The South Korea Biosimilars Market was valued at $380.8 Million in 2025 and projected to reach to $793.1 Million by 2030, representing a compound annual growth rate of 7.6%. South Korea's biosimilars market is positioned for sustained expansion driven by favorable regulatory policies, increasing prevalence of chronic diseases, and government cost-containment initiatives.
| Market Size in | USD 26.32 MN |
| Market Forecast in | |
| CAGR | |
| Forecast Period | |
| Units Considered | Value (USD MN) |
South Korea's biosimilars market is valued at USD 380.8 million in 2025, with a projected CAGR of 7.6% through 2030, reaching USD 793.1 million. This growth outpaces the global average of 7.5%, indicating strong regional momentum.
South Korea has established a robust regulatory pathway for biosimilar approval through the Ministry of Food and Drug Safety (MFDS), enabling faster market entry and competitive pricing strategies that drive adoption among healthcare providers.
Rising healthcare spending and government initiatives to control biologic drug costs have accelerated biosimilar penetration in South Korea, particularly in oncology, immunology, and rheumatology therapeutic areas.
South Korean healthcare systems increasingly prioritize biosimilar alternatives to reduce treatment costs while maintaining clinical efficacy, supported by growing physician confidence and patient acceptance of interchangeable biologics.
| Report Metric | Details |
|---|---|
| Base Year | 2025 |
| Fastest Growing Segment | USTEKINUMAB (Type) |
| Forecast Period | 2025–2030 |
| Growth Rate | CAGR of 7.5% from 2025 to 2030 |
| Largest Segment | MONOCLONAL ANTIBODIES (Drug Class) |
| Market Size Base Year (Billions) | ~USD 35.07 (2025) |
| Revenue Forecast (Billions) | ~USD 50.35 (2030) |
| Segments Covered | Drug Class, Type, Indication |
3 segment dimensions are covered across the global market.
| Company | HQ | Ownership | Strongest segments |
|---|---|---|---|
| PATHEON INC | Netherlands | Private Company | mAbs (Adalimumab, Infliximab, Rituximab, Trastuzumab and others),Insulin,GCSF, |
| ASTRAZENECA | United Kingdom | Public Company | mAbs (Adalimumab, Infliximab, Rituximab, Trastuzumab),Insulin,GLP-1, |
| SANOFI | Spain | Public Company | Insulin biosimilars and follow-on biologics,GLP-1 and obesity-adjacent biologic biosimilars,mAb biosimilars (adalimumab, infliximab, rituximab, trastuzumab), |
| NOVO NORDISK A/S | Denmark | Public Company | Insulin originators (human and analog),GLP-1 originators (incl. Wegovy and related),Rare disease biologics (incl. rhGH, rare endocrine), |
| BRISTOL-MYERS SQUIBB | United States | Public Company | mAbs (Oncology and Autoimmune originators),Anticoagulant (Eliquis and related),Cell and Gene / Advanced Therapies, |
| ALLERGAN PLC | Ireland | Private Company | mAbs (Adalimumab, Infliximab, Rituximab, Trastuzumab),Insulin,GCSF, |
| BIOGEN | United States | Public Company | mAbs – Adalimumab (Autoimmune),mAbs – Etanercept (Autoimmune),mAbs – Infliximab (Autoimmune), |
| GENENTECH | United States | Private Company | mAbs – Trastuzumab,mAbs – Rituximab,mAbs – Other (including Avastin-class and related), |
| GILEAD SCIENCES INC | United States | Public Company | mAbs-related oncology exposure (Trodelvy, cell therapy adjacencies),Autoimmune / inflammatory exposure via partnerships,Metabolic and GLP-1–adjacent exposure, |
| MERCK KGAA | United States | Public Company | mAbs-related (Adalimumab, Infliximab, Rituximab, Trastuzumab),Insulin and GLP-1–related,GCSF and anticoagulant-related, |
| SHIRE | Ireland | Private Company | mAbs (Adalimumab, Infliximab, Rituximab, Trastuzumab),GCSF,Insulin, |
| FLUOR CORPORATION | United States | Public Company | mAbs (Adalimumab, Infliximab, Rituximab, Trastuzumab and other mAbs),Insulin,GLP-1, |
| CELGENE CORPORATION | United States | Private Company | Oncology originators at risk from mAb and related biosimilars,Autoimmune and immunoscience originators,Hematology supportive and niche therapies, |
| SANDOZ GROUP AG | Switzerland | Public Company | mAbs (Adalimumab, Infliximab, Rituximab, Trastuzumab),GCSF,Insulin, |
| PFIZER INC. | India | Public Company | mAbs (Adalimumab, Infliximab, Rituximab, Trastuzumab),GCSF,Insulin, |
| AMGEN INC. | United States | Public Company | mAbs – Oncology (e.g., MVASI, trastuzumab, rituximab class),mAbs – Autoimmune (e.g., AMJEVITA/AMGEVITA, adalimumab class),GCSF (e.g., NEULASTA biosimilar class), |
| CELLTRION INC. | South Korea | Public Company | mAbs – Autoimmune (Infliximab, Adalimumab, SC formulations),mAbs – Oncology (Rituximab, Trastuzumab, Bevacizumab),Ophthalmology and Immunology (Omlyclo, Eydenzelt, Steqeyma, Avtozma), |
| BIOCON | India | Public Company | Insulin and insulin analog biosimilars,Oncology mAbs (including trastuzumab, rituximab, others),Autoimmune mAbs (including adalimumab, infliximab), |
| DR. REDDY’S LABORATORIES LTD. | India | Public Company | mAbs (Adalimumab, Infliximab, Rituximab, Trastuzumab),GCSF,Insulin, |
| ELI LILLY AND COMPANY | United States | Public Company | Insulin (Basaglar, Humalog, Humulin family),GLP-1 and incretin-based (Mounjaro, Trulicity, orforglipron pipeline),Oncology biologics (Cyramza, Erbitux, TYVYT, Verzenio, others), |
| TEVA PHARMACEUTICAL INDUSTRIES LTD. | Israel | Public Company | |
| STADA ARZNEIMITTEL AG | Germany | Private Company | mAbs (Adalimumab, Infliximab, Rituximab, Trastuzumab),GCSF,Insulin, |
| SAMSUNG BIOLOGICS | South Korea | Public Company | mAbs biosimilars (Adalimumab, Infliximab, Rituximab, Trastuzumab and other mAbs),GCSF and other hematology biosimilars,Insulin biosimilars, |
| AMNEAL PHARMACEUTICALS LLC | United States | Public Company | mAbs (Adalimumab, Infliximab, Rituximab, Trastuzumab),GCSF,Insulin, |
| COHERUS BIOSCIENCES | United States | Public Company | G-CSF (UDENYCA / Neulasta biosimilar),Oncology mAbs / Immunotherapies (LOQTORZI, Casdozokitug, CHS-114, toripalimab-related),Other biosimilars and partnered biologics, |
| BIO THERA SOLUTIONS | China | Public Company | mAbs – Autoimmune (Adalimumab, Infliximab, Tocilizumab-class, others),mAbs – Oncology (Bevacizumab-class and other oncology mAbs),Other Biologics for Autoimmune/Cardiovascular/Eye (non-mAb and novel biologics), |
Patheon Inc. is a Netherlands-based pharmaceutical company with 9,100 employees operating as a private entity. The company provides contract manufacturing and development services to the pharmaceutical industry.
AstraZeneca is a United Kingdom-based public pharmaceutical company founded in 1992 with 96,100 employees. It focuses on the discovery, development, and commercialization of prescription medicines across multiple therapeutic areas.
Sanofi is a Spain-based public pharmaceutical company founded in 1994 with 74,846 employees. The company engages in the research, development, and distribution of pharmaceutical products and vaccines.
Novo Nordisk A/S is a Denmark-based public company founded in 1923 with 67,900 employees. The company specializes in diabetes care, obesity management, and other chronic disease treatments.
Bristol-Myers Squibb is a United States-based public pharmaceutical company founded in 1887 with 32,500 employees. It develops and manufactures prescription medicines for oncology, immunology, cardiovascular, and cell therapy.
Allergan PLC is an Ireland-based private pharmaceutical company founded in 1983 with 17,400 employees. The company specializes in eye care, neurotoxin, and aesthetic pharmaceutical products.
Biogen is a United States-based public biotechnology company founded in 1978 with 7,500 employees. It focuses on discovering, developing, and delivering therapies for neurological and neurodegenerative diseases.
Genentech is a United States-based private biotechnology company founded in 1976 with 11,186 employees. The company specializes in the discovery and development of biopharmaceutical products.
Gilead Sciences Inc. is a United States-based public biopharmaceutical company founded in 1987 with 17,000 employees. It develops and commercializes antiviral drugs, immunology products, and oncology medicines.
Merck KGaA is a United States-based public company founded in 1668 with 59,077 employees. It operates in pharmaceuticals, life sciences, and performance materials sectors.
Shire is an Ireland-based private pharmaceutical company founded in 1986 with 23,044 employees. The company specializes in rare diseases, neuroscience, and gastrointestinal treatments.
Fluor Corporation is a United States-based public engineering and construction company founded in 1912 with 22,995 employees. It provides services to the energy, chemicals, and pharmaceutical industries.
Celgene Corporation is a United States-based private biopharmaceutical company founded in 1986 with 8,852 employees. It develops and commercializes therapies for cancer, inflammatory, and immunological diseases.
Sandoz Group AG is a Switzerland-based public pharmaceutical company founded in 1886 with 22,356 employees. It specializes in generic and biosimilar medicines.
Pfizer Inc. is an India-based public pharmaceutical company founded in 1950 with 1,244 employees. The company manufactures and distributes pharmaceutical products.
Amgen Inc. is a United States-based public biotechnology company founded in 1980 with 31,500 employees. It discovers, develops, manufactures, and delivers human therapeutics with a focus on oncology, cardiovascular disease, and inflammation.
Celltrion Inc. is a South Korea-based public biopharmaceutical company founded in 2002 with 2,680 employees. It specializes in the development and manufacturing of biosimilar and biopharmaceutical products.
Biocon is an India-based public biopharmaceutical company founded in 1978 with 16,447 employees. It develops and manufactures biopharmaceuticals, including insulins, monoclonal antibodies, and recombinant proteins.
Dr. Reddy's Laboratories Ltd. is an India-based public pharmaceutical company founded in 1984 with 27,527 employees. It manufactures and markets generic pharmaceuticals, active pharmaceutical ingredients, and specialty drugs.
Eli Lilly and Company is a United States-based public pharmaceutical company founded in 1876 with 50,000 employees. It discovers, develops, manufactures, and markets pharmaceutical products across multiple therapeutic areas.
Teva Pharmaceutical Industries Ltd. is an Israel-based public pharmaceutical company founded in 1901 with 32,008 employees. It develops and manufactures generic and specialty pharmaceutical products.
STADA Arzneimittel AG is a Germany-based private pharmaceutical company founded in 1895 with 11,500 employees. It develops and manufactures generic and branded pharmaceutical products.
Samsung Biologics is a South Korea-based public biopharmaceutical company founded in 2011 with 5,195 employees. It provides contract manufacturing services for biopharmaceutical products.
Amneal Pharmaceuticals LLC is a United States-based public pharmaceutical company founded in 2002 with 8,700 employees. It develops and manufactures generic and specialty pharmaceutical products.
Coherus BioSciences is a United States-based public biopharmaceutical company founded in 2010 with 145 employees. It focuses on the development and commercialization of biosimilar medicines.
Bio Thera Solutions is a China-based public biopharmaceutical company founded in 2003 with 1,426 employees. It engages in the research, development, and manufacturing of biopharmaceutical products.
South Korea's biosimilars market was valued at USD 380.8 million in 2025 and is expected to grow to USD 793.1 million by 2030.
South Korea's biosimilars market is projected to grow at a compound annual growth rate (CAGR) of 7.6% from 2025 to 2030.
South Korea's biosimilars market growth is driven by an aging population, increasing healthcare expenditure, favorable reimbursement policies, patent expirations of key biologics, and strong regulatory support for biosimilar approvals.
South Korea's biosimilars market is primarily driven by oncology and immunology segments, supported by high prevalence of cancer and autoimmune disorders in the country.
South Korea's regulatory pathway for biosimilars is aligned with international standards, enabling faster approval timelines and attracting both domestic and international manufacturers to establish production facilities in the country.
This research study extensively used secondary sources, directories, and databases to identify and collect valuable information to analyze the global biosimilars market. In-depth interviews were conducted with various primary respondents, including key industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry consultants, to obtain and verify critical qualitative and quantitative information and assess the growth prospects of the market. The global market size estimated through secondary research was then triangulated with inputs from primary research to arrive at the final market size.
Secondary research was used mainly to identify and collect information for the extensive, technical, market-oriented, and commercial study of the biosimilars market. The secondary sources used for this study are the US Food and Drug Administration (US FDA), the European Medicines Agency (EMA), World Health Organization (WHO), the National Institute for Health and Care Excellence (NICE), Health Canada, Australian Government Department of Health and Aged Care, Ministry of Food and Drug Safety (MFDS) (South Korea), the Brazilian Health Regulatory Agency (ANVISA), Health Products Regulatory Authority (HPRA), the Ministry of Health, Labour, and Welfare (Japan), the Central Drugs Standard Control Organization (CDSCO), the National Medical Products Administration (NMPA) (China), Purple Book, GaBI Generics and Biosimilars Initiative, the National Center for Biotechnology Information (NCBI), IQVIA, Academic Journals, Company Websites, Annual Reports, SEC Filings, Investor Presentations, and MarketsandMarkets Analysis. These sources also obtained key information about major players, market classification, and segmentation according to industry trends, regional/country-level markets, market developments, and technology perspectives.
Following an initial assessment of the global biosimilars market landscape through secondary research, comprehensive primary research was undertaken. This involved conducting in-depth interviews with market experts from the demand side, including stakeholders from pharmaceutical and biotechnology firms, CROs, CMOs, and academic and research institutions. Additionally, interviews were held with key supply-side participants, such as C-suite and senior executives, product managers, and marketing and sales leaders from prominent manufacturers, distributors, and channel partners. The research covered six major geographical regions: North America, Europe, Asia Pacific, Latin America, the Middle East, and Africa. Approximately 70% of the primary interviews were conducted with supply-side participants, while 30% involved demand-side experts. Data collection methods included structured questionnaires, email correspondence, online surveys, personal interviews, and telephonic discussions to understand the market dynamics comprehensively. The following is a breakdown of the primary respondents:
The following is a breakdown of the primary respondents:
To know about the assumptions considered for the study, download the pdf brochure
Both bottom-up and top-down approaches were used to estimate and validate the total size of the biosimilars market. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:

After arriving at the market size from the estimation process explained above, the total market was divided into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments, data triangulation and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides.
Biosimilars are complex biological products that exhibit high similarity to their reference (originator) biologics, demonstrating comparable efficacy, safety, and quality. These therapeutic alternatives can be developed and brought to market once the patent protection of the original biologic elapses. Per the US FDA's definition, a biosimilar is a biological product highly similar to an already approved reference product, with no clinically significant differences in safety, purity, or potency, despite minor variations in clinically inactive components. The biosimilars market encompasses currently available products and those anticipated for launch within the forecasting horizon. This market includes a diverse array of therapeutic areas, notably oncology and inflammatory and autoimmune diseases, where biosimilars are increasingly utilized as treatment options, providing cost-effective alternatives to reference biologics while ensuring patient safety and therapeutic efficacy.
Full forecast, segment splits, and company analysis for all Biosimilars Market.
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