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"Biopharmaceutical Excipients Market - Focused Insights 2024-2029"
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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:
Report Attribute
Details
No. of Pages
163
Forecast Period
2023 - 2029
Estimated Market Value (USD) in 2023
$2.43 Billion
Forecasted Market Value (USD) by 2029
$3.79 Billion
Compound Annual Growth Rate
7.6%
Regions Covered
Global
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
For more information about this report visit
https://www.researchandmarkets.com/r/7oy3j7
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