Manufacturing Chemist, March 2015
The sterile injectable market is an active segment for CMO investment right now and will continue to be as the market strengthens from outsourced vaccine production, biologics and increasingly, biosimilars. This, along with a shift we’ve seen towards engaging CMOs for their expertise more than just tactics, means there are opportunities to lock in long-term agreements, which benefit both drug innovators and CMOs.
In an area of the contract manufacturing industry that had been slow to see change, CMOs that offer sterile fill finish services have the opportunity to partner with drug innovatorsin new ways as biology based therapeutics become the focus of drug development pipelines and targeted / personalized medicines become more common. Current buzz in sterile fill revolves around scalability and flexibility of capabilities — both in terms of equipment and knowledge among the team. In order to ensure drug integrity when rapidly scaling up to meet avaccine need, or efficiently changing over to a new product, many CMOs, are investing in innovative, high performance production lines to attract business and offer drug innovators a competitive advantage by partnering with them.
Nice Insight’s research has shown that over the past five years there is a trend to engage external support earlier and earlier in the development cycle. The 2015 results reveal that 17 percent of respondents will engage a CMO for development services during phase I/II, and among those, 70 percent will do so for large molecule API support – a significantly greater number than those who will engage a CMO for small molecule API support, 53 percent. Two-thirds of the respondents engaging a CMO for development services are seeking injectable development support. When drug innovators are evaluating a CMO for an early phase partnership, they tend to seek one whose offering spans from development support through to fill finish. Additional opportunities come with expertise in drug delivery systems or lyophilization.
The Nice Insight research team reviewed the data for companies that have the following capabilities: injectable product development, commercial scale injectable, lyophilization, sterile fill finish and drug delivery expertise. These companies included in the study fit the bill: AAIPharma/Cambridge Major Laboratories, Akorn, AMRI, Boehringer Ingelheim’s Bioexcellence, Catalent, Cook Pharmica, Fareva, Hospira One 2 One, Pii, Therapure and Vetter.
When considering a CMO for an outsourced injectable project, especially when looking to utilize the same CMO for injectable development support through to fill finish, one should start by reviewing how the potential contract manufacturers are rated on key performance metrics. Nice Insight research measures customer awareness and customer perception based on six key performance metrics: quality, reliability, innovation, regulatory trackrecord, productivity and affordability. Companies are evaluated by buyers of CMO services on these six metrics, and an overall customer perception score is assigned based on the average rating ineach of the six categories.
A supplier with solid quality and reliability scores will assist in risk reduction, and a CMO with a strong productivity rating will likely support goals towards improved efficiency. Quality and reliability are consistently ranked as the number one and two drivers influencing CMO selection, and this year, productivity ranked third, having climbed up from fifth place just two years ago according to the overall respondent group. When looking specifically at how outsourcers of injectable development support rank thedrivers, the top three fell in line with the overall ranking; however, these outsourcers prioritized innovation over acompany’s regulatory track record and indicated that affordability was the least influential driver in selecting a CMO. It makes sense that these outsourcers in particular value a contract suppliers’ innovation, as a CMO’s investment in new production technologies enables the contract manufacturer to offer drug innovators solutions that are not available in-house.
According to survey respondents, the CMOs that offer early phase injectable product development outperform the average CMO. This is clear when reviewing the benchmarks for injectable development and comparing them to the overall CMO benchmarks. The aggregated customer perception score, which is a combined score based on all six outsourcing drivers, is five percentage points higher in the injectable development benchmark over the CMO benchmark. These CMOs had a five percentage point advantage over the CMO benchmark scores when it comes toquality, reliability and innovation as well; and a six percentage point difference when comparing the productivity benchmarks.
When looking specifically at the companies included in the research to see how buyers of injectable product development services rated their performance, Vetter showed clear favor, with the top score in three categories — quality, reliability and productivity. Vetter placed second in innovation. Boehringer Ingelheim’s Bioexcellence received top marks for innovation, and third position for reliability. Hospira One2One appeared in second place for reliability, and third for both productivity and innovation. The remaining companies received billing in the top three one time each: Catalent and AAI Pharma/CML took second and third place in quality. Therapure took second place for productivity and Cook Pharmicatied for third position with Hospira One2One in innovation.
Since seven of the eleven of the companies included in the Nice Insight research with injectable product development, commercial scale injectable, lyophilization, sterile fill finish and drug delivery expertise show strong scores in the key performance metrics specific tothe injectable development services buyers, it makes sense to consider additional factors that contribute to astrong long term relationship. When itcomes to hard traits—attributes that are easily quantifiable or measurable—buyers of injectable development services prioritized the same qualities as the broader group, with a track record /history of success as the primary metric. Financial stability of the supplier and technical/methodological expertise rounded out the top three.
In reviewing the soft traits — attributes that are difficult to measure, because theyare more evocative of a feeling — there werea couple of distinct differences between buyers of injectable development services when compared to the broader group of buyers of CMO services. Namely, those who outsource injectable product development stated that understanding the customers’ requirements to be the top priority, whereas, this metric placed third among the overall group. Good communication appeared in third place among injectable development outsourcers, as compared to first position in the wider group. Additionally, the adaptability of a CMO to meet changing needs or the innovator’s desired methodology was prioritized higher among those engaging CMOs for injectable development support.
Outsourcers of injectable product development stand to benefit from engaging a CMO during development because the CMO can help them to avoid potential pitfalls that may delay or derail a project. For example, utilizing the same CMO from development through to fill can ensure the drug product doesn’t react to or degrade due to the packaging or delivery system because the CMO can adjust ingredients, components or packaging materials in early clinical stages to avert problems during commercial scale up. Considering the CMOs that offer development services, especially sterile injectables, outperform CMOs in general on key performance metrics, it makes sense to partner during the development stage and maintain the relationship through to commercialization, especially when working with complex, sensitive biologic formulations.