In the third quarter of 2025, global pharmaceutical trade grew by 6.5% year-on-year, with South Korea's exports reaching USD 11.8 billion , a 9.2% increase. Growth was driven by biosimilars and vaccines, with market shares in Europe and North America simultaneously expanding.
The benefit of this information: By understanding the health regulations and intellectual property rights environments of each country in advance, you can determine export approval strategies and prioritize R&D investments.
division | HS code | Representative items | Strategy Points |
|---|---|---|---|
| synthetic drugs | HS 30.03 | Antibiotics, antipyretics, analgesics | Expanding exports centered on general medicine and OEM |
| biopharmaceuticals | HS 30.06 | protein/antibody therapeutics | Expanding EU and US approvals for high-value-added items |
| Vaccines and blood products | HS 30.02 | vaccines, serums, and blood products | Expansion of the public market based on WHO and CE certification |
By understanding the characteristics and technical difficulty of each HS item, you can establish certification and pricing strategies for each market.
Country/Region | Strong items | Market characteristics | Implications |
|---|---|---|---|
| USA | Biosimilars and antibody treatments | High-end market based on FDA approval | Quality and clinical data transparency are essential. |
| EU (Germany, France) | Vaccines and synthetic drugs | EU GMP and EMA approval required | Certification and standardization-centered approach |
| China and Southeast Asia | Generic · OTC products | price-sensitive market | Local partnerships and distribution networks are essential. |
You can develop export channel diversification strategies that reflect market-specific health regulations and price sensitivities.
item | Number/estimate | unit | note |
|---|---|---|---|
| Annual production | About KRW 17 trillion | one | Total domestic pharmaceutical production scale (Ministry of Food and Drug Safety 2025) |
| Exportable quantity | Approximately USD 11.8 billion (22% of the total) | USD | Rapid increase in the proportion of biosimilars |
| 3rd quarter export growth rate | +9.2% | % | Compared to the previous year |
You can predict production line operating rates and export surplus to establish production and contract plans.
field | Main specifications | note |
|---|---|---|
| Manufacturing and Quality Control | PIC/S GMP, EU GMP | Mandatory certification for pharmaceutical exports |
| Clinical and safety | ICH Guidelines, ISO 14155 | International Clinical Trial Standards |
| biopharmaceuticals | WHO Pre-Qualification | Entry into the international procurement market is essential. |
You can accelerate market entry by reducing the time and cost required for overseas approval.
division | Certification name | Applicable area |
|---|---|---|
| Quality control | PIC/S GMP, FDA CGMP | Global |
| Environment/ESG | ISO 14001 | Europe and the United States |
| Data Security | ISO 27001 | Clinical and Medical Data Management |
Obtaining certification expands opportunities to participate in public procurement and large-scale export contracts.
Product group | means of transportation | Lead time | Key Risks |
|---|---|---|---|
| biopharmaceuticals | Aviation refrigeration | 3 to 10 days | Temperature and humidity management |
| synthetic drugs | Air-sea mixed | 10 to 25 days | Customs clearance and permit delays |
| Vaccines and blood products | Cold chain only | 7 to 14 days | Temperature deviation and damage |
Logistics and storage system design can help maintain quality and reduce claims risk.
Product group | MOQ | unit | characteristic |
|---|---|---|---|
| biopharmaceuticals | 1 Batch (1,000 Vial Unit) | Batch | Focused on bulk supply contracts |
| synthetic drugs | 100,000 tablets | Piece | OEM · Generic Supply |
| vaccine | 5 thousand doses | Dose | public procurement unit |
You can efficiently design contract units and packaging structures based on MOQ.
cord | item | example | conjugation |
|---|---|---|---|
| (A) | Unit price/transaction price range | USD 1,500 ~ 3,000 /kg | Profitability and Pricing Strategy Design |
| (B) | seasonality | Q3 Demand for Vaccines and Pharmaceutical Intermediates Concentrated | Production and logistics planning |
| (C) | Tariffs and non-tariffs | US pharmaceutical tariffs 0%, EU 0-2% | Securing price competitiveness |
| (D) | Domestic alternative industries | Expansion of biosimilar production lines | Expanding export capacity |
| (E) | ESG · Net Zero | Strengthening biowaste management | ESG Risk Response |
| (F) | Country-specific risks | China risk 0.31 | Market diversification strategy |
| (G) | Buyer List | Pfizer, Novartis, Cipla | Expanding the global supply chain |
Quantitative indicators can help you select export markets and prioritize investment.
segment | ΔExport(%) | ΔPrice(%) | ΔCountryShare(pp) | TrustIndex(0–1) | 3M Forecast |
|---|---|---|---|---|---|
| biopharmaceuticals | +2.8% | +0.6% | +0.3 pp | 0.79 | Growth continues with expanded approvals in Europe and the US. |
| synthetic drugs | +1.5% | +0.4% | +0.1 pp | 0.73 | Generic demand stabilizes |
| Vaccines and blood products | +2.1% | +0.7% | +0.2 pp | 0.75 | Expansion of public procurement and export contracts |
It can be used for short-term export outlook and market-specific contract timing decisions.
