South Korea’s Samsung Biologics Completes Spin-Off of Bioepis to Refocus on Global CDMO Strategy

Samsung Biologics, South Korea’s leading biopharmaceutical contract development and manufacturing organization (CDMO), recently announced the completion of its full spin-off of subsidiary Samsung Bioepis, marking a strategic shift from a mixed biotech business into a pure CDMO model. 

By separating its investment and subsidiary-management unit into a newly formed holding company, Samsung Epis Holdings, the company has positioned itself to focus squarely on large-scale biologics manufacturing, moving away from drug-development and commercialization activities. The Bioepis spin-off was finalized within five months of board approval, securing 99.9% shareholder support for the restructuring. 

From Competitor to Partner: Samsung Biologics Positions Itself as a Neutral CDMO

Founded in 2011, Samsung Biologics grew quickly to become one of the largest global biologics manufacturers, working with multinational pharmaceutical firms and offering manufacturing services for monoclonal antibodies, vaccines and other biologic drugs.

With the spin-off complete, the firm states it will no longer engage in drug-development or commercialisation of its own therapies, but instead will concentrate on high-margin manufacturing services.

In practical terms, this strategic focus positions Samsung Biologics as a more neutral and trusted manufacturing partner for innovator-drug companies. By exiting biosimilar development through the Bioepis spin-off, the company eliminates potential conflicts of interest that may have arisen when it simultaneously developed its own drug pipeline. Industry observers have noted that some clients previously viewed Bioepis’ biosimilar activities as a source of concern, underscoring why the move strengthens Samsung Biologics’ credibility as a dedicated CDMO partner.

Bioepis to Operate Independently, Focus on Biosimilars and Next-Gen Platforms

Through the spin-off, Bioepis now sits under Samsung Epis Holdings and will focus on biosimilar drug development (autoimmune, oncology, diabetes) and next-generation biologic platforms. This separation grants Bioepis more operational flexibility and allows Samsung Biologics to claim a clearer operational identity. In practice, biosimilar development and contract manufacturing involve very different risk/reward profiles, regulatory dynamics and business models — so separating them aligns each with a more tailored strategic focus.

Global Growth Strategy: Top 40 Pharma Clients & Japan Expansion

In its latest release, Samsung Biologics said it currently serves 17 of the world’s top 20 pharmaceutical companies and now aims to expand to serve the top 40 global biopharma firms. 

Furthermore, as part of its global expansion, the company has identified Japan — the world’s third-largest pharmaceutical market — as a key growth region. With Japan’s ageing population and rising biologics demand, the company plans to deepen its presence via regional offices, strategic partnerships and potentially direct investment in manufacturing infrastructure.

In practice this means Samsung Biologics is aligning itself with two key real-world trends: (1) More pharma companies outsourcing manufacturing to focus on drug discovery and commercialization; (2) Global supply-chain concerns (especially post-pandemic) pushing companies to partner with large, flexible CDMOs.

Capacity Build-out: “Bio Campus II” by 2032

To support this expansion, Samsung Biologics has initiated an ambitious capacity build-out. It plans a new facility dubbed “Bio Campus II” in Incheon, South Korea, which is expected to be completed by 2032 and substantially increase its total manufacturing capacity to 1,324,000 litres. 

In a practical sense, capacity matters dramatically in biologics manufacturing: larger scale allows cost efficiencies, faster ramp-up of client programs, and improved time-to-market. The build-out thus signals the company’s intent to be a cost-effective and flexible global provider.

Spin-off Signals Market Revaluation and a Broader Industry Shift

Since disclosing the plan in May, Samsung Biologics moved quickly to execute the spin-off—submitting its prospectus in August, gaining regulatory approval in September, and securing shareholder consent at the October 17 Extraordinary General Meeting. The company paused trading of its shares until November 21 and will resume on November 24, coinciding with its re-listing and the new listing of Samsung Epis Holdings. From a market-structure standpoint, the separation enables investors to value the biosimilar and CDMO businesses more transparently, as manufacturing and drug-development operations attract different investor profiles and valuation models.

The decision also reflects a broader global biopharma trend in which companies treat manufacturing, development, and commercialization as distinct, specialized domains. Investors now evaluate CDMOs based not only on capacity and compliance but also on strategic neutrality and scalability, while biosimilar developers contend with unique regulatory timelines and market-access risks. Samsung Biologics’ spin-off aligns with this shift, emphasizing transparency, operational focus, and investor confidence through a streamlined business structure.

How Samsung’s Move Compares With Global CDMO Peers

The Samsung Bioepis spin-off signals more than a corporate restructuring. It marks a broader shift in the global CDMO industry, where specialization, neutrality, and scale increasingly define competitiveness.

Many leading CDMOs in the United States and Europe already operate as pure manufacturing partners, focusing on contract development and production rather than in-house drug pipelines. By adopting this model, Samsung Biologics reduces the “dual-hatted” risk of being both a developer and a manufacturer and strengthens client trust through clearer business separation.

The global biologics CDMO market continues to grow, driven by expanding biologics pipelines, the rise of complex modalities such as antibody-drug conjugates and cell or gene therapies, and accelerated outsourcing since the pandemic. Precedence Research projects the market will reach nearly USD 92 billion by 2034, with a CAGR of 8.7%.

Global CDMOs, however, face challenges including supply-chain disruptions, inconsistent regulations, and margin pressure from the commoditization of standard biologics. To maintain pricing power, Samsung Biologics must pair its capacity expansion with deeper specialization in next-generation modalities and high-value manufacturing.

For pharmaceutical clients, CDMO selection depends on reliability, flexibility, compliance, and global reach. Companies operating as pure-play CDMOs with transparent, non-competing structures often earn greater trust, making Samsung’s restructuring a strategic move to enhance neutrality and scalability.

On the risk side, Samsung Biologics must align major investments such as its Bio Campus II expansion with client demand. Overcapacity or delays in contract ramp-up could lower utilization and profitability.

Samsung Biologics’ November 3, 2025 update confirms the full separation of its biosimilar and manufacturing units, finalizing its shift to a pure-play CDMO. The move sharpens strategic focus and reinforces client neutrality, though success will depend on disciplined execution in expansion, utilization, and diversification.

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Author

Bernice Lottering