As the pharmaceutical landscape continues to evolve, contract development and manufacturing organizations (CDMOs) are stepping into an increasingly strategic role. The pace of innovation, the shift toward specialized therapies, and the demand for supply chain resilience have put CDMOs at the center of biopharma’s next chapter. To get a clearer picture of where the industry is heading, Contract Pharma invited executive leaders from across the CDMO sector to share their perspectives on the top three trends they see shaping 2025 and beyond.

This roundtable brings together insights from the people driving the industry forward—CEOs, presidents, and senior leaders who are on the ground, adapting to challenges and spotting opportunities. Their responses highlight not only the technologies and capabilities expected to define the next few years, but also the structural shifts in how CDMOs collaborate, invest, and deliver value. Topics range from the continued rise of advanced modalities and the impact of AI, to the growing importance of sustainability, agility, and end-to-end service models.

The goal of this feature is simple: cut through the noise and surface what truly matters. These are not trends for trend’s sake—they’re strategic priorities that are already influencing decisions in boardrooms and on production floors. Whether you’re a pharma partner, an investor, or a fellow CDMO, the following perspectives offer a real-time snapshot of where leaders are placing their bets and building their roadmaps.

Welcome to CDMOs: Key Leader Insights—a sharp, forward-looking take on the future of outsourced pharma services.

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Sean O’Brien
Chief Operating Officer
Abzena

Flexible and agile manufacturing models

As therapeutic innovation accelerates, the demand for adaptable and responsive manufacturing solutions has intensified. One-size-fits-all approaches are no longer viable in an industry characterized by diverse therapeutic modalities and rapidly shifting market needs. Abzena addresses this trend through its hallmark flexible and agile manufacturing models, specifically tailored to the unique demands of each customer. Leveraging advanced platform processes and deep technical expertise, Abzena efficiently adapts manufacturing capabilities, allowing customers to accelerate development timelines, reduce costs, and optimize scalability. This tailored approach empowers biopharma companies to swiftly pivot in response to emerging scientific advancements and evolving regulatory landscapes, thus significantly enhancing their competitive advantage.

Strategic partnerships and consolidation

Strategic partnerships and industry consolidation continue to reshape the CDMO landscape, underscoring the importance of collaborative innovation. Abzena exemplifies this trend through robust partnerships with leaders such as Argonaut Manufacturing, OncoDesign Services, Alloy Therapeutics and Proteonix. By establishing comprehensive platforms for antibodies, antibody-drug conjugate (ADC), and antibody-oligonucleotide conjugate (AOC) programs, these partnerships streamline development processes and deliver collective expertise, significantly reducing risk and enhancing efficiency for customers. Consolidation and strategic alliances enable Abzena to integrate diverse capabilities—from early-stage development through commercial manufacturing—providing customers with seamless and holistic support. This interconnected approach strengthens Abzena’s ability to deliver superior outcomes in complex biologics and targeted therapies, ensuring sustained industry leadership.

Resilient supply chains

Recent global disruptions have underscored the critical need for resilient and robust supply chains within the CDMO industry. In response, companies are increasingly prioritizing proactive risk management strategies. Abzena, leveraging its deep process expertise, actively advises customers on specific, actionable steps to de-risk their supply chains. By applying extensive process knowledge directly to supply chain management, Abzena helps customers anticipate vulnerabilities and implement effective mitigation strategies. Recent insights from internal thought leaders highlight Abzena’s commitment to ensuring supply chain resilience through meticulous planning, diversified sourcing strategies, and rigorous oversight. This strategic approach protects customers from disruptions, secures product availability, and reinforces trust in the CDMO partnership.

Beyond these key trends, the continued rise of ADCs, antibody-oligonucleotide conjugates (AOCs) and radionuclide conjugates (RDCs) will further shape the industry landscape as more biopharma companies explore these promising therapeutic areas.

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Srinivasan Shanmugam
Executive Director of Pharmaceutical Sciences
Adare Pharma Solutions

Tariffs and other supply chain disruptors

Global supply chains have faced extraordinary pressure in recent years—from a global pandemic and shifting tariffs to inflation and transportation bottlenecks. These disruptions have prompted a fundamental reassessment of how and where pharmaceutical products are developed and manufactured.

As a result, many sponsors are seeking greater stability and responsiveness from their CDMO partners. This has led to an increased focus on regional diversification, supplier flexibility, and localized sourcing strategies. CDMOs that can offer both geographic reach and operational agility are now better positioned to meet customer needs.

At Adare, our strong U.S. and European footprint allows us to support sponsors across markets while minimizing risk and delay. We’re expanding domestic sourcing capabilities, building strategic stockpiles of key materials, and diversifying our supplier network. We’re also actively supporting customers who are reshoring their manufacturing operations to ensure continuity and compliance.

Patient-centric dosage forms for special populations

For many patients—especially pediatric and geriatric populations—adherence is a persistent challenge due to factors like difficulty swallowing, unpleasant taste, or complicated dosing regimens. Patient-centric dosage forms have transformed the way we approach this problem. By focusing on convenience, flexibility, and adherence, CDMOs can develop formulations that ameliorate common barriers to treatment. Design and development of patient-centric products often require specialized technologies, deep formulation expertise, and years of experience. Not all CDMOs are equipped to meet these needs due to technological or operational limitations.

At Adare, our proprietary technologies, expertise, and decades of experience allow for precise drug release profile customization while taste-masking bitter active ingredients. These multiparticulate-based platforms have been designed specifically to meet the needs of vulnerable or hard-to-treat populations and support a wide range of acceptable formats, including sprinkles, chewables, dispersibles, ODTs, and powders.

As patient-centricity continues to shape healthcare delivery, CDMOs will need to focus on innovative dosage forms that improve outcomes and support long-term therapeutic success. 

The acceleration of digital innovation

Digital technologies are reshaping pharmaceutical manufacturing at an unprecedented pace. From AI and robotics to automation and 3D printing, the industry is undergoing a transformation that promises greater efficiency, precision, and flexibility. CDMOs must adopt these innovations strategically, focusing on solutions that deliver real impact across the drug development lifecycle.

At Adare, we’re prioritizing digital investments that help accelerate development, optimize manufacturing processes, and shorten project timelines. For example, through our partnership with Laxxon Medical, we’re integrating 3D printing into our capabilities to support more customized and scalable drug delivery solutions. 

To stay competitive, CDMOs must go beyond simply keeping up with technology…they must lead. That means allocating the right resources, building strategic partnerships, and constantly evolving to meet the changing needs of customers and patients alike.

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Henny Zijlstra
Chief Commercial Officer
Adragos Pharma

Consolidation of CDMO networks

The industry is witnessing the consolidation of CDMOs through mergers and acquisitions, seeing companies broaden the services they offer to customers by providing more comprehensive solutions, and reducing the need for innovators to use multiple outsourcing partners.

This reduces the management needs of innovators and enhances customer service by streamlining processes and increasing the progression of programs through development and onto commercialization.

The M&A strategy that Adragos Pharma has employed is in line with this and focuses on acquiring sites and capabilities that complement its existing portfolio, expanding technological capabilities and geo-graphic diversity to address the evolving global market needs. By integrating multiple technologies into a wider network of facilities, CDMOs are empowered to deliver holistic solutions to their customers, significantly improving program timelines and operational efficiency.

Client-centric digitalization

Digital transformation serves as a long-term enabler to enhance collaboration, communication, and delivery. Many CDMOs are looking at methods that leverage digital tools to improve manufacturing excellence and customer satisfaction by leveraging digital tools.

At Adragos Pharma, we are piloting initiatives at our facilities that integrate artificial intelligence (AI) and advanced data analytics into processes, with the goal of facilitating faster and more efficient tech transfers, improving visibility, and enhancing robustness. While these projects are currently in their early stages, we are committed to evolving our capabilities to match our clients’ needs and creating a smarter, more connected future for contract manufacturing.

Continued onshoring of projects

Geopolitical tensions have driven pharmaceutical companies to reevaluate their supply chains, resulting in a significant shift toward onshoring and regional production. As global political dynamics become increasingly complex, onshoring continues to be a more attractive for companies that seek greater stability by relocating operations closer to their home markets.

To address this at Adragos Pharma, the company has established a strong global footprint with five sites in Europe and one in Japan, allowing it to act as a local provider in customer countries and address specific market needs effectively. In Europe, the demand for premium services is surging, driven by stringent regulatory requirements and heightened quality expectations. Meanwhile, a presence in Japan’s stable market presents advantages for CDMOs that are looking to capitalize on high-quality manufacturing capabilities, reinforced by strong local support.

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Graeme McBurney
Chief Operating Officer
Almac Group

Complexity and capacity

Now more than ever there is a need for more precise, efficient, and patient-centric approaches to developing new therapies. Contract development and manufacturing organizations (CDMOs) offer access to advanced technologies, specialized expertise and available flexible capacity. Ensuring you’re partnered with a forward thinking CDMO will help sponsors stay in front of advances and complexities in Clinical Development. 

At Almac Group, we address these challenges through our comprehensive capabilities, such as Genomic Services and Diagnostics – Single cell RNA sequencing and specialty central lab services ensure precise biomarker research and seamless sample management. Advanced bioinformatics solutions help uncover novel insights from genomic data, aiding drug development, and Next-generation sequencing (NGS) and data analysis further enhance precision medicine, particularly for rare diseases.

We use green chemistry to enhance the efficiency of our chemical processes, not only reducing the environmental impacts but also achieving high specificity and efficiency in chemical reactions.

Investments in addressing challenges with poorly soluble and highly potent drugs ensure these drugs achieve good bioavailability, enhancing their therapeutic efficacy.  For biologics, we provide comprehensive solutions, including cold chain storage and distribution, ensuring the integrity and stability of biologics throughout the supply chain.

Additionally, our bespoke solutions for manufacturing and packaging drug products include ultra-low temperature storage and complex kit assembly.

Flexibility and adaptability

The pharmaceutical and biotechnology industries are marked by rapid advancements, intricate projects, and a growing need for speed and customization. CDMOs need to be more flexible and adaptable in their approach to supporting clients across the drug development pipeline due to the increasing complexity of trial design and the high-value products in development.

Being agile allows CDMOs to handle products of diverse scales, from small batches for niche therapeutics to larger volumes for larger treatment groups. Adopting Just In Time manufacturing strategies allows us to reduce lead times to customers, thereby reacting to their changing market needs.  These approaches can be applied both to conventional supply chain scenarios and direct-to-patient shipments.

To best support their customers, CDMOs must be flexible and adaptable to respond to a range of factors including the rise of novel therapeutic modalities like cell and gene therapies, global supply chain challenges, and the increasing complexity of drugs currently coming through development. Regulatory pressures and the drive for cost-efficiency and speed to market are also contributing to this need for adaptability.  

Forward-thinking partners that are strategically aligned with your business and committed to long term, transformational partnerships are vital to guaranteeing your ongoing success.

Data and digitization 

Data and digitization are pivotal trends shaping the CDMO industry. As the pharmaceutical and biotechnology industries evolve, CDMOs are increasingly integrating digital technologies to enhance efficiency, guarantee compliance for example active temperature monitoring during shipment, and streamline operations. 

One significant aspect of this trend is the integration with customers’ systems, allowing for seamless data uploads. This integration facilitates a faster product development cycle and accelerates the pathway to clinical review submissions.  

Data integration strategies are most effective within a transformational partnership between the customer and the CDMO.  Within these partnerships CDMOs are enabled to input and upload data directly into customer systems which ultimately leads to reduced impact on resources, resulting in a quicker and more cost-effective development for the customer.

By transferring data directly into their systems, CDMOs must ensure data integrity, which is crucial for regulatory compliance and quality control. This digitization not only improves the speed and accuracy of data management but also supports advanced analytics enabling faster and more informed decision-making throughout the drug development process.

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Jenn Adams
CEO
August Bioservices

Reshoring momentum: U.S. CDMOs attract major investment to bring pharma manufacturing home 

Over the past several years, there has been a noticeable shift in the pharmaceutical manufacturing landscape, with significant investment in U.S.-based CDMOs. This trend is driven by macro-economic and geopolitical factors focused on mitigating risk associated with reliance on suppliers outside of the U.S. The U.S. government has rolled out funding and tax incentives to encourage domestic production of both APIs (and finished drug products). From reducing dependency on complex global supply chains to increasing national security and ensuring better oversight of quality standards, the move toward domestic manufacturing is a strategy that drug manufacturers of all sizes are evaluating to ensure that they re-main competitively positioned. In response, U.S.-based CDMOs are expanding their capabilities, infrastructure, and workforce to accommodate this shift and the increased demand that it represents. Our clients report that their decision to partner with U.S.-based CDMOs doesn’t just mitigate risk, it accelerates timelines, improves transparency, and enables them to move their drug product more seamlessly through the development lifecycle and secure capacity that is needed for continuity of commercial supply. 

GLP-1 surge sparks unprecedented demand for PFS manufacturing capacity 

The explosive rise in GLP-1 drugs originally designed for diabetes and now making waves in the weight-loss market, has brought with it an unprecedented surge in demand for prefilled syringe (PFS) manufacturing capacity. These injectable therapies require scalable, sterile, and highly specialized fill-finish solutions, making CDMOs with advanced PFS capabilities more valuable than ever. GLP-1s typically require high-volume aseptic filling lines, cold chain handling and high-speed assembly and inspection. The equipment lead time and construction of fill-finish facilities takes years to bring online.

CDMOs equipped with flexible, high-throughput PFS lines are uniquely positioned, especially those that offer the ability to scale rapidly while maintaining rigorous quality and regulatory standards. The demand for PFS is here to stay, and the infrastructure needed to sup-port their growth requires significant capital investment and years between that investment and the qualification of new equipment and facilities.

With tariffs on the rise, U.S.-based, end-to-end CDMOs offer critical supply chain security

With rising tariffs on pharmaceutical imports and ongoing geopolitical uncertainty, the cost and complexity of global drug production have increased. These economic pressures are causing companies to reevaluate the efficiency and security of their supply chains. In this environment, CDMOs offering fully integrated, end-to-end capabilities within a single U.S.-based facility have emerged as preferred partners for their clients. From development through fill-finish, testing, packaging and distribution, CDMOs who offer this integrated portfolio of services can reduce risk, improve speed, and eliminate inefficiencies as-sociated with coordinating multiple vendors across borders. Beyond logistical convenience, this model provides better communication, stronger quality oversight, and leverages the product and process understanding that informs decisions to drive efficiencies while scaling up. A more consolidated, domestic manufacturing partner helps its clients to mitigate risk and build resilience into continuity of supply in an evolving macro environment.

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Dave Miller
Chief Scientific Officer
AustinPx

The rise of enabling formulation technologies for poorly soluble drugs

The shift in pharmaceutical pipelines toward molecularly complex compounds of high molecular weight, poor solubility, and low-permeability has placed enabling formulation technologies at the center of CDMO innovation. In 2025 and beyond, CDMOs must offer differentiated capabilities in amorphous solid dispersions, lipid-based formulations, and particle engineering to meet these challenges. Traditional approaches like micronization, spray drying, and hot melt extrusion remain core tools, but newer technologies such as KinetiSol—offering solvent-free, high-energy dispersion of APIs—are gaining traction for their ability to address solubility and bioavailability without compromising stability or scalability. The CDMOs best positioned for growth will be those that not only provide a toolkit of enabling technologies but can also scientifically guide sponsors through selection and development. Formulation know-how is no longer a niche—it’s foundational.

Consolidation and differentiation in a crowded CDMO market

The CDMO sector continues to undergo consolidation, with private equity-backed roll-ups and mergers creating megashops. Yet, this scale doesn’t always translate into customer value. In response, we’re seeing a countertrend: the rise of mid-sized, innovation-focused CDMOs that emphasize scientific problem-solving, transparent collaboration, and flexible execution. These companies are succeeding by delivering high-value services that often get lost in larger organizations—early formulation development, CMC strategy, tech transfer support, and creative problem solving for challenging molecules. As biopharma sponsors demand more agility and technical depth, CDMOs that prioritize intellectual partnership over transactional throughput will thrive.

Increasing importance of manufacturing science and tech transfer readiness

As more molecules advance from early development into Phase 2 and beyond, CDMOs are under pressure to develop formulations that are not just bioavailable—but also scalable, robust, and tech-transfer ready. Clients increasingly expect Phase 1 formulations to serve as the foundation for commercial process development, placing greater importance on manufacturability from day one. In this environment, CDMOs must integrate manufacturing science earlier in the development cycle, applying process modeling, material property characterization, and design-for-scale thinking. Technologies like continuous manufacturing and modular equipment platforms offer opportunities for more seamless scale-up, but only when coupled with deep process understanding. Forward-thinking CDMOs will evolve from formulators to industrialization partners.

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Kevin Li
Chief Marketing Officer
BioDuro

Peptide boom reshapes CRO and CDMO strategies

The explosive success of GLP-1 receptor agonists—such as semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound)—is shaping the future of contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs). At the core of GLP-1 therapies are a class of complex peptides that are driving a surge in the development of other peptide-based therapies. As a result, CROs and CDMOs are rapidly increasing investment in solid-phase peptide synthesis (SPPS) capabilities and capacity, including discovery chemistry for various complex peptides and peptide-based conjugates, scale-up production, and advanced analytical platforms.

While injectable GLP-1s currently dominate the market, oral peptide formulations are emerging quickly and are likely to significantly expand the use of GLP-1s as a treatment for obesity. CROs and CDMOs are investing in advanced formulation technologies such as permeation enhancers and enteric coatings to improve the oral bioavailability of peptides. They are also expanding their offerings to include more in vitro and in vivo permeability, stability, and absorption studies tailored specifically for oral peptides.

ADCs drive demand for integrated solutions

There is a surge in demand for highly specialized capabilities across both biologics and small molecule synthesis, and antibody-drug conjugates (ADCs) are a key driver. Accordingly, as more pharma and biotech companies race to develop targeted oncology therapies, CDMOs are investing heavily in high-potency compound handling for payload and linker synthesis, as well as in bioconjugation capabilities. Meanwhile, CROs are expanding their integrated discovery platforms to include antibody engineering, in vitro and in vivo efficacy modeling, and testing. The rise of ADCs is blurring the lines between biology and chemistry, pushing service providers to offer multidisciplinary, end-to-end solutions to support this sophisticated modality.

Global strategies strengthen supply chain resilience

As geopolitical tensions and global supply chain disruptions continue, with new threats to reliable material and finished dose supply emerging all too frequently, biopharma companies are placing greater emphasis on supply chain resilience. This has led to a growing shift toward dual sourcing strategies. Rather than relying on a single site or supplier, sponsors are now actively seeking CDMOs with global development and manufacturing capabilities across multiple geographies. In response, CDMOs are expanding their global footprint, investing in mirrored capabilities and capacities across continents, and building technology transfer frameworks that enable rapid scale-up or seamless transition between sites.

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Andrew Mitchell
Senior Director Business Development
Biovectra

Specialization and agility are keys to growth

We expect to see continued growth in the CDMO industry with focus in more specific areas of biologics and emerging modalities: GLP-1, ADCs & aseptic fill/finish capabilities. CDMOs will need to remain agile and adaptable in a market which is likely to see increased consolidation. Those with both large and small molecule capabilities are well-positioned to benefit.

Policy shifts push supply chain regionalization

The political landscape—shaped by things like the Biosecure Act and tariffs—is prompting biopharma companies to reassess and regionalize their supply chains. While U.S.-based firms are showing greater interest in domestic manufacturing, many global players are focused on building supply chain resilience. In this context, CDMOs based in politically stable, strategically located markets—such as Canada—are well-positioned to support North American programs while helping companies navigate evolving regulatory and trade environments. These dynamics are creating new opportunities for collaboration that balance access, reliability, and risk mitigation.

Process innovation accelerates drug manufacturing efficiency

Process intensification will remain a key focus for CDMOs, aimed at increasing titers with AI optimized target specific expression systems improving efficiency in large-molecule manufacturing. At the same time, small-molecule development continues to benefit from innovations such as flow chemistry, biocatalysis and other advanced optimization techniques, enabling faster, more scalable, sustainable and cost-effective production.

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Vincent Villegas
Sr. Director of Government Affairs and Strategic Initiatives
Jubilant HollisterStier

Annex 1 continues to drive sterile manufacturing 

GMP Annex 1 establishes the regulatory standard for all sterile medical products sold in the EU and focuses on best practices for aseptic and terminal sterilization. The final section regarding lyophilization protocol became legally binding as of August 2024.

While specific to the EU, these guidelines function as industry benchmarks that inform FDA and Health Canada inspection practices. Going forward, Annex 1 will influence decision-making, especially when manufacturers install new equipment or expand their facilities. Implementing the detailed guidance on the use of RABS (Restricted Access Barrier Systems) and isolators will encourage the use of the latest technology.  

Continuous improvement relies on the willingness and ability to close any technological or process gaps and to take a proactive approach to quality and risk management. Annex 1 will keep the industry moving toward best practices in sterility to protect patient safety and ensure regulatory confidence for fill-finish products sold both inside and outside EU markets. Partnering with a CMO experienced with following these guidelines can help ensure full compliance and regulatory confidence. 

Evaluating onshoring manufacturing ahead of proposed tariffs

With the future of the tariffs in constant flux, the whole industry is keeping a close eye on executive orders and monitoring the evolving political landscape. Many are drafting plans to minimize potential disruption and identify alternative suppliers. Others are considering what onshoring manufacturing operations might look like. 

Building new sterile manufacturing facilities from scratch takes a significant capital investment and years of planning and execution. The quickest and easiest way for many pharma companies to reach their US patients will be to partner with US-based CMOs with available capacity. CMOs should be prepared to discuss timelines, tech transfers, and project management approaches with partners interested in moving some of their production stateside. 

Pandemic preparedness remains critical

Researchers estimate that the COVID-19 vaccines likely saved the lives of over 14 million patients around the world during its first year of public availability.* Under public health emergency conditions, the biotech ecosystem needs access to multiple manufacturing sites and onshore options to build the groundwork for a resilient and flexible response to new challenges. In emergency situations, prepared manufacturers can employ operational flexibility and rapid tech transfer driven by a highly qualified workforce. These manufacturers will also be able to deploy a “go fast” model for expedited development while maintaining regulatory compliance. Working with a partner with proven experience operating under pandemic conditions can help both public and private entities respond with more confidence to the next health crisis and protect patient supply of crucial medications.

*Source: Global impact of the first year of COVID-19 vaccination: a mathematical modelling study. Watson, Oliver J et al The Lancet Infectious Diseases, Volume 22, Issue 9, 1293 – 1302 DOI: 10.1016/S1473-3099(22)00320-6

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Prasad Raje
CEO
LGM Pharma

CDMOs with a culture of adaptability

CDMOs that approach infrastructure with creativity and a willingness to evolve can deliver meaningful value by staying aligned with changing project needs. Whether it’s modifying equipment, reconfiguring batch lines, or making phased investments, a culture of adaptability enables speed and flexibility without compromising quality or compliance.

Robust and localized supply chains

CDMOs that combine U.S.-based manufacturing with global sourcing expertise are uniquely positioned to mitigate risk and maintain supply chain continuity. In today’s unpredictable environment, that dual capability is a strategic advantage.

Emphasis on quality by design

By shifting quality control upstream with Quality by Design principles, CDMOs reduce reliance on extensive end-product testing and enable more predictable, scalable processes. With FDA resources under pressure, regulators increasingly favor this proactive, data-driven approach to ease review burdens and support faster approvals.

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Nigel Stapleton
VP of Business Development – Head of Europe
Mabion

End-to-end CDMOs streamline biologics development

For companies developing biopharmaceutical assets, partnering with an end-to-end biologics CDMO offers a robust way to accelerate product development. By working with a provider which manages the entire clinical CMC path, from developing a cell line, a process and a suite of analytics, though to clinical manufacturing, formulation, and fill-finish sponsors can avoid complex, time-consuming tech transfers. This way regulatory complexity is reduced and process fit is optimized. Working with specialists also enables a more agile development path, which is important in particularly for programs targeting accelerated approval or breakthrough designations. A single project management point of contact and cross-functional teams allow downstream needs to be considered early in development. As pipelines become more complex and timelines more compressed, end-to-end CDMOs are increasingly viewed not just as manufacturers, but as strategic partners in the success of the molecule.

Europe rises as biologics manufacturing hub

The European biologics CDMO market is growing in a sustained and accelerated manner, positioning the EU as a critical global hub for complex biologics development and manufacturing. This expansion is driven by increasing worldwide demand for high-value biologics as well as Europe’s strategic commitment to strengthening biomanufacturing resilience post-pandemic. CDMOs across Europe are continuing to invest into cutting-edge facilities geared towards supporting mammalian cell culture platforms. This includes single-use bioreactor systems, continuous processing, and integrated Drug Substance/Drug Product facilities. These capabilities are particularly well-suited for clients seeking flexibility, speed-to-clinic, and technical expertise. 

In parallel, Europe benefits from a unique combination of a deep talent pool, strong local biotech and academic clusters, a robust regulatory infrastructure, and, increasingly, EU-wide harmonized quality standards. Importantly, the European Union also offers a relatively stable geopolitical environment—an increasingly valuable factor for global companies navigating complex supply chains and long-term partnerships. This ecosystem allows CDMOs to offer both scientific excellence and high regulatory confidence, making Europe a place to produce, but perhaps more so a place for biotech companies to find an ideal partner. As biologics continue to dominate new drug pipelines, European CDMOs are emerging as leading end-to-end service providers.

Mid-sized CDMOs deliver value and expertise

In the face of the increasing financial burden of healthcare globally, mid-sized, EU based CDMOs offer a cost-effective option for biopharmaceutics firms looking for high quality strategic collaborations. Instead of investing heavily in a broad panel of modalities like larger players are prone to do, mid-sized CDMOs with appropriate specialization focus their resources on reliably delivering high quality services in their area of expertise. This allows them to provide highly efficient, tailored solutions and expert scientific partnership, often delivering better value, particularly for complex biologics projects. Clients benefit from open and transparent communication, reasonable pricing and collaborative, rapid problem-solving. This minimizes delays and speeds up time to market, whilst reducing costs and ensuring broad patient access to life saving breakthrough medicines.

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Davuluri Saharsh Rao
Vice Chairman and Managing Director
Neuland Labs

Geopolitics increasingly influencing outsourcing decisions

Geopolitical considerations are becoming critical factors influencing CDMO outsourcing. We are seeing that on top of the issues raised by the Biosecure Act, potential tariffs and stricter trade policies from the U.S. administration are pressuring sponsors to carefully evaluate risks tied to their manufacturing partners’ locations. Countries like India, Japan, and South Korea, which show a willingness to navigate trade complexities, stand to benefit. European CDMOs face less certainty due to unclear policy responses from the region. Meanwhile, CDMOs are increasingly considering domestic U.S. production facilities to mitigate geopolitical risks, maintain reliable supply chains, and enhance operational stability.

Accelerated demand and investment in peptide manufacturing

We are continuing to see the surge in peptide-based therapies, particularly GLP-1 receptor agonists, driving significant growth and competition within the CDMO market. Manufacturing capacity for peptide APIs (GLP-1 and otherwise) remains constrained and is at a premium as more peptides enter the clinic. We are seeing CDMOs try to meet this demand by investing significantly in production infrastructure. Additionally, new market entrants are emerging, attracted by opportunities to produce peptide intermediates or fragments, creating greater competition and reshaping the peptide value chain. As peptides advance in clinical pipelines across therapeutic areas beyond diabetes and weight loss, sustained capacity expansions and strategic partnerships will likely intensify throughout 2025 and beyond.

Growing geographical diversity despite biotech funding challenges

Even amid broader weakness in biotech funding, CDMOs continue receiving a steady stream of new project opportunities, characterized by increasing geographical diversity. While China remains a notable contributor, Europe is emerging as a key region, especially for peptide-related innovations. This geographic diversification indicates broader global innovation activity and a resilience in CDMO pipelines despite macroeconomic pressures.

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Lee Karras
Group CEO
The Noramco Group

Domestic production and on shoring

The push for domestic pharma manufacturing in the U.S. has intensified due to geopolitical tensions, supply chain vulnerabilities, and policy shifts. The current administration is contemplating tariffs on imported drugs (finished products and APIs) which has prompted some pharma companies to begin preparations to move some products to U.S.-based facilities. CDMOs with established U.S. operations or the capacity to scale domestically are well-positioned to benefit from this trend, as clients seek to mitigate risks associated with international supply chains and align with government incentives.

Complex technologies

Drug makers are increasingly focusing on complex and niche technologies, moving away from high-volume, commodity products. This shift is driven by the growing demand for specialized delivery systems (i.e. cartridges and autoinjectors for GLP-1s). The production of these drug-device combination products requires CDMOs to possess specialized expertise in areas like aseptic manufacturing, device assembly, and packaging. CDMOs that offer integrated services, including design, development, kitting and packaging along with aseptic manufacturing should see benefits as they are becoming essential partners for companies aiming to bring complex therapies to market. 

Consolidation

The CDMO industry is experiencing significant consolidation, exemplified by Novo Holdings’ acquisition of Catalent. While this acquisition strengthens Novo Nordisk’s manufacturing capabilities, some capacity will become captive, leaving a supply gap especially for those seeking sterile CDMO services. Smaller and mid-sized CDMOs with the right technologies (parenteral manufacturing) and available capacity may find new opportunities to fill the gaps left by such consolidations.

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Tim Roberts
Chief Commercial Officer
PCI Pharma Services

ADCs and targeted therapies

The rise of targeted modalities like Antibody-Drug Conjugates (ADCs) and Targeted Protein Degraders (TPDs) is set to redefine expectations for CDMOs. Each presents unique scientific and operational challenges, demanding new levels of technical sophistication, cross-functional expertise, and investment.

ADCs are highly potent, complex biologics that require precise conjugation methods, robust containment capabilities, and rigorous analytical testing to ensure stability and batch consistency. Their manufacture often spans biologics and small molecule operations, making integrated service offerings and cross-disciplinary knowledge critical. CDMOs equipped with advanced aseptic fill-finish capabilities and high-containment infrastructure will be key partners as more ADCs move from early phase development through to commercial production.

TPDs, by contrast, are primarily oral dosage forms with significant challenges in solubility, permeability, and bioavailability. This positions a CDMO’s pharmaceutical development capabilities as critical differentiators. CDMOs with proven track records in overcoming these barriers through technologies like amorphous dispersion, lipid-based systems, and nanomilling will become invaluable to clients navigating this evolving space.

As pipelines expand, the future of the CDMO industry lies in flexible, agile partners who can evolve alongside these therapeutic innovations, not only with the right equipment, but with the experience and expertise to enable the next generation of precision therapies.

ESG

The Pharma industry is facing growing scrutiny regarding their Environmental, Social, and Governance (ESG) performance. With global pressure to operate more sustainably and ethically, a demand for greater transparency and accountability is being driven by investors, regulators and consumers. Key environmental concerns include high energy use, water consumption, and hazardous waste production, which has initiated a shift toward greener manufacturing practices and carbon reduction goals. Socially, stakeholders are evaluating labor and human rights practices, supply chain ethics, and access to affordable healthcare. Governance issues, such as regulatory compliance, anti-corruption measures, and board diversity, are also under the microscope.

As critical links in the pharma supply chain, CDMOs are expected to align with the ESG values of clients and suppliers. This alignment is no longer optional, but it’s becoming a pre-requisite for partnerships, investments, and market competitiveness. Organizations are joining global initiatives like Race to Zero, and We Mean Business Coalition and setting science-based targets (SBTi) as evidence of their commitment. As ESG metrics grow in influence, both pharma companies and their CDMOs must embed sustainability into core business strategies, not just for reputational benefits but to ensure long-term resilience and investor confidence in an evolving global market.

Patient centricity

Patient-centricity remains a core priority in the pharmaceutical industry, shaping both drug development strategies and advanced injectable packaging design. Delivery systems are now considered much earlier in the lifecycle, with increasing emphasis on understanding the drug-device combination and final product profile from the outset.

In the parenteral drug market, this has led to products designed to reduce injection frequency, minimize discomfort, and improve the overall patient experience. Manufacturers are investing in R&D to align formulations with patient preferences and are incorporating Human Factors engineering earlier to optimize usability, reduce user error, and support safe, effective, and potentially at-home administration.

CDMOs with integrated sterile fill-finish capabilities and advanced packaging expertise are evolving to meet these demands, offering not only drug substance and product expertise but also support for combination drug delivery systems.

Early collaboration with a CDMO that brings scientific, technical, and packaging expertise allows biopharma companies to make early, informed decisions about containers and de-vices. This minimizes changes during commercialization, reducing risk while improving speed and cost-efficiency—essential to a successful patient-centric path to market.

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Jeff Speicher
Commercial General Manager
PLD Pharma Services

Faster time-to-market with ready-to-customize formulations

To accelerate product launches, many OTC drug companies are turning to CDMOs that offer a robust library of pre-developed formulations. These platforms can be quickly customized and branded, allowing companies to bypass the lengthy development cycle and move swiftly from concept to commercialization. This speed-to-market advantage is especially valuable in fast-moving consumer health categories where timing can be critical to competitive success. At PLD, because of our private label business, we have a library of more than 600 formulations, which allows companies to build out their portfolios quickly and more cost effectively.

Expanding across dosage forms and delivery systems

Today’s consumers expect more choices in how they take medications and supplements, prompting drug developers to diversify their delivery formats. Companies increasingly rely on CDMOs with multi-format capabilities—those equipped to produce tablets, capsules, gel caps, liquids, gummies, and chewables. These partners also bring experience in working with active pharmaceutical ingredients (APIs) across delivery systems, helping brands expand their portfolios without having to invest in specialized internal infrastructure. One of the major concerns driving the use of diverse dosage forms is the desire to increase compliance. Consumers who find it difficult to swallow pills or capsules, for example, may find gummies to be more palatable, but this also means that the CDMO will need experience with flavor masking and dosage accuracy, both of which require experience working with APIs over a variety of delivery formats. 

CDMOs revitalize and extend product lifecycles

Beyond new launches, companies are also outsourcing existing products to CDMOs to enhance quality and extend product life cycles. CDMOs are improving methods, updating quality systems, introducing new flavors, and reformulating to eliminate ingredients—such as certain dyes—that are falling out of regulatory or consumer favor. This strategic shift not only supports compliance and marketability but also strengthens brand reputation in a competitive landscape.

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Eric Kaneps
Vice President, Sales and Marketing
Renaissance Lakewood

Expansion of nasal drug delivery & patient-centric design

Renaissance Lakewood is strategically leveraging the growing demand for nasal drug delivery systems. This market segment is gaining traction in the U.S., which has long been dominated by oral solid-dose medications. As patient needs and preferences evolve, Renaissance is focusing on optimizing nasal formulations and selecting the most effective delivery devices to improve both therapeutic outcomes and patient experience. This approach is designed to enhance patient compliance by making treatments more convenient and less invasive. By prioritizing the development of pre-filled, ready-to-use products, Renaissance is aligning with a broader industry movement toward user-friendly drug delivery solutions that simplify administration and support better adherence. This expansion not only reflects changing market dynamics but also underscores Renaissance’s commitment to innovation and improving quality of life through more accessible and effective treatment options.

Integrated services and long-term partnerships

Renaissance is observing a clear shift in customer expectations from purely transactional relationships to more integrated, end-to-end partnerships. Increasingly, clients are seeking comprehensive support that spans the full product development lifecycle—from early-phase formulation development through to commercial-scale manufacturing. This increased collaboration level allows for a more seamless and strategic approach to bringing products to market. One area gaining particular focus is tech transfer efficiency, which continues to be a major industry pain point. By streamlining this critical process, Renaissance helps clients avoid costly delays and reduce risk during scale-up and commercialization. Additionally, many customers are prioritizing long-term collaborations that go beyond product launch. These partnerships often include lifecycle management strategies and enhanced supply chain reliability. This trend reflects a broader industry movement toward sustainable, strategic alliances that provide enduring value for both parties.

Supply chain resilience and risk mitigation

Pharmaceutical companies are increasingly streamlining their supply chains and relocating manufacturing to the U.S. for strategic, economic and regulatory reasons. The COVID-19 pandemic exposed critical vulnerabilities in global supply networks, especially the overreliance on overseas manufacturers for essential drugs and APIs. In response, many firms are reshoring operations to strengthen supply chain resilience and reduce exposure to geopolitical risks and trade disruptions. Domestic manufacturing not only enhances reliability but also accelerates speed-to-market, offering faster regulatory approvals and easier compliance with FDA standards. Simplified supply chains shorten lead times and improve flexibility in scaling production. Additionally, government support has played a vital role in this shift, with initiatives like the Defense Production Act and federal funding incentivizing companies to localize essential drug production. While offshore manufacturing may seem more cost-effective, hidden costs such as tariffs, shipping delays and quality issues are prompting companies to reconsider. U.S.-based facilities may allow for greater oversight over quality, IP protection and integration of advanced technologies such as automation. Moreover, growing pressure from consumers, healthcare providers and investors is making “Made in the USA” a mark of trust, with stakeholders increasingly favoring transparent and reliable local supply chains.

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James Choi
Executive Vice President, Head of Sales Support
Samsung Biologics

Pre-filled syringes fuel capacity expansion

Pre-filled syringes help improve patient convenience thanks to the relative ease of administration compared to existing forms of injectable medicines, such as vial and syringe. While the demand for syringe filling capabilities had been growing, the market for weight loss drugs in the last couple years has been a key driver of this growth. GLP-1 drugs revealed a gap in the industry’s manufacturing capabilities for pre-filled syringes at the time and triggered an upward trajectory in capacity-building. Acquiring syringe filling capabilities to complete the drug product manufacturing line can be a strategic investment for CDMOs to meet rising market demand. 

ADCs and bispecifics drive new demand

After the clinical success of Enhertu by Daiichi Sankyo and AstraZeneca, ADCs have received positive attention, taking the place of the next promising modality to potentially replace chemotherapy. The clinical success of Ivonescimab (PD-1 x VEGF) by Summit Therapeutics also bodes well for its molecule’s place as one of the next-generation bispecific antibody therapeutics. These examples shed light on how the market for multispecifics, including bispecifics, will grow. An experienced CDMO can help clients navigate the complex process of manufacturing multispecific antibody therapeutics, as well as maintaining safety and quality for ADCs while handling toxins in the process. A strong manufacturing and development partnership can address any unmet needs in these areas. 

Digital transformation powers Biopharma 4.0

AI-implemented operations are being embraced by all sectors, including biopharma. Industry leaders are implementing digitalized systems to enhance advanced quality control on batch production as well as data handling. Embedding digital excellence into the organizational culture and process helps to automate processes toward consistently replicating the most optimized batch conditions while enhancing supply chain management. Digital twin technology, enabled by computational fluid dynamics, can provide actionable insights on cell growth, nutrient consumption, hydrodynamic behavior, and other critical bioreactor variables. Through the standardization—and normalization—of optimized end-to-end bioprocesses spearheaded by CDMOs prioritizing digital transformation, drug developers can successfully navigate the regulatory landscape and beyond, equipped for Biopharma 4.0.

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Amy Glekas
Head of Field Development
Solvias

Demand for flexibility & rapid scale-up in advanced modalities

The rapid evolution of modalities such as mRNA, cell therapies, and gene therapies has transformed expectations for CROs and CDMOs. Because the cell and gene therapy market is poised for growth, biopharma companies and research entities are increasingly seeking partners that can move quickly and adapt to changing product, process, and regulatory requirements without sacrificing quality in early development or during scale-up phases. This dynamic has placed a premium on analytical agility. Testing needs may change overnight, and the ability to rapidly develop, validate, and transfer methods is valued as a key differentiator. Whether these programs are first-in-human or moving into global commercialization, they require infrastructure and expertise that can scale with them—not just in manufacturing but also in analytical support.

Increasing regulatory scrutiny for data integrity

Across all modalities, regulatory agencies continue to raise the bar on data integrity, audit trails, and end-to-end traceability. Analytical testing is under particular scrutiny, as quality data increasingly drives not only batch release but also broader regulatory strategy and product lifecycle decisions. In this context, many organizations are investing in greater standardization and centralized oversight for their testing operations. Whether through integrated digital systems, harmonized assay platforms, or consolidated QA/QC review processes, the goal is to reduce variability and ensure every test result is reliable, reproducible, and inspection-ready.  As regulatory expectations continue to evolve, a high-quality, highly reputable contract testing laboratory becomes essential for helping organizations uphold data integrity, ensure compliance and maintain stakeholder confidence throughout the product lifecycle. 

Centralized labs as a strategic extension

As manufacturing models diversify, so too do testing strategies. Many organizations are adopting a hybrid approach, where centralized labs operate in concert with inhouse or onsite capabilities. Centralized labs serve as a strategic extension of the manufacturing ecosystem—offering specialized analytical expertise, accelerated method development, and a platform for harmonization across sites or programs. They are especially valuable for high-complexity assays, long-term stability studies, or scenarios involving multiple CROs, CDMOs or global tech transfers. Centralized labs help build resilience, speed, and scalability into the quality infrastructure. As the industry evolves, this kind of strategic collaboration—between CROs, CDMOs, sponsors, and dedicated testing partners—will be key to keeping pace with innovation.

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Mat Minardi
Executive Vice President
Sterling Pharma Solutions

Increased need for flexible outsourcing

Regardless of an organization’s size, the market has collectively increased its outsourcing levels to address a variety of changes, including geopolitical uncertainties. Customers are pre-emptively seeking to derisk their supply chains and diversify across alternative territories.

This necessitates more than just outsourcing. Instead, customers require a CDMO partner that can respond and adapt to differing needs with agility and flexibility, whether these are driven by challenges within the market, growing demand, technical challenges, or internal capacity constraints. This is where contractor models, such as Sterling’s Extended Bench come into play: customers want a partner that can become a truly integrated extension of their team, providing additional support from across the globe in a variety of disciplines and time zones, as and when a project dictates, or simultaneously for greater speed. 

Increasing pressures to be the fastest to market, which are present across all stages of the lifecycle, mean that customers require a CDMO with experience that can be leveraged to ensure the most viable routes are selected—and issues designed out of processes early in development—to provide the greatest chances of success. This also enables access to technologies that may help optimize processes, shorten timelines, and ultimately, reduce costs.

Desire for partnership

As a direct result of increased outsourcing, changing customer needs and the economic environment, there has been a shift away from contractual and transactional relationships with CDMOs towards more strategic models. This has given rise to the partnership development and manufacturing organization (PDMO), developed and trademarked by Sterling in 2020.

Although customers now prioritize collaboration and transparency with their outsourced projects, traditional assurances regarding technical and regulatory capabilities, supply chain robustness and resilience remain top of mind.

This more valuable, long-term strategic relationship also provides customers with peace of mind that when approaching a new project, their selected partners will already understand communication preferences and ways of working, in turn, speeding up processes and delivering a more favorable experience.

Customers recognize the depth of experience and robust internal processes afforded by a partner, and the critical role they play in supporting them to successfully navigate the unpredictable and complex challenges the market, and globe, face. A flexible and transparent partner that is working towards a shared goal is essential to enabling the customer, and CDMO, to deliver the life-saving medicines that patients are waiting for, together. 

Retaining and fostering talent

The industry has witnessed changes in the way outsourcing partnerships have evolved, moving away from transactional interactions and instead placing importance on people, relationships and communication. A culture that empowers its people to deliver a partnership experience, born of transparency, innovation, and flexibility, is critical to best support the changing needs of the customer and market. This sort of culture can only be achieved by having employees that are secure and looked after,and having clear values that are demonstrated throughout all levels of the business.

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Carsten Press
Managing Director
Vetter

Sustainability

Sustainability has become a central focus for us, driven by increasing regulations and the growing demand from biopharma companies for environmentally conscious practices. For our customers, partnering with a sustainable provider is crucial as it directly im-pacts their own sustainability goals and reporting requirements, particularly in terms of Scope 3 emissions along the value chain. Customers are increasingly scrutinizing the environmental practices of their service providers to confirm alignment with their own sustainability commitments. Above all, we implement sustainability initiatives due to our own organizational priorities and commitment to forward-thinking operations. By prioritizing accountability in sustainability programs and initiatives, we can not only provide proof points of our commitment to current and potential customers, but actually achieve the ambitious goals we are striving for. In turn, we play a meaningful role in an emission-intensive industry to make a positive impact on the wellbeing of our environment for the sake of our customers, their patients, and our employees. To advance sustainability in the pharma and biotech industry, steps must be taken at all points in the value chain. For CDMOs, this means looking at redesigning processes, infrastructure and social aspects with environmental outputs in mind.

Digitalization

Digitalization is rapidly transforming our landscape, enabling greater efficiency and compliance with evolving regulatory standards. The integration of advanced technologies such as artificial intelligence (AI) and machine learning into manufacturing operations is enhancing our ability to manage complex product lines that support the highest possible quality and efficiency. As an example, we are investing in digitization and automation to meet the stringent requirements of Annex 1, focusing on contamination control and patient safety. These technological advancements not only streamline our processes but also position us as a forward-thinking partner capable of supporting innovative customer projects. Given the timeline required to implement new technological developments within the pharmaceutical manufacturing process—roughly 8-10 years—it is critical that forward-thinking CDMOs begin applying digitization efforts early on to be early adopters that customers can rely on for advanced processes. This supports efficient time to market, regulatory approval, and quality standards in a fast-changing industry where stagnancy is as good as failure. 

Flexibility

Flexibility is essential in an industry characterized by changing market conditions, evolving customer and patient demands, and shifting regulatory requirements. CDMOs must be agile and adaptable to thrive in this dynamic environment. To meet the high expectations, we need a proactive approach to trend scouting and forecasting that allows us to anticipate and respond to emerging trends, enabling the company to remain at the fore-front of the industry. Particularly as customer demands become increasingly complex, specifically related to the need for dual manufacturing capabilities for blockbuster and small-batch orphan drugs, it is paramount that CDMOs maintain flexibility to adapt systems and processes in lockstep. We need to maintain a willingness to enhance our expertise, empowering us to work with new biologic molecules to support customers who are quickly advancing their products to meet changing patient expectations and requirements.