(PharmaNewsWire.Com, July 18, 2024 ) InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the "Global Biopharmaceutical Excipient Manufacturing Market By Product Type (Solubilizers & Surfactants/Emulsifiers, Polyols, Carbohydrates, Speciality Excipients), By Type of Biologics (Antibodies, Vaccines, Cell Therapies, and Other Biologics), By Scale Of Operation (Preclinical, Clinical, and Commercial),- Market Outlook And Industry Analysis 2031"
Biopharmaceutical excipients play a vital role in the formulation of biological drugs by stabilizing, delivering, and enhancing the performance of active pharmaceutical ingredients (APIs). Typically derived from minerals, sugars, wheat, corn, and other natural sources, these inert substances offer significant benefits such as efficiently binding ingredients, improving drug stability in various dosage forms, and modifying API solubility. By fulfilling these functions, biopharmaceutical excipients not only optimize operational costs and enhance productivity but also elevate product quality standards.
Biopharmaceutical excipients are crucial across various biologics such as antibodies, vaccines, cell therapies, recombinant proteins, and gene therapies, each requiring specialized formulations to meet strict regulatory standards. Manufacturing these excipients involves advanced technologies and specialized facilities to ensure quality and safety, aligning with evolving regulations.
Processes like filtration, purification, isolation, and blending are complex and require specialized equipment to maintain substance purity and stability. Manufacturers face challenges including regulatory compliance, raw material availability, and high operational costs, prompting increased use of advanced technologies for improved quality and performance of biopharmaceutical excipients, crucial for effective drug formulations.
List of Prominent Players in the Biopharmaceutical Excipient Manufacturing Market:
ABITEC Corporation Aceto Angus Chemical Apothecon Ashland Global Associated British Foods plc Avantor BASF SE BioSpectra BOC Sciences G. Group Clariant Colorcon Croda International Plc DFE Pharma DOW Eastman Chemical Evonik Industries AG IMCD N.V. Innophos Invitria RETTENMAIER & SึHNE GmbH + Co KG Kirsch Pharma Meggle Pharma Merck KGaA Novo Nordisk Pfanstiehl, Inc. Pharmonix Roquette Freres Shin-Etsu Chemical Sigachi Industries Limited Signet Excipients Pvt. Ltd (IMCD) Spectrum Chemical Manufacturing Corp. SPI Pharma Stepan Company Tereos The Lubrizol Wacker Chemie
Market Dynamics:
Drivers-
The biopharmaceutical excipients market is experiencing robust growth driven by several key factors. There is a significant rise in the use of excipients in biopharmaceutical formulations to improve drug stability, solubility, and bioavailability, bolstering market expansion. Manufacturers are actively developing specialized excipients tailored to the unique needs of biological therapeutics, which is expected to further propel industry growth.
Additionally, the increasing demand for innovative biologics such as antibodies, vaccines, cell therapies, and recombinant proteins is driving the need for advanced biopharmaceutical excipients. Moreover, the escalating prevalence of chronic diseases like cancer, autoimmune disorders, and infectious diseases has heightened the demand for biopharmaceuticals, thereby increasing the requirement for specialized excipients. The adoption of lipid-based and sucrose-based excipients in drug formulations is also on the rise, further contributing to the market's growth trajectory.
Challenges:
The biopharmaceutical industry grapples with stringent regulatory requirements for integrating excipients in drug formulations, posing complex compliance challenges. High development costs further hinder adoption, particularly in resource-constrained settings, encompassing expenses from research and development to regulatory approvals. These factors underscore significant barriers that market participants must navigate to advance in this competitive landscape.
Regional Trends:
North America hosts major pharmaceutical and biopharmaceutical companies, along with contract manufacturing organizations (CMOs), involved in biopharmaceutical excipient production. Leading firms such as Avantor, BASF, Evonik, Merck, and Pfanstiehl operate advanced facilities for specialized excipient manufacturing. The region benefits from a supportive regulatory framework, notably in the U.S., where the FDA ensures excipient quality and safety through stringent guidelines. In 2021, small, pre-profit biopharma firms in the U.S. invested an average of $712,258 in R&D per employee, comprising 18% of the sector's total R&D investments, according to the Information Technology and Innovation Foundation (ITIF). This highlights their significant contribution to innovation in North America. This collaborative environment fosters ongoing advancements in excipient technology, enhancing capabilities and competitiveness within the biopharmaceutical industry.
Recent Developments: In November 2023, IFF's Pharma Solutions and BASF have partnered to integrate IFF's leading pharmaceutical excipient brands into BASF's ZoomLab platform. ZoomLab is a digital tool that uses scientific insights to swiftly and precisely recommend optimal excipients for new pharmaceutical formulations, aiding in overcoming formulation challenges. This collaboration aims to enhance efficiency and innovation in pharmaceutical development.
In October 2023, Clariant, a sustainability-focused specialty chemicals company, introduces three new VitiPureฎ excipients at CPHI Barcelona. These additions expand their portfolio of pharmaceutical ingredient solutions, catering to a wide range of API formulations and administration routes, including sensitive applications like mRNA vaccines and biologics. Clariant aims to establish itself as a comprehensive solutions provider to the pharmaceutical industry.
In October 2022, Ashland Inc. announced that the FDA's Center for Drug Evaluation and Research Office of New Drugs has accepted Ashland Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the review cycle of the FDA Novel Excipient Review Pilot Program.
Segmentation of Biopharmaceutical Excipient Manufacturing Market- By Type of Biologics: Antibodies Vaccines Cell Therapies Other Biologics
By Type of Product: Solubilizers & Surfactants/Emulsifiers o Triglycerides o Esters o Others (Sodium Cocoyl Glutamate, Glyceryl Caprylate; Citric Acid;
Polyglyceryl-6 Oleate; Sodium Surfactin) Polyols o Mannitol o Sorbitol o Others (Lactitol, Isomalt, xylitol) Carbohydrates o Sucrose o Dextrose o Starch o Others (Lactose, Cellulose, Fructose) Specialty Excipients
By Scale of Operation: Preclinical Clinical Commercial By Region- North America- The US Canada Mexico
Europe- Germany The UK France Italy Spain Rest of Europe
Asia-Pacific- China Japan India South Korea Southeast Asia Rest of Asia Pacific
Latin America- Brazil Argentina Rest of Latin America Middle East & Africa- GCC Countries South Africa Rest of Middle East and Africa
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