Angela Strzelecki, PhD, is senior vice president of the Roquette Group and CEO of Roquette’s Health & Pharma Solutions Business Unit

Angela Strzelecki

Scientific and technological background. Image of dna molecule with technological elements. | Image Source: ©Alex -stock.adobe.com

The pharmaceutical industry is entering a new era, where the traditional boundaries between pharma, biopharma, and consumer healthcare are blurring. For those working at these intersections, multiple trends, including a global aging population, rising healthcare costs, and greater demand for better patient outcomes, are reshaping how therapies are developed, delivered, and experienced. Preventive health and wellness are becoming the new norm (e.g., GLP-1 weight loss drugs, dietary supplements, digital health monitoring, and regular health screenings). Personalized medicine is getting closer to clinical reality. Advances in biopharma are unlocking treatments for complex and rare conditions. And digital technologies (e.g., artificial intelligence [AI]-enabled formulation development to 3D printing) are opening new possibilities for precision, efficiency, and more patient-centric medicine.

This article explores how these trends are driving the next generation of medicine and what they will mean for the future of pharmaceutical innovation, patient outcomes, and industry leadership.

Personalized Medicine Moves Closer to Reality

For decades, pharmaceutical manufacturing has been built around scale and standardization, a highly efficient approach for producing millions of identical tablets that meet various patient needs. Age, metabolism, comorbidities, and genetic background all influence how medicines perform, while factors such as taste, convenience, and ease of administration significantly affect whether patients follow treatment regimens consistently. Drug non-adherence remains a major challenge globally, with an estimated 30% to 50% of patients failing to take their prescribed medications as directed.

This is driven in part by complex dosing schedules, as well as inconvenient or unpleasant delivery formats. To address this, the industry has recognized that innovation in therapeutics must be matched by innovation in delivery. This is particularly important for certain patient groups, such as the elderly and children, as they often prefer dosage forms that are easier to swallow and more palatable.

In a collaboration, clinicians at Gustave Roussy Hospital in France worked with formulation experts at Roquette to develop a child-friendly gummy format for a combination antibiotic that was not available in an existing commercial medicine.

Using plant-based excipients, they developed a gummy format that achieved the required pharmaceutical performance while significantly improving palatability compared with existing oral suspensions. This type of patient-centered formulation development reflects a broader industry direction: moving beyond “one-size-fits-all” medicines toward therapies designed with specific patient needs in mind.

3D Printing Is Creating New Possibilities for Precision Therapies

3D printing could play a major role in making personalized medicine a clinical reality. Additive manufacturing enables the creation of highly customized dosage forms, including medicines with multiple APIs and staggered release profiles designed to reduce pill burden and simplify treatment regimens. This is particularly promising in areas such as oncology and rare diseases, where patient populations are small and precision dosing is critical. For rare conditions, 3D printing could help overcome some of the economic limitations associated with conventional large-scale manufacturing by enabling smaller production runs and rapid prototyping of individualized therapies.

However, significant barriers remain between technical feasibility and robust commercial-scale production. While the innovation pipeline and regulatory interest in 3D-printed drugs continues to expand, there is currently only one FDA-approved 3D-printed drug on the market (for epilepsy). Bridging this gap will require continued advances in formulation science, deep excipient knowledge and innovation as parameters, such as printability, flow behavior, rheology, and drug release, are all heavily influenced by excipient selection. Closer collaboration between regulators and manufacturers will also be essential to establish approval pathways that support innovation while maintaining patient safety and product quality.

Biopharma Innovation Is Redefining what Medicine Can Treat

Few areas of healthcare are advancing as rapidly as biopharma right now. Cell and gene therapies, advanced biologics, and next-generation vaccines are transforming the treatment landscape, particularly for rare and previously untreatable diseases, such as spinal muscular atrophy and inherited retinal dystrophies. But the success of these therapies depends not only on the active treatment itself, but also on the formulation and delivery systems that preserve stability, improve manufacturability, and support accessibility.

Adenovirus vectors, for example, are widely used in vaccines and gene therapies but are highly sensitive to environmental stressors such as heat, light, and freeze-thaw cycling. Stabilizing excipients, such as cyclodextrins, can help protect sensitive biologics during manufacturing and storage, improving stability and supporting broader patient access. As innovation in biopharma continues to accelerate, advances in therapeutic science must be matched by equal progress in formulation and delivery technologies.

AI Could Transform Pharmaceutical Development–But Only with the Right Data

Digital technologies and AI are also beginning to reshape pharmaceutical development. Predictive AI tools have the potential to drive formulation development and support more efficient regulatory documentation. However, the effectiveness of these systems depends entirely on the quality of the underlying data. Much of the data used in pharmaceutical research today remain fragmented, incomplete, or stored in incompatible formats. In one internal exercise at Roquette, researchers began with raw data from 20,000 separate formulation experiments and found that only 600 were fully complete. Just 3% proved viable for AI model training.

Companies that want to get the most out of these digital tools need to invest in robust data management through tools such as electronic laboratory notebooks and rigorous traceability, while systematically recording failed assays. AI models cannot predict what they have not had the opportunity to learn. So-called digital formulation assistants, designed to optimize formulations and support regulatory submissions, have the potential to be transformative. But their impact will only be as strong as the data and governance that underpin them and the security and accountability frameworks that protect patient information.

Final Thoughts: Why Collaboration Matters More than Ever

The advances shaping the future of medicine from AI-enabled formulation tools to personalized therapies and next-generation biologics cannot happen in isolation. Real progress will depend on collaboration across the healthcare ecosystem, bringing together formulation scientists, manufacturers, regulators, clinicians, and technology partners to solve increasingly complex challenges.

This creates an important opportunity for leaders across the industry: not only to accelerate innovation, but to build cultures where cross-functional collaboration, adaptability, and shared problem-solving can thrive. As scientific advancement continues at pace, the organizations best positioned for success will be those able to connect expertise across disciplines and translate innovation into practical, accessible solutions for patients.

Chapman SCE and Chan AHY. Medication nonadherence - definition, measurement, prevalence, and causes: reflecting on the past 20 years and looking forwards. 

Stoops M, et al. Clinical implementation of a paediatric 3D-printed combination of Sulfamethoxazole and Trimethoprim. 

Angela Strzelecki, PhD, Senior Vice President of the Roquette Group and CEO of Roquette’s Health & Pharma Solutions Business Unit

Angela Strzelecki, PhD, is senior vice president of the Roquette Group and CEO of Roquette’s Health & Pharma Solutions Business Unit.

Articles

Traditional scale-driven manufacturing is giving way to patient-centric, precision approaches as preventive health demand rises and personalized medicine becomes more feasible. Nonadherence (30%–50%) underscores the need to innovate not only APIs but also delivery formats, particularly for pediatric and geriatric populations. 3D printing offers individualized, multi-API, modified-release dosing and could enable economically viable small-batch production, though excipient science and regulatory pathways remain limiting. Biopharma advances heighten the importance of stabilization and delivery technologies. AI can accelerate development only with high-integrity, governed data.

Advances in personalized medicine, biopharma, and digital technologies are unlocking treatments for complex and rare conditions.