Report

The global biopharmaceutical excipients market is expected to grow at a CAGR of 7.67% from 2023 to 2029.

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.

By Excipient
- Bulking Agents
- Solubilizers & Surfactants
- Buffering & Tonicity Agents
- Others

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.

By Biologics
- Monoclonal Antibodies
- Vaccines
- Others

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.

By Scale of Operation
- Commercial
- Research

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.

By Origin
- Organic Excipients
- Inorganic Excipients

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.

By End-User
- Pharma & Biotech Companies
- CMOs & CDMOs
- Academic & Research Institutes

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.

By Geography

- North America
o The U.S.
o Canada
- Europe
o Germany
o The U.K.
o France
o Italy
o Spain
- APAC
o Japan
o China
o India
o Australia
o South Korea
- Latin America
o Brazil
o Mexico
o Argentina
- Middle East & Africa
o Turkey
o South Africa
o Saudi Arabia

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.

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

KEY QUESTIONS ANSWERED:

1. How big is the global biopharmaceutical excipients market?
2. What is the growth rate of the global biopharmaceutical excipients market?
3. What are the key trends in the global biopharmaceutical excipients market?
4. Which region shows the highest growth in the global biopharmaceutical excipients market?
5. Who are the major players in the global biopharmaceutical excipients market?