Pharmaceutical Excipients Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Pharmaceutical Excipients Market is projected to increase from USD 8.97 Billion in 2025 to USD 12.19 Billion by 2031, reflecting a CAGR of 5.25%. These pharmacologically inactive substances are formulated alongside active pharmaceutical ingredients to facilitate drug delivery, improve stability, and ensure dosage consistency. Market growth is primarily supported by the rising prevalence of chronic diseases and an aging global population, which drive the demand for high-volume solid dosage medications. Additionally, the sustained expansion of the generic drug sector serves as a vital catalyst for volume growth. According to the Association for Accessible Medicines, generic and biosimilar medicines accounted for 90 percent of all prescriptions filled in the United States in 2024, demonstrating the critical role of cost-effective therapies in driving the demand for bulk formulation ingredients.

A significant challenge hindering market expansion is the growing complexity of regulatory compliance and supply chain transparency. Manufacturers are subject to rigorous standards regarding impurity limits, which necessitate extensive risk assessments and raw material tracing. These stringent requirements often result in higher operational costs and extended approval timelines, creating barriers for suppliers who must invest heavily to meet the evolving safety expectations of global health authorities.

Market Drivers

The rapid expansion of the biopharmaceutical manufacturing sector is fueling demand for high-purity, functional excipients essential for parenteral delivery. Biologics, such as monoclonal antibodies, require specialized stabilizers and surfactants to maintain molecular integrity, shifting the market focus from traditional solid dosage fillers to advanced formulation ingredients.

This structural trend toward complex therapies is accelerating rapidly; according to CPHI's 'Annual Report 2024' from September 2024, the industry is undergoing a major shift where approvals for complex molecules are projected to surpass small molecules, highlighted by the authorization of 17 biologics and nine peptide or oligonucleotide therapies among the 55 new drugs approved in 2023. This innovation is underpinned by substantial capital allocation; according to the European Federation of Pharmaceutical Industries and Associations (EFPIA), the research-based pharmaceutical industry invested an estimated €55.00 billion in R&D in Europe in 2024, directly fueling the development pipeline for these novel drug delivery systems.

The expansion of the pharmaceutical contract manufacturing market further propels growth as drug developers increasingly outsource production to optimize costs and access specialized capabilities. Contract Development and Manufacturing Organizations (CDMOs) are becoming centralized purchasers, often requiring large volumes of multi-compendial excipients to meet diverse global regulatory standards. This consolidation of procurement is evident in the financial performance of leading service providers; according to Lonza's 'Annual Report 2023' released in March 2024, the company reported sales of CHF 6.7 billion, achieving a sales growth of 7.9 percent primarily driven by strong performance in its Biologics and Small Molecules divisions. As CDMOs expand their operational footprint, they necessitate a reliable supply chain of versatile excipients that facilitate streamlined manufacturing across varying dosage forms.

Market Challenges

The increasing complexity of regulatory compliance and supply chain transparency acts as a significant restraint on the Global Pharmaceutical Excipients Market. As international health authorities enforce stricter limits on impurities and demand rigorous raw material traceability, excipient manufacturers face a steep escalation in operational burdens. This compliance pressure forces suppliers to allocate substantial resources toward continuous risk assessments and validation protocols rather than production capacity expansion. Consequently, the time and capital required to bring compliant ingredients to market increase, creating barriers that disproportionately impact smaller suppliers and reduce the overall fluidity of the supply chain.

These regulatory bottlenecks directly impede market growth by disrupting the availability of essential formulation ingredients, leading to production stalls. According to the American Society of Health-System Pharmacists, the U.S. healthcare sector reported an all-time high of 323 active drug shortages in 2024, a crisis partially attributed to persistent manufacturing quality challenges and regulatory hurdles. This instability in the downstream manufacturing sector restricts the consistent volume demand for excipients, as finished dose manufacturers cannot maintain steady production schedules amidst such heightened compliance-driven disruptions.

Market Trends

The adoption of multifunctional and co-processed excipients is intensifying as manufacturers seek to streamline oral solid dosage production and reduce formulation complexity. These advanced, pre-formulated systems - such as ready-to-use film coatings and high-functionality binders - eliminate the need for multi-step blending, thereby enhancing operational efficiency and minimizing batch variability. This drive for manufacturing optimization is prompting major suppliers to expand their production footprints to ensure a reliable supply of these critical ingredients. According to Indian Chemical News in the July 2025 article 'Colorcon opens new film coating manufacturing facility in Malaysia', the company inaugurated a new 200,000 square-foot production plant specifically designed to support the growing regional demand for advanced coating systems and functional excipients.

Concurrently, the market is witnessing a decisive transition toward plant-based and clean label ingredients, driven by evolving patient preferences for non-animal derived formulations and strict dietary requirements. This shift is compelling excipient providers to pivot away from traditional animal-sourced materials like gelatin in favor of cellulose-based alternatives, such as HPMC, which offer comparable performance with broader consumer acceptance. Reflecting this strategic realignment, according to Nutritional Outlook in the October 2025 article 'ACG will invest $200 million in its first empty-capsule manufacturing facility in the US', the company announced a phased capital allocation of $200 million to establish a new facility capable of producing vegetarian hard-shell capsules to meet the rising need for clean label delivery forms in North America.

Key Players Profiled in the Pharmaceutical Excipients Market

• BASF SE
• Origin Instruments Corporation
• Ashland Global Holdings
• DuPont de Nemours, Inc.
• Roquette Feres
• Evonik Industries AG
• Associated British Foods
• Archer Daniels Midland Company
• Lubrizol Corporation
• Croda International
• Kerry Group

Report Scope

In this report, the Global Pharmaceutical Excipients Market has been segmented into the following categories:

Pharmaceutical Excipients Market, by Product:

• Organic Chemicals
• Oleochemicals(Fatty Alcohols
• Metal Stearates
• Glycerin
• Other)
• Carbohydrates(Sugars
• Alcohol
• Starches)
• Petrochemicals
• Proteins
• Calcium Phosphate
• Metal Oxides
• Halites
• Calcium Carbonate
• Calcium Sulphate
• Others

Pharmaceutical Excipients Market, by Functionality:

• Fillers & Diluents
• Suspending & Viscosity Agents
• Coating Agents
• Binders
• Flavoring Agents & Sweeteners
• Disintegrants
• Colorants
• Lubricants & Glidants
• Preservatives
• Emulsifying Agents
• Others

Pharmaceutical Excipients Market, by Formulation:

• Oral Formulations
• Tablets
• Capsules(Hard-gelatin Capsules
• Soft-gelatin Capsules)
• Liquid Formulations
• Topical Formulations
• Parenteral Formulations
• Other

Pharmaceutical Excipients Market, by Region:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Pharmaceutical Excipients Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

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