Medical Systems Corp, and i -Sens.
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