Global Sustained Release Excipients Market—By Excipient Type: Polymers (Cellulose, PVP, Acrylates), Lipid-Based Excipients, Gums & Waxes, Others (Ion Exchange Resins, Osmotic Agents); By Route of Administration: Oral, Injectable, Transdermal, Others (Implants, Buccal); By End User: Pharmaceutical Companies, Contract Manufacturing Organizations (CMOs), Research Institutes, Others; By Region: North America, Europe, Asia-Pacific, Latin America, Middle East & Africa.
Market Overview
Sustained release excipients are essential in pharmaceutical formulations because they enable controlled drug delivery over long periods. These excipients help achieve consistent therapeutic levels, lower dosing frequency, and improve patient compliance. Common excipients include polymers, lipids, gums, and waxes used in oral, injectable, and transdermal dosage forms. As the prevalence of chronic diseases increases and regulatory focus on patient-centered delivery systems grows, the market for sustained release excipients continues to expand.
Market Size and Forecast
|
Year |
Market Value (USD Billion) |
Notes |
|
2019 |
1.93 |
Based on excipient supplier sales and sustained-release drug formulation trends |
|
2024 |
3.01 |
Five-year CAGR 9.4 % |
|
2031 |
5.82 |
Seven-year CAGR 10.1 % (2024–2031) |
Demand is projected to exceed USD 6 billion by 2031, driven by innovation in oral controlled-release systems and novel biologics stabilization.
Primary Market Drivers
• Rising prevalence of chronic conditions requiring long-term medication (e.g., diabetes, hypertension, epilepsy)
• Growing geriatric population demanding low-frequency dosing formats
• Expanding pipeline of controlled-release generic and branded formulations
• Technological advancements in polymer science and hydrophilic matrices
• Regulatory guidance supporting extended-release delivery platforms
Market Challenges
• Complexity in formulating and scaling up SR dosage forms
• Higher development costs compared to IR systems
• Regulatory scrutiny over excipient safety and interactions with APIs
• Compatibility and stability issues with certain biologicals and peptides
• Limited adoption in emerging markets due to cost concerns
Competitive Landscape
|
Company / Organization |
2024 Share |
Core Strengths |
Recent Moves |
|
BASF SE |
20 % |
Polyvinylpyrrolidone, controlled-release polymers |
Expanded Kollidon® SR line (Q1 2024) |
|
Evonik Industries |
18 % |
EUDRAGIT® polymers for oral sustained release |
Opened excipient innovation center in Germany (Q3 2024) |
|
Ashland Global |
16 % |
Cellulose ethers, hydrophilic matrix systems |
Launched new grades of Benecel™ for SR tablets (Q2 2024) |
|
Dow Chemical Company |
12 % |
Methocel™ polymers and oral film formulations |
Partnered with CDMOs for SR film technology (Q1 2025) |
|
Others (Colorcon, Gattefossé, Lubrizol) |
34 % |
Specialized lipid matrices, coatings, and ion exchange resins |
Colorcon expanded Surelease® coating capacity (Q2 2025) |
Detailed Market Segmentation
By Excipient Type
• Polymers (Cellulose, PVP, Acrylates) – 52 %
• Lipid-Based Excipients – XX %
• Gums & Waxes – XX %
• Others (Ion Exchange Resins, Osmotic Agents) – XX %
By Route of Administration
• Oral – 68 %
• Injectable – XX %
• Transdermal – XX %
• Others (Implants, Buccal) – XX %
By End User
• Pharmaceutical Companies – 59 %
• Contract Manufacturing Organizations (CMOs) – XX %
• Research Institutes – XX %
• Others – XX %
Regional Analysis
• North America (39%) – Strong presence of generics and branded controlled-release drugs
• Europe (XX%) – High investment in SR R&D and regulatory support for excipient safety
• Asia-Pacific (XX%) – Fastest CAGR of 11.6%, driven by India and China’s generic industry scale
• Latin America & MEA (XX%) – Emerging opportunities with increasing chronic disease burden and pharma outsourcing
Technology and Innovation
• Hydrophilic matrix systems enable linear drug release kinetics
• Smart polymers with pH-dependent swelling and erosion control
• Lipid multiparticulates for sustained absorption in the GI tract
• Advanced coatings provide site-specific drug release
• Modular manufacturing lines with precise excipient blending
Regulatory Environment
• US FDA guidance on extended-release oral dosage forms
• EMA focus on excipient safety, compatibility, and IPEC certification
• Chinese NMPA promotes local excipient standardization and innovation
• ISO and ICH Q8/Q9 guidelines on formulation design and risk management
Recent Developments (Q4 2023 – Q2 2025)
• BASF introduced Kollidon® SR+ polymer for modified-release tablets (Q1 2024).
• Ashland released Benecel™ CR for small-batch personalized meds (Q2 2024).
• Colorcon expanded coating production in India to meet Asia-Pacific demand (Q2 2025).
• Evonik collaborated with pharma CDMOs for multi-particulate SR delivery (Q3 2024).
• Dow launched polymeric oral films integrating SR microspheres (Q1 2025).
Strategic Outlook
• Suppliers should invest in polymer diversification and coating innovations.
• CMOs can benefit by offering excipient-based formulation differentiation.
• Pharma companies should adopt excipient risk profiling to accelerate regulatory approvals.
• Emerging regions present untapped potential in sustained delivery generics.
Methodology
Clearview Market Insights analyzed excipient sales data from 58 suppliers, reviewed 130 SR product filings, and interviewed 46 formulation experts worldwide. Forecasts were built using bottom-up excipient demand modeling across major dosage forms.
About Clearview Market Insights
Clearview Market Insights provides global pharmaceutical ingredient and delivery platform intelligence to formulators, excipient manufacturers, and healthcare investors.
• Track opportunities in chronic disease-oriented drug delivery markets
• Understand regulatory and technical considerations for SR excipients
• Evaluate innovation in polymer science and coating technologies
• Benchmark global and regional players by excipient portfolio and market share
• Revenue projections for excipient types by route of administration (2019–2031)
• Global segmentation by polymer type, end use, and geography
• Innovation trends in controlled-release delivery formats
• Market share benchmarking for excipient providers
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