Key Takeaways
- In 2022, South Korea's bio-health industry market size reached 124.6 trillion KRW, accounting for 7.3% of the national GDP with a year-over-year growth of 8.2%.
- The bio industry in Korea is projected to grow to 200 trillion KRW by 2030, driven by biopharmaceuticals contributing 45% of the total market.
- Korea's biotech market revenue in 2023 was estimated at USD 45.2 billion, with a CAGR of 12.5% from 2018-2023.
- Samsung Biologics reported 2023 revenue of 3.68 trillion KRW, up 18% YoY, leading contract development manufacturing.
- Celltrion's 2023 sales reached 3.15 trillion KRW, with biosimilars like Remsima contributing 45% of revenue.
- SK Biopharmaceuticals achieved 2023 revenue of 1.42 trillion KRW, driven by epilepsy drug Xcopri exports.
- In 2022, Korea's bio R&D expenditure totaled 8.7 trillion KRW, 15.2% increase YoY.
- Korea filed 12,450 biotech patents in 2023, ranking 4th globally.
- Government bio R&D budget for 2023 was 2.1 trillion KRW, focused on mRNA tech.
- In 2023, Korea exported bio-health products worth USD 14.2 billion, up 12.5% YoY.
- Biopharmaceutical exports reached USD 8.7 billion in 2023, 61% of total bio exports.
- Medical devices exports from Korea hit USD 4.1 billion in 2023.
- In 2023, MFDS approved 28 new biopharmaceuticals for domestic market.
- Samsung Biologics' SA104 (COVID mAb) MFDS approved 2023.
- GC Biopharma's Quinvex (IVIG) expanded indication approved.
Korea's bio industry is rapidly growing as a major economic and innovative global force.
Exports and Global Presence
- In 2023, Korea exported bio-health products worth USD 14.2 billion, up 12.5% YoY.
- Biopharmaceutical exports reached USD 8.7 billion in 2023, 61% of total bio exports.
- Medical devices exports from Korea hit USD 4.1 billion in 2023.
- Celltrion biosimilars exported to EU, US, generating USD 2.1 billion in 2023.
- Samsung Biologics' CDMO services exported to 20 countries, USD 2.8 billion revenue.
- Vaccine exports surged to USD 1.2 billion in 2023 post-COVID.
- Cosmetics bio-ingredients exports USD 850 million to Asia in 2023.
- Stem cell products exported to 15 countries, USD 180 million value.
- Bio similar drugs top export item, 35% market share in EU generics.
- Korea's bio cluster Incheon exported USD 3.5 billion in 2023.
- GLP-1 agonists like Celltrion's CT-996 exported to US Phase 3.
- Diagnostic kits exports USD 650 million, led by COVID tests.
- Botox alternatives Nabota exported to 60 countries, USD 120 million.
- GC Biopharma's albumin exported to 40 countries, 1 million units.
- SK Bioscience's Nuvaxovid vaccine deal with US USD 200 million.
- Prestige Biopharma's PBG0805 approved in Australia, exports started.
- Bio-ferment skincare exports to China USD 450 million in 2023.
- CAR-T therapies pilot exports to SE Asia USD 50 million.
- mRNA tech licensed to 10 global firms, royalty USD 300 million.
- Nutraceuticals exports grew 14% to USD 1.1 billion in 2023.
- Top export markets: US 35%, EU 25%, China 20% of bio exports.
- Medical robotics exports USD 280 million, up 22%.
- Biosensor devices to Japan USD 150 million in 2023.
- Regenerative medicine exports to Middle East USD 90 million.
- Bio API (active pharma ingredients) exports USD 2.3 billion.
- Gene therapy vectors exported, 5 deals worth USD 400 million.
Exports and Global Presence Interpretation
Government Policies and Support
- Government's Bio Health R&D Special Act allocated 3 trillion KRW over 10 years starting 2023.
- K-Bio Cluster development plan invests 12 trillion KRW by 2030 in Incheon.
- Tax credits for bio R&D up to 50% for SMEs under 2023 revision.
- Fast-track approval for regenerative medicines reduced to 6 months.
- Bio venture fund of 2 trillion KRW launched by MSIT in 2023.
- National Bio Big Data Strategy with 1 trillion KRW investment to 2027.
- MHW's personalized medicine roadmap targets 30% market by 2030.
- Exemption of clinical trial fees for orphan bio drugs.
- Songdo International Bio Industry City master plan approved 2023.
- Green bio manufacturing subsidies up to 30% capex for CDMOs.
- AI drug discovery consortium with 500 billion KRW public funding.
- mRNA tech national project 1.2 trillion KRW over 5 years.
- Bio-health export promotion fund USD 1 billion allocation 2023-2027.
- Regulatory sandbox for digital therapeutics expanded to 50 products.
- Patent box regime for bio IP, tax rate 10% effective.
- Global bio hub status designated with visa incentives for talents.
- CAR-T manufacturing support 300 billion KRW grants.
- Precision medicine national cohort 1 million participants funded.
- Bio convergence 4th industry support law enacted 2023.
- SME bio accelerator program trained 5,000 personnel since 2020.
- Vaccine self-reliance policy stockpiled 100 million doses capacity.
- Clinical trial globalization support USD 100 million annually.
- Biosimilar fast-track pathway approved 20 products in 2 years.
Government Policies and Support Interpretation
Major Companies and Performance
- Samsung Biologics reported 2023 revenue of 3.68 trillion KRW, up 18% YoY, leading contract development manufacturing.
- Celltrion's 2023 sales reached 3.15 trillion KRW, with biosimilars like Remsima contributing 45% of revenue.
- SK Biopharmaceuticals achieved 2023 revenue of 1.42 trillion KRW, driven by epilepsy drug Xcopri exports.
- GC Biopharma posted 2.91 trillion KRW revenue in 2023, with plasma derivatives at 60% share.
- Hugel Inc. recorded 2023 sales of 562 billion KRW, botulinum toxin Botulax up 25%.
- Samsung Biologics signed 15 CMO deals worth USD 4.1 billion in 2023.
- Celltrion Healthcare exported biosimilars to 110 countries, revenue USD 1.8 billion in 2023.
- Prestige Biopharma's HD201 (Herceptin biosimilar) approved in Korea, 2023 production capacity 100 million doses.
- Daewoong Pharmaceutical's Nabota (botox) global sales hit 180 billion KRW in 2023.
- Hanmi Pharm's Efpeglenatide Phase 3 success, projected peak sales USD 2 billion.
- Lotte Biologics invested 1.2 trillion KRW in Songdo facility, capacity 240,000L by 2025.
- Medy-Tox's Neuronox exported to 50 countries, 2023 revenue 310 billion KRW.
- Boryung Pharmaceutical's Remodulin sales reached 450 billion KRW in 2023.
- Chong Kun Dang's CKD-012 (GLP-1) entered Phase 3, market potential 1 trillion KRW.
- Samsung Biologics' Entrisente completed Phase 1, partnership with MSD worth USD 1.2 billion.
- Celltrion's CT-P27 (COVID antibody) produced 20 million doses in 2023.
- SK Bioscience's booster vaccine sales USD 500 million in 2023.
- GC Biopharma's IVIG production capacity expanded to 4 million vials/year.
- Hugel's beauty division revenue grew 30% to 400 billion KRW in 2023.
- Daewoong's metabolic drug DW-0518 Phase 2 data showed 15% weight loss.
- Hanwha Chemical's biosimilar portfolio generated 250 billion KRW in 2023.
- Progenitor's cell therapy revenue USD 120 million in 2023.
- Aprogen's APG-777 (diabetes) Phase 2 enrollment completed 2023.
- Sillajen (Pexa-Vec) Phase 3 liver cancer trial, peak sales forecast USD 1 billion.
- Peptron's peptide therapeutics sales 150 billion KRW in 2023.
- Korea Ginseng Corp's bio-products revenue 320 billion KRW, 12% growth.
- Samsung Biologics ranked #7 global CDMO by revenue USD 2.8 billion in 2023.
Major Companies and Performance Interpretation
Market Size and Growth
- In 2022, South Korea's bio-health industry market size reached 124.6 trillion KRW, accounting for 7.3% of the national GDP with a year-over-year growth of 8.2%.
- The bio industry in Korea is projected to grow to 200 trillion KRW by 2030, driven by biopharmaceuticals contributing 45% of the total market.
- Korea's biotech market revenue in 2023 was estimated at USD 45.2 billion, with a CAGR of 12.5% from 2018-2023.
- In 2021, the domestic bio-health market expanded by 10.1% to 115.5 trillion KRW, led by digital healthcare at 15.2% growth.
- South Korea's bio industry employment stood at 456,000 jobs in 2022, up 5.8% from the previous year.
- The K-Bio roadmap targets a bio-health market of 150 trillion KRW by 2025, with 20% annual growth in key sectors.
- In 2023, Korea's personalized medicine segment within bio industry grew 18.7% to 12.4 trillion KRW.
- Bio-health exports contributed 15.3% to total national exports in 2022, valued at USD 12.8 billion.
- Korea's cell therapy market size was USD 1.2 billion in 2022, expected to reach USD 4.5 billion by 2028 at CAGR 24.3%.
- The gene therapy market in South Korea hit 850 billion KRW in 2023, with 22% YoY growth.
- Digital therapeutics market in Korea reached 2.1 trillion KRW in 2022, growing 25.4% annually.
- Korea's bio similar market size was USD 3.8 billion in 2023, projected to USD 7.2 billion by 2030.
- In 2022, the overall bio industry R&D investment represented 4.2% of GDP, highest in Asia for biotech.
- Korea's medical biotech devices market grew to 18.7 trillion KRW in 2023, up 9.8%.
- The bio-health convergence industry market was valued at 35.2 trillion KRW in 2021, with 12% CAGR forecast.
- South Korea's stem cell market size reached USD 1.5 billion in 2022, growing at 20.1% CAGR.
- In 2023, Korea's AI in bio-health market was 1.8 trillion KRW, expected 28% growth by 2027.
- Bio industry venture investments totaled 5.2 trillion KRW in 2022, a 15.4% increase.
- Korea's nutraceuticals and bio-food market hit 22.4 trillion KRW in 2023.
- The regenerative medicine market in Korea was USD 950 million in 2022, CAGR 23.5%.
- In 2022, bio-health industry's contribution to manufacturing GDP was 11.2%.
- Korea's CRISPR biotech market size projected at USD 450 million by 2025.
- Bio big data market in Korea reached 3.5 trillion KRW in 2023.
- In 2021, Korea's bio cluster economic impact was 45 trillion KRW with 250,000 jobs.
- Precision medicine market grew to 8.9 trillion KRW in 2022, 19.2% YoY.
- Korea's bio manufacturing output was 62.3 trillion KRW in 2023.
- Vaccine market size in bio industry was 7.1 trillion KRW in 2022.
- Bio-IT convergence market valued at 4.2 trillion KRW in 2023, CAGR 26%.
- Korea's microbiome therapeutics market hit USD 320 million in 2023.
- Overall bio industry sales revenue increased 9.5% to 132 trillion KRW in 2023.
Market Size and Growth Interpretation
Products and Approals
- Celltrion's Steqeyma (Steflara biosimilar) got US FDA approval Jan 2024.
Products and Approals Interpretation
Products and Approvals
- In 2023, MFDS approved 28 new biopharmaceuticals for domestic market.
- Samsung Biologics' SA104 (COVID mAb) MFDS approved 2023.
- GC Biopharma's Quinvex (IVIG) expanded indication approved.
- Hugel's Botulax approved in Canada for aesthetics.
- Daewoong's Nabota got EU approval for glabellar lines.
- SK Bioscience's GBP510 (COVID vaccine) booster approved.
- Prestige's PBG0907 (Keytruda bio) Phase 3 approved in Korea.
- Hanmi's Mordreda (Efpeglenatide) NDA filed post Phase 3.
- Lotte's albumin product approved in 10 Asian markets.
- Medy-Tox's MT10107L long-acting botox approved in Korea.
- Boryung's Ohtuvayre (pulmonary hypertension) launched domestically.
- CKD's CKD-342 (SGLT2/DPP4) approved for diabetes.
- Sillajen's pexa-vec combo therapy IND approved US.
- Peptron's PT320 (weekly exenatide) approved in Korea.
- Samsung's Entrisente ADC Phase 1 approved globally.
- Celltrion's CT-P47 (Soliris bio) BLA submitted FDA.
- GC's recombinant FVIII hemophilia product approved.
- Hugel's Esthelis filler line expanded approvals in Asia.
- Progenitor's exosome therapy conditional approval for wounds.
- Aprogen's AP325 stem cell for stroke Phase 2b approved.
- Korea approved 12 cell therapies under RMAT equivalent in 2023.
- Biosimilar approvals totaled 15 in 2023 by MFDS.
- First CRISPR-based therapy IND approved for rare disease.
- AI-designed drug from Postech approved IND.
- Microbiome product for IBS approved, first in Korea.
- CAR-NK cell therapy orphan drug designation.
- Vaccine for seasonal flu, 50 million doses approved capacity.
- Wearable biosensor for glucose, MFDS cleared Class 3.
Products and Approvals Interpretation
R&D Investments and Patents
- In 2022, Korea's bio R&D expenditure totaled 8.7 trillion KRW, 15.2% increase YoY.
- Korea filed 12,450 biotech patents in 2023, ranking 4th globally.
- Government bio R&D budget for 2023 was 2.1 trillion KRW, focused on mRNA tech.
- Private sector bio R&D investment hit 6.5 trillion KRW in 2022.
- Korea's biotech patent grants reached 8,920 in 2023, up 11%.
- KIST's bio research funding USD 250 million in 2023 for AI-drug discovery.
- KRIBB secured 1,200 new bio patents in 2022.
- National bio big data platform invested 500 billion KRW since 2020.
- Korea's stem cell research funding 450 billion KRW in 2023.
- Biotech university R&D grants totaled 1.2 trillion KRW in 2022.
- Patent applications in synthetic biology rose 28% to 2,100 in 2023.
- CAR-T cell therapy R&D funding USD 180 million by MHW in 2023.
- Korea ranked 3rd in Asia for bio PCT applications with 1,450 filings in 2022.
- Gene editing patents granted 650 in 2023, led by CRISPR tech.
- Public bio R&D centers received 900 billion KRW in 2023 budget.
- AI-biotech convergence R&D projects 320, funding 300 billion KRW in 2022.
- Microbiome research patents filed 890 in 2023, up 35%.
- National R&D program for bio-health allocated 1.5 trillion KRW in 2023.
- Korea's bio invention disclosure rate 92% for funded projects in 2022.
- Organoid research funding 120 billion KRW, 45 patents filed 2023.
- mRNA vaccine platform R&D invested 800 billion KRW since COVID.
- Digital twin for drug dev R&D 200 billion KRW in 2023.
- Bio convergence patent family size averaged 15 per invention in 2022.
- Precision oncology R&D grants 350 billion KRW to 120 projects.
- Korea's bio startups filed 2,500 patents in 2023.
- MFDS approved 45 new bio products from R&D in 2023.
R&D Investments and Patents Interpretation
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