The Flooded Sea of Biologics Manufacturing

Imagine a bustling medieval marketplace, filled with vendors trying to sell their wares. Except, instead of carrots and onions, these vendors are selling bioreactor capacity, cell lines, and late-stage filing support. The world of biologics contract development and manufacturing organizations (CDMOs) is a lot like that marketplace—crowded, competitive, and not a carrot in sight. Welcome to the complex landscape of biologics, where differentiation is tough, and everyone is jostling for a spot in the spotlight.

1. The Overcrowded CDMO Marketplace

The biologics CDMO space is, to put it mildly, packed. Samsung Biologics, Lonza, FUJIFILM Diosynth, and countless smaller players all vie for clients needing support, from early-phase research to large-scale manufacturing. But the real challenge? It's not just about getting into the marketplace—it's about surviving there.

The truth is, anyone with a lab, a bit of regulatory knowledge, and experience in mammalian cell cultures can market themselves as a CDMO capable of handling early-phase material. But standing out is an entirely different challenge. Companies like Samsung Biologics have managed to differentiate through sheer scale—building huge manufacturing capacities in a short time. Meanwhile, competitors like FUJIFILM Diosynth and Lonza are trying to carve out their niches in capacity, geographic reach, and specialized offerings.

2. Supply, Demand, and the Gene Therapy Crunch

Now, let’s zoom into one of the hottest areas of biologics: gene therapy. Over the past few years, there’s been a surge in interest and funding for gene therapy—thanks to the success of mRNA technologies during the pandemic. Venture capital poured in, and suddenly, everyone wanted in on the game. But with increased demand came a glaring supply problem: not enough capacity to manufacture GMP-grade viral vectors, the essential ingredients for gene therapies.

At one point, getting a custom viral vector from a supplier like Aldevron could take up to 18 months. Companies started to internalize production to bypass these long waits. Now, as we step into late 2024, the pendulum has swung again. Demand has slowed, funding has dried up, and capacity has outstripped need. The once-scarce supply is now a bit like those medieval vendors trying to sell turnips—everyone has them, but not enough people want them.

3. Bioreactors—Scaling Up or Multiplying Risk?

Bioreactors are where the magic happens in biologics manufacturing. These giant, high-tech cauldrons are where cells grow, producing the antibodies or viral vectors needed for therapies. But scaling up isn’t as easy as just building a bigger pot. Imagine you’re cooking a massive batch of soup. The bigger the pot, the harder it is to make sure every part is evenly heated. Bioreactors work similarly—the geometry changes as they grow, impacting mass transfer and mixing.

So, what’s the alternative? Instead of one big cauldron, you could have ten smaller pots—but then you’re juggling ten sets of ingredients, ten chances for something to go wrong. In biomanufacturing, this translates to contamination risks and the complexities of ensuring batch consistency across multiple reactors.

Samsung Biologics prefers one big reactor over multiple smaller ones. Why? Because scaling linearly is generally more predictable, and the fewer reactors you have, the fewer points of potential failure. Sure, if that big reactor gets contaminated, it’s a disaster—but the risk of contamination is minimized with rigorous quality control, making the one-reactor approach a calculated gamble.

4. Setting Up Facilities for Dual Cultures—A Balancing Act

Setting up a facility to handle both microbial fermentation and mammalian cell culture is like trying to build a house with a jungle gym attached. The requirements are fundamentally different—you need strict separation to avoid cross-contamination, and each culture type has its own environmental needs.

Many companies have tried to do both under one roof, but it’s challenging. You have to maintain a delicate balance to keep microbial processes away from sensitive mammalian cultures, which can easily be ruined by rogue contaminants. This separation is especially crucial when you’re dealing with gene therapies, where the precision and purity required are at a whole different level.

5. Differentiating Through Customer Relationships

In the CDMO world, not all customers are created equal. A big pharma client is worlds apart from a small biotech startup. For small biotech, the goal is often to just get to Phase I trials with minimal fuss—speed is the name of the game. For big pharma, on the other hand, the focus is on quality and scalability right from Phase I, because they’re already thinking about Phase III and beyond.

Samsung Biologics approaches these two types of clients differently. For startups, it’s about offering a straightforward path to get proof of concept. For big pharma, it’s about showcasing the capability to scale efficiently while maintaining the highest quality standards. The sales process often involves scorecards, RFPs, and the inevitable time-quality-price triangle—everyone wants it good, fast, and cheap, but you can usually only pick two.

6. The Road Ahead for Biologics

The biologics industry is in a fascinating place. The market is crowded, the technology is advancing, and the pendulum of supply and demand keeps swinging back and forth. For Samsung Biologics, the focus remains on maintaining massive manufacturing capacity and scaling efficiently, even as new players and technologies keep emerging.

The big question is whether the market will see a real inflection point soon—will gene therapy finally reach the blockbuster status everyone’s been hoping for? Or will the market remain a bustling, crowded medieval fair, where everyone’s yelling over each other to be heard? Only time will tell.