Global Sustained Release Excipients Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Product;
Gelatin, Polymers, Minerals, Sugars, Alcohol, and ChitosanBy Route of Administration;
Oral, Intramuscular, Subcutaneous, Transdermal, Vaginal, Ophthalmic, Intravenous, and OthersBy Technology;
Targeted Delivery, Microencapsulation, Wurster Technique, Transdermal, Implants, Coacervation, and OthersBy Application;
Pharmaceuticals and NutraceuticalsBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031)Sustained Release Excipients Market Overview
Sustained Release Excipients Market (USD Million)
Sustained Release Excipients Market was valued at USD 1,303.21 million in the year 2024. The size of this market is expected to increase to USD 2,113.30 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 7.2%.
Global Sustained Release Excipients Market Growth, Share, Size, Trends and Forecast
*Market size in USD million
CAGR 7.2 %
Study Period | 2025 - 2031 |
---|---|
Base Year | 2024 |
CAGR (%) | 7.2 % |
Market Size (2024) | USD 1,303.21 Million |
Market Size (2031) | USD 2,113.30 Million |
Market Concentration | Medium |
Report Pages | 333 |
Major Players
- Teva Pharmaceutical Industries Ltd.
- Mylan N.V
- Valeant Pharmaceuticals International, Inc
- Pfizer, Inc
- Sun Pharmaceutical Industries Ltd.
- Novartis AG
- AstraZeneca
- GlaxoSmithKline plc
- Allergan plc
- Janssen Pharmaceuticals, Inc
- Mayne Pharma Group Limited
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Global Sustained Release Excipients Market
Fragmented - Highly competitive market without dominant players
The sustained release excipients market is witnessing robust growth as pharmaceutical companies increasingly adopt controlled release drug formulations. These excipients enable medications to maintain therapeutic levels over an extended period, improving overall treatment effectiveness. Currently, nearly 55% of drug formulations incorporate sustained release mechanisms, largely driven by the need for improved patient adherence and reduced dosing frequency.
Improving Treatment Efficiency and Patient Adherence
Sustained release excipients are crucial in enhancing patient-centric treatment models. By providing steady drug release, they reduce side effects and prevent plasma level fluctuations. Approximately 60% of long-acting medications rely on polymer-based excipients, known for their role in optimizing drug absorption and bioavailability, which is essential for achieving consistent therapeutic outcomes.
Technological Advancements in Excipient Design
There is a growing emphasis on the development of innovative excipients that offer dual functionality, such as binding and release control. Nearly 40% of new product developments in this market focus on multifunctional excipients, which contribute to enhanced formulation adaptability and greater stability of pharmaceutical products.
Expanding Applications Across Therapeutic Categories
The application of sustained release formulations is rapidly growing across various therapeutic areas, particularly in the treatment of chronic diseases. More than 50% of such therapies utilize sustained release excipients to extend drug activity and reduce dosing frequency. As demand for long-acting treatments continues to rise, the market is poised for continued expansion supported by ongoing research and innovation.
Sustained Release Excipients Market Recent Developments
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In June 2023, Croda, Inc. announced the commencement of construction on a new manufacturing plant in Pennsylvania, USA. This facility is expected to enhance Croda's manufacturing capacity and better address the evolving market demands for sustained release excipients.
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In September 2022, Nutriventia developed Prolanza ashwagandha (Withania somnifera) with continuous release. This innovative extract, made solely from ashwagandha roots, is designed to provide long-lasting support for stress relief. Nutriventia specializes in connecting global suppliers and buyers in the food, health, and natural ingredients sectors.
Sustained Release Excipients Market Segment Analysis
In this report, the Sustained Release Excipients Market has been segmented by Product, Route of Administration, Technology, Application, and Geography.
Sustained Release Excipients Market, Segmentation by Product
The Sustained Release Excipients control release dosage form Market has been segmented by Product into Gelatin, Polymers, Minerals, Sugars, Alcohol and Chitosan.
Gelatin
Gelatin accounts for approximately 20% of the market. Known for its biodegradability and controlled-release properties, gelatin is widely used in pharmaceutical formulations. Its excellent biocompatibility supports sustained market demand.
Polymers
Polymers represent about 35% of the market, playing a key role in controlling drug release over extended periods. Advanced polymer technologies offer customizable release profiles and enhanced drug stability, driving significant market growth.
Minerals
Minerals contribute approximately 10% of the market, utilized for their adsorption and stabilizing properties. Their ability to modulate drug release and enhance tablet integrity supports adoption in control release formulations.
Sugars
Sugars hold around 10% of the market, offering viscosity control and drug stability benefits. Their natural origin and biodegradability make them ideal for oral formulations in sustained release applications.
Alcohol
Alcohol-based excipients represent about 15% of the market, used for solubilizing agents and controlled release matrices. Their versatility and enhanced dissolution properties drive their use in advanced formulations.
Chitosan
Chitosan holds approximately 10% of the market, favored for its mucoadhesive properties and ability to control drug release. Its biocompatibility and natural origin make it a preferred excipient in biomedical applications.
Sustained Release Excipients Market, Segmentation by Route of Administration
The Sustained Release Excipients Market has been segmented by Route of Administration into Oral, Intramuscular, Subcutaneous, Transdermal, Vaginal, Ophthalmic, Intravenous and Others.
Oral
Oral administration represents approximately 60% of the sustained release excipients market. This segment benefits from high patient compliance, ease of use, and cost-effective formulations. Rising demand for extended-release tablets and capsules supports growth.
Intramuscular
Intramuscular administration accounts for around 10% of the market, offering prolonged drug action and enhanced bioavailability. Excipients used here ensure controlled release and steady drug levels for extended periods.
Subcutaneous
Subcutaneous administration contributes approximately 8% of the market. It supports patient-friendly delivery of biologics and injectables, using excipients that facilitate controlled absorption and reduced injection frequency.
Transdermal
Transdermal administration holds about 7% of the market. Sustained release excipients in patches and films enable continuous drug delivery through the skin, ensuring steady plasma levels and enhanced patient compliance.
Vaginal
Vaginal administration represents around 5% of the market, offering localized drug delivery with minimal systemic side effects. Sustained release excipients enhance mucoadhesion and prolonged residence time at the site of action.
Ophthalmic
Ophthalmic administration accounts for about 4% of the market. Excipients used in gels and inserts provide prolonged ocular drug exposure and reduce the need for frequent dosing, improving patient compliance.
Intravenous
Intravenous administration holds around 3% of the market. Sustained release excipients help maintain therapeutic drug levels for extended periods, reducing the frequency of IV infusions and hospital visits.
Others
The 'Others' category, including rectal and nasal delivery, represents about 3% of the market. Continuous R&D and innovative formulations enhance growth in this segment, targeting specialized delivery needs.
Sustained Release Excipients Market, Segmentation by Technology
The Sustained Release Excipients Market has been segmented by Technology into Targeted Delivery, Microencapsulation, Wurster Technique, Transdermal, Implants, Coacervation and Others.
Targeted Delivery
Targeted delivery represents approximately 20% of the sustained release excipients market. This technology ensures precise drug delivery to specific sites, enhancing therapeutic efficacy and reducing systemic side effects. It is widely used in oncology and chronic disease management.
Microencapsulation
Microencapsulation accounts for about 25% of the market, leveraging controlled release particles to provide steady drug delivery. This method supports drug stability and enhances bioavailability in oral and injectable formulations.
Wurster Technique
The Wurster technique holds around 15% of the market, using fluidized bed coating to achieve uniform particle coverage. This method ensures extended drug release and is commonly applied in oral dosage forms.
Transdermal
Transdermal technology represents approximately 10% of the market, facilitating continuous drug delivery through the skin. Patches and films with excipients ensure consistent plasma drug levels and improved patient compliance.
Implants
Implants contribute about 8% of the market, offering long-term drug release through biodegradable matrices. This technology is commonly used in contraceptives and chronic disease treatments for improved adherence.
Coacervation
Coacervation holds around 7% of the market, utilizing phase separation techniques to form encapsulated drug particles. This method enhances drug protection and controlled release for various formulations.
Others
The 'Others' category, including emulsions and nanotechnology-based delivery systems, accounts for about 15% of the market. Innovations in this segment focus on specialized delivery needs and enhanced drug targeting.
Sustained Release Excipients Market, Segmentation by Application
The Sustained Release Excipients control release dosage form Market has been segmented by Application into Pharmaceuticals, and Nutraceuticals.
Pharmaceuticals
Pharmaceuticals account for approximately 85% of the sustained release excipients market. These excipients are used in oral, parenteral, and transdermal dosage forms to enhance therapeutic efficacy and improve patient compliance by reducing dosing frequency.
Nutraceuticals
Nutraceuticals represent around 15% of the market, leveraging sustained release excipients in vitamin and supplement formulations for extended nutrient delivery. Rising consumer demand for functional foods and natural health products supports growth in this segment.
Sustained Release Excipients Market, Segmentation by Geography
In this report, Sustained Release Excipients Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Sustained Release Excipients Market Share (%), by Geographical Region
North America
North America holds approximately 40% of the sustained release excipients market. The region’s advanced healthcare infrastructure, high adoption of innovative excipients, and strong presence of pharmaceutical companies support significant market dominance.
Europe
Europe accounts for about 30% of the market, fueled by a strong focus on high-quality formulations and regulatory compliance. Increasing adoption of controlled-release formulations in pharmaceutical and nutraceutical sectors supports steady growth.
Asia Pacific
Asia Pacific represents approximately 20% of the market, with rapid growth driven by expanding pharmaceutical manufacturing capabilities, rising healthcare expenditure, and increasing awareness of sustained release technologies.
Middle East and Africa
Middle East and Africa contribute around 5% of the market, supported by government healthcare initiatives, growing pharmaceutical sector, and increasing demand for advanced excipients for sustained release formulations.
Latin America
Latin America holds about 5% of the market, driven by expanding healthcare infrastructure and rising adoption of nutraceuticals and pharmaceuticals using sustained release excipients.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Sustained Release Excipients Market. These factors include; Market Drivers, Restraints and Opportunities.
Comprehensive Market Impact Matrix
This matrix outlines how core market forces—Drivers, Restraints, and Opportunities—affect key business dimensions including Growth, Competition, Customer Behavior, Regulation, and Innovation.
Market Forces ↓ / Impact Areas → | Market Growth Rate | Competitive Landscape | Customer Behavior | Regulatory Influence | Innovation Potential |
---|---|---|---|---|---|
Drivers | High impact (e.g., tech adoption, rising demand) | Encourages new entrants and fosters expansion | Increases usage and enhances demand elasticity | Often aligns with progressive policy trends | Fuels R&D initiatives and product development |
Restraints | Slows growth (e.g., high costs, supply chain issues) | Raises entry barriers and may drive market consolidation | Deters consumption due to friction or low awareness | Introduces compliance hurdles and regulatory risks | Limits innovation appetite and risk tolerance |
Opportunities | Unlocks new segments or untapped geographies | Creates white space for innovation and M&A | Opens new use cases and shifts consumer preferences | Policy shifts may offer strategic advantages | Sparks disruptive innovation and strategic alliances |
Drivers, Restraints and Opportunity Analysis
Drivers:
- Increasing demand for long-acting medications
- Growing prevalence of chronic diseases
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Technological advancements in drug delivery systems - Continuous technological advancements in drug delivery systems are significantly driving the growth of the global sustained release excipients market. Innovations such as nanoformulations, polymer-based carriers, and osmotic pump technologies are improving the ability to deliver active pharmaceutical ingredients in a controlled and efficient manner. These systems rely on excipients that enable prolonged drug release, maintaining therapeutic levels over extended periods and reducing the frequency of dosing.
As the demand grows for patient-friendly and targeted therapies, pharmaceutical manufacturers are investing in advanced excipient technologies that support formulation stability, bioavailability, and precision drug delivery. Sustained release excipients play a crucial role in enabling these modern systems, making them indispensable in the development of oral, injectable, and implantable dosage forms. This trend is expected to accelerate with the increasing complexity of drug molecules and the rising need for chronic disease management solutions.
Restraints:
- Regulatory challenges and approval processes
- High development costs and complexity
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Patent expirations and generic competition - The rising number of patent expirations for branded drugs significantly impacts the sustained release excipients market, as it leads to increased entry of generic formulations. These generics often focus on cost reduction rather than innovation, placing downward pressure on the use of specialized excipients that support controlled-release profiles. As price-sensitive markets grow, manufacturers may shift toward more cost-effective excipient alternatives, limiting the adoption of advanced sustained release technologies.
Additionally, intellectual property protection plays a crucial role in supporting the development and commercialization of complex drug delivery systems. With the loss of exclusivity, pharmaceutical companies often cut R&D investments and reformulation initiatives, which can slow the demand for high-performance excipients. This environment of intensified generic competition presents a substantial restraint, particularly for premium excipient manufacturers targeting innovative sustained release formulations.
Opportunities:
- Expansion of the pharmaceutical industry in emerging markets
- Strategic collaborations and partnerships
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Focus on patient-centric drug delivery solutions - The increasing shift toward patient-centric drug delivery solutions presents a major opportunity for the global sustained release excipients market. As chronic disease management becomes a priority, there is rising demand for drug formulations that improve treatment adherence and offer enhanced convenience. Sustained release systems, supported by specialized excipients, reduce dosing frequency and maintain consistent therapeutic levels, aligning well with patient preferences for simplified medication regimens.
Pharmaceutical companies are investing in advanced excipient technologies to develop personalized, controlled-release formulations that minimize side effects and optimize therapeutic outcomes. Innovations such as biodegradable polymers, matrix-forming agents, and multi-particulate systems are driving the creation of next-generation drug products designed for user comfort and effectiveness. This focus on patient-centric care continues to create long-term growth prospects for the sustained release excipients market.
Competitive Landscape Analysis
Key players in Global Sustained Release Excipients Market include:
- Teva Pharmaceutical Industries Ltd.
- Mylan N.V.
- Valeant Pharmaceuticals International, Inc.
- Pfizer, Inc.
- Sun Pharmaceutical Industries Ltd.
- Novartis AG
- AstraZeneca
- GlaxoSmithKline plc
- Allergan plc
- Janssen Pharmaceuticals, Inc.
- Mayne Pharma Group Limited
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Market Share Analysis
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Product
- Market Snapshot, By Route of Administration
- Market Snapshot, By Technology
- Market Snapshot, By Application
- Market Snapshot, By Region
- Sustained Release Excipients Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Increasing demand for long-acting medications
- Growing prevalence of chronic diseases
- Technological advancements in drug delivery systems
- Restraints
- Regulatory challenges and approval processes
- High development costs and complexity
- Patent expirations and generic competition
- Opportunities
- Expansion of the pharmaceutical industry in emerging markets
- Strategic collaborations and partnerships
- Focus on patient-centric drug delivery solutions
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Sustained Release Excipients Market, By Product, 2021 - 2031 (USD Million)
- Gelatin
- Polymers
- Minerals
- Sugars
- Alcohol
- Chitosan
- Sustained Release Excipients Market, By Route of Administration, 2021 - 2031 (USD Million)
- Oral
- Intramuscular
- Subcutaneous
- Transdermal
- Vaginal
- Ophthalmic
- Intravenous
- Others
- Sustained Release Excipients Market, By Technology, 2021 - 2031 (USD Million)
- Targeted Delivery
- Microencapsulation
- Wurster Technique
- Transdermal
- Implants
- Coacervation
- Others
- Sustained Release Excipients Market, By Application, 2021 - 2031 (USD Million)
- Pharmaceuticals
- Nutraceuticals
- Sustained Release Excipients Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Sustained Release Excipients Market, By Product, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Teva Pharmaceutical Industries Ltd.
- Mylan N.V
- Valeant Pharmaceuticals International, Inc
- Pfizer, Inc
- Sun Pharmaceutical Industries Ltd.
- Novartis AG
- AstraZeneca
- GlaxoSmithKline plc
- Allergan plc
- Janssen Pharmaceuticals, Inc
- Mayne Pharma Group Limited
- Company Profiles
- Analyst Views
- Future Outlook of the Market