Sustained-Release Excipients Market – By Product Type, By Route of Administration, By Technology, By Application – Global Forecast, 2025 – 2034

Report ID: GMI12657
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Published Date: December 2024
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Report Format: PDF

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Sustained-Release Excipients Market Size

The global sustained-release excipients market size was valued at USD 1.4 billion in 2024 and is estimated to grow at 8.3% CAGR from 2025 to 2034, facilitated by the rising rate of chronic diseases and the increasing need for controlled release matrices.
 

Sustained-Release Excipients Market

Many chronic diseases such as diabetes, hypertension, and cardiovascular diseases pose major challenges today and require novel medications. Such conditions tend to demand long-term medication management with stable therapeutic effects that are achieved through enhanced drug release formulations like sustained-release excipients. With enhanced drug release formulations, the frequency of medication needed is limited, minimizing the burden on patients who require multiple medications. For instance, according to the World Health Organization (WHO), noncommunicable diseases account for over 41 million deaths each year, highlighting the requirement of controlled release long-term treatment options that can be supplemented by sustained-release excipients.
 

Sustained-release excipients are a class of specialized excipients that are incorporated into certain pharmaceutical formulations that slowly and gradually release their active components. They aid in the release of drugs at controlled rates to maintain specific levels of the drug in circulation for longer durations of time. They are critical in the design of drug formulations where management of the release rate of active pharmaceutical ingredients (APIs) is important to maintain effectiveness of the medicines for extended periods without causing adverse effects from high drug concentrations.
 

Sustained-Release Excipients Market Trends

  • The market growth is primarily driven by the increasing prevalence of chronic diseases as well as the need for controlled-release formulations.
     
  • The expansion of the sustained release excipients market is highly influenced by the increasing prevalence of chronic diseases. Several chronic conditions including diabetes, hypertension, and cardiovascular diseases require long-term therapies, and often, add more than one medication that has a stable therapeutic effect over a long period of time. Continued therapy means patients are likely to skip doses; therefore, sustaining medication releases at set intervals improves long-term patient outcomes.
     
  • Sustained release excipients are unique among excipients as their function is to get the medication released over a long period of time. Their primary purpose for metabolic stability excipients is to hold the drug at a constant level for extended periods. This eliminates the need for frequent doses and leads to better compliance. They are crucial for formulations that need to control the release rates of active pharmaceutical ingredients (APIs) to prolong the effectiveness of medication and prevent dose dumping or rapid changes in drug concentration.
     
  • In addition to intangible benefits of these developments, these advancements help make medications more efficacious and safer, ease the manufacturing of dosage forms, which further increases the market demand.
     

Sustained-Release Excipients Market Analysis

Sustained-Release Excipients Market, By Product Type, 2021 – 2034 (USD Billion)

Based on product type, the market is segmented into polymers, gelatin, minerals, sugars, and other product types. In 2024, the polymers segment of the market led the way, generating a substantial revenue of USD 435.2 million.
 

  • Polymers are very flexible and can be designed to work with a range of APIs. Their ability to form various structures such as matrices and coatings allows for controlled drug release that meets therapeutic needs. This versatility is one of the reasons polymers are the most utilized materials among pharmaceutical companies developing drug delivery systems that increase the drug's effectiveness and the patient's compliance.
     
  • Furthermore, for the polymer-based materials, the ability to use a matrix to control the release of the active ingredients enables an effective means of controlled drug release. This is especially useful in chronic diseases, where stable blood stream drug levels are vital. There is a stronger push towards long-acting and extended release polymer medications, which further embeds their leading position in the pharmaceutical excipient market.
     

Based on route of administration, the sustained-release excipients market is segmented into oral, intravenous (IV), transdermal, intramuscular (IM), and other routes of administration. The oral segment dominated the market in 2024 with the revenue of USD 467 million.
 

  • Patients can comply with treatment more easily because medications taken orally do not require any special gadgets. Oral dosage forms like tablets and capsules are also widely used because they are easy to take and use.
     
  • Moreover, the oral route provides more area for the drug to be absorbed than any other approach. This allows for more efficient prodrug absorption within the gastrointestinal tract and increases the availability of APIs. In addition, the ability to formulate sustained-release medicines using this large absorptive area also makes it easy to control the therapeutic effects while reducing the peak side effects. Thus, it makes the oral route more favorable in the market.
     

Based on technology, the sustained-release excipients market is segmented into targeted delivery, microencapsulation, implants, wurster technique, coacervation, and other technologies. The targeted delivery segment dominated the market in 2024 by generating market share of 24.7%.
 

  • Targeted delivery systems are created to administer the medication where its effects are most needed while avoiding non-targeted areas, which helps reduce the overall side effects of the medication. In this manner, the precision of the delivery systems addresses the common problems associated with the global intake of medication. The benefits of targeted delivery systems are not only limited to reducing side effects but also improving outcomes in patients being treated for a disorder. That is why healthcare professionals and pharmaceutical companies prefer targeted systems.
     
  • Additionally, as the healthcare industry is moving towards personalized medicines, there is a growing demand for drug delivery systems which can be designed to meet specific patient needs. The same targeted delivery technologies that aid in meeting this demand enable the creation of formulations that can respond to defined biological requirements for each unique patient. The advantages that targeted delivery systems offer take compliance to a higher level while also saving patients from suffering caused by ineffective treatments. Because of this, the aid provided by the targeted delivery market is highly required for effective global medicine.
     
Sustained-Release Excipients Market, By Application (2024)

Based on application, the sustained-release excipients market is segmented into pharmaceuticals and nutraceuticals. The pharmaceuticals segment is anticipated to dominate the market in 2034 by generating market revenue of 2 billion.
 

  • The pharmaceutical market has witnessed rapid growth largely due to improved infant and maternal care. Excipient composition is crucial to the formulation of medications for chronic diseases which engage the patient to be adherent to the therapy over time. Most people suffering from diabetes or other cardiovascular ailments need consistent moderate dosage regulation. This augurs well for the growth of the effective sustained release formulations in the market with pharmaceuticals being the optimum application of the products.
     
  • Additionally, the development and marketing of pharmaceuticals is strongly monitored by regulations and well-entrenched processes which makes it easy to develop and market sustained released formulations. This degree of preparedness makes it easier for manufacturers to roll out new products into the market in a bid to achieve better safety and efficacy. It is because of this experience with regulatory frameworks that most companies are investing in the development of sustained release drugs. The use of newer technologies in this area ensures that the nutraceuticals regulatory frameworks are less stringent than for other areas.
     
U.S. Sustained-Release Excipients Market, 2021 – 2034 (USD Million)

The U.S. sustained-release excipients market is forecasted to reach USD 967.4 million by 2034. In 2024, the U.S. led the North American market, generating a revenue of USD 457.6 million.
 

  • Around 60% of the U.S. adult population grapples with at least one chronic condition, which reveals the high levels of demand for newly developed sustained-release formulations that are stable, effective over a prolonged period, and lead to increased patient adherence due to few dosages. The alarming statistics concerning sustained chronic conditions illustrate the economic burden caused by these ailments.
     
  • Additionally, there is an ever-increasing need for excipients with multifunctional characteristics in the US, because as more and more pharmaceutical companies adopt modern techniques, the need for advanced sustained-release formulations will also rise. The continuous innovation of drug delivery systems and the new APIs are expanding the possibilities for the existing excipients.
     

Between 2025 and 2034, the Asia Pacific sustained-release excipients market is set for significant growth.
 

  • Substantial growth is developing in the construction of healthcare facilities in the Asia Pacific region as it augurs well for the access to medicines such as sustained-release formulations. The transformation is particularly notable in China and India where advanced healthcare reforms are making more sophisticated drug delivery systems available.
     
  • Additionally, there is an increasing requirement specifically from these populations as the population gets older and the understanding of pediatric healthcare escalates which will also elongate in the future. These formulations are particularly important for the effective management of chronic conditions common in older adults and effective therapeutic options for children.
     

The UK is poised for substantial growth in the global sustained-release excipients market.
 

  • The UK healthcare system is very focused on the patient's wellbeing, resulting in an ever-increasing demand for improved customer sustained-release excipients that meets expectations. Such formulations help in reducing the frequency of dosing and this addresses the healthcare issue of treatment effectiveness.
     
  • Additionally, the UK has a well-developed regulatory system which acts as an impetus for creativity in the field of drug delivery systems. In this context, limitations which slow down new product development and registration of sustained-release excipients are absent and this is good for business.
     

Japan is set to experience notable growth in its sustained-release excipients market during the forecast period.
 

  • The proportion of elderly individuals in Japan is among the highest in the world. This tends to translate to high incidences of chronic diseases that are likely to need sustained treatment. To meet the changing demographic needs, sustained-release amorphous excipients are important and will propel the market growth.
     
  • Additionally, Japan is well known for its rich portfolio of drug R&D activities. There are various opportunities stemming from innovation in drug formulation technology that can improve bioavailability and therapeutic effectiveness through better sustained-release systems.
     

Sustained-Release Excipients Market Share

The competition within the market is vigorous, incited by the adoption of effective and innovative drug delivery systems in the pharmaceutical industry. Major firms have a strong grip in the market because of their coverage in almost all available excipients, including polymers, gelatin, and sugar, which are integral to the development of sustained-release formulations. Nevertheless, new companies are establishing themselves by offering simple and inexpensive excipients for purposes in the pharmaceutical industry.
 

New technologies, such as targeted delivery systems and microencapsulation techniques, are important competitive advantages that enhance the performance of drug release profiles. In this environment, there is a need for innovative solutions for excipients formulation, regulatory integration, as well as advanced drug delivery systems in order to satisfy the booming demand for patient-centered healthcare solutions, while preventing inadvertent neglect of the safety and effectiveness of the sustained-release formulation.
 

Sustained-Release Excipients Market Companies

  • Evonik Industries is a worldwide business leader in the production of polymer-based excipients for sustained-release dosage forms with proprietary EUDRAGIT polymers that have integrated patient compliance features through custom tailoring of release rates. The cost-effective nature of these advanced R&D capabilities strengthens the alliances with pharmaceutical manufacturers by enabling the design of bespoke solutions for challenging formulations.
     
  • Colorcon is proficient in the functional coatings and excipients including METHOCEL, a range of cellular esters that aids in dose-dependant specific controlled release of drugs. Their clients benefit from their superior technical customer support and global presence as it helps make production more efficient without compromising product quality.
     
  • BASF is known for its many different types of excipients including Kollidon and Kollicoat that are widely used in systems for sustained drug release. The company’s innovation and environmentally friendly focus can better assist the advancement of pharmaceuticals with sustainable and cost-effective solutions.
     
  • Roquette is well known for its non-GMO plant-based excipients like PEARLITOL and STARLAC which have excellent sustained-release properties. Their focus on natural, non-GMO ingredients are favorable to consumers while achieving the desired functionality in the pharmaceutical industry.
     

Sustained-Release Excipients Market Companies

Prominent players operating in the sustained-release excipients industry include:

  • BASF
  • Ashland Global
  • Colorcon
  • Croda International
  • DFE Pharma
  • Eastman
  • Evonik Industries
  • FMC Corporation
  • Gattefosse
  • International Flavors & Fragrances
  • JRS Pharma
  • Merck
  • Roquette
  • Seppic
  • Shin-Etsu Chemical
     

Sustained-Release Excipients Industry News:

  • In June 2023, Croda International announced the expansion of its pharmaceutical excipients manufacturing capabilities. The company started the construction of a new 23,680 square feet facility in Pennsylvania. This advanced facility was intended to produce ingredients used in drug delivery systems for new therapeutic drugs. With the expansion, the company was expected to increase its biological delivery capabilities and broaden its scope of services.
     

Sustained-release excipients market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2034 for the following segments:

Market, By Product Type

  • Polymers
  • Gelatin
  • Minerals
  • Sugars
  • Other product types

Market, By Route of Administration

  • Oral
  • Intravenous (IV)
  • Transdermal
  • Intramuscular (IM)
  • Other routes of administration

Market, By Technology

  • Targeted delivery
  • Microencapsulation
  • Implants
  • Wurster technique
  • Coacervation
  • Other technologies

Market, By Application  

  • Pharmaceuticals
  • Nutraceuticals

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Spain
    • Italy
    • Netherlands
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East and Africa
    • South Africa
    • Saudi Arabia
    • UAE

 

Authors: Mariam Faizullabhoy, Gauri Wani
Frequently Asked Question(FAQ) :
Who are some of the prominent players in the sustained-release excipients industry?
Key players in the market include BASF, Ashland Global, Colorcon, Croda International, DFE Pharma, Eastman, Evonik Industries, FMC Corporation, Gattefosse, International Flavors & Fragrances, and JRS Pharma.
How big is the sustained-release excipients market?
Why is the polymers segment leading the sustained-release excipients industry?
What is the forecast for the U.S. sustained-release excipients industry?
Sustained-Release Excipients Market Scope
  • Sustained-Release Excipients Market Size
  • Sustained-Release Excipients Market Trends
  • Sustained-Release Excipients Market Analysis
  • Sustained-Release Excipients Market Share
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    Base Year: 2024

    Companies covered: 15

    Tables & Figures: 110

    Countries covered: 19

    Pages: 130

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