Biopharmaceutical Excipients Market by Product (Carbohydrates, Polyols, Solubilizers & Surfactants/Emulsifiers), Function (Binders, Coatings, Disintegrants), Application - Global Forecast 2024-2030
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.
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.
Market Insights
Market Dynamics
The market dynamics represent an ever-changing landscape of the Biopharmaceutical Excipients 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 Demand for Advanced and Functional Biopharmaceutical Drug Formulations
Increasing Need for Large-Molecule Development
Increasing Development of Biosimilars
Increasing Demand for Hormone and Gene Therapy
Bulk Vaccine Production Worldwide
Market Restraints
High Price of Biopharmaceutical Excipients
Market Opportunities
Emerging Trends of Outsourcing for the Production of Biologics
Substantial Rise in Need of Functional Excipients
Developments in Recombinant DNA Technologies
Market Challenges
Manufacturing Complexities and Contamination Issues of Biopharmaceutical Excipients
Time Consuming Biopharmaceutical Clinical Trials
Market Segmentation Analysis
Product: Carbohydrates are prominent excipients used in pharmaceutical formulations for formulation stability and patient compliance
Function: Increasing utilization of preservatives in biologic formulation for improved stability
Application: Growing significance of biopharmaceutical excipients in advanced delivery systems for control drug release
Market Disruption Analysis
Porter’s Five Forces Analysis
Value Chain & Critical Path Analysis
Pricing Analysis
Technology Analysis
Patent Analysis
Trade Analysis
Regulatory Framework Analysis
FPNV Positioning Matrix
The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Biopharmaceutical Excipients 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).
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 Biopharmaceutical Excipients 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.
Recent Developments
Roquette launches three moisture-protecting ingredients for nutraceuticals
Roquette has expanded its portfolio of biopharmaceutical excipients with the introduction of three new grades specifically tailored to enhance the stability of moisture-sensitive active pharmaceutical and nutraceutical ingredients. The newly unveiled grades are the partially pregelatinized starch Lycatab CT-LM and two microcrystalline cellulose variants, Microcel 103 SD and Microcel 113 SD, which provide an unparalleled combination of stabilizing properties and moisture protection.
Croda Pharma Breaks Ground on Excipients Manufacturing Facility
Croda Pharma has initiated the construction of an advanced manufacturing facility in Lamar, Pennsylvania, focused on producing advanced biopharmaceutical excipients crucial for cutting-edge drug delivery systems. With a footprint of 23,680 square feet, this facility is poised to significantly bolster the production of ingredients vital for mRNA vaccines, gene therapies, and innovative cancer treatments, fulfilling an emerging demand in therapeutic modalities.
Strategy Analysis & Recommendation
The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Biopharmaceutical Excipients Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.
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 & Söhne GmbH + Co KG, Meggle Group GmbH, Merck KGaA, Roquette Frères 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
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
Please Note: PDF & Excel + Online Access - 1 Year
1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Market Dynamics
5.1.1. Drivers
5.1.1.1. Rising Demand for Advanced and Functional Biopharmaceutical Drug Formulations
5.1.1.2. Increasing Need for Large-Molecule Development
5.1.1.3. Increasing Development of Biosimilars
5.1.1.4. Increasing Demand for Hormone and Gene Therapy
5.1.1.5. Bulk Vaccine Production Worldwide
5.1.2. Restraints
5.1.2.1. High Price of Biopharmaceutical Excipients
5.1.3. Opportunities
5.1.3.1. Emerging Trends of Outsourcing for the Production of Biologics
5.1.3.2. Substantial Rise in Need of Functional Excipients
5.1.3.3. Developments in Recombinant DNA Technologies
5.1.4. Challenges
5.1.4.1. Manufacturing Complexities and Contamination Issues of Biopharmaceutical Excipients
5.1.4.2. Time Consuming Biopharmaceutical Clinical Trials
5.2. Market Segmentation Analysis
5.2.1. Product: Carbohydrates are prominent excipients used in pharmaceutical formulations for formulation stability and patient compliance
5.2.2. Function: Increasing utilization of preservatives in biologic formulation for improved stability
5.2.3. Application: Growing significance of biopharmaceutical excipients in advanced delivery systems for control drug release
5.3. Market Trend Analysis
5.4. Cumulative Impact of Russia-Ukraine Conflict
5.5. Cumulative Impact of High Inflation
5.6. Porter’s Five Forces Analysis
5.6.1. Threat of New Entrants
5.6.2. Threat of Substitutes
5.6.3. Bargaining Power of Customers
5.6.4. Bargaining Power of Suppliers
5.6.5. Industry Rivalry
5.7. Value Chain & Critical Path Analysis
5.8. Regulatory Framework Analysis
5.9. Client Customization
6. Biopharmaceutical Excipients Market, by Product
6.1. Introduction
6.2. Carbohydrates
6.3. Polyols
6.4. Solubilizers & Surfactants/Emulsifiers
6.5. Specialty Excipients
7. Biopharmaceutical Excipients Market, by Function
7.1. Introduction
7.2. Binders
7.3. Coatings
7.4. Disintegrants
7.5. Lubricants & glidants
7.6. Pharmaceutical Fillers
7.7. Preservatives
8. Biopharmaceutical Excipients Market, by Application