[197 Pages Report] The Pharmaceutical Excipient Market size was estimated at USD 8.62 billion in 2023 and expected to reach USD 9.22 billion in 2024, at a CAGR 7.62% to reach USD 14.42 billion by 2030.
Pharmaceutical excipients are added to pharmaceutical products for various purposes, including improving the manufacturing process, enhancing stability, ensuring the bioavailability of the drug, and facilitating the administration and dosing of the final product. Excipients are essentially inactive components that support the overall formulation and delivery of the active ingredient. The market for pharmaceutical excipients is primarily driven by the increasing demand for pharmaceutical products due to the rising global population and chronic diseases. Technological advancements in drug formulation and developing novel excipients also contribute to market growth. Furthermore, the expansion of the generic pharmaceuticals sector and the trend toward self-medication for minor health issues provide a strong impetus for the excipient market. However, stringent regulatory requirements leading to lengthy approval processes can impede the introduction of new excipients, and the high cost associated with developing and producing advanced excipients hamper its market growth. The shift toward multifunctional and co-processed excipients and ongoing advancements and research activities for developing biobased excipients opens significant opportunities for market players, offering benefits such as improved product performance and production efficiency.
The Americas region has a significant landscape in the pharmaceutical excipient market as countries exhibit a high demand for excipients, directed by stringent regulatory environments, advanced healthcare systems, and strong intellectual property frameworks. Having a significant landscape in pharmaceutical innovation, the countries in the region strongly focus on advanced and novel excipients for drug formulations. The EMEA region, which encompasses Europe, the Middle East, and Africa, shows diverse market characteristics. The stringent regulatory environment in the European Union drives the demand for compliant and high-quality excipients, whereas markets in the Middle East and Africa are burgeoning, with increasing investment in pharmaceutical manufacturing infrastructure and regulation. The EU market demonstrates a high need for cutting-edge pharmaceutical excipients that cater to complex drugs and sophisticated drug delivery systems. Moreover, the EU's investment in biopharmaceuticals and biosimilars is complemented by the growing demand for novel excipients in these areas. Countries in the Asia-Pacific region are key players in the pharmaceutical excipient sector experiencing substantial growth due to a large patient pool, increasing healthcare expenditures, and supportive government initiatives. The region focuses on innovating high-functional excipients with ongoing research and development, reducing its historical reliance on imports.
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Market Dynamics
The market dynamics represent an ever-changing landscape of the Pharmaceutical Excipient Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.
- Market Drivers
- Rising incidence of cancer and other chronic and infectious diseases worldwide
- Growth of the pharmaceuticals industry coupled with significant demand for generics & orphan drugs
- Significant emphasis on the production of multifunctional excipients
- Market Restraints
- High cost associated with the production of advanced excipient
- Market Opportunities
- Technological advancements in nanotechnology for excipients
- Ongoing research and development of excipients with numerous properties (Biobased)
- Market Challenges
- Increasing regulatory stringency and issues regarding the compatibility of excipients
Market Segmentation Analysis
Type: Potential demand and utilization of organic excipients
Inorganic excipients are substances not of organic origin and are included in pharmaceutical formulations to serve various functions. These excipients include calcium carbonate, widely used as a filler or diluent, and a source of calcium in pharmaceutical tablets. It is favored for its high purity, non-toxic nature, and cost-effectiveness. Calcium phosphate excipients, including dicalcium phosphate and tricalcium phosphate, are utilized for their excellent compressibility and flow properties, making them ideal for tableting operations. Calcium sulfate is used in pharmaceuticals as a tablet excipient and a co-processed excipient to improve the mechanical strength of tablets. Halites, especially sodium chloride, create isotonic solutions and are used as stabilizers and taste-masking agents in oral medications. In pharmaceutical formulations, metal oxides such as magnesium and zinc oxide function as pH adjusters, colorants, and nutrient supplements. Organic excipients refer to substances of organic (carbon-based) origin that are included in pharmaceutical formulations. Carbohydrates are fillers, binders, and stabilizers in oral solid dose formulations. Cellulose derivatives, including microcrystalline cellulose, are prolific in the excipient market, valued for their binding, disintegrating, and film-forming properties. Starch and its derivatives are used as disintegrants, binders, and fillers in tablets, providing good mechanical properties to pharmaceutical forms. Sugars such as sucrose are often used in syrups and lozenges as sweeteners and crystalline bases for water-soluble drugs. Fatty alcohols are non-ionic surfactants and emollients in topical formulations, aiding in skin penetration of APIs. Glycerin is used as a solvent, humectant, and preservative in various pharmaceutical preparations, including oral, topical, and parenteral formulations. Mineral stearates such as magnesium are predominantly used as lubricants in tablet manufacture, ensuring the efficient running of tablet presses. In tablet formulations, petrochemicals such as acrylic polymers, including polymethyl methacrylate, serve as film coatings, binders, and sustained-release matrix formers. Glycols such as propylene glycol are versatile solvents for APIs and are used in many pharmaceutical preparations, including injectables, topical formulations, and syrups. Mineral hydrocarbons such as paraffin are used for their lubricating properties in capsules and as bases in various ointments and creams. Furthermore, povidones are used as binders in tablet formulations, as solubilizers in liquids, and as bioadhesives for buccal applications. Proteins such as gelatin and collagen are used to form drug capsules and as film-forming agents. Their biodegradability and compatibility with the human body make them vital for specific pharmaceutical applications.
Formulation: Significant demand for oral formulations owing to its convenient drug delivery
Oral formulations are dosage forms administered through the oral route, one of the most convenient and commonly used drug delivery methods. This segment includes a variety of excipients designed to aid the active pharmaceutical ingredient's stability, release, and bioavailability (API). Hard gelatin capsules are solid dosage forms in which one or more drug substances and excipients are enclosed within a small shell. They also offer advantages such as dose precision and good stability. Soft gelatin capsules (soft gels) are an oral dosage form for medicine similar to capsules; however, they consist of a gelatin-based shell surrounding a liquid fill. They are favored for their ease of swallowing and ability to enhance the bioavailability of poorly soluble APIs. Liquid formulations include solutions, suspensions, and emulsions that are taken orally. The choice of excipients in these formulations is critical to ensure stability, palatability, and proper absorption of the API. Tablets are a popular oral dosage form, and the excipient market for tablets remains robust. The ingredients used in tablet manufacturing bind the compound, aid in disintegration, and enhance stability. Parenteral formulations are sterile preparations intended to be administered directly into the body tissues. Topical formulations are applied to the skin or mucous membranes to deliver active ingredients directly to the site of action or systemic circulation.
Porter’s Five Forces Analysis
The porter's five forces analysis offers a simple and powerful tool for understanding, identifying, and analyzing the position, situation, and power of the businesses in the Pharmaceutical Excipient Market. This model is helpful for companies to understand the strength of their current competitive position and the position they are considering repositioning into. With a clear understanding of where power lies, businesses can take advantage of a situation of strength, improve weaknesses, and avoid taking wrong steps. The tool identifies whether new products, services, or companies have the potential to be profitable. In addition, it can be very informative when used to understand the balance of power in exceptional use cases.
Value Chain & Critical Path Analysis
The value chain of the Pharmaceutical Excipient Market encompasses all intermediate value addition activities, including raw materials used, product inception, and final delivery, aiding in identifying competitive advantages and improvement areas. Critical path analysis of thePharmaceutical Excipient Market identifies task sequences crucial for timely project completion, aiding resource allocation and bottleneck identification. Value chain and critical path analysis methods optimize efficiency, improve quality, enhance competitiveness, and increase profitability. Value chain analysis targets production inefficiencies, and critical path analysis ensures project timeliness. These analyses facilitate businesses in making informed decisions, responding to market demands swiftly, and achieving sustainable growth by optimizing operations and maximizing resource utilization.
Regulatory Framework Analysis
The regulatory framework analysis for the Pharmaceutical Excipient Market is essential for ensuring legal compliance, managing risks, shaping business strategies, fostering innovation, protecting consumers, accessing markets, maintaining reputation, and managing stakeholder relations. Regulatory frameworks shape business strategies and expansion initiatives, guiding informed decision-making processes. Furthermore, this analysis uncovers avenues for innovation within existing regulations or by advocating for regulatory changes to foster innovation.
Market Share Analysis
The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Pharmaceutical Excipient Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
FPNV Positioning Matrix
The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Pharmaceutical Excipient Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Recent Developments
Roquette Introduces New Advancement in Moisture Protection
Roquette Pharma launched innovative excipient solutions specifically designed to enhance moisture protection. These advanced formulations cater to the growing need for high-performance excipients capable of extending the shelf-life and stability of moisture-sensitive drugs, responding to a critical challenge within the sector. By leveraging cutting-edge technology, Roquette Pharma is poised to set a new standard in excipient functionality, further solidifying its position in the pharmaceutical excipient market. [Published On: October 25, 2023]
Clariant Launches New Range Of Excipients To Improve Stability And Solubility of Apis at CPHI Barcelona
Clariant announced the introduction of an innovative portfolio of pharmaceutical experiments, unveiled at CPHI Barcelona. These cutting-edge products are formulated to enhance the stability and solubility of active pharmaceutical ingredients (APIs). The new range addresses critical formulation challenges faced by pharmaceutical companies, enabling easier administration and improved patient compliance. [Published On: October 18, 2023]
BASF, IFF Partner on Virtual Pharma Assistant Platform ZoomLab
BASF and International Flavors & Fragrances (IFF) have partnered to create an innovative virtual pharma assistant platform designed to enhance the functionality and application of pharmaceutical excipients. This digital tool aims to streamline the formulation process by providing real-time, data-driven insights and guidance on selecting and combining excipients. [Published On: August 11, 2023]
Key Company Profiles
The report delves into recent significant developments in the Pharmaceutical Excipient Market, highlighting leading vendors and their innovative profiles. These include GATTEFOSSE SAS, SPI Pharma, Inc., Colorcon Inc., Fuji Chemical Industries Co., Ltd., Ashland Inc., BIOGRUND GmbH, DuPont de Nemours, Inc., Omya International AG, Mallinckrodt plc, Innophos Holdings, Inc., Kerry Group P.L.C., Resonac Holdings Corporation, Shin-Etsu Chemical Co., Ltd., Asahi Kasei Corporation, NOF Corporation, International Flavors & Fragrances Inc., BASF SE, DFE Pharma GmbH & Co KG, Archer Daniels Midland Company, Peter Greven GmbH & Co. KG, Darling Ingredients, Inc., Lipoid GmbH, R.T. Vanderbilt Holding Company, Inc., JRS PHARMA GmbH + Co. KG, Lubrizol Corporation, Nagase & Co., Ltd., Aceto Corp., ABITEC Corporation, Merck KGaA, MEGGLE GmbH & Co. KG, ARMOR PROTEINES S.A.S., Thermo Fisher Scientific Inc., Roquette Frères S.A., Croda International Plc, Clariant AG, Corel Pharma Chem Private Limited, Evonik Industries AG, Nipon Soda Co., Ltd., L’AIR LIQUIDE S.A., Chemische Fabrik Budenheim KG, and Solvay S.A..
Market Segmentation & Coverage
This research report categorizes the Pharmaceutical Excipient Market to forecast the revenues and analyze trends in each of the following sub-markets:
- Type
- Inorganic
- Calcium Carbonate
- Calcium Phosphate
- Calcium Sulfate
- Halites
- Metal Oxides
- Organic
- Carbohydrates
- Cellulose
- Starch
- Sugars
- Oleochemicals
- Fatty Alcohols
- Glycerin
- Mineral Stearates
- Petrochemicals
- Acrylic Polymers
- Glycols
- Mineral Hydrocarbons
- Povidones
- Proteins
- Carbohydrates
- Inorganic
- Formulation
- Oral Formulations
- Hard Gelatin Capsules
- Liquid Formulations
- Soft Gelatin Capsules
- Tablets
- Parenteral Formulations
- Topical Formulations
- Oral Formulations
- Function
- Binders
- Coating Agents
- Colorants
- Disintegrants
- Emulsifying Agents
- Fillers & Diluents
- Flavoring Agents & Sweeteners
- Lubricants & Glidants
- Preservatives
- Suspending & Viscosity Agents
- Region
- Americas
- Argentina
- Brazil
- Canada
- Mexico
- United States
- California
- Florida
- Illinois
- New York
- Ohio
- Pennsylvania
- Texas
- Asia-Pacific
- Australia
- China
- India
- Indonesia
- Japan
- Malaysia
- Philippines
- Singapore
- South Korea
- Taiwan
- Thailand
- Vietnam
- Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom
- Americas
This research report offers invaluable insights into various crucial aspects of the Pharmaceutical Excipient Market:
- Market Penetration: This section thoroughly overviews the current market landscape, incorporating detailed data from key industry players.
- Market Development: The report examines potential growth prospects in emerging markets and assesses expansion opportunities in mature segments.
- Market Diversification: This includes detailed information on recent product launches, untapped geographic regions, recent industry developments, and strategic investments.
- Competitive Assessment & Intelligence: An in-depth analysis of the competitive landscape is conducted, covering market share, strategic approaches, product range, certifications, regulatory approvals, patent analysis, technology developments, and advancements in the manufacturing capabilities of leading market players.
- Product Development & Innovation: This section offers insights into upcoming technologies, research and development efforts, and notable advancements in product innovation.
Additionally, the report addresses key questions to assist stakeholders in making informed decisions:
- What is the current market size and projected growth?
- Which products, segments, applications, and regions offer promising investment opportunities?
- What are the prevailing technology trends and regulatory frameworks?
- What is the market share and positioning of the leading vendors?
- What revenue sources and strategic opportunities do vendors in the market consider when deciding to enter or exit?
- Preface
- Research Methodology
- Executive Summary
- Market Overview
- Market Insights
- Pharmaceutical Excipient Market, by Type
- Pharmaceutical Excipient Market, by Formulation
- Pharmaceutical Excipient Market, by Function
- Americas Pharmaceutical Excipient Market
- Asia-Pacific Pharmaceutical Excipient Market
- Europe, Middle East & Africa Pharmaceutical Excipient Market
- Competitive Landscape
- List of Figures [Total: 21]
- List of Tables [Total: 849]
- List of Companies Mentioned [Total: 41]
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