CROs and CMOs Continuing Drug Delivery Innovation

Drug delivery has been an avenue for innovation in the drug development industry for decades.  Initial improvements focused around delivering medicine with the maximum efficacy and safety in a form accepted by patients, leading to greater patient compliance. At the time, the potential financial impact of drug delivery technology wasn’t appreciated and therefore couldn’t sway Big Pharma’s focus from finding the next blockbuster. As a result, specialty pharmaceutical companies took up the mantle and began to offer the service while Big Pharma retained its focus. This resulted in partnerships with benefits for both parties when it became clear that improved drug delivery boosted therapeutic potential and that experimentation with delivery forms could lead to additional therapeutic indications, providing a different facet of innovation. As the need for drug delivery innovations specific to biologics unfolds, we can anticipate a new type of relationship emerging. Over the past ten years, a number of contract research and contract manufacturing organizations have added drug delivery technologies to their service offering.  It makes sense for manufacturers to be concerned with improved delivery as it helps to reduce wastage of valuable therapeutics.  Whether in the form of overfill, disintegration or lack of absorption, a reduction in the required dosage increases profit margins for manufacturers. In addition to the benefits inherent to manufacturing, proprietary delivery technology can cement customers into long-term relationships. Looking to 2013, there is a steady demand among buyers of outsourced services for drug delivery support. Results from the Nice Insight Pharmaceutical and Biotechnology Outsourcing survey show that one in five plan to outsource a drug delivery project in the coming year. Big Pharma comprises the largest segment of drug delivery outsourcers at 42%, followed by Biotech (23%), Specialty Pharma (16%), Emerging Pharma (12%) and Emerging Biotech (7%). Considering the challenges inherent to delivering biologics-based therapeutics, it isn’t surprising that four out of five who outsource drug delivery are engaged in the development of biologic-based therapeutics. The development of biologics-based therapeutics drives the need to consider drug delivery technology earlier in the development cycle, which was reflected in research results in several ways. These outsourcers supported a growing trend among biopharma companies, which is to engage outsourcing partners earlier in the development lifecycle.  More than half (55%) of drug delivery outsourcers agree it would be valuable to use the same delivery form from early phases through the development cycle.  Also, when respondents were asked specifically which companies they would consider when outsourcing a project, CROs held two of the top three positions. Respondents selected Boehringer Ingelheim, Covance, ICON and Baxter BioPharma as their top four choices when outsourcing drug delivery.  There was a three-way tie for fifth between AAI Pharma, Alkermes and Catalent.  The top CMOs mentioned by respondents—Boehringer Ingelheim and Baxter BioPharma—received “excellent” scores for quality and reliability, which are the two most important outsourcing drivers according to this group.  However, these two companies were perceived as less affordable compared to CROs, Covance and ICON. Among CROs that offer drug delivery services, Covance and ICON received the highest quality and reliability scores of the group. Yet, interestingly, the CRO companies received their highest scores in productivity and regulatory compliance.  This suggests that different criteria are driving drug delivery business to CMOs (quality and reliability) and CROs (productivity and regulatory history). As the outsourcing model evolves towards more strategic partnerships, where biopharmaceutical companies are looking to CROs and CMOs in order to access specialty skills as well as improving quality, it makes sense for these contract providers to expand their service offering to include drug delivery. The results will likely be mutually beneficial to the drug developer and contract organization, helping each of them to maximize their resources.
Survey Methodology: The Nice Insight Pharmaceutical and Biotechnology Survey is deployed to outsourcing-facing pharmaceutical and biotechnology executives. The 2012-2013 report includes responses from 10,036 participants. The survey is comprised of 500+ questions and randomly presents ~30 questions to each respondent in order to collect baseline information with respect to customer awareness and customer perceptions on the top 100+ CMOs and top 50+ CROs servicing the drug development cycle. Over 900 marketing communications, including branding, websites, print advertisements, corporate literature and trade show booths are reviewed by our panel of respondents.  Five levels of awareness from “I’ve never heard of them” to “I’ve worked with them” factor into the overall customer awareness score.  The customer perception score is based on six drivers in outsourcing: Quality, Innovation, Regulatory Track Record, Affordability, Productivity and Reliability.