Korea’s Pharma-Bio Industry Makes Money from Biosimilars and Manufacturing, Not New Drugs
The core of Korea’s pharma-biotech industry is still not inventing new drugs but biosimilars and manufacturing. Some people may find that uncomfortable, but it’s hard to deny when you look at the numbers and the company names. From 2020 to 2024, the domestic No. 1 was Samsung Biologics, and from 2025 to the present, Samsung Biologics and Celltrion are still leading the pack. In other words, more than the romance of R&D, it is clinical development, large-scale cell culture, commercialization, and a portfolio that can actually be sold that makes money.
What’s interesting is that the face of the global No. 1 has changed as well. After the eras of Pfizer, Roche, and Novartis, it is now Novo Nordisk and Eli Lilly. The market has always rewarded not “who is scientifically more impressive,” but “who successfully commercialized in areas with massive patient demand.” Is Korea any different? No. The rise of Celltrion and Samsung Biologics makes that point unmistakably clear.
Factories and approvals matter more than labs
The pharma-bio value chain starts with R&D, but profits are decided further downstream. If R&D is the seed, clinical development is the gate that filters out failures, and APIs and finished drug products are where real manufacturing capability shows. Once you get to distribution and sales, the game becomes even more grounded in reality. Prescriptions, channels, pricing, supply stability. In the end, this industry does not succeed on the back of a single good molecule.
Korea’s strongest links today are large-scale animal cell culture and biosimilar commercialization. That is why names like Samsung Biologics, Lotte Biologics, Celltrion, and Samsung Bioepis stand out. By contrast, the story changes at the very front end of R&D, especially in novel drug candidate discovery, antibody therapeutics, and small-molecule innovative drugs. This is not an industry that excels across the entire value chain; it is a structure with overwhelming strength in the middle to later stages.
| Stage | Description | Subsegments |
|---|---|---|
| R&D | Novel drug candidate discovery, AI drug development, nonclinical research | Basic research/target discovery, drug candidate discovery, AI drug development, genomics/precision medicine, nonclinical/preclinical, CRO-preclinical, etc. |
| Clinical development | Clinical trial execution and regulatory approval (including accelerated approval/orphan drug tracks) | Phase 1, Phase 2, Phase 3, decentralized/digital trials, CRO-clinical, clinical trial centers, etc. |
| APIs | Active pharmaceutical ingredients (APIs), ADC payloads/linkers, peptides/oligonucleotides | Synthetic APIs, bio APIs, high-potency APIs (HPAPIs), ADC linkers/payloads, peptide raw materials, oligonucleotides, etc. |
| Finished drug products | Finished drug product manufacturing (small molecules, antibodies, cell/gene therapies, mRNA, radiopharmaceuticals) | Prescription drugs-synthetic, prescription drugs-biologics, ADC finished products, GLP-1/obesity treatments, cell therapies, gene therapies, etc. |
| Distribution/Sales | Pharmaceutical distribution and sales (cold chain, global licensing-out) | Wholesale/distribution, hospital sales, pharmacy distribution, online distribution, exports/licensing-out, cold chain/logistics |
| Support services | Support for the pharma/bio industry (digital therapeutics, AI clinical, manufacturing equipment) | Pharma equipment, bio equipment, analytical/QC equipment, packaging materials/containers, digital therapeutics (DTx), IT/digital health, etc. |
What Korea does well, it does very well—and what it doesn’t have is still barely there
We shouldn’t use the word “localization” too casually. Pharma and biotech are not industries where you just swap out a few parts. Platforms, processes, clinical trials, approvals, patents, and sales all move as one tightly linked system. So if you talk about fields where the technology gap is within 1 and fields where it has widened to 3–5 in the same tone, you end up blurring reality.
Korea’s clear strengths are antibody biosimilars, high-difficulty biosimilars, biobetters, stem cell therapies, and large-scale animal cell culture. Celltrion and Samsung Bioepis have already established a real presence in antibody biosimilars, and more complex biosimilars in ophthalmology and immunology sit on that same axis. Alteogen and Hanmi Pharmaceutical’s biobetters may not be entirely new drugs, but they are credible plays where clinical improvement and commercial viability can line up. Stem cell therapies from Medipost, Pharmicell, and CHA Biotech are also an area Korea has stuck with for a long time. That part is good. Credit where credit is due.
The problem is that the lagging areas are too central to ignore. Protein structure prediction (AI) is gap 5, and CRISPR gene-editing therapies are gap 4. Small-molecule innovative drugs, antibody drugs, and new drug candidate discovery are all gap 3. In other words, Korea is strong at well-built processes and fast catch-up, but still weak when it comes to the invention engine needed for something close to first-in-class. In that context, saying “Korea is now a new-drug powerhouse” is an exaggeration. That said, the opportunity is also clear. If Korea can layer biobetters on top of its already strong manufacturing and biosimilar base, and if some companies can turn candidate-discovery capabilities into actual clinical results, the industry could move into a different weight class. But that has to be proven with data, not words. As always.
Table below: Domestic vs. global TRL (technology readiness level 1–9) by technology, and key companies
| Technology | Domestic | Global | Assessment | Key companies | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| New Drug Development | ||||||||||||||||||||||||||||||||
| Small-molecule innovative drugs | 6 | 9 | Caution · Gap 3 | Yuhan, Hanmi Pharmaceutical, Daewoong Pharmaceutical | ||||||||||||||||||||||||||||
| These are the familiar pill-form medicines made from very small chemical molecules. Because the molecules are small, they penetrate deep into the body and can enter cells, and they are relatively cheap because they are easy to mass-produce through chemical synthesis. They work by fitting into the active site of a target protein (such as an enzyme or receptor) like a lock and key, blocking or altering its function. The downside is that small molecules can also bind to normal proteins with similar shapes, making side effects more likely. Korea’s Yuhan reached a milestone with its lung cancer drug Lazcluze (lazertinib), which entered the ranks of the country’s first homegrown global innovative drugs after winning U.S. FDA approval and generating global sales. | ||||||||||||||||||||||||||||||||
| Antibody drugs (biologic innovative drugs) | 6 | 9 | Caution · Gap 3 | Celltrion, Hanmi Pharmaceutical, CKD Pharm | ||||||||||||||||||||||||||||
| These are medicines made from antibodies, the immune proteins in our bodies. Antibodies can bind with high precision to a specific target (a particular site on an antigen), like a lock and key, so they are more selective and generally cause fewer side effects than chemical pills. More recently, the trend has moved toward bispecific antibodies, where one antibody targets two sites at once to improve efficacy. Because they are proteins, they are broken down by stomach acid and digestive enzymes if taken orally, so most are given by injection. Korea is a global powerhouse in biosimilar production, but in first-in-class in-house antibody drug discovery it is still in catch-up mode versus the global leaders. | ||||||||||||||||||||||||||||||||
| ADC (antibody-drug conjugate) | 6 | 8 | Catch-up · Gap 2 | LigaChem Biosciences, ABL Bio, Celltrion | ||||||||||||||||||||||||||||
| ADCs are “guided missile” cancer therapies that attach a potent anticancer drug payload to an antibody that selectively homes in on cancer cells, using a chemical linker to reduce damage to normal cells. The antibody acts like a courier, finding the address of a specific antigen on the cancer cell surface and entering the cell, where the linker is then cut and the bomb—the anticancer drug—is released. The key technologies are targeting precision, linker design that stays intact in the bloodstream but breaks only inside the cell, and control over how many drug molecules are attached to each antibody (DAR). Korea’s LigaChem Biosciences has been recognized for the competitiveness of its proprietary linker platform, ConjuALL. | ||||||||||||||||||||||||||||||||
| New drug candidate discovery | 6 | 9 | Caution · Gap 3 | Hanmi Pharmaceutical, Daewoong Pharmaceutical, JW Pharmaceutical | ||||||||||||||||||||||||||||
| This is the earliest stage of drug development research: finding the “seed” of a future drug—a candidate compound likely to work against a disease—out of tens of thousands to hundreds of millions of substances. The process involves selecting molecules that bind well to a target protein while showing low toxicity. The faster you find a good seed, the higher the odds of downstream development success and the lower the cost and time required. Traditionally this meant screening huge numbers of compounds experimentally, but more recently AI has been used to pre-select candidates and shorten timelines. In Korea, companies combine in-house discovery with open innovation—buying early-stage overseas assets and co-developing them. | ||||||||||||||||||||||||||||||||
| Biosimilars | ||||||||||||||||||||||||||||||||
| Antibody biosimilars | 9 | 9 | Strong · Gap 0 | Celltrion, Samsung Bioepis | ||||||||||||||||||||||||||||
| Biosimilars are “copy biologics” modeled after expensive biologic innovative drugs—mostly antibody drugs—whose patents have expired. Unlike generic chemical pills, biologics are made using living cells, and because the molecules are large and structurally complex, they cannot be reproduced identically. That is why they are called “similar” rather than identical, and clinical studies are required to prove that their efficacy and safety are essentially the same as the original. They offer comparable efficacy at much lower prices, reducing the burden on both patients and insurance systems. Korea’s Celltrion and Samsung Bioepis are among the global leaders both in the number of approved biosimilar products and in global market share. | ||||||||||||||||||||||||||||||||
| High-difficulty biosimilars (ophthalmology/immunology) | 8 | 8 | Strong · Gap 0 | Samsung Bioepis, Celltrion | ||||||||||||||||||||||||||||
| These are biosimilars modeled after blockbuster original drugs that are difficult to make, such as ophthalmic injectables like Eylea and autoimmune therapies like Stelara. Because the molecular structures are complex or the mode of administration is highly precise—as with intraocular injections—both manufacturing and clinical development are more difficult. That also means fewer competitors and higher profitability if successful. The race is decided by who can launch first, and simultaneously in the U.S. and Europe, when the original product’s substance patent expires. Korea’s leading companies have already launched multiple high-difficulty products globally. | ||||||||||||||||||||||||||||||||
| Biobetters (improved biologics) | 7 | 8 | Strong · Gap 1 | Alteogen, Hanmi Pharmaceutical | ||||||||||||||||||||||||||||
| Biobetters are improved versions of existing biologic drugs. For example, they can convert a long hospital-administered intravenous infusion (IV) into a subcutaneous injection (SC) that patients can self-administer at home with a pen in just a few minutes, or extend the duration of effect to reduce dosing frequency. One key mechanism is the use of the enzyme hyaluronidase, which temporarily loosens tissue under the skin so that a large amount of drug can be absorbed quickly. Korea’s Alteogen developed this SC-conversion platform, ALT-B4, and has repeatedly out-licensed it to global big pharma companies. | ||||||||||||||||||||||||||||||||
| Cell & Gene Therapy | ||||||||||||||||||||||||||||||||
| CAR-T cell therapy | 6 | 8 | Catch-up · Gap 2 | Curocell, AbClon, GC Cell | ||||||||||||||||||||||||||||
| CAR-T is a “custom immune-cell army” made by taking a patient’s own immune cells (T cells), inserting the gene for an artificial receptor (CAR) that recognizes markers on cancer cells, and then reinfusing those engineered cells into the body. In effect, your own cells are turned into cancer-tracking weapons. For some blood cancers that did not respond to other treatments, a single infusion can even produce complete remission. The drawbacks are that each therapy must be made individually for each patient, manufacturing is complex, one-time treatment costs can run into hundreds of thousands of dollars, and side effects such as excessive immune reactions must be managed. In Korea, Curocell has entered the domestic approval process for the country’s first homegrown CAR-T therapy. | ||||||||||||||||||||||||||||||||
| Gene-editing (CRISPR) therapy | 4 | 8 | Weak · Gap 4 | ToolGen, GenKORE | ||||||||||||||||||||||||||||
| CRISPR gene editing is a “genetic editor” that precisely finds and cuts out—or rewrites—the part of DNA responsible for disease. A short RNA acts as a guide to locate the target sequence, and a protein acting as the scissors (such as Cas9) cuts that spot, allowing the cell’s own repair process to modify the genetic information. It is like searching for a typo in a Word document and correcting it directly. The first CRISPR therapy in the world, for sickle cell disease, was approved in 2023–2024, opening the door to commercialization. Korea’s ToolGen holds key foundational patents and is one of the important players in global disputes and licensing around the technology. | ||||||||||||||||||||||||||||||||
| Gene delivery systems (viral vectors) | 5 | 8 | Caution · Gap 3 | GC Cell, CHA Biotech, SK bioscience | ||||||||||||||||||||||||||||
| These are the “delivery couriers” that safely carry corrected genes or CAR designs to target cells inside the body. In most cases, viruses stripped of their disease-causing ability—viral vectors such as AAV or lentivirus—are used as the delivery vehicle. The virus’s natural ability to enter cells is preserved, but the genes responsible for replication and disease are removed so that only the desired genetic material is delivered safely. The efficacy and safety of gene and cell therapies depend heavily on how accurately and consistently this delivery system works, which is why large-scale manufacturing capability remains a major industry bottleneck. | ||||||||||||||||||||||||||||||||
| Stem cell therapy | 6 | 7 | Strong · Gap 1 | Medipost, Pharmicell, CHA Biotech | ||||||||||||||||||||||||||||
| This is a therapy that uses “master cells” capable of transforming into many different cell types—stem cells—to regenerate damaged tissue. Stem cells can self-replicate and differentiate into needed cells such as cartilage, nerve, or muscle, with the goal of restoring areas that do not heal easily on their own, almost like replacing broken parts with new ones. Beyond directly becoming tissue, they are also used for their ability to secrete signaling molecules that reduce inflammation and help surrounding cells regenerate. Korea has a relatively large number of globally approved stem cell therapy products. | ||||||||||||||||||||||||||||||||
| CDMO & Manufacturing | ||||||||||||||||||||||||||||||||
| Large-scale animal cell culture | 9 | 9 | Strong · Gap 0 | Samsung Biologics, Lotte Biologics | ||||||||||||||||||||||||||||
| A CDMO is a “contract biomanufacturing plant” that makes biologic drugs developed by other companies. The core process is to grow living animal cells—usually CHO cells—engineered to secrete the drug substance, such as an antibody, in massive bioreactors holding thousands to tens of thousands of liters, and then purify and isolate the drug from the culture medium. Know-how in growing cells consistently, massive sterile facilities, and the ability to expand capacity quickly are what define competitiveness. With Plant 5 coming online, Samsung Biologics became the world’s largest CDMO, with total culture capacity of about 780,000 liters. | ||||||||||||||||||||||||||||||||
| Drug product & aseptic fill-finish | 8 | 9 | Strong · Gap 1 | Samsung Biologics, SK bioscience, ST Pharm | ||||||||||||||||||||||||||||
| This is the stage where the purified bulk drug substance is aseptically filled into syringes or vials in precise doses and turned into the final product. Because filling, sealing, and inspection are all carried out in an ultra-clean sterile environment where not even a single bacterium or microparticle can be allowed in, it is called “fill and finish.” Competitiveness in winning contracts is only complete when a company can handle not just drug substance production but also drug product manufacturing in one place. Korea proved its capabilities internationally through contract fill-finish production of COVID vaccines and therapeutics. | ||||||||||||||||||||||||||||||||
| Contract manufacturing for cell & gene therapy (CGT) | 5 | 8 | Caution · Gap 3 | GC Cell, CHA Biotech, Lotte Biologics | ||||||||||||||||||||||||||||
| This is the next-generation CDMO business that manufactures advanced therapies made from living cells or viral vectors, such as CAR-T and gene therapies, on behalf of others. Conventional antibody drugs are mass-produced as identical products, but CGT is often patient-specific, with long and complex processes, making each batch highly valuable and the segment highly value-added. Core competitive strengths are sterile and low-temperature handling that preserves living cells, along with vector production capability. The market is still in its early stages globally, which gives Korea—already strong in antibody CDMOs—a chance to establish an early lead. | ||||||||||||||||||||||||||||||||
| API & peptide synthesis | 7 | 8 | Strong · Gap 1 | ST Pharm, Hanmi Fine Chemical, CKD Bio | ||||||||||||||||||||||||||||
| This is the business of chemically synthesizing the core active ingredient of a drug—the API—and supplying it to finished-dose pharmaceutical companies. Demand is surging in particular for peptides used in obesity and diabetes treatments (GLP-1 drugs such as semaglutide) and for oligonucleotide raw materials used in gene-based medicines. Peptides require the precise linking of amino acids one unit at a time, while oligos require the same kind of precision with DNA or RNA fragments. Korean companies such as ST Pharm supply these materials to global pharmaceutical companies under long-term contracts. | ||||||||||||||||||||||||||||||||
| AI Drug Discovery & Digital Health | ||||||||||||||||||||||||||||||||
| AI drug discovery platforms | 5 | 8 | Caution · Gap 3 | Standigm, Pharos iBio, Oncocross | ||||||||||||||||||||||||||||
| This is the use of AI to quickly identify promising drug candidates from hundreds of millions of molecules and to predict efficacy, toxicity, and side effects in advance. AI learns from existing drug and target data to recommend what kinds of molecular shapes are likely to work for a given target, or to find new uses for existing drugs—drug repositioning. It serves as a kind of navigation system for drug development, cutting a search process that once took years of human experimentation down to months. Korean startups have begun pushing AI-discovered candidates into clinical-stage development. | ||||||||||||||||||||||||||||||||
| Protein structure prediction (AI) | 4 | 9 | Weak · Gap 5 | Galux, Kakao Brain (healthcare) | ||||||||||||||||||||||||||||
| This is the use of AI to predict the three-dimensional shape of the target protein that a drug will bind to. Proteins are formed when amino acid chains fold into 3D structures, and drugs work by fitting like keys into pockets and grooves on the protein surface, so you need to know the shape in order to design the right drug. In the past, determining a single structure could take years and require expensive equipment, but after Google DeepMind’s AlphaFold, AI can now predict structures almost instantly from amino acid sequences alone. In Korea, companies such as Galux are chasing the global leaders in applied areas such as antibody structure and binding prediction. | ||||||||||||||||||||||||||||||||
| Digital therapeutics & healthcare AI | 6 |
Why the global No. 1 shifted from Pfizer to Lilly—and why Korea moved to Samsung BiologicsThe changing lineup of No. 1 companies in each era is the industry’s report card. From the 1990s to 2008, Pfizer globally and Yuhan Corporation and Hanmi Pharmaceutical domestically were the defining names. From 2009 to 2016, Roche and Novartis led globally, while Celltrion came to the forefront in Korea. From 2017 to 2019, Samsung Biologics expanded its presence alongside Celltrion in Korea, and from 2020 to 2024, Samsung Biologics firmly took the top spot.
The key to these power shifts is not who talked about having more pipelines, but who commercialized the era’s demand at the biggest scale. It was no accident that global leadership moved to Novo Nordisk and Eli Lilly. The market rewarded companies with clear demand, large addressable markets, and the ability to execute. The same logic explains Samsung Biologics’ rise in Korea. Manufacturing capacity, customer base, and speed of execution won out. If Celltrion symbolized 2009~2019, then Samsung Biologics shows where the center of gravity in Korea’s pharma-biotech industry has been from 2020 to the present. And the fact that both Samsung Biologics and Celltrion are listed together as domestic leaders from 2025 onward is quite telling. Korea’s current position is clear: not so much the center of global innovative drug discovery, but a country that can go head-to-head with the world in biosimilars and manufacturing. That is not a bad position. But if it stops there, the upside on valuation gets capped as well. The next set of numbers will show up first in approvals and contract wins, not in the labWhat matters from here is the commercialization of high-complexity biosimilars and the sustainability of large-scale cell culture competitiveness. The key questions are how much Samsung Bioepis and Celltrion can expand their presence in high-complexity biosimilars such as ophthalmology and immunology, and how consistently Samsung Biologics and Lotte Biologics can retain customers in large-scale mammalian cell culture. On top of that, if the biobetter players such as Alteogen and Hanmi Pharmaceutical can prove genuinely differentiated value, the industry’s fundamentals move up another level. The risks are clear. In new drug candidate discovery, novel antibody drugs, and small-molecule therapeutics, the gap is 3; in protein structure prediction (AI), the gap is 5; and in gene-editing (CRISPR) therapies, the gap is 4. If front-end invention capabilities remain weak, relying only on downstream process competitiveness leaves the industry exposed to pricing pressure and intensifying competition. In the end, Korean pharma and biotech can keep making money from what they already do well, but the next phase will be decided by how much they can narrow this map of technological weaknesses. If they fail, they stop at being merely ‘a country that manufactures well.’ Is that really enough? ※ This analysis is based on public data and industry materials, and some figures and assessments are estimates. It should not be used as a direct basis for investment decisions. Written: June 2026. Ealexandro | ||||||||||||||||||||||||||||||
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