[190 Pages Report] The Biopharmaceutical Excipients Market size was estimated at USD 2.29 billion in 2023 and expected to reach USD 2.53 billion in 2024, at a CAGR 10.75% to reach USD 4.70 billion by 2030.
Biopharmaceutical excipients are substances other than therapeutic molecules that are included in a biopharmaceutical formulation to aid in the production, stability, usability, and delivery of the drug. Biopharmaceutical excipients play a pivotal role in drug formulation. Their applications span diverse categories, such as binders, fillers, diluents, disintegrants, and stabilizers. Rising demand for advanced and functional biopharmaceutical drug formulations and increasing need for large-molecule development are driving the adoption of biopharmaceutical excipients. In addition, rising investment in drug development is boosting the utilization of biopharmaceutical excipients. However, the compatibility issues of biopharmaceutical formulations with active pharmaceutical ingredients pose considerable challenges. Furthermore, the continuous development of biologics and biosimilars leads to an increased need for compatible excipients. Technological advancements in extended-release formulations and the exploration of alternative routes of administration provide significant potential for market expansion.
Product: Carbohydrates are prominent excipients used in pharmaceutical formulations for formulation stability and patient compliance
Carbohydrates are a common class of excipients used in pharmaceutical formulations for various purposes, including bulking agents, fillers, and stabilizers, and to improve the shelf life of biopharmaceuticals. Dextrose is a simple sugar extracted from corn and is widely used as an energy source in many biological systems. In the context of biopharmaceutical excipients, dextrose serves multiple purposes. It acts as a tonicity-adjusting agent, isotonicity contributor, and a carbohydrate source in parenteral nutrition. Starch is a polysaccharide extracted from various sources, such as corn, potatoes, and rice. It is commonly used in pharmaceutical formulations as a binder, disintegrant, and filler. The biodegradability and non-toxic nature of starch make it a favorable choice for oral drug delivery systems. Sucrose is a disaccharide constituted of glucose and fructose. In the pharmaceutical industry, sucrose is used as a bulking agent, sweetener, and stabilizer. Its inclusion in lyophilized (freeze-dried) products, particularly vaccines and biologics, is crucial as it helps preserve the structure of proteins and other biological molecules during the drying process. Polyols are critical in biopharmaceuticals where moisture control is essential. Mannitol is a polyhydric alcohol that is frequently included in pharmaceutical products as a bulking agent and diluent. Its particular merit lies in its inert nature, which renders it suitable for use where minimal interactions with active pharmaceutical ingredients (APIs) are desired. Sorbitol is another widely used polyol excipient, appreciated for its sweetening properties and humectant capabilities. It plays various roles in pharmaceutical formulations, including acting as a non-cariogenic sweetener for oral liquid medications and chewable tablets and a plasticizer and stabilizer in gels and films. Solubilizers and surfactants play a major role in increasing the solubility of APIs and in forming stable emulsions. Esters are a category of excipients that serve as effective solubilizers by enhancing the solubility of poorly soluble drugs. These chemical compounds form through the reaction between an acid and an alcohol. Esters in the biopharmaceutical sector are often derived from fatty acids and are utilized for their emulsifying, lubricating, and solubilizing abilities. Triglycerides, which are composed of glycerol esterified with three fatty acid chains, represent another essential class of solubilizers and surfactants. They are widely utilized as safe and inert carriers for lipophilic drugs in oral and injectable formulations. Specialty excipients are developed to meet specific needs in drug formulations. They include products such as cryoprotectants, sustained-release matrices, enteric coating systems, and super disintegrants.
Function: Increasing utilization of preservatives in biologic formulation for improved stability
Binders are critical excipients used to provide cohesiveness to the formulation, allowing various powder particles to stick together and form granules and tablets. Binders are vital in the manufacturing of solid dosage forms. Pharmaceutical binders must be non-toxic, compatible with other formulation ingredients, and should not alter the bioavailability of the drug. Coatings are applied to tablets, capsules, and other oral dosage forms to shield the drug substance from external factors, improve patient compliance by masking unpleasant tastes, and provide modified and delayed drug release. Materials used for coatings include polymers, such as polyvinyl alcohol (PVA), and plasticizers, such as triacetin. Disintegrants are substances that promote the breakup of tablets in the gastrointestinal tract, aiding faster drug release and absorption. Common disintegrants include croscarmellose sodium, sodium starch glycolate, and crospovidone. Lubricants such as magnesium stearate are used to prevent ingredients from clumping together and adhering to the equipment during tablet production. Glidants, such as colloidal silica, improve the flow properties of the powder mix. Fillers are inert substances that increase the bulk of a formulation, enabling accurate dosing for APIs with low active doses. Fillers chosen must not react with the API and alter the drug’s pharmacokinetic profile. Preservatives in pharmaceuticals prevent the growth of microorganisms, which could potentially contaminate the product and cause harm to the patient. These include parabens, benzalkonium chloride, and phenol derivatives.
Application: Growing significance of biopharmaceutical excipients in advanced delivery systems for control drug release
Advanced delivery systems refer to sophisticated technologies designed to precisely control drug release, target specific areas of the body, and enhance the absorption of biologically active molecules. These systems may include liposomes, microspheres, and nanoparticles, which require specialized excipients to ensure stability and functionality. Biocompatibility and the ability to interact favorably with biological barriers are significant considerations for excipients within these systems. Oral administration is the most preferred and convenient route for drug delivery. Excipients used in oral formulations aim to aid in tablet binding, disintegration, and taste masking and to ensure the stability of the drug during its shelf life. Parenteral delivery refers to the administration of drugs bypassing the gastrointestinal tract, primarily through intramuscular, intravenous, and subcutaneous injections. Excipients for parenteral formulations need to be of the highest purity and sterility, as they can directly affect bioavailability and compatibility with the body. The topical application includes drugs administered to the skin and mucous membranes. Key characteristics of topical excipients include non-irritancy, compatibility with APIs and skin, and the ability to deliver the drug effectively through the dermal layers.
Regional Insights
In the Americas, the United States stands as a dominant player within the biopharmaceutical excipients market due to a robust pharmaceutical industry, significant investment in R&D, and a steady number of FDA approvals. Canada contributes to regional demand, and both countries exhibit a high interest in novel, multifunctional excipients that enhance drug delivery and stability. European Union (EU) countries possess a well-established pharmaceutical sector with stringent regulatory standards. Consumer need is driven by the production of biosimilars and biologics that demand high-quality ingredients. Ongoing investments by the European Union in research and innovation programs indicate a continued commitment to excipient development, including potential patent applications that aim at improving the performance and safety of biopharmaceuticals. In the APAC region, the focus is on the innovation and development of new excipients and a strong government push for upgrading the pharmaceutical industry. In India, a hub for generic drug production, the excipient demand aligns with cost efficiency and compliance with international standards. Across the Asia Pacific, diverse customer needs steer the demand for specific excipients, which are expected to fuel market growth.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Biopharmaceutical Excipients Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis 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: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Biopharmaceutical Excipients Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. 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 this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Biopharmaceutical Excipients Market, highlighting leading vendors and their innovative profiles. These include ABITEC Corporation, Actylis, Ashland Global Holdings Inc., BASF SE, Clariant International Ltd., Colorcon, Inc., Croda International PLC, DFE Pharma GmbH & Co KG, Eastman Chemical Company, Evonik Industries AG, Fuji Chemical Industries Co., Ltd., IMCD N.V., Innophos Holdings, Inc., J. Rettenmaier & S?hne GmbH + Co KG, Meggle Group GmbH, Merck KGaA, Roquette Fr?res S.A., Sigachi Industries Limited, Spectrum Laboratory Products, Inc., SPI Pharma, Inc., The Dow Chemical Company, The Lubrizol Corporation, VWR International, LLC by Avantor, and Wacker Chemie AG.
Market Segmentation & Coverage
This research report categorizes the Biopharmaceutical Excipients Market to forecast the revenues and analyze trends in each of the following sub-markets:
- Product
- Carbohydrates
- Dextrose
- Starch
- Sucrose
- Polyols
- Mannitol
- Sorbitol
- Solubilizers & Surfactants/Emulsifiers
- Esters
- Triglycerides
- Specialty Excipients
- Carbohydrates
- Function
- Binders
- Coatings
- Disintegrants
- Lubricants & glidants
- Pharmaceutical Fillers
- Preservatives
- Application
- Advanced Delivery System
- Oral
- Parenteral
- Topical
- 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
The report offers valuable insights on the following aspects:
- Market Penetration: It presents comprehensive information on the market provided by key players.
- Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
- Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
- Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
- Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
The report addresses key questions such as:
- What is the market size and forecast of the Biopharmaceutical Excipients Market?
- Which products, segments, applications, and areas should one consider investing in over the forecast period in the Biopharmaceutical Excipients Market?
- What are the technology trends and regulatory frameworks in the Biopharmaceutical Excipients Market?
- What is the market share of the leading vendors in the Biopharmaceutical Excipients Market?
- Which modes and strategic moves are suitable for entering the Biopharmaceutical Excipients Market?
US $
Euro €
GBP £
