Before CDMO Live, we ask external manufacturing leaders and CMC consultants to tell us, in their own words, what they’re working on, what’s keeping them up at night, and what they hope to get from the event.

This year eight interconnected themes emerged. None of them are surprising in isolation. What is striking is how consistently the same anxieties surface whether you’re a CMC consultant supporting a Series A biotech or a network strategy director at a top-ten pharmaceutical company.

1. Finding the Right Fit (49% of respondents)

Nearly half of all respondents cited this as a challenge — making it the most consistently raised issue across buyer types. The challenge encompasses both finding a partner with the right technical capability for a given programme, and finding one with the capacity and flexibility to take it on.

“One of the main challenges is navigating the large number of CDMOs available in the market and developing a clearer understanding of their respective capabilities. This includes mapping CDMOs against specific project needs and identifying the most suitable partners when new commercial programmes arise.” — Procurement Lead, mid-sized biopharma

“Identifying CDMOs that are a good fit for small and early-stage companies. Many available CDMOs are more oriented towards large pharmaceutical clients, which can limit suitability for early-stage programmes.” — CMC Consultant

“Capacity remains a major challenge. It is often difficult to find the right match between CDMO capacity and our internal timelines. As a smaller company, we require flexibility, which can be challenging when working with larger CMOs.” — Senior CMC Manager, European biotech

“The main challenge is identifying the right CDMO partner. This includes ensuring strong technical fit, alignment in quality standards, and good relationship and cultural fit. A significant amount of time is spent on due diligence, meeting potential partners, and evaluating whether they are the right fit.” — Director, CDMO Integration, global pharma

“Consolidation of a very fragmented CMO landscape.” — Director, large European pharma

“One of the main challenges is finding the right CDMO when the project requires a technology, capability, or manufacturing environment that is not readily available. For highly specialised or emerging technologies, the number of suitable options can be very limited.” 

2. Geopolitical Risk and Supply Resilience (29%)

Almost a third of respondents cited challenges related to geopolitics, trade disruption, or supply network resilience — and these two issues were consistently raised together, reflecting how directly geopolitical events are forcing buyers to rethink supply strategy.

“Right now the impact of the war and US policies are my main concerns.” — Senior External Manufacturing Leader, global pharma

“The Biosecure Act may impact the decision to engage CDMOs in China, and changes in the international situation over the last year could impact future decisions. I would be interested to learn how others navigate this.” — Head of External Manufacturing, large pharma

“How to hedge against volatility and unforeseen events without spending too much on inventory. Is price indexation advisable in these times or not? For example, transport disruption due to the Iran war. Inflation, energy prices.” — External Manufacturing Director, global pharma

 “The main challenges are uncertainty driven by the overall state of the industry, geopolitical instability, tariffs, and cross-border supply concerns. Working internationally creates uncertainty around whether partners in different regions can reliably supply customers.” — Managing Director, pharma distribution

 “How to diversify the external network to build a resilient supply chain in times of uncertainty.” — External Manufacturing Leader, large pharma

 “To establish a sustainable and resilient network of CDMOs globally.” — Senior Director, Global Procurement, large biotech

3. Cost Pressure and Pricing (24%)

Around a quarter of respondents cited cost as a primary challenge — covering both rising CDMO prices and the increasing difficulty of keeping external manufacturing budgets aligned with programme needs.

“Rising CDMO costs, driven by external factors such as geopolitical instability. Budget constraints from clients, particularly small biotech companies and university spin-offs. Finding CDMOs that balance cost, quality, and flexibility for early-stage programmes.” — Senior CMC Consultant

“The main challenges are cost and budget pressures. Project costs often increase unexpectedly, leading to renegotiations with CDMO partners. Late deliveries and operational issues are also recurring challenges. In addition, increasing regulatory complexity adds further pressure on timelines, costs, and resources.” — External Supply Manager, global pharma

“From a strategic perspective, the increasing shift toward external manufacturing across the portfolio presents challenges in pricing, value realisation, and ensuring we obtain the best return on investment. Another challenge is ensuring CDMO partners understand the broader pharma perspective, including supply chain integration, dual sourcing strategies, secure supply needs, and long-term portfolio planning.” — Finance Director, External Manufacturing, large pharma

“The main challenge has been cost pressure following CDMO development. We are continuously screening the market to identify CDMOs that can offer competitive pricing while maintaining high quality standards.” — API Sourcing Manager, European pharma

“To adapt CMC programmes to tight budgets, short timelines and evolving clinical plans, while also positioning the CMC strategy to be compelling for investors.” — Head of CMC, clinical-stage biotech

4. Timeline Reliability and Tech Transfer (23%)

Around one in four respondents raised challenges connected to timelines and delivery — a figure that rises when technology transfer is included, as the two issues are closely linked operationally. Both reflect the gap between what is planned and what is delivered.

“One of the biggest challenges is managing timelines in early development programmes. In many cases, CDMOs provide very optimistic timelines during business development discussions, but in reality those timelines are not always achievable. One of the key things I look for is CDMOs that provide realistic planning and transparent project timelines from the start.” — Co-founder, CMC Consultancy

“The main challenge is managing the gap between project initiation and on-time delivery. Timelines can be affected by many external factors such as supply chain issues, changes in raw material costs, regulatory or market developments, and other unforeseen disruptions.” — External Supply Integration Manager, global pharma

“Experienced stakeholders and realistic resource planning: successful execution requires committed teams, and commitment from their line managers to ensure sufficient time allocation. Preparedness for change: projects frequently undergo scope, timeline, and budget adjustments. Building plans that anticipate change rather than react to it is essential.” — External Manufacturing Leader, global pharma

“During Tech Transfers it is very likely that not everything runs according to plan. How to cope with production failures and subsequent losses — who’s taking the risk and costs?” — External Manufacturing Director, large pharma

“Onboarding new CDMOs following acquisition of products. Technology transfer of commercial products.” — Head of Manufacturing and Technology Transfer, European pharma

“Knowledge transfer, risk management, training of people.” — Head of Technical Transfer, External Manufacturing, large pharma.

5. Strategic Partnership versus Transactional Vendor (19%)

Nearly one in five respondents raised the distinction between CDMOs who operate as genuine development partners and those who behave as transactional service providers.

“Finding CDMOs willing to partner and not just buying services. Finding CDMOs with the right level of expertise and quality. Finding CDMOs reliable with project timelines.” — CMC Consultant

“More and more complex projects with outsourcing paths not always transparent from CDMOs.” — President, fill-finish consultancy

“There is a need for better transparency regarding CDMO focus, long-term strategy, and true capabilities. The objective is to identify partners who are aligned strategically and capable of building sustainable, long-term collaborations rather than short-term contracts.” — Sourcing Manager, European pharma

“A major challenge is shifting from reactive issue management to a more strategic, proactive approach in managing CMO operations. This includes establishing stronger governance and KPI-driven performance oversight, embedding risk-based approaches, improving long-term planning around capacity, materials, and tech transfers, building more strategic, transparent partnerships with CMOs.” — Manager, Global Contract Manufacturing, large pharma

“Journey to strategic partnerships with CDMOs: I would like to learn from other, more mature biopharma companies how they established a preferred partnership network and which parameters have been the most critical — for example, communication, capacities.” — External Manufacturing Director, large pharma

6. Biotech Funding Constraints (10%)

CMC consultants working with early-stage biotech clients — cited funding as a primary challenge. The common thread is that client funding position directly gates CMC and CDMO decisions.

“Funding is a major challenge, particularly when supporting biotech companies, as projects often depend on securing the next round of funding to progress. Another key challenge is identifying the right CDMO for the right work package.” — CMC Director, independent consultancy

“The primary challenge is funding. The early-stage biotech companies I support often face difficulties in securing sufficient funding to progress their programmes, which creates delays in development and decision-making.” — CMC Consultant

“One of the main challenges currently is the funding environment for early-stage biotech companies. Although there are some improvements, many biotech companies are still facing difficulties in securing sufficient funding.” — Owner, CMC Consultancy

“To adapt CMC programmes to tight budgets, short timelines and evolving clinical plans, while also positioning the CMC strategy to be compelling for investors.” — Head of CMC, clinical-stage biotech

7. AI and Digital: Hype vs Reality (8%)

respondents raised AI and digitalisation as explicit challenges — though the nature of the challenge was consistent: how to identify practical use cases rather than navigate the broader hype.

“There is a lot of hype regarding AI. Are there any low-hanging fruit, simple use cases?” — External Manufacturing Leader, global pharma

“AI use cases at the interface of CMOs and their customers.” — External Manufacturing Leader, global pharma

“Understanding how AI can support quality and compliance functions.” — Quality Operations Lead, global pharma

“Is digitalisation a driver to reduce time to market?” — External Manufacturing Leader, large pharma

8. Regulatory Complexity (7%)

A smaller but consistent group of respondents — primarily from quality and external manufacturing functions at large pharma — cited an increasingly demanding regulatory environment as a direct operational challenge.

“Navigating an increasingly dynamic and evolving regulatory environment, especially FDA and EU. Ensuring consistent inspection readiness across global operations.” — Quality Operations Lead, global pharma

“Supplier instability linked largely to capabilities and inspection outcomes.” — Head of External Manufacturing, European pharma

“The main challenges are cost and budget pressures. Project costs often increase unexpectedly, leading to renegotiations with CDMO partners. Late deliveries and operational issues are also recurring challenges. In addition, increasing regulatory complexity adds further pressure on timelines, costs, and resources.” — External Supply Manager, global pharma

“Key challenges include performance consistency, quality, and navigating broader geopolitical and trade-related discussions, particularly those impacting global manufacturing and supply.” — Head of External Manufacturing Integration, global pharma

Eight connected themes. 
Geopolitics is driving cost pressure, which is squeezing biotech budgets, which is making CDMO selection more consequential at exactly the moment when the landscape is hardest to navigate. Unreliable timelines erode trust and push buyers toward the partner model — but finding CDMOs who can genuinely operate as partners requires the kind of track record information the market does not yet share well. Technology transfer is where all of these tensions crystallise into a single high-stakes operational moment.

While no-one walking into the event is short of knowledge about these issues, we could all do with more for honest conversations with people who are managing the same pressures from the same position.  That is what CDMO Live is for.

CDMO Live Europe 2026 takes place 19–21 May in Rotterdam.