75 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2026 FLAMMA 4) Ownership Matters: PE Time Horizons and Tariff Whiplash Private‑equity CDMO ownership can bring investment, but short‑term return cycles sometimes ripple into sourcing pivots or operational instability.9 The focus of PE CDMOs tends to be much more focused on the bottom line and when the next flip will occur. This is short sighted and provides less customer focused service than others. Tariff uncertainty further complicates asset pricing and long‑range capacity commitments, and those shocks cascade quickly to sponsors if priorities shift.5 5) Onshoring: Strategic Where It Fits Yet It Is Not a Silver Bullet Regulators are exploring acceleration tools (e.g., the FDA’s proposed approaches to prioritize domestic capacity), yet policy analyses caution that forced, rapid onshoring can raise costs and aggravate shortages. Just look at the generic marketplace.6,7,8 Still, tariff threats and reshoring narratives have catalyzed new U.S. footprints and expansions by large pharmas, even as validation, talent, and timelines remain binding constraints.9 Politically, it sounds good to reshore but realistically, it is very complex and complicated. Those sitting in Washington D.C. fail to understand how interconnected the pharmaceutical marketplace is. It is global and that cannot be denied. 6) ‘Big Likes Big’ But Fit Can Beat Scale Large buyers often prefer large CDMOs for slot access, validation muscle, and global QA systems. The 2026 outlook has U.S.-based CDMOs and China‑based CDMOs with commercial assets leading growth, especially in biologics and aseptic fill‑finish.21 But consolidation can eject capable mid‑sized partners and reduce competitive tension so hedge concentration risk with genuine optionality.5 Do not discount the smaller CDMOs who pride themselves a true service organizations that are extensions of your team. They are partners you want on your side. Not everyone wants to (or needs to) shop at Walmart. 7) GLP‑1 and the Peptide Pile‑On: Capability Over Press Release GLP‑1 demand is fueling device and drug‑product investments (e.g., recent revenue mix shifts and capacity build‑outs), and peptide platforms are scaling with multi‑year, multi‑site commitments backed by long‑term contracts.10,11 New capacity in India is also coming online to relieve bottlenecks from GLP‑1 programs.12,13 For peptide sourcing, interrogate route control, chiral management, non‑animal feedstocks, and purification throughput—areas repeatedly highlighted in API manufacturing reviews.14 But just like the HPAPI revolution where CDMOs bought isolators and claimed to be experts in the manufacture of HPAPIs, peptides are now the “flavor of the month”. Is the marketplace huge for GLP-1 related materials? YES! With that said, not everyone who claims to be able to produce peptides and the requisite high value amino acids can do so. You now have not only chemical purity but chiral purity that are in play. If you look for low priced suppliers, you substantially risk the quality that is required. Experience matters. 8) Treat the RFP Like Your First Unit Operation Your RFP isn’t a brochure request. It is the first step of your process. If you order at the drive‑thru without specifics, you shouldn’t be surprised by what shows up in the bag. Feed real inputs up front: phase, tox knowledge, prior scale, analytical readiness, quantities, timing, and geographic constraints. Do this and you’ll filter out the superficial bids and prevent avoidable change orders.15 A good CDMO will slow you down to speed you up by asking the hard questions early and refusing to gloss over process unknowns. It may take a bit longer for the proposal but it will be well thought out and provide the details to show that they seriously looked at the proposal. Others will use the cookie cutter approach. Comparisons of the two are night and day. 9) How to Buy Well (and Sleep at Night) - Anchor on total delivered value, not the lowest bid; pre‑price change‑order triggers and require evidence of route control and analytical readiness.12 - Commit to dual sourcing for critical upstream steps: split RSM/KSM awards across geographies and keep a live allocation on Plan B.7 - For peptides: demand worked‑example impurity maps, chiral control strategy, non‑animal feedstocks, and purification capacity.14 - Reward candor over charisma; interrogate proposals the way you would a unit operation. Look at mass balance, failure modes, analytics, and throughput.3,15 Conclusion In a market defined by pricing pressure, supply‑chain interdependence, and modality‑driven capacity
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