The Industrialization Of Advanced Modalities

By Louis Garguilo, Chief Editor, Outsourced Pharma

Every few days or so I receive an industry/market report of one kind or another. They include a few attention-grabbing statistics, soaring anticipated growth curves, and a prod to purchase the complete research.

These are valuable; readers know I dive into a number of them during the year.

Recently three such reports arrived: on the oligonucleotide CDMO market; mRNA synthesis and manufacturing; and the bioconjugation space.

Although diverse, it occurs to me they narrate a single direction our outsourcing industry is headed. Part of the story is the (ever) increasingly important role of CDMOs.

The Modality Boom Matures

First, a glimpse of the numbers: the oligo CDMO market is projected to rise to ~$7 billion over the next few years; mRNA synthesis and manufacturing market to ~$3 billion; and bioconjugation market to ~$11 billion.

Ostensibly, different market slices. Yet these present a unified demonstration that the industrialization of what we might generally call new-generation modalities is well underway, and it's powered by your outsourcing proclivities.

Clearly, oligonucleotides, mRNA, and bioconjugates are no longer scientific novelties or boutique therapeutic bets. They have been advancing (and maturing) platforms boasting of expanding clinical pipelines and commercial footprints.

But it's the rapid compound annual growth rate (CAGR) across all three that's of note, with oligo manufacturing in particular projected to more than double in the next five years.

Growth drivers are consistent and include:

• A rising demand for precision (and personalized) medicines, and oncology’s insatiable appetite for more powerful, targeted modalities
• The acceleration of RNA-based technologies and a broadening of applications
• Advancing site-specific and next-generation conjugation methods

Striking is the scale and pace of production momentum has the contours of an industrialization (even of personalized medicines): broader technology-led facilities; larger (but also right-sized) batching or continuous capacities; improved quality systems and analytics; multimodal platforms; and integrated supply chains.

Science that once occupied the edge of feasibility is now pressing the bounderies of large-scale, advanced manufacturability.

CDMOs Go From Enablers To Drivers

All three reports include this phrase: “growth driven by increasing outsourcing.”

Do CDMOs drive biopharma industry growth?

I’ve suggested as much for over a decade. My own phraseology, though, has been that outsourcing enables growth.

That is, it enables biotechs to put ideas into practice and build business cases, and to develop profitable ways to create new modalities and molecules. Outsourcing fuels the confidence of both sponsors and investors to keep going.

Because today’s modalities are complex, capital-intensive, and evolving rapidly, CDMOs have become the structural backbone of new-gen therapeutic development and manufacturing.

External partners provide specialized knowhow, services and equipment, and at the same time are equipping themselves for a modality-agnostic manufacturing-facility future. (Quite a feat, when you think about it.)

Sponsors, thus, can venture into nucleic acids, nanoparticles, conjugates, newer biologics pursuits, and find capacity for blockbusters like GLP-1s and large-scale small-molecule needs, but also for orphan drugs or personalized medicine.

The fact is we heard comparatively little about capacity challenges after settling into 2025. Our industrialization has not been disruptive. Current needs are being served as there are options for single-modality vendors as we head towards integrated modality ecosystems – both with adequate (large-scale) capacity.

Asia Pacific: The Center of It All

Another shared theme among these three reports from MarketsAndMarkets is the countries of the Asia Pacific remain the fastest-growing.

That’s despite – or better yet, alongside – the estimable growth the Trump administration is spurring in the U.S. (whether you agree to the spurring methods or not). Investments in both geographies are coming from Big Pharma and the CDMO sector.

Not withstanding tariffs and geopolitical tensions, China and India – early disrupters in small-molecule and large-scale biologics manufacturing – have aggressively expanded into RNA, conjugation, LNPs, complex biologics, oligos, and the like.

Reasons for this growth and prowess remain:

• Cost competitiveness (via labor availability, relatively lower wages, and government incentives)
• Growing domestic R&D engines and candidate/product development (particularly in China)
• International CDMOs achieving for clients FDA approvals and global GMP certifications
• A geographic hedge for global biopharma seeking diversified supply chains and markets

Although U.S.-China tensions muddy the environment, according to these three reports the magnitude of investment in Asia Pacific demonstrates the region is positioning as the center of global scale-up of next-gen modalities.

Innovation is spread more globally than it ever has, and geographies of industrialization are impacting the entire landscape.

CDMOs are a huge factor in all such realities. 

Technology Is the New Capacity

We are also witnessing a cross-market thread of the rapid advancement of digital (and analytical) technologies.

AI-powered microscopes, high-throughput mass spectrometers, improved conjugation chemistry, self-amplifying RNA workflows – these and other tools have become critical enabling technologies that make complex modalities scalable, compliant, and commercially viable.

In the CDMO world, capacity used to mean cleanrooms, reactors, and fill-finish lines. Today, capacity also registers as digital integration, analytical depth, and enhanced precision control of chemistry and biology manufacturing and processing.

The CDMOs that will lead the 2030s are those that master this industrialization era.

So what do these three market reports indicate as we enter 2026?

Biopharma’s future depends on an industrial base now being built out and largely dependent on CDMOs; this spans continents, modalities, and technologies.

Advanced therapies are rapidly scaling. Modalities are converging. Asia is still rising (presumably along with the U.S.). Biopharma players are investing their way into the future.

Every step of the way, outsourcing is both enabling and driving progress.