The future of the global pharmaceutical excipient market looks promising with opportunities in the oral formulation, topical formulation, and parenteral formulation markets. The global pharmaceutical excipient market is expected to grow with a CAGR of 5.1% from 2025 to 2031. The major drivers for this market are the increasing demand for drug delivery, the rising use of generics, and the growing pharmaceutical manufacturing activities.
- Lucintel forecasts that, within the type category, cellulose & derivatives are expected to witness the highest growth over the forecast period.
- Within the application category, oral formulation is expected to witness the highest growth.
- In terms of region, APAC is expected to witness the highest growth over the forecast period.
Emerging Trends in the Pharmaceutical Excipient Market
The pharmaceutical excipient industry is influenced by some major emerging trends that mirror the changing requirements of the pharma industry and innovations in material science. These trends are pushing the innovation processes and impacting the future of excipient development and use.
- Multifunctional Excipients Development: Excipients with more than one functionality are in increasing demand as a trend. For instance, an excipient could function both as a binder and a disintegrant, reducing formulation complexities and enhancing manufacturing efficiency. This can result in more stable and cost-efficient drugs with enhanced functionality.
- Excipients to Improve Bioavailability of Poorly Soluble Drugs: As a large percentage of new drug candidates have poor aqueous solubility, there is an intense drive to create excipients to improve their bioavailability. This involves the employment of solubilizers, cyclodextrins, and lipid excipients to increase drug absorption and ultimately therapeutic performance.
- Patient-Focused Excipients for Specialized Dosage Forms: The growth in demand for patient-friendly dosage forms, like orally disintegrating tablets, chewable tablets, and pediatric formulations, is leading to the growth in specialist excipients. These excipients enhance palatability, ease of drug administration, and compliance of the patient, especially for particular patient groups.
- Biodegradable and Biocompatible Excipients for Drug Delivery Systems: The growth of advanced drug delivery systems such as nanoparticles and implants is driving the creation of biodegradable and biocompatible excipients. These excipients guarantee the controlled and safe release of drugs in the body and reduce long-term accumulation of non-degradable parts.
- Responsive Excipients for Targeted Drug Delivery: One of the newer trends is the creation of "smart" or responsive excipients that release drugs in response to certain physiological stimuli, such as pH, temperature, or enzymatic activity. The excipients allow for targeted drug delivery to a particular location in the body, enhancing drug efficacy and minimizing systemic adverse effects.
These trends are all together redefining the pharmaceutical excipient market by promoting the creation of more functional, patient-centric, and efficient excipients that respond to the changing challenges of drug formulation and delivery.
Recent Developments in the Pharmaceutical Excipient Market
Recent trends in the pharmaceutical excipient market reflect the ongoing innovation and evolution in this key area of the pharmaceutical industry. These developments are focused on enhancing drug product performance, safety, and manufacturing processes.
- Novel Co-processed Excipients: Co-processed excipients, which are two or more excipients combined by a unique manufacturing process, are becoming popular. They provide synergistic benefits and enhanced performance over physical mixtures, resulting in better tablet compaction, flowability, and drug release behavior.
- Evolution of Excipients for Biologics and Gene Therapies: The acceleration of growth for biologics and gene therapies is leading the way to innovate specialized excipients that will be able to stabilize these complicated molecules and provide delivery in an efficient manner. They include new-generation buffers, stabilizers, and delivery enhancers specifically for such therapeutic platforms.
- Creation of Excipients From Renewable Sources: More interest has developed in excipients that have originated from sustainable and renewable resources as the larger industry focuses more on being green. Examples of this include excipients made from non-wood cellulose-based sources and those that are obtained from agricultural residues.
- Emphasis on Increased Characterization and Quality Control: Regulatory agencies are placing more and more importance on the complete characterization and strict quality control of pharma excipients. This is leading to the use of modern analytical methodologies to provide assurance of the safety and reproducibility of excipient supply.
- Designing Excipients for Continuous Processing Technologies: The shift of the pharmaceutical industry towards continuous manufacturing is driving the development of excipients that are appropriate for such cutting-edge production systems, with guaranteed flowability and compatibility with continuous processing equipment.
These innovative developments reflect the vibrant character of the pharmaceutical excipient market, with continuous efforts to develop more functional, sustainable, and quality ingredients which facilitate the creation of new drug products.
Strategic Growth Opportunities in the Pharmaceutical Excipient Market
The pharmaceutical excipient industry offers high strategic growth opportunities across different key applications based on the changing demands for drug formulation and drug delivery. Strategizing around these opportunities can result in remarkable market growth and innovation.
- Solid Oral Dosage Forms with Improved Performance: Solid oral dosage forms are the leading drug delivery system, and there are ongoing opportunities for excipients to enhance their performance. These include excipients that improve dissolution of drugs, regulate release of the drug, enhance stability of tablets in harsh climates, and provide improved patient compliance by better organoleptic properties.
- Parenteral Formulations to Improve Solubility and Stability: Parenteral medications frequently encounter solubility and stability problems. Strategic development is creating new solubilizers, stabilizers, and preservatives that can effectively solve these problems, especially for sophisticated molecules such as biologics, to ensure they are delivered safely and effectively through injection or infusion.
- Topical and Transdermal Drug Delivery Systems: The topical and transdermal drug delivery market is growing, and with it opportunities exist for excipients which will drive drug penetration through the skin, add formulation aesthetics, and deliver controlled release at the site of application. Penetration enhancers, emulsifiers, and film-forming polymers are included.
- Inhalation and Nasal Drug Delivery: Excipients are an important part of inhalation and nasal drug delivery systems, impacting aerosolization, particle size, and deposition of the drug in the respiratory tract. Potential lies in the development of excipients that enhance the efficacy and targeting of drugs delivered through these routes, especially for respiratory diseases.
- Advanced Drug Delivery Systems (Nanoparticles, Microparticles, Implants): The formulation of sophisticated drug delivery systems such as nanoparticles, microparticles, and implants heavily depends on custom excipients for drug encapsulation, controlled drug release, and biocompatibility. Targeting excipients designed for these new delivery platforms presents substantial growth opportunities.
Seizing these strategic growth potentialities through application-specific research, development, and partnering with pharmaceutical firms can dramatically increase the pharmaceutical excipient industry and help develop drug delivery technologies.
Pharmaceutical Excipient Market Driver and Challenges
The pharmaceutical excipient market is influenced by a complex interplay of drivers and challenges that shape its growth, innovation, and overall landscape. Understanding these factors is crucial for stakeholders to navigate the market effectively.
The factors responsible for driving the pharmaceutical excipient market include:
1. Growing Complexity of Drug Molecules: The drug industry is increasingly designing complex drug molecules, such as biologics and poorly soluble drugs. These drugs tend to need specialized excipients to maintain their stability, solubility, and delivery efficiency, hence the demand for novel excipients.
2. Expansion of the Generic Drug Market: The growth in the generic drug market requires cost-effective and high-quality excipients to establish bioequivalence and cost-effective manufacturing. This ensures a steady demand for a variety of known and new excipients.
3. Increased Need for Patient-Friendly Dosage Forms: With the increasing focus on patient convenience and compliance, demand is increasing for patient-friendly dosage forms, including orally disintegrating tablets, chewable tablets, and liquids. This requires the use of advanced excipients with features that improve palatability, ease of administration, and stability.
4. Emerging Trends in Drug Delivery Technologies: The ongoing development of drug delivery systems, such as controlled release formulations, targeted delivery systems, and new routes of delivery, necessitates the introduction of innovative excipients with certain functionalities to facilitate these technologies.
5. Stringent Regulatory Requirements and Emphasis on Quality: Global regulatory bodies are placing more emphasis on pharmaceutical excipient quality, safety, and traceability. This focus necessitates high-quality excipients from high-quality sources and innovation in excipient manufacturing processes and characterization.
Challenges in the pharmaceutical excipient market are:
1. Time and High Cost Involved in Novel Excipient Development: Novel excipient development and approval is a time-consuming process as well as costly due to large safety testing and characterization demands. This can make it difficult to bring new excipients into the market.
2. Variability in Raw Material Sources and Quality: Excipients are often derived from natural or synthetic raw materials, and variability in their sources and quality can impact the performance and consistency of the final drug product. Ensuring a reliable and consistent supply of high-quality raw materials is a significant challenge.
3. Insufficient Harmonization in Worldwide Regulatory Requirements: Regulatory standards for pharmaceutical excipients may be quite different in different countries, making it difficult for global drug companies to manage formulations and supply chains. More harmonization of the regulations would be helpful.
The market for pharmaceutical excipients is being driven considerably by the complexity of drug molecules, the development of the generic market, the need for patient-friendly formulations, advancements in drug delivery, and rigorous regulatory emphasis on quality. Yet, difficulties in terms of cost and time for the development of new excipients, raw material variability, and global regulatory harmonization must be overcome to encourage greater innovation and ensure a consistent supply of high-quality excipients to the pharmaceutical industry. Addressing these will be vital in enabling the development of safe and effective drugs.
List of Pharmaceutical Excipient Companies
Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leveraging integration opportunities across the value chain. With these strategies, pharmaceutical excipient companies cater to increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the pharmaceutical excipient companies profiled in this report include:
- DowDuPont
- JRS Pharma
- BASF
- Lubrizol
- Ashland
- Croda International
- Roquette
- Shin-Etsu
- Evonik
- Associated British Foods
Pharmaceutical Excipient Market by Segment
The study includes a forecast for the global pharmaceutical excipient market by type, application, and region.
Pharmaceutical Excipient Market by Type [Value from 2019 to 2031]:
- Starch & Derivatives
- Sucrose
- Cellulose & Derivatives
- Dextrose
- Polyols
- Inorganic Salts
- Others
Pharmaceutical Excipient Market by Application [Value from 2019 to 2031]:
- Oral Formulations
- Topical Formulations
- Parenteral Formulations
- Others
Pharmaceutical Excipient Market by Region [Value from 2019 to 2031]:
- North America
- Europe
- Asia Pacific
- The Rest of the World
Country Wise Outlook for the Pharmaceutical Excipient Market
Recent growth in the pharmaceutical excipient industry indicates the vital importance of these inactive components in drug formulation and delivery. Excipients improve drug stability, bioavailability, and manufacturability. The industry is experiencing heightened innovation fueled by the escalating complexity of drug molecules, the growth of biologics, and the need for patient-focused dosage forms. Regulatory pressure is likewise building, demanding increased quality and safety levels. This has initiated research into new excipients with greater functionalities and better safety profiles in large pharmaceutical markets all over the world.
- United States: The US pharmaceutical excipient market is dominated by a keen emphasis on innovation and quality. Recent trends have involved the introduction of new polymers for controlled release formulations as well as the creation of excipients specifically tailored for biologic drugs. Safety and regulatory compliance of excipients are also increasingly emphasized, prompted by strict guidelines from the Food and Drug Administration.
- China: China's pharmaceutical excipient market is witnessing high growth, driven by the rapidly growing domestic pharma industry. Some of the latest trends include rising investment in research and development in high-quality excipients to achieve international standards. There is also an increasing emphasis on creating natural-source-derived excipients and enhancing the sustainability of the excipient manufacturing process.
- Germany: Germany is an important player in the pharmaceutical excipient industry, with high standards and technology. New developments include the creation of excipients with special functionalities for novel drug delivery systems, including solubility enhancers and permeation enhancers. Ecology and green production techniques are also becoming increasingly relevant.
- India: India's pharmaceutical excipient market is a major driver for the international supply chain with cost-oriented manufacturing as its emphasis. Recent trends have involved attempts to increase domestically produced excipients' quality and their regulatory compliance for sale in foreign markets. There is also growing research in new excipients based on indigenous materials.
- Japan: The Japanese excipient market for pharmaceuticals is known to place a lot of stress on innovation and patient-focused formulations. Some recent trends involved the establishment of excipients for orally disintegrating tablets and other patient-friendly product forms. Excipients that increase the stability and potency of complex drug molecules such as biologics are also given attention.
Features of the Global Pharmaceutical Excipient Market
- Market Size Estimates: Pharmaceutical excipient market size estimation in terms of value ($B).
- Trend and Forecast Analysis: Market trends (2019 to 2024) and forecast (2025 to 2031) by various segments and regions.
- Segmentation Analysis: Pharmaceutical excipient market size by type, application, and region in terms of value ($B).
- Regional Analysis: Pharmaceutical excipient market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
- Growth Opportunities: Analysis of growth opportunities in different types, applications, and regions for the pharmaceutical excipient market.
- Strategic Analysis: This includes M&A, new product development, and the competitive landscape of the pharmaceutical excipient market.
Analysis of the competitive intensity of the industry based on Porter's Five Forces model.
This report answers the following 11 key questions:
- Q.1. What are some of the most promising, high-growth opportunities for the pharmaceutical excipient market by type (starch & derivatives, sucrose, cellulose & derivatives, dextrose, polyols, inorganic salts, and others), application (oral formulations, topical formulations, parenteral formulations, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
- Q.2. Which segments will grow at a faster pace and why?
- Q.3. Which region will grow at a faster pace and why?
- Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
- Q.5. What are the business risks and competitive threats in this market?
- Q.6. What are the emerging trends in this market and the reasons behind them?
- Q.7. What are some of the changing demands of customers in the market?
- Q.8. What are the new developments in the market? Which companies are leading these developments?
- Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
- Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
- Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?