The Impact of Patient-Centric Formulations on Service Providers

Patient-centric drug development focuses on the patient’s experience and needs to better ensure adherence and enhance treatment. This approach collects and uses patient and caregiver input to inform both drug development and regulatory decision making (1). In 2025, FDA published a series of guidance documents that allows for the patient’s voice to be incorporated into the development process (2) and for a better patient experience.

Medicines, such as those used to treat cancer or rare diseases, developed and formulated using this tailored approach often require pharmaceutical companies to enlist the services of contract development and manufacturing organizations (CDMOs) to assist sponsor companies in performing formulation services, such as drug delivery innovations, predictive modeling, modified-release formulations, solubility, and bioavailability.

PharmTech spoke with Dr. Asma Patel, VP Global Commercial and Scientific Consulting–Drug Product, to find out how the growth in patient-centric drug formulations is impacting the CDMO market and how CDMOs can assist sponsor companies in this important work.

PharmTech: Which 2025 trends in drug formulation impacted outsourcing of formulation services?

Patel (Quotient Sciences): In 2025, advanced modalities such as peptides and RNA therapies increased formulation complexity, driving greater outsourcing to CDMOs with specialized scientific acumen and integrated platform capabilities. At Quotient Sciences, Translational Pharmaceutics enabled rapid, data-driven make-test cycles, accelerating development by more than 12 months and lowering costs. This method allows rigorous optimization of formulation parameters from human pharmacokinetic data. Industry dynamics have shifted, with CDMOs moving beyond mere transactional service providers to become strategic partners, providing adaptive manufacturing solutions, robust scalability, and strong regulatory support while maintaining high quality standards.

How has the shift to patient-centric formulations impacted CDMOs?

Patient-centric methodologies have reshaped CDMO operations, emphasizing pharmaceutical solutions tailored for convenience, adherence, and personalization, especially for pediatric and rare disease populations. [This can be demonstrated by] focusing on advanced formulation approaches like taste masking and flexible clinical dosing, boosting compliance and therapeutic outcomes. The adoption of digital and AI technologies supports predictive modeling and process optimization, reducing development risks and formulation failures. As a result, CDMOs now offer adaptive GMP [good manufacturing practice] manufacturing and integrated clinical testing to meet the complex needs of patient-centric drug development.

In developing patient-centric formulations, where can CDMOs best support sponsor companies?

CDMOs play a pivotal scientific role in the advancement of patient-centric drug formulations, particularly through expertise in enhancing solubility and bioavailability, and in developing innovative drug delivery systems, such as modified-release and targeted formulations. An integrated formulation strategy [can] enable rapid optimization using real-time clinical pharmacokinetic data, which minimizes development risk and shortens proof-of-concept timelines. Beyond initial design, CDMOs manage scale-up and ensure commercial readiness, addressing key patient requirements like reduced pill burden and improved dosing convenience. Their ability to align formulation science with manufacturing processes guarantees that patient-centric therapies remain scalable, regulatory compliant, and clinically effective.

How early do CDMOs get involved in discovery/formulation of a novel orphan or rare-disease drug?

CDMOs are increasingly integrated into the preclinical stages of orphan drug development, frequently commencing support during pre-formulation and discovery. Their scientific expertise is vital for maximizing the efficiency of limited API, expediting development timelines, and navigating intricate regulatory frameworks. Early-stage involvement [can] enable design of patient-ready formulations within significantly reduced timeframes, thereby conserving scarce APIs and facilitating accelerated regulatory pathways. Through the deployment of specialized infrastructure and adaptive manufacturing processes, CDMOs effectively address the unique challenges associated with small, heterogeneous patient cohorts and the bespoke requirements inherent to niche pharmaceutical manufacturing.

How important are CDMOs in the formulation and regulatory approval of orphan drugs?

CDMOs play a pivotal role in the development and commercialization of orphan drugs, leveraging specialized expertise in small-batch manufacturing, advanced packaging solutions, and global regulatory compliance. Their integrated platforms facilitate efficient management of complex CMC [chemistry, manufacturing, and controls] processes, ensuring rigorous quality standards and adherence to multi-jurisdictional regulatory requirements. By streamlining workflows and mitigating risks particularly associated with accelerated approval pathways, CDMOs enable rapid scale-up and supply chain resilience for niche patient populations. This strategic collaboration extends beyond formulation, encompassing risk management, and expedited market access, thereby maximizing therapeutic outcomes for orphan and rare diseases.

What do you anticipate for 2026 and beyond for outsourcing formulation services?

The outsourcing landscape for pharmaceutical formulation services is projected to exhibit robust growth, fueled by increased biotechnology investment, the increasing sophistication of novel therapeutic modalities, and mounting requirements for integrated development platforms. The sector is being revolutionized by the deployment of AI, machine learning, and advanced automation, particularly in the rational design of formulations, which facilitates substantial reductions in development cycles. Strategic alliances, such as the Quotient Sciences-Intrepid Labs collaboration (3), exemplify the utilization of predictive modeling to refine formulation parameters and curtail experimental iterations, thereby enhancing efficiency and scientific rigor in drug development.

References

1. FDA. CDER Patient-Focused Drug Development. FDA.gov. March 21, 2025. https://www.fda.gov/drugs/development-approval-process-drugs/cder-patient-focused-drug-development

2. FDA. FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making. FDA.gov. Oct. 23, 2025. https://www.fda.gov/drugs/development-approval-process-drugs/fda-patient-focused-drug-development-guidance-series-enhancing-incorporation-patients-voice-medical

3. Quotient Sciences. Quotient Sciences and Intrepid Labs form Strategic Partnership to Accelerate AI-guided Formulation Development. Press Release. Dec. 4, 2025.

About the author

Susan Haigney is lead editor for Pharmaceutical Technology®.