Global Pharma Excipients Market Analysis By Function (Pharmaceutical Fillers, Binders, Coatings, Disintegrants, Preservatives, Others), By Product (Organic, Oleochemicals, Carbohydrates, Petrochemicals, Othe Organic Chemicals, Inorganic Chemicals, Calcium Phosphate, Calcium Carbonate, Metal Oxides, Calcium Sulphate, Other Inorganic Chemicals), By Functionality Application (Taste Masking, Stablizers, Modified-Release, Solubility & Bioavailablity Enhancement, Others), By Formulation (Oral, Topical), By Region and Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2024-2033

Report Overview

The Global Pharma Excipients Market size is expected to be worth around US$ 18.8 Billion by 2033, from US$ 9.3 Billion in 2023, growing at a CAGR of 7.3% during the forecast period from 2024 to 2033.

Pharma excipients are inactive substances used in pharmaceutical formulations, such as tablets, capsules, and syrups. They do not have therapeutic effects but play a critical role in drug delivery. These excipients enhance stability, improve taste, control the release of the active ingredient, and aid in the manufacturing process. Common examples of excipients include binders, fillers, stabilizers, preservatives, coloring agents, and flavoring agents. As the pharmaceutical industry grows, the demand for excipients continues to rise to support various dosage forms like oral, injectable, and topical drugs.

The global pharma excipients market is expanding rapidly due to advancements in drug delivery technologies and increased demand for personalized medicine. According to GEP reports, the market is expected to reach 3,155,500 tons by 2027. This growth is driven by innovation in excipient formulations, rising healthcare needs, and the growing pharmaceutical sector. Additionally, increased spending on research and development (R&D) and bioequivalence is contributing to the demand for excipients. Market segments include excipient types, applications, and regional distributions.

Stability is a significant concern in drug development. Environmental factors such as light, air (oxygen), and heat can negatively affect the chemical and physical integrity of drugs. These factors may reduce the effectiveness of the drug or create harmful degradation products. According to a study by MDPI, ensuring drug stability is essential for maintaining the quality and safety of pharmaceutical products. Researchers are continuously exploring new methods for improving drug stability under varying environmental conditions.

Ongoing research and development in pharmaceutical excipients are focused on addressing challenges such as photostability, in-use stability, and preventing drug degradation. Collaboration between pharmaceutical scientists, chemists, and clinicians is critical in these efforts. For instance, new stabilization techniques are being developed to protect drugs from environmental degradation. This research is essential to creating more robust pharmaceutical formulations that can maintain efficacy over time, regardless of external conditions.

The role of excipients in drug formulations has evolved significantly. Traditionally considered as inactive and cost-effective substances, excipients now account for 80-90% of the final product. According to the International Pharmaceutical Excipient Council (IPEC), excipients are now recognized as essential components that enhance the functionality and effectiveness of drugs. As pharmaceutical sciences advance, excipients are becoming increasingly important, particularly in solid dosage forms. This shift is due to the rapid development of drug delivery systems and the growing demands of biopharmaceutics.

For example, in July 2023, Croda International Plc acquired Solus Biotech, a leader in biotechnology-derived materials. This acquisition, valued at £232 million, allowed Croda to enhance its portfolio of high-purity excipients. The addition of Solus Biotech’s ceramide and phospholipid technologies strengthens Croda’s position in the pharmaceutical market by providing innovative excipients for drug formulations. Such strategic moves demonstrate the ongoing investment in the excipient sector to meet the evolving needs of the pharmaceutical industry.

In addition to acquisitions, companies are also investing in new technologies to improve drug delivery systems. For instance, in October 2023, Ashland introduced a new bioresorbable polymer technology platform at industry events like CPHI Barcelona and AAPS PharmSci 360. This platform aims to enhance drug delivery systems by providing materials that safely dissolve in the body after serving their purpose. Similarly, in June 2023, Lubrizol licensed its novel excipient polymer technology, Apisolex™, to Welton Pharma. This polymer enhances the solubility of active pharmaceutical ingredients (APIs), potentially increasing their efficacy significantly.

Key Takeaways

• The global Pharma Excipients Market is projected to reach US$ 18.8 billion by 2033, growing at a CAGR of 7.3% from US$ 9.3 billion in 2023.
• In 2023, the Pharmaceutical Fillers segment led the Function Segment, securing over 29.4% of the market share in the Pharma Excipients Market.
• The Inorganic Chemicals segment dominated the product category in 2023, accounting for more than 60.4% of the total market share in Pharma Excipients.
• The Modified-Release segment captured more than 31.6% of the market share in the Functionality Application Segment of the Pharma Excipients Market in 2023.
• In 2023, the Oral formulation segment led the market with a share exceeding 67.3% in the Formulation Segment of Pharma Excipients.
• Europe was the largest regional market in 2023, holding more than 38.6% of the global market share, valued at US$ 3.6 billion.

Industrial Advantages

Pharmaceutical excipients enhance drug formulations by reducing production costs and extending product shelf life. They improve drug bioavailability, ensuring effectiveness at lower doses and reduced side effects. These components assist manufacturers in meeting rigorous regulatory standards, which can accelerate drug approvals and market entry. Additionally, by incorporating novel excipients, companies can create distinct formulations, setting their products apart in a competitive market.

Excipients are pivotal in modern drug delivery technologies, including controlled-release systems, providing a strategic market advantage. They offer formulation versatility, allowing the production of diverse dosage forms tailored to specific patient needs. Furthermore, excipients enhance the stability and efficacy of pharmaceutical products, ensuring reliable performance under various conditions. They also solve solubility issues, facilitating the development of new drugs.

The development of generic drugs offers significant opportunities for utilizing excipients in reformulations, enabling entry into various market segments. Excipients also support the creation of drugs for novel therapeutic areas by addressing formulation challenges associated with new drug candidates. Collaboration opportunities with biotech firms can lead to specialized formulations for biologically derived treatments. Additionally, improved excipients can help companies penetrate emerging markets by adhering to local regulatory standards.

There is a rising demand for sustainable and environmentally friendly manufacturing processes. Excipient manufacturers investing in green chemistry technologies can gain a competitive edge. This approach not only meets the market demand for sustainability but also opens up global expansion opportunities. By focusing on sustainable practices, excipient manufacturers can appeal to a broader audience, enhancing their market presence and fostering growth in new regions.

Function Analysis

In 2023, the Pharmaceutical Fillers segment held a dominant market position in the Function Segment of the Pharma Excipients Market, capturing more than a 29.4% share. Fillers are primarily used to enhance the size of tablets, making them easier to handle. They also improve manufacturing efficiency and ensure accurate dosage. This segment’s strong performance highlights its critical role in ensuring quality and compliance in pharmaceutical formulations.

The Binders segment followed closely, contributing significantly to the market. These excipients are essential for holding powdered materials together, ensuring tablet integrity. Binders also enhance stability during storage and manufacturing. Their demand is particularly high in formulations requiring extended shelf life. This segment’s growth is supported by advancements in binder technology and increasing adoption in modern drug formulations.

Coatings also showcased steady growth, reflecting their importance in pharmaceutical applications. Coatings are used to control drug release, mask unpleasant tastes, and protect active ingredients from environmental factors. Their use improves the appearance of dosage forms and enhances patient acceptance. These benefits have driven their adoption in both prescription and over-the-counter medications.

Other functional segments, such as Disintegrants and Preservatives, showed consistent contributions to the market. Disintegrants help tablets dissolve efficiently, improving drug bioavailability. Preservatives are crucial for extending the shelf life of liquid and semi-solid products by preventing microbial contamination. Additionally, niche excipients like stabilizers and flavoring agents cater to specialized formulation needs, further diversifying the market. Collectively, these segments underline the growing importance of excipient functionality in modern pharmaceutical products.

Product Analysis

In 2023, the Inorganic Chemicals segment held a dominant position in the product segment of the Pharma Excipients Market. It captured over 60.4% market share. These excipients, including calcium phosphate, calcium carbonate, and metal oxides, are essential in pharmaceutical formulations. Their stability and compatibility with active ingredients make them a preferred choice. These features ensure reliable performance, contributing to the high adoption rate across pharmaceutical industries worldwide.

The Organic Chemicals segment is experiencing steady growth. This includes excipients like oleochemicals, carbohydrates, and other organic compounds. Their biodegradable nature and multifunctionality enhance their appeal. Oleochemicals are widely used for stabilizing emulsions and improving formulations. Additionally, carbohydrates such as starches and cellulose derivatives play a key role in improving drug solubility. Their natural origin aligns with the rising demand for sustainable pharmaceutical solutions.

Petrochemicals remain an important part of the excipient market. These compounds are used in solvents, binders, and tablet coatings. Their cost-effectiveness and durability support their growing demand. Petrochemical-based excipients ensure long-lasting stability, making them indispensable in certain drug formulations. Their role in creating high-quality coatings for tablets and capsules also strengthens their position in the market.

Other categories, such as Calcium Sulphate and Other Inorganic Chemicals, also contribute significantly. These excipients are valued for their non-toxic nature and compatibility with different formulations. Their ability to enhance drug delivery and safety is noteworthy. Together, these diverse excipient options help meet evolving pharmaceutical needs. Each product type offers unique benefits that improve the safety, stability, and efficiency of drug formulations globally.

Functionality Application Analysis

In 2023, the Modified-Release segment held a dominant market position in the Functionality Application Segment of the Pharma Excipients Market. It captured more than a 31.6% share. This segment’s prominence stems from its growing role in controlled and sustained drug delivery. Modified-release excipients help reduce dosing frequency, improving patient adherence. Their ability to deliver drugs over extended periods has made them a preferred choice for chronic disease treatments and other long-term therapies.

Another key area of growth is the Solubility and Bioavailability Enhancement segment. This category saw increased adoption due to its role in improving the performance of poorly soluble drugs. Many pharmaceutical formulations rely on these excipients to enhance drug absorption and therapeutic impact. This trend is driven by the need for more effective drug formulations that improve patient outcomes. With a rising number of poorly water-soluble drugs in development, this segment is poised for further expansion.

Taste masking excipients also gained traction, particularly in pediatric and geriatric treatments. These excipients enhance the palatability of medicines, making them easier to consume for sensitive patient groups. They are widely used in liquid formulations, chewables, and orally disintegrating tablets. The demand for patient-friendly drug formulations has fueled the growth of this segment. As a result, taste-masking excipients have become an essential component in many pharmaceutical products.

Other excipients, such as stabilizers, binders, fillers, and disintegrants, play critical roles in formulation development. Stabilizers ensure the stability of drugs during storage and transportation. Binders and fillers provide structural integrity to dosage forms, while disintegrants ensure rapid dissolution. Together, these excipients support the performance and quality of pharmaceutical products. Their versatile applications continue to drive their demand across the industry, contributing to the overall growth of the excipients market.

Formulation Analysis

In 2023, the Oral segment held a dominant market position in the Formulation Segment of the Pharma Excipients Market, capturing more than 67.3% of the share. This significant share can be attributed to the growing preference for oral medications globally. Oral formulations like tablets, capsules, and oral suspensions offer convenience and ease of administration, making them the most popular choice for both patients and healthcare providers.

The demand for oral drugs is also being driven by the rise in chronic diseases and the increasing aging population. As more people require long-term treatment, oral medications remain a reliable and cost-effective solution. Excipients play an essential role in these formulations, with ingredients such as binders, fillers, and disintegrants enhancing the drug’s stability and effectiveness.

In addition to the Oral segment, the Topical segment is gaining traction. Topical formulations, including creams, gels, and ointments, are commonly used for localized treatments. They are applied directly to the skin and offer fast relief for various conditions, such as skin infections, pain, and inflammation. This has led to a steady demand for excipients tailored to enhance the performance of topical drugs.

Despite the rise in alternative formulations, the Oral segment remains the largest contributor to the Pharma Excipients Market. The steady advancements in drug formulations, coupled with the growing global demand for oral therapies, ensure the continued dominance of this segment in the market.

Key Market Segments

By Function

• Pharmaceutical Fillers
• Binders
• Coatings
• Disintegrants
• Preservatives
• Others

By Product

• Organic
• Oleochemicals
• Carbohydrates
• Petrochemicals
• Othe Organic Chemicals
• Inorganic Chemicals
• Calcium Phosphate
• Calcium Carbonate
• Metal Oxides
• Calcium Sulphate
• Other Inorganic Chemicals

By Functionality Application

• Taste Masking
• Stablizers
• Modified-Release
• Solubility & Bioavailablity Enhancement
• Others

By Formulation

• Oral
• Topical

Drivers

Growing Demand for Generic Medications

The increasing prevalence of chronic diseases worldwide has escalated the demand for generic drugs, which are more affordable compared to branded ones. Pharma excipients are crucial in the development and manufacturing of these medications, thus driving their market growth.

According to recent statistics, the global rise in chronic diseases has heightened the demand for generic drugs. These medications serve as cost-effective alternatives to branded options, thereby promoting the growth of pharma excipients in the drug manufacturing sector. Generic drugs not only ensure affordability but also support broad access to essential treatments. The robust demand reflects an ongoing shift towards sustainable healthcare solutions, driven by economic and health considerations alike.

A study by STATISTA highlights the substantial economic benefits of generic drugs in the United States. From 2014 to 2023, generics and biosimilars have generated over $3 trillion in savings for the healthcare system. This financial impact underscores the critical role that generic medications play in enhancing healthcare affordability and accessibility. Such savings are pivotal for both consumers and healthcare providers, enabling continued investment in health services and innovation.

For instance, the Food and Drug Administration (FDA) has been proactive in facilitating the availability of generic drugs. In 2023 alone, the FDA’s Office of Generic Drugs approved numerous applications, including first-time generics. These approvals are crucial for expanding patient access to vital medications and fostering a competitive market that drives down prices. This regulatory support is essential for ensuring that more patients benefit from cost-effective treatment options.

Economic studies, like the one by ZIPPIA, indicate that the pharmaceutical industry, encompassing both brand-name and generic drugs, significantly contributes to the U.S. economy, with an estimated impact of approximately $1.4 trillion. This figure highlights the industry’s role not only in healthcare but also as a major economic driver. The continued focus on generic drugs is likely to further enhance this impact, offering both health and economic benefits on a large scale.

Restraints

Stringent Regulatory Requirements

The pharmaceutical excipients industry operates under stringent regulatory oversight. These regulations focus on ensuring the safety, quality, and efficacy of excipients used in medicinal products. This level of scrutiny is critical to maintain trust and ensure that products meet rigorous health standards. However, the necessity to adhere to these regulations poses significant challenges to manufacturers.

Compliance with these regulatory standards involves both time and financial investment. The processes can often be lengthy, involving multiple stages of verification and validation. This adds layers of complexity to production schedules and increases the cost of excipient production. For new entrants in the market, these factors can act as significant barriers to entry.

The costs associated with meeting these regulatory demands are substantial. They encompass everything from the initial testing and documentation to ongoing compliance audits. These expenses ultimately contribute to the overall production costs of pharmaceutical products, influencing market dynamics and pricing strategies.

The rigorous regulatory framework, while essential for safety and efficacy, can impede the growth of the pharma excipients market. Potential delays in product launches and increased operational costs are some of the direct consequences. Companies must navigate these challenges carefully to maintain competitive while ensuring compliance with all regulatory requirements.

Opportunities

Advancements In Nanotechnology

Advancements In Nanotechnology are poised to revolutionize the pharmaceutical industry. According to recent studies, incorporating nanotechnology in drug formulation can significantly enhance the solubility and delivery mechanisms of various drugs. This integration offers a promising opportunity to expand the market by developing more efficient drug formulations, potentially leading to improved patient outcomes and streamlined pharmaceutical processes.

According to Seed Scientific, Carbon nanotubes present another exciting development in the field of material science. With mechanical tensile strength up to 400 times greater than that of regular steel, these structures are invaluable for creating strong, yet lightweight materials. This remarkable property positions carbon nanotubes as essential components in the advancement of new materials that could transform various industrial applications.

The exposure to nanoparticles is an emerging concern within the realm of public health and safety. A study by SEED SCIENTIFIC indicates that approximately 2 million Americans currently face significant exposure to nanoparticles, a number projected to double to 4 million in the near future. This increase underscores the urgent need for robust safety protocols and regulations to manage nanoparticle exposure effectively and ensure public safety.

Nanotechnology’s economic impact is most notable in the electronics, energy, and biomedical sectors. Together, these sectors account for over 70% of the global nanotechnology market. This substantial market share highlights the critical role that nanotechnology plays in driving technological innovations and economic growth within these high-stake industries.

Trends

Rising Popularity of Orally Disintegrating Tablets (ODTs)

Orally Disintegrating Tablets (ODTs) are becoming increasingly popular, particularly for patients who struggle with swallowing pills, such as those with dysphagia. This preference is notably prevalent among various demographics, including pediatric, geriatric, and long-term care patients. According to Wikipedia, dysphagia impacts approximately 35% of the general population and can affect up to 60% of institutionalized elderly individuals and 18–22% of all patients in long-term care facilities.

Studies underscore a strong patient preference for ODTs over traditional tablets or liquids. For example, Pharmaceutical Technology reports that more than half of patients favor ODTs, with over 80% citing ease of administration and the elimination of the need for water as their primary reasons. This highlights the functional benefits and enhanced patient compliance associated with ODTs.

From a regulatory perspective, the U.S. Food and Drug Administration (FDA) sets high standards for these innovative products. They recommend an in vitro disintegration time of about 30 seconds or less for ODTs to ensure rapid absorption and effectiveness. This guideline underscores the critical quality attributes that contribute to the unique positioning of ODTs in the pharmaceutical market.

The global market for ODTs is expanding, with more than 100 products currently available and annual sales surpassing €3 billion, as noted by Pharmaceutical Technology. This growth is driven by continuous advancements in excipient technology, which improve dissolution, stability, and taste masking, further bolstering the market dynamics and adoption of ODTs across diverse patient populations.

Regional Analysis

In 2023, Europe held a dominant market position, capturing more than a 38.6% share and a market value of US$ 3.6 billion. This success can be attributed to the region’s strong pharmaceutical industry. Europe is home to numerous leading pharmaceutical companies. These companies drive the demand for excipients, particularly due to the growing production of generic drugs and significant investments in research and development.

The regulatory environment in Europe also plays a key role. Strict quality standards ensure that pharmaceutical excipients meet high safety and efficacy levels. This builds trust in European suppliers, not just within the region but globally. As a result, Europe has become a reliable source of excipients for drug formulations.

Europe’s well-established healthcare systems further support the excipient market. The region’s strong healthcare infrastructure ensures a constant demand for pharmaceutical products. Additionally, the aging population and rise in chronic diseases add to the market’s growth. These trends drive the need for excipients in drug production, making Europe a leader in the global market.

Innovation is another factor contributing to Europe’s market dominance. The region continues to lead in developing advanced excipients, such as those used in controlled-release formulations. These innovations improve drug delivery systems, enhancing the effectiveness of treatments. As Europe focuses on new technologies and tailored solutions, the demand for pharmaceutical excipients remains strong.

Key Regions and Countries

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • The UK
  • Spain
  • Italy
  • Russia
  • Netherland
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • South Korea
  • India
  • New Zealand
  • Singapore
  • Thailand
  • Vietnam
  • Rest of APAC
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of MEA

Key Players Analysis

The Pharma Excipients Market is highly competitive, with innovation and growing demand for advanced drug formulations driving growth. Key players such as Ashland Global Holdings, Croda International, and BASF SE are leading advancements in the industry. Ashland specializes in cellulose derivatives and controlled-release systems, which improve drug solubility. Croda focuses on sustainable solutions like surfactants and lipids, tailored for oral and topical applications. Meanwhile, BASF offers a broad portfolio of excipients, including solubilizers and binders, supporting extended-release and transdermal drug delivery systems.

Lubrizol Corporation and Evonik Industries AG also hold significant shares in the excipient market. Lubrizol excels in bioadhesive polymers and emulsifiers, with Carbopol® polymers widely used in drug formulations. The company consistently explores innovative solutions to address complex drug needs. Evonik specializes in EUDRAGIT® polymers, known for controlled-release drug delivery. The company emphasizes customer-focused solutions and invests in technologies to meet pharmaceutical industry demands. Both companies demonstrate strong R&D capabilities and global operations.

Other market players include regional and local manufacturers offering cost-effective solutions. These smaller companies collaborate with pharmaceutical firms to address specific needs. Strategies such as product launches, acquisitions, and partnerships further enhance market dynamics. The leading players collectively focus on sustainability, advanced excipient technologies, and expanding their portfolios. These efforts cater to the evolving requirements of drug formulations, making the market highly dynamic and growth-oriented.

Market Key Players

• Ashland Global Holdings
• Croda International
• BASF SE
• Lubrizol Corporation
• Evonik Industries AG
• Associated British Foods
• The Dow Chemical Company
• FMC Corporation
• Evonik Industries
• Roquette
• Colorcon Inc.

Recent Developments

• In September 2024: Evonik inaugurated a new spray drying facility at its Darmstadt site to produce EUDRAGIT® polymers, which are functional excipients for oral drug delivery. This investment, amounting to a double-digit million-euro figure, aims to meet the growing demand for these excipients. The facility operates using green electricity and steam from local waste incineration, resulting in annual savings of over 1,000 metric tons of CO₂ equivalents.
• In February 2024: ABF successfully launched its inaugural public bond, raising £400 million with a 2.5% interest rate due in 2034. This move diversified the Group’s funding sources and extended the duration of its borrowings, supporting ongoing investments across its business sectors, including pharmaceutical excipients.

Report Scope