Reshaping the future of patient-centric drug development
Across the pharmaceutical industry, innovation has always been driven by a fundamental commitment to developing therapies that meaningfully improve patients’ lives. It’s a commitment that carries throughout the entire drug development journey, shaping not only what scientists are targeting during discovery, but how therapies are formulated, manufactured, and delivered. Over the years, many of the most impactful medicines are those that patients can access reliably, administer safely, and sustain over the course of their treatment.
Today, pipelines are shifting to include more complex molecules as technology continues to advance. Pharma companies are exploring complex biologics and large molecule-based drugs across therapeutic areas, and many are bringing new drugs to market faster than ever before. In 2025, the US Food and Drug Administration (FDA) approved 46 novel drugs, with biologics accounting for a quarter of approvals. At the same time, advances in concentration limits for biologics are enabling lower injection volumes, supporting more convenient delivery methods such as subcutaneous administration. Across modalities, the patient-centric imperative has become an essential pillar of drug development and manufacturing strategy.
Repurposing and expanding the indications of already approved therapies has also accelerated in recent years, extending the impact of existing drugs across broader patient populations. GLP-1 medications illustrate this convergence clearly. What began as a targeted therapy for type 2 diabetes management has grown into one of the most impactful therapies for organisations and patients alike, with expanded use in areas such as obesity and weight management. While the science behind GLP-1s is striking, accessible drug delivery formats – from prefilled syringes and self-injection devices to oral formulations that remove the injectable barrier entirely – have helped make these therapies the blockbuster drugs they are today. In many ways, this “pharma darling” has become a case study in what happens when clinical ambition and patient-centric design advance in parallel.
Industry forecasts and biopharma investment figures reflect the scale of the GLP-1 impact. In fact, a recent report from JP Morgan Global Research estimated that approximately 25 million Americans will be on a GLP-1 treatment by 2030, which is an increase of 250% from 2025. While demand for GLP-1s as an obesity treatment continues to grow, scientists are also evaluating GLP-1 receptor agonists across other indications, such as Alzheimer's disease, chronic kidney disease, and more. For pharma companies and manufacturing organisations, this expanding clinical and commercial footprint demands scalable sterile manufacturing without compromising quality or speed.
Meeting demand at scale requires more than capacity
Demand for GLP-1 therapies has tested the limits of global manufacturing infrastructure. These biologic and peptide-based therapies require aseptic processing, rigorous container integrity controls, and validated fill-finish operations, all at high volumes. Pharmaceutical companies navigating this environment are increasingly turning to strategic partnerships with contract development and manufacturing organisations (CDMOs) to balance commercial supply readiness and a commitment to quality.
Beyond capacity, CDMOs allow pharmaceutical companies to reap the benefits of technical expertise across molecule types, dosage formats, and regulatory requirements. CDMOs with a global footprint provide strategic flexibility that enables demand planning and supply chain resiliency. For companies developing complex biologics and peptide-based therapies like GLP-1s, the depth of experience and the breadth of capabilities are a prerequisite for reducing risk at scale. Engaging a partner early in development, rather than at point of scale-up, can help create end-to-end efficiencies and avoid unnecessary delays.
A broader shift: Patient centricity across therapeutic areas
The shift toward patient-centric drug delivery formats, from prefilled syringes in autoinjectors or on-body drug delivery systems, is straightforward. For patients managing long-term or chronic conditions, the feasibility of long-term adherence to a treatment plan is often linked to the ease of drug management. In fact, studies have shown that patients would rather have access to therapies that can be easily self-administered at home, rather than in clinical settings.
For pharmaceutical companies, this means rethinking, reformulating, and relaunching therapies that are more convenient to administer. The technical requirements, however, can be significant. For example, products that were launched in a vial format may need to be redeveloped as a high-concentration formulation to reduce injection volume in a prefilled syringe. Other products may require specialised filling lines or inspection processes. While these challenges are not insurmountable, they underscore why formulation and manufacturing expertise should not be considered in isolation.
Quality amid growth demands innovation
Quality is a non-negotiable, both for patient safety and regulatory compliance. This is especially true for sterile injectables, where product defects, such as visible particulates, can jeopardise safety and efficacy. As GLP-1 batch sizes grow, manual visual inspection processes become impractical. However, automated inspection methods created new sources of variability, such as distinguishing genuine defects from benign anomalies. Many manufacturing organisations are adopting hybrid human- and AI-assisted inspection approaches that bring greater consistency to defect identification. In high volume programmes, operational efficiency and high yield is essential to supply reliability.
Quality strategies must evolve at the same pace as the therapies they support. Technology adoption, robust quality infrastructure, and manufacturing partners with experience across the full sterile drug product lifecycle are all part of that equation.
Building a foundation for long-term success
The GLP-1 market is expected to continue to expand, in volume, indication, and the diversity of patients it serves. Across oncology, immunology, neurology, and metabolic diseases, the industry is navigating a growing pipeline, increasing patient expectations for convenient drug administration and evolving regulatory requirements that leave no room for quality compromise. Meeting these needs requires the industry to think beyond the challenges of today toward building the infrastructure for tomorrow’s innovation. In practice, this means strategic partnerships, robust quality systems, and manufacturing know-how to support next-generation therapies with patient-centric designs. Companies that are best positioned for long-term success will be those that keep scientific rigour, manufacturing discipline, and a genuine commitment to the patient at their core.
About the author
Christy Eatmon, global subject matter expert, steriles, Thermo Fisher Scientific, supports the global sales and business development teams in providing technical support, designing strategies, and supporting new business opportunities for Thermo Fisher's sterile manufacturing business. Eatmon has more than 15 years of experience in the pharmaceutical industry, with an emphasis on process engineering, product development, aseptic manufacturing, and filling. Previously, she supported the Greenville, North Carolina site as a senior principal scientist in the commercial operations and pharmaceutical development services areas.
