A Second Wave of Renaissance: Insights from CPHI Frankfurt 2025 Digital Event
There are a variety of challenges facing the small molecule drug sector, from U.S. tariff challenges and regulatory uncertainty to the demands of latest wave of complexity, meaning that CDMOs must act as proactive strategic partners.
Small-molecule drug products are a mainstay of the pharmaceutical industry and comprise the vast majority of commercially available drugs and a large proportion of those in development. While these low molecular weight drugs have simpler structures than the larger biological drugs, they are not without their own challenges, particularly as newer, more complex modalities gain prominence.
To discuss the industry trends, regulatory uncertainty, and new technologies shaping the small-molecule manufacturing sector, a panel of top executives assembled ahead of CPHI Frankfurt 2025 (1). Moderated by Elliot Berger, Board Director at Orientation Marketing and former Chief Marketing Officer at Catalent, the panel comprised: Gil Roth, President of the Pharma and Biopharma Outsourcing Association; John Chiminski, former Chair and CEO of Catalent; and Julien Meissonnier, former Chief Scientific Officer at Catalent and senior advisor.
Impact of Geopolitics and Tariffs
The current U.S. tariff landscape is “awfully confusing” and marked by significant uncertainty, specified Roth in his opening discussion of the panel session (1). Driven by policy initiatives coming out of the White House, he explained that the primary legal tool for imposing tariffs is the International Emergency Economic Powers Act (IEEPA), which has never been used for tariffs before. These tariffs target specific countries to inspire new trade deals, but their implementation is currently being challenged in the courts, with a Supreme Court hearing scheduled to take place shortly after the CPHI event. Roth also highlighted an ongoing Section 232 report by the Department of Commerce, examining the security and robustness of the pharmaceutical supply chain.
“The vibe I get is that the Department of Commerce is looking more for a scalpel and less for a blunt instrument when it comes to the use of the Section 232 recommendations,” Roth added.
While the report’s recommendations could range from tariff imposition to regulatory and financial incentives to spur domestic manufacturing, Roth highlighted the uncertainty over what actions the White House will ultimately take.
Beyond tariffs, Roth noted other policy challenges impacting the pharmaceutical CDMO sector, which could severely limit the ability of smaller and mid-sized companies to attract skilled foreign workers. He also referenced immigration enforcement incidents that have added to concerns about foreign workforce stability and discouraged some foreign investments in the U.S. Additionally, Roth pointed out ongoing uncertainty at the FDA, where workforce reductions and staffing concerns raise questions about the agency’s capacity to meet its regulatory commitments amid reauthorization discussions this fall.
These complex and evolving policy pressures make it essential for CDMOs and their clients to engage in proactive strategic discussions, particularly at forums like CPHI, emphasized Roth.
AI as a Transformational Force
Hoping to provide a more uplifting view, Chiminski alluded to the promise of artificial intelligence (AI) for the industry. AI represents a “second wave of renaissance” for the CDMO industry, with the potential to substantially improve the operational quality of pharmaceutical and biotech manufacturing while lowering costs, he pointed out.
Chiminski went on to explain that AI can make a significant difference in managing critical aspects of pharma manufacturing — such as deviations and quality issues — which should be used to help categorize and identify root causes and streamline corrective actions. He projected that AI could deliver an improvement of two to three percentage points in operational margins.
However, Chiminski also stressed the importance of cautious implementation of AI, highlighting regulatory guidance from bodies, such as the EMA and FDA, advising against the use of large language models, and that companies must develop bespoke AI solutions tailored to their internal environments.
While optimistic about AI's rapid acceleration, Chiminski cautioned that it is not a cure-all. He described the pharmaceutical development process as “hard work” that requires persistence and collaboration. Alongside this balanced perspective, Chiminski encouraged industry players to connect with AI solution providers and remarked that the next three to five years will be an important window for gaining competitive advantage through AI before it becomes an industry standard.
Small Molecule Innovation and Complexity
A new wave of complexity is now facing the small molecule space, asserted Meissonnier, which is being driven by emerging modalities such as targeted protein degraders, oligonucleotides, and peptides. These advanced small molecules bring unprecedented challenges in synthesis, formulation, manufacturing, containment, and handling, requiring fresh approaches and innovation to manage this novel complexity effectively, he explained.
Meissonnier urged CDMOs to boldly partner with new innovators and to use these partnerships as a learning experience to be able to better design new capabilities that are tailored to more complex modalities. He emphasized the need for continued specialization and investment in scientific expertise and infrastructure so that CDMOs remain indispensable in delivering the next wave of therapies.
Finally, Meissonnier reviewed the growing momentum in peptide and oligonucleotide therapeutics, likening their rise over the past decade to a transformative moment reminiscent of previous advances in small molecule drugs. He advised that future conversations should focus on defining the opportunities of these next generation platforms and reinforcing the vital role CDMOs play in driving manufacturing innovation that enables these sophisticated therapies to reach patients.
Company Spotlights on Capabilities and Investments
In addition to the panellists, top executives from leading CDMOs added their voice and opinion to the challenges they are seeing on a day-to-day basis.
Tom Sellig, CEO at Adare Pharma Solutions, highlighted the industry-wide challenges of technological deployment and tariffs impacting global supply chains, and emphasized AI as a key solution to improve manufacturing efficiency and development processes. His company is focusing on creatively optimizing manufacturing and packaging across multiple global facilities to reduce costs and accelerate time to market. He specifically pointed to Adare’s technological potential of leveraging oral solid dose forms to address complex chemistry and patient needs, which is notably important to the ongoing relevance of glucagon-like peptide-1s (GLP-1s).
Phillip MacNabb, CEO of Curia, acknowledged the fluctuating funding environments and shifting global supply chains as key challenges for the industry. As a global CDMO operating across India, Europe, and the U.S., Curia has refocused on being excellent across their service areas including sterile drug products, research and discovery, and API production, he specified. For other CDMOs, he emphasized the importance for them to refine their value proposition, find their niche, and maintain high service standards for customers.
Jeremie Trochu, CEO at Ardena, reiterated the challenges of geopolitical risks, macroeconomic pressures, and an evolving regulatory landscape. Referring to the volatility experienced during the COVID years, he discussed how the past few years have proven even more complex with increasing uncertainties surrounding trade policies, supply chain disruptions, and funding environments for biopharma innovators of all sizes. Echoing other’s insights, he emphasized the importance of digital transformation and how CDMOs must accelerate the adoption of automation, AI-enabled systems, and AI-driven discovery to maintain competitiveness and operational agility. For Ardena specifically, he highlighted how the company is building resilient, regionally diversified supply chains that reflect current realities, focusing on building footprints in key markets such as the U.S., Europe, and Asia, including hubs in China, Korea, and Japan.
Vivek Sharma, Executive Chairman at Cohance, revealed the three priorities shaping pharma’s future: strengthening supply chain resilience, advancing complex manufacturing, and deepening strategic partnerships. Sharma also emphasized the need to rebalance global supply networks to improve security and sustainability, while maintaining cost efficiency in line with the growth of biologics and gene-based therapies that are driving major investments in cutting-edge technologies, high-containment facilities, and skilled CDMO support. He also stressed that traditional vendor relationships are evolving into long-term, risk-sharing collaborations designed to accelerate drug development and commercialization, with these shifts defining a new, more sustainable, and innovation-driven era for the pharmaceutical industry.
Jarlath Keating, President of Solvias USA, mentioned the pharmaceutical industry’s rapid shift from small molecules to advanced modalities like biologics, cell and gene therapies, and messenger RNA (mRNA), with Solvias’ focus on supporting safe, efficient delivery of these next-generation therapies. He noted that these innovations are transforming manufacturing and enabling complex molecules to be produced at scale — pointing to gene editing, self-amplifying RNA, and living medicines as the next frontier to combine the practicality of small molecules with unprecedented precision.
Kent Payne, Managing Director and Board Member of Wilmington PharmaTech, alluded to the potential of AI to supercharge drug discovery and reduce the time and cost burdens associated with R&D. Additionally, he raised the issue of looming patent cliffs, which will increase and intensify competition and opportunities within the marketplace. As a result of these shifts, companies are seeking out greater innovation to be able to gain a competitive edge, meaning that agile and specialist market expertise is in greater demand, he noted.
Small Molecule CDMO Capabilities at CPHI
The following CDMOs showcased their latest innovations, expanded capabilities, and strategic investments at CPHI Frankfurt, and demonstrated the evolving technologies and services that they offer to meet industry demands and accelerate drug delivery worldwide.
Adare: Global CDMO with Expanded Capabilities
Adare is a global, technology-driven CDMO specializing in oral solid dosage forms, including multi-particulates, mini-tabs, tableting, and capsule filling, with expertise in taste masking, customized release profiles, and patient-centric dosing solutions. With manufacturing and packaging facilities in both the U.S. and Europe, Adare offers end-to-end services ranging from early drug development through commercial packaging and distribution. The company recently completed a new 3,000 m² packaging facility near Milan, to expand in-house blister packaging and warehousing capabilities, and are also investing in cutting-edge technologies to provide flexibility in dosage form development and rapid prototyping.
Ardena: Precision Medicine and Global Expansion
Presenting itself as a CDMO and CRO, Ardena specializes in precision medicine for biopharma innovators with integrated solutions from drug substance through drug product, analytics, bioanalysis, and CMC regulatory services. Ardena recently announced three core updates: the acquisition of a GMP oral solid manufacturing site in Somerset, NJ, the opening of a state-of-the-art nanomedicine GMP facility in the Netherlands, and increased investment in bioclinical capabilities in Europe and the U.S.
Bend Bioscience: Integrated Sites and Tech-Driven Innovation
Bend Bioscience, now operating three U.S. sites, demonstrated their combined technical and service capabilities to address complex drug development challenges. The Oregon facility specializes in formulation and drug delivery innovation, Florida covers end-to-end development and manufacturing, and Georgia brings expertise in tech transfers, solvent-based processing, and handling controlled and high-potency substances. Their integrated services span early development to commercial launch, with expanded capability for advanced dosage forms, orphan and rare diseases, spray-drying, and process scale-up.
Cohance Life Sciences: Multi-Modality, ADCs, and Nucleic Acids
Cohance Life Sciences emerged from the merger of seven pharma/biotech companies to create a multi-modality CDMO with 14 manufacturing and seven R&D sites and over 500 scientists. The company supports drug development from small molecule APIs through antibody-drug conjugates (ADCs) and nucleic acid therapeutics and delivers large-scale API production and complex chemistries. The company offers expertise in payload, linker, and complex biomolecule synthesis, with advanced oligonucleotide manufacturing.
Wilmington PharmaTech: Solid-State Chemistry and U.S. Expansion
Wilmington PharmaTech specializes in complex API process development centered on advanced solid-state and process chemistry. For over 20 years, they have supported more than 200 drug candidates and expanded into pilot and commercial-scale facilities, including new capabilities for HPAPI and ADC production by prioritizing speed, reliability, and U.S.-based manufacturing. The company has not missed a single delivery across hundreds of CGMP batches and is further expanding with over 50 acres for new facilities to meet rising demand.
Reference
Informa. Small Molecule: Top Pharma Execs on Burning Challenges and Promising Solutions to Explore. Special Informa Digital Event in Partnership with Orientation Marketing, Oct. 16, 2025. Available On Demand.