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    Sustained release excipients Market

    ID: MRFR/HC/20477-HCR
    128 Pages
    Rahul Gotadki
    October 2025

    Sustained Release Excipients Market Research Report Information By Product Type (Gelatin, Polymers, Minerals, Sugars, and Others), By Route of Administration (Oral, Intramuscular, Subcutaneous, Transdermal, Intravenous, and Others), By Technology (Targeted Delivery, Microencapsulation, Wurster Technique, and Others), And By Region (North America, Europe, Asia-Pacific, And Rest Of The World) –Market Forecast Till 2035

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    Sustained release excipients Market Summary

    As per MRFR analysis, the Sustained Release Excipients Market Size was estimated at 1.5 USD Billion in 2024. The Sustained Release Excipients industry is projected to grow from 1.62 in 2025 to 3.498 by 2035, exhibiting a compound annual growth rate (CAGR) of 8.0 during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    <p>The Sustained Release Excipients Market is poised for substantial growth driven by technological advancements and increasing patient-centric solutions.</p>

    • The market is witnessing a growing demand for patient-centric solutions, particularly in North America, which remains the largest market.
    • Advancements in material science are propelling the development of innovative excipients, especially in the Asia-Pacific region, recognized as the fastest-growing market.
    • Gelatin continues to dominate the excipients segment, while polymers are emerging as the fastest-growing category due to their versatility.
    • The increasing prevalence of chronic diseases and rising investment in research and development are key drivers fueling market expansion.

    Market Size & Forecast

    2024 Market Size 1.5 (USD Billion)
    2035 Market Size 3.498 (USD Billion)
    CAGR (2025 - 2035) 8.0%

    Major Players

    BASF SE (DE), Evonik Industries AG (DE), Ashland Global Holdings Inc. (US), Dow Inc. (US), JRS Pharma (DE), Colorcon Inc. (US), FMC Corporation (US), Gattefossé (FR), Merck KGaA (DE), Shin-Etsu Chemical Co., Ltd. (JP)

    Sustained release excipients Market Trends

    The Sustained Release Excipients Market is currently experiencing notable growth, driven by the increasing demand for advanced drug delivery systems. These excipients play a crucial role in enhancing the bioavailability and therapeutic efficacy of pharmaceutical formulations. As the healthcare sector continues to evolve, the focus on patient-centric solutions has intensified, leading to a greater emphasis on sustained release technologies. This shift is likely to foster innovation in excipient development, as manufacturers strive to meet the diverse needs of the pharmaceutical industry. Moreover, the rising prevalence of chronic diseases necessitates the creation of medications that provide prolonged therapeutic effects. Consequently, the Sustained Release Excipients Market is poised to expand as pharmaceutical companies seek to improve patient compliance and treatment outcomes. The integration of novel materials and technologies into excipient formulations may further enhance their performance, thereby attracting significant interest from researchers and developers alike. As the market progresses, collaboration between excipient manufacturers and pharmaceutical companies appears essential for driving advancements and ensuring the successful implementation of sustained release systems.

    Growing Demand for Patient-Centric Solutions

    The Sustained Release Excipients Market is witnessing an increasing focus on patient-centric drug delivery systems. This trend emphasizes the need for formulations that enhance patient compliance and improve therapeutic outcomes. As healthcare providers prioritize personalized medicine, the demand for excipients that facilitate sustained release mechanisms is likely to rise.

    Advancements in Material Science

    Innovations in material science are significantly influencing the Sustained Release Excipients Market. The development of new polymers and biocompatible materials is enhancing the performance of sustained release formulations. These advancements may lead to more effective drug delivery systems, catering to the evolving needs of the pharmaceutical industry.

    Regulatory Support for Novel Formulations

    Regulatory bodies are increasingly supporting the development of novel sustained release formulations. This trend indicates a favorable environment for innovation within the Sustained Release Excipients Market. As guidelines evolve, manufacturers may find it easier to introduce new excipients that meet stringent safety and efficacy standards.

    The ongoing evolution in pharmaceutical formulations underscores a growing preference for sustained release excipients, which are increasingly recognized for their ability to enhance therapeutic efficacy and patient compliance.

    U.S. Food and Drug Administration (FDA)

    Sustained release excipients Market Drivers

    Increasing Prevalence of Chronic Diseases

    The rising incidence of chronic diseases such as diabetes, hypertension, and cardiovascular disorders is a pivotal driver for the Sustained Release Excipients Market. As the global population ages, the demand for medications that require prolonged therapeutic effects intensifies. This trend is reflected in the pharmaceutical sector, where sustained release formulations are increasingly favored for their ability to enhance patient compliance and minimize side effects. According to recent data, chronic diseases account for a substantial portion of healthcare expenditures, prompting pharmaceutical companies to invest in innovative excipients that facilitate sustained drug release. This shift not only addresses the therapeutic needs of patients but also aligns with the industry's focus on developing more effective and patient-friendly drug delivery systems.

    Rising Investment in Research and Development

    The Sustained Release Excipients Market is experiencing a surge in investment directed towards research and development. Pharmaceutical companies are increasingly allocating resources to explore novel excipients that can improve drug solubility and bioavailability. This trend is underscored by the growing emphasis on developing complex formulations that cater to specific patient needs. Recent statistics suggest that R&D spending in the pharmaceutical sector has reached unprecedented levels, with a significant portion dedicated to excipient innovation. This investment not only fosters the creation of new sustained release products but also enhances the overall quality and performance of existing formulations, thereby driving market expansion.

    Growing Focus on Patient Compliance and Convenience

    The increasing focus on patient compliance and convenience is a significant driver for the Sustained Release Excipients Market. Patients often prefer medications that require less frequent dosing, as this enhances adherence to treatment regimens. Sustained release formulations address this need by providing prolonged therapeutic effects, thereby reducing the burden of multiple daily doses. Market analysis reveals that products designed for improved patient convenience are gaining traction, leading to a shift in pharmaceutical strategies. As healthcare providers prioritize patient-centric approaches, the demand for excipients that facilitate sustained release mechanisms is likely to grow, further influencing market trends.

    Regulatory Support for Innovative Drug Formulations

    Regulatory bodies are increasingly supportive of innovative drug formulations, which is a crucial driver for the Sustained Release Excipients Market. The establishment of streamlined approval processes for novel excipients and formulations encourages pharmaceutical companies to invest in sustained release technologies. This regulatory environment fosters innovation and facilitates the introduction of new products to the market. Data indicates that regions with proactive regulatory frameworks have seen a higher rate of new product launches, reflecting the positive impact of regulatory support on market dynamics. As companies navigate the complexities of drug development, the backing of regulatory agencies plays a vital role in promoting sustained release excipients.

    Technological Advancements in Drug Delivery Systems

    Technological innovations in drug delivery systems are significantly influencing the Sustained Release Excipients Market. The integration of advanced materials and manufacturing techniques, such as 3D printing and nanotechnology, has enabled the development of more sophisticated sustained release formulations. These advancements allow for precise control over drug release profiles, enhancing the efficacy and safety of medications. Market data indicates that the adoption of these technologies is expected to grow, driven by the need for personalized medicine and targeted therapies. As pharmaceutical companies increasingly seek to differentiate their products, the demand for high-performance excipients that support sustained release mechanisms is likely to rise, further propelling market growth.

    Market Segment Insights

    By By Product Type: Gelatin (Largest) vs. Polymers (Fastest-Growing)

    In the Sustained Release Excipients Market, the product type segment displays a varied distribution of market share among 'Gelatin', 'Polymers', 'Minerals', 'Sugars', and 'Others'. Gelatin is currently the largest segment due to its extensive application in pharmaceuticals and well-established market presence. Meanwhile, Polymers are rapidly gaining traction, characterized by an increasing adoption in drug delivery systems that require controlled release characteristics, positioning them as a key player in the segment.

    Gelatin (Dominant) vs. Polymers (Emerging)

    Gelatin continues to dominate the Sustained Release Excipients Market with its advantageous properties such as biocompatibility and ease of processing, making it a preferred choice for various pharmaceutical applications. Its longstanding usage and established methods in formulation technologies enhance its position. In contrast, Polymers are emerging rapidly, driven by their versatility and innovative applications in drug delivery. Their ability to offer tailored release profiles makes them appealing for new therapeutic developments, particularly in complex formulations that require precise release mechanisms. This duality highlights the dynamic nature of the market, as traditional materials meet innovative demands.

    By By Route of Administration: Oral (Largest) vs. Transdermal (Fastest-Growing)

    In the Sustained Release Excipients Market, the 'Route of Administration' segment showcases a diverse distribution with Oral administration commanding the largest share due to its ease of use and patient compliance. This segment is well-established and widely favored for various therapeutic applications. Other methods like Intramuscular and Subcutaneous are also significant but hold smaller shares compared to Oral administration, while Transdermal emerges as a competitive player in the market, capturing attention for its innovative delivery mechanisms. The growth trends in this segment are driven by the increasing demand for patient-friendly drug delivery systems. Oral and Transdermal routes are gaining traction due to advancements in formulation technology and a surge in chronic disease prevalence, which drives the need for sustained release drugs. Moreover, changing consumer preferences toward non-invasive methods solidify Transdermal's position as the fastest-growing route among emerging options. Industries are focusing on improving therapeutic effectiveness and minimizing side effects, further promoting these routes of administration.

    Oral (Dominant) vs. Subcutaneous (Emerging)

    The Oral route of administration remains dominant in the Sustained Release Excipients Market due to its extensive usage and high patient adherence. Offering advantages such as convenience and versatility, Oral formulations encompass tablets, capsules, and liquid formulations that ensure consistent drug release. By contrast, the Subcutaneous route is rapidly emerging due to innovations in injectable sustained-release formulations that provide extended therapeutic effects with reduced dosing frequency. This growing interest reflects a shift towards targeted therapies, driven by advancements in biopharmaceuticals, making the Subcutaneous route appealing for diseases that require constant drug levels in the bloodstream, enhancing both efficacy and patient quality of life.

    By By Technology: Targeted Delivery (Largest) vs. Microencapsulation (Fastest-Growing)

    The Sustained Release Excipients Market is segmented into various technologies, prominently featuring Targeted Delivery, Microencapsulation, Wurster Technique, and others. Targeted Delivery holds the largest share of the segment, primarily due to its widespread application in the pharmaceuticals industry, where precision in drug delivery is crucial. Microencapsulation, on the other hand, is quickly gaining traction as the fastest-growing segment, driven by increased demand for advanced drug formulations that require controlled release mechanisms.

    Technology: Targeted Delivery (Dominant) vs. Microencapsulation (Emerging)

    Targeted Delivery is recognized as the dominant technology within the Sustained Release Excipients Market, widely adopted for its ability to direct drugs to specific sites in the body, enhancing therapeutic efficacy while minimizing side effects. Its established presence in various therapeutic areas positions it as a preferred choice among manufacturers. Microencapsulation, however, is emerging rapidly as a vital technology, characterized by its versatility in encapsulating active ingredients in polymers or lipids, thus improving stability, bioavailability, and controlled release profiles. This technology's adaptability to diverse applications across pharmaceuticals and nutraceuticals secures its position as an innovative alternative for future growth.

    Get more detailed insights about Sustained release excipients Market

    Regional Insights

    By region, the study provides the market insights into North America, Europe, Asia-Pacific and the Rest of the World. The North American sustained release excipients market area will dominate this market. Increased R&D efforts and the presence of significant pharmaceutical businesses in the area are credited with the region's success. Over the course of the forecast period, the region is expected to become more profitable due to patent expirations and the subsequent arrival of generics.

    Further, the major countries studied in the market report are the US, Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

    Figure 2: SUSTAINED RELEASE EXCIPIENTS MARKET SHARE BY REGION 2023 (USD Billion)

    SUSTAINED RELEASE EXCIPIENTS MARKET SHARE BY REGION 2023

    Source: Secondary Research, Primary Research, Market Research Future Database and Analyst Review

    Europe sustained release excipients market accounts for the second-largest market share. The primary driver of market expansion is the aging population. Furthermore, it is projected that the advancement of complex biologics and the growing need for novel drug delivery systems will drive market growth in this sector. Further, the German sustained release excipients market held the largest market share, and the UK sustained release excipients market was the fastest growing market in the European region.

    The Asia-Pacific Sustained Release Excipients Market is expected to grow at the fastest CAGR from 2024 to 2032. The increased incidence of numerous infectious diseases, the quickly expanding healthcare system, and the growing need for highly potent medications are all factors contributing to this region's rise. Moreover, China’s sustained release excipients market held the largest market share, and the Indian sustained release excipients market was the fastest growing market in the Asia-Pacific region.

    Key Players and Competitive Insights

    Leading market players are investing heavily in research and development in order to expand their product lines, which will help the sustained release excipients market, grow even more. Market participants are also undertaking a variety of strategic activities to expand their global footprint, with important market developments including new product launches, contractual agreements, mergers and acquisitions, higher investments, and collaboration with other organizations. To expand and survive in a more competitive and rising market climate, the sustained release excipients industry must offer cost-effective items.

    Manufacturing locally to minimize operational costs is one of the key business tactics used by manufacturers in the global sustained release excipients industry to benefit clients and increase the market sector. In recent years, the sustained release excipients industry has offered some of the most significant advantages to medicine. Major players in the sustained release excipients market are attempting to increase market demand by investing in research and development operations, including Allergan PLC, AstraZeneca, GlaxoSmithKline PLC, Mayne Pharma Group Limited, Mylan NV, Novartis AG, Pfizer Inc., Salix Pharmaceuticals, and Sun Pharmaceutical Industries Ltd.

    As a division of AbbVie Inc., Allergan Ltd. (Allergan) is a specialty pharmaceutical business that creates and distributes over-the-counter (OTC) and branded medications as well as biosimilars. The company sells goods in the following therapeutic categories: anti-infective, urology, women's health, dermatology, central nervous system, eye care, and gastroenterology. Its clients include mail-order merchants, hospitals, clinics, government agencies, and managed healthcare providers, including health maintenance organizations and other institutions. It also distributes its products to retailers, drug wholesalers, and distributors, including national retail medicine and grocery store chains.

    Biopharmaceuticals are discovered, developed, produced, and marketed by Pfizer Inc. (Pfizer). The company offers solutions to address a variety of conditions, such as those related to women's health, cancer, inflammatory diseases, immune system issues, and metabolic, cardiovascular, and pain disorders. Additionally provided are sterile injectable drugs, biosimilars, contract manufacturing services, and active pharmaceutical ingredients (APIs). For over $6.7 billion, US-based pharmaceutical and biotechnology company Pfizer Inc. purchased Arena Pharmaceuticals in December 2021.

    The purchase of Arena bolsters Pfizer's capabilities and expertise in immunology and inflammation, a Pfizer innovation engine that develops effective therapies for patients with debilitating immuno-inflammatory diseases in need of new treatment options.

    Key Companies in the Sustained release excipients Market market include

    Industry Developments

    • Q2 2024: Colorcon Expands Manufacturing Capacity in India to Meet Growing Demand for Pharmaceutical Excipients Colorcon announced the opening of a new manufacturing facility in India to increase production of pharmaceutical excipients, including those used in sustained release formulations, to support growing demand in Asia and globally.
    • Q1 2024: Lubrizol Life Science Health Launches New Sustained Release Excipient for Oral Solid Dose Formulations Lubrizol Life Science Health introduced a new excipient designed for sustained release oral solid dose pharmaceuticals, expanding its product portfolio for controlled drug delivery applications.
    • Q2 2024: Ashland Receives FDA Approval for New Sustained Release Excipient in Extended-Release Tablets Ashland announced that the U.S. FDA approved its latest sustained release excipient for use in extended-release tablet formulations, marking a regulatory milestone for the company.
    • Q3 2024: BASF Partners with Indian Pharma Firm to Develop Next-Generation Sustained Release Excipients BASF entered into a partnership with an Indian pharmaceutical manufacturer to co-develop and commercialize new sustained release excipients for advanced drug delivery systems.
    • Q2 2024: Evonik Opens New Production Line for Sustained Release Excipients in Germany Evonik inaugurated a new production line at its German facility dedicated to manufacturing excipients for sustained release drug formulations, aiming to meet rising demand in Europe.
    • Q1 2025: Roquette Appoints New Head of Global Pharmaceutical Excipients Division Roquette announced the appointment of a new executive to lead its global pharmaceutical excipients division, with a focus on expanding the company’s sustained release excipient offerings.
    • Q2 2025: DuPont Acquires Specialty Excipients Business from Smaller European Firm DuPont completed the acquisition of a European specialty excipients business, strengthening its portfolio in sustained release and controlled release excipient technologies.
    • Q3 2024: DFE Pharma Launches New Co-Processed Excipient for Sustained Release Tablets DFE Pharma introduced a new co-processed excipient specifically engineered for use in sustained release tablet formulations, targeting improved performance and manufacturability.
    • Q1 2024: Gattefossé Announces Strategic Partnership with US Biotech for Sustained Release Drug Delivery Gattefossé entered a strategic partnership with a US-based biotech company to jointly develop lipid-based excipients for sustained release drug delivery applications.
    • Q2 2025: Lonza Invests $50 Million to Expand Excipients Manufacturing for Controlled Release Drugs Lonza announced a $50 million investment to expand its excipients manufacturing capacity, with a focus on ingredients used in controlled and sustained release pharmaceutical products.
    • Q1 2025: Merck KGaA Launches New Polymer Excipient for Extended-Release Oral Formulations Merck KGaA introduced a new polymer excipient designed for use in extended-release oral drug formulations, enhancing its offerings in the sustained release excipients market.
    • Q3 2025: Shin-Etsu Chemical Expands Production Capacity for Hydroxypropyl Methylcellulose Used in Sustained Release Tablets Shin-Etsu Chemical announced the expansion of its production capacity for hydroxypropyl methylcellulose, a key excipient in sustained release tablet manufacturing, to meet increasing global demand.
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    Future Outlook

    Sustained release excipients Market Future Outlook

    The Global Sustained Release Excipients Market is projected to grow at a 8.00% CAGR from 2025 to 2035, driven by increasing demand for advanced drug delivery systems and biopharmaceutical innovations.

    New opportunities lie in:

    • Develop novel excipients tailored for biologics and biosimilars.
    • Invest in sustainable sourcing of excipients to meet regulatory demands.
    • Leverage digital technologies for enhanced formulation development and testing efficiency.

    By 2035, the market is expected to exhibit robust growth, positioning itself as a pivotal segment in pharmaceutical advancements.

    Market Segmentation

    Sustained Release Excipients Regional Outlook

    North America
    • US
    • Canada
    Europe
    • Germany
    • France
    • UK
    • Italy
    • Spain
    • Rest of Europe
    • Asia-Pacific
    China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
    Rest of the World
    • Middle East
    • Africa
    • Latin America

    Sustained Release Excipients Technology Outlook

    • Targeted Delivery
    • Microencapsulation
    • Wurster Technique
    • Others

    Sustained Release Excipients Product Type Outlook

    • Gelatin
    • Polymers
    • Minerals
    • Sugars
    • Others

    Sustained Release Excipients Route of Administration Outlook

    • Oral
    • Intramuscular
    • Subcutaneous
    • Transdermal
    • Intravenous
    • Others

    Report Scope

    Report Attribute/Metric Details
    Market Size 2024 USD 1.5 Billion
    Market Size 2035 3.50 (Value (USD Billion))
    Compound Annual Growth Rate (CAGR) 8.00% (2025 - 2035)
    Base Year 2024
    Market Forecast Period 2025 - 2035
    Historical Data 2019-2022
    Market Forecast Units Value (USD Billion)
    Report Coverage Revenue Forecast, Market Competitive Landscape, Growth Factors, and Trends
    Segments Covered Product Type, Route of Administration, Technology, and Region
    Geographies Covered North America, Europe, Asia Pacific, and the Rest of the World
    Countries Covered The US, Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil
    Key Companies Profiled Allergan PLC, AstraZeneca, GlaxoSmithKline PLC, Mayne Pharma Group Limited, Mylan NV, Novartis AG, Pfizer Inc., Salix Pharmaceuticals, and Sun Pharmaceutical Industries Ltd.
    Key Market Opportunities ·       Growing government initiatives, along with a rise in early intervention and prevention techniques are anticipated to drive market expansion.
    Key Market Dynamics ·       Prevalence of both acute and chronic illnesses is a key element driving market expansion in the upcoming years. ·       Antibiotic resistance and the increased benefits of traditional dosage forms are expected to fuel market expansion.
    Market Size 2025 1.62 (Value (USD Billion))

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    FAQs

    What is the projected growth of the Sustained Release Excipients market?

    The Sustained Release Excipients market is the expected increase in total market value of 3.5 USD billion over a defined forecast period 2025–2035. It is driven by factors such as demand trends, technological advances, regulatory changes, and geographic expansion.

    What is the size of the Sustained Release Excipients market?

    Sustained Release Excipients market size was valued at approximately 1.5 billion USD in 2024. This figure will reach 3.5 billion USD covering all regions (America, Europe, Asia, MEA and ROW), focusing its segments / services / distribution channels till 2035.

    What is the CAGR of the Sustained Release Excipients market?

    Sustained Release Excipients market is expected to grow at a CAGR of 8% between 2025 and 2035.

    How much will the Sustained Release Excipients market be worth by 2035?

    Sustained Release Excipients market is expected to be worth of 3.5 billion USD, reflecting growth driven by usage, technology and global demands by the end of 2035.

    How will the Sustained Release Excipients market perform over the next 10 years?

    Over the next 10 years the Sustained Release Excipients market is expected to shift from usd billion 1.5 to 3.5 billion USD, led by adoption of advanced tech, demographic trends, regulatory approvals, with potential headwinds from 2025 to 2035.

    Which region held the largest market share in the sustained release excipients market?

    North America had the largest share in the global market

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