A Summary Of CDMO And Its Recent Market Development

It takes years of hard work for any biotech or  pharmaceutical company to develop and launch its new products. These efforts include factors like long regulatory approval, launch procedures, costly manufacturing, and clinical trials. Furthermore, entering the market involves a different set of challenges for these companies. They have to plan and execute effective promotions and marketing strategies. We see that biotech and pharmaceutical companies have to handle various tasks which can be effectively managed by CMOS and CDMOS.

CDMO, or Contract Development and Manufacturing Organisation, consists of organizations that provide extensive services/solutions to the pharma and biotech industries. The services include everything from the packaging of the product to the drug development process. This broad range of services includes regulatory support, efficient packaging services, formulation guidance, smooth manufacturing process, clinical research and development, among others.

Benefits of CDMOs include:

• Expertise.
• Scalability.
• Cost-Effectiveness.
• Equipment and Technology.

Different stages of CDMOs operations include:

• Phase I – Sample Preparation, Lab Development, Route Scouting.
• Phase II – Impurity Characterization, Analytical Development, Safety Studies, Process Optimization.
• Phase III (Launch) – Analytical Validation, GMP/Non-GMP DMF Filing, Process Validation.
• Phase IV (Lifecycle Extension) – Cost reduction, Varying degree of continuous improvement, Manufacturing to several MT levels.

Key Players in the CDMO Market include:

Top companies such as Windlas Biotech, Syngene International Limited, Wavelength Pharmaceuticals, Novasep, NextPharma GmbH, Northway Biotech, Neuland Laboratories Ltd, Laviana Pharma Co. Ltd, Lonza Group AG, Laurus Labs, Hovione, Jubilant Biosys Limited, Frontage Laboratories Inc, Fujifilm Diosynth Biotechnologies, Formosa Laboratories Inc, Dipharma Francis Srl, Flamma Group, CARBOGEN AMCIS, CordenPharma, Cambrex Corporation, Baxter BioPharma, Boehringer Ingelheim, Pfizer, and many others.

Recent Developments in the CDMO market:

• September 2021: PharmaZell and Novasep enter negotiations to combine both companies.
• September 2021: Idifarma acquired by Ardena.
• August 2021: Drug-product manufacturing services established by Lonza in Guangzhou, China.
• August 2021: Approval of RheinCell Therapeutics GmbH being acquired by  Catalent.
• August 2021: Curia’s investment for expanding its commercial small-molecule manufacturing facility in Rensselaer, New York.
• July 2021: Specialty Ingredients operations and business of Lonza divested to Bain Capital and Cinven.
• July 2021: Curia acquires LakePharma.
• June 2021: Aldevron’s acquisition announced by Danaher.
• May 2021: Vigene Biosciences to be acquired by Charles River Laboratories.
• May 2021: WuXi Biologics acquires CMAB Biopharma; Pfizer’s facilities in Hangzhou, China; former Bayer bio-manufacturing facility in Wuppertal, Germany.
• Feb 2021: Bristol Myers Squibb’s manufacturing facility in Couvet, Switzerland acquired by WuXi STA.
• Feb 2021: Acorda Therapeutics Inc acquired by Catalent.

Source: Contract Development and Manufacturing Organisation – Market Analysis, By DelveInsight.