Global Pharmaceutical Excipients Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2031

Pharmaceutical Excipients Market Analysis

The pharmaceutical excipients market is witnessing substantial growth, driven by the increasing demand for advanced drug formulations and the rising focus on drug delivery systems. As pharmaceutical companies strive for enhanced bioavailability and patient compliance, excipients play a critical role in the development of effective and stable formulations. Recent developments in this market include the introduction of multifunctional excipients that serve traditional roles such as binders and fillers and offer enhanced functionalities, such as improved solubility and targeted release profiles. Innovations in biocompatible materials are also gaining traction, particularly for parenteral formulations, to ensure safety and efficacy. Furthermore, the rise of personalized medicine has prompted the development of tailored excipients that cater to specific patient needs, leading to increased research and investment in this area. Regulatory agencies are also evolving their guidelines, promoting the use of excipients with proven safety profiles. In addition, collaborations between excipient manufacturers and pharmaceutical companies are on the rise, fostering innovation and expanding the scope of applications. Overall, the pharmaceutical excipients market is poised for continued growth, with ongoing advancements driving the evolution of drug formulations and delivery systems.

Pharmaceutical Excipients Market Size

The global pharmaceutical excipients market size was valued at USD 8.31 billion in 2023 and is projected to reach USD 13.86 billion by 2031, with a CAGR of  6.60% during the forecast period of 2024 to 2031. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Pharmaceutical Excipients Market Trends

“Growing Demand for Natural and Bio-Based Excipients”

The pharmaceutical excipients market is witnessing substantial growth, driven by the increasing demand for advanced drug formulations and the rising focus on drug delivery systems. One significant trend in the pharmaceutical excipients market is the growing demand for natural and bio-based excipients, driven by increasing consumer awareness of safety and environmental sustainability. As pharmaceutical companies seek to develop formulations that align with health-conscious consumer preferences, the shift towards natural ingredients is becoming more pronounced. For instance, excipients derived from plant sources, such as starch and cellulose, are gaining popularity due to their compatibility with various drug formulations and their perceived safety advantages over synthetic alternatives. Companies such as Roquette are leading the charge by offering a range of natural excipients that meet both regulatory requirements and consumer expectations. Such trend is further supported by regulatory bodies advocating for the use of safer, more environmentally friendly materials in pharmaceutical products. As a result, the adoption of natural and bio-based excipients is expected to accelerate, helping manufacturers enhance the safety profiles of their drug formulations while also appealing to a more environmentally conscious market.

Report Scope and Pharmaceutical Excipients Market Segmentation 

Pharmaceutical Excipients Market Definition

Pharmaceutical excipients encompass all components of a drug except for the active pharmaceutical ingredients. These substances do not have medicinal effects on their own; instead, they are used to improve the physiological absorption of the drug. Being inert, pharmaceutical excipients ensure that the drug is delivered to patients in the appropriate form. While traditional excipients were typically simple molecules, advancements in technology and the growing need for innovative drug delivery systems have led to increased complexity in pharmaceutical excipients.

Pharmaceutical Excipients Market Dynamics

Drivers

• Increasing Production and Use of Generic Drugs

According to the U.S. Food and Drug Administration (FDA) and the National Center for Biotechnology Information (NCBI), a generic drug is designed to resemble an approved brand-name drug in dosage form, encompassing similar safety, strength, route of administration, quality, and performance. Although the cost savings associated with generic drug use may not be immediately evident after a drug's patent expires, competition in the generic market typically leads to significant price reductions. Generally, two to three years following the loss of exclusivity, the price of a generic drug is often 60-70% lower than that of its brand-name counterpart. In India, where per capita spending on healthcare is high, the availability of generic drugs can result in substantial savings that can be redirected to address other health issues. The national adoption of generic medications has seen significant growth in recent years, and the availability of affordable alternatives to branded drugs is likely to further stimulate the pharmaceutical industry. Consequently, the increasing demand for and production of generic drugs are expected to drive growth in the global pharmaceutical excipients market, as their lower costs encourage higher usage.

• Rising Demand for Excipients

Pharmaceutical excipients are substances included in pharmaceutical dosage forms that do not provide direct therapeutic effects but serve to aid in the manufacturing, protection, support, or enhancement of stability and availability. With the growing development of the global pharmaceutical sector, the role of excipients has become increasingly significant. Recently, the rising demand for generic drugs has further boosted the need for excipients. In addition, there has been a notable increase in chronic disease cases. Excipients are inert substances, distinct from active pharmaceutical ingredients, that are incorporated into the manufacturing process or dosage forms of pharmaceutical products. They are commonly used in drug formulations to add bulk to solid forms, ensure long-term stability, and facilitate drug absorption. Moreover, excipients enhance the overall safety and functionality of products during use or storage. As a result, the extensive application of excipients in drug formulation is expected to drive growth in the global pharmaceutical excipients market.

Opportunities

• Rising Technological Advancements in Drug Formulation

Technological advancements in drug formulation and excipient technology are transforming the pharmaceutical landscape by enabling the development of multifunctional excipients that enhance the efficacy and patient-friendliness of medications. For instance, excipients such as Polyplasdone Plus, a multifunctional superdisintegrant, improve tablet disintegration and enhance powder flow and lubrication, thereby streamlining the manufacturing process. These innovations facilitate the production of high-quality drugs and address specific patient needs, such as improving the bioavailability of active pharmaceutical ingredients. As pharmaceutical companies increasingly seek to create more effective and tailored drug formulations, the demand for advanced excipients is set to rise significantly. This trend presents a substantial market opportunity for excipient manufacturers to expand their product offerings and capture a larger share of the growing pharmaceutical market, ultimately driving improvements in therapeutic outcomes and patient satisfaction.

• Increasing Expansion of Biopharmaceuticals

The expansion of biopharmaceuticals is driving a growing demand for specialized excipients capable of stabilizing proteins and peptides, which are crucial for the efficacy of these complex drugs. For instance, excipients such as sucrose and trehalose are commonly used to protect biologics during freeze-drying processes, helping to maintain their structural integrity and activity. As the biopharmaceutical industry continues to advance, with an increasing number of therapeutic proteins and monoclonal antibodies entering the market, the need for excipients that can enhance the stability and bioavailability of these products becomes paramount. This presents a significant market opportunity for excipient suppliers to innovate and develop tailored solutions that meet the unique challenges posed by biopharmaceutical formulations. By investing in research and development to create excipients specifically designed for biopharmaceutical applications, suppliers can position themselves as essential partners in the evolving landscape of drug development, ultimately capturing a larger share of the expanding biopharmaceutical market.

Restraints/Challenges

• Increasing Regulatory Stringency

Generic drug approval regulations are largely uniform across the globe, with minimal variations in developing countries. This is primarily due to the fact that bioequivalence (BE) studies are not mandatory in these regions for obtaining generic drug approvals. Medical experts emphasize that governments must ensure the consistent quality of all generic medications to instill confidence among healthcare providers. Only then will doctors feel assured in prescribing generic drugs. A significant factor contributing to the skepticism among physicians and patients alike is the absence of stringent regulatory requirements concerning the number of generic drugs allowed and the permissible levels of impurities.

• Intellectual Property (IP) Issues

Intellectual property (IP) issues pose significant challenges in the global pharmaceutical excipients market, particularly as the patenting of novel excipient technologies can create barriers for smaller companies and new entrants. When larger firms secure patents for innovative excipients, they effectively restrict access to these crucial materials, limiting the ability of smaller companies to develop and market competitive products. For instance, if a major pharmaceutical company patents a multifunctional excipient that significantly enhances drug stability and bioavailability, smaller firms may find it difficult to innovate without infringing on those patents. This situation can lead to reduced competition in the market, stifling the development of new formulations that could address unmet medical needs. Moreover, the high costs associated with patent litigation can further deter smaller companies from entering the market or pursuing innovative excipient solutions.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Pharmaceutical Excipients Market Scope

The market is segmented on the basis of functionality, dosage form, route of administration, end user, and distribution channel. The growth amongst these segments will help you analyse meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Functionality

• Binders and Adhesives
• Disintegrants
• Coating Material
• Coloring Agents
• Solubilizers
• Flavors
• Sweetening Agents
• Diluents
• Lubricants
• Buffers
• Emulsifying Agents
• Preservatives
• Antioxidants
• Sorbents
• Solvents
• Emollients
• Glidants
• Chelating Agents
• Antifoaming Agents
• Others

Dosage Form

• Solid
• Semi-Solid
• Liquid

Route of Administration

• Oral Excipients
• Topical Excipients
• Parenteral Excipients
• Other Excipients

End User

• Pharmaceutical and Biopharmaceutical Companies
• Contract Formulators
• Research Organizations and Academics
• Others

Distribution Channel

• Direct Tender
• Retail Sales
• Others

Pharmaceutical Excipients Market Regional Analysis

The market is analysed and market size insights and trends are provided by country, functionality, dosage form, route of administration, end user, and distribution channel as referenced above.

The countries covered in the market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E., South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America leads the nootropics market, primarily driven by significant investments in research and development, which are anticipated to fuel further growth. Within this region, the United States holds a dominant position thanks to the presence of major industry players such as Evonik, Dow, and Croda International Plc. These companies' commitment to innovation and product development enhances the competitive landscape, positioning North America as a key hub for nootropic advancements.

China is leading the Asia-Pacific region in the pharmaceuticals market, driven by a significant increase in the production of generic drugs. This growth can be attributed to the country’s strong investments in research and development, which enhance the manufacturing capabilities and innovation in the pharmaceutical sector. In addition, the expanding healthcare infrastructure and rising consumer demand for affordable medications further support China's dominance in this rapidly evolving market.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.  

Pharmaceutical Excipients Market Share

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

Pharmaceutical Excipients Market Leaders Operating in the Market Are:

• Kerry Group plc. (Ireland)
• DFE Pharma (Germany)
• Cargill, Incorporated (U.S.)
• Pfanstiehl (U.S.)
• Colorcon (U.S.)
• MEGGLE GmbH & Co. KG (Germany)
• Omya AG (Switzerland)
• Peter Greven GmbH & Co. KG (Germany)
• Ashland (U.S.)
• Evonik (Germany)
• Dow (U.S.)
• Croda International Plc (U.K.)
• Roquette Frères (France)
• The Lubrizol Corporation (U.S.)
• BASF SE (Germany)
• Avantor, Inc. (U.S.)
• BENEO (Germany)
• Chemie Trade (Germany)

Latest Developments in Pharmaceutical Excipients Market

• In October 2023, Clariant, a specialty chemicals company committed to sustainability, introduced its new range of high-performing pharmaceutical ingredient solutions aimed at advancing the development of safe and effective medications. In addition, Clariant Health Care expanded its selection of functional excipients designed to address challenges related to the delivery and bioavailability of active pharmaceutical ingredients (APIs)
• In September 2023, Roquette, a company specializing in plant-based ingredients and offering pharmaceutical and nutraceutical excipients, added three new excipient grades to its portfolio. These new grades are specifically tailored for moisture-sensitive active pharmaceutical and nutraceutical ingredients
• In June 2023, Ashland launched Polyplasdone Plus, a co-processed multifunctional direct compression superdisintegrant that incorporates a glidant and lubricant. Designed to streamline development and save time, this multifunctional disintegrant enhances powder flow and lubrication in pharmaceutical manufacturing. By reducing two manufacturing steps and simplifying equipment setup, this innovative product not only improves tablet hardness but also ensures the consistent production of high-quality products in both batch and continuous manufacturing processes
• In September 2022, DFE Pharma, a prominent provider of pharmaceutical and nutraceutical excipient solutions, launched its new “Closer to the Formulator” (C2F) Center of Excellence in Hyderabad, India. The C2F aims to assist pharmaceutical companies in reducing the time from concept to finished commercial product by leveraging its expertise throughout all stages of pharmaceutical development. This initiative has allowed the company to demonstrate its progress in the industry
• In February 2022, Kerry Group Plc, a global leader in taste and nutrition, announced two significant biotechnology acquisitions that enhanced its expertise, technology portfolio, and manufacturing capabilities. The company acquired c-LEcta, a top biotechnology innovation firm specializing in precision fermentation, optimized bio-processing, and bio-transformation, along with Enmex, a well-established enzyme manufacturer in Mexico that provides various bio-process solutions for the food, beverage, and animal nutrition sectors

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