Biologic Excipients Market Size - Industry Analysis Report, Regional Outlook, Growth Potential, Competitive Market Share & Forecast, 2025 – 2034

Biologic Excipients Market Size

The global biologic excipients market registered strong growth in 2024 and is predicted to observe a significant CAGR from 2025 to 2034 due to heightened demand for biologics as well as improvements in drug formulation technologies. As the pharmaceutical industry continues to shift with an increased focus on biopharmaceuticals, the demand for excipients that improve the stability, solubility, delivery, and overall effectiveness of complex biologic medicines is increasingly important. The growth in biologic pharmaceutical development, such as monoclonal antibodies, mRNA-based therapies, cell and gene therapies, and biosimilars, has generated an environment that necessitates creative excipient solutions that can ensure product quality and safety through manufacturing, storage, and administration.
 

The market for biologic excipients is also being fueled by the rise in chronic and life-threatening diseases, such as cancer, autoimmune diseases, and genetic conditions. This health burden is driving research in biologic therapies, which, in turn, drives excipient demand customized to ensure potency, improve bioavailability, and enhance patient compliance via innovative dosage forms. The biologic's complexity, along with the demand for uniform performance and longer shelf-life, has prompted pharmaceutical developers to look for advanced excipients that enable sophisticated drug delivery systems like liposomal, nanoparticle-based, and controlled-release technologies.
 

As drug manufacturers seek safer and more effective mechanisms for delivering drugs, the value of excipients that can provide controlled release, targeted delivery, and formulation flexibility has grown. The use of such technologies has become critical in meeting logistical hurdles related to global distribution, especially in areas with limited infrastructure for temperature-sensitive biologics.
 

In addition, the market for biologic excipients is supported by increasing regulatory clarity and support for biopharmaceutical innovation. Regulatory bodies like the FDA and EMA are promoting the utilization of well-characterized, GMP-grade excipients in biologic drug products. This transition not only fortifies the quality assurance process but also presents new possibilities for excipient manufacturers to secure regulatory approvals for excipients developed specifically for biologics. Consequently, the regulatory landscape is changing to meet the challenges of biologics and foster the creation of new excipient systems with improved functionality and safety profiles.
 

For instance, in December 2023, Roquette broadened its excipient portfolio with the introduction of three new grades that are specially designed for moisture-sensitive pharmaceutical and nutraceutical actives. These excipients impart improved stabilization and moisture protection, giving pharmaceutical makers flexible solutions for maximizing drug delivery across formulations and manufacturing processes. These newest products further augment Roquette's robust moisture protection portfolio—a broad family of low water activity (Aw) excipients well-tested and established to enhance the formulation development and stability of moisture-sensitive active ingredients.
 

Biologic Excipients Market Trends

One of the trends most visible in the biologic excipients sector is the creation and implementation of multifunctional excipients. Multifunctional excipients perform not only the conventional roles of bulking or binding agents but also play roles in drug stability, delivery efficiency, and patient compliance. As pharmaceutical developers want to minimize the number of ingredients in drug products and streamline manufacturing operations, multifunctional excipients provide a means to achieve several formulation requirements with fewer materials. This is especially important in biologics, where ingredient compatibility and formulation integrity are key.
 

As a case in point, in November 2024 Clariant presented its new range of healthcare product solutions, bringing to market three high-performance excipients: VitiPure® LEX 3350 S, VitiPure® LEX 4000 S, and Polyglykol® 1450 S. These ground-breaking solutions were designed specifically to tackle issues pertaining to API delivery and bioavailability.
 

Relative to standard excipient grades, all three products provide excellent stability for finished API preparations. They are also packaged in steel containers that have been purged with nitrogen, thus significantly reducing peroxide formation during storage and providing long-term product integrity.
 

Another major trend is the increasing need for clean-label and titanium dioxide-free excipients, fueled by regulatory pressure and consumer demand for safer, more natural ingredients. In response, companies are reformulating their excipient portfolios to eliminate contentious additives and meet changing safety standards.
 

The biologic excipients industry is also undergoing digitalization, with the adoption of digital formulation platforms and cloud-based solutions that automate excipient selection and formulation design. The platforms allow drug companies to model drug-excipient interactions and formulate optimized products earlier in the development cycle, decreasing time-to-market and enhancing formulation efficiency.
 

Biologic Excipients Market Analysis

The inorganic product segment will remain the market leader in the market until 2034 because of its extensive usage and well-established safety record. Inorganic excipients like calcium phosphate, magnesium stearate, and silicon dioxide are extensively used in biologic products for stabilizing, buffering, and anti-caking activities. These excipients are critical in maintaining the long-term stability of sensitive biologics during storage and transportation.
 

The topical formulation market is expected to capture a significant market share between 2025 and 2034, driven by increasing demand for non-invasive delivery systems in the treatment of skin diseases and chronic conditions. Biologic drugs designed for topical use are increasingly being used in dermatology and pain management, driven by patient convenience and localized action. Innovations in transdermal patches, creams, and gels are improving the penetration of drugs and therapeutic effects, opening up new avenues for excipient manufacturers to offer customized solutions for this administration route.
 

The Asia Pacific region will be one of the fastest-growing regions in the biologic excipients market, posting a significant CAGR during the forecast period. Some of the factors responsible for the region's dominance include increased healthcare spending, a growing middle-class population, government support for local manufacturing, and rising investment in biologic drug development. China, India, South Korea, and Japan are not just key consumers of biopharmaceuticals but are also emerging as key hubs for biologic drug and excipient manufacturing.
 

Biologic Excipients Market Share

• Kerry Group PLC
• Colorcon Inc. (BPSI Holdings)
• Evonik Industries AG (Rag-Stiftung)
• Roquette Frères
• Ashland
• Croda International
• DuPont De Nemours, Inc.
• BASF SE
• Meggle USA
   

Market leaders in the biologics excipient space are expanding their portfolios, pursuing strategic partnerships, and investing in research and development to remain competitive. They are innovators in sophisticated excipients to address specific formulation issues with biologics such as improved solubility, stability across conditions, and compatibility with novel drug delivery systems.
 

Strategic partnerships with pharmaceutical and biotech companies give excipients vendors the flexibility to respond to the changes in the biodegradability requirements of drug formulators and increase attention to regulatory compliance and sustainability, which makes them desirable partners across the pharma value chain. By embracing ongoing innovation, technology infusion, and tactical industry positioning, they are shaping the biologic excipients market.
 

Biologic Excipients Industry News

In March 2024, the world's number-one food ingredient and pharmaceutical excipient producer, Roquette, signed a deal to buy IFF's Pharma Solutions business for $2.85 billion. The company is proficient in the production of a wide variety of oral drug excipients and is a combination of sites from several former owners that have been brought together in recent years.
 

In April 2024, Roquette made a strategic investment in Danish start-up Biograil through Roquette Ventures in order to facilitate innovative solutions to health and sustainability. In addition to financial resources, Roquette will supply its expertise in pharmaceutical excipients to support Biograil's development of platform technology that will enhance the start-up's focus on next generation drug delivery systems.