Choosing a drug development partner in 2026: A practical selection framework

Navigating early-phase challenges

According to GlobalData, among planned clinical trials for 2026, 29% are Phase I. But delivering these early-phase trials on a global scale is among the most operationally complex undertakings in drug development. Sponsors are increasingly confronted with a fragmented landscape in which speed, consistency, and risk management are difficult to balance.

A significant challenge is the lack of harmonization, with regulatory authorities and ethics bodies across regions imposing differing requirements for study design, safety justification, and patient protection. These variations slow study start-up through repeated queries and approval cycles and introduce uncertainty into timelines and planning.

Limited availability of GMP-grade material, short product shelf lives, and the logistical demands of global supply chains can also stall dose escalation and delay site activation. Furthermore, as trials become more geographically dispersed, maintaining real-time safety oversight becomes increasingly challenging. This means that coordinating rapid decision-making across time zones, managing differing pharmacovigilance requirements, and ensuring consistent dose-escalation governance require robust operational frameworks.

Contract negotiations, country-specific budget expectations, and fluctuating exchange rates introduce further unpredictability into cost management, while differing interpretations of Good Clinical Practice (GCP) and inspection readiness across jurisdictions heighten compliance risk. Data privacy regulations, including the GDPR, together with restrictions on biological sample handling, add another layer of operational constraint.

In response to these challenges, many sponsors are turning to integrated global partners to bring structure and consistency to early-phase development.

The strategic advantage of integrated CDMOs

Establishing internal manufacturing capabilities is costly and complex. As such, smaller biotech companies are often more reliant on CDMOs. However, even among larger organizations, outsourcing is increasingly strategic rather than purely capacity driven. Recent industry data indicates that nearly 87% of biopharmaceutical companies outsource at least part of their development or manufacturing activities. Outsourcing is particularly prevalent in analytical and testing functions, while more strategic areas such as process development remains less outsourced, though this is expected to increase as companies increasingly seek cost and speed efficiencies.

Biopharma companies often frame partner selection as a choice between small, specialized CMOs and large, integrated CDMOs. Smaller providers are typically perceived as more agile and flexible, offering deep expertise in niche technologies or specific modalities. This can be attractive for early-stage programs. However, this approach can introduce structural risks. Managing multiple vendors increases coordination complexity, creates data silos, and weakens accountability. As programs progress to later stages, these inefficiencies often become more pronounced.

GlobalData’s analysis shows that a relatively small number of large CMOs capture a significant share of commercial manufacturing contracts, particularly for approved products, suggesting a shift towards scale and reliability as programs mature. Beyond greater capacity, scale in CDMO partnerships offers several structural advantages:

• End-to-end capabilities from early development to commercial manufacturing
• Cross-modality expertise spanning small molecules, biologics, and advanced therapies
• Integrated data environments that enable better process understanding and comparability
• Regulatory experience, including global submission strategies and inspection readiness
• Operational resilience with established supply chains and redundant capacity

These capabilities reduce the need to seek additional support from other specialist vendors, which simplifies governance and improves continuity across the development lifecycle.

Several CDMOs have responded to this shift by expanding beyond traditional manufacturing services to provide more coordinated development, clinical, and supply capabilities. The goal is to reduce operational fragmentation and create greater continuity as programs advance through development. Thermo Fisher Scientific’s Accelerator™ Drug Development model, for example, combines CRO, CDMO, and clinical supply capabilities within a shared execution framework designed to support continuity across development. This reduces fragmentation and enables more consistent application of process knowledge.

The value of this approach is increasingly evident as programs become more complex. Rather than trading flexibility for scale, sponsors are recognizing that integration can enhance both.

A practical framework for selecting the right CDMO partner

To identify the right CDMO partner, teams must go beyond evaluating capabilities at a high level and ask targeted questions that reveal a provider’s true areas of expertise, operational strengths, and experience with similar programs. For example:

• How many successful tech transfers have been completed across your network?
• How is process knowledge maintained between development and commercial teams?
• How will your team troubleshoot process development challenges during scale-up?
• What are your standard lead times for production, and how do you handle supply chain delays?
• Can you provide a detailed breakdown of costs and fees, including how you handle changes or modifications to the scope of work?
• Will I have a dedicated project manager, and what is your standard communication and progress reporting cadence?

The responses to these questions will provide the foundations for selection, but given the strategic importance of CDMO collaborations, implementing a structured evaluation framework is crucial. Seven key criteria that CDMOs should meet are:

The responses to these questions will provide the foundations for selection, but given the strategic importance of CDMO collaborations, implementing a structured evaluation framework is crucial. Seven key criteria that CDMOs should meet are:

1. Lifecycle continuity

   A CDMO should be able to demonstrate how early design choices will be maintained and scaled up to commercialization. This includes preserving process knowledge across development, manufacturing, regulatory and commercial teams and reducing the risk of disruption as the program progresses through phases.

   
   
2. Managing complexity at scale
   
   Clinical pipelines are becoming increasingly diverse, so sponsors need partners with experience across small molecules, biologics, advanced therapies, and complex clinical supply models. The right CDMO should be able to manage varying regulatory landscapes, global site requirements, specialized storage and distribution needs, and modality-specific manufacturing constraints without creating additional vendor dependencies.
   
   
3. Data visibility and decision support
   
   Access to integrated, high-quality data is a core differentiator for sponsors evaluating whether a CDMO can support faster, better-informed decisions. A leading CDMO should be able to provide clear programme visibility, timely reporting, and decision-support tools that help sponsors identify risks, understand variability, track deviations and make informed decisions during development and scale-up.
   
   
4. Tech transfer maturity
   
   The right CDMO should have proven capability in transferring processes between development and manufacturing sites. This includes standardized documentation, analytical comparability, defined risk-mitigation strategies, and systems to ensure that critical process knowledge is retained across teams, sites and development stages.
   
   
5. Regulatory readiness
   
   The ability to anticipate regulatory expectations across regions can significantly reduce delays. Sponsors should assess whether the CDMO has experience with accelerated pathways, global submissions, pharmacovigilance expectations, data privacy requirements, and inspection management across relevant jurisdictions.
   
   
6. Program governance and accountability
   
   Integrated capability adds value, but only when accountability is well-defined. Sponsors need to ensure that CDMOs have established governance structures, designated program leads, transparent escalation processes, and agreed reporting schedules, as well as clear ownership of risks, decisions, and deliverables.
   
   
7. Cultural fit and collaboration model
   
   Alignment in communication, transparency, and a problem-solving approach are often underestimated but are critical for long-term success. Sponsors should ask how the CDMO manages challenges such as supply constraints, technical setbacks, and regulatory questions, as these moments can determine whether a partnership can sustain momentum.

As development programs become more complex, selecting a CDMO is increasingly about evaluating how effectively a partner can connect decisions across development, manufacturing, regulatory strategy, and clinical supply.

Organizations that assess partners through this broader operational lens are often better positioned to reduce risk, maintain momentum, and accelerate progress toward commercialization.