Navigating Growth: Challenges and Opportunities in the Small Molecule CDMO Sector
Current Opportunities and Reasons for Rising Demand:
The dynamics of pharmaceutical manufacturing situate small molecule Contract Development and Manufacturing Organization (CDMO) sector at the intersection of the challenges and opportunities, navigating complexities while seeking avenues for growth and innovation. Globally, the surge in demand for the small molecule CDMO sector remains increasing and there are several reasons for this. Firstly, the rising demand of personalized medicine is spearheading the need for small molecule CDMO manufacturers. Secondly, the increasing global outsourcing trends of drug discovery, development, and manufacturing activities to CDMOs. The need to reduce drug manufacturing cost and reduce the lab-to-market timeline also seems to be fueling the need to employ small molecules CDMO services.
Expansion in the generic drug market and favourable government support for CMO/CDMOs has led to a sharp increase in partnership between the service providing organizations and pharma companies.
Patient-centric care and manufacturing has led the pharma companies to design patient-focussed drug products. For both patients and healthcare providers, oral solid dosage is the best and convenient route for drug administration. Driven by technological innovation and specialization in small molecule drug discovery, CDMOs have been successful in supporting pharma companies. CDMOs have already been providing microcapsule formulation and taste masking solutions, thereby improving swallowability and palatability, resulting in patient adherence to the dose regimen.
The pharma industry has always been driven by constant innovations with the need for cost efficiency, quality assurance and regulatory compliance, CDMOs’ ability to provide integrated services during all the phases of drug development and manufacturing offers the pharma companies one-stop solution.
Apart from tremendous organic growth seen by CMOs/CDMOs, they have also been growing through mergers and acquisitions, and simultaneously expanding their capacity and capabilities, such as formulation and hard-to-formulate drugs.
Challenges in the Small Molecule CDMO sector:
Complexities in Development:
There are various complexities involved in small molecule drug manufacturing. It requires special expertise and latest technologies to handle formulations, process optimization, late-phase development, and commercial supply capabilities. Additionally, regulatory compliance is a significant challenge, with CMC (chemistry, manufacturing, and controls). CDMOs have developed proficiency in advanced manufacturing technologies and hence are the most sought-out partners for pharmaceutical companies.
Due to the complexity involved in small molecule development, optimizing manufacturing processes is vital for smooth manufacturing. CDMOs specialize not only in process development and optimization but can also help in overcoming formulation challenges. CDMOs can provide customized solutions, streamline production, and reduce costs, thereby enhancing the chances of successful product development.
Sourcing of Raw Materials:
Sourcing of the key raw materials was severely impacted during COVID-19. Post-COVID-19, CDMOs still continue to face bottlenecks in procuring raw materials. These procurement issues lead to understocking and sometimes overstocking of raw materials, as well as expiration of materials. These issues affect production, increase cost, and result in delays and disruptions. To counter this, CDMOs have developed multi-sourcing and right-shoring strategies to enhance capacity and capability, and have shifted supply chain segments to strategic locations.
Innovative Packaging Solutions:
The pharma continues to face logistics, supply chain, sustainability issues and counterfeit drugs. Consequently, these factors result in a drastic drop in revenue and above all can be detrimental for patient health. CDMOs have been at the forefront in providing solutions by using softwares to develop clinical packaging and labeling.
Conclusion:
CMOs/CDMOs continue to work towards making every complex procedure simple, improve efficiencies, optimize production, eliminate wastage, and avoid bottlenecks while maintaining the highest standard of compliance. Overcoming these challenges definitely help all the stakeholders involved including the pharmaceutical companies, CMOs/CDMOs and patients.
