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THE GLOBAL BIOPHARMACEUTICAL EXCIPIENTS MARKET WAS VALUED AT USD 2.43 BILLION IN 2023 AND IS EXPECTED TO REACH USD 3.79 BILLION BY 2029, GROWING AT A CAGR OF 7.67% DURING THE FORECAST PERIOD.
The Biopharmaceutical Excipients Market Size, Share & Trend Analysis Report By
- Excipient: Bulking Agents, Solubilizers & Surfactants, Buffering & Tonicity Agents, and Others
- Biologics: Monoclonal Antibodies, Vaccines, and Others
- Scale of Operation: Commercial and Research
- Origin: Organic Excipients and Inorganic Excipients
- End-User: Pharma & Biotech Companies, CMOs & CDMOs, and Academic & Research Institutes
- Geography: North America, Europe, APAC, Latin America, and Middle East & Africa
Industry Analysis Report, Regional Outlook, Growth Potential, Price Trends, Competitive Market Share & Forecast 2024–2029.
This report includes market data points, ranging from trend
analyses to market estimates & forecasts that you can customize
BIOPHARMACEUTICALS EXCIPIENTS MARKET REPORT SCOPE
REPORT ATTRIBUTE | DETAILS |
---|---|
Market Size (2029) | USD 3.79 Billion |
Market Size (2023) | USD 2.43 Billion |
CAGR (2023-2029) | 7.67% |
HISTORIC YEAR | 2020-2022 |
BASE YEAR | 2023 |
FORECAST YEAR | 2024-2029 |
MARKET SEGMENTS BY | Excipient, Biologics, Scale of Operations, Origin, End-Users, and Geography |
GEOGRAPHIC ANALYSIS | North America, Europe, APAC, Latin America, and Middle East & Africa |
KEY PLAYERS | Merck KGaA, BASF SE, Avantor, Evonik Industries, Roquette Freres, and Associated British Foods |
MARKET INSIGHTS
The global biopharmaceutical excipients market was valued at USD 2.43 billion in 2023 and is expected to reach USD 3.79 billion by 2029, growing at a CAGR of 7.67% during the forecast period. The rising demand for biopharmaceuticals is the major factor driving the demand for excipients to manufacture various biological drugs. With the growing prevalence of cancer and infectious diseases, there is a high need for developing vaccines, monoclonal antibodies, and other therapeutics for treating such conditions. Furthermore, there is a growing need to develop novel and multifunctional excipients, as there are advances in various therapies.
MARKET TRENDS & DRIVERS
Demand for Novel Excipients in Advancing Biopharmaceutical Development
Developing new and improved biopharmaceutical drugs relies on novel excipients essential for advanced product formulations. Unlike conventional excipients, these novel substances have not been used in FDA-approved drug products and lack established food use. Advocates highlight their public health benefits, including enhanced drug delivery and their utility in abuse-deterrent opioid formulations. Recognition by the FDA as novel excipients would assure drug developers of their safety, reducing concerns during application review. While many approved drug excipients are listed in the FDA's Inactive Ingredient Database (IID) and have been used for decades, novel excipients are typically not included in the IID. They may be intended for new administration routes, higher dosages, or modifications like particle engineering. In a significant step towards modernizing drug formulation, the FDA has initiated a program to test the safety and suitability of novel inactive ingredients for new drugs and biologics. This initiative encourages using novel excipients in clinical trials, providing excipient suppliers with a faster route to market and promoting innovative therapies.
Increasing Demand for Excipients in Vaccine and Regenerative Medicine Formulations
Excipients play a critical role in stabilizing vaccines and developing regenerative medicines, ensuring safety, stability, and efficacy. Vaccines, inherently unstable and prone to degradation, require various excipients like diluents, preservatives, stabilizers, adjuvants, and buffering agents. For instance, preservatives such as formaldehyde prevent contamination, while stabilizers like sucrose and gelatin maintain potency during storage and transport. Aluminum salts are used as adjuvants, enhancing immune response, and buffering agents like sodium chloride maintain pH balance. In regenerative medicine, the demand for novel excipients is rising, driven by the growth in cell and gene therapies to treat rare diseases. These therapies utilize excipients such as buffers, salts, polymers, and proteins to stabilize formulations and ensure physiological osmolality. The investment in cell and gene therapy has surged, necessitating innovative excipients to support the development of advanced therapeutic solutions.
Strategic Outsourcing in Biopharmaceutical Excipient Manufacturing
Pharmaceutical companies are increasingly outsourcing the manufacturing of biopharmaceutical excipients due to several key factors. Rapid advancements in biopharmaceutical R&D have created a need for specialized excipients that enhance drug efficacy, stability, and delivery, requiring complex and costly manufacturing processes. Outsourcing allows pharmaceutical firms to focus on core activities like drug discovery, clinical trials, and regulatory affairs, leveraging the expertise of specialized manufacturers to streamline operations and accelerate market entry for new therapies. Outsourcing also provides flexibility and scalability, enabling companies to adjust capacity and maintain compliance with evolving regulatory standards, ensuring a reliable supply chain. Additionally, it offers cost-effectiveness by reducing the capital expenditures for in-house manufacturing facilities and allowing more efficient resource allocation while maintaining high-quality standards. The need for innovation, operational efficiency, regulatory compliance, and cost savings drives the trend toward outsourcing.
INDUSTRY RESTRAINTS
Supply Chain and Integrity Issues with Biopharmaceutical Excipients
The integrity and reliability of the biopharmaceutical excipient supply chain are crucial for the quality and efficacy of biopharmaceutical products. This complex global supply chain, involving multiple suppliers and distributors, poses significant challenges. Though pharmacologically inert, excipients require strict management to prevent adulteration and ensure patient safety. The rise of novel excipients and delivery systems amplifies the need for robust quality control, certification, and supply chain management. The extended supply chains and increased importation introduce risks of counterfeit or substandard excipients, potentially causing production delays and adverse effects. Ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards is essential. Historical incidents, such as the 2012 contamination with industrial-grade gelatin, highlight the importance of strict controls. Regulatory bodies like the FDA and China's SFDA have enforced stricter regulations on high-risk excipients. To maintain market growth, pharmaceutical manufacturers must prioritize high-quality excipients, adhering to stringent regulatory requirements despite the complexities of the supply chain.
SEGMENT INSIGHTS
INSIGHT BY EXCIPIENT
The global biopharmaceutical excipients market by excipient type is segmented into bulking agents, solubilizers & surfactants, buffering & tonicity agents, and others. The bulking agents segment holds the largest market share. The dominant share of the segment is because the bulking agents play a crucial role in developing advanced formulations, supporting the overall growth of the biopharmaceutical market. Bulking agents are essential in biopharmaceutical formulations, providing a matrix that supports the active drug, especially when present in low quantities. These agents include a variety of compounds such as sugars, polyols, amino acids, polymers, and proteins. Commonly used bulking agents in biopharmaceuticals include lactose, sucrose, mannitol, trehalose, dextran, and glycine. These compounds are integral in enhancing the stability and efficacy of pharmaceutical products, particularly those administered in aqueous solutions.
INSIGHT BY BIOLOGICS
The global biopharmaceutical excipients market by biologics type is categorized into monoclonal antibodies, vaccines, and others. The other segment shows significant growth, with the fastest-growing CAGR during the forecast period. Others include cell therapies, gene therapies, growth factors, interferons, and recombinant hormones, including insulin, polyclonal antibodies, and antibody fragments. Several excipients (e.g., buffers and salts, polymers, and preservatives) can stabilize or alter cells' permeability. Excipients play a crucial role in formulating therapeutic proteins like recombinant human growth hormone (rhGH), ensuring their stability from manufacture to patient delivery. These additives, including buffers, polymers, and preservatives, are essential for maintaining the protein's integrity during storage and transportation. They serve various functions, such as controlling pH, stabilizing against environmental stress during lyophilization, adjusting tonicity, and preventing protein aggregation.
INSIGHT BY SCALE OF OPERATION
The global biopharmaceutical excipients market by scale of operation type is segmented into commercial and research. The commercial segment accounted for the largest market share and showed highest growth during the forecast period. The demand for biologics, driven by the need to combat infectious diseases and pandemics, has surged, necessitating the rapid manufacture of billions of doses within short timeframes. This poses significant challenges in biopharmaceutical manufacturing, particularly in scaling production to meet commercial demands while maintaining product consistency and quality. Biologic drugs, such as monoclonal antibodies, are complex molecules composed of large amino acid chains far larger than conventional small molecule injectables. As these drugs enter the commercial phase, the excipients required become substantial. Excipients play a crucial role in biological formulations, aiding in stability, solubility, and overall product efficacy.
INSIGHT BY ORIGIN
The organic excipient dominates with the largest global biopharmaceutical excipient market share based on origin type. Improved extraction and purification technologies have made producing high-quality organic excipients easier and more cost-effective, boosting their adoption. The biopharmaceutical excipient market has significantly shifted towards using organic excipients, driven by multiple factors, including safety, biocompatibility, and consumer preferences. Organic excipients, which include a wide range of natural substances like polysaccharides, proteins, lipids, and organic acids, have become increasingly popular in the formulation of biopharmaceutical products. These excipients offer several advantages over their synthetic counterparts, such as reduced toxicity, improved patient compliance, and better compatibility with the active pharmaceutical ingredients (APIs) used in biologics and other complex drugs.
INSIGHT BY END-USER
Based on end-users, the CMOs & CDMOs segment shows prominent growth, with the highest CAGR during the forecast period. Biopharmaceuticals, characterized by their large molecular size and complex manufacturing processes, differ significantly from traditional small molecule drugs' behavior, production methods, and therapeutic action within the body. The intricacies involved in manufacturing biopharmaceuticals have led many biopharma companies to increasingly rely on Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) for their expertise and capabilities. Outsourcing to CMOs and CDMOs has become a popular strategy among biopharma companies due to the specialized knowledge and infrastructure these organizations offer. Biopharma developers can concentrate on product commercialization and clinical development by outsourcing manufacturing responsibilities. This trend has fueled steady growth in CMO sales, driven not only by increased outsourcing but also by expanding new and existing product lines, including clinical trial supply services.
GEOGRAPHICAL ANALYSIS
APAC shows significant growth, with the fastest-growing region in the global biopharmaceutical excipients market. The APAC region is poised for significant growth, driven by several key factors. The region's expanding pharmaceutical industry, advancements in functional excipients, and the rising use of orphan drugs underscore robust growth prospects. The emergence of multifunctional excipients and the shift of pharmaceutical manufacturing to emerging markets further enhance these prospects. Additionally, the burgeoning biosimilar industry in APAC presents new opportunities for excipients used in biopharmaceutical formulations. The region is witnessing an increasing target patient population, particularly those affected by cancer, which remains the second-highest cause of death globally.
COMPETITIVE LANDSCAPE
The global biopharmaceutical excipients market report contains exclusive data on 36 vendors. The market is characterized by diverse vendors, from emerging mid-sized companies to well-established players, contributing to its revenue. Leading companies are employing various strategies to increase their market share and presence. These include launching new products, securing approvals, engaging in marketing and promotional activities, investing heavily in R&D, and strengthening their distribution networks. Major players such as Merck KGaA, BASF SE, Avantor, Evonik Industries, Roquette Freres, Associated British Foods, and others are also focusing on strategic licensing, acquisitions, and collaboration agreements with emerging companies to quickly enter the biopharmaceutical excipients market and access commercially available products. Expanding into existing and new markets to meet the needs of a growing customer base, broadening product portfolios, and enhancing production capabilities are key strategies to attract end-users. Additionally, companies are introducing advanced and novel excipient solutions to support pharmaceutical drug development, ensuring robust distribution chains to meet market demand.
Frequently Asked Questions
How big is the global biopharmaceutical excipients market?
What is the growth rate of the global biopharmaceutical excipients market?
What are the key trends in the global biopharmaceutical excipients market?
Which region shows the highest growth in the global biopharmaceutical excipients market?
Who are the major players in the global biopharmaceutical excipients market?
The global biopharmaceutical excipients market size is expected to grow at a CAGR of approximately 7.67% from 2023 to 2029.
Base Year: 2023
Forecast Year: 2024-2029
The report considers the present scenario of the global biopharmaceutical excipients market and its market dynamics for 2024−2029. It covers a detailed overview of several market growth enablers, restraints, and trends. The study covers both the demand and supply sides of the market. It also profiles and analyzes leading companies and several other prominent companies operating in the market.
VENDORS LIST
Key Vendors
- Merck KGaA
- BASF SE
- Avantor
- Evonik Industries AG
- Roquette Freres
- Associated British Foods plc
Other Prominent Vendors
- Actylis
- Advancion
- Apothecon Pharmaceuticals
- Ashland
- BioSpectra
- BOC Sciences
- CG Group
- Clariant
- Colorcon
- DFE Pharma
- Dow
- Eastman Chemical Company
- IMCD
- Innophos
- InVitria
- ABITEC
- CordenPharma
- Croda International plc
- JRS Pharma
- Kirsch Pharma
- MEGGLE
- Novo Nordisk
- Pfanstiehl
- Shin-Etsu Chemical
- Sigachi Industries
- Spectrum Chemical
- Stepan Company
- Tereos
- The Lubrizol Corporation
- WACKER CHEMI
SEGMENTATION & FORECAST
- By Excipient
- Bulking Agents
- Solubilizers & Surfactants
- Buffering & Tonicity Agents
- Others
- By Biologics
- Monoclonal Antibodies
- Vaccines
- Others
- By Scale of Operation
- Commercial
- Research
- By Origin
- Organic Excipients
- Inorganic Excipients
- By End-User
- Pharma & Biotech Companies
- CMOs & CDMOs
- Academic & Research Institutes
- By Geography
- North America
- The U.S.
- Canada
- Europe
- Germany
- The U.K.
- France
- Italy
- Spain
- APAC
- Japan
- China
- India
- Australia
- South Korea
- Latin America
- Brazil
- Mexico
- Argentina
- Middle East & Africa
- Turkey
- South Africa
- Saudi Arabia
Exhibit 1: Projected Revenues of Global Biopharmaceutical Excipients (2020–2029; $ MN)
Exhibit 2: Market Size & Forecast – Bulking Agents (2020–2029; $ MN)
Exhibit 3: Market Size & Forecast – Solubilizers & Surfactants (2020–2029; $ MN)
Exhibit 4: Market Size & Forecast – Buffering & Tonicity Agents (2020–2029; $ MN)
Exhibit 5: Market Size & Forecast – Others (2020–2029; $ MN)
Exhibit 6: Market Size & Forecast – Monoclonal Antibodies (2020–2029; $ MN)
Exhibit 7: Market Size & Forecast – Vaccines (2020–2029; $ MN)
Exhibit 8: Market Size & Forecast – Others (2020–2029; $ MN)
Exhibit 9: Market Size & Forecast – Commercial (2020–2029; $ MN)
Exhibit 10: Market Size & Forecast – Research (2020–2029; $ MN)
Exhibit 11: Market Size & Forecast – Organic Excipients (2020–2029; $ MN)
Exhibit 12: Market Size & Forecast – Inorganic Excipients (2020–2029; $ MN)
Exhibit 13: Market Size & Forecast – Pharma & Biotech Companies (2020–2029; $ MN)
Exhibit 14: Market Size & Forecast – CMOs & CDMOs (2020–2029; $ MN)
Exhibit 15: Market Size & Forecast – Academic & Research Institutes (2020–2029; $ MN)
Exhibit 16: Projected Revenues of Biopharmaceutical Excipients in North America (2020–2029; $ MN)
Exhibit 17: Projected Revenues of Biopharmaceutical Excipients in the US (2020–2029; $ MN)
Exhibit 18: Projected Revenues of Biopharmaceutical Excipients in Canada (2020–2029; $ MN)
Exhibit 19: Projected Revenues of Biopharmaceutical Excipients in Europe (2020–2029; $ MN)
Exhibit 20: Projected Revenues of Biopharmaceutical Excipients in Germany (2020–2029; $ MN)
Exhibit 21: Projected Revenues of Biopharmaceutical Excipients in France (2020–2029; $ MN)
Exhibit 22: Projected Revenues of Biopharmaceutical Excipients in the UK (2020–2029; $ MN)
Exhibit 23: Projected Revenues of Biopharmaceutical Excipients in Switzerland (2020–2029; $ MN)
Exhibit 24: Projected Revenues of Biopharmaceutical Excipients in Italy (2020–2029; $ MN)
Exhibit 25: Projected Revenues of Biopharmaceutical Excipients in Spain (2020–2029; $ MN)
Exhibit 26: Projected Revenues of Biopharmaceutical Excipients in APAC (2020–2029; $ MN)
Exhibit 27: Projected Revenues of Biopharmaceutical Excipients in China (2020–2029; $ MN)
Exhibit 28: Projected Revenues of Biopharmaceutical Excipients in Japan (2020–2029; $ MN)
Exhibit 29: Projected Revenues of Biopharmaceutical Excipients in South Korea (2020–2029; $ MN)
Exhibit 30: Projected Revenues of Biopharmaceutical Excipients in India (2020–2029; $ MN)
Exhibit 31: Projected Revenues of Biopharmaceutical Excipients in Australia (2020–2029; $ MN)
Exhibit 32: Projected Revenues of Biopharmaceutical Excipients in Latin America (2020–2029; $ MN)
Exhibit 33: Projected Revenues of Biopharmaceutical Excipients in Brazil (2020–2029; $ MN)
Exhibit 34: Projected Revenues of Biopharmaceutical Excipients in Mexico (2020–2029; $ MN)
Exhibit 35: Projected Revenues of Biopharmaceutical Excipients in Argentina (2020–2029; $ MN)
Exhibit 36: Projected Revenues of Biopharmaceutical Excipients in the MEA (2020–2029; $ MN)
Exhibit 37: Projected Revenues of Biopharmaceutical Excipients in Turkey (2020–2029; $ MN)
Exhibit 38: Projected Revenues of Biopharmaceutical Excipients in Saudi Arabia (2020–2029; $ MN)
Exhibit 39: Projected Revenues of Biopharmaceutical Excipients in UAE (2020–2029; $ MN)
Exhibit 40: Projected Revenues of Biopharmaceutical Excipients in South Africa (2020–2029; $ MN)
List of Tables
Table 1: Projected Revenues of Global Biopharmaceutical Excipients Market (2020–2029; $ MN)
Table 2: Global Biopharmaceutical Excipients Market by Origin (2020–2029; %)
Table 3: Global Biopharmaceutical Excipients Market by Origin (2020–2029; $ MN)
Table 4: Global Biopharmaceutical Excipients Market by Biologics (2020–2029; %)
Table 5: Global Biopharmaceutical Excipients Market by Biologics (2020–2029; $ MN)
Table 6: Global Biopharmaceutical Excipients Market by Scale of Operation (2020–2029; %)
Table 7: Global Biopharmaceutical Excipients Market by Scale of Operation (2020–2029; $ MN)
Table 8: Global Biopharmaceutical Excipients Market by End-User (2020–2029; %)
Table 9: Global Biopharmaceutical Excipients Market by End-User (2020–2029; $ MN)
Table 10: Global Biopharmaceutical Excipients Market by Excipient (2020–2029; %)
Table 11: Global Biopharmaceutical Excipients Market by Excipient (2020–2029; $ MN)
Table 12: Global Biopharmaceutical Excipients Market by Geography (2020–2029; %)
Table 13: Global Biopharmaceutical Excipients Market by Geography (2020–2029; $ MN)
CHAPTER – 1: Biopharmaceutical Excipients Market Overview
- Executive Summary
- Key Findings
CHAPTER – 2: Biopharmaceutical Excipients Market
- GLOBAL: Projected Revenue of Biopharmaceutical Excipients Market (2020-2029; $Millions)
CHAPTER – 3: Biopharmaceutical Excipients Market Segmentation Data
- GLOBAL: Projected Revenue by Excipient (2020-2029; $Millions)
- Bulking Agents
- Solubilizers & Surfactants
- Buffering & Tonicity Agents
- Others
- GLOBAL: Projected Revenue by Biologics (2020-2029; $Millions)
- Monoclonal Antibodies
- Vaccines
- Others
- GLOBAL: Projected Revenue by Scale of Operation (2020-2029; $Millions)
- Commercial
- Research
- GLOBAL: Projected Revenue by Origin (2020-2029; $Millions)
- Organic Excipients
- Inorganic Excipients
- GLOBAL: Projected Revenue by End-User (2020-2029; $Millions)
- Pharma & Biotech Companies
- CMOs & CDMOs
- Academic & Research Institutes
CHAPTER – 4: Key Regions Overview
- North America: Projected Revenue of Biopharmaceutical Excipients Market (2020-2029; $Millions)
- Projected Revenue of Biopharmaceutical Excipients Market in US
- Projected Revenue of Biopharmaceutical Excipients Market in Canada
- Europe: Projected Revenue of Biopharmaceutical Excipients Market (2020-2029; $Millions)
- Projected Revenue of Biopharmaceutical Excipients Market in Germany
- Projected Revenue of Biopharmaceutical Excipients Market in France
- Projected Revenue of Biopharmaceutical Excipients Market in UK
- Projected Revenue of Biopharmaceutical Excipients Market in Switzerland
- Projected Revenue of Biopharmaceutical Excipients Market in Italy
- Projected Revenue of Biopharmaceutical Excipients Market in Spain
- APAC: Projected Revenue of Biopharmaceutical Excipients Market (2020-2029; $Millions)
- Projected Revenue of Biopharmaceutical Excipients Market in China
- Projected Revenue of Biopharmaceutical Excipients Market in Japan
- Projected Revenue of Biopharmaceutical Excipients Market in South Korea
- Projected Revenue of Biopharmaceutical Excipients Market in India
- Projected Revenue of Biopharmaceutical Excipients Market in Australia
- Latin America: Projected Revenue of Biopharmaceutical Excipients Market (2020-2029; $Millions)
- Projected Revenue of Biopharmaceutical Excipients Market in Brazil
- Projected Revenue of Biopharmaceutical Excipients Market in Mexico
- Projected Revenue of Biopharmaceutical Excipients Market in Argentina
- Middle East & Africa: Projected Revenue of Biopharmaceutical Excipients Market (2020-2029; $Millions)
- Projected Revenue of Biopharmaceutical Excipients Market in Turkey
- Projected Revenue of Biopharmaceutical Excipients Market in Saudi Arabia
- Projected Revenue of Biopharmaceutical Excipients Market in UAE
- Projected Revenue of Biopharmaceutical Excipients Market in South Africa
CHAPTER – 5: Biopharmaceutical Excipients Market Prospects & Opportunities
- Biopharmaceutical Excipients Market Opportunities & Trends
- Biopharmaceutical Excipients Market Drivers
- Biopharmaceutical Excipients Market Constraints
CHAPTER – 6: Biopharmaceutical Excipients Industry Overview
- Biopharmaceutical Excipients Market - Competitive Landscape
- Biopharmaceutical Excipients Market – Key Vendor Profiles
- Biopharmaceutical Excipients Market – Other Prominent Vendors
- Biopharmaceutical Excipients Market - Key Strategic Recommendations
CHAPTER – 7: Appendix
- Research Methodology
- Abbreviations
- About Arizton
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Frequently Asked Questions
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Which region shows the highest growth in the global biopharmaceutical excipients market?
Who are the major players in the global biopharmaceutical excipients market?