Tim Roberts, chief commercial officer for PCI Pharma Services, explores the current pharmaceutical contract manufacturing landscape.
PCI Pharma Services
What are the key trends currently shaping the pharmaceutical contract manufacturing landscape?
We're seeing a clear shift toward complex modalities driving demand for specialised capabilities, such as biologics, cell and gene therapies, and targeted therapies like TPDs and ADCs. Supply chain diversification remains critical post-COVID, while regulatory scrutiny around quality and data integrity continues intensifying. Sustainability also has become a key differentiator, with clients evaluating partners on environmental and carbon emissions reduction credentials.
How are global supply chain disruptions still affecting contract manufacturers post-COVID?
While acute shortages have eased, CDMOs like PCI are still managing extended lead times for certain critical elements, such as raw materials and specialised equipment. The savvier partners have modified traditional just-in-time approaches, incorporating strategic inventory buffers and dual-sourcing strategies while maintaining lean principles wherever feasible.
Geopolitical tensions and shifting tariff dynamics have introduced additional complexity, mandating mitigation strategies like supply chain regionalisation to reduce single-market dependencies. These adaptations have increased operational costs but significantly improved supply security and business continuity.
How are CMOs/CDMOs responding to increased demand for personalised medicine and cell & gene therapies?
The personalised medicine revolution is driving significant changes across PCI’s core competencies. For instance, with oral solid dose (OSD) products, we're seeing increased demand for smaller batch sizes, more complex formulations like targeted degradation therapies such as molecular glues and PROTACs, and flexible manufacturing platforms that can handle multiple product variants efficiently.
For sterile injectables, the shift toward targeted therapies requires enhanced aseptic capabilities, specialised filling technologies for smaller volumes, and more sophisticated cold-chain logistics to support temperature-sensitive biologics and companion diagnostics. PCI has made substantial recent investments to assure we stay ahead of the curve concerning both capabilities and capacity.
What role is digital transformation playing in modern contract manufacturing?
Simply put, a tremendous one. The rising demand for complex, lower-volume therapies necessitate enterprise-wide agility and efficiency, with a steadfast commitment to compliance. Digital transformation is revolutionising operations by enabling organisations to rethink what is possible through the optimisation and redesign of core manufacturing processes. Targeted therapies, which often involve intricate molecules and advanced drug delivery systems, present unique manufacturing challenges such as rapid changeovers and high degrees of automation. To remain competitive, advanced data processing, interpretation, and reporting are essential.
More and more, such next-gen capabilities are becoming “essentials” rather than “extras.” Regulators are increasingly focused on achieving "right-first-time" quality, advocating tools such as continuous process verification, Quality by Design (QbD), and Process Analytical Technology (PAT) to monitor and understand manufacturing processes for capability and control. Digital transformation initiative are instrumental in helping manufacturers meet these stringent standards by automating critical processes, reducing human intervention, and employing data analytics for condition-based monitoring to minimise downtime. They also further leverage big data modelling to ensure consistent validation, leading to improvements in manufacturing cost of goods (MCOGs) and other key operational and performance indicators.
How have pharma clients’ expectations changed in terms of flexibility, speed, and partnership models?
Clients now expect true partnership rather than transactional relationships. Speed-to-market has become paramount, with compressed development timelines requiring seamless integration between development and manufacturing phases.
Our strategic partnerships with upstream specialists in spray drying, micronisation, and hot melt extrusion exemplify this evolution for OSD development and manufacture; clients value integrated networks that can accelerate projects from early development through commercial scale-up. Flexibility in manufacturing capacity, regulatory support, and supply chain management has become non-negotiable, with sponsors seeking partners who can adapt quickly to changing clinical outcomes and market demands.
Are you seeing more long-term strategic partnerships versus transactional relationships?
Absolutely. The industry has shifted decisively toward strategic partnerships as clients recognise the value of deep, collaborative relationships over project-by-project transactions. Long-term partnerships enable better capacity planning, shared risk management, and coordinated development strategies that accelerate time-to-market. We're seeing multi-year agreements that encompass everything from early-stage formulation development through commercial manufacturing. Such partnerships allow for superior resource allocation, regulatory alignment, and ultimately more predictable outcomes for complex development programs.
How do you balance innovation with regulatory compliance and cost pressures?
If done correctly, the former can offset the latter. Organisations that have strong Quality Management Systems (QMS) and a culture of quality have an automatic competitive advantage within the CMO/CDMO space, as they don’t need to divert their attention to costly and time-consuming quality events.
Innovation, specifically technology, can be employed in various ways to increase compliance and reduce costs. First, a digital strategy and roadmap is required to prioritise first initiatives so that finite resources and organisational focus can be directed accordingly. From there, implementing centralised systems within the manufacturing value stream pulls data from lines, laboratories, and supporting activities – helping track line downtime, human errors, right-first-time, waste and other metrics. Consolidated data allows the operation to quickly identify opportunities to drive improvements for an overall reduction in total costs of quality and MCOGs.
Ultimately, there must be a shift in the traditional quality focus. While there will always be a requirement for audits, risk assessment, oversight and traditional quality roles, the process transitions from 'review behind the walls' to a more engineering focused 'quality at the line.' This approach involves reviewing process and product data near real time to determine product quality right-first-time, along with process capability and control. By collecting data at the line and reviewing in tandem, the traditional length of time for review and release becomes shorter and more meaningful.
What are the top regulatory challenges CMOs/CDMOs face today?
The ongoing consolidation within the CMO/CDMO sector, driven by mergers and acquisitions, accelerates inorganic growth but also poses challenges in establishing a unified, overarching Quality Management System (QMS). Achieving standardisation across the expanding organisational hierarchy can prove difficult amid such rapid growth.
Depending on the specific responsibilities a CMO/CDMO is undertaking, operating globally can also prove challenging in a landscape where various countries or regions have specific regulations that may not always be harmonised with the FDA or origin country requirements. For example, if a CMO/CDMO is asked to operate a customer's supply chain distribution model through Brexit impacted territories, regulatory and commerce requirements differ between trade zones. Decisions must be made in these cases concerning the type of import-export model to establish for acceptable lead times and ease of process management.
What steps are being taken to make manufacturing more sustainable?
Evaluating the environmental impact of manufacturing encompasses a myriad of factors, including energy sourcing, consumption, waste management, material utilisation, and more. Across the industry, significant strides are being made to reduce carbon emissions, with the adoption of renewable energy sources serving as an immediate and impactful solution. In contrast, the transition to energy-efficient equipment is a more protracted process, as the lead times for sourcing, validating, and integrating such alternatives can span months, if not years. Strategic planning and the implementation of sustainable procurement policies will, over time, enable organizations to meet their energy consumption goals.
Furthermore, pharmaceutical and biopharmaceutical companies now have access to an array of advanced technologies and resources to mitigate the environmental impact of product packaging. At PCI, our packaging design experts conduct comprehensive life cycle assessments for clients, offering tailored recommendations for sourcing more sustainable materials and reengineering packaging designs to reduce material usage without compromising product protection or shelf life.
Are clients actively prioritising ESG factors when choosing manufacturing partners?
Pharma and biopharma companies increasingly recognise the importance of sustainability and ethical practices across their supply chains. As a result, they are actively seeking manufacturing partners that share their values and support their long-term ESG goals.
From an environmental perspective, companies are prioritising partners that demonstrate a clear commitment to reducing carbon emissions, implementing effective waste management systems, and embracing circular economy principles.
Social responsibility is equally critical. Companies favour partners that uphold ethical labour practices, champion diversity, equity, and inclusion, comply with global labor standards, and protect human rights throughout their operations.
To validate these commitments, manufacturers can pursue globally recognised certifications such as ISO 14001 for environmental management, ISO 45001 for occupational health and safety, and ISO 26000 for social responsibility. Independent ESG ratings and third-party reports also help companies evaluate the sustainability performance of potential partners.
For our part, PCI recently had its greenhouse gas emissions targets validated by the internationally recording Science Based Targets initiative. Such measures demonstrate commitment to reducing GHG emissions through meaningful, publicly-stated goals.
Where do you see the greatest opportunities for growth in the next few years?
One sector showing outsized opportunities is high-potent oral solid dosage formulations, which are growing at a CAGR of roughly 8%, driven largely by rising demand for highly potent and targeted therapies, and by the growing demand for oncology treatments. Sterile injectables represent an even stronger growth opportunity at 9.73% CAGR, fuelled by the expanding biologics pipeline and increasing demand for low-volume, high-value products from smaller biotech companies.
Both markets favour established players with proven capabilities and robust regulatory track records, as well as strong development partnerships, positioning PCI well for sustained growth.
What advice would you give to pharma companies looking to form successful partnerships with CMOs/CDMOs?
Look beyond cost and focus on capabilities, quality systems, and cultural fit. The most successful partnerships are built on transparency, so please do share your development challenges early and be realistic about timelines and volumes. Evaluate potential partners' regulatory track record, particularly their inspection history and remediation capabilities. Don't underestimate the importance of communication and project management; these soft skills often determine success more than technical capabilities. Finally, consider the CDMO's strategic direction and capacity planning. You want a partner that's investing in the technologies and markets that align with your pipeline, not one that is spreading resources too thin across disparate areas.