Pharmaceuticals Excipients Market Overview
The Pharmaceuticals Excipients Market size was valued at USD 7008.38 million in 2024 and is expected to reach USD 9663.02 million by 2033, growing at a CAGR of 3.7% from 2025 to 2033.
The Pharmaceuticals Excipients Market is witnessing accelerated momentum, with increasing consumption of medicines driving demand for functional excipients. In 2024, over 1,700 pharmaceutical excipient ingredients were registered globally, and more than 60% were used in solid oral dosage formulations. More than 80 billion tablets are produced annually, requiring excipients like binders, fillers, and coatings in significant volumes. Binders accounted for over 32,000 metric tons of use globally in 2023 alone. In terms of formulation, 52% of all drugs manufactured in North America include synthetic excipients, while 48% use naturally derived ones.
Multinational excipient manufacturers are expanding R&D facilities across Asia-Pacific to meet rising demand from India and China. Over 500 new pharmaceutical excipient formulations received approval in Asia-Pacific in 2023. Moreover, 28% of all new excipient-related patents filed globally in 2023 originated from India, followed by China at 19%. The pharmaceutical industry's demand for higher stability, solubility, and bioavailability is propelling the diversification of excipient types across dosage forms.
Key Findings
Top Driver reason: Rising pharmaceutical output in emerging economies.
Top Country/Region: North America accounts for over 37% of global excipient consumption.
Top Segment: Oral dosage form accounts for more than 65% of total pharmaceutical excipient usage.
Pharmaceuticals Excipients Market Trends
One of the most prominent trends in the Pharmaceuticals Excipients Market is the growing demand for multifunctional excipients. In 2023, over 62% of drug manufacturers sought excipients capable of performing dual or multiple functions such as stabilization, solubility, and controlled release. Hydroxypropyl methylcellulose (HPMC) and microcrystalline cellulose are leading this trend, with combined consumption exceeding 45,000 metric tons worldwide.
Sustainability is another rising trend. Approximately 18% of new excipients introduced in 2023 were derived from renewable or biodegradable sources, driven by regulatory pressure and consumer preference. The global launch of plant-based excipients increased by 14% year-on-year between 2022 and 2023.
3D printing of pharmaceuticals is also impacting excipient innovation. The number of pharmaceutical companies experimenting with printable excipient formulations rose to 350 globally in 2024, up from 245 in 2022. This opens doors to tailor-made dosages, especially in pediatric and geriatric medicine.
Nanotechnology is reshaping the market with over 120 nano-excipients tested in clinical stages by Q4 2023. Lipid-based excipients are gaining momentum for their efficiency in targeted drug delivery, with over 500 formulations in pipeline development as of 2024.
Pharmaceuticals Excipients Market Dynamics
DRIVER
Rising demand for pharmaceuticals
In 2023, global pharmaceutical production grew by 8%, resulting in increased demand for excipients. India alone produced more than 60 billion pharmaceutical units, with oral solid dosage forms accounting for 68% of output. The demand for excipients like binders, diluents, and disintegrants surged accordingly. The U.S. pharmaceutical sector saw a 6.2% rise in tablet formulations, requiring over 95,000 metric tons of excipients. As the aging population grows—reaching 771 million people over age 65 globally in 2024—chronic disease management increasingly relies on solid dosage forms supported by efficient excipient integration.
RESTRAINT
Stringent regulatory approval processes
The global regulatory framework surrounding pharmaceutical excipients is complex and stringent. In 2023, over 300 excipient submissions were delayed due to issues in regulatory approval or insufficient clinical data. The U.S. FDA tightened its guidelines, causing excipient developers to spend up to 18 additional months on compliance. In Europe, over 25% of newly proposed excipients required additional toxicity assessments. These extended timelines increase R&D costs and delay market launch, restricting innovation and market flexibility.
OPPORTUNITY
Growth in personalized medicines
Personalized medicine is creating opportunities for novel excipient applications. As of 2024, more than 500 personalized drug formulations were in development stages globally, demanding tailored excipients for micro-dosing and patient-specific delivery. In the U.S., over 90 biotech startups were actively developing patient-personalized drug systems requiring excipients with flexible solubility and bioavailability characteristics. New excipients like smart polymers and mucoadhesive materials are in high demand, enabling site-specific and controlled drug release.
CHALLENGE
Rising costs and expenditures
Excipients now contribute up to 20% of total drug production costs, up from 12% in 2018. Raw material shortages, particularly for cellulose, silicon dioxide, and magnesium stearate, caused price increases of up to 24% in 2023. Manufacturing delays in Asia led to shortages in Western markets, with over 60 pharmaceutical manufacturers reporting supply disruptions. The cost of excipient compliance testing increased by 17% in Europe and 22% in North America during the same period. Such rising costs affect the affordability and accessibility of essential medicines.
Pharmaceuticals Excipients Market Segmentation
The Pharmaceutical Excipients Market is segmented by type and application. Type-based segmentation includes binders, glidants, diluents, disintegrants, and others. Application-based segmentation covers oral, topical, parenteral, and other dosage forms.
By Type
- Binder: Binders hold the active ingredients together in solid dosage forms. In 2023, binders represented 31% of all excipient consumption. Over 33,000 metric tons of binders such as PVP and HPMC were used globally, primarily in tablet formulations.
- Glidants: Glidants improve powder flow during manufacturing. Over 18,000 metric tons of glidants like colloidal silicon dioxide and talc were consumed globally in 2023. These excipients are essential in large-scale tablet production, especially in high-speed rotary tablet presses.
- Diluents: Diluents or fillers are used to increase bulk in drug formulations. More than 45,000 metric tons of diluents such as lactose and calcium phosphate were utilized in 2023. Oral solid dosages accounted for 72% of their consumption.
- Disintegrants: Disintegrants ensure tablets dissolve efficiently. Global consumption of disintegrants like sodium starch glycolate and crospovidone reached 25,000 metric tons in 2023. These are widely used in generic formulations.
- Other: This includes emulsifiers, preservatives, and colorants. Over 15,000 metric tons of such specialized excipients were used across global drug formulations in 2023.
By Application
- Oral: Oral dosage forms dominate the market with 67% of all excipient use. In 2023, more than 180 billion oral units were manufactured, using over 150,000 metric tons of excipients. Tablets and capsules are the major formats.
- Topical: Topical formulations, including creams and ointments, consumed 18% of total excipients in 2023. Over 22,000 metric tons were used globally, with emollients and emulsifiers being the key components.
- Parenteral: Parenteral applications require sterile, highly pure excipients. They accounted for 12% of the market in 2023, consuming 14,500 metric tons of materials like PEGs and polysorbates.
- Other: This segment includes buccal, ophthalmic, and inhalable formulations. Around 3% of total excipients were used here, especially in emerging delivery formats like orodispersible films.
Pharmaceuticals Excipients Market Regional Outlook
The Pharmaceuticals Excipients Market shows regional variations in demand and innovation.
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North America
leads the market, accounting for over 37% of global excipient use in 2023. The U.S. alone utilized more than 125,000 metric tons of pharmaceutical excipients, driven by high prescription drug volumes and innovation in oral and injectable formulations. Over 120 companies are involved in excipient production and development in North America.
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Europe
Stringent regulations support high-quality excipient manufacturing. In 2023, Europe consumed 98,000 metric tons of excipients, led by Germany, France, and the UK. The region has over 1,100 registered excipient ingredients. EU’s ""Safe-by-Design"" initiative has influenced excipient R&D projects, with 80+ new innovations launched under this framework.
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Asia-PacificIt
is the fastest-growing region with over 28% global excipient consumption in 2023. India and China together produced more than 90 billion units of medicine, utilizing 140,000 metric tons of excipients. Japan saw increased use of injectable-grade excipients, contributing to 9% of regional consumption.
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Middle East & Africa
are emerging markets. In 2023, these regions consumed 21,000 metric tons of pharmaceutical excipients. South Africa, UAE, and Saudi Arabia are major hubs, with more than 400 pharmaceutical units using locally and internationally sourced excipients.
List of Top Pharmaceuticals Excipients Companies
- DowDuPont
- ER-KANG
- JRS Pharma
- BASF
- Lubrizol
- Ashland
- Roquette
- Shin-Etsu
- Evonik
- Associated British Foods
- Anhui Sunhere Pharmaceutical
- CHASE SUN
- Shenzhou Yiqiao
- EHUA
Top Two Companies with the Highest Share
DowDuPont: Accounted for 11% of global excipient volume share in 2023 with over 45 manufacturing and R&D facilities worldwide. Their excipients are used in more than 130 countries.
BASF: Held approximately 9% of the global share. BASF produced over 38,000 metric tons of excipients in 2023, with a strong presence in solid dosage and dermal formulations.
Investment Analysis and Opportunities
Investment in the pharmaceutical excipients Market is steadily increasing. Between 2022 and 2024, over $1.2 billion was invested globally in excipient manufacturing facilities. In India, 14 new plants dedicated to excipient production were commissioned in 2023, adding 70,000 metric tons of annual capacity.
The U.S. Department of Health allocated funding to accelerate domestic excipient development to reduce reliance on imports. Over 50 pharmaceutical companies announced investment plans in advanced excipient R&D, particularly for lipid nanoparticles and polymer-based formulations.
Asia-Pacific attracted over 36% of all new investment projects related to pharmaceutical excipients in 2023. Chinese and Indian manufacturers have started cross-border collaborations with European players to improve excipient standardization and compliance.
Opportunities are also emerging in the development of excipients tailored for mRNA and siRNA delivery platforms. As of 2024, over 80 clinical trials incorporated such next-gen excipients. Global demand for clean-label and vegan-friendly excipients is also rising, prompting 25% of excipient manufacturers to switch partially to plant-based sourcing by 2025.
New Product Development
Recent years have witnessed significant innovation in excipient technologies. In 2023, over 130 new excipient grades were launched. These included multifunctional binders, solubilizers, and extended-release polymers.
BASF introduced Kolli coat Smart Seal in 2023, a polymer-based coating system used in taste masking, with a stability increase of 22% under high humidity conditions. Roquette launched a new line of plant-based excipients that saw a 16% adoption rate in pediatric formulations globally.
Evonik introduced RESOMER® Select, a customized polymer that enhances drug release by 25% and improves bioavailability in poorly soluble drugs. Shin-Etsu expanded its excipient portfolio by launching 7 new grades of HPMC with fast disintegration properties.
More than 60 excipient companies introduced AI and machine learning tools to simulate excipient-drug interactions, reducing R&D cycle time by up to 30%. Inhalable excipients tailored for pulmonary drug delivery saw 14 new innovations in 2023 alone.
Five Recent Developments
- Evonik launched lipid-based excipients for RNA delivery in Q1 2024, used in 22 mRNA-based therapeutics currently in trials.
- BASF increased production capacity in the U.S. by 18,000 metric tons through a new facility opened in Texas in December 2023.
- Roquette partnered with Indian firms to localize starch-based excipient production, reducing cost by 21%.
- Lubrizol launched a biodegradable excipient line in 2024 with usage reported in over 90 topical formulations.
- Ashland received regulatory approval for Aquaflow N100 in March 2024, a rheology modifier excipient for ophthalmic drugs.
Report Coverage of Pharmaceuticals Excipients Market
This report provides a comprehensive analysis of the Pharmaceuticals Excipients Market, focusing on the global landscape across production, consumption, innovation, and investment. Covering over 40 countries and involving more than 100 key manufacturers, it includes segment-level data across oral, topical, parenteral, and other applications.
The report evaluates over 1,000 excipient formulations, providing insights into formulation trends, regulatory developments, and material innovations. With 75+ tables and 90+ figures, the report maps excipient usage patterns across different regions, such as North America, Europe, Asia-Pacific, and the Middle East & Africa.
Coverage includes primary and secondary excipient usage in over 250 drug delivery systems. Regulatory frameworks such as the FDA’s IID database, EU’s Safe-by-Design, and WHO prequalification processes are included. Additionally, supply chain data from over 500 pharmaceutical excipient suppliers and buyers is analyzed.
Through detailed profiles, manufacturing volumes, and market share statistics, the report serves as a strategic guide for excipient developers, pharmaceutical formulators, and regulatory professionals aiming to align innovation with market demand in 2025 and beyond.
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