Key Takeaways
CDMO network consolidation can reduce governance and planning complexity, but fewer partners do not automatically produce lower costs, faster timelines, or stronger performance.
Sponsors should target duplicated functions for consolidation rather than eliminating specialist partners simply because their roles or volumes are relatively narrow.
Supplier count and manufacturing redundancy are different considerations, and several CDMOs may still rely on common upstream manufacturing sources.
Technology transfer, site qualification, validation, and postapproval change management can materially affect the value and timing of a consolidation decision.
A CDMO network can be evaluated across four dimensions: capability value, interface cost, resilience value, and exit cost.
A Smaller CDMO Network Is Not Automatically a Better One
For a sponsor managing a growing portfolio of outsourced development and manufacturing activities, consolidation can have an intuitive appeal. Every additional contract development and manufacturing organization (CDMO) adds another commercial relationship, planning interface, quality arrangement, and stream of information that must be managed. Nonetheless, the number of CDMOs alone says little about whether an external manufacturing network has become unnecessarily complex.
Supply-base complexity can reflect the number of suppliers, the degree to which those suppliers differ from one another, and the relationships and dependencies among them. Reducing complexity can lower transaction costs and improve responsiveness under some circumstances, but it can also increase supply risk or reduce access to supplier innovation. The consequences depend on which forms of complexity are removed.1
This is particularly relevant in pharmaceutical manufacturing because sponsors may outsource formulation, filling and finishing, chemical synthesis, cell culture or fermentation, analytical testing, packaging and labeling, sterilization, and other manufacturing activities. Specialized technologies and equipment can also lead different organizations to perform different portions of a biologics manufacturing process.2,3 A network with several CDMOs may reflect historical fragmentation, but it may also represent a deliberate division of work among organizations with genuinely different capabilities.
If several partners perform largely interchangeable work and contribute little additional resilience, consolidation may simplify the network with limited downside. If a partner provides specialized expertise, an alternate manufacturing path, or a capability that the remaining network cannot readily reproduce, eliminating it could leave the sponsor less capable or more exposed.
Consolidation is better understood as network design than as vendor reduction. The objective is to remove relationships that consume management resources without contributing enough capability, flexibility, or resilience to justify their place.
Where Consolidation Creates Real Value
The case for consolidation begins with the work required to govern outsourced manufacturing. A pharmaceutical company remains responsible for ensuring that appropriate processes control outsourced activities. That includes assessing a partner’s suitability and competence, defining responsibilities and communication processes, monitoring performance, and managing the agreed supply chain.4 U.S. Food and Drug Administration (FDA) guidance likewise emphasizes defining and documenting manufacturing activities and current good manufacturing practice (cGMP) responsibilities between product owners and contract facilities.2
Those requirements create a clear argument for pruning relationships that no longer contribute enough value to justify their upkeep. A separate quality agreement, planning cadence, governance structure, performance-review process, and escalation pathway may be entirely appropriate for an important specialist or backup partner. The same infrastructure becomes harder to justify when another established CDMO could absorb the work without sacrificing a meaningful capability or source of resilience.
Outsourced operations are not simple purchasing transactions. They can involve multiple, hierarchically connected decisions over time, requiring richer communication and ordering patterns than a conventional buyer–supplier model might suggest.5 Adding CDMOs therefore adds planning interfaces that must function coherently, not merely additional contracts.
Consolidation can also create room for deeper relationships with the partners best equipped to support them. Pharmaceutical case research has evaluated outsourcing partners on dimensions extending beyond immediate operational performance, including project delivery, communication, cost accuracy, financial and human resources, breadth of services, geographic presence, and prior collaboration experience. In one case, fully integrated relationships were reserved for partners judged to possess stronger dynamic capabilities rather than simply adequate operational performance.6
Another pharmaceutical manufacturing case developed a partner-selection approach that included technical qualification, quality and compliance, and supply chain partnership capabilities, with strategic alignment considered once a preferred partner had been identified.7 Concentrating more work with fewer partners makes the most sense when the organizations that remain are demonstrably capable of carrying a broader role.
The clearest benefit is not an automatic reduction in cost or timelines. It is a more manageable set of interfaces and the ability to direct greater organizational attention toward the relationships that contribute the most value.
Consolidate Duplicated Function, Not Narrow Scope
A partner may look expendable because its role is narrow, its spend is modest, or its activity overlaps nominally with work performed elsewhere. None of those conditions proves that the relationship is duplicative.
One network may contain several CDMOs performing substantially substitutable work. Another may rely on multiple organizations because each controls a distinct technology, manufacturing platform, analytical capability, or process step. A third may deliberately maintain a secondary source for a supply-critical operation. Those situations create very different cases for consolidation.
Supply-chain modeling supports considering the capabilities of the partners that remain when reducing supplier numbers. Supplier-base reduction is inseparable from whether the surviving organizations can absorb the required work without degrading performance or increasing exposure elsewhere.8
Pharmaceutical partner-selection research points in the same direction. External manufacturing partners may differ in technical competence, operational resources, service breadth, geographic presence, quality and compliance characteristics, communication capabilities, and experience supporting a particular kind of relationship.6,7 Two CDMOs may offer the same broad service category while still differing materially in what they can contribute to a specific program.
Duplicated function is a better target for consolidation than narrow scope. A specialist CDMO may handle only a small portion of the overall manufacturing program yet remain strategically important because its capability is difficult to replace. By contrast, several providers offering essentially comparable services, with no clear difference in capability or resilience contribution, may represent avoidable complexity.
Consolidation Is Not the Same as Eliminating Redundancy
Reducing the total number of CDMO relationships is not synonymous with moving every manufacturing activity to a single source.
A sponsor could consolidate multiple activities with a strategic CDMO and still maintain a second qualified source for an operation where uninterrupted supply is especially important. It could also maintain a large supplier base yet have little useful redundancy if none of those partners could take over another’s work. Supplier count and supply protection need to be evaluated separately.
Modeling illustrates why. One study of manufacturing disruption risk analyzes risk-mitigation inventory, dual sourcing, and agility capacity as distinct but interacting mechanisms. Within the model, those mechanisms can substitute for one another under some conditions, depending on whether an alternative source already exists.9 Resilience can therefore be built in more than one way, and the value of maintaining an additional manufacturing source depends partly on what other protections are already in place.
A separate supply chain reliability model found that increased redundancy or manufacturing-facility quality could reduce modeled drug shortages. In the specific generic injectable oncology case examined, adding a backup supplier to a lean configuration produced the largest improvement among the individual interventions modeled.10 The result does not support a universal recommendation to dual source every product, but it shows why removing apparently redundant capacity can affect supply reliability in ways that a vendor-count exercise may miss.
Meaningful redundancy also has to be usable. A nominal alternative source offers limited protection if it cannot take over the relevant work when needed. Maintaining a viable second source requires qualification, preparedness, and continued oversight, which is precisely why redundancy should be deliberate rather than indiscriminate.
For some operations, a second qualified source may justify that burden. For others, inventory, available capacity, or another risk-mitigation mechanism may provide sufficient protection. Different activities within the same product may warrant different answers.
Count Independent Sources, Not Logos
Even a multi-supplier strategy can create a false sense of security if apparently separate sources depend on the same upstream manufacturing infrastructure.
A cohort study examining 407 authorized medicinal products across 10 high-use pharmaceutical substances in the Netherlands found at least four distinct active pharmaceutical ingredient (API) and finished pharmaceutical product (FPP) manufacturing sites for each substance, yet substantial concentration remained within individual product networks. Sixteen of 32 amoxicillin products depended entirely on the same API site, while 39 of 85 omeprazole products depended entirely on the same FPP site. Only 61 of the 407 authorized products listed at least two API and at least two FPP manufacturing sites.11
A U.S.-focused analysis of generic API manufacturing found a related pattern. About one-third of the APIs examined were manufactured at a single facility, and another third were produced by only two or three facilities. More than one in five API markets had three or fewer API manufacturers despite having four or more manufacturers of finished generic drugs.12
These studies do not examine individual sponsors’ CDMO portfolios, so their prevalence estimates should not be applied directly to sponsor networks. They nevertheless show that multiple downstream products or suppliers can converge on a much smaller number of upstream manufacturing sources.
The value of a second CDMO as a source of resilience depends on how independent its supply path actually is. A second finished-product manufacturer may provide substantial protection, but less so if both sources depend on the same critical upstream site.
A meaningful consolidation review therefore needs to extend beyond the list of contractual counterparties. Mapping manufacturing sites and upstream dependencies can reveal both unnecessary duplication and hidden concentration. Removing one partner may have little effect on resilience if its pathway was never truly independent. In another network, a relatively small relationship may preserve the only genuinely separate route remaining.
Timing Matters
Identifying a CDMO that no longer appears strategically necessary does not mean removing it will be simple. Work already assigned to that organization may have to move elsewhere, and pharmaceutical technology transfer is itself a structured technical and quality activity.
Technology transfer can occur during development, commercialization, or commercial manufacturing, and the rigor applied should reflect the product’s life cycle phase. It involves transferring products, processes, and knowledge with supporting documentation and expertise rather than simply reproducing manufacturing instructions at a new location.13
A transfer project may require a documented plan, quality risk management, technical, quality, and regulatory gap analysis, assessment of differences between sending and receiving units, qualified personnel, knowledge management, and effective communication. Successful transfer should produce documented evidence that the receiving unit can routinely reproduce the transferred product, process, or procedure against predefined specifications. Site readiness can also involve facilities and equipment, personnel qualification and training, change management, control strategy, qualification, and validation.13
For an approved product, the regulatory dimension becomes more prominent. FDA guidance on postapproval changes covers manufacturing-site and process changes and distinguishes reporting pathways according to the nature of the change.14 The International Council for Harmonisation (ICH) Q12 framework provides tools for managing postapproval chemistry, manufacturing, and controls changes, while its annexes include illustrative protocols for adding an alternative small-molecule manufacturing site and transferring biotechnology drug substance among sites, including contract manufacturers.15,16
Those examples are illustrative rather than universal requirements, but they show the types of technical and regulatory considerations that can become relevant, including risk assessment, comparative batch analysis, stability, site compliance status, technology transfer, process qualification, validation, and differences in facilities and equipment.16
A future-state network may be simpler once the transition is complete, but reaching that state can require significant technical, quality, and regulatory work. Manufacturing-network modeling also shows that regulatory approval times can influence product allocation and outsourcing decisions.17
A network change that is relatively straightforward early in development may become more consequential after approval, when removing a partner can require formal technology transfer and postapproval change management. The continuing burden of the incumbent relationship has to be weighed against the full technical, regulatory, and operational cost of reaching the proposed new configuration.
When Consolidation Makes Sense
A strong consolidation candidate is a partner whose capabilities are substantially duplicated elsewhere, whose continued presence contributes little independent resilience, and whose work can be absorbed by another capable CDMO without sacrificing something strategically important. The case becomes stronger when the relationship requires disproportionate governance and planning effort and when the work can be moved without an excessive technical or regulatory burden.
The opposite case is a relationship that appears narrow but contributes something the broader network cannot easily replace. That may be a differentiated technical capability, a genuinely independent manufacturing route, or qualified capacity that protects a supply-critical operation. Pharmaceutical partner-selection research supports evaluating external manufacturers across capabilities, resources, communication, experience, quality, compliance, and broader relationship characteristics rather than judging them solely on immediate transaction performance.6,7
Resilience deserves the same discipline. Dual sourcing can provide meaningful protection, but pharmaceutical modeling also shows that inventory and agility capacity can interact with or substitute for dual sourcing under some conditions.9 Maintaining another CDMO solely because redundancy is desirable can be as simplistic as eliminating one solely because consolidation appears efficient.
What matters is the marginal value of the relationship. If a partner adds little beyond work another CDMO can already perform, consolidation may improve the network. If removing it eliminates the only independent pathway for an important activity, the apparent simplification may create a larger exposure than it removes.
A Four-Part Framework for Reviewing the CDMO Network
A practical network review can be organized around four dimensions: capability value, interface cost, resilience value, and exit cost.
Capability value asks what the partner contributes that the rest of the network cannot readily provide. This can include technical and operational capabilities, breadth or specialization of services, geographic presence, quality and compliance suitability, and the ability to support the required relationship.6,7 A CDMO with a narrow role may still score highly if that role is difficult to replace.
Interface cost captures what the sponsor must do simply because the relationship exists. Outsourced activities require partner assessment and qualification, defined responsibilities and communications, ongoing performance monitoring, and control of the agreed supply chain.4 Pharmaceutical outsourcing can also introduce planning and communication demands that extend across multiple connected decisions over time.5 A relationship that provides little distinct value but consumes substantial attention naturally becomes a stronger candidate for consolidation.
Resilience value asks what happens if the partner or its associated manufacturing path becomes unavailable. The issue is whether another route is both qualified and sufficiently independent to matter. Pharmaceutical resilience research supports considering dual sourcing alongside inventory and agility capacity, while upstream supply-chain studies show why multiple visible suppliers can still conceal shared manufacturing dependencies.9,11,12
Exit cost captures what removing the relationship would require. Technology transfer can involve gap analysis, receiving-site preparation, qualification, validation, knowledge transfer, and change management, while approved products may also require formal regulatory handling of the change.13–15 A relationship that offers modest ongoing value may still be rational to retain if replacing it would require substantially more effort and risk than maintaining it.
Applied together, these dimensions distinguish four broad relationship types. Strategic core partners justify a broad role, specialist partners preserve differentiated capabilities, resilience partners provide important independent supply routes or qualified capacity, and consolidation candidates contribute comparatively little capability or resilience relative to their management and exit costs.
The categories are not regulatory classifications or a standardized industry taxonomy. Their purpose is to prevent supplier rationalization from collapsing into a single metric such as spend, vendor count, or service breadth.
Build the Smallest Network That Preserves What Matters
There is no evidence-based ideal number of CDMOs for a sponsor. The appropriate network depends on what each partner does, how substitutable those capabilities are, how dependencies connect beneath the contractual layer, and how much resilience the sponsor requires for particular activities.
A fragmented network can create avoidable planning, quality, and governance demands. Reducing supplier numbers without examining differentiated capabilities and underlying dependencies, however, can exchange administrative complexity for concentration risk. The challenge is to distinguish relationships that merely add interfaces from those that preserve something the sponsor would otherwise have difficulty replacing.
The answer will rarely be uniform across an entire portfolio. Some activities may belong with broader strategic partners, others with specialists, and selected supply-critical operations may warrant independent qualified redundancy. Elsewhere, relationships that persist mainly because they have always existed deserve closer scrutiny.
The right end state is not the fewest possible CDMOs. It is the smallest network that preserves the capabilities, resilience, and optionality the sponsor has decided it actually needs.
References
1. Choi, Thomas Y, and Daniel R Krause. “The Supply Base and Its Complexity: Implications for Transaction Costs, Risks, Responsiveness, and Innovation.” Journal of Operations Management. 24: 637–652 (2006).
2. Contract Manufacturing Arrangements for Drugs: Quality Agreements: Guidance for Industry. U.S. Food and Drug Administration. 23 Nov. 2016.
3. Cooperative Manufacturing Arrangements for Licensed Biologics: Guidance for Industry. U.S. Food and Drug Administration. 28 Nov. 2008.
4. “Q10 Pharmaceutical Quality System.” U.S. Food and Drug Administration. 8 Apr. 2009.
5. Boulaksil, Youssef, and Jan C Fransoo. “Implications of Outsourcing on Operations Planning: Findings from the Pharmaceutical Industry.” International Journal of Operations & Production Management. 30: 1059–1079 (2010).
6. Zhang, Min, et al. “Evaluating Outsourcing Partners’ Capability: A Case Study from the Pharmaceutical Supply Chain.” Journal of Manufacturing Technology Management. 24: 1080–1101 (2013).
7. Festel, Gunter, Mikko De Nardo, and Timo Simmen. “Outsourcing of Pharmaceutical Manufacturing – A Strategic Partner Selection Process.” Journal of Business Chemistry. 11: 117–132 (2014).
8. Song, Dong-Ping, Jing-Xin Dong, and Jingjing Xu. “Integrated Inventory Management and Supplier Base Reduction in a Supply Chain with Multiple Uncertainties.” European Journal of Operational Research. 232: 522–536 (2014).
9. Lücker, Florian, and Ralf W Seifert. “Building up Resilience in a Pharmaceutical Supply Chain through Inventory, Dual Sourcing and Agility Capacity.” Omega. 73: 114–124 (2017).
10. Tucker, Emily L, and Mark S Daskin. “Pharmaceutical Supply Chain Reliability and Effects on Drug Shortages.” Computers & Industrial Engineering. 169: 108258 (2022).
11. Postma, Doerine J, et al. “Upstream Pharmaceutical Supply Chains of 10 High-Use Pharmaceuticals in the Netherlands: A Cohort Study.” BMJ Open. 15: e099697 (2025).
12. Socal, Mariana P, et al. “Competition And Vulnerabilities In The Global Supply Chain For US Generic Active Pharmaceutical Ingredients.” Health Affairs. 42: 407–415 (2023).
13. “TRS 1044 - Annex 4: WHO Guidelines on Technology Transfer in Pharmaceutical Manufacturing.” World Health Organization.30 Apr. 2022.
14. Changes to an Approved NDA or ANDA: Guidance for Industry. U.S. Food and Drug Administration. 8 Apr. 2004.
15. Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management: Guidance for Industry. U.S. Food and Drug Administration. 11 May 2021.
16. Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex. U.S. Food and Drug Administration. 11 May 2021.
17. Blossey, Gregor, Gerd J Hahn, and Achim Koberstein. “Planning Pharmaceutical Manufacturing Networks in the Light of Uncertain Production Approval Times.” International Journal of Production Economics. 244: 108343 (2022).
