Market Trends of Investigational New Drug CDMO Industry
The Contract Manufacturing Segment is Expected to Witness Significant Growth During the Forecast Period
Pharmaceutical drugs have a complex structure, which makes it difficult for companies to meet the requirements of specific techniques and equipment during mass production. Therefore, companies usually opt for a contract manufacturing process.
Segmental growth is majorly driven by factors such as increasing strategic activities taken by the companies and the growing demand for contract manufacturing in the pharmaceutical and biotechnology sectors. For instance, in May 2022, ALSA Ventures collaborated with Lonza to help ALSA’s development of pre-clinical and early clinical biotechnology products and manufacture biologics and small molecule drug candidates. The collaboration aimed to significantly increase the chances for the future success of these therapies by providing early de-risking, development, and manufacturing services. Such company activities in contract manufacturing are expected to propel segmental growth over the forecast period.
In September 2022, Bora Pharmaceutical Laboratories Inc. (Zhunan), a division of Bora Pharmaceuticals, partnered with TaiRx Inc., a new drug development company based in Taiwan, to manufacture a novel anti-cancer drug, CVM-1118. In various human cancer cell lines, CVM-1118, a novel small molecule chemical entity, exhibits substantial anti-cancer efficacy, a large safety margin, and multiple modes of action in targeting cancer-specific components.
Therefore, owing to rapid movement by the CDMOs, the segment is expected to grow significantly during the forecast period.
North America is Expected to Hold a Significant Market Share Over the Forecast Period
The North American countries have well-established pharmaceutical and biotechnology sectors, which is beneficial for the market. Also, these countries have made significant investments in research and development activities, fueling market growth across the region.
The growing focus on expanding and launching manufacturing facilities in various countries to fuel the production of biopharmaceutical drugs is expected to propel the growth of the market. For instance, in September 2023, Bolt, a California-based clinical-stage biotechnology company, partnered with Samsung Biologics to accelerate the execution of its early-phase drug development for IND submission. With such partnerships, the market is expected to witness considerable growth in the United States.
Companies that are involved in investigational new drugs tend to wait for the FDA's Safe To Proceed letter before proceeding further. The process is time-consuming; hence, companies are taking advantage of a pre-IND labeling and packaging strategy for their clinical studies. Companies such as PCI Pharma Services are doing this by working with a CDMO operating in Canada. PCI Pharma Services is the only company in Canada that provides clinical trial services. Hence, with the emergence of such companies, the IND CDMO market in the country is expected to grow significantly in the coming years.
Therefore, with increasing company activities and high investments in R&D, the market is expected to grow in the region during the forecast period.
