Outsourcing Formulation Activities May Advance Drug Development

Drug discovery can involve extensive research to identify new products for pharmaceutical companies to invest in. After discovery, the development of these products involves decisions on delivery options, materials selection, and quality operations to bring a new drug to market. Contract research organizations (CROs) and contract research, development, and manufacturing organizations (CRDMOs) assist sponsor pharmaceutical companies in performing the varied tasks involved in research and development.

PharmTech spoke with Tuneer Ghosh, executive vice president and head of CMC Services at Sai Life Sciences; Lidia Garcia Martin, MSAT & New Productions head, at Recipharm; and Marcio Temtem, vice president for Strategic Business Management at Hovione, to find out more about outsourcing of research and formulation activities.

Which Overall 2025 Trends Impacted the Pharma Industry the Most?

Garcia Martin: Throughout 2025, the pharmaceutical landscape was reshaped by the accelerating demand for targeted and increasingly complex therapies. Growth in oncology, immunology, and precision-medicine pipelines intensified the focus on molecules with higher potency and narrower therapeutic windows. These compounds offer notable clinical promise but demand far more sophistication in handling, containment, and process control.

As sponsors advanced more niche and personalized modalities, manufacturers were pushed to adopt holistic approaches to safety and quality. For example, integrating equipment design, facility layout, cleaning strategies, and procedural controls to manage occupational exposure and maintain compliance.

The industry also saw expanded investment in scalable containment solutions, digitalized process oversight, and the technical capabilities required to progress highly active compounds through development. Successful drug development depends on managing potent materials safely, efficiently, and with strong technical discipline.

Temtem: One of the trends that we see today is the increased complexity of small molecules. They are not so small anymore. These days, they have reached a size and complexity that require multiple chemical steps and very often high potency. On the formulation side, poor solubility and consequently poor bioavailability became a major trend. At Hovione, the platform of amorphous solid dispersions by spray drying has been gaining relevance in addressing these challenges, with multiple products approved each year.

Another trend is the “faster pace” at which new molecules are being added to development pipelines. AI is booming across the industry, and with this new way of synthesizing molecules also comes complexity and the need to debottleneck the chemistry, manufacturing, and controls section, achieving clinical supply and processes scale-up in much tighter timelines.

The third trend is the growing concern about the regionalization of supply chains. In our case, we look at this as an opportunity. Hovione has sites in three continents: in Asia (China, Macau), in Europe (Portugal, Ireland), and the United States. All these sites are regularly inspected by the medical authorities, including FDA, and we believe this is an opportunity for Hovione to continue serving our clients globally.

What Standout Trends Specifically Impacted Drug Formulation in 2025?

Ghosh: In 2025, drug formulation was shaped by the rise of complex modalities, broader use of AI-enabled tools, increased focus on patient-centric dosage forms, and advances in drug delivery technologies. These trends increased formulation complexity and regulatory expectations. As a result, clients increasingly gravitated toward CRDMOs that offer integrated services across formulation, analytical development, scale-up, and regulatory readiness under one roof. The growth of peptides, PROTACs [proteolysis targeting chimeras], and gene therapies, among others, also accelerated the shift away from fragmented outsourcing toward full-service CRDMO models.

How Early Do CRDMOs Typically Get Involved in Orphan or Rare-Disease Drug Development?

Ghosh: At Sai Life Sciences, we are often engaged at very early stages of orphan and rare-disease programs, starting with preclinical formulation screening and extending through first-in-human studies. Early involvement allows integrated teams to assess feasibility, define formulation strategy, support small-batch manufacturing, and align development decisions with downstream regulatory requirements. More broadly, this reflects a growing trend where customers and clients involve CRDMOs earlier in orphan programs to manage compressed timelines, small patient populations, and complex formulation challenges more effectively.

How Important Are CRDMOs in the Formulation and Regulatory Approval of Orphan Drugs?

Ghosh: CRDMOs play a critical role in orphan drug development, where flexibility, speed, and specialized expertise are essential. They support formulation and delivery challenges, including low-dose, pediatric-friendly, and alternative dosage forms, while contributing to regulatory strategy. Integrated formulation, analytical, and regulatory teams should work together to generate robust data packages, conduct stability and comparability studies, and align development with accelerated or orphan approval pathways. This integrated model helps clients advance programs efficiently toward regulatory approval.

What Do You Anticipate for Outsourced Formulation Services in 2026 and Beyond?

Ghosh: Outsourced formulation services are expected to evolve toward deeper integration, greater use of AI-driven development tools, and increased demand for specialized delivery technologies. Growth in personalized and precision medicine will drive more tailored formulation approaches, particularly for complex and low-volume programs. Clients are also likely to favor long-term partnerships with integrated CRDMOs who can support formulation, analytics, manufacturing, and regulatory needs across the development lifecycle, moving beyond transactional outsourcing models.

Which Trends Do You See Driving Innovation and Drug Development in 2026?

Temtem: Some of the trends I mentioned before, such as increased complexity and acceleration, are being managed by Hovione, with a focus on developing new hardware and software.

On the hardware side, we recently signed a partnership with GEA, one of the leading suppliers of continuous tableting rigs for the pharma industry. As part of this partnership, we have launched a new solution for the continuous manufacturing of tablets—the new ConsiGma CDC Flex.1 Such a disruptive offer enables having three modes of operation in one single instrument. There’s an opportunity to run the press in batch tableting or running the equipment in continuous mode at modes that would typically require distinct units, for very low or commercial throughputs. The unit has been designed with this modularity, expecting this flexibility to accelerate development while minimizing API use and learner scale-up.

Another hardware example is our partnership with Microinnova to develop modular continuous-flow setups.2 With the use of Module Type Packages, enabling “plug-and-produce” in a process orchestration that builds versatility and flexibility on the shop floor. Chemists start from the early stages of development, working and establishing, in a “Lego fashion,” the setup that will later be used in commercial manufacturing.

On the software side, we have also been exploring new ways of doing sustainable chemistry, with micellar chemistry surfacing as one of the neatest additions to our toolbox. This proprietary process technology enables the use of less energy-intensive conditions, lower levels of precious-metal-containing catalysts, and reduced use of organic solvents in the chemical synthesis of APIs.

Another example is modeling, where Hovione has spent the past 10–15 years developing tools (databases, models, proprietary lab setups, etc.) that enable formulation development, scale-up, and process transfer with minimal API use and in a short time frame, particularly in the areas of solubility enhancement through amorphous solid dispersions.

Garcia Martin: A key trend we can expect to see drive innovation in 2026 is the surge in high-potency APIs for high-potency drug development, as more therapies rely on highly active compounds for targeted efficacy. This shift places a premium on specialist capabilities to ensure both operator safety and predictable product quality, particularly advanced containment, automation, and data-driven process control.

The next wave of progress will likely stem from robotics and closed-system technologies that reduce manual handling and mitigate exposure risks, alongside digitalized monitoring that strengthens science-based decision-making and enhances risk management. As developers seek to move potent candidates from early development toward commercial readiness, technical transfer expertise and integrated containment strategies will become differentiators.

References

1. Hovione. Hovione and GEA Set New Standards for Continuous Tableting. Press Release. Dec. 2, 2025. https://www.hovione.com/press-room/press-release/hovione-and-gea-set-new-standards-continuous-tableting
2. Hovione. Hovione and Microinnova Partner to Advance Modular Flow Chemistry for Multi-Purpose Manufacturing. Press Release. Sept. 24, 2025. https://www.hovione.com/press-room/press-release/hovione-and-microinnova-partner-advance-modular-flow-chemistry-multi-purpose-manufacturing

About the author

Susan Haigney is lead editor of PharmTech.