The "Biopharmaceutical Excipients Market - Focused Insights 2024-2029" report has been added to ResearchAndMarkets.com's offering.

The Biopharmaceutical Excipients Market was valued at USD 2.43 billion in 2023, and is expected to reach USD 3.79 billion by 2029, rising at a CAGR of 7.69%

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.

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.

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.

KEY QUESTIONS ANSWERED:

• 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?

Key Attributes:

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

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

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