Sustained Release Excipients Market Report 2025

The sustained release excipients market size has grown strongly in recent years. It will grow from $1.4 billion in 2024 to $1.53 billion in 2025 at a compound annual growth rate (CAGR) of 9.1%. The growth in the historic period can be attributed to increased demand for controlled drug release, chronic disease prevalence, patient compliance and convenience, pharmaceutical industry innovations, regulatory support for extended-release formulations.

The sustained release excipients market size is expected to see strong growth in the next few years. It will grow to $2.13 billion in 2029 at a compound annual growth rate (CAGR) of 8.8%. The growth in the forecast period can be attributed to increasing geriatric population, focus on personalized medicine, challenges in patient adherence, rise in complex drug formulations, advancements in disease management, global healthcare expansion. Major trends in the forecast period include patient-centric drug delivery, collaborations for formulation development, regulatory compliance and safety, global expansion of drug formulation technologies, influence of biopharmaceuticals.

The rising prevalence of chronic and acute diseases is expected to fuel the growth of the sustained-release excipients market. Chronic diseases are long-term conditions that persist for three months or more, while acute diseases are marked by a sudden onset of symptoms that are typically severe but short-lived, lasting from hours to weeks. Sustained-release excipients are commonly used in pharmaceutical formulations for both chronic and acute diseases, enhancing patient adherence, maintaining stable drug levels, reducing side effects, and improving overall disease management. This drives demand for sustained-release excipients. For instance, in September 2022, the World Health Organization (WHO) reported that cardiovascular diseases were the leading cause of non-communicable disease (NCD) deaths, resulting in 17.9 million deaths annually, followed by chronic respiratory illnesses (4.1 million), diabetes (2 million, including deaths from diabetes-related kidney disease), and cancer (9.3 million). Additionally, an August 2022 report from the American College of Cardiology projected a rise in major cardiovascular risk factors in the U.S. from 2025 to 2060, with diabetes expected to increase by 39.3% to 55 million cases, followed by dyslipidemia (27.6% to 126 million), hypertension (25.1% to 162 million), and obesity (18.3% to 126 million). Cardiovascular disease rates are also anticipated to increase for stroke (33.8% to 15 million), heart failure (33.4% to 13 million), ischemic heart disease (30.7% to 29 million), and heart attacks (16.9% to 16 million). Thus, the growing incidence of chronic and acute diseases is driving the demand for sustained-release excipients.

The sustained-release excipients market is also expected to benefit from the growing demand for personalized medicine. Personalized medicine involves studying individual genes, proteins, and bodily components to provide customized care using precision medicine. Sustained-release excipients play a crucial role in this field by facilitating the development of drug formulations tailored to individual patient needs. In 2022, the US Food and Drug Administration (FDA) approved 12 personalized medicines, accounting for approximately 34% of all newly approved therapeutic molecular entities, as reported by The Scope and Significance of Progress in 2022 by the Personalized Medicine Coalition. Therefore, the increasing demand for personalized medicine contributes to the growth of the sustained-release excipients market.

The sustained-release excipients market is witnessing a significant trend of product innovation. Major companies in this market are actively engaged in developing innovative products to enhance their market position. For instance, in September 2022, Nutriventia Limited, an India-based pharmaceutical company, introduced Prolanza, a sustained-release ashwagandha ingredient (Withania somnifera). Prolanza, an advanced Ashwagandha root-only extract, provides continuous stress-reduction support with a unique release mechanism, allowing therapeutic effects over an extended period with a once-daily dose. This sustained-release profile was demonstrated through better relative absorption, improved bioavailability, and a longer elimination half-life compared to the control component. Manufactured from natural herbs, Prolanza has been clinically proven to be effective.

Major companies in the sustained-release excipients market are directing their efforts toward technological innovations, including direct compression solutions, to gain a competitive advantage. Direct compression is an efficient tablet manufacturing process involving the direct conversion of a blend of active pharmaceutical ingredients (APIs) and excipients into tablets without additional steps such as granulation or wet massing. For example, in October 2022, Roquette Frères, a France-based provider of plant-based ingredients, introduced PEARLITOL CR-H and PEARLITOL 200 GT for direct compression. PEARLITOL CR-H, a patented blend of mannitol and hydroxypropyl methylcellulose (HPMC), allows sustained release of APIs in direct compression formulations. PEARLITOL 200 GT, a granulated form of mannitol, enhances the flowability and tabletability of direct compression formulations.

In March 2024, France-based pharmaceutical excipient provider Roquette acquired IFF Pharma Solutions for an undisclosed sum. This acquisition is intended to bolster Roquette's presence in the pharmaceutical excipients market. IFF Pharma Solutions, a U.S.-based company, specializes in manufacturing sustained-release excipients, which are key ingredients in pharmaceutical formulations designed to regulate the release rate of active pharmaceutical ingredients (APIs).

Major companies operating in the sustained release excipients market include BASF SE, Ashland Global Holdings Inc., Colorcon Inc., Croda International Plc, Dow Chemical Company, DuPont de Nemours Inc., Roquette Frères, Evonik Industries AG, Lubrizol Corporation, Merck KGaA, JRS Pharma GmbH & Co. KG, Shin-Etsu Chemical Co.Ltd., Gattefossé SAS, Eastman Chemical Company, Cellulose Solutions Private Limited, Avantor Inc., SPI Pharma Inc., Asahi Kasei Corporation, Chemische Fabrik Budenheim KG, Associated British Foods plc, Ransom Naturals Ltd, Balchem Corporation, IMCD Group, Lonza Group AG.

North America was the largest region in the global sustained release excipients market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the sustained release excipients market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the sustained release excipients market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Sustained-release excipients are pharmaceutical ingredients or additives utilized in formulating drug delivery systems with the aim of achieving controlled or sustained release of active pharmaceutical ingredients (APIs) over an extended period. These excipients play a critical role in regulating the release rate and duration of drug action, optimizing therapeutic efficacy, and enhancing patient compliance.

The primary types of sustained-release excipient products encompass gelatin, polymers, minerals, sugars, alcohol, and chitosan. Gelatin, a protein derived from collagen, the most abundant protein in animal connective tissues such as skin, bones, and tendons, is administered through various routes such as oral, intramuscular, subcutaneous, transdermal, vaginal, ophthalmic, intravenous, and others. Various technologies are employed, including targeted delivery, microencapsulation, the Wurster technique, transdermal delivery, implants, and coacervation.

The sustained release excipients market research report is one of a series of new reports that provides sustained release excipients market statistics, including sustained release excipients industry global market size, regional shares, competitors with a sustained release excipients market share, detailed sustained release excipients market segments, market trends and opportunities, and any further data you may need to thrive in the sustained release excipients industry. This sustained release excipients market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The sustained-release excipients market consists of sales of ethyl cellulose, lipid-based excipients, waxes, fatty acids, polyethylene glycol (PEG), copovidone, and osmotic agents. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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