Pharmaceutical Excipients Market Size & Outlook, 2026-2034

Pharmaceutical Excipients Market Overview

The global pharmaceutical excipients market size is valued at USD 11.12 billion in 2025 and is estimated to reach USD 18.96 billion by 2034, growing at a CAGR of 6.15% during the forecast period. The observed market growth is stimulated by rising demand for multifunctional excipients, enhancing complex drug formulation stability.

Key Market Trends & Insights

• North America held a dominant share of the global market, accounting for 37.41% in 2025
• The Asia Pacific region is expected to grow at the fastest pace, with a CAGR of 7.86% during the forecast period.
• Based on product, the oleochemicals segment is expected to register the fastest CAGR of 6.87% during the forecast period.
• By formulation type, the oral segment dominated the market with the highest share of 52.79% in 2025.
• By functionality, the binders segment dominated the market in 2025 with a revenue share of 12.36%.
• The U.S. dominates the market, valued at USD 3.64 billion in 2024 and reaching USD 3.85 billion in 2025.

Table: U.S. Pharmaceutical Excipients Market Size (USD Million)

Source: Straits Research

Market Size & Forecast

• 2025 Market Size: USD 11.12 billion
• 2034 Projected Market Size: USD 18.96 billion
• CAGR (2026-2034): 6.15%
• Dominating Region: North America
• Fastest-Growing Region: Asia Pacific

The pharmaceutical excipients market comprises various products, such as oleochemicals, carbohydrates, petrochemicals, proteins, polymers, and others. Based on formulation type, excipients are widely used in oral, topical, parenteral, and other dosage forms to enhance drug efficacy and delivery. Functionally, they act as fillers and diluents, suspending & viscosity agents, coating agents, binders, flavoring agents & sweeteners, disintegrants, colorants, lubricants and glidants, preservatives, emulsifying agents, among others, ensuring desired consistency, safety, and effectiveness in pharmaceutical manufacturing processes.

Latest Market Trends

Rising Demand for Multifunctional Excipients

The use of multifunctional excipients is gaining strong traction across pharmaceutical manufacturing. Companies such as BASF SE and Evonik Industries AG are developing excipients that combine multiple functionalities such as binding, coating, and stabilization within a single formulation component. This trend supports cost efficiency, simplifies manufacturing processes, and enhances product performance, aligning with the industry’s shift toward efficient and innovative drug formulation technologies.

Shift from Synthetic to Bio-Based Excipients

A major trend in the pharmaceutical excipients market is the ongoing shift from synthetic to bio-based excipients, driven by rising environmental concerns and stricter sustainability regulations. Manufacturers such as Roquette Frères and Ashland Inc. are increasingly replacing petrochemical-derived ingredients with plant-based, renewable alternatives. This transition supports eco-friendly manufacturing, reduces carbon emissions, and aligns with the pharmaceutical industry’s broader commitment to sustainable solutions.

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Pharmaceutical Excipients Market Driver

Increasing Demand for Advanced Drug Formulations

Growing demand for advanced drug formulations is a key driver in the pharmaceutical excipients market. With the growth of biologics and complex dosage forms, excipients are essential for improving stability and bioavailability. For instance, in March 2025, BASF SE announced the expansion of its Kollidon range to support controlled-release formulations for biopharmaceuticals. This growing focus on innovation and formulation efficiency continues to drive global demand for high-performance pharmaceutical excipients.

Market Restraints

Stringent Regulatory Requirements for New Excipients

Stringent regulatory requirements remain a major restraint in the pharmaceutical excipients market, as developing and approving new excipients involves complex and time-consuming processes. Regulatory bodies such as the U.S. FDA and EMA demand extensive safety and compatibility data before market approval. For example, in 2024, the U.S. FDA reiterated its guidance on novel excipient evaluation, emphasizing detailed toxicological assessments.

These stringent regulations increase development costs and delay commercialization, limiting innovation and market expansion.

Market Opportunity

Expansion in Emerging Pharmaceutical Manufacturing Hubs

A major opportunity in the pharmaceutical excipients market lies in the rapid expansion of pharmaceutical manufacturing across emerging economies. Countries such as India, China, and Brazil are witnessing increased investment in formulation development and generic drug production. Recently, India’s Department of Pharmaceuticals announced a new incentive scheme to boost domestic excipient manufacturing. This initiative enhances local production capabilities, reduces import dependence, and creates strong growth prospects for global excipient suppliers.

Regional Analysis

North America dominated the pharmaceutical excipients market in 2025, accounting for 37.41% market share in 2025, driven by the region’s robust biopharmaceutical manufacturing ecosystem in the U.S., where major pharmaceutical companies and excipient suppliers collaborate closely on formulation development and high‑performance excipient innovation.

In Canada, the country’s well-established generics manufacturing industry, where high penetration of generic prescriptions creates strong demand for excipients used in tablet and capsule production, which, in turn, supports the market growth.

Asia Pacific Market Insights

Asis Pacific is emerging as the fastest-growing region with a CAGR of 7.86% from 2026-2034. This growth is augmented by the rapid expansion of domestic pharmaceutical manufacturing. This surge in local production increases demand for excipients to support formulation development, quality compliance, and export-oriented pharmaceutical operations, positioning the region as a key growth hub in the global excipients market.

In Japan, a key driver for the pharmaceutical excipients market is the nation’s strong focus on regulatory approval acceleration and innovation-friendly policies, such as the Pharmaceuticals and Medical Devices Agency’s expedited pathways for advanced therapies and generics. This climate accelerates formulation innovation and heightens demand for high-performance excipients supporting novel drug delivery systems.

Regional Market Share (%) in 2025

Source: Straits Research

Europe Market Insights

In Europe, the pharmaceutical excipients market growth is attributed to the growing integration of Industry 4.0 technologies within formulation manufacturing, enabling real-time process monitoring, predictive analytics, and digital twinned systems that streamline production, reduce rework, and meet high-quality regulatory standards across excipient supply chains.

In Italy, the market is driven by the country’s strategic life sciences investment ecosystem, where more than USD 38 billion is allocated to pharma and medical device R&D, and Italy ranks first in the EU for CDMO manufacturing value, thereby strengthening domestic excipient output and innovation.

Latin America Market Insights

A key growth driver in the Latin America pharmaceutical excipients market is the region’s increasing participation in global contract manufacturing and export-oriented pharmaceutical partnerships, driving demand for high-quality excipients that meet international standards and enabling regional manufacturers to serve global markets.

In Argentina, a notable factor fueling growth in the market is the government’s imposition of import substitution policies, which mandate local production of medicines and drug components. These policies boost domestic manufacturing of excipients and formulations, increasing demand for locally sourced high‑quality excipient materials.

Middle East and Africa Market Insights

The Middle East and Africa pharmaceutical excipients market is growing due to the expansion of medical tourism-driven pharmaceutical demand, where countries such as the UAE and Saudi Arabia attract international patients, increasing demand for drug production and corresponding excipients to supply hospitality-driven healthcare ecosystems.

In Saudi Arabia, a compelling growth factor driving the market is the establishment of special‑economic‑zone (SEZ) based pharmaceutical clusters that facilitate local production, lower import dependency, and promote formulation manufacturing. For instance, several African SEZs are actively attracting excipient and intermediate‑chemical manufacturing operations to capture local demand growth.

Product Insights

The polymers segment dominated the market with the highest revenue share of 36.78% in 2025, driven by the increased use of advanced polymer excipients that facilitate controlled release and targeted drug delivery formulations, enabling pharmaceutical companies to meet complex therapeutic demands with improved product stability.

The oleochemicals segment is projected to account for a 6.87% CAGR during the forecast period, owing to the expanding use of glycerin and fatty acids as excipients in pharmaceutical formulations, offering improved biocompatibility and formulation stability for oral and topical drugs.

Formulation Type Insights

The oral segment dominated the market with a revenue share of 52.79% in 2025, supported by the rising prevalence of chronic diseases that require long-term oral medication regimens. This high and sustained consumption of tablets and capsules notably boosts excipient demand.

The topical segment is projected to grow at a CAGR of 6.81% during the forecast period. This growth is stimulated by a marked rise in demand for semisolid formulations such as creams and gels for dermatological applications, driven by a surge in chronic skin disorders and consumer preference for non‑invasive therapies.

By Formulation Type Market Share (%), 2025

Source: Straits Research

Functionality Insights

The binders segment dominated the market with a revenue share of 12.36% in 2025. This dominance is driven by the increasing shift toward direct compression tablet manufacturing techniques, which demand binders with exceptional compressibility and flow characteristics to support faster production.

The coating agents segment is expected to grow at the fastest pace during the forecast period. This growth is stimulated by the increasing adoption of thin film and multi-layer coatings that enable extended drug release profiles and enhance patient compliance.

Competitive Landscape

The global pharmaceutical excipients market is fragmented, characterized by the presence of numerous international, regional, and specialty manufacturers competing across diverse formulation segments. The major players, such as BASF SE, Dow, Evonik Industries AG, Ashland Inc., and Roquette Frères, account for notable revenue shares through extensive product portfolios and strong R&D capabilities. Several emerging and regional companies, such as BIOGRUND GmbH and DFE Pharma, intensify competition by offering low-cost excipient solutions, catering to evolving formulation requirements across global pharmaceutical markets.

BIOGRUND GmbH: An emerging market player

BIOGRUND GmbH, a Germany-based manufacturer, is rapidly emerging in the global market with its innovative ready-to-use coating systems and tableting excipients. The company focuses on simplifying formulation processes while ensuring superior consistency and quality. For instance, its Quick Coat and CompactCel product lines enhance tablet functionality and production efficiency, which continues to strengthen its position as an innovation-driven excipient provider.

List of key players in Pharmaceutical Excipients Market

1. BASF SE
2. ABITEC Corporation
3. Air Liquide
4. Archer Daniels Midland Company
5. Ashland Inc.
6. BIOGRUND GmbH
7. Colorcon Inc.
8. Croda International PLC
9. DFE Pharma GmbH & Co KG
10. Dow
11. DuPont de Nemours Inc.
12. Evonik Industries AG
13. Gattefosse
14. JRS PHARMA
15. Kerry Group plc
16. Lubrizol Corporation
17. Merck KGaA
18. Roquette Frères
19. Shin‑Etsu Chemical Co. Ltd.
20. Wacker Chemie AG
21. Others

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Strategic Initiatives

• October 2025:Roquette, a global leader in pharmaceutical excipients, launched its novel pharmaceutical excipient, KLEPTOSE Crysmeb methyl-beta-cyclodextrin (MßCD).
• October 2025: Asahi Kasei expanded its product portfolio with the launch of two new Sonanos excipients.