The global pharmaceutical excipients market size was accounted for USD 8.37 billion in 2023 and it is projected to increase over USD 14.72 billion by 2033 with a CAGR of 5.81% from 2024 to 2033.
The global pharmaceutical excipients market size was accounted for USD 8.37 billion in 2023 and it is projected to increase over USD 14.72 billion by 2033 with a CAGR of 5.81% from 2024 to 2033.
Pharmaceutical Excipients Market Overview
Pharmaceutical excipients are inert substances used alongside active pharmaceutical ingredients (APIs) in drug formulations. They serve various purposes such as enhancing drug stability, solubility, and bioavailability, as well as facilitating drug delivery and improving patient acceptability. Excipients can be categorized into various types, including binders, fillers, disintegrants, lubricants, preservatives, and coatings, among others.
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Their applications span across various pharmaceutical dosage forms including tablets, capsules, powders, creams, ointments, and parenteral formulations. In tablet manufacturing, excipients aid in binding the active ingredients into a cohesive mass and impart desired mechanical strength to the tablet. In liquid formulations, they help stabilize the active ingredients and maintain their shelf life. Excipients are also crucial in the development of novel drug delivery systems such as nanoparticles, liposomes, and microspheres, where they play a vital role in controlling drug release kinetics and targeting specific sites of action within the body.
Key Insights
- U.S. pharmaceutical excipients market size will reach around USD 5.06 billion by 2033 with a CAGR of 6.31% from 2024 to 2033.
- North America pharmaceutical excipients market size was valued at USD 3.15 billion in 2023 and it is expected to hit around USD 5.66 billion by 2033, registering a CAGR of 6.04% from 2024 to 2033.
- Europe pharmaceutical excipients market size is projected to be worth around USD 3.95 billion by 2033, registering a CAGR of 5.30% from 2024 to 2033.
- By Region, North America has generated highest revenue share of 38.32% in 2023.
- By Excipient Type, Lactose-based Excipients segment has captured 41.26% revenue share in 2023.
- By Functionality, Binders & Fillers has generated revenue share of 49.72% in 2023.
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Regional instances
The dominance of the pharmaceutical excipients market in North America can be attributed to several factors. Firstly, North America, particularly the United States, boasts a robust pharmaceutical industry characterized by significant research and development investments, advanced manufacturing capabilities, and a large market for both generic and branded drugs. This creates a high demand for pharmaceutical excipients to support the formulation and production of various drug products. Additionally, stringent regulatory standards enforced by agencies such as the U.S. Food and Drug Administration (FDA) necessitate the use of high-quality excipients, further driving market growth as manufacturers strive to comply with regulatory requirements.
North America benefits from a well-established infrastructure for pharmaceutical manufacturing and distribution, facilitating the efficient supply chain management of excipients. The region also hosts several key excipient manufacturers and suppliers, fostering competition and innovation within the market. Furthermore, the increasing prevalence of chronic diseases and the aging population in North America contribute to the growing demand for pharmaceuticals, consequently fuelling the demand for excipients.
Europe is emerging as a significant market for pharmaceutical excipients due to various factors. Europe possesses a strong pharmaceutical industry characterized by a high level of innovation, particularly in drug delivery technologies and formulation strategies. This fosters the demand for advanced excipients capable of enhancing drug performance and patient compliance. Additionally, Europe’s favourable regulatory environment and emphasis on patient safety drive the adoption of excipients that comply with stringent quality and safety standards, further bolstering market growth. The increasing focus on personalized medicine and the development of biopharmaceuticals in Europe necessitate specialized excipients tailored to meet the unique requirements of these therapeutic modalities. Additionally, partnerships and collaborations between European pharmaceutical companies and excipient manufacturers promote innovation and the development of novel excipient formulations, contributing to market expansion. Overall, Europe’s evolving pharmaceutical landscape, coupled with favourable regulatory trends and a focus on innovation, position it as an emerging market for pharmaceutical excipients.
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Report Highlights
By Product
In the pharmaceutical excipients market, the organic chemicals segment dominated the landscape by product type in 2023. This dominance can be attributed to their versatility and wide range of applications in drug formulations. Organic chemicals such as sugars, alcohols, polymers, and surfactants serve various functions including binding, solubilizing, and stabilizing active pharmaceutical ingredients (APIs). They are preferred for their compatibility with diverse drug compounds and their ability to meet stringent regulatory requirements. Additionally, advancements in organic chemistry and synthesis techniques continue to drive innovation, leading to the development of new and improved organic excipients for pharmaceutical applications.
By Formulation
In the pharmaceutical excipients market, the oral formulations segment dominates due to several reasons. Firstly, oral dosage forms such as tablets, capsules, and syrups are widely preferred by patients due to ease of administration and convenience. Consequently, there is a high demand for excipients used in oral formulations to enhance drug stability, solubility, and bioavailability. Additionally, oral drug delivery is a well-established and extensively researched area within the pharmaceutical industry, leading to continuous innovation in excipient formulations tailored for oral administration. Overall, the dominance of oral formulations reflects the importance of excipients in facilitating effective and patient-friendly drug delivery via the oral route.
Pharmaceutical Excipients Market (US$ Mn), By Functionality, 2020-2023
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By Functionalities
In the pharmaceutical excipients market, the segment fillers and diluents dominated which is primarily driven by their essential functionality in drug formulation. Fillers and diluents are widely used to increase the bulk volume of a tablet or capsule, facilitating uniform dosing and ensuring proper manufacturing processes. Additionally, they contribute to the mechanical properties of the dosage form, such as hardness and disintegration time. With the increasing demand for oral solid dosage forms and the need for cost-effective formulations, fillers and diluents continue to hold a significant share in the pharmaceutical excipients market.
Market dynamics
Driver
Technological advancements
The pharmaceutical excipients market is experiencing significant growth driven by technological advancements in drug delivery systems and formulation techniques. Innovations such as nanotechnology, lipid-based drug delivery, and 3D printing are revolutionizing drug development, creating a demand for excipients that can enhance drug solubility, stability, and bioavailability. Additionally, advancements in functional excipients, such as polymers and surfactants, are enabling controlled and targeted drug delivery, catering to the growing need for personalized medicine. These technological breakthroughs are propelling the pharmaceutical excipients market forward, offering new opportunities for excipient manufacturers and suppliers.
Restraint
Regulatory challenges
The pharmaceutical excipients market faces significant restraints due to stringent regulatory requirements imposed by health authorities worldwide. Compliance with complex and evolving regulations often entails substantial investments in research, testing, and documentation, increasing the cost of excipient development and manufacturing. Additionally, regulatory scrutiny regarding excipient safety, quality, and compatibility with active pharmaceutical ingredients (APIs) poses challenges for excipient manufacturers. Delays in regulatory approvals and the risk of non-compliance can impede market entry and expansion. Therefore, navigating the regulatory landscape remains a key restraint for the pharmaceutical excipients market, impacting growth prospects and innovation.
Opportunity
Expansion of biopharmaceuticals field
As the biopharmaceutical sector continues to flourish, fueled by advancements in biotechnology and increasing demand for personalized medicine, there lies a substantial opportunity for the pharmaceutical excipients market. Biopharmaceutical formulations often require specialized excipients to enhance stability, solubility, and delivery of complex biological molecules. Excipients tailored to meet the unique needs of biopharmaceuticals, such as stabilizers for proteins and enhancers for nucleic acid-based therapies, are in high demand. By innovating and developing excipients specifically designed for biopharmaceutical applications, manufacturers can capitalize on this growing market segment and drive further expansion in the pharmaceutical excipients industry.
Recent Advancements
- In October 2023, Clariant introduced VitiPure® excipients at CPHI Barcelona, addressing API delivery challenges. These additions expand Clariant Health Care’s portfolio, offering effective carrier systems for oral, topical, and parenteral applications. With a focus on formulation flexibility, Clariant emerges as a one-stop shop for excipients, catering from standard to highly purified grades.
- In January 2023, Roquette introduced three new excipient grades at CPHI Barcelona, including LYCATAB CT-LM partially pregelatinized starch, MICROCEL 103 SD, and MICROCEL 113 SD microcrystalline cellulose. These moisture protective solutions aim to enhance drug stability in formulations with moisture sensitive active ingredients, offering flexibility and innovation for pharmaceutical and nutraceutical manufacturers.
Market Key Players
- Ashland Global Holdings
- BASF SE
- DuPont
- Roquette Feres
- Evonik Industries AG
- Associated British Foods
- Archer Daniels Midland Company
- Lubrizol Corporation
- Croda International
- Kerry Group
Market Segmentation:
By Functionality
- Fillers and Diluents
- Suspending and Viscosity Agents
- Coating Agents
- Binders
- Disintegrants
- Colorants
- Lubricants and Glidants
- Preservatives
- Emulsifying Agents
- Flavoring Agents and Sweeteners
- Other Functionalities
By Formulations
- Topical Formulations
- Oral Formulations
- Parenteral Formulations
- Other Formulations
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