Pharmaceutical industry has witnessed an exponential growth since last decade, many small and large pharmaceutical companies are focusing on new drug development and process optimization to stay competitive in the market. This is primarily driving the demand for CDMO worldwide. Vast services offered by CDMO such as research and development of small and large molecules, manufacturing process optimization, screening tests, oligos & peptides, high potency & ADC, aseptic fill finish, etc. have created a shift from in-house research to research outsourcing. Many pharmaceutical companies lack well equipped research facilities that can work on multiple aspects of the drug research, also working on different drug manufacturing process is difficult for small to mid-sized pharma companies which is why many pharma companies are approaching CDMO for drug development and its manufacturing. Further, increasing prevalence of viral diseases has created tremendous opportunities for new and effective drug developments in pharmaceutical industries. However, developing biological drug requires high investments and it can take years to develop new biological drugs. This is why many pharmaceutical companies are outsourcing their projects to CDMO to fasten the process of drug development and its commercialization. Services offered by CDMO does not only help in saving time on research and manufacturing, but it significantly reduces the overall process cost.
Both multinational and domestic Contract Development and Manufacturing Organizations (CDMOs) are striving to enter in emerging countries where the expansion of pharmaceutical industry is at peak. The recent regulatory transformations regarding expansion of pharmaceutical industry have created potential opportunities for CDMOs in such countries which in turn is up-swelling the interest and investment of CDMO. Moreover, increasing focus on plant-based biologics is also contributing towards the increasing demand for CDMO. Rapidly increasing global demand for newer drugs is difficult to maintain with current drug development and production platforms such as mammalian cell culture owing to inadequate scalability and higher process cost. This has created a major shift in developing plant-based biological which in turn offered a great opportunity for CDMOs.
The onset of COVID-19 pandemic positively affected the growth of the biologics CDMO market. Many countries around the world are grappled with the pandemic which created huge shortage of COVID related drugs and vaccines during peak waves. With the understanding of the diseases, it was clear that vaccine is the only way to fight against COVID-19 which is why many small and large pharmaceutical players directed their strengths towards development of vaccines and related biological drug to curb the spread of infection. With the extreme need for rapid drug development process, CDMOs have worked hard to fast-forward the vaccine development and its pre-clinical tests. Moreover, the switch from pharma to biologics has also brought about a substantial change to the overall manufacturing requirements. This change has also increased the importance of biological CDMO in the pandemic period.
The global biologics CDMO market is mainly categorized into type, type of service, and end use industry. Plant-based and microbial & mammalian based biologics CDMO are the major types of CDMO covered in the market. Among these, microbial & mammalian segment hold large share of the market. Different types of service offered by biologics CDMO is categorized as manufacturing services and development services. Major end-use industries for CDMO include small pharma, big pharma, generic pharma, etc.
The highly competitive nature of the industry is forcing key market players to adopt newer technologies and solutions to stay ahead in the market. For instance, Samsung Biologics invested US$ 1.7 for a new biomanufacturing plant and bio complex. Similarly, in 2020, Catalent’s acquire MaSTherCell to broaden the CDMO services, the total acquisition cost was US$ 315 million.
Some of the major players operating in the market include Lonza Group AG, Thermo Fisher Scientific, Boehringer Ingelheim BioXcellence, Samsung BioLogics, Catalent, Inc., AGC Biologics, Inc., Wuxi Biologics, Medicago Inc., iBio Inc., Protalix-Pfizer, Mapp Biopharmaceautical - Leaf Bio, Ventria Bioscience, Kentucky BioProcessing, Inc., PhycoBiologics, INC., Synthon International Holding B.V., Fraunhofer, and Icon Genetics GmbH.
Future tends/developments
- In 2020, AGC Biologics, announced heavy investments, approximately UD$194 million to enlarge the production capacity of its Copenhagen, Denmark facility
- In 2020, Thermo Fisher Scientific started a new bioprocessing collaboration center in St. Louis, Missouri, where several Thermo Fisher businesses will jointly develop bioprocessing products.
- In August 2020, Lonza proclaimed expansion of company’s microbial manufacturing facility in Visp, Switzerland to offer mid-scale commercial manufacturing to several customers.