Biopharmaceutical Excipient Manufacturing: Driving Efficiency in Pharmaceutical Production

"Biopharmaceutical Excipient Manufacturing Market" in terms of revenue was estimated to be worth $1,372.7 Mn in 2023 and is poised to reach $2,892.5 Mn by 2031, growing at a CAGR of 9.82% from 2024 to 2031 according to a new report by InsightAce Analytic.

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Market Analysis:

Biopharmaceutical excipients serve an important role in biologic drug formulation by stabilizing, delivering, and improving the performance of active pharmaceutical ingredients (APIs). The growing research and marketing of biologic drugs create a demand for specialized excipients designed to meet the unique formulation requirements of biopharmaceuticals.

Latest Drivers Restraint and Opportunities Market Snapshot:

Key Factors Influencing The Global Biopharmaceutical Excipient Manufacturing Market Are:
• Rise In Biologics Development
• Advancements In Bioprocessing Technologies
• Increasing Demand For Specialized Formulations

The Following Are The Primary Obstacles To The Biopharmaceutical Excipient Manufacturing Market's Expansion:
• Stringent Regulatory Requirements
• High Development Costs
• Supply Chain Disruptions

Future Expansion Opportunities For The Global Biopharmaceutical Excipient Manufacturing Market Include:
• Innovative Drug Delivery Systems
• Investment In Advanced Manufacturing Technologies
• Focus On Personalized Medicine

Key Industry Insights & Findings from the Report:

• Emerging economies provide considerable growth prospects for excipient makers, owing to rising healthcare spending, increased demand for biopharmaceuticals, and increased healthcare access.
• There is an increasing demand for specialized excipients tailored to the unique formulation requirements of biological therapeutics. It is expected to drive industry growth.
• North America dominated the market and accounted for a revenue share of global revenue in 2023.
• One of the significant concerns restraining industry growth are Supply chain disruptions, including raw material shortages, quality issues, geopolitical factors, and transportation delays.

List of Prominent Players in the Biopharmaceutical Excipient Manufacturing Market:
• ABITEC Corporation
• Aceto
• Angus Chemical
• Apothecary
• 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 & SÖHNE GmbH + Co KG
• Kirsch Pharma
• Meggle Pharma
• Merck KGaA
• Novo Nordisk
• Pfanstiehl, Inc.
• Harmonix
• 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

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Recent Developments:
• In July 2023, Roquette purchased Qualicaps to expand its knowledge and competence in the creation of pharmaceutical excipients.
• In June 2023, Lubrizol Corporation agreed to a licensing arrangement with Welton Pharma, allowing Welton to use the Apisolex excipient in various locations with the goal of developing and commercializing a unique SN-38 formulation to treat colorectal and related gastrointestinal malignancies.
• In March 2023, Evonik Industries AG commenced building a new site in Indiana, United States. The facility expansion is planned to ensure a global supply of functional excipients for RNA therapeutics while also boosting the biopharmaceutical excipient sector.

Biopharmaceutical Excipient Manufacturing Market Dynamics:
Market Drivers: Rise in Biologics Development
As the cancer burden grows, so does the demand for a wide range of biological therapies. Biopharma businesses, large and small, are still searching for the molecular origins of cancer and developing medications to prevent cancer cells from spreading. Thus, the biopharma business is influencing various aspects of the oncology market. Furthermore, infectious diseases pose a significant burden in both developed and developing countries. Contagious diseases such as HIV/AIDS, tuberculosis, malaria, and others kill a lot of people, especially in low- and middle-income countries.

Challenges: Stringent Regulatory Requirements
One of the primary concerns of regulators is the quality and safety of pharmaceutical therapeutic products. In recent years, regulatory organizations have toughened their stance on avoiding pharmaceutical adulteration in excipients and APIs. However, the existing regulatory landscape requires an independent excipient approval procedure, which may hinder the market entry of innovative excipients and medicinal products. Furthermore, excipient makers and product developers are unwilling to invest significant resources and time in developing a new excipient because it is uncertain whether the product will be approved in the regulatory review, stifling market growth.

North America Is Projected To Experience The Highest Compound Annual Growth Rate (CAGR) During The Forecast Period.
The biopharmaceutical excipient manufacturing market in North America is expected to have substantial revenue growth and a strong CAGR in the near future. The region's growth can be attributed to the existence of multiple prominent pharmaceutical manufacturing enterprises. The region has seen a major increase in biopharmaceutical production, as well as a requirement to preserve the high-quality raw materials needed in biopharmaceutical development. This has prompted some regional excipient manufacturers to attain the necessary production scalability by utilizing biopharmaceutical excipients that meet regulatory standards.

Segmentation of Biopharmaceutical Excipient Manufacturing Market-
By Type-
• Antibodies
• Vaccines
• Cell Therapies
• Other Biologics

By 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 Operations
• Research
• 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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