South Korea has established itself as a major player in the global active pharmaceutical ingredients (API) manufacturing over the past few decades. The country is now among the top five exporters of APIs worldwide. South Korea's API has seen steady growth supported by a strong manufacturing base, advanced technology capabilities, and government incentives to promote the pharmaceutical sector.

The South Korean government has provided various incentives to boost domestic API production since the 1980s. Tax exemptions and subsidies were offered to pharmaceutical companies investing in API manufacturing facilities and R&D. This helped attract global pharmaceutical firms to set up API manufacturing units in South Korea. Local companies like Dong-A ST, Bukwang Pharmaceutical, and Il-Dong Pharmaceutical also expanded their API portfolios.

By the 2000s, South Korea had emerged as an important API supplier to many large pharmaceutical s like the US, Europe, and Japan. The nation's API exports grew at an average annual rate of over 10% during this period. Today, South Korea exports APIs across various therapeutic categories such as oncology, cardiology, anti-infectives and hormones. Leading exported APIs include atorvastatin, azithromycin, ibuprofen, and cyclophosphamide.

Domestic And South Korea Active Pharmaceutical Ingredients

South Korea's domestic API is quite developed today. Local manufacturers produce APIs for both domestic consumption as well as exports. The country has a strong technical expertise in fermentation-based and chemical synthesis-based API manufacturing technologies. South Korean firms have demonstrated high proficiency in complex chemical processes like stereoselective and multi-step synthesis to produce advanced APIs.

Many South Korean API makers have fully integrated manufacturing facilities with capabilities for fermentation, purification, isolation, analytical testing, and formulation. They are well-equipped to handle most phases of API production from R&D to commercial manufacturing and quality testing. Several large domestic companies have multiple FDA- and EMA- approved API manufacturing sites in South Korea.

In terms of production capacities, South Korean API facilities can range from small laboratories to large industrial scale plants with capacities over 10,000 liters for fermentation products. Their combined annual API production is estimated at over 100,000 tonnes currently. Besides traditional bulk drug substances, some Korean companies have also developed capabilities in producing complex APIs like peptides, nucleotides and conjugate compounds.

Patent Expirations Driving New Opportunities

The patent expiries of many blockbuster drugs in recent years have opened up lucrative opportunities for South Korean API makers. As patents of successful drugs like Lipitor, Nexium, and Plavix expired, South Korean producers ramped up their manufacturing volumes of the off-patent APIs coxib, esomeprazole, and clopidogrel.

They supplied these generic APIs aggressively to not only capture share abroad but also address increased domestic demand as the South Korean government liberalized its insurance coverage policy for generic medications. Korean API producers have leveraged their competitive cost position and reliable quality standards to gain approval and supply contracts from major generic drug manufacturers worldwide.

Looking Ahead

Going forward, the South Korean API will continue its steady growth trajectory on the back of global demand for affordable medicines and growing domestic pharmaceutical consumption within an aging population. Government programs to promote the biopharmaceuticals will further augment capabilities in advanced API modalities.

The emerging areas like biosimilars, complex generics, and active pharmaceutical ingredients for niche technologies are some key segments South Korean manufacturers are targeting for future expansion. Strategic collaborations, overseas acquisitions and building end-to-end integrated supply chains will also help Korean API makers scale up and address more global opportunities. With its established track record and focus on quality, South Korea is well-placed to play an increasingly important long-term role in the global API supply chain.

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Author Bio:

Alice Mutum is a seasoned senior content editor at Coherent Market Insights, leveraging extensive expertise gained from her previous role as a content writer. With seven years in content development, Alice masterfully employs SEO best practices and cutting-edge digital marketing strategies to craft high-ranking, impactful content. As an editor, she meticulously ensures flawless grammar and punctuation, precise data accuracy, and perfect alignment with audience needs in every research report. Alice's dedication to excellence and her strategic approach to content make her an invaluable asset in the world of market insights. (LinkedIn: https://www.linkedin.com/in/alice-mutum-3b247b137%20)