Vetter is a global provider for fill and finish of aseptically prefilled syringe systems, cartridges and vials. Headquartered in Ravensburg, Germany, the company operates production facilities in Germany and the U.S., as well as sales offices in Singapore and Tokyo, Japan. The contract development and manufacturing organization (CDMO) serves small, midsize, and the top 10 (bio-)pharmaceutical companies. Its portfolio spans manufacturing from early clinical development through commercial filling and final packaging of parenteral drugs. More than 80% of Vetter’s active projects are biologics, and Vetter currently manufactures five of the world’ top 10. In January, Vetter began operations in its expanded Visual Inspection and Logistics Center in Ravensburg, which cost the company $107 million and took five years to complete. Contract Pharma talked with Mr. Soelkner about trends in the market and Vetter’s response to them.
Contract Pharma: What pharma/biopharma macro trends are you seeing and how are they trickling down to impact aseptic fill/finish operations?
Peter Soelkner: One trend that we see, in particular, is the increase in the overall complexity of individual drug substances, which, in turn, affects all parties along the supply chain that are involved in the handling and processing of these substances.
We are experiencing an increase in therapies that are focused on conditions affecting small patient populations, what we commonly refer to as orphan drugs. By U.S. definition, orphan drugs are those developed for treating conditions affecting fewer than 200,000 persons. According to the Evaluate Pharma, World Preview 2016, Outlook to 2022, from the period of September 2016 until 2022, sales volume in orphan drugs is expected to increase significantly, effectively doubling.
Patients are requesting innovative drug-delivery systems that fit better with their mobile lifestyle of today as compared to several years ago. Having access to modern systems is important since it helps support patient acceptance and compliance. The digitalization of systems, for example, a pen system that reminds you to take your medication in a calculated dosage, supports this need and is likely to increase its importance within the (bio-)pharmaceutical industry.
Meanwhile, major areas of the developed world are experiencing growth in aged populations which has resulted in an increase in associated diseases such as cancer and diabetes, to name but a few. Because illnesses like diabetes can often be treated in private settings, there has been an impact on the homecare sector, creating a need for appropriate devices to be used in this setting.
Costs and their downward pressure on healthcare systems are also increasing. That means a greater need for efficient, but at the same time price-attractive treatments. Today, we see that in a lot of countries those drugs that have proven efficacy and therapeutic effect, and which offer advantages over existing therapies, are reimbursed. Pressures on pricing will also further support the homecare sector in an effort to avoid cost-intensive treatments in hospitals or at the local doctor.
CP: What are the most important trends in aseptic fill/finish outsourcing today?
PS: The primary trend we experience first-hand is the increase in demand of quality requirements from customers and regulatory bodies. To fulfill these requirements on a day-to-day base is a challenging task because the drug substances themselves have become ever more complex. Large molecules like biologics are, by their very nature, complex products. Their share in the overall global pharmaceutical market has increased continuously over the past several years. According to a 2016 IMS report, the global biologic medicines market is projected to exceed $390 billion by 2020, with sales rates growing anywhere from 10-15% annually.
Another important trend is combination products which have increased in importance as (bio-)pharmaceutical companies look to more attractive drug-delivery devices to help differentiate their products. Such an approach creates both opportunities and challenges for contract development and manufacturing organizations (CDMOs). Starting with the opportunities, they result from a growing demand for higher-value filling requirements and the subsequent need to assemble and package the devices. The challenges arise from the non-standard nature of the devices and the fact that they are of course designed to appeal to the patient, but some of which with little regard for ability to manufacture. This situation easily results in complex, and therefore cost intensive, manual assembly operations.
CP: How would you describe the current state of the aseptic fill/finish outsourcing market?
PS: According to the business information portal Visiongain, over the past several years the global contract (bio-)pharmaceutical manufacturing market grew at an average annual rate of 7.5%. Therefore, we remain optimistic for the future and expect the global market to continue this growth in 2017.
According to a 2016 survey by the trade magazine International Pharmaceutical Industry (IPI), which included more than 400 professionals from the (bio-)pharmaceutical and contract services industry, 73% answered ‘yes’ to the question that pertained to an increase in demand for outsourcing. The reasons given included a 41% response rate for a focus on core competencies, and 59% spread between their virtual character, such as a lack of in-house capabilities, or the use of suppliers to incorporate a secondary supply strategy. Approximately 80% of sponsor company respondents view contract relationships as partnerships. This too, is how we see and define our role in this business.
Aging populations have created an increased demand for associated diseases like cancer, diabetes, autoimmune, metabolic, and nervous system disorders, as well as a demand for additional new diseases including orphan drug treatments.
In our opinion, prefilled syringes are one of the growth drivers of the fill and finish market, and consequently for the outsourcing business, representing one of the most rapidly expanding segments of the injectable drug delivery device market. This is not surprising since they are able to offer key differentiating factors such as improved safety, accurate dosing, reduced risks of contamination, as well as ease of administration.
When we look at the hurdles the industry will likely face, we can indeed expect new future challenges in various aspects such as in the regulatory, financing, human resources, or process field. That is why as an industry, we must work hard and smart, and in a well-orchestrated manner. This must be our priority if we are to meet the needs of the patients who are, afterall, at the very core of our reason for being. Members of this promising market need to overcome individual roadblocks successfully, which means achieving the required quality levels and the foresight to go in new and innovative directions in order to succeed. Doing this in the form of trustful partnerships will most likely increase ones chances for success in this industry.
CP: What are the key new technology innovations making an impact?
PS: We believe that technology must always be linked to, and aligned with the needs and demands of the market. With that said, we see major requirements for flexible and multi-product facilities.
There is a trend for smaller batch sizes, resulting from therapies for a small population. This need must be reflected in the technological performance of the manufacturing companies as well as the respective service providers. This means finding appropriate ways to efficiently handle the smaller batch size itself, but also the higher switch rate from one order to the next. And, it means that next to the filling process itself, the decontamination of the cleanroom is affected. Innovative concepts in this field can help contribute to increased operational excellence in aseptic manufacturing. One of the two distinct cleanroom technologies available today is the restricted access barrier systems (RABS) technology, and the other being isolators. RABS achieves the sterility assurance level (SAL) required by regulatory authorities and allows for rapid product changeover along with high safety. To better meet future industry trends in quality, safety and flexibility, combining the advantages of isolator and RABS technology seems quite promising. Applying a form of “Improved RABS concept” and thus, achieving by today’s standards, a uniquely fast and fully-automated decontamination of the cleanroom using hydrogen peroxide (H2O2), means a high level of technological and process innovation.
Single-use technology is another emerging trend along with innovation in the fill and finish segment. However, large parts of the industry do not believe that single-use equipment will replace stainless steel technology overall. Nevertheless, it can be a valuable option within special fields of the production process. Both technologies have their respective pros and cons. As a key guideline, single-use equipment is especially suitable in cases when a drug substance comes in direct contact with the equipment being used.
CP: Where do you see the market down the road, say in five years time?
PS: We see the increase in access to medicine in developing and emerging countries being one of the results of a continuous increase in globalization. This development generates new potential and growth opportunities for the market and its participants. In regards to supply chain and its requests from the customer end, its complexity is increased and becomes more multi-faceted. Applying digital innovations such as the successful collection, storing, analyzing and processing of what is called “Big Data”, can be helpful tools in supporting the production and supply planning processes for (bio-)pharmaceutical companies and their strategic partners.
We see individual treatments increasing due to continuous advances in the discovery of the human body, and enabling subsequent targeted medical treatments.
While outsourcing is on the rise, sponsor firms are becoming more selective about which service provider they are willing to partner with. CDMOs that consistently meet various global regulatory standards, quality requirements, and customer’s reliability expectations will clearly have a competitive advantage.
The September 2016 PharmSource Information Services report revealed that the service provider market can be segmented into either “innovation-driven” CMOs, or “capacity-driven”. Innovation driven CMO’s, which supported a significant number of new drug application approvals over the past ten years, focus on higher-value market opportunities. Capacity-driven CMO’s are essentially focused on filling undifferentiated manufacturing capacity, and primarily produce generics and/or late lifecycle branded products.
We also see the continuation in the consolidation of companies being part of the pharma and biotech medical market, along with an increase in investments and in modular manufacturing.
In conclusion, we believe the market will continue with promising opportunities for those companies that are well-orchestrated and prepared for the needs of their large and small (bio-)pharmaceutical customers today and tomorrow.
CP: What is the latest news at Vetter on the aseptic fill/finish front?
PS: In January, Vetter began operations in its expanded Visual Inspection and Logistics Center located in Ravensburg. The enlargement, in which we invested approximately €100 million ($107mn), bundles capacity for our final product inspection and logistics in one cutting-edge site. By finalizing the second construction stage of the site that was initially put into operation five years ago, we are now able to offer more than double the capacity for state-of-the-art quality control, cold-storage and room-temperature storage. Given the increasing industry-specific requirements emanating from the customer and regulatory side, we now provide even more efficient and flexible supply chain processes. The expanded center is located on approximately 50,000 square meters (538,000 square feet) of floor space and offers a 35,000-pallet warehouse capacity for storing pharmaceuticals in refrigeration or room temperature conditions. This allows us to react with greater flexibility to individual market and customer needs.