GITNUXREPORT 2026

Korea Pharmaceutical Industry Statistics

South Korea's pharmaceutical industry is growing through strong exports and advanced biotech innovation.

Gitnux Team

Expert team of market researchers and data analysts.

First published: Feb 13, 2026

Our Commitment to Accuracy

Rigorous fact-checking · Reputable sources · Regular updatesLearn more

Key Statistics

Statistic 1

The Korean pharmaceutical industry employed 105,000 workers in 2023, up 3.2% from 2022.

Statistic 2

Average annual salary for pharma R&D scientists in Korea was KRW 85 million in 2023.

Statistic 3

Women comprised 38% of the pharma workforce in South Korea as of 2022.

Statistic 4

Top 10 Korean pharma companies employed 62,000 people in 2023, led by Celltrion at 8,500.

Statistic 5

New hires in pharma sector reached 12,500 in 2023, with 40% in manufacturing.

Statistic 6

Labor productivity in Korean pharma was KRW 450 million per worker in 2022.

Statistic 7

25% of pharma employees had STEM degrees from top universities like KAIST in 2023.

Statistic 8

Turnover rate in Korean pharma was 8.2% in 2022, lowest in manufacturing sectors.

Statistic 9

Contract workers made up 22% of pharma employment in 2023.

Statistic 10

Regional employment: Gyeonggi-do hosted 55% of pharma jobs in 2022.

Statistic 11

Pharma PhD graduates: 1,200 annually from Korean universities in 2022.

Statistic 12

Youth employment rate in pharma: 65% for under-30s in 2023.

Statistic 13

Samsung Biologics workforce grew to 3,200 in 2023, 50% in production.

Statistic 14

Unionized workforce in pharma: 35% of total employees in 2022.

Statistic 15

Overseas Korean pharma employees: 15,000 in global subsidiaries 2023.

Statistic 16

Training programs certified 5,000 pharma technicians in 2023 by HRD Korea.

Statistic 17

Gender pay gap in pharma narrowed to 12% in 2022.

Statistic 18

Incheon Free Economic Zone hosts 40% of pharma jobs outside Seoul 2023.

Statistic 19

Average tenure for pharma managers: 11 years in 2022.

Statistic 20

Digital skills training reached 20,000 pharma workers in 2023.

Statistic 21

In 2023, Korean pharma production exports reached KRW 12.8 trillion, up 15% from 2022.

Statistic 22

South Korea exported pharmaceuticals worth USD 3.2 billion in 2023, ranking 10th globally.

Statistic 23

Biosimilars accounted for 45% of Korea's pharma exports in 2022, valued at USD 1.4 billion.

Statistic 24

Vietnam was the top destination for Korean pharma exports in 2023, with USD 450 million in sales.

Statistic 25

Korean pharma exports to the US grew 22% in 2023 to USD 680 million, led by generics.

Statistic 26

In 2022, Korea's pharma trade surplus was USD 2.1 billion, driven by high-value biologics.

Statistic 27

EU market share of Korean pharma exports was 18% in 2023, totaling EUR 550 million.

Statistic 28

Samsung Biologics secured USD 2.5 billion in export contracts for biologics in 2023.

Statistic 29

Korean CDMO exports surged 28% to KRW 5.6 trillion in 2023.

Statistic 30

Pharma exports to Southeast Asia reached USD 900 million in 2023, with Indonesia at 25% share.

Statistic 31

Korean pharma exports to China grew 18% to USD 520 million in 2023.

Statistic 32

EU-MDCG approval for 12 Korean biosimilars in 2023 boosted exports by USD 300 million.

Statistic 33

Samsung Biologics' US FDA approvals enabled USD 1.8 billion export revenue in 2023.

Statistic 34

Korean generics exports to Latin America totaled USD 250 million in 2022.

Statistic 35

Biosimilar exports to India reached USD 180 million in 2023 via Celltrion partnerships.

Statistic 36

Pharma export diversification: Africa share rose to 8% or USD 256 million in 2023.

Statistic 37

Hanmi Pharm's ADC drug exported to 15 countries, generating USD 120 million in 2022.

Statistic 38

Korean CDMO services exported to 50+ countries, KRW 3.2 trillion in 2023.

Statistic 39

Vaccine exports hit USD 400 million in 2023, led by SK Bioscience to COVAX.

Statistic 40

Middle East pharma imports from Korea USD 350 million in 2023, UAE top buyer.

Statistic 41

In 2022, the South Korean pharmaceutical market size reached approximately KRW 29.4 trillion (about USD 23.5 billion), marking a 5.2% year-on-year growth driven by increased demand for chronic disease treatments.

Statistic 42

The Korean generic drug market accounted for 65.3% of the total pharmaceutical market volume in 2023, with sales totaling KRW 19.2 trillion.

Statistic 43

Biopharmaceuticals represented 18.7% of the Korean pharma market revenue in 2022, up from 15.4% in 2018, fueled by biosimilar launches.

Statistic 44

Over-the-counter (OTC) drug sales in South Korea grew by 7.1% in 2023 to KRW 2.8 trillion, driven by health supplement trends post-COVID.

Statistic 45

The hospital drug market in Korea constituted 72% of total pharma sales in 2022, amounting to KRW 21.1 trillion.

Statistic 46

Korean pharma retail market per capita spending was USD 147 in 2022, ranking 15th globally among OECD countries.

Statistic 47

In 2023, the Korean vaccine market size was valued at KRW 1.5 trillion, with a projected CAGR of 8.2% through 2028.

Statistic 48

Cell and gene therapy market in Korea reached KRW 0.3 trillion in 2022, expected to grow at 25% annually.

Statistic 49

Korean digital therapeutics market generated KRW 0.12 trillion in revenue in 2023, with 15 approved products.

Statistic 50

The antidiabetic drug segment dominated the Korean pharma market with 12.4% share in 2022, sales at KRW 3.6 trillion.

Statistic 51

In 2022, the South Korean pharmaceutical market size was valued at USD 22.1 billion, with a CAGR of 4.8% from 2018-2022.

Statistic 52

Oncology drugs captured 22% of the Korean prescription drug market in 2023, sales KRW 6.5 trillion.

Statistic 53

The Korean contract development and manufacturing organization (CDMO) market was worth KRW 7.2 trillion in 2023.

Statistic 54

Cardiovascular drugs held 11.5% market share in Korea in 2022, KRW 3.4 trillion sales.

Statistic 55

Korean pharma e-commerce sales surged to KRW 1.1 trillion in 2023, 15% growth.

Statistic 56

Rare disease drug market in Korea reached KRW 0.9 trillion in 2022, orphan drug incentives applied.

Statistic 57

In 2023, Korean pharma imports totaled KRW 8.5 trillion, 60% from Europe and US.

Statistic 58

Nutraceuticals market size was KRW 6.7 trillion in 2022, blending with pharma OTC.

Statistic 59

Korean pharmaceutical market forecast to reach USD 28 billion by 2027 at 4.5% CAGR.

Statistic 60

GLP-1 agonists like Ozempic drove 25% growth in anti-obesity segment to KRW 0.8 trillion in 2023.

Statistic 61

South Korea's active pharmaceutical ingredient (API) production capacity stood at 150,000 tons annually in 2022.

Statistic 62

In 2023, Korean pharmaceutical production totaled KRW 35.2 trillion, with 85% from domestic firms.

Statistic 63

Samsung Biologics' production capacity reached 600,000 liters of bioreactor volume by end-2023.

Statistic 64

Celltrion's biosimilar production output was 120,000 units in 2022, primarily Remsima.

Statistic 65

Korean contract manufacturing organizations (CMOs) handled 40% of global biosimilar production in 2023.

Statistic 66

In 2022, 1,247 pharmaceutical manufacturing facilities operated in South Korea, employing advanced GMP standards.

Statistic 67

API self-sufficiency rate in Korea for essential medicines was 92% in 2023.

Statistic 68

Hanmi Pharm's annual tablet production capacity exceeded 2 billion units in 2023.

Statistic 69

Korean sterile injectables manufacturing output grew 12% YoY to KRW 4.1 trillion in 2022.

Statistic 70

75% of Korean pharma production adhered to PIC/S GMP standards as of 2023.

Statistic 71

GC Biopharma's annual plasma fractionation capacity is 1.2 million liters as of 2023.

Statistic 72

Hugel Inc. produced 50 million units of botulinum toxin (Botulax) in 2022.

Statistic 73

Korean oral solid dosage forms production was 15 billion units in 2023.

Statistic 74

Prestige Biopharma's monoclonal antibody production line yields 100,000 doses/year in 2023.

Statistic 75

92% of Korean pharma facilities certified under WHO GMP in 2023.

Statistic 76

Lotte Biologics expanded capacity to 180,000 liters for mammalian cell culture in 2023.

Statistic 77

Domestic production of insulin formulations reached 250 million units in 2022.

Statistic 78

Korean ampoule production output was 1.2 billion units annually in 2023.

Statistic 79

Binex Co. Ltd. vial filling capacity is 500 million units per year as of 2023.

Statistic 80

Pharma packaging materials production in Korea hit 50 billion units in 2022.

Statistic 81

MFDS issued 1,450 manufacturing licenses in 2023, ensuring workforce compliance.

Statistic 82

Drug price reduction under Korean NHI was 15.2% for 300 off-patent drugs in 2023.

Statistic 83

95% of new drugs underwent health technology assessment (HTA) by NECA in 2022.

Statistic 84

MFDS approved 520 generic drugs in 2023, with bioequivalence data mandatory.

Statistic 85

Korean Pharmacopoeia 12th edition updated 450 monographs in 2023.

Statistic 86

Adverse drug reaction reports totaled 28,000 in 2022 via KIDS system.

Statistic 87

Biosimilar approval pathway shortened to 12 months under MFDS 2023 guidelines.

Statistic 88

Import tariffs on pharma raw materials reduced to 0% for 80% of APIs in 2023.

Statistic 89

Clinical trial regulation amendments in 2022 increased IND approvals by 20%.

Statistic 90

GMP inspector workforce: 450 certified by MFDS in 2023.

Statistic 91

NHI drug reimbursement list added 120 new items in 2023.

Statistic 92

Patent linkage system blocked 250 generic entries in 2022.

Statistic 93

Real-world evidence (RWE) mandatory for 30% of reexaminations in 2023.

Statistic 94

MFDS pharmacovigilance inspections: 320 facilities in 2022.

Statistic 95

Positive list drug pricing system covered 92% of market in 2023.

Statistic 96

Advanced therapy medicinal products (ATMP) regulation framework enacted 2023.

Statistic 97

Export certificate issuance: 2,500 for pharma products in 2023.

Statistic 98

Drug master file (DMF) registrations: 1,800 active in Korea 2022.

Statistic 99

Personalized medicine guidelines issued for 10 drugs in 2023 by MFDS.

Statistic 100

South Korea's R&D expenditure in pharmaceuticals was KRW 5.8 trillion in 2022, 16.5% of sales.

Statistic 101

In 2023, 1,256 new drug pipelines were under development by Korean firms, with 320 in Phase III.

Statistic 102

Korean biotech firms filed 450 patents in oncology drugs in 2022.

Statistic 103

Government R&D funding for pharma reached KRW 1.2 trillion in 2023 via MSIT and MHW.

Statistic 104

42 new molecular entities (NMEs) were approved by MFDS in 2023, 15 from domestic developers.

Statistic 105

Clinical trials in Korea numbered 2,150 in 2022, with 60% pharma-related.

Statistic 106

mRNA vaccine R&D investment hit KRW 0.4 trillion in 2023 by firms like SK Bioscience.

Statistic 107

Korean pharma's success rate for Phase II to III trials was 35% in 2022, above global average.

Statistic 108

In 2023, 28 CAR-T cell therapies were in preclinical development in Korea.

Statistic 109

ADC (antibody-drug conjugate) pipelines numbered 15 from Korean companies in 2023.

Statistic 110

R&D personnel in Korean pharma industry totaled 45,000 in 2022, 12% PhD holders.

Statistic 111

Korean firms invested KRW 2.1 trillion in R&D alliances with global pharma in 2023.

Statistic 112

67 Korean biotech IPOs on KOSDAQ in 2022, raising KRW 1.5 trillion for R&D.

Statistic 113

Precision medicine R&D projects funded: 120 in 2023 by MHW, KRW 0.3 trillion.

Statistic 114

MFDS fast-track designation for 35 innovative drugs in 2023.

Statistic 115

Korean AI-drug discovery startups developed 200 candidates in 2022.

Statistic 116

National R&D program for next-gen biologics allocated KRW 0.8 trillion in 2023.

Statistic 117

15 Korean drugs licensed out to Big Pharma for USD 10 billion total in 2023.

Statistic 118

Stem cell therapy clinical trials: 45 ongoing in Korea 2023.

Statistic 119

Organoid-based drug screening platforms used in 20 pharma R&D labs in 2022.

Statistic 120

R&D tax credits claimed KRW 1.1 trillion by pharma firms in 2023.

Trusted by 500+ publications
Harvard Business ReviewThe GuardianFortune+497
While the global spotlight often shines on K-pop and Korean dramas, a far more impactful powerhouse—the Korean pharmaceutical industry—is scripting a global health revolution, with its market swelling to nearly KRW 30 trillion in 2022, generic drugs dominating sales volume, and cutting-edge biopharmaceuticals driving record-breaking exports.

Key Takeaways

  • In 2022, the South Korean pharmaceutical market size reached approximately KRW 29.4 trillion (about USD 23.5 billion), marking a 5.2% year-on-year growth driven by increased demand for chronic disease treatments.
  • The Korean generic drug market accounted for 65.3% of the total pharmaceutical market volume in 2023, with sales totaling KRW 19.2 trillion.
  • Biopharmaceuticals represented 18.7% of the Korean pharma market revenue in 2022, up from 15.4% in 2018, fueled by biosimilar launches.
  • South Korea's active pharmaceutical ingredient (API) production capacity stood at 150,000 tons annually in 2022.
  • In 2023, Korean pharmaceutical production totaled KRW 35.2 trillion, with 85% from domestic firms.
  • Samsung Biologics' production capacity reached 600,000 liters of bioreactor volume by end-2023.
  • In 2023, Korean pharma production exports reached KRW 12.8 trillion, up 15% from 2022.
  • South Korea exported pharmaceuticals worth USD 3.2 billion in 2023, ranking 10th globally.
  • Biosimilars accounted for 45% of Korea's pharma exports in 2022, valued at USD 1.4 billion.
  • South Korea's R&D expenditure in pharmaceuticals was KRW 5.8 trillion in 2022, 16.5% of sales.
  • In 2023, 1,256 new drug pipelines were under development by Korean firms, with 320 in Phase III.
  • Korean biotech firms filed 450 patents in oncology drugs in 2022.
  • The Korean pharmaceutical industry employed 105,000 workers in 2023, up 3.2% from 2022.
  • Average annual salary for pharma R&D scientists in Korea was KRW 85 million in 2023.
  • Women comprised 38% of the pharma workforce in South Korea as of 2022.

South Korea's pharmaceutical industry is growing through strong exports and advanced biotech innovation.

Employment and Workforce

  • The Korean pharmaceutical industry employed 105,000 workers in 2023, up 3.2% from 2022.
  • Average annual salary for pharma R&D scientists in Korea was KRW 85 million in 2023.
  • Women comprised 38% of the pharma workforce in South Korea as of 2022.
  • Top 10 Korean pharma companies employed 62,000 people in 2023, led by Celltrion at 8,500.
  • New hires in pharma sector reached 12,500 in 2023, with 40% in manufacturing.
  • Labor productivity in Korean pharma was KRW 450 million per worker in 2022.
  • 25% of pharma employees had STEM degrees from top universities like KAIST in 2023.
  • Turnover rate in Korean pharma was 8.2% in 2022, lowest in manufacturing sectors.
  • Contract workers made up 22% of pharma employment in 2023.
  • Regional employment: Gyeonggi-do hosted 55% of pharma jobs in 2022.
  • Pharma PhD graduates: 1,200 annually from Korean universities in 2022.
  • Youth employment rate in pharma: 65% for under-30s in 2023.
  • Samsung Biologics workforce grew to 3,200 in 2023, 50% in production.
  • Unionized workforce in pharma: 35% of total employees in 2022.
  • Overseas Korean pharma employees: 15,000 in global subsidiaries 2023.
  • Training programs certified 5,000 pharma technicians in 2023 by HRD Korea.
  • Gender pay gap in pharma narrowed to 12% in 2022.
  • Incheon Free Economic Zone hosts 40% of pharma jobs outside Seoul 2023.
  • Average tenure for pharma managers: 11 years in 2022.
  • Digital skills training reached 20,000 pharma workers in 2023.

Employment and Workforce Interpretation

While Korea's pharmaceutical industry is diligently brewing a potent workforce potion—growing to 105,000 with impressive STEM talent and rising salaries—its labor ecosystem reveals a complex formula where stability, regional concentration, and persistent contract work simmer alongside promising gains for women and youth.

Exports and International Trade

  • In 2023, Korean pharma production exports reached KRW 12.8 trillion, up 15% from 2022.
  • South Korea exported pharmaceuticals worth USD 3.2 billion in 2023, ranking 10th globally.
  • Biosimilars accounted for 45% of Korea's pharma exports in 2022, valued at USD 1.4 billion.
  • Vietnam was the top destination for Korean pharma exports in 2023, with USD 450 million in sales.
  • Korean pharma exports to the US grew 22% in 2023 to USD 680 million, led by generics.
  • In 2022, Korea's pharma trade surplus was USD 2.1 billion, driven by high-value biologics.
  • EU market share of Korean pharma exports was 18% in 2023, totaling EUR 550 million.
  • Samsung Biologics secured USD 2.5 billion in export contracts for biologics in 2023.
  • Korean CDMO exports surged 28% to KRW 5.6 trillion in 2023.
  • Pharma exports to Southeast Asia reached USD 900 million in 2023, with Indonesia at 25% share.
  • Korean pharma exports to China grew 18% to USD 520 million in 2023.
  • EU-MDCG approval for 12 Korean biosimilars in 2023 boosted exports by USD 300 million.
  • Samsung Biologics' US FDA approvals enabled USD 1.8 billion export revenue in 2023.
  • Korean generics exports to Latin America totaled USD 250 million in 2022.
  • Biosimilar exports to India reached USD 180 million in 2023 via Celltrion partnerships.
  • Pharma export diversification: Africa share rose to 8% or USD 256 million in 2023.
  • Hanmi Pharm's ADC drug exported to 15 countries, generating USD 120 million in 2022.
  • Korean CDMO services exported to 50+ countries, KRW 3.2 trillion in 2023.
  • Vaccine exports hit USD 400 million in 2023, led by SK Bioscience to COVAX.
  • Middle East pharma imports from Korea USD 350 million in 2023, UAE top buyer.

Exports and International Trade Interpretation

While Korea's pharmaceutical industry is no longer just playing "K-pop" with generics but is now headlining a global biotech arena, its strategic shift to high-value biosimilars and contract manufacturing has clearly paid off, vaulting it into the top 10 exporters with a trade surplus fueled by precision-targeted global expansion from Vietnam to the FDA's doorstep.

Market Overview

  • In 2022, the South Korean pharmaceutical market size reached approximately KRW 29.4 trillion (about USD 23.5 billion), marking a 5.2% year-on-year growth driven by increased demand for chronic disease treatments.
  • The Korean generic drug market accounted for 65.3% of the total pharmaceutical market volume in 2023, with sales totaling KRW 19.2 trillion.
  • Biopharmaceuticals represented 18.7% of the Korean pharma market revenue in 2022, up from 15.4% in 2018, fueled by biosimilar launches.
  • Over-the-counter (OTC) drug sales in South Korea grew by 7.1% in 2023 to KRW 2.8 trillion, driven by health supplement trends post-COVID.
  • The hospital drug market in Korea constituted 72% of total pharma sales in 2022, amounting to KRW 21.1 trillion.
  • Korean pharma retail market per capita spending was USD 147 in 2022, ranking 15th globally among OECD countries.
  • In 2023, the Korean vaccine market size was valued at KRW 1.5 trillion, with a projected CAGR of 8.2% through 2028.
  • Cell and gene therapy market in Korea reached KRW 0.3 trillion in 2022, expected to grow at 25% annually.
  • Korean digital therapeutics market generated KRW 0.12 trillion in revenue in 2023, with 15 approved products.
  • The antidiabetic drug segment dominated the Korean pharma market with 12.4% share in 2022, sales at KRW 3.6 trillion.
  • In 2022, the South Korean pharmaceutical market size was valued at USD 22.1 billion, with a CAGR of 4.8% from 2018-2022.
  • Oncology drugs captured 22% of the Korean prescription drug market in 2023, sales KRW 6.5 trillion.
  • The Korean contract development and manufacturing organization (CDMO) market was worth KRW 7.2 trillion in 2023.
  • Cardiovascular drugs held 11.5% market share in Korea in 2022, KRW 3.4 trillion sales.
  • Korean pharma e-commerce sales surged to KRW 1.1 trillion in 2023, 15% growth.
  • Rare disease drug market in Korea reached KRW 0.9 trillion in 2022, orphan drug incentives applied.
  • In 2023, Korean pharma imports totaled KRW 8.5 trillion, 60% from Europe and US.
  • Nutraceuticals market size was KRW 6.7 trillion in 2022, blending with pharma OTC.
  • Korean pharmaceutical market forecast to reach USD 28 billion by 2027 at 4.5% CAGR.
  • GLP-1 agonists like Ozempic drove 25% growth in anti-obesity segment to KRW 0.8 trillion in 2023.

Market Overview Interpretation

South Korea's pharmaceutical market is steadily growing into a complex beast, where the reliable heart of generics beats in over 65% of volume, while the high-margin, high-tech brains of biopharma and advanced therapies are rapidly expanding, all fueled by a population proactively spending on everything from chronic disease management to post-pandemic wellness.

Production and Manufacturing

  • South Korea's active pharmaceutical ingredient (API) production capacity stood at 150,000 tons annually in 2022.
  • In 2023, Korean pharmaceutical production totaled KRW 35.2 trillion, with 85% from domestic firms.
  • Samsung Biologics' production capacity reached 600,000 liters of bioreactor volume by end-2023.
  • Celltrion's biosimilar production output was 120,000 units in 2022, primarily Remsima.
  • Korean contract manufacturing organizations (CMOs) handled 40% of global biosimilar production in 2023.
  • In 2022, 1,247 pharmaceutical manufacturing facilities operated in South Korea, employing advanced GMP standards.
  • API self-sufficiency rate in Korea for essential medicines was 92% in 2023.
  • Hanmi Pharm's annual tablet production capacity exceeded 2 billion units in 2023.
  • Korean sterile injectables manufacturing output grew 12% YoY to KRW 4.1 trillion in 2022.
  • 75% of Korean pharma production adhered to PIC/S GMP standards as of 2023.
  • GC Biopharma's annual plasma fractionation capacity is 1.2 million liters as of 2023.
  • Hugel Inc. produced 50 million units of botulinum toxin (Botulax) in 2022.
  • Korean oral solid dosage forms production was 15 billion units in 2023.
  • Prestige Biopharma's monoclonal antibody production line yields 100,000 doses/year in 2023.
  • 92% of Korean pharma facilities certified under WHO GMP in 2023.
  • Lotte Biologics expanded capacity to 180,000 liters for mammalian cell culture in 2023.
  • Domestic production of insulin formulations reached 250 million units in 2022.
  • Korean ampoule production output was 1.2 billion units annually in 2023.
  • Binex Co. Ltd. vial filling capacity is 500 million units per year as of 2023.
  • Pharma packaging materials production in Korea hit 50 billion units in 2022.

Production and Manufacturing Interpretation

South Korea's pharmaceutical sector has clearly decided that if you want something done right—and in staggering, billion-unit batches—you should probably just do it yourself, as it now churns out everything from essential drug ingredients to vials of toxin with a self-sufficient swagger that would make even a pandemic blush.

Regulations and Policies

  • MFDS issued 1,450 manufacturing licenses in 2023, ensuring workforce compliance.
  • Drug price reduction under Korean NHI was 15.2% for 300 off-patent drugs in 2023.
  • 95% of new drugs underwent health technology assessment (HTA) by NECA in 2022.
  • MFDS approved 520 generic drugs in 2023, with bioequivalence data mandatory.
  • Korean Pharmacopoeia 12th edition updated 450 monographs in 2023.
  • Adverse drug reaction reports totaled 28,000 in 2022 via KIDS system.
  • Biosimilar approval pathway shortened to 12 months under MFDS 2023 guidelines.
  • Import tariffs on pharma raw materials reduced to 0% for 80% of APIs in 2023.
  • Clinical trial regulation amendments in 2022 increased IND approvals by 20%.
  • GMP inspector workforce: 450 certified by MFDS in 2023.
  • NHI drug reimbursement list added 120 new items in 2023.
  • Patent linkage system blocked 250 generic entries in 2022.
  • Real-world evidence (RWE) mandatory for 30% of reexaminations in 2023.
  • MFDS pharmacovigilance inspections: 320 facilities in 2022.
  • Positive list drug pricing system covered 92% of market in 2023.
  • Advanced therapy medicinal products (ATMP) regulation framework enacted 2023.
  • Export certificate issuance: 2,500 for pharma products in 2023.
  • Drug master file (DMF) registrations: 1,800 active in Korea 2022.
  • Personalized medicine guidelines issued for 10 drugs in 2023 by MFDS.

Regulations and Policies Interpretation

While maintaining a watchful regulatory eye on everything from factory floors to pharmacies, Korea is streamlining its pharmaceutical landscape to boost innovation and access, yet it remains a complex dance of encouraging new drugs while tightly controlling prices and protecting intellectual property.

Research and Development

  • South Korea's R&D expenditure in pharmaceuticals was KRW 5.8 trillion in 2022, 16.5% of sales.
  • In 2023, 1,256 new drug pipelines were under development by Korean firms, with 320 in Phase III.
  • Korean biotech firms filed 450 patents in oncology drugs in 2022.
  • Government R&D funding for pharma reached KRW 1.2 trillion in 2023 via MSIT and MHW.
  • 42 new molecular entities (NMEs) were approved by MFDS in 2023, 15 from domestic developers.
  • Clinical trials in Korea numbered 2,150 in 2022, with 60% pharma-related.
  • mRNA vaccine R&D investment hit KRW 0.4 trillion in 2023 by firms like SK Bioscience.
  • Korean pharma's success rate for Phase II to III trials was 35% in 2022, above global average.
  • In 2023, 28 CAR-T cell therapies were in preclinical development in Korea.
  • ADC (antibody-drug conjugate) pipelines numbered 15 from Korean companies in 2023.
  • R&D personnel in Korean pharma industry totaled 45,000 in 2022, 12% PhD holders.
  • Korean firms invested KRW 2.1 trillion in R&D alliances with global pharma in 2023.
  • 67 Korean biotech IPOs on KOSDAQ in 2022, raising KRW 1.5 trillion for R&D.
  • Precision medicine R&D projects funded: 120 in 2023 by MHW, KRW 0.3 trillion.
  • MFDS fast-track designation for 35 innovative drugs in 2023.
  • Korean AI-drug discovery startups developed 200 candidates in 2022.
  • National R&D program for next-gen biologics allocated KRW 0.8 trillion in 2023.
  • 15 Korean drugs licensed out to Big Pharma for USD 10 billion total in 2023.
  • Stem cell therapy clinical trials: 45 ongoing in Korea 2023.
  • Organoid-based drug screening platforms used in 20 pharma R&D labs in 2022.
  • R&D tax credits claimed KRW 1.1 trillion by pharma firms in 2023.

Research and Development Interpretation

South Korea's pharmaceutical sector has become a high-stakes, well-funded innovation engine, pumping money, trials, and patents into the global arena with a surprisingly sharp success rate, all while managing to license out homegrown breakthroughs for eye-watering sums.

Sources & References