Asia-Pacific (APAC) has refined its development, manufacturing, and regulatory strategy to become a role model in the global advanced therapeutic market. With substantial growth expected to continue in the coming decade, we wanted to better understand exactly what the region is doing right.
Here, Roman Necina, VP and GM, Viral Vector at Cytiva, shares insights into how APAC’s new approach to clinical development and commercialization is helping to reshape the industry worldwide.
Q: You've been observing some remarkable developments in APAC markets, particularly around advanced therapies. What's caught your attention most?
A: What's really striking is how APAC markets have learned from pioneering work in the US and Europe, but they've implemented those learnings in fundamentally more efficient ways. Take China, for example. When we look at clinical development frameworks there, companies are moving from IND submission to first patient recruitment in only a few months. That's significantly faster than what we typically see for advanced therapies elsewhere.
But it’s not just about speed ― APAC is also finding an economic edge. Chinese companies are reporting they can recruit 20 patients for the price of recruiting two patients in the US, and they're completing entire trials within one to two years because the process is supported and funded by government programs that are harmonized across different regions.
Q: That's a dramatic cost difference. How is APAC achieving these efficiencies?
A: It comes down to standardization and government coordination. Patient treatment protocols are standardized across all these therapies, which reduces costs significantly. There's also this harmonized infrastructure across different regions that enables faster regulatory review and approval processes.
The clever part is that their regulatory guidelines are very similar to FDA guidelines. So, the main body of data they generate in phase 1 and 2 trials can be used for submissions in the US and, to some extent, Europe. Essentially the early, expensive development work is done at a fraction of the cost, then leveraged globally. Of course, as regulatory environments ― particularly the FDA ― continue to evolve, there may be some variability in how these efficiencies play out over time.
Q: What about the therapeutic manufacturing side? Are you seeing similar innovations there?
A: Absolutely, and this is where it gets really interesting from a manufacturing perspective. We're seeing companies developing AAV-based hemophilia therapies manufacturing at a 1000-L scale with very reproducible, robust data. Meanwhile, many CDMOs in Europe and the US are still operating at 200 or 500-L scales.
As APAC targets larger patient populations from the start, they can't manufacture in small batches ― they simply need more volume. This forces them to solve therapeutic manufacturing scaling challenges early, which actually helps fix a significant portion of their cost structure through economies of scale.
Q: You mentioned government programs. How significant is that support?
A: It's transformative. In China, India, and, interestingly, Japan as well, there’s massive government funding specifically for building infrastructure and therapeutic manufacturing capacity for advanced therapies. These aren't just research grants, they're programs designed to build entire development units and manufacturing facilities.
This focused effort addresses two critical gaps we see globally: the lack of manufacturing capacity and the shortage of organizations that can take preclinical assets and move them through phase 1 and 2 development. The government investment is creating an integrated ecosystem that didn't exist before.
Q: Are "second generation" therapies being developed in APAC showing advantages over earlier therapies developed elsewhere?
A: These companies have the advantage of developing their constructs more recently, so they're incorporating much better understanding of protein expression, payload optimization, and vector design. They're applying lessons that took us years to learn.
Plus, they've brought back talent: people who were trained in Europe and the US and have now returned to build teams in India, China, and other APAC markets. So, you have this rich ecosystem of skills and experience that's being applied with better tools and more recent knowledge.
Q: What lessons can companies and regulators across the globe take from APAC’s developments?
A: First, the value of harmonized, government-supported infrastructure. When you have standardized processes and coordinated support across regions, everything moves faster and more efficiently.
Second, the importance of thinking about therapeutic manufacturing scale early. Too many companies in the West are still thinking small-scale when they should be planning for larger populations and higher volumes from the beginning.
Third, there's something to be said for the focused approach we're seeing in APAC. There's less of the "left and right" decision-making paralysis. When there's clear direction and aligned incentives, innovation moves much faster.
Q: How is APAC’s cohesive development and therapeutic manufacturing strategy changing the global competitive landscape?
A: We're seeing a lot change. A huge percentage of meaningful ADC [antibody-drug conjugate] deals in the past year have come out of China. About 30% to 40% of all phase 1 and 2 clinical assets globally are now coming from Chinese companies. Large US and European companies are increasingly looking to acquire these early-stage assets rather than developing them internally.
The question for the rest of the industry is: How do we learn from these approaches and adapt to pull ahead in both speed and cost-efficiency? The companies that can combine the innovation happening in APAC with global regulatory and commercial capabilities are going to be the winners.
Q: What's your advice for companies trying to benefit from these global trends?
A: Don't ignore what's happening in APAC markets. The innovation, the speed, the cost structures — they're real competitive advantages. Whether that means partnering with companies in these regions, learning from their approaches, or investing in similar infrastructure, the key is recognizing that this isn't just a regional trend. APAC is actively reshaping how advanced therapies will be developed globally.
The future belongs to organizations that can be truly global in their approach, taking the best innovations and efficiencies from wherever they emerge and applying them thoughtfully across their entire development and manufacturing strategy.