Sustained Release Excipients Market Size, Share, Growth, and Industry Analysis, By Type (gelatin, polymers, minerals, sugars, alcohol & chitosan), by application, (pharmaceutical companies, biopharmaceutical companies, nutraceutical manufacturers & contract manufacturing organizations), and Regional Insights and Forecast to 2034

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SUSTAINED RELEASE EXCIPIENTS MARKET OVERVIEW

The global sustained release excipients market size was USD 1.236 billion in 2025 and is projected to touch USD 1.576 billion by 2034, exhibiting a CAGR of 2.8% during the forecast period.

Sustained Release Excipient market has been an important aspect in the contemporary pharmaceutical formulation, and it has helped to develop pharmaceuticals that release active ingredients at a slow rate over time. These excipients help to augment stability, bioavailability and patient adherence of drug by decreasing the dosing rate and achieving consistent therapeutic impacts. Market growth is being propelled by growing need of sophisticated drug delivery systems and long acting formulations in therapeutic applications in the cardiovascular, neurological and diabetic therapy. In addition, the polymer technology and biocompatible material innovations are playing a role in making the process of sustained-release more efficient. Increased R&D by pharmaceutical firms and more uses in both oral and injectable formulations are other strengths with regard to market potential. The development of the market is consistent with the international tendency of patient-centred therapies and precision medicine, which increase their effectiveness and safety of treatment.

COVID-19 IMPACT

Pandemic hindered the market growth due to manufacturing delays and transportation issues

The COVID-19 pandemic impact the sustained release excipients market growth, on world supply chains, manufacturing delays, and transportation issues had an effect on the production and distribution of pharmaceutical excipients. Nevertheless, the pandemic speeded up the study of sophisticated drug delivery methods because drug companies wanted more effective formulations to use in long-term treatments, as well as vaccine ingredients. The rising interest in patient compliance and home-based therapies drove the need to use sustained-release formulations. Moreover, the growth of pharmaceutical R&D and government support to enhance healthcare infrastructure significantly increased the market recovery after the pandemic. With the adjustment of the industry to the new standards, digitalization, increased production at the local level, and excipient technologies appeared as the new tools, which finally allowed creating more resilience in the market and preconditions to achieve a further long-term growth in the post-COVID environment.

LATEST TRENDS

Material science and formation technologies to be prominent trends

The market of sustained release excipient is in the dynamic phase with remarkable development of material science and formation technologies. One of the key trends is the growing popularity of biocompatible and biodegradable polymers, including hydroxypropyl methylcellulose (HPMC) and ethyl cellulose, to improve drug stability and controlled delivery. Nanotechnology and 3D printing are also taking off, which allows customizing the drug release profile with high precision. Drug manufacturers are also prioritizing patient-centric dosages that enhance convenience and adherence particularly in chronic illness. In addition, the increase in the demand of oral sustained-release dosage forms and injectable long-acting therapies is contributing to innovation. Excipient development is being influenced by sustainability and regulatory compliance, which have resulted into safer and environmentally friendly materials. The recent strategic partnerships between excipient companies and drug developers are also enhancing the use of superior sustained-release technology in the world markets.

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SUSTAINED RELEASE EXCIPIENTS MARKET SEGMENTATION

By Type

Based on type, the global market can be categorized into gelatin, polymers, minerals, sugars, alcohol & chitosan.

• Gelatin: Gelatin is very popular in sustained release formulations because it is biocompatible and film forming, which allows controlled release of drugs and increases stability in capsules and in microencapsulation systems.

• Polymers: The essential polymers include HPMC, ethyl cellulose and PVA that control drug diffusion, prolong diffusion and flexibility of formulation of both the oral and injectable sustained-release drugs.

• Minerals: Individual minerals such as calcium phosphate and magnesium stearate function as binding and stabilizing agents in sustained release preparations, which can be used to maintain the constant release of the drug and enhances the hardness of the tablet as well as its dissolution ability.

• Sugars: Lactose and sucrose sugars are employed as fillers or coating agents, which increase the stability of the tablets and allow the release of the drugs gradually in the controlled oral dosage systems.

• Alcohol: Alcohols (and fatty alcohols) are used as the matrix-forming agents of sustained release formulations, and regulate the diffusion of drugs and release profiles at a sustained rate with sustained coverage.

• Chitosan: Chitosan is a natural biopolymer, which is appreciated as a mucoadhesive, biodegradable biopolymer that facilitates controlled drug release or absorption and oral and transdermal sustained-release drug delivery systems.

By Application

Based on application, the global market can be categorized into pharmaceutical companies, biopharmaceutical companies, nutraceutical manufacturers & contract manufacturing organizations.

• Pharmaceutical Companies: Pharmaceutical manufacturers use sustained release excipients to create long-acting formulations, which enhance drug stability, drug compliance, and therapeutic efficacy, as well as, reducing the dosing frequency in several chronic disease therapies.

• Biopharmaceutical Companies: The sustained release excipients applied by biopharmaceutical firms tend to improve the delivery of biologics, peptides and proteins to ensure release is controlled, drugs are stable and in targeted therapeutic action to the complex macromolecular drugs.

• Nutraceutical Manufacturers: Nutraceutical companies add sustained release excipients in dietary supplements to provide slow absorption of nutrients, prolonged bioavailability and enhanced convenience of vitamins, mineral and herbal products in consumption by humans.

• Contract Manufacturing Organizations: Using sustained release excipients, CMOs offer specialized formulation and production services to assist pharmaceutical brands in creating controlled-release products with performance, quality, and regulatory compliance that is consistent.

MARKET DYNAMICS

Market dynamics include driving and restraining factors, opportunities and challenges stating the market conditions.

Driving Factors

Increasing rate of chronic illnesses to increase the market growth

The increasing rate of chronic illnesses such as diabetes, cardiovascular conditions, respiratory, and neurological conditions is one of the catalysts behind the Sustained Release Excipient market. These chronic ailments need constant and successful management, and sustained-release preparations would make the best option in keeping the drug levels constant and reducing the dosing schedule. These formulations with high-quality excipients are beneficial to increase patient compliance, efficacy, and convenience. Due to the global healthcare systems has been keen on enhancing the management of chronic diseases, pharmaceutical companies have highly embraced the use of the controlled-release technology in order to come up with the long-acting drugs. Besides, the elderly population and lifestyle diseases also enhance the increasing number of people requiring sustained-release therapies. The trend is driving ongoing excipient materials and formulation development to address the changing patient and provider needs.

Emphasis on patient compliance to increase the market growth

The increased emphasis on patient compliance is one of the major drivers of the Sustained Release Excipient market. Sustained-release excipients are important in the development of drugs, which discharge active ingredients over a sustained period, thereby giving a consistent effect of therapy as well as minimizing the necessity to take drugs often. The convenience and compliance of this feature are greatly enhanced insofar as the patients with chronic ailments such as diabetes, hypertension or arthritis are concerned. These formulations improve the outcomes of the entire treatment by reducing the variation in drug concentration and side effects. Drug design Pharmaceutical companies are placing an increasing focus on patient-centred drug designs that make medication schedules easier and enhance quality of life. Moreover, health care providers and regulators are focusing on adherence enhancing technologies, which are stimulating excipient development. Consequently, the trend of advanced, biocompatible sustained-release excipient is on the increase in the world pharmaceutical industries.

Restraining Factor

Regulatory demands to limit the market growth

The regulatory demands in the market are also a major obstacle to the Sustained Release Excipient market since excipients are essential in the drug safety, performance, and stability. Several regulatory authorities such as the U.S FDA and the European medicines agency (EMA) have stringent testing, documentation, and validation procedures that guarantee the quality of all excipients and compatibility of sustained release formulations. It has high standards in terms of purity, biocompatibility, and consistency that make the manufacturers spend more time and money to develop. In addition, when there is a change in the formulation composition or manufacturing techniques that needs new approvals or comprehensive justifications, product launches take even longer. The absence of standardized international laws also makes international trade and international compliance a problem. Even though these regulations are important to protect the safety of patients, they create both operational and financial impacts on companies, especially smaller ones, sluggishly contributing to the establishment of new excipient technologies in the market.

Development of drug delivery technologies and the increasing popularity of patient-oriented therapy to opportunity in the market

Opportunity

The sustained release excipient business has a high potential in the future due to the further development of drug delivery technologies and the increasing popularity of patient-oriented therapy. Greater use of more biocompatible and biodegradable excipients will make more efficient and safer formulations with chronic disease management. The increasing research in the field of biopharmaceuticals and the emergence of personalized medicine will improve innovation in sustained-release systems.

The potentials in emerging markets in Asia-Pacific and Latin America have not been exploited since the healthcare infrastructure is expanding and domestic drug production is increasing. In addition, the partnerships between the excipients manufacturers and the pharmaceutical firms will enhance faster innovations of new, high performance materials consistent with long-term treatment efficacies.

Complex design might demand sophisticated materials and technical knowledge could be a potential challenge

Challenge

The market of Sustained Release Excipient would have a number of challenges in the future irrespective of its potential growth. Formulation design is one serious challenge since a complex design might demand sophisticated materials and technical knowledge to attain accurate drug release profiles. Product innovation and product entry are further inhibited by high development costs and high regulatory requirements. Drug stability and performance may also be affected by compatibility problems between excipients and active ingredients.

Moreover, there are inadequate qualified personnel in the pharmaceutical formulation field and poor standardization in the global markets that result in inefficiency. To address these challenges, it will be necessary to invest more in R&D, harmonize the regulations, and enhance collaboration in the industry, which will guarantee the successful delivery of quality and innovation.

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SUSTAINED RELEASE EXCIPIENTS REGIONAL INSIGHTS

• North America

The North America dominated the sustained release excipient market share, which is prompted by the high concentration of Pharmaceutical and biotechnological firms, well-developed R&D network and high healthcare spending. The United States sustained release excipient market is influential because it has a strong drug-developing pipeline and growing need of the controlled-release formulations that increase patient compliance and are more effective in treatment. The further growth of the market is also caused by the continuous innovation of drug delivery technologies and the positive attitude of FDA. In addition, the rising rates of chronic disease such as diabetes, cardiovascular diseases and neurological conditions elevate the demand of sustained release drugs. The main market players and association between pharmaceutical companies and excipient manufacturing in the U.S. are still working towards innovations to make North America a global leader in the production and innovation of sustained release excipients.

• Europe

Europe is a tremendous market of sustained release excipients, which is motivated by robust pharmaceutical manufacturing, strict control regulatory systems and increased use of sophisticated drug delivery systems. Germany, the U.K., France, and Switzerland are the most developed countries in the region because they have developed a pharmaceutical industry and continue to invest in R&D. The recent preference towards patient-centric therapy and long-acting preparations underlies the need to have sustained release excipients that enhance the stability and effectiveness of the drug. Furthermore, rising numbers of chronic illnesses and the elder generation are contributing to the demand of the controlled-release drugs. The focus of the European regulatory bodies on product safety and quality also enhances innovation of novel excipient solutions that prompt manufacturers to provide biocompatible, efficacious, and regulatory compliant excipient materials to respond to the dynamic needs of the pharmaceutical industry.

• Asia

Asia Pacific sustained release excipient market is experiencing high growth rates given the fast growth of the pharmaceutical industry, growth in healthcare investments, and the demand of new drug delivery systems. The major contributors are countries such as China, India, Japan and South Korea, which have been encouraged by the strong generic drug production and the rising research and development potential. Current trends in the rising incidence of chronic illnesses such as diabetes and cardiovascular disorders are compelling the demands to sustain-release formulation that enhances effectiveness of therapies in patients in terms of compliance. Further, the positive governmental programs, increasing spending on healthcare and partnership between multinational pharmaceutical companies and local pharmaceutical manufacturers are promoting market growth. The increase in the use of high quality excipients alongside the growth in biopharmaceutical research are also making Asia Pacific a key centre in the long term production of sustained release excipients and technological advancements in the drug industry.

KEY INDUSTRY PLAYERS

Key Players are developing the sustained release excipient market across the world by developing and updating technologies, quality improvement and adherence to regulations

The market of sustained release excipient was stimulated by the existence of global and regional players and leaders who are oriented on innovation and progressive formulation technologies. The giants, including BASF SE, Evonik Industries AG, Colorcon Inc., Dow Chemical Company, Ashland Global Holdings, and Lubrizol Corporation are leading by far and provide an extensive variety of high-performance excipients such as polymers, gums, and cellulose derivatives that can be used to produce a controlled and sustained drug release. These firms have heavy investment in R&D to come up with biocompatible and multifunctional materials that enhance drug efficacy and compliance by the patient. The existence of strategic alliances between excipient suppliers and pharmaceutical companies are driving drug delivery systems innovation. In addition, there is an increase in production capacity by regional players in Asia-Pacific to respond to the increasing demand. Collectively, the said key players are developing the sustained release excipient market across the world by developing and updating technologies, quality improvement and adherence to regulations.

List Of Top Sustained Release Excipients Companies

• BASF (Germany)
• Ashland (U.S.)
• Colorcon (U.S.)
• Croda Health Care (U.K.)
• Dow (U.S.)
• DuPont (U.S.)

KEY INDUSTRY DEVELOPMENT

June 2023: Croda International declared its development of pharmaceutical excipient production capacities with a new 23,680-square-foot plant in Pennsylvania. This modern location is dedicated to the development of quality substances in drug delivery system in innovative therapeutic drugs. The growth empowers Croda in the life sciences industry, in terms of its biological delivery capabilities and increasing its services to serve the ever-increasing demand of developing the advanced pharmaceutical solutions and the next generation drug formulations.

REPORT COVERAGE

This historical analysis report on the sustained release excipients market in the world covering the years 2018 to 2022 and calculations of forecasts in 2023 to 2034 has offered a holistic view of the market in the perspective of various aspects. It provides useful data on market trends, drivers, restraints, opportunities and competitive dynamics that are developing the industry. The analysis is based on the market dynamics of key regions, such as North America, Europe, Asia Pacific, and others, with the focus on the potential of regional growth and the new demand trends. It also looks into the technological innovations, changing trends of pharmaceutical production and strategic moves of top players that affect market performance. The analysis of product type, applications and end-user segments provides the report with a complete picture of the market structure and future growth. This knowledge will be an important asset to the pharmaceutical companies, investors, and policymakers to make strategic decisions and exploit new opportunities in the market of sustained release excipients.