[E-Daily Reporter KIM SAE-MI ] As the global biosimilar market is being restructured around a small number of top-tier companies with comprehensive capabilities in development, production, and sales, Celltrion(068270)’s position is becoming even more prominent. Although regulatory authorities are streamlining biosimilar development procedures, experts note that because the commercialization stage requires a wide range of capabilities simultaneously, the advantage held by companies that have secured an early foothold in the market is unlikely to be easily shaken.

Revenue Doubled in Two Years, Products Expanded from 6 to 11… Solidifying Position as a Global Top 3 Player

According to the biotech industry on the 25th, Celltrion has established itself as the world’s third-largest biosimilar company, trailing only the leading firms in Europe and North America based on annual revenue figures from the pharmaceutical market research firm IQVIA. Although its revenue scale still falls short of the top two companies, it is distinguishing itself in terms of growth rate and the expansion of its commercialized product portfolio.

Celltrion’s biosimilar revenue increased by 104%, from $2.3 billion (approximately 3.2 trillion won) in 2023 to $4.7 billion (approximately 6.5 trillion won) in 2025, while the number of commercialized products rose from 6 to 11 during the same period. The company is solidifying its position among the top three, showing a clear lead over its competitors in both revenue and the number of products.

It is particularly noteworthy that the expansion of its product portfolio is translating into actual revenue growth. Celltrion’s biopharmaceutical revenue for the second quarter of this year reached 1.2639 trillion won, a 43% increase compared to the same period last year. Revenue from new products rose 76% to 824.9 billion won, accounting for 65% of total biopharmaceutical revenue.

The combined quarterly sales of five new products—‘Stecima,’ ‘Omriclo,’ ‘Stovoclo,’ ‘Osenvelt,’ and ‘Aptozma’—totaled 314.4 billion won, a 4.7-fold increase from the same period last year. Compared to the previous quarter, sales rose by 49%, confirming that new products have become the main driver of growth.

The expansion of direct sales globally is also bolstering the company’s competitiveness. Celltrion’s direct sales revenue in North America has grown steadily since the transition to the 2023 business model, reaching 228.7 billion won in the second quarter of this year. Among existing products, “Remsima” in Europe maintains a market share of approximately 59%, while “Inflectra” in the U.S. holds approximately 30%. In essence, the company is simultaneously establishing new products in the market and defending the market share of its existing products.

This growth trend has also translated into strong financial results. Last year, Celltrion posted record-breaking consolidated revenue of 4.1625 trillion won and operating profit of 1.1685 trillion won. In the first half of this year, the company recorded revenue of 2.5387 trillion won and operating profit of 773.7 billion won, representing year-over-year increases of 40.8% and 97.4%, respectively. The operating profit margin for the first half also rose to 30.5%, an increase of 8.8 percentage points (p) compared to the same period last year.

Even with Lower Development Thresholds, Commercialization Barriers Remain… Top-Tier Oligopoly Expected to Persist

Recently, regulatory authorities in the U.S. and Europe have been refining their regulations to reduce the burden of biosimilar development.

Following its move to reduce the requirement for comparative clinical efficacy trials, the U.S. Food and Drug Administration (FDA) released a draft proposal in March that would also streamline certain pharmacokinetic (PK) studies if scientifically justified. The FDA estimated that this could reduce PK testing costs by up to 50%, or approximately $20 million (about 27.7 billion won). The European Medicines Agency (EMA) also adopted a “Reflection Paper” that same month, stating that comparative clinical efficacy trials can be omitted if there is sufficient analytical equivalence and PK data.

However, analysts note that even if development procedures are streamlined, this does not necessarily lower the barriers to entry at the commercialization stage. This is because companies must secure large-scale commercial production and cost competitiveness after approval, while also navigating country-specific tenders and gaining access to hospital and distribution networks. In the U.S., gaining access to insurance channels—such as Prescription Benefit Managers (PBMs)—is also crucial for expanding sales. Ultimately, since comprehensive capabilities spanning development, production, supply, and sales determine market competitiveness, analysts predict that the fruits of market growth are likely to be concentrated among a small number of top-tier companies.

The securities industry is also paying close attention to this market structure. Kim Seung-min, an analyst at MIRAE ASSET SECURITIES, stated, “The global biosimilar market is being restructured around a small number of top-tier companies that possess all the necessary capabilities—including development, approval, in-house production, supply stability, and a sales portfolio,” adding, “The pattern of a market oligopoly dominated by three companies from the U.S., Europe, and South Korea is becoming increasingly clear for the 2023–2025 period.”

Analyst Kim noted that when calculating Celltrion’s enterprise value, it is not appropriate to simply compare valuation multiples with Sandoz, a global leader in biosimilars. He explained, “Sandoz derives approximately 65% of its revenue from generics, while biosimilars account for only about 33%,” adding, “Considering that the valuation multiple for generic drug companies typically struggles to exceed 10x, the multiple inherent in Sandoz’s biosimilar business is estimated to be in the high 20x range or higher.”

He also cited the fact that Celltrion is securing higher profitability than Sandoz based on its own production system as a key differentiator. Analyst Kim concluded, “Taking this into account, an enterprise value-to-EBITDA (EV/EBITDA) multiple of 28 times is fully justifiable, and the current stock price remains undervalued even when compared to the value of Sandoz’s biosimilars business.” Based on this assessment, MIRAE ASSET SECURITIES raised Celltrion’s target price from 260,000 won to 280,000 won immediately following the announcement of its second-quarter earnings.

Celltrion is targeting annual revenue of 5.3 trillion won and operating profit of 1.8 trillion won this year. The company aims to exceed its annual targets by leveraging supply to major markets in the second half of the year, expanded listings in U.S. formularies, and increased market share for new products in Europe. With plans to expand its portfolio of commercialized biosimilars from the current 11 to 18 by 2030, the key focus will be on how quickly it can solidify its position as one of the top three global players while narrowing the gap with the top two companies.

A Celltrion spokesperson emphasized, “In addition to our current 11 commercialized products, the development of seven biosimilars is also progressing smoothly,” adding, “We will expand our portfolio to 18 products by 2030 and 41 by 2038 to further strengthen our leadership in the global biosimilar market.”