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. The increasing prevalence of chronic diseases and the rising demand for controlled-release formulations are primarily expected to drive market growth.

The growing prevalence of chronic diseases significantly contributes to the expansion of the market. Chronic conditions such as diabetes, hypertension, and cardiovascular diseases require long-term management, often necessitating medications that provide stable therapeutic effects over extended periods. Sustained-release formulations can help achieve this by minimizing the frequency of dosing, which is particularly beneficial for patients who may struggle with adherence to multiple daily doses. According to the World Health Organization, nearly 41 million people die annually due to noncommunicable diseases, underscoring the urgent need for effective long-term treatment options, which sustained-release excipients can provide.

Sustained-release excipients are specialized substances used in pharmaceutical formulations designed to release a drug slowly over an extended period. These excipients help maintain consistent drug levels in the bloodstream, reducing the need for frequent dosing and enhancing patient compliance. They are essential in creating formulations that can effectively modulate the release profile of active pharmaceutical ingredients (APIs), ensuring that the medication remains effective for longer durations without causing dose dumping or rapid fluctuations in drug concentration.

Sustained-Release Excipients Market Trends

The increasing prevalence of chronic diseases and the rising demand for controlled-release formulations are primarily expected to drive market growth.

• The growing prevalence of chronic diseases significantly contributes to the expansion of the market. Chronic conditions such as diabetes, hypertension, and cardiovascular diseases require long-term management, often necessitating medications that provide stable therapeutic effects over extended periods. Sustained-release formulations can help achieve this by minimizing the frequency of dosing, which is particularly beneficial for patients who may struggle with adherence to multiple daily doses. According to the World Health Organization, nearly 41 million people die annually due to noncommunicable diseases, underscoring the urgent need for effective long-term treatment options, which sustained-release excipients can provide.
  
• Sustained-release excipients are specialized substances used in pharmaceutical formulations designed to release a drug slowly over an extended period. These excipients help maintain consistent drug levels in the bloodstream, reducing the need for frequent dosing and enhancing patient compliance. They are essential in creating formulations that can effectively modulate the release profile of active pharmaceutical ingredients (APIs), ensuring that the medication remains effective for longer durations without causing dose dumping or rapid fluctuations in drug concentration.
  

• These advancements not only improve the efficacy and safety of medications but also facilitate the production of more patient-friendly dosage forms, further stimulating market demand.
  

Sustained-Release Excipients Market Analysis

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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 highly versatile and can be formulated to work with a wide range of active pharmaceutical ingredients (APIs). Their ability to form various structures, such as matrices and coatings, allows for tailored drug release profiles that meet specific therapeutic needs. This adaptability makes polymers a preferred choice for pharmaceutical companies seeking to develop innovative drug delivery systems that enhance drug efficacy and patient compliance.
  
• Additionally, polymers provide effective mechanisms for controlled drug release by forming a matrix that regulates the release of active ingredients over time. This capability is particularly important for chronic disease management, where maintaining stable drug levels in the bloodstream is crucial. The demand for long-acting and extended-release medications continues to drive the use of polymers in pharmaceutical formulations, solidifying their position as the leading excipient type in this 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.

• Medications administered orally can be taken without the need for specialized equipment or training, which enhances patient compliance. The familiarity and comfort associated with oral dosage forms, such as tablets and capsules, contribute significantly to their widespread use.
  
• Additionally, the oral route allows for a larger active surface area for drug absorption compared to other administration methods. This characteristic facilitates more efficient drug uptake in the gastrointestinal tract, leading to improved bioavailability of the active pharmaceutical ingredients (APIs). The ability to design sustained-release formulations that leverage this extensive absorption area further solidifies the oral route's dominance in the market, as it enables consistent therapeutic effects over extended periods while minimizing side effects associated with peak drug concentrations.
  

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 designed to deliver medication directly to specific sites of action within the body, minimizing exposure to non-target areas. This precision reduces the likelihood of systemic side effects and enhances the therapeutic efficacy of the drug. By concentrating the drug's effects where they are needed most, targeted delivery can significantly improve treatment outcomes, making it a preferred choice among healthcare providers and pharmaceutical companies alike.
  
• Additionally, as the healthcare industry shifts toward personalized medicine, there is an increasing need for drug delivery systems that can be tailored to individual patient needs. Targeted delivery technologies facilitate this customization by allowing formulations that respond to specific biological markers or conditions unique to each patient. This trend not only improves patient compliance and satisfaction but also aligns with the broader movement toward more effective and individualized treatment regimens, further solidifying the dominance of the targeted delivery segment in the market.

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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 pharmaceuticals sector primarily addresses the treatment of chronic diseases, which often require long-term medication regimens. Sustained-release excipients are essential in formulating medications that provide consistent therapeutic effects over extended periods, thereby improving patient adherence and outcomes. The increasing prevalence of chronic conditions, such as diabetes and cardiovascular diseases, drives the demand for effective sustained-release formulations, positioning pharmaceuticals as the leading application segment in this market.
  
• Additionally, the pharmaceutical industry operates under well-defined regulatory guidelines that facilitate the development and approval of sustained-release formulations. This established framework enables manufacturers to efficiently bring new products to market while ensuring safety and efficacy. The familiarity with regulatory processes further encourages pharmaceutical companies to invest in sustained-release technologies, reinforcing the dominance of this segment over nutraceuticals, which may face more variability in regulatory standards.

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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.

• The U.S. has a significant number of individuals suffering from chronic diseases, with approximately 60% of adults living with at least one chronic condition. This high prevalence drives the demand for sustained-release formulations that can provide stable therapeutic effects and improve patient compliance by reducing dosing frequency.
  
• Additionally, the continuous development of new active pharmaceutical ingredients (APIs) and innovative drug delivery systems is enhancing the capabilities of sustained-release excipients. As pharmaceutical companies adopt cutting-edge technologies, there is an increasing need for multifunctional excipients that can support these advanced formulations, further propelling market growth in the U.S.
  

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

• The Asia Pacific region is witnessing substantial investments in healthcare infrastructure, improving access to medications, including sustained-release formulations. This growth is particularly evident in countries like China and India, where healthcare reforms are expanding the availability of advanced drug delivery systems.
  
• Additionally, as the population ages and awareness of pediatric healthcare needs rises, there is a growing demand for sustained-release excipients tailored to these demographics. These formulations are essential for managing chronic conditions prevalent in older adults and ensuring effective treatment options for children.
  

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

• The UK healthcare system emphasizes patient-centered care, which drives demand for sustained-release formulations that enhance patient adherence and satisfaction. These formulations reduce the burden of frequent dosing, aligning with healthcare goals to improve overall treatment outcomes.
  
• Additionally, the UK has established regulatory frameworks that encourage innovation in drug delivery technologies. This supportive environment facilitates the development and approval of new sustained-release excipients, fostering market growth.
  

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

• Japan has one of the highest proportions of elderly individuals globally, leading to an increased prevalence of chronic diseases that require long-term management. Sustained-release excipients are crucial for developing formulations that cater to this demographic's specific needs, thereby driving market growth.
  
• Furthermore, Japan is known for its robust pharmaceutical research and development landscape. Continuous innovations in drug formulation technologies are creating opportunities for enhanced sustained-release systems that improve bioavailability and therapeutic efficacy, further boosting the market.
  

Sustained-Release Excipients Market Share

The market is highly competitive, driven by increasing demand for effective and innovative drug delivery solutions across the pharmaceutical sector. Established companies dominate the market with extensive portfolios of excipients, including polymers, gelatin, and sugars, which are essential for developing sustained-release formulations. However, emerging players are gaining traction by introducing cost-effective and user-friendly excipients tailored for specific applications in pharmaceuticals. Technological advancements, such as targeted delivery systems and microencapsulation techniques, are significant differentiators that enhance the precision and efficacy of drug release profiles.

In this evolving landscape, continuous innovation in excipient formulation, regulatory compliance, and integration with advanced drug delivery technologies is crucial to meet the growing need for patient-centric healthcare solutions and to maintain high standards of safety and effectiveness in sustained-release formulations.

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 made significant strides in expanding its manufacturing capabilities for pharmaceutical excipients. The company broke ground on a new 23,680 square-foot facility in Pennsylvania. This state-of-the-art facility is designed to manufacture ingredients for drug delivery systems utilized in novel therapeutic drugs. The expansion is expected to enhance the company’s biological delivery capabilities and expand its offerings.
  

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:

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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