This past July, the World Health Organization and the United Nations Office on Drugs and Crime unveiled in a landmark report (Contaminated Medicines and Integrity of the Pharmaceuticals Excipients Supply Chain) that there are persistent and preventable threats of contaminated medicines with industrial-grade toxic chemicals, notably diethylene glycol and ethylene glycol. The result is lost lives and compromised patient health. The report claims that in the past 90 years, there have been 25 documented incidents of excipient contamination, resulting in more than 1,300 deaths worldwide. The agencies point to systemic vulnerabilities in the global supply chain of pharmaceutical excipients as the culprit. WHO and UNODC are urging global action to close regulatory gaps and strengthen oversight of excipient supply chains.

Additional challenges include geopolitical instability, raw material shortages, economic uncertainty, and manufacturing bottlenecks, all of which can disrupt the pharmaceutical excipients market (BCC Research). While working to overcome these disruptions, excipient suppliers are focused on a shifting pharma landscape that is calling for multifunctional excipients for more personalized medicine, natural and plant-based excipients for fewer side effects, and nanoexcipients for more targeted drug delivery.

“By ensuring reliable supply, advancing sustainability, and supporting the precision demands of personalized medicine, excipients are helping shape the future of drug development,” says Dr. Sreejit Menon, Head of Life Sciences R&D, North America – Croda. “Excipients are no longer passive ingredients; they are strategic enablers of therapeutic innovation.”

Drug Development & Delivery’s annual excipient report highlights this innovation and reveals how excipient suppliers are doing their part to ensure a reliable, resilient, and compliance-driven supply chain.

Ashland: Collaborative Customer-Centric Approach

The pharmaceutical industry is wit­nessing a surge in interest around novel chemistries that enable nanoparticle drug delivery — particularly those that offer bio­compatibility, tunable release profiles, and scalability for complex formulations. Among these, bioresorbable polymers, such as Poly D,L-lactide-co-Glycolide (PLGA), Poly D,L-Lactide (PDLLA), cus­tomized variants, and cationic chemistries, have emerged as frontrunners due to their proven safety, versatility, and regulatory acceptance.

The ability to modulate degradation rates through compositional changes, as well as the flexibility to functionalize with tailored end groups, offers versatility for precision medicine and personalized ther­apies. “Ashland has responded to this growing demand by expanding our via­tel™ bioresorbable polymer platform, which now supports a broad range of nanomedicine and parenteral applications — including cationic variants for nucleic acid delivery,” says Sean McMahon, PhD, Director of Pharmaceutical Business Devel­opment and Strategic Marketing, Injecta­bles, Ashland.

The vitatel scalable technology plat­form enables the creation of advanced drug delivery systems, including injectable hydrogels, nanoparticle carriers, drug de­pots, implants, stents, device coatings, and tissue regeneration scaffolds and wound closure devices.

Dr. McMahon explains: “These poly­mers are metabolized into non-toxic byproducts and are compatible with mod­ern processing techniques like solvent-based processing, 3D printing, hot melt extrusion, and injection molding — mak­ing them ideal for both clinical and com­mercial scale-up.”

Customized polymer solutions are de­veloped at Ashland through a collabora­tive engagement, enabling the company to tailor excipients to meet drug compound needs in terms of stability, as well as drug delivery needs related to tissue targeting or processing requirements. He adds: “The recent completion of a $15 million facility expansion in Mullingar, Ireland, significantly

enhances Ashland’s capacity to accelerate drug development programs. This means we can help our customers bring more life-changing medicines to pa­tients, reinforcing our position as a leader in polymer innovation and R&D.”

BASF Pharma Solutions: Virtual Guidance Empowers Formulators

Formulators are increasingly encoun­tering challenges with poor drug solubility, as many new drug candidates are difficult to solubilize. This can lead to suboptimal dissolution profiles and reduced bioavail­ability. To address these issues, solubilizers like BASF’s Kolliphor® HS 15 or Soluplus® can be used in various formulations. “To assist formulators in identifying suitable solubilizer options, BASF developed ZoomLab®, a virtual formulation assistant that applies algorithm-based analysis to offer science-backed formulation guid­ance,” says Gloria Ho, PharmD RPh, Global Technical Marketing Manager, BASF Pharma Solutions.

Formulation guidance is also needed in the regulatory landscape, particularly as nitrosamines have emerged in the last year as a major concern for authorities worldwide. In response, BASF proactively developed nitrite-tested grades of povi­done, copovidone, and crospovidone, which are supported by validated nitrite testing protocols. Additionally, to help cus­tomers navigate the nitrosamine risk, a “Nitrosamine Risk Assessment and Mitiga­tion” app is available for users of Zoom­Lab®. “The app offers structure-based prediction tools and formulation guidance, empowering formulators to assess ni­trosamine formation risks and select ap­propriate excipients with confidence,” says Claudia Scholten, Strategic Marketing & Innovation Manager Excipients, BASF Pharma Solutions.

Aligning with regulatory expectations are customer sustainability goals, particu­larly in Europe where demand for trace­able supply chains is accelerating. To that end, a shift toward sustainable and trace­able sourcing in the future will be shaped by a balanced portfolio that includes RSPO-certified, SuCCESS-certified, and re­duced product carbon footprint (rPCF) ex­cipients, says Ms. Scholten. “Today, we are focusing on our lipids portfolio, which is 100% RSPO-certified, ensuring responsi­ble palm sourcing.”

There is also a trend towards more personalized therapies, which is directly in­fluencing the demand for tailored excipi­ent solutions (e.g., for targeted delivery, controlled release, bioavailability en­hancement). At BASF’s new GMP Solution Center in Wyandotte, Michigan, the focus is on high-performance poloxamers and other surfactants that are uniquely suited to the needs of precision therapies by, for example, allowing specific gelling behav­ior or meeting a very narrow specification range, she says.

Croda: Vast Surfactant Toolkit for Advanced Drug Delivery

The pharmaceutical excipients market faces multiple pressures, including geopo­litical instability, raw material shortages, and stringent regulatory oversight. These challenges have highlighted the impor­tance of supply chain resilience and com­pliance-driven innovation. To mitigate disruptions, Croda has strengthened re­gional partnerships and implemented multi-source procurement strategies, en­suring reliable access to high-quality ma­terials. “Embedding compliance into development workflows has accelerated robust excipient advancements,” says Dr. Sreejit Menon, Head of Life Sciences R&D, North America – Croda.

Innovation remains central to Croda’s business, he says, helping customers meet strict regulatory standards while also pro­viding them with a wide surfactant toolbox. For example, Super Refined™ Poloxamer 188 and Tween™ 20 HP LSA were devel­oped to enhance cell viability in upstream bioprocessing and improve biologic for­mulation stability, respectively. “Super Re­fined Poloxamer 188 acts as a reliable shear protectant and protein stabilizer, while Tween 20 HP LSA features ultra-low peroxide and aldehyde levels and a con­trolled fatty acid profile, ideal for enzymat­ically sensitive formulations,” he explains. “Together, these excipients support cus­tomers in achieving high-performance, regulatory-compliant formulations in a geopolitically charged environment.”

Looking ahead, organic excipients are expected to dominate the sector within the next four years (The Business Research Company). As sustainability and biocom­patibility become central to formulation strategies, organic excipients, particularly those from renewable, non-animal sources, are gaining traction due to their favorable safety profiles and reduced en­vironmental impact. Their adoption, how­ever, will depend on overcoming variability and ensuring scalability.

“Our high-purity lipid technologies for mRNA delivery illustrate how organic ma­terials can meet the stringent demands of advanced therapeutics, undergoing rigor­ous purification for consistency and per­formance,” says Dr. Menon. “Refined synthetic excipients, such as Super Refined Poloxamer 188 and Tween 20 HP LSA, re­main indispensable in biologic formula­tions where ultra-low impurity levels are critical. The future will likely be a hybrid landscape, with organic excipients leading in some areas and refined synthetics sup­porting others.”

Personalized medicine is further shap­ing excipient innovation. Tailored therapies demand excipient systems that are equally precise, supporting route-specific delivery, enhanced bioavailability, and patient-spe­cific therapeutic goals. High-purity lipid platforms for nucleic acid delivery are op­timized for encapsulation efficiency, cellu­lar uptake, and endosomal escape – all critical for personalized therapies. He says: “Similarly, excipients such as Tween 20 HP LSA or Super Refined Poloxamer 188, with ultra-low impurity profiles, stabilize pro­tein-based therapies, ensuring each for­mulation meets its intended patient population’s needs.”

As nanoparticle delivery systems gain prominence, interest is rising in novel sub­stances that can enhance their perform­ance. Lipid carriers, surface modifiers, and polymeric stabilizers are increasingly de­signed to preserve nanoparticle integrity and improve intracellular delivery. “Our high-purity lipids for mRNA and siRNA therapeutics support stability and consis­tency in lipid nanoparticle systems while boosting delivery efficiency, critical for next-generation vaccines and gene thera­pies,” says Dr. Menon. “At the same time, our work with novel surfactants and poly­mers focuses on modulating immune re­sponse and optimizing biodistribution, expanding the toolkit for advanced drug delivery.”

A practical example of excipient im­pact is seen with customers developing monoclonal antibody injectables. Protein aggregation and oxidative degradation present significant challenges, and con­ventional surfactants can increase instabil­ity, compromising both shelf life and efficacy, he describes. Pointing to real-world scenarios, he says: “Super Refined Poloxamer 188 reduced oxidative stress in a high-concentration protein formulation, enhancing stability and supporting lower immunogenicity risk, while Tween 20 HP LSA stabilized a formulation requiring a non-ionic surfactant, supporting successful scale-up and regulatory submission. These cases demonstrate how carefully designed excipients, aligned with therapeutic needs, can transform an unstable formulation into a commercially viable biologic.”

Evonik Health Care: Excipients for Difficult-to-Formulate Substances

Evonik is involved in the development of excipients and solutions for poorly sol­uble APIs and biologics, offering polymeric carriers as well as functional capsules that enable the delivery of difficult-to-formulate drug substances. The company develops formulations and supplies excipients for lipid nanoparticles and polymeric nanoparticles.

Evonik takes a proactive approach to current supply chain disruptions and reg­ulatory hurdles by diversifying suppliers. Dr. Tom Tice, Senior Director Global Strategies & Technical Marketing Par­enteral Drug Delivery, Evonik Health Care, says the company has a robust global net­work to avoid dependence on single re­gions for raw materials. As part of its global network, Evonik supplies excipients locally around the world via regional warehouses, and bioresorbable excipients for long-acting injectables are manufac­tured in Europe and the US. When it comes to sustainability, Evonik’s excipients are manufactured under stringent quality systems, and the company actively en­gages with regulators to stay ahead of evolving compliance standards.

“We are implementing digital tools for supply chain visibility and predictive ana­lytics, which enables us to anticipate and respond to disruptions more effectively,” says Dr. Tice.

Thomas Froehlich, Global Product Manager Oral Drug Delivery Solutions, Evonik Health Care, adds that an addi­tional challenge is increasing complexity of oral drug formulations. “Evonik is meeting this challenge by investing in, and building up, a robust body of knowledge on ad­vanced polymer technologies. We use this to create the customized excipient solutions that are needed to support these complex formulations and meet the needs of both immediate- and controlled-release pro­files,” he says.

Evonik is also evaluating its portfolio of functional organic excipients due to an increasing regulatory preference for natu­ral and organic excipients that are favored in regulatory submissions because of their safety profiles. “Biocompatibility and biodegradability are becoming increas­ingly important for drug developers be­cause these properties enable formula­tions to be more sustainable and patient friendly,” says Mr. Froehlich. “As the num­ber of biologics and sensitive APIs being developed increases, there is also a greater need for organic excipients. This is because these materials often exhibit bet­ter stability and performance in complex formulations.”

Personalized medicine is also trans­forming the way excipients are developed. “One major trend is the growing need for tailored release profiles — precision ther­apeutics often require drugs to be released at specific sites or times within the body,” says Mr. Froehlich. “EUDRAGIT® and EU­DRACAP® platforms are designed to meet these demands, offering flexible solutions for controlled and targeted drug delivery.”

For parenteral applications, Evonik’s RESOMER® and LACTEL® bioabsorbable polymers are tunable to meet the needs of precision therapeutics. RESOMER and LACTEL polymers have been used in com­mercial long-acting injectable products since 1986. These polymers enable the re­lease of the active ingredients over a de­sired period of weeks or months for many classes of drugs and continue to be an ex­cipient for development of new long-acting injectables and polymeric nanoparticles. Moreover, RESOMER and LACTEL are being tested in multiple immunotherapy applications, including treatments for var­ious cancers, allergies and other autoim­mune diseases.

The rise of individualized therapies also calls for excipients that can scale effi­ciently from small clinical batches to full commercial production. Evonik has engi­neered its excipients to support this scala­bility. The company also works closely with pharmaceutical partners to adapt excipient properties such as solubility, permeability, and stability, ensuring they align with the needs of specific patient populations for customized therapies.

A recent project involved EUDRACAP, a customizable enteric capsule system. One of Evonik’s pharmaceutical partners was developing an oral biologic drug, but faced significant hurdles — namely, degradation in the stomach and poor ab­sorption in the intestine. “By leveraging EUDRACAP, we were able to enable tar­geted release in the intestinal tract, effec­tively shielding the active ingredient from gastric acid and enhancing its bioavail­ability,” says Mr. Froehlich. “What made this solution particularly impactful was the capsule’s modular design, which allowed for rapid prototyping and seamless scale-up. This not only resolved the formulation issue, but also supported the client’s goal of accelerating development timelines and reducing costs.”

Gattefossé: Lipid Excipients Are A Readily Accessible Source of Innovation

With ongoing supply chain uncer­tainty and increasingly complex APIs in de­velopment, it is critical that US innovators have access to a reliable supply of func­tional excipients. Gattefossé partners with customers to de-risk both formulation de­velopment and commercialization. To bet­ter serve its customers worldwide, Gattefossé has invested in the construction of a third manufacturing facility (in addi­tion to France and Singapore), strategically located in Lufkin, Texas.

“The Lufkin facility specializes in lipid-based excipients to serve both the human and animal health markets, providing dedicated manufacturing capacity for North American customers,” says Nick DiFranco, MEM – Senior Marketing Man­ager, Pharmaceutical Division, Gattefossé USA. “This expansion enables Gattefossé to provide faster delivery, greater produc­tion flexibility, and a more resilient supply chain, even amid market uncertainty.”

The Lufkin facility achieved EXCiPACT certification in early 2025 and will soon supply lipid excipients to the North Ameri­can market. This facility, together with a Technical Center of Excellence in Paramus, NJ, offers an end-to-end solution for North American customers – from excipient selection and screening to large-scale supply.

“Gattefossé’s Lufkin plant arrives at a pivotal moment for the North American market,” says Mr. DiFranco. “The pharma­ceutical industry is at an inflection point, with modalities such as PROTACs and mo­lecular glues advancing into clinical trials, and the rise of GLP-1 receptor agonists fu­eling new interest in oral peptide delivery. These molecules face significant permeabil­ity challenges that traditional formulation approaches may not adequately address. If formulators wish to succeed in these prom­ising segments, they must be willing to change their perspective and work with the body to enhance drug exposure.”

Lipid excipients, which rely on fatty acid chains derived from plants, can lever­age the body’s natural processes to over­come in vivo obstacles and access alternative absorption pathways. When in­gested, lipid excipients trigger the diges­tion process, forming colloidal structures that fight recrystallization and maintain the drug in a supersaturated state, he ex­plains. This process can also mitigate food effect to minimize dosing variability.

For poorly permeable compounds, lipid excipients containing medium-chain fatty acid esters (e.g., Labrasol® ALF) en­hance both transcellular and paracellular absorption through supersaturation and tight junction modulation. This is a useful formulation tool for BCS Class III/IV com­pounds as well as oral peptides, says Mr. DiFranco. Highly lipophilic compounds can also utilize long-chain fatty acids (e.g., Maisine® CC) to access lymphatic uptake and bypass first pass metabolism.

“By harnessing the body’s natural processes, lipid excipients provide distinct advantages for both emerging small mol­ecule modalities and orally administered peptides, serving as a readily accessible source of innovation,” he says.

Lubrizol: Building Formulator Confidence in Novel Excipients

Excipient suppliers face a regulatory Catch-22 that is stifling innovation on all sides. As drug molecules become more complex, the need for novel excipient technologies to overcome their formulation challenges has snowballed. This is particularly the case with the growing number of insoluble and poorly bioavailable active pharmaceutical ingredients (APIs).

“Many excipients with precedence of use are decades old and suboptimal for transforming today’s challenging APIs into effective therapeutics,” says Meera Raghuram, Director of Regulatory and Sustainability Strategy, Lubrizol. “However, regulatory approval ambiguity for novel excipients means formulators are risk-averse, preferring to use familiar ingredients even when better novel options exist. In turn, excipient manufacturers are reluctant to develop new excipients whose market success is essentially dependent on their assessment as part of a complete drug product submission package.”

Thus, she says Lubrizol believes early collaboration between excipient suppliers and pharmaceutical manufacturers is the solution for building formulator confidence in novel excipients and supporting the development of promising brick-dust APIs. It can enable inclusion of the excipient in an API’s non-clinical toxicology studies, for example, helping to demonstrate safety and highlight any data gaps. Lubrizol supports this model by partnering with formulators to co-develop data and regulatory submissions, using Drug Master Files (DMFs) and data-sharing agreements in regions where DMFs are not used. She adds that bridging arguments – using an approved excipient’s safety data to support a novel excipient where the two have similar chemistry – is also an effective strategy.

Regulatory bodies are increasingly focusing on the patient experience, so selecting a novel excipient that enables more patient-centric drug delivery is highly desirable, she says. Lubrizol’s Apinovex™, for example, is a high molecular weight polyacrylic acid excipient designed to provide processing and formulation benefits for spray-dried amorphous solid dispersions (ASDs).

“Apinovex enables formulators to enhance the solubility of brick-dust APIs and develop more efficient oral dosage forms with high, stable drug loading,” says Ms. Raghuram. “This maximizes the API’s benefits and allows a customized, consistent extended-release profile.”

API particle size reduction is an effective way to combat solubility issues by creating nanoparticles of crystalline API that can be used for virtually any route of administration. Polymeric micelles are another proven method to create stable nanoparticles. Lubrizol’s Apisolex polymer for parenteral and injectable formulations, for example, utilizes micellar technology to encapsulate molecules of hydrophobic API. This enhances solubility by up to 50,000-fold, with minimal API loss and more than 90% API recovery.

Additionally, the high drug-loading capabilities of novel excipients such as Lubrizol’s Carbopol® polymer can allow for smaller, easier-to-swallow tablets – key considerations for pediatric and geriatric populations – and reduced dosing frequency. Carbopol BioSense Polymer is a naturally derived rheology modifier and sensory enhancer for use in topical applications, including serums, lotions, and creams. “Responsibly sourced from sustainable eucalyptus plantations under certified forest management practices in Brazil, it is biodegradable, non-GMO, Cosmos-approved, and addresses the 12 principles of green chemistry,” says Ms. Raghuram.

In one example, Carbopol enabled an ophthalmic solutions manufacturer to create a market-leading, easy-to-use eyedrop that enables clearer vision. Key benefits included superior water-binding capabilities, improved wetting properties, and greater dwell time on the eye’s surface, she explains.

Thermo Fisher Scientific: Tailoring Excipients for Precision Medicine

The global precision medicine market is experiencing robust growth, accounting for at least a quarter of all new drug ap­provals annually. In 2024, the FDA ap­proved numerous personalized medicines, with reports suggesting 18 to 38 new drugs classified as precision medicine. “The rise of precision medicine is altering how formulators approach new product development and patient care,” says Anil Kane, Executive Director, PhD, Global Head of Technical & Scientific Affairs at Thermo Fisher Scientific. “Instead of look­ing to treat a large population with one blanket therapy, pharmaceutical compa­nies are shifting to a more patient-centric approach that considers factors unique to an individual.”

Precision therapies typically have pa­tient populations of around 200,000, in­dicating a small market requirement. APIs and formulations designed for precision drug products are often highly complex, requiring specialized handling and solu­tions to challenges such as stability, ab­sorption, and processing. Similarly, they often utilize specialized manufacturing procedures. Throughout this process, se­lecting the right amount of the appropriate functional excipients is critical in overcom­ing complex formulation challenges.

Excipients play an important role in the oral solid drug product performance with respect to manufacturability and sta­bility. This is in addition to its release pro­file’s ability to deliver the drug at the right concentration to the appropriate site for the optimum outcome. “Excipients take on a similar role for sterile injectable products in regard to solubilization, by maintaining pH, osmolality, preservation, lyophilized cake formation/stability and other aspects,” says Dr. Kane. “In this way, excipients can solve formulation issues for many biotech and biopharma clients.”

For example, Thermo Fisher Scientific leveraged excipient se­lection to improve the solubility and bioavailability of a poorly soluble and permeable BCS Class IV drug candidate. He explains that Thermo Fisher’s computer-based modelling (AI) tool – Quad­rant 2® – and simulation played a critical role in both excipient and technology selection for solubility enhancement. Modelling predicted any interaction of functional groups of excipients and APIs, as well as the technology selection predicting “spray drying as a method of creating amorphous dispersions,” with a high probability of success for solubility enhancement. Among the var­ious polymers evaluated from vinyl polymers (including polyvinyl pyrrolidone (PVP), cellulosic polymers and acrylic polymers), only a specific grade of cellulosic polymer showed promise both in prediction as well as confirmed with an in-vivo animal pharma­cokinetic (pK) study.

In another example, polymer and technology selection played a role in Thermo Fisher’s development of a patient-centric once-a-day (QD) formulation of a drug candidate for a neuro­logical condition. A robust formulation design and process for a controlled release drug product was required to meet the follow­ing criteria:

• Release in a reliable and consistent manner at a predefined release rate and at the site of release/activity;
• Demonstrate High Quality Attributes, consistently meeting the critical quality specifications and providing the pharmacody­namic and PK response after the drug product is administered;
• Manufacturable, including ease of manufacture with a robust manufacturing process;
• Stable throughout the shelf life with respect to degradation products and consistent, predictable drug release; and
• Consistent in performance in patient population, meeting the release rates and thereby efficacy in a variety of patient pop­ulations across the globe, disease states, age groups, etc.

After successful utilization of a physiological-based pharma­cokinetic (PBPK) modelling and determining the release rates at specific target sites in the gastro-intestinal tract, polymers such as hypromellose acetate succinate (HPMCAS) of a specific grade and viscosity for the membrane coating on an osmotic delivery system followed by a laser-drilled orifice of a specific diameter helped in meeting the release specifications and confirming the efficacy of the drug candidate, explains Dr. Kane.

“While these examples demonstrate a few solutions in action, it’s clear that, as precision medicine and therapeutic approvals continue to increase and expand into broader markets like Alzheimer’s and autoimmune diseases, precision medicine and tailored excipient solutions are moving from niche applications to the mainstream,” he says.