Global Next-Generation Excipients Market Size, Share, Trends and Forecasts 2031

Key Findings

• The next-generation excipients market focuses on novel, multifunctional excipients that enhance drug solubility, stability, bioavailability, and patient compliance.

• Rising demand for advanced drug delivery systems and poorly soluble APIs is accelerating the adoption of co-processed and polymer-based excipients.

• Biopharmaceutical and mRNA-based therapeutics require specialized excipients tailored for injectability, stability, and reduced immunogenicity.

• Regulatory support for novel excipient qualification and real-world safety data collection is improving acceptance and market access.

• North America and Europe lead in innovation and regulatory adoption, while Asia-Pacific emerges as a fast-growing manufacturing hub.

• Co-processing, nanotechnology, and spray drying are being leveraged to enhance excipient functionality and API compatibility.

• Pharmaceutical companies are increasingly co-developing excipients in collaboration with formulation technology providers.

• Demand for patient-centric dosage forms such as ODTs, abuse-deterrent tablets, and pediatric-friendly formulations is rising.

• Excipient suppliers are focusing on digital traceability, GMP compliance, and sustainability in production workflows.

• High investment costs, lack of monograph support, and limited regulatory familiarity remain barriers to widespread adoption.

Next-Generation Excipients Market Size and Forecast

The global next-generation excipients market was valued at USD 1.84 billion in 2024 and is projected to reach USD 4.19 billion by 2031, growing at a CAGR of 12.6%. Growth is driven by the increased use of poorly soluble and biologically complex drug molecules, which require enhanced solubilization, stabilization, and targeted delivery.

Excipients with multifunctional properties reduce formulation complexity and support innovative dosage forms such as nanoparticle-based systems and long-acting injectables. Rising partnerships between excipient manufacturers and pharmaceutical innovators are expanding the pipeline of excipients that address formulation bottlenecks and improve therapeutic performance.

Market Overview

Next-generation excipients are advanced pharmaceutical ingredients designed to deliver enhanced functional performance beyond traditional inert roles. These include novel polymers, co-processed materials, amphiphilic carriers, lipids, and cyclodextrin-based systems that enhance drug absorption, improve stability, and enable targeted delivery.

They support high-performance oral, injectable, inhalable, and transdermal drug products. As APIs become more complex, the need for excipients that enable effective formulation, patient compliance, and manufacturing scalability is growing. Regulatory agencies, including the FDA and EMA, are increasingly receptive to new excipients, especially when linked with innovative drug applications. The market is gaining momentum as biopharmaceutical development expands and patient-centric drug design becomes a priority.

Future Outlook

The future of the next-generation excipients market will be shaped by increased regulatory support, AI-driven excipient design, and rising demand for complex drug formulations. Digital technologies and computational modeling will accelerate the screening of excipient-API interactions, reducing development timelines. Growing investments in novel oral biologic delivery systems and gene-based therapies will create new excipient requirements. Regulatory harmonization of novel excipient approval pathways will simplify market entry across regions.

As personalized medicine gains prominence, customizable excipients will enable dosage tailoring and improved patient experience. Sustainable and green manufacturing of excipients will become increasingly important for global suppliers.

Next-Generation Excipients Market Trends

• Growth in Co-Processed and Multifunctional Excipients
  Co-processed excipients combine two or more functional materials to deliver synergistic benefits in drug formulation. These materials improve compressibility, flowability, and binding in high-speed tablet production. Pharmaceutical manufacturers use them to reduce the number of ingredients and simplify quality control. Multifunctional excipients support controlled-release, taste-masking, and rapid disintegration. The trend aligns with demand for efficient, scalable, and patient-centric drug products. Co-processing also enhances compatibility with sensitive APIs, reducing degradation risk.

• Emergence of Excipient Technologies for Biologics and mRNA Therapeutics
  Biologic drugs and mRNA-based therapies require excipients that ensure stability during freezing, transport, and reconstitution. Lipid nanoparticles, cyclodextrins, and cryoprotectants like trehalose are critical in these formulations. Novel surfactants and polymers minimize aggregation and immunogenicity. As biologic pipelines expand, next-gen excipients are becoming essential for successful delivery. Manufacturers are developing specialized excipients for cell therapies, ADCs, and vaccines. These materials support both clinical efficacy and regulatory compliance in complex biologic systems.

• Increased Use of Patient-Centric and Abuse-Deterrent Excipient Systems
  Pharmaceutical developers are focusing on excipients that enable patient-friendly formats such as chewables, orally disintegrating tablets, and pediatric liquids. At the same time, regulatory agencies are encouraging the use of excipients in abuse-deterrent opioid formulations. Functional materials that resist crushing, extraction, or dose dumping are gaining traction. Patient-centric excipients improve taste, mouthfeel, and dosing flexibility. These innovations improve adherence, reduce misuse, and differentiate branded products in competitive markets.

• Integration of Digital and Predictive Modeling in Excipient Development
  AI and machine learning tools are increasingly used to simulate excipient-API interactions and optimize formulation design. Digital twins, modeling software, and molecular simulations accelerate excipient screening and reduce trial-and-error development. Predictive modeling supports early-stage decision-making and identifies potential stability risks. Companies are building digital databases of excipient functionalities and performance outcomes. This data-driven approach enhances formulation efficiency and regulatory documentation quality.

• Regulatory Evolution Supporting Novel Excipient Qualification
  Regulatory bodies such as the FDA, EMA, and IPEC are working to streamline the approval and use of new excipients. Programs like the FDA’s Novel Excipient Review Pilot facilitate early engagement with developers. Regulators now accept safety data and real-world evidence to assess novel materials. Harmonization across pharmacopoeias will ease global deployment of advanced excipients. As these frameworks mature, market access for next-gen materials will improve. This regulatory shift supports innovation in formulation science.

Market Growth Drivers

• Rising Number of Poorly Soluble and Biopharmaceutical Class IV APIs
  Modern drug pipelines are dominated by poorly water-soluble molecules that challenge traditional formulation techniques. Next-generation excipients such as solubilizers, wetting agents, and permeation enhancers are required to improve bioavailability. These excipients help overcome dissolution and permeability limitations, especially in oral dosage forms. Demand is strong from both new chemical entities and 505(b)(2) reformulations. Improved absorption translates into better therapeutic outcomes and patient compliance.

• Increased Demand for Advanced Drug Delivery Technologies
  Controlled-release, fast-dissolving, mucoadhesive, and transdermal systems rely on high-functionality excipients. These systems require excipients that interact with biological membranes, control pH, or respond to stimuli. Next-gen materials like smart polymers and amphiphilic carriers meet these needs. Their use improves dose precision and reduces dosing frequency. Rising interest in wearable drug delivery and long-acting injectables enhances excipient demand. These technologies are driving innovation across therapeutic categories.

• Expansion of Biologics and Personalized Medicine
  Biologics and precision therapies often require unique excipient profiles to maintain stability, safety, and efficacy. Patient-specific formulations involve tailored excipients for solubility, immunogenicity, and pharmacokinetics. The complexity of these therapies increases the importance of excipient design in achieving clinical success. Market adoption of biosimilars and personalized vaccines also supports excipient diversification. Growth in specialty pharma and niche indications fuels demand for novel excipient functionalities.

• Pharmaceutical Industry Focus on Formulation Efficiency and Cost Optimization
  Streamlining formulation development reduces time-to-market and production costs. Multifunctional and co-processed excipients reduce excipient count and simplify process validation. They enable faster scale-up and reduce risk of excipient incompatibility. Improved flow properties and compressibility enhance manufacturing output. These cost and process benefits are critical for both branded and generic manufacturers. The trend supports wider acceptance of next-gen excipients across formulation platforms.

• Partnerships and Licensing Models with Excipient Innovators
  Collaboration between excipient developers and pharma companies is enabling co-development of tailor-made materials. Licensing models allow formulation exclusivity and brand protection. These partnerships speed up product innovation and improve clinical performance. CDMOs are also engaging with excipient suppliers to offer integrated solutions. This collaborative model enhances R&D productivity and commercial competitiveness. Strategic alliances are emerging as a key driver for excipient innovation.

Challenges in the Market

• Limited Regulatory Pathways and Monograph Support
  Unlike APIs, new excipients often lack established monographs and safety data frameworks. Regulatory review can be slow, delaying adoption in commercial formulations. Companies must generate toxicological data and conduct bridging studies. The absence of harmonized global acceptance complicates multinational filings. Lack of regulatory clarity deters investment in novel excipient development. Overcoming these challenges requires increased collaboration between regulators and industry.

• High R&D Costs and Development Timelines
  Creating new excipients involves significant investment in synthesis, characterization, toxicology, and stability testing. The development cycle is long and may not align with fast-paced drug pipelines. Uncertainty in regulatory outcomes further adds financial risk. Smaller excipient suppliers often lack the resources to compete with established players. High R&D costs limit the number of new excipients entering the market each year. Innovative funding models and partnerships may help overcome this barrier.

• Compatibility and Stability Concerns with Novel APIs
  New excipients must be evaluated for compatibility with APIs, packaging, and processing conditions. Unexpected interactions can lead to degradation, polymorphism, or reduced bioavailability. Establishing long-term stability requires accelerated and real-time studies. Excipient variability across batches can impact formulation reproducibility. These technical risks require thorough preformulation studies and material standardization. Managing API-excipient interactions remains a central challenge.

• Lack of Awareness and Hesitancy in Generic Formulators
  Generic drug manufacturers often prefer well-known, cost-effective excipients with existing regulatory precedence. Concerns about excipient novelty, regulatory burden, and cost hinder uptake. Educating formulators about the performance benefits of next-gen materials is essential. Demonstrating bioequivalence and process efficiency improves trust. Market adoption in the generic sector remains slow despite growing availability. Overcoming hesitancy requires value-based communication and collaborative development support.

• Supply Chain Complexity and GMP Compliance
  Next-generation excipients often involve complex synthesis or sourcing from specialized vendors. Ensuring consistent quality, traceability, and regulatory documentation is resource-intensive. GMP-compliant excipient manufacturing must meet stringent expectations for pharma-grade materials. Disruptions in raw material availability or regulatory non-conformity can delay product timelines. Supply chain risk management and quality assurance remain critical focus areas. Robust compliance is essential for sustained excipient market growth.

Next-Generation Excipients Market Segmentation

By Type

• Co-Processed Excipients

• Modified Polymers

• Lipid-Based Excipients

• Cyclodextrins

• Surfactants and Solubilizers

• Others

By Functionality

• Binders and Fillers

• Disintegrants

• Controlled-Release Agents

• Solubilizing Agents

• Stabilizers

• Taste-Masking and Patient-Centric Agents

By Formulation Type

• Oral Solid Dosage Forms

• Parenteral Formulations

• Inhalation and Nasal Products

• Topical and Transdermal Systems

• Ophthalmic and Mucosal Applications

By End User

• Pharmaceutical Companies

• Biopharmaceutical Companies

• CDMOs and CROs

• Academic and Research Institutions

By Region

• North America

• Europe

• Asia-Pacific

• Latin America

• Middle East & Africa

Leading Key Players

• BASF SE

• Ashland Global Holdings Inc.

• Evonik Industries AG

• DuPont de Nemours, Inc.

• Roquette Frères

• Lubrizol Corporation

• Kerry Group plc

• DFE Pharma

• Croda International Plc

• Colorcon Inc.

Recent Developments

• Evonik Industries launched a new line of biodegradable polymer excipients designed for long-acting injectables.

• BASF SE partnered with a CDMO to co-develop multifunctional excipients for pediatric oral formulations.

• Ashland introduced co-processed excipients with enhanced binding and rapid disintegration properties for ODTs.

• Roquette Frères expanded its R&D center to support lipid-based and solubilizer excipient innovation for biologics.

• Colorcon unveiled a digital platform for real-time excipient performance modeling in complex formulations.

This Market Report Will Answer the Following Questions

• What is the projected market size and growth rate of the next-generation excipients market through 2031?

• Which excipient types are gaining traction in biologics and novel drug delivery platforms?

• How are regulatory developments impacting excipient innovation and approval timelines?

• What are the major technical and commercial challenges in excipient adoption?

• Who are the leading players and what are their innovation strategies?

• How is co-processing changing the functional landscape of excipients?

• What role do partnerships play in accelerating formulation development?

• Which dosage forms and therapeutic areas drive demand for advanced excipients?

• How are AI and digital platforms transforming excipient screening and selection?

• What is the future outlook for sustainable and patient-centric excipient development?