Sustained Release Excipients Market

Sustained Release Excipients Market Outlook (2025 to 2035)

The global sustained release excipients market was USD 1.58 billion in 2025 and is expected to grow at an 8.1% CAGR during the period from 2025 to 2035. The global sustained release excipients market is expected to reach USD 3.45 billion by 2035.

One of the key drivers for this ongoing growth is the growing demand for sophisticated drug delivery systems that ensure higher therapeutic consistency and reduce dosing frequency, especially for the treatment of chronic diseases.

These formulations are becoming more popular in long-term treatment regimens due to their ability to provide constant levels of drugs steadily, enhance patient compliance, and minimize side effects inherent with peak-and-trough drug delivery patterns. Continuing innovation in formulation science is promoting a broader utilization of high-performance excipients that are capable of providing more precise drug release.

Excipients such as hydroxypropyl methylcellulose, ethylcellulose, and polyvinyl alcohol are being incorporated into controlled-release platforms to achieve maximum bioavailability and therapeutic effects. Excipients are at the center of driving the development of non-differentiated drug products, such as complex oral solids and injectables, including dosage forms.

Favorable regulatory guidance, particularly in the U.S. and EU, is also propelling growth by streamlining paths for approvals of sustained-release drugs. Europe and North America will remain among the front runners of the global sustained release excipients market within the forecasting period owing to earlier technology embrace as well as a strong base for innovation.

The Asia-Pacific is, however, expected to attain the most pronounced growth rate by virtue of expanding pharma production capacity, expanding healthcare outlay, and an even higher growth pace for generics production.

Other countries such as India and China are also becoming leading formulation outsourcing locations, thereby providing new avenues for extended-release excipient manufacturers for large-scale manufacturing units. Upcoming trends are directed toward moving to more sophisticated excipient systems offering increased biologic, biosimilar, and extremely potent active pharmaceutical ingredient compatibility.

There is a growing interest in biodegradable and patient-specific excipients that are able to provide site-specific or condition-related release. The increasing application of sustained-release excipients in pediatric and geriatric products is also enhancing their opportunity as formulators try to improve ease of use and compliance among different patient segments.

Over the next decade, collaborative strategic partnerships between excipient manufacturers and pharmaceutical drug developers will become more distinctive in the industry. Such cooperation will be motivated by the objectives of accelerating excipient development, facilitating timely testing and validation, and condensing development timeframes overall.

As value-based care becomes the industry's mantra, the role of excipients in helping optimize drug delivery efficacy and life cycle management will further become central to competitive business strategy in the world pharmaceuticals market.

Report Attributes	Details
Sustained Release Excipients Market Size (2025E)	USD 1.58 billion
Sustained Release Excipients Market Size (2035F)	USD 3.45 billion
Global Market Growth Rate (2025 to 2035)	8.1% CAGR
U.S. Market Value (2025)	USD 463.8 million
China Market Value (2035)	USD 421 million
Key Companies Profiled	BASF; International Flavors & Fragrances, Inc.; Ashland Global; Evonik Industries; Croda International Plc; Gattefossé; Merck KGaA; Valeant Pharmaceuticals International, Inc.; Pfizer, Inc.; Sun Pharmaceutical Industries Ltd.

Market Shifts between 2020 and 2024 and Future Trends 2025 to 2035

From 2020 to 2024, the sustained release excipients market experienced moderate growth, driven mainly by an increase in generics and a greater focus on patient compliance. However, adoption was still uneven geographically due to uneven regulatory guidelines and raw material supply chain challenges. Growth during this period was also restrained by limited innovation in excipient chemistry and formulation diversity.

Conversely, the 2025-2035 vision is a more dynamic and innovation-based one. Players in the industry are investing more in biodegradable and responsive-release excipients sensitive to physiological conditions. Formulation development is being revolutionized by principles of precision medicine, whereby excipients are not passive carriers but active participants in treatment optimization.

Additionally, regulatory alignment, greater utilization of artificial intelligence in formulation design, and rising demand for biologics are all expected to underpin growth in the sustained release excipients market during the next decade.

A Comparative Market Shift Analysis (2020 to 2024 vs. 2025 to 2035)

2020 to 2024	2025 to 2035
Growth was driven by increasing generics and emphasis on enhancing patient compliance.	Innovation-led industry influenced by biologics, precision medicine, and AI-led formulation.
Minimal innovation in excipient chemistry and functional flexibility.	Increased development of biodegradable, responsive, and multifunctional excipients.
Excipients are used mainly as passive vehicles for controlled release.	Excipients are utilized as active therapeutic facilitators, actively responding to physiological conditions.
Potentially restricted formulation development application of digital capabilities.	Machine learning and artificial intelligence widespread application in excipient selection and formulation customization.
Uneven use resulting from variable regulatory frameworks and raw material availability challenges.	Enhanced global standardization and harmonized regulatory guidelines promote wider use.
Focused mainly on generic pharmaceuticals and extended-release oral solids.	Enlarging to complex drug delivery systems, advanced biologics, and customized therapies.
Considerations for sustainability were restricted, with attention primarily directed to functionality and price.	Greater need for green, biodegradable excipients synchronized with global sustainability objectives.

Sustained Release Excipients Market: Country-Wise CAGR Table (2025 to 2035)

Country	Projected CAGR (2025 to 2035)
U.S.	5.5%
UK	5.2%
France	5.3%
Germany	5.4%
Italy	5.1%
South Korea	5.6%
Japan	5.4%
China	5.9%
Australia	5.3%
New Zealand	5.1%

The U.S.

The U.S. sustained release excipients market will grow at a CAGR of 5.5% during 2025-2035. Rising demand for controlled drug delivery technology in the treatment of chronic diseases, particularly cardiovascular, neurological, and metabolic disorders, is driving growth. Sustained release excipients such as hydrophilic matrices, lipid-based systems, and polymer-coated granules are widely utilized to enhance patient compliance and efficacy.

Major pharmaceutical companies and excipient manufacturers, including Dow Chemical, Lubrizol Corporation, and Ashland Inc., are investing in formulation science and co-development with branded and generic drug manufacturers. U.S. Food and Drug Administration regulatory control guarantees high-quality excipient characterization and guarantee of safety in the inactive ingredient database system .

UK

The UK sustained release excipients market will expand with a CAGR of 5.2%. Increasing applications of modified-release drug products in outpatient treatment and geriatric care are propelling consistent demand for sustained-release excipients. Formulations based on hydrophobic matrix systems and ion exchange resins are being researched to deliver extended dosing intervals and reduce side effects.

Manufacturers like Croda International and Colorcon UK engage in partnerships with local pharmaceutical companies to aid in excipient solution development according to British Pharmacopoeia requirements. Medicines and Healthcare Products Regulatory Agency compliance ensures quality assurance and transparency of excipients, ensuring robust growth in therapeutic categories.

France

France’s sustained release excipients market is anticipated to register growth at a CAGR of 5.3%. The segment is witnessing growth due to the growing need for patient-centered drug delivery in oncology, cardiology, and psychiatric care. Sustained release excipients are finding application in extended-release tablets, pellets, and osmotic systems.

Companies such as Roquette Frères and Seppic are investing in premium hydroxypropyl methylcellulose (HPMC) grades, ethylcellulose dispersions, and starch matrices. Harmonization with the European Medicines Agency and French national health agencies at the regulatory level guarantees that excipients are subject to strict safety, compatibility, and pharmacotechnical performance standards .

Germany

Germany's sustained release excipients market is also likely to grow at a CAGR of 5.4%. Strong pharmaceutical manufacturing capabilities and increased focus on drug delivery innovation fuel the growth. Increased demand for excipients that enable sustained plasma concentration and reduced dosing events in long-term therapy regimens is boosting growth.

Large players such as BASF SE and Evonik Industries are developing multifunctional excipients for solid oral dosage forms, including polymeric binders and controlled-release coatings. The country's adherence to EU GMP regulations and excipient Good Manufacturing Practice standards ensures quality and traceability for local and export manufacturing .

Italy

Italy’s sustained release excipients market is anticipated to grow at a CAGR of 5.1% over the forecast period. Sales growth is supported by the country's growing generic pharma industry and the growing use of sustained-release products in cardiovascular and gastroenterological therapy. Excipients such as carbomers, polyvinyl acetate, and modified cellulose are being used more and more in enteric and delayed-release formulations.

Firms like Faci Group and Farmalabor are focusing on pharmaceutical-grade polymer innovation and bioadhesive systems. EU quality framework compliance is ensured by national regulation in accordance with the Italian Medicines Agency, which enables the safe and effective use of excipients within long-acting products.

South Korea

South Korea’s sustained release excipients market is expected to grow with a CAGR of 5.6% over the forecast period. Government funding-supported pharmaceutical innovation and the growing contract manufacturing services are some of the drivers of growth. Sustained release excipients have widespread applications in diabetes, hypertension, and psychiatric disorders formulations.

Companies such as Daicel Pharma and Hanmi Pharmaceutical are integrating new excipients in modified-release preparations meant for the domestic and international markets. Stringent regulatory conditions within the Ministry of Food and Drug Safety favor accelerated approval routes for excipient-contained generics that will drive commercial opportunities.

Japan

Japan’s sustained release excipients market is poised to expand at a CAGR of 5.4%. The aging of populations and high rates of chronic disease drive demand for long-term release formulations, particularly in oncology and neurology. Functional excipients that enhance bioavailability with sustained-state plasma levels are used abundantly in oral and transdermal dosage forms.

Firms such as Shin-Etsu Chemical Co. and Fuji Chemical Industries are establishing portfolios of cellulose ethers, pH-dependent paints, and natural polymers. Regulation by the Pharmaceuticals and Medical Devices Agency governs the standardization of safety, traceability, and formulation performance based on the Japanese Pharmacopoeia.

China

China is projected to dominate the sustained release excipients market at a CAGR of 5.9%, driven by industrialization of the pharma industry and higher use of high-end formulation technologies. Increased incidence of chronic diseases and rapid expansion of domestic drug manufacturing underlie growing demand for excipients that enable extended-release therapies.

Local firms such as Shandong Head Group and Zhejiang Huakang Pharmaceutical Co. are developing high-purity excipients to use in matrix, reservoir, and coated drug delivery systems. The National Medical Products Administration is backing harmonization with ICH standards and drug-excipient compatibility testing innovation promotion.

Australia

Australia’s sustained release excipients market is anticipated to grow at a CAGR of 5.3%. Increasing demand for modified-release products in outpatient and elderly care is propelling growth. Functional excipients that improve stability, control release rates, and assist in patient compliance are gaining popularity in therapeutic segments like pain management and diabetes.

Companies and educational institutions are investing in research on excipients and emerging formulation technologies. Regulatory oversight by the Therapeutic Goods Administration makes it easier to approve new drug-excipient combinations and provides pharmacopoeial consistency between local and foreign excipients.

New Zealand

New Zealand’s sustained release excipients market is expected to grow at a CAGR of 5.1%. The nation's pharmaceutical sector is showing an increased interest in long-term release technologies, particularly for export-oriented generic products. Excipients to extend drug half-life and also reduce dosing frequency are in demand in oral as well as topical delivery systems.

Manufacturers and contract development houses are importing high-functionality excipients conforming to international pharmacopeial standards. Harmonization of regulation through Medsafe and the uniform labeling standards enhance the relevance of excipient applications in multipurpose drug delivery.

Segment-wise Analysis

By Product Type

Sustained release excipients will remain governed by two major product types in 2025. Polymers hold a large share of 42%, while Minerals contribute 15%. Innovations in drug formulation and new concepts in patient-focused dosing regimens are driving demand for these excipients in regulated drug delivery systems.

Polymers hold the largest share in the sustained release excipients market since they can control the release rate of active pharmaceutical ingredients (APIs) over extended periods. They exhibit the necessary versatility to be engaged in the design of matrix systems, reservoir systems, and osmotic pump applications regarding oral solid dosage forms in general.

Such wide applications cover both synthetic polymers, such as ethyl cellulose and hydroxypropyl methylcellulose (HPMC), as well as natural polymers, such as xanthan gum and alginate. BASF SE, Ashland Global, and Evonik Industries AG are the leaders in advanced sustained-release formulations. In this respect, Evonik's EUDRAGIT® product family includes polymers with pH-independent release characteristics that may find application in once-daily dosing formulations for enhanced patient compliance.

Minerals such as calcium phosphate and magnesium stearate play an important supportive role with respect to modifying drug release characteristics and enhancing tablet compressibility and stability. While accounting for a mere 15 % revenue share, minerals are important for certain applications, especially in conjunction with polymers. Merck KGaA and JRS Pharma are well-known suppliers of mineral-based excipients used for a variety of sustained-release formulations.

Both polymers and minerals will remain essential in the development of next-generation therapeutics as the pharmaceutical industry increasingly seeks to develop drugs for extended release for chronic conditions such as hypertension, diabetes, and psychiatric disorders.

By Technology

By technology, the sustained release excipients market is segmented into targeted delivery, holding about 28% of the share, and microencapsulation, accounting for around 22%. These technologies aim to enhance the bioavailability of drugs and improve therapeutic efficacy while minimizing side effects through controlled release profiles of active pharmaceutical ingredients (APIs).

Targeted Delivery leads in this sector because it is also in high demand in chronic disease treatment, including oncology, cardiovascular, and gastrointestinal disorders, where localized release of drugs at specific targets in the body occurs to reduce systemic exposure and side effects. Sustained release excipients play a critical role in such formulations by either binding the drug or allowing gradual dissolution or free release.

The targeted delivery aspect involves a lot of heavy investments by companies such as Evonik Industries AG and Ashland Inc. for advanced polymers like methacrylate copolymers and cellulosic derivatives, which support site-specific release.

Microencapsulation, which covers 22% of the area, is the enclosing of the active pharmaceutical ingredient with a protective coating such that it will dissolve after a time; this is mainly for the sustained release of the drug. This technology is used more in pharmaceuticals and nutraceuticals for areas such as pain management, diabetes, and neurological disorders. Among the microencapsulation technologies offered are BASF SE and Colorcon, which offer functional coatings that provide uniform release rates and protect sensitive APIs from environmental degradation.

Both technologies show a rising need for individualized, patient-friendly dosage forms to enhance compliance and therapeutic outcomes. Such advances in drug delivery technology will remain a focal innovative area at the level of sustained release formulations in the future of the pharmaceutical sector, now progressing into more precise and long-acting therapeutic modalities.

Competitive Outlook

The Sustained Release Excipients Market is characterized by intense rivalry between manufacturers of pharmaceutical excipient types, specialists in drug formulation, and organizations focusing on innovations in chemicals.

The key players dominate, with BASF, International Flavors & Fragrances (IFF), Ashland Global, Evonik Industries and Croda International Plc offering highly advanced excipients designed for controlling drug release, enhancing bioavailability and improving patient acceptability.

These companies sustain their competitive advantage through strategic relationships with pharmaceutical manufacturers, proprietary excipient technologies, and regulatory-compliant product portfolios.

Companies such as Gattefossé, Merck KGaA, and Valeant Pharmaceuticals International, Inc. in the mid-ranking category rely mostly on lipid and polymer-based sustained release technology. Innovations include biodegradable polymers, hydrophilic matrices, and ionic gelation methods, which impart great precision to the modulation of drug release. They also cater to both branded and generic companies, aiming to be an important formulation partner for the pharmaceutical industry all over the globe.

Regional and emerging players like Pfizer Inc. and Sun Pharmaceutical Industries Ltd. would like to capitalize on their foothold in the finished drug formulations industry to drive demand for proprietary excipient technology.

Pfizer's strong commitment toward oral controlled-release formulations and its focus on the construction of modified-release generic drugs by Sun Pharma make it a relatively significant player in the sustained-release excipients market. Their ongoing R&D investments in nanotechnology and extended-released coatings help in differentiating their offerings.

The competitive scenario, however, does not end with mergers, acquisitions and joint ventures; therein lies the forward momentum of the most important companies moving towards the integration of AI-enabled formulation development to nanotechnology-based drug carriers and biodegradable excipient innovations.

One such case would be Ashland Global and Evonik Industries, which have also pioneered intelligent excipient systems with functional coating and polymeric drug carrier technologies to maximize their extended-release dosage forms across multiple therapeutic areas.

Market Share Analysis by Company

Company Name	Market Share (%)
BASF	20-24%
International Flavors & Fragrances (IFF)	15-19%
Ashland Global	12-16%
Evonik Industries	10-14%
Croda International Plc	8-12%
Others (combined)	25-35%

Key Company Offerings and Activities

Company Name	Key Offerings and Activities
BASF	Leading provider of polymer-based sustained-release excipients for oral and injectable formulations.
International Flavors & Fragrances (IFF)	Develops innovative cellulose-based excipients for extended drug release applications.
Ashland Global	Specializes in hydrophilic and bioadhesive polymers for controlled drug release.
Evonik Industries	Offers functional coatings and biodegradable polymer matrices for oral and parenteral sustained-release drugs.
Croda International Plc	Focuses on lipid-based and emulsified excipients for enhanced bioavailability and controlled drug release.

Key Company Insights

BASF (20-24%)

Key leader in polymer-based excipients, focusing on smart release technologies for long-acting injectables and controlled oral dosage forms.

International Flavors & Fragrances (IFF) (15-19%)

Strengthens its position with cellulose-based excipients, ensuring consistent drug dissolution rates for enhanced therapeutic outcomes.

Ashland Global (12-16%)

Innovates in hydrogel-based and bioadhesive excipients, optimizing extended-release drug delivery in pain management and neurology segments.

Evonik Industries (10-14%)

Pioneering biodegradable polymeric excipients, facilitating parenteral controlled release applications in oncology and biologics.

Croda International Plc (8-12%)

Expanding in lipid-based sustained release excipients, enhancing bioavailability and dissolution control for lipophilic drugs.

Other Key Players

• Gattefossé
• Merck KGaA
• Valeant Pharmaceuticals International, Inc.
• Pfizer, Inc.
• Sun Pharmaceutical Industries Ltd.

Key Players

• BASF
• International Flavors & Fragrances (IFF)
• Ashland Global
• Evonik Industries
• Croda International Plc
• Gattefossé
• Merck KGaA
• Valeant Pharmaceuticals International, Inc.
• Pfizer, Inc.
• Sun Pharmaceutical Industries Ltd.

Segmentation

By Product :

The segmentation is into gelatin, polymers, minerals, sugars, alcohol, and chitosan.

By Route of Administration :

The segmentation is into oral, intramuscular, subcutaneous, transdermal, vaginal, ophthalmic, intravenous, and other routes of administration.

By Technology :

The segmentation is into targeted delivery, micro encapsulation, wurster technique, transdermal, implants, coacervation, and others.

By Region :

The segmentation is into North America, Latin America, Europe, Asia Pacific, and Middle East & Africa (MEA).