Market Trends of Large Molecules Drug Substance CDMO Industry
The Cell Line Development Segment is Expected to Hold a Significant Share During the Forecast Period
Cell line development for large molecules of drug substance involves creating and optimizing host cell lines that can express and produce the desired therapeutic proteins, such as monoclonal antibodies or other biologics. CDMOs specializing in cell line development may be engaged to provide expertise, infrastructure, and resources for efficient and effective large-molecule drug substance production. The company aims to establish a robust and reproducible cell line capable of producing the therapeutic protein at the required scale and quality for clinical and commercial use.
Cell line development requires specialized knowledge and skills in molecular biology, genetics, and bioprocessing. CDMOs with expertise in these areas can offer valuable insights and capabilities, attracting companies looking to outsource this complex aspect of drug development. In addition, CDMOs offer scalability in cell line development and subsequent bioprocessing. They have the infrastructure to scale production to meet increasing demands, providing flexibility for pharmaceutical companies without requiring substantial capital investments.
Moreover, market players' strategic activities are expected to boost the segment during the forecast period. For instance, in November 2022, Abzena invested USD 20 million to expand biologics drug substance capacity to 2000L scale, extra cell line development, and chemistry laboratory space in a new GMP facility. Additionally, in November 2023, Lonza announced the launch of its new GS Effex cell line to develop therapeutic antibodies with enhanced potency.
Similarly, in April 2023, Lotte Biologics and Excellence entered a collaboration agreement to join forces in the biopharmaceutical CDMO market. The partnership aims to offer comprehensive CDMO services encompassing pharmaceutical cell line development and large-scale manufacturing. In addition, AGC Biologics, a prominent CDMO, has garnered recognition from Acquisition International as a 2022 Leading Innovator in Mammalian Cell Line Development for the United States of America.
Hence, the benefits offered by the CDMO for cell line development and market players' strategic activities are expected to boost segment growth during the forecast period.
North America is Expected to Hold a Significant Market Share During the Forecast Period
North America is expected to hold a significant share owing to increasing extensive molecule drug approvals by the USFDA, rising incidence of infectious diseases, high demand for novel therapeutics, and higher capital investments by pharma and biotech firms in advanced technologies for establishing partnerships with CDMOs are the key factors driving the market.
The increasing investment in R&D and approval of biologics products are expected to boost the market during the forecast period. For instance, the Pharmaceutical Research and Manufacturers of America reported in 2023 that American pharmaceutical companies spent USD 238 billion on R&D in 2022. Thus, the need for innovative treatments and therapies for chronic diseases drives extensive research and development activities. Large molecule contract manufacturers support these efforts by providing high-quality, reliable products for treating chronic diseases, likely boosting the market during the forecast period.
Many players, such as Catalent, Cambrex Corporation, LabCorp Drug Development, and Fujifilm Diosynth Biotechnologies, drive the market. For instance, in April 2022, Catalent announced a multi-year investment worth USD 350 million at its Bloomington, Indiana, facility to broaden large molecule drug product and drug substance manufacturing capabilities. Key players employed mergers, acquisitions, partnerships, and facility expansions to sustain their market dominance. For instance, in November 2023, FUJIFILM Diosynth Biotechnologies, a CDMO, hosted a site unveiling celebration for its USD 2 billion large-scale cell culture manufacturing facility in Holly Springs. The site will provide drug substance manufacturing, automated fill-finish and assembly, packaging, and labeling services for global biopharmaceutical customers.
Increased R&D investments and strategic initiatives from market participants are anticipated to propel market expansion throughout the forecast period, resulting in a boost to the market.
