The global Solubility Enhancement Excipients Market Size is estimated as 57,138 Tons in 2024 and is expected to grow from 62,955 Tons in 2025 to 1,32,081 Tons in 2032 growing at a CAGR of 11.17%.
Introduction and Overview
Solubility is a critical parameter in drug development, as it greatly influences a drug’s bioavailability. Solubility Enhancement (SE) excipients play a vital role in enhancing and protecting the drug effectiveness and modulating the release of the active pharmaceutical ingredient (API). These excipients enhance dissolution and absorption, contributing to the formulation of stable dosage forms. Primarily, drugs classified under Classes II and IV of the Biopharmaceutical Classification System (BCS) exhibit poor aqueous solubility.
Ongoing progress in drug discovery, design, and receptor targeting has led to a growing number of compounds with poor aqueous solubility, thereby intensifying the need for improved solubility techniques and specialized excipients. Currently, close to half of the commercially available drugs and around 90% of clinical candidates confront solubility and permeability hurdles. Many pharmaceutical firms now incorporate these solubility enhancing excipients to produce innovative formulations and to prolong proprietary market exclusivity of existing products. Generally, solubility-enhancing excipients are sorted into three main classes: polymers, surfactants, and lipid-based agents. Among these, polymer-based excipients are projected to witness a notable expansion, attributed to their high adoption rate by formulators
Global market expansion for solubility enhancement excipients is primarily driven by the upsurge in poorly soluble drug candidates, heightened demand for parenteral and injectable dosage forms, advancements in solubility-enhancing technologies, and broader adoption of prodrugs and alternative administration routes. Additionally, a rise in chronic conditions—including diabetes, hypertension, HIV, and various cancers—has spurred the need for more efficient and patient-centric formulations. Nevertheless, key constraints holding back sector growth encompass rigorous excipient approval processes, elevated costs, and a limited general understanding of excipients. Compatibility challenges between drugs and excipients, alongside scale-up complexities, further impede broader market progression. One central regulatory hurdle remains that novel excipients must obtain approval concurrent with the new molecular entity, thus lacking an independent clearance pathway.
Latest Trends in the Solubility Enhancement Excipients Market
Rapid Growth in Polymers Category: Polymers play an instrumental role in addressing the persistent challenge of insoluble APIs. By enhancing dissolution and subsequent absorption, polymer-based excipients can significantly boost a drug’s therapeutic impact. The sector’s appetite for novel dosage forms both oral and injectable has accelerated the adoption of polymer solutions. Standard examples include PVP, PEG, and HPMC, all known to offer improved stability and controlled release capabilities. Natural polysaccharides are gaining attention for their sustainability, whereas synthetic variants allow further fine-tuning of drug release kinetics. Both approaches enable more consistent control of drug solubility and release, meeting the needs of a broad swath of active molecules.
In July 2023, BASF introduced a cutting-edge polymer excipient to enhance solubility for complex APIs.
In November 2023, Evonik launched a targeted solubility enhancement platform, augmenting its line up of pharmaceutical excipients.
Co-processed Excipients Represent a Significant Advancement: By physically combining two or more excipients, co-processed excipients can circumvent the chemical reactivity hurdles and deliver multiple functionalities simultaneously. This approach simplifies drug product development, bolsters performance, and streamlines manufacturing. Key advantages revolve around accelerated R&D and stable, reproducible outcomes, which together minimize production bottlenecks. Most co-processed excipients are found in solid dosage forms, enabling direct compression processes or more advanced continuous manufacturing frameworks. They may even apply to topical and transdermal products, aiding in better penetration and simpler process flows. Regulatory uncertainties, however, still present potential obstacles to the widespread acceptance of these novel blends.
Drivers and Challenges in the Solubility Enhancement Excipients Market
Growing Number of Poorly Soluble Drug Compounds (BCS Class II & IV): Insufficient aqueous solubility remains a top concern for the pharmaceutical field, with over 70–90% of new molecular entities exhibiting limited solubility and more than 40% of approved medicines struggling to dissolve adequately. Enhancing dissolution rates, therefore, is an essential technology to assure sufficient bioavailability for these compounds. Poorly soluble molecules routinely rely on excipients like surfactants, lipid-based carriers, or cyclodextrins to boost plasma concentrations. Similarly, polymers or gel-forming agents designed to alter drug release are integral in fabricating extended or sustained-release products. Core solubility enhancement methodologies, such as particle size diminution, solid dispersion creation, or surfactant incorporation, stand at the forefront of current formulation improvements and open doors for advanced pharmacological R&D.
Growing Research Innovations to Develop New Technologies & Excipient Products for SE: Cutting-edge drug delivery innovations have expanded demand for specialized excipients. Notably, nanotechnology has facilitated the manufacture of liposomes, nanoparticles, and micelles capable of amplifying the bioavailability of insoluble compounds. Excipients used here often involve polymeric systems (e.g., PLGA, PEG), lipid emulsions, or surfactants. Concurrently, “smart excipients” have gained traction, reacting to shifts in pH, temperature, or enzyme presence. This adaptability paves the way for advanced controlled or site-specific drug release, delivering improved therapeutic indices. The recent pandemic also spurred widespread repurposing of existing drugs, many of which had low water solubility. This surge translated into heightened use of cyclodextrins, lipid transporters, and polymeric dispersions to ensure effective absorption profiles.
Growing Requirements for Regulatory Compliance will limit market growth: Because excipients make up part of final drug formulations, their quality, safety, and efficacy profiles must meet regulatory standards set by bodies like the FDA, EMA, and ICH, as well as relevant pharmacopeias (USP, Ph. Eur.). This strict oversight can be especially pivotal when novel or multifunctional excipients come into play. Comprehensive toxicological evaluations and proof of consistent quality are necessary to demonstrate safety for patients. Manufacturers must maintain thorough product documentation, including specification sheets and manufacturing details, while accurately labeling excipients on packaging. These stringent demands can often elongate developmental timelines and elevate costs, dissuading companies from the swift adoption of new excipient technologies.
High Equipment, Operational, and Ingredient Costs of Advanced SE Technologies: Developing and manufacturing next-level excipients can require significant capital, especially when advanced drug delivery systems like biologics or personalized therapies are involved. While traditional materials, such as surfactants or co-solvents, may be less expensive, specialized approaches including cyclodextrins, lipid-based carriers, and polymeric nanoparticles tend to incur greater No portion of this report may be reproduced, reused, or otherwise distributed in any form without prior written consent from regulatory and production expenditures. Establishing robust scale-up processes for techniques like amorphous solid dispersions, hot-melt extrusion, or nanocrystal creation further adds to the budget. Companies must carefully weigh these elevated costs against the potential returns, namely superior drug efficacy and prolonged patent coverage.
Market Segmentation
Solubility Enhancement Excipients Market, By Technology
- Particle size reduction
- Crystal Engineering
- Solid dispersions
- Lipid solubilization
- Others
Solubility Enhancement Excipients Market, By Excipient Type
- Polymers
- Cyclodextrins
- Lipids
- Surfactants/Emulsifiers
- Others
Solubility Enhancement Excipients Market, By Dosage Form
- Oral
- Injectable
- Topical
- Others
Solubility Enhancement Excipients Market, By End User
- Pharmaceutical Industry
- Contract Development & Manufacturing Organizations (CDMOs)
- Research Institutes & Academic Laboratories
- Other
Solubility Enhancement Excipients Market, By Region
- North America (USA, Canada, Mexico)
- Europe (Germany, UK, France, Spain, Italy, Rest of Europe)
- Asia-Pacific (China, India, Japan, Australia, Rest of APAC)
- The Middle East and Africa (Middle East, Africa)
- South and Central America (Brazil, Argentina, Rest of SCA)
Companies Covered
- BASF SE
- ABITEC Corporation
- Ashland Inc.
- Clariant International Ltd.
- Croda International Plc
- Dow Chemical Company
- Evonik Industries AG
- FREUND Corporation
- Gattefossé SAS
- Kerry Group PLC
- Lipoid GmbH
- Lubrizol Corporation
- Merck KGaA
- Roquette Frères
- SEPPIC SA
- Shin-Etsu Chemical Co., Ltd.
1. TABLE OF CONTENTS
1.1. List of TABLES
1.2. LIST of FIGURES
2. GLOBAL SOLUBILITY ENHANCEMENT EXCIPIENTS INDUSTRY
2.1. Market Scope and Definition
2.2. Study Assumptions
3. SOLUBILITY ENHANCEMENT EXCIPIENTS MARKET LATEST TRENDS, DRIVERS AND CHALLENGES, 2024-2032
3.1. Solubility Enhancement Excipients Market Latest Trends
3.2. Solubility Enhancement Excipients Market Insights, 2024-2032
3.2.1. Leading Solubility Enhancement Excipients Technology, 2024-2032
3.2.2. Dominant Solubility Enhancement Excipient Type, 2024-2032
3.2.3. Leading Solubility Enhancement Excipients Dosage Form, 2024-2032
3.2.1. Largest Solubility Enhancement Excipients End User, 2024-2032
3.2.2. Fast-Growing Geographies for Solubility Enhancement Excipients, 2024-2032
3.3. Solubility Enhancement Excipients Market Drivers to 2031
3.3.1. Collaborating with Vendors Through Technology Partnerships:
3.3.2. Integration with Electronic Health Records (EHRs):
3.3.3. Emerging Economies: United States & China Government Prioritizing Deployment of CPOE Systems:
3.3.4. Shift Towards Personalized, Holistic Healthcare Delivery Models:
3.3.5. Increasing Healthcare IT (Information Technology) Adoption & Quality of Healthcare:
3.4. Solubility Enhancement Excipients Market Restraints to 2031
3.4.1. Volatility in Cost of Raw Materials:
3.4.2. Interoperability issues have also been a longstanding challenge:
3.4.3. High Initial Costs & Maintenance Costs Hindering the Market:
3.4.4. Adaptability/Workflow Disruption & Data Entry Challenges Limiting Market Growth:
3.4.5. Lack of Skilled Expertise in Healthcare IT Segment:
3.4.6. Barriers to CPOE Implementation:
3.5. Solubility Enhancement Excipients Market-Five Forces Analysis
4. GLOBAL SOLUBILITY ENHANCEMENT EXCIPIENTS MARKET GROWTH
4.1. Global Solubility Enhancement Excipients Market, By Technology
4.1.1. Solubility Enhancement Excipients Market, By Technology, Biological Solutions
4.1.2. Solubility Enhancement Excipients Market, By Technology, Chemical Solutions
4.1.3. Solubility Enhancement Excipients Market, By Technology, Physical Solutions
4.2. Global Solubility Enhancement Excipients Market, By Pollutant Source
4.2.1. Solubility Enhancement Excipients Market, By Pollutant Source, Nonpoint Source
4.2.2. Solubility Enhancement Excipients Market, By Pollutant Source, Point Source
4.3. Global Solubility Enhancement Excipients Market, By Segment
4.3.1. Solubility Enhancement Excipients Market, By Segment, Services
4.3.2. Solubility Enhancement Excipients Market, By Segment, Equipment
4.3.3. Solubility Enhancement Excipients Market, By Segment, Chemicals
4.4. Global Solubility Enhancement Excipients Market, By Application
4.4.1. Solubility Enhancement Excipients Market, By Application, Groundwater Resources
4.4.2. Solubility Enhancement Excipients Market, By Application, Soil Resources
4.4.3. Solubility Enhancement Excipients Market, By Application, Farming
4.4.4. Solubility Enhancement Excipients Market, By Application, Other Applications
4.5. Global Solubility Enhancement Excipients Market, By Region
5. ASIA-PACIFIC SOLUBILITY ENHANCEMENT EXCIPIENTS MARKET GROWTH
5.1. Asia-Pacific Solubility Enhancement Excipients Market, By Technology
5.2. Asia-Pacific Solubility Enhancement Excipients Market, By Pollutant Source
5.3. Asia-Pacific Solubility Enhancement Excipients Market, By Segment
5.4. Asia-Pacific Solubility Enhancement Excipients Market, By Application
5.5. Asia-Pacific Solubility Enhancement Excipients Market, By Country
5.5.1. Taiwan Solubility Enhancement Excipients Market
5.5.2. China Solubility Enhancement Excipients Market
5.5.3. Thailand Solubility Enhancement Excipients Market
5.5.4. Indonesia Solubility Enhancement Excipients Market
5.5.5. Vietnam Solubility Enhancement Excipients Market
5.5.6. Australia Solubility Enhancement Excipients Market
5.5.7. Rest of Asia-Pacific Solubility Enhancement Excipients Market
5.5.8. India Solubility Enhancement Excipients Market
6. EUROPE SOLUBILITY ENHANCEMENT EXCIPIENTS MARKET GROWTH
6.1. Europe Solubility Enhancement Excipients Market, By Technology
6.2. Europe Solubility Enhancement Excipients Market, By Pollutant Source
6.3. Europe Solubility Enhancement Excipients Market, By Segment
6.4. Europe Solubility Enhancement Excipients Market, By Application
6.5. Europe Solubility Enhancement Excipients Market, By Country
6.5.1. Germany Solubility Enhancement Excipients Market
6.5.2. France Solubility Enhancement Excipients Market
6.5.3. UK Solubility Enhancement Excipients Market
6.5.4. Rest of Europe Solubility Enhancement Excipients Market
6.5.5. Italy Solubility Enhancement Excipients Market
6.5.6. Russia Solubility Enhancement Excipients Market
6.5.7. Spain Solubility Enhancement Excipients Market
7. MIDDLE EAST AFRICA SOLUBILITY ENHANCEMENT EXCIPIENTS MARKET GROWTH
7.1. Middle East Africa Solubility Enhancement Excipients Market, By Technology
7.2. Middle East Africa Solubility Enhancement Excipients Market, By Pollutant Source
7.3. Middle East Africa Solubility Enhancement Excipients Market, By Segment
7.4. Middle East Africa Solubility Enhancement Excipients Market, By Application
7.5. Middle East Africa Solubility Enhancement Excipients Market, By Country
7.5.1. Africa Solubility Enhancement Excipients Market
7.5.2. Middle East Solubility Enhancement Excipients Market
8. NORTH AMERICA SOLUBILITY ENHANCEMENT EXCIPIENTS MARKET GROWTH
8.1. North America Solubility Enhancement Excipients Market, By Technology
8.2. North America Solubility Enhancement Excipients Market, By Pollutant Source
8.3. North America Solubility Enhancement Excipients Market, By Segment
8.4. North America Solubility Enhancement Excipients Market, By Application
8.5. North America Solubility Enhancement Excipients Market, By Country
8.5.1. United States Solubility Enhancement Excipients Market
8.5.2. Mexico Solubility Enhancement Excipients Market
8.5.3. Canada Solubility Enhancement Excipients Market
9. SOUTH AND CENTRAL AMERICA SOLUBILITY ENHANCEMENT EXCIPIENTS MARKET GROWTH
9.1. South and Central America Solubility Enhancement Excipients Market, By Technology
9.2. South and Central America Solubility Enhancement Excipients Market, By Pollutant Source
9.3. South and Central America Solubility Enhancement Excipients Market, By Segment
9.4. South and Central America Solubility Enhancement Excipients Market, By Application
9.5. South and Central America Solubility Enhancement Excipients Market, By Country
9.5.1. Brazil Solubility Enhancement Excipients Market
9.5.2. Argentina Solubility Enhancement Excipients Market
9.5.3. Chile Solubility Enhancement Excipients Market
9.5.4. Rest of SCA Solubility Enhancement Excipients Market
10. SOLUBILITY ENHANCEMENT EXCIPIENTS MARKET STRUCTURE
11. APPENDIX
11.1. About Us
11.2. Sources
11.3. Research Methodology
11.4. Research Process
11.5. Research Execution
11.6. Contact Information
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