Pharmaceutical Excipients Market Size, Share, Growth, Report 2024 to 2033

Pharmaceutical Excipients Market Size and Growth 2024 to 2033

The global pharmaceutical excipients market size was valued at USD 9.24 billion in 2023 and is expected to be worth around USD 14.96 billion by 2033, growing at a compound annual growth rate (CAGR) of 4.93% from 2024 to 2033.

Pharmaceutical excipients are not active substances but are, instead, blended with the active ingredients of drugs to facilitate formulation and performance. Although some of them offer no therapeutic benefits, excipients greatly assist in stabilizing formulations, enhancing bioavailability, and improving patient compliance. They enhance taste, texture, and shelf life. Important excipients are binders, fillers, disintegrants, lubricants, and preservatives, which assist with manufacturing and product uniformity. Besides, they are ideal for improving drug absorption and controlling the release of active ingredients into the systemic circulation.

Report Highlights

• North America region is leading the market, accounted revenue share of 39.21% in 2023.
• Europe has accounted revenue share of 28.15% in 2023.
• By type, the organic chemicals segment has accounted revenue share of 57% in 2023.
• By functionality, the fillers and diluents segment is poised to hit the highest revenue share in 2023.
• By formulation, the oral segment is expected to contribute the highest revenue share in 2023.

Pharmaceutical Excipients Market Growth Factors

• Rapid Growth in the Pharmaceutical Sector: The constant growing pharmaceutical sector directly translates itself into the growing demand for excipients, or indispensable components in drug formulation. With the continuous rollout of new drugs to tackle various health issues, this means more demand for innovation and ideation among excipients to enhance stability, bioavailability, and patient compliance driving the market growth and diversification.
• Increase in the Prevalence of Chronic Diseases: The rise in demand for medication driven by the increase in the prevalence of chronic diseases, including diabetes and cardiovascular disorders, also adds up to their relevance in the pharmaceutical excipients market as a prerequisite for the formulation of effective therapies. Manufacturers invest talents in the design of excipients to boost the performance and delivery of medications resting on those conditions.
• Increase in Generic Drug Production: The rise in generic drug production is of substantial effect on the excipients market. As generic formulations are a clone of branded medications, there is a growing demand for excipients for manufacturing, either cheaper or because of minor formulations, while ensuring quality. Such situations provide opportunities for manufacturers to continue their innovation and best practices to ensure that excipients are in compliance with regulatory standards in generic formulations.
• Heightened Focus on Innovative Drug Development: The recent increase in funding for R&D in medicine encourages innovative formulation of drugs. It compels excipient manufacturers to innovate formulations for highly sophisticated and evolved delivery mechanisms for ever-developing R&D activities. Hence, excipient manufacturers are now urged to innovate based on the changing needs in relation to R&D.

Pharmaceutical Excipients Market Trends

• The Rising Demand for Multifunctional Excipients: Growing demand for multifunctional excipients in the pharmaceutical sector and manufacturers is hastily moving toward multifunctional excipients intended to solve diverse functions, such as improvement in solubility and stability. Such excipients might reduce the number of components needed for a certain formulation, which produces drug formulations that are easier to manufacture and that perform better.
• Shift Toward Green: With safety becoming a focus in drug formulation, increased demand for green is coming for the excipient arena. Pharmaceutical companies do not want excipients to produce additional side effects, and thus they want to make sure the therapies produced are going to be safe for patients, especially sensitive subpopulations, such as children and the elderly.
• Heightened Patient-Centric Formulations: The patient-centric trend in drug development propagates the need for formulations that augment patient compliance and experience. Development of dosage forms with easy ways of administration such as fast-dissolving tablets, good-tasting liquid dosage forms will enhance treatment outcome and patient satisfaction.
• The Growing Popularity of Green and Sustainable Excipients: Environmentalism is making a significant mark on the pharmaceutical industry's transition to the use of green and sustainable excipients. Manufacturers are sourcing their material from renewable sources and minimizing the environmental impact of their products on users, hence remaining compliant with regulations and succumbing to consumers' desires for more environmentally safe solutions in pharmaceuticals.

Report Scope

Pharmaceuticals Excipients Market Dynamics

Drivers

The rising geriatric population drives the demand for pharmaceuticals

• Global population aging is playing an essential role in the constantly increasing demand for pharmaceuticals. The elderly population, usually with coexisting diseases, would demand polypharmacy treatments; this, in turn, necessitates a larger volume of excipients for use in drug formulation. This demographic shift means growth opportunities for excipients that are suited for management of chronic diseases and polypharmacy solutions.

Expansion in the production of generics

• One of the most significant market drivers for pharmaceutical excipients is the rising production of generic drugs. As generics gain a firm foothold due to their cost-benefit characteristics, there arises a concurrent demand for excipients that support these formulations. This change presents an opportunity for manufacturers to initiate drug design and optimize excipients for various applications.

Rising use of nanotechnology in drug formulations

• The transformation that nanotechnology creates in drug delivery systems, enhancing bioavailability and targeted delivery, further builds the scenario for demand for specialized excipients to cater to immense and numerous forms of nanotherapy, with further growth opportunities in excipient development.

Restraints

High-cost parentage of novel and specialized excipients

• The development and production of novel and specialized excipients is an expensive undertaking. These costs could, on their part, deter adoption, especially from small pharmaceutical companies, hence making the incorporation of advanced excipient solutions in standard formulations an arduous task that brings down overall market uptake.

Growing environmental concerns and sustainability hurdles

• More intense scrutiny with regard to environmental impact and sustainability in practice makes things difficult for expending manufacturers. They must navigate through arcane regulations and consumer demand for eco-friendly materials, which in some cases would require a significant investment through sustainable sources and particularly sustainable manufacturing processes.

Challenges

Challenges of Developing Excipients for Biologics

• The proposition of developable excipients, which would stabilize and properly administer these formally distinct medicinal products, is a complex task because of the special characteristics of biologics. This task, being tangled in a web of complexity, entails investigational and inventive research towards the development of these excipients to assure the safety and efficacy of any biologic formulation. Such complexities hinder effective profitability of operations in this segment.

Lack of Standardisation in Excipient Regulations Across Regions

• Different regions have varying standards of excipients regulation, making it challenging to comply with regulatory requirements. Such variability in the regulatory mechanisms becomes an obstacle for global marketers in their process development since it raises costs and limits the potential to leverage excipient innovations across diverse markets.

Pharmaceuticals excipients Market Segmental Analysis

Dosage Form Analysis

Based on dosage form, the global market is segmented into solid, semi-solid, and liquid. The solid segment has dominated the market with highest revenue share in 2023.

Solid: Solid forms, i.e. they will encapsulate, tablets, and powders, are some of the most used amongst various pharmaceutical applications. Solid formulations are also common and are the popular choice among marketers owing to the capability to alter their stability, handling, and ability to deliver a fixed dosage. In the solid state, the physical properties of the product formulation are very much supported by the addition of solid excipients, for instance, fillers, binders, and disintegrants. The growth is driven by a high volume of solid dosage forms due to the convenience and efficacy in delivery provided by the dosages of medicines in the treatment of chronic diseases.

Semi-solid: Semi-solid dosage forms, for example, creams, ointments, and gels, that are targeted generally for topical and transdermal applications, form vital components of the pharmaceutical industry. These aforementioned dosage forms require special excipients in order to achieve the required consistency, stability, and drug release qualities. Emulsifiers, thickeners, and preservatives include most excipients in this section. Growth in this market segment would be driven by an increasing demand for dermatological products and of localized therapy too, as sought by patients for more effective and highly bioavailable semi-solid formulations as deliverable.

Liquid: Liquid dosage forms, including solutions, suspensions, and emulsions, are essential for delivering medications, especially for patients with swallowing difficulties, such as children and the elderly. Liquid excipients play a vital role in stabilizing active pharmaceutical ingredients (APIs), enhancing solubility, and ensuring uniform distribution. This segment is experiencing growth due to the rising demand for liquid formulations in various therapeutic areas, including pediatrics and injectables, as well as the increasing trend towards personalized medicine that emphasizes patient-centric solutions

Application Analysis

Based on application, the global market is segmented into taste masking, stabilizers, modified-release, solubility & bioavailability enhancement, and others.

Taste Masking: Taste masking is a critical application of excipients, particularly for pediatric and geriatric formulations. Many APIs have unpleasant tastes, which can hinder patient compliance. Excipients such as sweeteners, flavoring agents, and coating materials are employed to mask these tastes, making medications more palatable. This application is vital for solid and liquid dosage forms, ensuring that patients, especially children, can ingest medications without resistance, ultimately improving adherence to treatment regimens.

Stabilizers: Stabilizers are essential excipients that enhance the physical and chemical stability of pharmaceutical formulations. They prevent degradation of APIs due to environmental factors like temperature, light, and humidity. Stabilizers, including antioxidants and preservatives, are crucial in both liquid and semi-solid forms. Their use ensures the shelf-life and efficacy of medications, thereby safeguarding patient safety. The demand for stabilizers is increasing as more complex formulations are developed, requiring advanced technologies to maintain product integrity over time.

Modified-Release: Modified-release formulations are designed to control the release rate of an API, improving therapeutic effectiveness while minimizing side effects. Excipients play a crucial role in achieving this goal through various mechanisms, such as coating and matrix formation. These formulations are particularly beneficial for chronic conditions requiring steady drug levels over extended periods. The rising prevalence of chronic diseases and the focus on patient compliance are driving demand for modified-release excipients, promoting innovations in formulation technologies.

Solubility & Bioavailability Enhancement: Many APIs face challenges related to solubility and bioavailability, impacting their therapeutic effectiveness. Excipients that enhance solubility, such as surfactants and solubilizers, are crucial for improving drug absorption in the body. This application is especially important for poorly soluble compounds, which are increasingly prevalent in drug development. The growing focus on developing new formulations with improved bioavailability is driving demand for excipients that facilitate enhanced drug release and absorption, ultimately leading to better patient outcomes.

Others: The Others category encompasses a variety of applications for excipients that do not fit into the primary segments. This includes functionalities such as fillers, lubricants, and anti-caking agents that enhance the manufacturing process and improve product quality. These excipients contribute to the overall performance and stability of pharmaceutical formulations, supporting a wide range of dosage forms. The diverse applications in this category indicate the versatility of excipients and their crucial role in optimizing pharmaceutical products to meet specific therapeutic needs.

Pharmaceutical Excipients Market Regional Analysis

Based on region, the global market is segmented into North AMerica, Europe, Asia-Pacific, Latin America and Middle East and Africa. The North America has accounted dominance in the market in 2023.

Why is North America leading the pharmaceutical excipients market?

The North America pharmaceutical excipients market size was valued at USD 3.62 billion in 2023 and is expected to reach around USD 5.87 billion by 2033. North America is a leading market for pharmaceutical excipients, driven by the strong presence of pharmaceutical companies, advanced healthcare infrastructure, and significant R&D investments. The United States dominates the region, with Canada also contributing to the market’s growth. The region’s mature pharmaceutical industry, coupled with increasing demand for innovative drug formulations, supports the demand for advanced excipients. Additionally, the rising prevalence of chronic diseases, an aging population, and the expansion of generic drug production fuel market growth. Regulatory frameworks like those from the FDA ensure high standards for excipient production, further enhancing the region’s market potential.

Europe Pharmaceutical Excipients Market Trends

The Europe pharmaceutical excipients market size was estimated at USD 2.60 billion in 2023 and is projected to hit around USD 4.21 billion by 2033. Europe is another key market for pharmaceutical excipients, with countries such as Germany, France, the United Kingdom, and Switzerland playing pivotal roles. The region benefits from its highly regulated pharmaceutical industry and a robust focus on quality and safety. Europe's pharmaceutical excipient market is supported by strong R&D initiatives, particularly in biologics and personalized medicine. The region's aging population and increasing demand for over-the-counter medications drive the use of innovative excipients. Additionally, environmental and sustainability concerns in countries like Germany and the Netherlands are pushing manufacturers to focus on eco-friendly excipients, further influencing market dynamics in Europe.

Why is Asia-Pacific fastest-growing regions for pharmaceutical excipients market?

The Asia-Pacific pharmaceutical excipients market size was accounted for USD 2.11 billion in 2023 and is predicted to surpass around USD 3.42 billion by 2033. The Asia-Pacific is one of the fastest-growing regions for pharmaceutical excipients, with countries like China, India, Japan, and South Korea leading market expansion. The region’s growth is fuelled by increasing pharmaceutical production, rising healthcare spending, and growing demand for generic drugs. China and India, in particular, have become global manufacturing hubs for excipients, driven by cost-effective production and favourable government initiatives. Japan and South Korea focus on advanced drug formulations and R&D, further enhancing the demand for specialized excipients. The region’s expanding middle-class population and increasing prevalence of chronic diseases also boost the pharmaceutical excipients market.

LAMEA Pharmaceutical Excipients Market Growth

The LAMEA pharmaceutical excipients market was valued at USD 0.91 billion in 2023 and is anticipated to reach around USD 1.47 billion by 2033. The LAMEA region represents a growing pharmaceutical excipients market, with Brazil, Mexico, and South Africa emerging as key contributors. In Latin America, rising healthcare access and government initiatives to improve pharmaceutical production are boosting the demand for excipients. Brazil and Mexico are leading in the production of generic drugs, increasing the demand for cost-effective excipients. In the Middle East, countries such as Saudi Arabia and the UAE are investing heavily in healthcare infrastructure, supporting market growth. In Africa, improving healthcare systems and rising pharmaceutical production in countries like South Africa are creating opportunities for the excipient market’s expansion.

Pharmaceutical Excipients Market Top Companies

• Roquette
• Colorcon, Inc
• Ashland Global Holdings
• Associated British Foods
• Roquette Feres
• Avantor Performance Materials, Inc.
• Croda International
• Archer Daniels Midland Company
• DuPont
• FMC Corporation
• Evonik Industries
• Lubrizol Corporation
• BASF SE
• Lubrizol Corporation
• Evonik Industries AG
• The Dow Chemical Company

The pharmaceutical excipients industry is dominated by a few central players, including Kerry Group plc., DFE Pharma, Cargill, Incorporated, Pfanstiehl, Colorcon, MEGGLE GmbH & Co. KG, Omya AG, Peter Greven GmbH & Co. KG, among others. These organizations are recognized for their innovative solutions and commitment to advancing Pharmaceutical Excipients through technology.

Continuous advancements in technology, sustainability initiatives, and the growing trend of personalized medicine are shaping the future of this market. As companies focus on developing high-quality excipients to meet regulatory standards and consumer demands, strategic partnerships and R&D investments will be crucial for competitive advantage.

CEO Statements

Harald Schwager – Deputy CEO of Evonik

“Darmstadt has been at the center of oral drug delivery innovation for five generations. That’s why it is with great pride that we begin a new chapter in EUDRAGIT history here. Our new facility enables our customers to develop oral drugs more efficiently and innovatively, improving the lives of more patients worldwide.”

Mark Schiller – CEO of IFF (International Flavors & Fragrances)

"We are excited to showcase our new innovations in excipients at CPHI 2024, especially our solutions aimed at nitrosamine mitigation. This reflects our commitment to supporting the pharmaceutical and biotech industries through advanced product development."

Giorgio O. Garofalo – CEO of Dow

"Our strategic initiatives in the excipients sector are designed to ensure that we are at the forefront of sustainability and innovation. We are committed to providing materials that enhance drug delivery and safety."

Recent Developments

Strategic acquisition highlights the dynamic advancements and collaborative efforts within the pharmaceutical excipients industry. Industry players are actively involved in various initiatives aimed at enhancing technological capabilities and manufacturing expertise. For instance, in February 2022, Kerry Group Plc., a global leader in taste and nutrition, made significant strides by acquiring c-LEcta, a biotechnology innovator focused on precision fermentation and optimized bioprocessing, along with Enmex, an established enzyme manufacturer in Mexico. These acquisitions not only expanded Kerry Group’s biotechnology portfolio but also contributed to revenue growth. Some notable examples of key developments in the market include:

• In February 2022, Kerry Group Plc., a global leader in taste and nutrition, announced two strategic biotechnology acquisitions that significantly enhanced its technological capabilities and manufacturing expertise. The company acquired c-LEcta, a leading biotechnology innovator specializing in precision fermentation, optimized bioprocessing, and bio-transformation, and Enmex, a well-established enzyme manufacturer based in Mexico. Enmex supplies bio-process solutions to the food, beverage, and animal nutrition sectors. These acquisitions have expanded Kerry Group’s biotechnology portfolio and boosted its revenue growth.
• In September 2022, DFE Pharma, a global leader in pharmaceutical and nutraceutical excipient solutions, inaugurated its "Closer to the Formulator" (C2F) Center of Excellence in Hyderabad, India. C2F assists pharmaceutical companies in accelerating the development process from concept to commercial product, showcasing DFE Pharma's progress in pharmaceutical development expertise.

Market Segmentation

By Dosage Form   

• Solid
• Semi-Solid
• Liquid

By Type

• Organic Chemicals
  
  • Oleochemicals
    
    • Fatty Alcohols
    • Mineral Stearates
    • Glycerin
    • Other
  • Carbohydrates
    
    • Sugars
      
      • Actual Sugars
      • Sugar Alcohols
      • Artificial Sweeteners
    • Cellulose
      
      • Microcrystalline cellulose
      • Cellulose ethers
      • Carboxymethyl cellulose (CMC) and croscarmellose sodium
      • Cellulose esters
    • Starch
      
      • Modified Starch
      • Dried Starch
      • Converted Starch
  • Petrochemicals
    
    • Glycols
    • Povidones
    • Mineral Hydrocarbons
    • Acrylic Polymers
    • Other
  • Proteins
  • Other
• Inorganic Chemicals
  
  • Calcium Phosphate
  • Metal Oxides
  • Halites
  • Calcium Carbonate
  • Calcium Sulphate
  • Others
• Other Chemicals

By Functionality

• Fillers and Diluents
• Coating Agents
• Colorants
• Binders
• Suspending and Viscosity Agents
• Disintegrants
• Emulsifying Agents
• Lubricants and Glidants
• Preservatives
• Flavoring Agents and Sweeteners
• Other Functionalities

By Formulation

• Oral Formulations
  
  • Tablets
  • Capsules
    
    • Hard-gelatin Capsules
    • Soft-gelatin Capsules
  • Liquid Formulations
  • Other
• Topical Formulations
• Parenteral Formulations
• Other

By Application

• Taste Masking
• Stabilizers
• Modified-Release
• Solubility & Bioavailability Enhancement
• Others

By End User

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

By Distribution Channel

• Direct Tender
• Retail Sales
• Others

By Region

• North America
• APAC
• Europe
• LAMEA