Determining the full and accurate cost of developing a novel drug is a complex process involving many variables. Each of these variables is in turn defined by a variety of intricate processes and considerations, and virtually every factor involved is both difficult to estimate and prone to unexpected and unpredictable complications.
Ascertaining New Drug Development Costs
When speaking of industry average costs, it is important to bear in mind that biotech companies typically present final cost calculations that may not include complete data. Some companies may choose to report numbers that do not include capital costs incurred during the lengthy preclinical drug discovery process, which will generally entail a period of at least 10 years.
Even if a company chooses to include these costs in addition to the considerable expenses involved in conducting various clinical trials, they seldom indicate whether their final figures include out-of-pocket expenses, capitalized costs, or both. An additional complicating factor is that published figures are based solely on information that companies release voluntarily; these figures may not reflect an accurate assessment of costs due to the withholding of confidential or proprietary information.
High Stakes, High Risk
Though arriving at an accurate figure for the average cost of new drug development may be difficult due to the nature of the analyzed data, various studies over the past decade have estimated capitalized costs alone to average out to approximately US $1.8 billion. Combined with out-of-pocket costs, that figure climbs significantly; in some studies, the total cost involved in the development and approval process of a new drug compound was reported to be as high as US $5.5 billion.
This variance underscores a central reality in drug development: the process is highly mutable and involves significant unpredictability. Though industry average numbers may be difficult to accurately determine, developing a new drug and bringing it to market involves substantial investment and considerable risk.
Minimizing Exposure to Risk: Strategic Outsourcing
Tremendous costs are involved in the design, construction, and ongoing maintenance of new facilities capable of providing the components necessary for successful drug development. The risks entailed in this significant investment are compounded by the highly variable length of time involved in process development. Once a new drug is finally identified, these facilities would be tasked with handling the necessary migration from lab-scale to commercial-scale manufacturing. For a company that opts to construct its own facilities, this phase represents additional capital investment needs as these facilities are expanded or retooled to handle scale-up.
The ability to forgo some of the costs involved in this process represents an important tactical option for companies involved in identifying new drug compounds. Through outsourcing every phase of process development and scale-up to an adequately equipped contract development and manufacturing organization (or CDMO), biotech companies can minimize their risk in terms of initial necessary and ongoing investment. Furthermore, this allows these companies to focus their efforts on their primary objectives and areas of expertise: research and development.
The Right CDMO: Samsung BioLogics
The CDMO outsourcing options available to companies focused on identifying and developing new drugs continue to grow. Finding the right CDMO for your company can be overwhelming, especially for newer companies which may be outsourcing for the first time. Determining the range of services offered by a candidate CDMO is critical when choosing an outsourcing partner.
Samsung BioLogics is alone among CDMOs in possessing the largest and most advanced capabilities in the world. They are a fully integrated CDMO capable of handling every step of the process, from cell-line and process development, manufacturing for both clinical and commercial phases, drug product filling, independent quality-control testing in a laboratory setting, and essential biosafety testing for all developed products.
Samsung BioLogics is unique in being able to provide and manage the considerable coordination and complicated interactions needed between personnel, cleanroom facilities, filling and finishing equipment, and sterile product and filling components necessary for aseptic filling through every stage of bringing a new drug to the commercial market. This capability ensures that the small or mid-sized pharmaceutical company can rely on Samsung BioLogics to provide custom, tailored service through the entire lifecycle of new drug development—from small-scale clinical and developmental production all the way through rapid and streamlined scaleup in manufacturing for the commercial phase.
To further mitigate costs and contribute to the successful development and approval of new drug compounds, a CDMO must also have a proven record of exceptional quality and regulatory management. Here again, Samsung BioLogics represents unparalleled excellence. Samsung BioLogics has a batch success rate that reaches a remarkable 98% and can list scores of international product approvals from the US Food and Drug Administration, the European Medicines Agency, and Japan’s Pharmaceuticals and Medical Devices Agency.
Finally, perhaps the most important criterion in choosing a CDMO partner involves product delivery. In order to safeguard the successful development and approval of a novel drug compound, a CDMO must be capable of unfailingly delivering product both by the deadline and in complete quantities.
Redefining Excellence in the CDMO Sector
Samsung BioLogics is a one-stop service provider with an industry-leading capacity of 362,000 liters across three of the world’s most advanced facilities. Developed over the company’s eight years in business, these facilities are capable of handling every phase of drug development, testing, approval, and manufacture.
Samsung BioLogics continues to offer unrivaled performance in terms of quality, cost of services, and speed of development and production. By providing a truly end-to-end service, Samsung BioLogics maximizes client satisfaction, providing the most advantageous, reliable, and advanced outsourcing partnership available in drug manufacturing.
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