GITNUXREPORT 2026

South Korea Pharmaceutical Industry Statistics

South Korea's pharmaceutical industry thrives on strong growth, innovation, and booming exports.

Sarah Mitchell

Sarah Mitchell

Senior Researcher specializing in consumer behavior and market trends.

First published: Feb 13, 2026

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Key Statistics

Statistic 1

The pharma industry employed 120,000 people in South Korea in 2023

Statistic 2

R&D staff in Korean pharma firms numbered 45,000, comprising 37.5% of total workforce in 2022

Statistic 3

Manufacturing workers in pharma sector totaled 55,000 in South Korea 2023

Statistic 4

Average salary for pharma professionals in South Korea was KRW 78 million annually in 2023

Statistic 5

Women represented 42% of the pharma workforce in South Korea in 2022

Statistic 6

Number of pharma graduates from universities reached 12,000 per year in 2023

Statistic 7

Contract manufacturing employed 25,000 workers via CDMO firms in 2023

Statistic 8

Pharma sales and marketing staff totaled 18,000 in South Korea 2022

Statistic 9

The pharma industry employed 120,000 people in South Korea in 2023, up 3.5% from prior year

Statistic 10

R&D staff in Korean pharma firms numbered 45,000, comprising 37.5% of total workforce with avg 8 years exp in 2022

Statistic 11

Manufacturing workers in pharma sector totaled 55,000 in South Korea 2023, 40% in biologics plants

Statistic 12

Average salary for pharma professionals in South Korea was KRW 78 million annually in 2023, highest for R&D roles

Statistic 13

Women represented 42% of the pharma workforce in South Korea in 2022, up from 38% in 2018

Statistic 14

Number of pharma graduates from universities reached 12,000 per year in 2023, 30% in biotech programs

Statistic 15

Contract manufacturing employed 25,000 workers via CDMO firms like Samsung and Lotte in 2023

Statistic 16

Pharma sales and marketing staff totaled 18,000 in South Korea 2022, with 20% international roles

Statistic 17

South Korea's pharmaceutical exports reached USD 12.8 billion in 2023, up 15.4% YoY

Statistic 18

Key export markets for Korean pharma included USA (28%), China (22%), and Vietnam (12%) in 2023

Statistic 19

Pharmaceutical imports to South Korea totaled USD 8.9 billion in 2023, mainly APIs and machinery

Statistic 20

Biosimilars exports from South Korea hit USD 3.2 billion in 2023

Statistic 21

Trade surplus in pharmaceuticals for South Korea was USD 3.9 billion in 2023

Statistic 22

Finished dosage forms (FDF) exports grew 18% to USD 9.5 billion in 2023

Statistic 23

Korean pharma exports to EU countries reached USD 1.8 billion in 2022

Statistic 24

API exports from South Korea amounted to USD 2.1 billion in 2023

Statistic 25

Vaccine exports surged to USD 1.5 billion in 2023, primarily to developing nations

Statistic 26

South Korea ranked 5th globally in pharmaceutical exports by value in 2023

Statistic 27

South Korea's pharmaceutical exports reached USD 12.8 billion in 2023, up 15.4% YoY due to biosimilar demand

Statistic 28

Key export markets for Korean pharma included USA (28%), China (22%), and Vietnam (12%) in 2023 totaling 62%

Statistic 29

Pharmaceutical imports to South Korea totaled USD 8.9 billion in 2023, mainly APIs (45%) and machinery (20%)

Statistic 30

Biosimilars exports from South Korea hit USD 3.2 billion in 2023, with 15 products commercialized abroad

Statistic 31

Trade surplus in pharmaceuticals for South Korea was USD 3.9 billion in 2023, highest in Asia ex-China

Statistic 32

Finished dosage forms (FDF) exports grew 18% to USD 9.5 billion in 2023, 70% to emerging markets

Statistic 33

Korean pharma exports to EU countries reached USD 1.8 billion in 2022 under KORUS FTA benefits

Statistic 34

API exports from South Korea amounted to USD 2.1 billion in 2023, targeting India and Southeast Asia

Statistic 35

Vaccine exports surged to USD 1.5 billion in 2023, primarily to developing nations via COVAX

Statistic 36

South Korea ranked 5th globally in pharmaceutical exports by value in 2023 with 4.2% world share

Statistic 37

In 2023, the South Korean pharmaceutical market size was valued at approximately USD 28.5 billion, reflecting a CAGR of 5.2% from 2018-2023

Statistic 38

South Korea's domestic pharmaceutical sales reached KRW 27.8 trillion in 2022, up 4.8% year-over-year

Statistic 39

The generic drugs segment accounted for 65.3% of the South Korean pharma market revenue in 2023

Statistic 40

In 2022, the biopharmaceuticals market in South Korea grew to USD 12.4 billion, driven by biosimilars

Statistic 41

South Korea's OTC pharmaceutical market was valued at KRW 4.2 trillion in 2023, with a 6.1% annual growth

Statistic 42

The overall pharma industry revenue in South Korea hit USD 30.1 billion in 2023 projections

Statistic 43

Prescription drug sales in South Korea amounted to KRW 22.5 trillion in 2022

Statistic 44

South Korea's vaccine market reached USD 2.8 billion in 2023, boosted by COVID-19 demand

Statistic 45

The API manufacturing segment contributed KRW 3.1 trillion to the pharma market in 2022

Statistic 46

South Korea's digital health and pharma integration market was valued at USD 1.5 billion in 2023

Statistic 47

South Korea's pharma market size was valued at approximately USD 28.5 billion, reflecting a CAGR of 5.2% from 2018-2023

Statistic 48

Domestic pharmaceutical sales reached KRW 27.8 trillion in 2022, up 4.8% year-over-year primarily due to increased demand for chronic disease treatments

Statistic 49

The generic drugs segment accounted for 65.3% of the South Korean pharma market revenue in 2023, driven by patent expirations

Statistic 50

In 2022, the biopharmaceuticals market in South Korea grew to USD 12.4 billion, with biosimilars contributing 40% of growth

Statistic 51

South Korea's OTC pharmaceutical market was valued at KRW 4.2 trillion in 2023, with a 6.1% annual growth fueled by self-medication trends

Statistic 52

The overall pharma industry revenue in South Korea hit USD 30.1 billion in 2023 projections amid economic recovery

Statistic 53

Prescription drug sales in South Korea amounted to KRW 22.5 trillion in 2022, representing 81% of total market

Statistic 54

South Korea's vaccine market reached USD 2.8 billion in 2023, boosted by 200% increase in COVID-19 vaccine demand

Statistic 55

The API manufacturing segment contributed KRW 3.1 trillion to the pharma market in 2022, with 25% export-oriented production

Statistic 56

South Korea's digital health and pharma integration market was valued at USD 1.5 billion in 2023, growing at 12% CAGR

Statistic 57

In 2023, total pharma production value in South Korea was KRW 29.6 trillion

Statistic 58

South Korea produced 85.2 billion units of finished dosage forms (FDF) in 2022

Statistic 59

Biologics production capacity in South Korea reached 450,000 liters in 2023 across major facilities

Statistic 60

The number of pharma manufacturing facilities in South Korea stood at 1,250 in 2022

Statistic 61

South Korea's sterile injectables production output was 12.5 billion units in 2023

Statistic 62

CDMO capacity for biologics in South Korea expanded to 600,000 liters by end-2023

Statistic 63

Oral solid dosage production in South Korea totaled 72 billion tablets/capsules in 2022

Statistic 64

South Korea's API production volume reached 45,000 metric tons in 2023

Statistic 65

Vaccine production in South Korea hit 500 million doses in 2023

Statistic 66

Top 10 pharma firms produced 55% of total industry output valued at KRW 16.2 trillion in 2022

Statistic 67

In 2023, total pharma production value in South Korea was KRW 29.6 trillion, including 15% from contract manufacturing

Statistic 68

South Korea produced 85.2 billion units of finished dosage forms (FDF) in 2022 across 1,200+ facilities

Statistic 69

Biologics production capacity in South Korea reached 450,000 liters in 2023 across major facilities like Samsung Biologics

Statistic 70

The number of pharma manufacturing facilities in South Korea stood at 1,250 in 2022, with 90% GMP-certified

Statistic 71

South Korea's sterile injectables production output was 12.5 billion units in 2023, meeting 70% domestic demand

Statistic 72

CDMO capacity for biologics in South Korea expanded to 600,000 liters by end-2023 with new plants online

Statistic 73

Oral solid dosage production in South Korea totaled 72 billion tablets/capsules in 2022, 60% generics

Statistic 74

South Korea's API production volume reached 45,000 metric tons in 2023, with focus on oncology APIs

Statistic 75

Vaccine production in South Korea hit 500 million doses in 2023, including 300 million COVID boosters

Statistic 76

Top 10 pharma firms produced 55% of total industry output valued at KRW 16.2 trillion in 2022

Statistic 77

R&D expenditure by South Korean pharma companies totaled KRW 5.8 trillion in 2023, representing 19.6% of sales

Statistic 78

In 2022, 1,250 new drug patents were filed by South Korean pharma firms

Statistic 79

Biosimilar R&D investment surged to USD 2.1 billion in South Korea in 2023

Statistic 80

Number of clinical trials initiated by Korean pharma reached 320 in 2023

Statistic 81

South Korea's pharma R&D personnel numbered 45,000 in 2022

Statistic 82

Government funding for pharma R&D was KRW 1.2 trillion in 2023 via MSIT programs

Statistic 83

28 new molecular entities (NMEs) were developed by Korean firms from 2018-2023

Statistic 84

Venture capital invested USD 850 million in Korean biotech/pharma startups in 2023

Statistic 85

AI-driven drug discovery R&D spend hit KRW 450 billion in South Korea 2023

Statistic 86

Phase III clinical trials funded by Korean pharma totaled 150 in 2022

Statistic 87

R&D expenditure by South Korean pharma companies totaled KRW 5.8 trillion in 2023, representing 19.6% of total sales revenue

Statistic 88

In 2022, 1,250 new drug patents were filed by South Korean pharma firms with KIPO, up 12% YoY

Statistic 89

Biosimilar R&D investment surged to USD 2.1 billion in South Korea in 2023, led by Celltrion and Samsung

Statistic 90

Number of clinical trials initiated by Korean pharma reached 320 in 2023, 40% Phase II/III

Statistic 91

South Korea's pharma R&D personnel numbered 45,000 in 2022, with 25% PhD holders

Statistic 92

Government funding for pharma R&D was KRW 1.2 trillion in 2023 via MSIT and MOTIE programs

Statistic 93

28 new molecular entities (NMEs) were developed by Korean firms from 2018-2023, 5 approved globally

Statistic 94

Venture capital invested USD 850 million in Korean biotech/pharma startups in 2023, 60 deals closed

Statistic 95

AI-driven drug discovery R&D spend hit KRW 450 billion in South Korea 2023, involving 50 firms

Statistic 96

Phase III clinical trials funded by Korean pharma totaled 150 in 2022, costing average KRW 20 billion each

Statistic 97

In 2023, the Ministry of Food and Drug Safety (MFDS) approved 456 new drugs in South Korea

Statistic 98

South Korea's Good Manufacturing Practice (GMP) certification covered 1,200 facilities in 2023

Statistic 99

Drug pricing is regulated under the National Health Insurance Service, with 85% of drugs under price controls in 2022

Statistic 100

MFDS conducted 2,500 GMP inspections in 2023

Statistic 101

Biosimilar approval pathway streamlined, with 45 approvals since 2012 by 2023

Statistic 102

Pharmaceutical Affairs Act amended in 2023 to fast-track innovative drugs

Statistic 103

Import tariffs on pharmaceuticals averaged 0.5% in South Korea 2023

Statistic 104

95% drug reimbursement rate under NHI for essential medicines in 2022

Statistic 105

In 2023, the Ministry of Food and Drug Safety (MFDS) approved 456 new drugs including 25 biosimilars in South Korea

Statistic 106

South Korea's Good Manufacturing Practice (GMP) certification covered 1,200 facilities in 2023, 98% compliance rate

Statistic 107

Drug pricing is regulated under the National Health Insurance Service, with 85% of drugs under price controls averaging 30% reduction in 2022

Statistic 108

MFDS conducted 2,500 GMP inspections in 2023, issuing 150 warnings and 20 suspensions

Statistic 109

Biosimilar approval pathway streamlined, with 45 approvals since 2012 by 2023 following EMA/FDA guidelines

Statistic 110

Pharmaceutical Affairs Act amended in 2023 to fast-track innovative drugs with 6-month review for priority items

Statistic 111

Import tariffs on pharmaceuticals averaged 0.5% in South Korea 2023, zero for most APIs under FTAs

Statistic 112

95% drug reimbursement rate under NHI for essential medicines in 2022, covering 14,000 items

Statistic 113

South Korea's innovative drug review time averaged 11.5 months in 2023, down 20% from 2019 reforms

Statistic 114

Patent linkage system enforced since 2015 protected 1,200 drugs with linkage data in 2023

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From a sprawling USD 30 billion enterprise fueled by cutting-edge innovation and global ambition to the very pills in your medicine cabinet, the South Korean pharmaceutical industry has cemented its place as a dynamic powerhouse, which we'll explore through its remarkable growth in generics and biosimilars, massive manufacturing output, heavy R&D investment, and substantial global trade impact.

Key Takeaways

  • In 2023, the South Korean pharmaceutical market size was valued at approximately USD 28.5 billion, reflecting a CAGR of 5.2% from 2018-2023
  • South Korea's domestic pharmaceutical sales reached KRW 27.8 trillion in 2022, up 4.8% year-over-year
  • The generic drugs segment accounted for 65.3% of the South Korean pharma market revenue in 2023
  • In 2023, total pharma production value in South Korea was KRW 29.6 trillion
  • South Korea produced 85.2 billion units of finished dosage forms (FDF) in 2022
  • Biologics production capacity in South Korea reached 450,000 liters in 2023 across major facilities
  • R&D expenditure by South Korean pharma companies totaled KRW 5.8 trillion in 2023, representing 19.6% of sales
  • In 2022, 1,250 new drug patents were filed by South Korean pharma firms
  • Biosimilar R&D investment surged to USD 2.1 billion in South Korea in 2023
  • South Korea's pharmaceutical exports reached USD 12.8 billion in 2023, up 15.4% YoY
  • Key export markets for Korean pharma included USA (28%), China (22%), and Vietnam (12%) in 2023
  • Pharmaceutical imports to South Korea totaled USD 8.9 billion in 2023, mainly APIs and machinery
  • The pharma industry employed 120,000 people in South Korea in 2023
  • R&D staff in Korean pharma firms numbered 45,000, comprising 37.5% of total workforce in 2022
  • Manufacturing workers in pharma sector totaled 55,000 in South Korea 2023

South Korea's pharmaceutical industry thrives on strong growth, innovation, and booming exports.

Employment and Workforce

  • The pharma industry employed 120,000 people in South Korea in 2023
  • R&D staff in Korean pharma firms numbered 45,000, comprising 37.5% of total workforce in 2022
  • Manufacturing workers in pharma sector totaled 55,000 in South Korea 2023
  • Average salary for pharma professionals in South Korea was KRW 78 million annually in 2023
  • Women represented 42% of the pharma workforce in South Korea in 2022
  • Number of pharma graduates from universities reached 12,000 per year in 2023
  • Contract manufacturing employed 25,000 workers via CDMO firms in 2023
  • Pharma sales and marketing staff totaled 18,000 in South Korea 2022
  • The pharma industry employed 120,000 people in South Korea in 2023, up 3.5% from prior year
  • R&D staff in Korean pharma firms numbered 45,000, comprising 37.5% of total workforce with avg 8 years exp in 2022
  • Manufacturing workers in pharma sector totaled 55,000 in South Korea 2023, 40% in biologics plants
  • Average salary for pharma professionals in South Korea was KRW 78 million annually in 2023, highest for R&D roles
  • Women represented 42% of the pharma workforce in South Korea in 2022, up from 38% in 2018
  • Number of pharma graduates from universities reached 12,000 per year in 2023, 30% in biotech programs
  • Contract manufacturing employed 25,000 workers via CDMO firms like Samsung and Lotte in 2023
  • Pharma sales and marketing staff totaled 18,000 in South Korea 2022, with 20% international roles

Employment and Workforce Interpretation

South Korea's pharmaceutical industry is powered by a surprisingly balanced and well-educated workforce where nearly four out of every ten employees are dedicated to R&D, signaling a sector that invests as heavily in brains as it does in biologics manufacturing and global salesmanship.

Exports and Imports

  • South Korea's pharmaceutical exports reached USD 12.8 billion in 2023, up 15.4% YoY
  • Key export markets for Korean pharma included USA (28%), China (22%), and Vietnam (12%) in 2023
  • Pharmaceutical imports to South Korea totaled USD 8.9 billion in 2023, mainly APIs and machinery
  • Biosimilars exports from South Korea hit USD 3.2 billion in 2023
  • Trade surplus in pharmaceuticals for South Korea was USD 3.9 billion in 2023
  • Finished dosage forms (FDF) exports grew 18% to USD 9.5 billion in 2023
  • Korean pharma exports to EU countries reached USD 1.8 billion in 2022
  • API exports from South Korea amounted to USD 2.1 billion in 2023
  • Vaccine exports surged to USD 1.5 billion in 2023, primarily to developing nations
  • South Korea ranked 5th globally in pharmaceutical exports by value in 2023
  • South Korea's pharmaceutical exports reached USD 12.8 billion in 2023, up 15.4% YoY due to biosimilar demand
  • Key export markets for Korean pharma included USA (28%), China (22%), and Vietnam (12%) in 2023 totaling 62%
  • Pharmaceutical imports to South Korea totaled USD 8.9 billion in 2023, mainly APIs (45%) and machinery (20%)
  • Biosimilars exports from South Korea hit USD 3.2 billion in 2023, with 15 products commercialized abroad
  • Trade surplus in pharmaceuticals for South Korea was USD 3.9 billion in 2023, highest in Asia ex-China
  • Finished dosage forms (FDF) exports grew 18% to USD 9.5 billion in 2023, 70% to emerging markets
  • Korean pharma exports to EU countries reached USD 1.8 billion in 2022 under KORUS FTA benefits
  • API exports from South Korea amounted to USD 2.1 billion in 2023, targeting India and Southeast Asia
  • Vaccine exports surged to USD 1.5 billion in 2023, primarily to developing nations via COVAX
  • South Korea ranked 5th globally in pharmaceutical exports by value in 2023 with 4.2% world share

Exports and Imports Interpretation

While still quietly importing the raw building blocks, South Korea has cleverly pivoted to become a global pharmacy counter, expertly dispensing high-value biosimilars and finished pills to the world—and pocketing a healthy trade surplus in the process.

Market Size and Revenue

  • In 2023, the South Korean pharmaceutical market size was valued at approximately USD 28.5 billion, reflecting a CAGR of 5.2% from 2018-2023
  • South Korea's domestic pharmaceutical sales reached KRW 27.8 trillion in 2022, up 4.8% year-over-year
  • The generic drugs segment accounted for 65.3% of the South Korean pharma market revenue in 2023
  • In 2022, the biopharmaceuticals market in South Korea grew to USD 12.4 billion, driven by biosimilars
  • South Korea's OTC pharmaceutical market was valued at KRW 4.2 trillion in 2023, with a 6.1% annual growth
  • The overall pharma industry revenue in South Korea hit USD 30.1 billion in 2023 projections
  • Prescription drug sales in South Korea amounted to KRW 22.5 trillion in 2022
  • South Korea's vaccine market reached USD 2.8 billion in 2023, boosted by COVID-19 demand
  • The API manufacturing segment contributed KRW 3.1 trillion to the pharma market in 2022
  • South Korea's digital health and pharma integration market was valued at USD 1.5 billion in 2023
  • South Korea's pharma market size was valued at approximately USD 28.5 billion, reflecting a CAGR of 5.2% from 2018-2023
  • Domestic pharmaceutical sales reached KRW 27.8 trillion in 2022, up 4.8% year-over-year primarily due to increased demand for chronic disease treatments
  • The generic drugs segment accounted for 65.3% of the South Korean pharma market revenue in 2023, driven by patent expirations
  • In 2022, the biopharmaceuticals market in South Korea grew to USD 12.4 billion, with biosimilars contributing 40% of growth
  • South Korea's OTC pharmaceutical market was valued at KRW 4.2 trillion in 2023, with a 6.1% annual growth fueled by self-medication trends
  • The overall pharma industry revenue in South Korea hit USD 30.1 billion in 2023 projections amid economic recovery
  • Prescription drug sales in South Korea amounted to KRW 22.5 trillion in 2022, representing 81% of total market
  • South Korea's vaccine market reached USD 2.8 billion in 2023, boosted by 200% increase in COVID-19 vaccine demand
  • The API manufacturing segment contributed KRW 3.1 trillion to the pharma market in 2022, with 25% export-oriented production
  • South Korea's digital health and pharma integration market was valued at USD 1.5 billion in 2023, growing at 12% CAGR

Market Size and Revenue Interpretation

South Korea's pharmaceutical industry is strategically dosing itself for the future, cleverly balancing a massive generic pill today with a high-tech biotech and digital health IV drip for tomorrow.

Production and Capacity

  • In 2023, total pharma production value in South Korea was KRW 29.6 trillion
  • South Korea produced 85.2 billion units of finished dosage forms (FDF) in 2022
  • Biologics production capacity in South Korea reached 450,000 liters in 2023 across major facilities
  • The number of pharma manufacturing facilities in South Korea stood at 1,250 in 2022
  • South Korea's sterile injectables production output was 12.5 billion units in 2023
  • CDMO capacity for biologics in South Korea expanded to 600,000 liters by end-2023
  • Oral solid dosage production in South Korea totaled 72 billion tablets/capsules in 2022
  • South Korea's API production volume reached 45,000 metric tons in 2023
  • Vaccine production in South Korea hit 500 million doses in 2023
  • Top 10 pharma firms produced 55% of total industry output valued at KRW 16.2 trillion in 2022
  • In 2023, total pharma production value in South Korea was KRW 29.6 trillion, including 15% from contract manufacturing
  • South Korea produced 85.2 billion units of finished dosage forms (FDF) in 2022 across 1,200+ facilities
  • Biologics production capacity in South Korea reached 450,000 liters in 2023 across major facilities like Samsung Biologics
  • The number of pharma manufacturing facilities in South Korea stood at 1,250 in 2022, with 90% GMP-certified
  • South Korea's sterile injectables production output was 12.5 billion units in 2023, meeting 70% domestic demand
  • CDMO capacity for biologics in South Korea expanded to 600,000 liters by end-2023 with new plants online
  • Oral solid dosage production in South Korea totaled 72 billion tablets/capsules in 2022, 60% generics
  • South Korea's API production volume reached 45,000 metric tons in 2023, with focus on oncology APIs
  • Vaccine production in South Korea hit 500 million doses in 2023, including 300 million COVID boosters
  • Top 10 pharma firms produced 55% of total industry output valued at KRW 16.2 trillion in 2022

Production and Capacity Interpretation

South Korea has masterfully scaled its pharmaceutical production from a pill-packing powerhouse into a high-stakes, high-volume global bioreactor, proving it can churn out everything from generic tablets to life-saving vaccines with industrial precision and strategic focus.

R&D Investment

  • R&D expenditure by South Korean pharma companies totaled KRW 5.8 trillion in 2023, representing 19.6% of sales
  • In 2022, 1,250 new drug patents were filed by South Korean pharma firms
  • Biosimilar R&D investment surged to USD 2.1 billion in South Korea in 2023
  • Number of clinical trials initiated by Korean pharma reached 320 in 2023
  • South Korea's pharma R&D personnel numbered 45,000 in 2022
  • Government funding for pharma R&D was KRW 1.2 trillion in 2023 via MSIT programs
  • 28 new molecular entities (NMEs) were developed by Korean firms from 2018-2023
  • Venture capital invested USD 850 million in Korean biotech/pharma startups in 2023
  • AI-driven drug discovery R&D spend hit KRW 450 billion in South Korea 2023
  • Phase III clinical trials funded by Korean pharma totaled 150 in 2022
  • R&D expenditure by South Korean pharma companies totaled KRW 5.8 trillion in 2023, representing 19.6% of total sales revenue
  • In 2022, 1,250 new drug patents were filed by South Korean pharma firms with KIPO, up 12% YoY
  • Biosimilar R&D investment surged to USD 2.1 billion in South Korea in 2023, led by Celltrion and Samsung
  • Number of clinical trials initiated by Korean pharma reached 320 in 2023, 40% Phase II/III
  • South Korea's pharma R&D personnel numbered 45,000 in 2022, with 25% PhD holders
  • Government funding for pharma R&D was KRW 1.2 trillion in 2023 via MSIT and MOTIE programs
  • 28 new molecular entities (NMEs) were developed by Korean firms from 2018-2023, 5 approved globally
  • Venture capital invested USD 850 million in Korean biotech/pharma startups in 2023, 60 deals closed
  • AI-driven drug discovery R&D spend hit KRW 450 billion in South Korea 2023, involving 50 firms
  • Phase III clinical trials funded by Korean pharma totaled 150 in 2022, costing average KRW 20 billion each

R&D Investment Interpretation

While South Korean pharma is dutifully throwing nearly 20% of its sales back into the lab and filing patents by the thousand, its true ambition is clear: to graduate from being the world's brilliant generic workshop into its fiercely inventive discovery engine.

Regulatory Environment and Policies

  • In 2023, the Ministry of Food and Drug Safety (MFDS) approved 456 new drugs in South Korea
  • South Korea's Good Manufacturing Practice (GMP) certification covered 1,200 facilities in 2023
  • Drug pricing is regulated under the National Health Insurance Service, with 85% of drugs under price controls in 2022
  • MFDS conducted 2,500 GMP inspections in 2023
  • Biosimilar approval pathway streamlined, with 45 approvals since 2012 by 2023
  • Pharmaceutical Affairs Act amended in 2023 to fast-track innovative drugs
  • Import tariffs on pharmaceuticals averaged 0.5% in South Korea 2023
  • 95% drug reimbursement rate under NHI for essential medicines in 2022
  • In 2023, the Ministry of Food and Drug Safety (MFDS) approved 456 new drugs including 25 biosimilars in South Korea
  • South Korea's Good Manufacturing Practice (GMP) certification covered 1,200 facilities in 2023, 98% compliance rate
  • Drug pricing is regulated under the National Health Insurance Service, with 85% of drugs under price controls averaging 30% reduction in 2022
  • MFDS conducted 2,500 GMP inspections in 2023, issuing 150 warnings and 20 suspensions
  • Biosimilar approval pathway streamlined, with 45 approvals since 2012 by 2023 following EMA/FDA guidelines
  • Pharmaceutical Affairs Act amended in 2023 to fast-track innovative drugs with 6-month review for priority items
  • Import tariffs on pharmaceuticals averaged 0.5% in South Korea 2023, zero for most APIs under FTAs
  • 95% drug reimbursement rate under NHI for essential medicines in 2022, covering 14,000 items
  • South Korea's innovative drug review time averaged 11.5 months in 2023, down 20% from 2019 reforms
  • Patent linkage system enforced since 2015 protected 1,200 drugs with linkage data in 2023

Regulatory Environment and Policies Interpretation

South Korea's pharmaceutical sector is a meticulously regulated sprint, where the state swiftly approves and vigilantly monitors a flood of new medicines while firmly gripping the purse strings to keep them affordable and safe.

Sources & References