Pharmaceutical Excipients Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented 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), By Functionality (Fillers & Diluents, Suspending & Viscosity Agents, Coating Agents, Binders, Flavoring Agents & Sweeteners, Disintegrants, Colorants, Lubricants & Glidants, Preservatives, Emulsifying Agents, Others), By Formulation (Oral Formulations, Tablets, Capsules(Hard-gelatin Capsules, Soft-gelatin Capsules), Liquid Formulations, Topical Formulations, Parenteral Formulations, Other), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 8.97 Billion
CAGR (2026-2031)	5.25%
Fastest Growing Segment	Organic Chemicals
Largest Market	North America
Market Size (2031)	USD 12.19 Billion

Market Overview

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

One significant challenge impeding market expansion is the increasing 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.

Key Market Drivers

Rapid expansion of the biopharmaceutical manufacturing sector is driving 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, September 2024, in the 'Annual Report 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), in 2024, the research-based pharmaceutical industry invested an estimated €55,000 million in R&D in Europe, 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, March 2024, in the 'Annual Report 2023', the company reported sales of CHF 6.7 billion, achieving a sales growth of 7.9 percent which was 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.

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Key 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, in 2024, the U.S. healthcare sector reported an all-time high of 323 active drug shortages, 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.

Key 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, July 2025, in the 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, October 2025, in the 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.

Segmental Insights

The Organic Chemicals segment is currently experiencing the most rapid expansion within the Global Pharmaceutical Excipients Market due to the rising global demand for oral solid dosage forms. Pharmaceutical manufacturers increasingly utilize organic compounds, such as carbohydrates and oleochemicals, because they effectively enhance drug stability and bioavailability. This growth is further supported by a distinct industry shift toward biocompatible ingredients that comply with rigorous safety standards established by major regulatory bodies like the U.S. Food and Drug Administration. Consequently, companies are prioritizing organic excipients to ensure regulatory acceptance while maintaining high formulation quality.

Regional Insights

North America maintains a dominant position in the Global Pharmaceutical Excipients Market due to its extensive pharmaceutical manufacturing infrastructure and sustained investment in drug development. The region experiences high demand for oral solid dosage forms and complex drug delivery systems, necessitating the use of specialized excipients. Additionally, the United States Food and Drug Administration (US FDA) implements stringent quality standards that drive manufacturers to adopt compliant ingredients for safety assurance. The high concentration of key industry players and a strong focus on generic drug production further reinforces North America’s leadership in this sector.

Recent Developments

• In November 2024, Clariant introduced a new range of high-purity excipients at the CPHI India trade show to address the evolving needs of the global pharmaceutical sector. The launch included the VitiPure Superior line, which featured products specifically designed for parenteral formulations and sensitive active pharmaceutical ingredients. These new excipients were engineered to ensure low microbial loads and minimal endotoxin levels, making them suitable for high-risk applications where purity is paramount. The company emphasized that this expansion of its health care portfolio was intended to support the development of safe and effective medicines by providing ingredients that offer enhanced stability and bioavailability for complex drug delivery systems.
• In October 2024, Colorcon announced an exclusive global partnership with LOTTE Fine Chemical to collaborate on the development and supply of pharmaceutical excipients. Through this agreement, the company became the exclusive representative for a specific range of hypromellose polymers used in controlled-release and immediate-release formulations, as well as hypromellose phthalate for enteric coatings. The collaboration was established to leverage the manufacturing capabilities of the partner alongside the company’s own technical support network. This strategic alliance aimed to accelerate formulation development for pharmaceutical customers worldwide by providing a comprehensive portfolio of high-quality cellulose ethers backed by regulatory and application expertise.
• In October 2024, IFF Pharma Solutions presented breakthrough research at the AAPS PharmSci 360 conference, focusing on excipient selection for nitrosamine risk mitigation and controlled-release performance. The company demonstrated the critical role of specific polymers and microcrystalline cellulose grades in reducing the risk of nitrosamine formation in finished drug products. Additionally, they unveiled new data regarding the use of excipients in extrusion-spheronization processes and the stability of plant-based softgel technologies. This research was aimed at empowering pharmaceutical manufacturers to develop safer and more effective formulations by leveraging deep expertise in polymer chemistry to address stringent regulatory challenges in the industry.
• In September 2024, Evonik expanded its portfolio of drug delivery solutions with the launch of a new functional, ready-to-fill capsule designed for targeted ileo-colonic delivery. The product, branded as EUDRACAP colon, was developed to address the growing industry demand for the oral administration of sensitive active ingredients, such as live biotherapeutic products, to specific regions of the gastrointestinal tract. This innovation was engineered to protect sensitive compounds against gastric acidity while ensuring precise release. The launch complemented the company's existing platform of oral drug delivery technologies, offering pharmaceutical developers a customizable and efficient solution for complex formulations.

Key Market Players

• 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

By Product	By Functionality	By Formulation	By Region
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	Fillers & Diluents Suspending & Viscosity Agents Coating Agents Binders Flavoring Agents & Sweeteners Disintegrants Colorants Lubricants & Glidants Preservatives Emulsifying Agents Others	Oral Formulations Tablets Capsules(Hard-gelatin Capsules, Soft-gelatin Capsules) Liquid Formulations Topical Formulations Parenteral Formulations Other	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Pharmaceutical Excipients Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• 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
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE