CGT Summit Seoul: South Korea’s Cell and Gene Therapy Play Turns to Manufacturing, Access, and Real-World Delivery

The Asia-Pacific cell and gene therapy (CGT) sector is entering a decisive phase of maturity—one defined less by scientific possibility and more by the ability to translate that science into durable, real-world systems.

At the 4th CGT Innovation & Access Congress Asia in Seoul, discussions across both discovery and manufacturing tracks converged on a single reality: the field is no longer constrained by whether therapies can be designed, but by whether they can be operationalized—reliably, repeatedly, and at scale.

This shift comes as the global CGT market accelerates from an estimated $21.3 billion in 2025 to $26.2 billion in 2026, according to The Business Research Company, with Asia-Pacific emerging as the fastest-growing region—not necessarily because of novel biology, but because of its increasing ability to align science with system execution.

Regulation as Infrastructure, Not Constraint

One of the clearest signals from the region is that regulation is no longer functioning solely as a gatekeeper—it is being actively redesigned as an enabling layer of the ecosystem.

South Korea’s revised Advanced Regenerative Bio Act reflects this shift. Rather than limiting access to narrowly defined, high-risk patient populations, the framework expands eligibility while introducing mechanisms that allow therapies to exist within real clinical and economic systems, as outlined by the Korea Ministry of Health and Welfare.

The introduction of paid treatment pathways is particularly consequential. It shifts CGT out of the purely experimental domain and into a model where hospitals can justify long-term investment in infrastructure, training, and delivery capabilities—an issue that has historically constrained adoption even in advanced markets.

This policy direction aligns with broader global pressure to move beyond single-indication approvals toward sustainable reimbursement frameworks, particularly as therapies like CAR-T continue to exceed $400,000 per treatment, based on reimbursement analyses.

In practice, regulatory flexibility is already translating into scale. Medipost’s CARTISTEM, for example, has treated more than 36,000 patients in Korea and is expanding internationally, according to company disclosures and coverage in Evaluate Ltd..

Regulation, in this context, is no longer reacting to innovation. It is increasingly co-evolving with it.

Manufacturing Is Becoming the Product

If early CGT development was defined by biological innovation, the current phase is being defined by manufacturing control.

Across the congress, a consistent pattern emerged: therapies are no longer evaluated solely on mechanism, but on whether their production systems can maintain identity across scale—a requirement that has quietly become one of the leading causes of late-stage failure.

This dynamic underpins what the industry refers to as the “comparability trap,” where process changes during scale-up can alter the therapy in ways that regulators no longer recognize as equivalent.

The response is structural. Developers are increasingly embedding scalability into early design through:

• Closed, automated production systems that reduce operator variability
• Platform-based manufacturing approaches that standardize processes across pipelines
• Strategic partnerships with CDMOs, which are projected to capture over 80% of CGT manufacturing capacity by 2030, according to Boston Consulting Group

At the same time, non-viral engineering systems—such as electroporation-based platforms—are gaining traction as a way to bypass the cost and complexity of viral vector production, where single batches can exceed $500,000. The implication is no longer subtle: in CGT, manufacturing is not downstream—it defines the therapy itself.

Convergence of Modalities and Platforms

Another defining feature of the congress was the erosion of boundaries between therapeutic modalities.

Rather than advancing in parallel silos, cell therapy, gene therapy, RNA systems, and cell-free approaches are increasingly converging into integrated therapeutic platforms.

This shift reflects both scientific and operational pressures. As pipelines expand, developers are prioritizing approaches that can be adapted across multiple indications without requiring entirely new infrastructure.

The result is a move toward programmable therapeutic systems, where:

• RNA platforms extend beyond protein expression into regulation and degradation
• Engineered cells function as delivery vehicles rather than endpoints
• Cell-free systems offer scalable alternatives to live-cell therapies

This convergence aligns with broader industry trends. The RNA therapeutics market alone is projected to exceed $25 billion by 2030. What matters is no longer the modality—but how effectively it integrates into the larger system of development and delivery.

Asia’s Strategic Position: Speed, Scale, and System Design

While these pressures are global, Asia-Pacific is responding with a distinct strategic model.

Rather than optimizing individual components, the region is increasingly building end-to-end ecosystems, where regulatory reform, manufacturing capacity, and clinical deployment evolve together.

This is reflected in several structural advantages:

• Faster regulatory iteration cycles compared to the U.S. and EU
• Strong government-backed investment into biomanufacturing infrastructure, outlined in Korea’s national bioeconomy strategy from the Korea Health Industry Development Institute
• Early adoption of allogeneic, “off-the-shelf” therapies to improve scalability

These factors are contributing to a regional shift in market positioning. While North America still holds a majority of the global CGT market share, Asia-Pacific is closing the gap through execution efficiency.

To contextualize this divergence:

The distinction is not absolute—but it highlights a meaningful divergence in how the next phase of CGT is being built.

The Real Bottleneck: The Last Mile of Clinical Reality

Despite advances in design and manufacturing, the most persistent constraint remains the final step—delivery into real healthcare systems.

This “last mile” problem is increasingly recognized as the limiting factor for growth. Even as manufacturing capacity expands, uptake is constrained by:

• Physician workflow complexity
• Referral and patient identification systems
• Site readiness and infrastructure limitations

Industry estimates suggest that fewer than 10–15% of eligible patients currently receive advanced CGT treatments, according to access analyses from IQVIA.

As a result, the field is beginning to prioritize simplification:

• decentralized manufacturing tools
• reduced cleanroom dependency
• cell-free or off-the-shelf therapeutic formats

At the same time, companies and CROs are placing greater emphasis on early-stage clinical design, recognizing that decisions made during first-in-human studies can determine whether a therapy is scalable globally.

From Innovation to Execution

Taken together, the congress did not signal a breakthrough in any single technology. Instead, it marked a broader transition in how progress is defined.

Cell and gene therapy is no longer advancing as a sequence of scientific discoveries. It is evolving into a discipline of execution—where success depends on aligning biology, manufacturing, regulation, and clinical systems into a coherent whole.

The next phase of the field will not be determined by what can be invented, but by what can be sustained, scaled, and integrated into real-world use. And increasingly, that is where the true frontier lies.

Author

Bernice Lottering

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