TOP STORIES

Deal CDMO M&A poised for 2026 rebound as PE exits unfreeze and specialization replaces scale

After three years of depressed deal activity, the CDMO sector is entering what dealmakers describe as a turning point. ION Analytics reported on March 3 that 2026 opened with double the deal value and volume compared to the same period in 2025, citing Bourne Partners senior managing director Jeremy Johnson and Alvarez & Marsal managing director Mark Freitas. The catalysts are threefold: improving credit markets are reopening leveraged buyout financing; multiple PE-backed CDMOs have been held well beyond typical hold periods during the 2022–2024 valuation trough; and the onshoring trend driven by tariff policy and BIOSECURE Act implementation is creating strategic premiums for U.S.-based capacity. Likely exit candidates include Permira-backed Cambrex (which Permira acquired for $2.4 billion in 2019 and began marketing at a potential $4 billion valuation last September), EQT-backed Recipharm, Thomas H. Lee/Frazier-backed Adare Pharma Solutions, and CD&R-backed Sharp Packaging Services.

Competitive implications: Radiopharmaceutical CDMOs are emerging as the hottest subsegment, per Bourne Partners, with AtomVie and PharmaLogic flagged as companies to watch given the specialized isotope production requirements of a surging clinical pipeline. MedTech CDMO activity is also accelerating, with device makers carving out manufacturing assets—Teleflex’s $1.5 billion sale of its Medical OEM business to Montagu and Kohlberg in December 2025 is the benchmark transaction. On the biopharma side, ADC-focused CDMOs command premium positioning: Axplora announced a multi-million-euro lyophilization expansion at its Le Mans, France facility in February to support ADC payload and linker manufacturing, part of a €30 million multi-year investment program.

Key risks: Valuation expectations between buyers and sellers remain the primary friction point. PE firms that acquired CDMOs at 2019–2021 peak multiples need exits that justify their hold periods, but buyers in 2026 have more options as capacity expands globally. The Cambrex process will set the tone: if Permira achieves its reported $4 billion target (a significant markup from the $2.4 billion entry), it signals the market is fully recovered. If it settles below, recalibration across the PE-backed CDMO portfolio follows.

Tariff MFN pricing deals go mandatory—CMS proposes GLOBE and GUARD models that fuse tariff immunity with Medicare pricing controls

What began as bilateral demand letters in July 2025 has become a comprehensive pricing-manufacturing framework. Gibson Dunn’s Biotech Briefings reported on March 2 that sixteen of the seventeen largest pharmaceutical manufacturers have now signed voluntary MFN agreements committing to Medicaid price parity, MFN pricing on new product launches, and participation in the TrumpRx.gov platform—in exchange for three-year tariff immunity and improved regulatory positioning. But the voluntary phase is giving way to compulsion: CMS published two proposed rules in the Federal Register—GLOBE (Medicare Part B) and GUARD (Medicare Part D)—with the comment period closing February 23, 2026. If finalized as proposed, GLOBE takes effect October 2026 and GUARD in January 2027.

Timeline context: The 100% tariff on branded/patented pharmaceutical imports was announced by President Trump on September 25, 2025, with an October 1, 2025 effective date, following months of escalating trade actions that began with 10% duties on Chinese imports in February 2025 and culminated in tariffs reaching up to 245% on Chinese APIs. The only exemptions: companies actively building U.S. manufacturing facilities (having broken ground or under construction) or those covered by the September 2025 EU-U.S. agreement capping pharma tariffs at 15%. February 2026 added another layer with the Supreme Court ruling in Learning Resources v. Trump (February 20) finding executive overreach under IEEPA, prompting the administration’s pivot to a 10% Global Surcharge under Trade Act Section 122. The legal architecture of the tariff regime remains in flux.

CDMO Samsung Biologics plants U.S. flag with $280M Rockville acquisition as Genentech doubles Holly Springs to $2B

Two transactions from the past ten weeks illustrate the geographic reshuffling underway in biologics manufacturing. Samsung Biologics announced on December 22, 2025 that its U.S. subsidiary would acquire GSK’s Human Genome Sciences facility in Rockville, Maryland, for $280 million—securing the world’s largest CDMO its first U.S. production site. The Rockville campus includes two cGMP plants with 60,000 liters of combined drug substance capacity, and Samsung plans further investment to expand capacity and upgrade technology. The deal, expected to close by end of Q1 2026, will bring Samsung’s total global capacity to 845,000 liters. CEO John Rim stated the acquisition enables Samsung to address U.S. tariff uncertainties while positioning for North American customer demand—the company generates nearly 39% of sales from the U.S. market.

Separately, Genentech announced on January 20, 2026 that it would more than double its investment in a new Holly Springs, North Carolina manufacturing facility to approximately $2 billion, up from the initial $700 million commitment in May 2025. The 700,000-square-foot site, which broke ground in August 2025 and is expected to become operational by 2029, will produce next-generation metabolic medicines including obesity treatments. The expansion supports Roche and Genentech’s broader $50 billion U.S. investment commitment, adding an expected 500+ manufacturing jobs and 1,500 construction positions. Holly Springs continues to concentrate biomanufacturing investment—Pharmaphorum noted that J&J announced a $2 billion bulk drug substance facility at the nearby Fujifilm Biotechnologies campus just days earlier.

CAPACITY & SUPPLY CHAIN

• CDMO Bora Pharmaceuticals renewed a $250 million, five-year manufacturing agreement with GSK (announced February 23), covering end-to-end production of more than 20 commercial product lines and 335+ products spanning HIV, malaria, pneumonia, depression, and dermatology. The deal is anchored at Bora’s 170,000-sq-ft Mississauga, Ontario facility and extends a near-decade partnership, with GSK now the largest pharma partner operating at the site.
• CDMO Axplora announced a multi-million-euro lyophilization expansion at its Le Mans, France ADC manufacturing site (February 3), adding commercial-scale lyophilization capability by early 2027 as part of a €30 million multi-year investment program. The expansion responds to demand for integrated ADC payload and linker intermediate manufacturing, where stability and safe handling during isolation are critical.
• Capacity DCAT Value Chain Insights’ annual CDMO roundup catalogued major 2025 capacity moves: Simtra BioPharma added flexible clinical fill-finish lines and a dedicated 150,000-sq-ft GLP-1 building in Bloomington, IN; Lonza invested CHF 500M in fill-finish at Stein, Switzerland (operational 2027); GRAM added 150,000-sq-ft syringe/cartridge filling in Grand Rapids, MI; and CordenPharma’s $500M+ Colorado SPPS expansion is on track to deliver 42,000L by 2028.
• Capacity Supply Chain Magazine reported on January 14 that J&J entered a voluntary MFN arrangement on January 13, 2026, committing to expanded domestic operations in exchange for tariff exemption. AbbVie became the 16th major drugmaker to finalize a comparable agreement, pledging $100 billion toward U.S. R&D and manufacturing over the next decade. BD announced $110 million for glass prefillable syringe manufacturing in Nebraska to meet GLP-1 delivery device demand. Novartis opened its fourth U.S. radioligand therapy manufacturing facility in Winter Park, Florida (January 9), within its broader $23 billion investment program.
• Peptide Oral GLP-1 manufacturing economics remain the defining CMC story heading into DCAT Week. Oral semaglutide’s ~1% bioavailability demands approximately 25x more API per patient than injectable formulations, and SPPS processes require roughly 13,000 kg of input per kg of API. Small-molecule oral GLP-1 candidates—Eli Lilly’s orforglipron foremost among them—could transform these economics. Pharmaceutical Technology’s 2026 outlook noted that continuous and intensified bioprocessing is shifting from innovation to standard practice, driven partly by the complex molecule pipeline pushing conventional manufacturing processes to their limits.

REGULATORY & COMPLIANCE

• Regulatory Holland & Knight’s FDA outlook identifies PDUFA VII reauthorization as the key legislative event for manufacturing in 2026, with debates expected on manufacturing policies, product development incentives, and whether the CNPV program will be codified in statute. FDA has awarded 16 CNPVs to date, with the first program approval (a U.S.-manufactured oral antibiotic) completed in December 2025. Congress has not yet passed comprehensive domestic manufacturing incentive legislation, leaving FDA to fill the gap via PreCheck and CNPV.
• Regulatory FDA’s CGT manufacturing flexibility (announced January 11, 2026) continues generating industry response. The changes allow looser quality controls during later efficacy trials, permit minor manufacturing changes between Phase I and Phase II without full revalidation, and relax certain post-marketing oversight requirements. Pharmaceutical Technology’s February 20 roundup noted an industry-wide strategic pivot toward advanced modalities including cell therapies and targeted protein degradation, with orphan drug pathways creating specific challenges for small-batch manufacturing and agile quality systems.
• Quality European Pharmaceutical Manufacturer reported (February 18) on a structural shift toward Grade C and D cleanrooms enabled by closed isolator systems, driven by EU GMP Annex 1 requirements. The guidance encourages RABS or isolators in contamination control strategies, with facilities that adopt these systems achieving both enhanced sterility assurance and cost savings versus traditional Grade A/B environments. Separately, industry demand is rising for contamination control solutions that reduce operator exposure to harsh chemicals—a maturation signal for manufacturing environments balancing throughput with workplace safety.
• Quality FDA foreign site inspection pressure remains elevated: over 62% of drug quality inspections in FY2024 targeted overseas facilities, with warning letters increasingly focused on systemic quality system failures and data integrity. The proportion of warning letters issued to foreign sites has risen from 22.9% in 2019 to 33% currently, and the Trump administration is explicitly framing quality enforcement as a trade policy lever—Outsourced Pharma characterized the dynamic as a new “quality tax” on foreign manufacturers lacking MFN deals.

WHAT TO WATCH NEXT

DCAT Week 2026—the make-versus-buy decision under tariff pressure

DCAT Week convenes in New York later this month with the make-versus-buy decision as a central program theme. The question for 2026 is whether the $480B+ in announced U.S. manufacturing investments represent genuine geographic capacity shifts or are primarily signaling exercises designed to secure tariff exemptions and MFN deal terms. DCAT’s education program, featuring IQVIA analysis, will provide the first comprehensive industry assessment. Manufacturing strategy teams should watch for concrete indicators: how many of the announced greenfield projects have moved from “announced” to “under construction” status since October 2025, and whether bioequipment procurement data from suppliers like Repligen, Sartorius, and Cytiva confirm acceleration in U.S.-directed orders.

Samsung Biologics Rockville close—and what comes next

Samsung’s GSK acquisition is expected to close by end of Q1 2026. The immediate operational question is how quickly Samsung can transition from contract continuity (manufacturing existing GSK products) to capacity expansion and third-party CDMO services. Samsung has indicated plans for further investment at the 60,000-liter Rockville site, but scale and timeline details are pending. The broader strategic question is whether Samsung’s U.S. entry triggers competitive responses from Lonza, Fujifilm, and Thermo Fisher—all of which have established U.S. biologics operations and may see Samsung’s arrival as a threat to their reshoring-driven pricing power.

PE exits set market-clearing prices for CDMO valuations

The Cambrex sale process, if it progresses toward a formal launch in H1 2026, will establish the post-trough valuation benchmark for PE-backed CDMOs. Other likely exits—Recipharm, Adare, Sharp, Kindeva—are watching Cambrex for price discovery. The critical dynamic: buyers are now differentiating sharply between specialized platforms (sterile injectables, radiopharmaceuticals, ADCs) and generalist CDMOs. Manufacturing leaders at PE-backed CDMOs should assess whether their capabilities map to the high-value modalities that buyers are willing to pay premium multiples for, or whether they’re positioned in increasingly commoditized segments where consolidation pressure will compress valuations.