The 9 Fastest-Growing Outsourcing Segments

By Jeffrey S. Buguliskis, PhD, Deputy Chief Editor, Outsourced Pharma

The Capacity Myth—and What Actually Matters

Everyone says biopharma manufacturing is booked solid. It's half true. Some CDMOs are so full they're turning away work. Others have reactors sitting idle. The difference? It's not about space on the calendar. It's about whether they know how to make your molecule and whether you trust them to hit your deadline.

This year, the real game is finding partners with proven expertise in your specific modality, then locking them in before everyone else figures that out. Capacity matters less than you think, while capability and execution… mean everything.

Below are the nine fastest-growing segments in biopharma outsourcing, ranked by forecasted compound annual growth rates (CAGR). If you understand what's driving them, you'll know where to move early and where you can afford to wait.

1. Cell & Gene Therapy (CGT) Manufacturing: 23% CAGR

Editor's note: The CAGR for this space varied widely over the past year (11% - 28%), and an average value was used in this instance. Moreover, internal conversations at Outsourced Pharma with industry experts suggest that growth in this space might be on the decline. Worth keeping a watchful eye on trends in this sector.

The fundamental constraint here is expertise and equipment flexibility, not raw capacity. A CDMO cannot easily retool for novel cell-processing techniques or build a new vector suite overnight. Emerging CGT sponsors quickly learn that dedicated, experienced partners are non-negotiable and that they book slots months in advance.

What this means for sponsors: Don't assume capacity exists. Find a partner with a proven track record in your specific modality. Lock in capacity early. Establish what "early" means: 18–24 months before IND, not 6 months. Secure a second source not for redundancy alone, but to reduce single-partner execution risk.

2. Viral Vector Manufacturing: 21% CAGR

Lead times are long and unpredictable. You're managing DNA manufacturing, cell banking, drug substance production, and release testing, each with dependencies. A delay in one stage cascades. The real issue isn't whether capacity exists; it's whether a CDMO has mastered your specific vector platform and can reliably hit release dates.

Many CDMOs claim vector capability. Few deliver consistently on the timeline. Those who do are fully committed.

What this means for sponsors: Qualify two vector suppliers rigorously: ask for release timelines for comparable programs, not projections. Align your assay packages to each CDMO's proven platform, not an idealized one. Build in contingency. If speed matters, accept that you may pay more for a proven partner than a cheaper newcomer.

3. Peptide Therapeutics: 13% CAGR

GLP-1 agonists genuinely transformed peptide manufacturing from craft to scale. Contract manufacturers have poured investment into larger suites, but demand has outpaced supply. This segment has real, visible capacity constraints. If you're launching a peptide therapeutic in 2025–2026, you will compete for slots.

What this means for sponsors: Capacity can be legitimately tight here. If feasible, lock in the primary supply now, even if the commercial launch is 18+ months away. Pair immediately with fill-finish and device capacity. Don't assume you can "optimize costs later." Later may be too late.

4. Oligonucleotide Synthesis: 12% CAGR

The winners are integrated shops that handle everything in-house: DNA synthesis, mRNA manufacturing, lipid nanoparticle formulation, and final drug product. It sounds simple, but it matters. Every time you hand off to a new vendor, you lose weeks to miscommunication and spec disputes. You get rework. That's the real edge integrated players have, not more capacity, but fewer handoffs.

What this means for sponsors: For asset-light teams, integrated oligonucleotide partners compress cycle time not because they have more capacity, but because they eliminate the friction of managing multiple vendors. That's often worth more than raw speed alone.

5. Antibody-Drug Conjugates (ADCs): 11% CAGR

ADCs combine three distinct challenges: antibody production, high-potency payload synthesis, and precise conjugation chemistry. The real challenge is finding a partner that executes conjugation consistently and coordinates with payload and fill-finish suppliers without bottlenecks.

What this means for sponsors: You have two paths: (1) commit to a true end-to-end ADC partner that owns conjugation, or (2) manage multiple vendors with ruthless clarity on specifications, transfers, and timelines. Most sponsors choosing path two regret it. Ambiguity in handoffs is expensive.

6. Sterile Injectables & Fill-Finish: 9% CAGR

The pandemic revealed how scarce high-throughput aseptic lines are. Today's constraint isn't speed alone; it's flexibility—the ability to shift from vials to lyophilized products to prefilled syringes without extending timelines. If you need a specific format at a particular time, you may not have options. If you're flexible, choices exist.

What this means for sponsors: Declare your final format as early as possible, don't keep it open "pending market research." If you require a non-standard format or a rush timeline, lock capacity now. If you can be flexible on format or timing, you retain optionality and often negotiate better terms.

7. High-Potency & Oncology Small Molecules: 9% CAGR

You can't retool a standard small-molecule site to handle high-potency chemistry overnight. Training takes months; validation takes longer. So even if a CDMO has available reactor volume, they may not have available high-potency capacity. This segment reflects specialization scarcity, not just capacity scarcity.

What this means for sponsors: Verify the site's actual containment pedigree and ask to see recent batches and timelines, not just certifications. Insist on measurable corrective and preventive action commitments with realistic turnaround times. Keep a backup fill-finish path warm. Don't rely on a single high-potency source; the risk of site disruption (contamination, regulatory action, personnel turnover) is real.

8. CRO & Outsourced R&D Services: 8% CAGR

The emerging model is the CRDMO, in which one partner carries you from hit-finding through GMP manufacturing. This model works when you trust the partner's execution and communicate clearly. It fails when sponsors expect a CRDMO to be a commodity vendor.

What this means for sponsors: A CRDMO that genuinely delivers can cut total cycle time by 20–30% versus managing three separate vendors. But you're trading direct control for speed. That only works if the partner is reliable and communication is clear.

9. Biologics & Monoclonal Antibodies: 7% CAGR

This segment is the foundational capacity layer. Growth is steady because demand is durable. You won't face a capacity cliff here, but you also won't find empty slots at premium facilities without advanced planning.

What this means for sponsors: Book drug substance bioreactor windows with optionality—don't commit to a single slot without flexibility. For speed-to-launch, co-locate fill-finish at the same site or pre-contract a second partner for peak demand. If you wait until Phase 3 to think about manufacturing scale, you're already behind.

The Bottom Line: Capability Beats Capacity

Capacity constraint is real in specific segments (peptides, vectors, ADCs) and looser in others. But that's only half the story. The actual constraint is often capability, finding a partner with proven experience in your specific modality and reliable execution under timeline pressure.

Early engagement wins. Not because capacity fills up (though it does, selectively), but because early partners become more invested in your success and more willing to communicate trade-offs honestly.

For emerging biotechs: Start talking to manufacturers before you think you need to. Find someone who's done your specific thing before, don't be the first experiment. Bundle services where you'd otherwise be juggling three different vendors. And here's the key: make sure payment is structured when key milestones are reached in the manufacturing process, and not prior to, if and when possible.

For larger sponsors: Use your leverage to commit capital early where execution risk is highest. Keep a credible second source warm—not as a threat, but as a real alternative—if the primary partner stumbles.

For all sponsors: Capability is the weapon. Choose partners wisely. Communicate expectations relentlessly. Tie cash to outcomes. That's how you turn manufacturing from a constraint into a competitive edge.