Ypsomed’s platform product transformation and approach to strategic partner networking

Pharma – the great outsourcer

​In 2023 global pharma sales were estimated at USD 1.6 Trillion, with the top 25 global pharma companies accounting for around 50 % of these sales. Today, biologics account for over USD 500 Billion or just over 30 % of global pharma sales. This is set to grow further as pharma develops more self-injection devices in the focus therapy areas of oncology, neurology, and rare diseases in addition to the larger and growing markets for treating broader autoimmune diseases and insulin/GLP1-based drugs for treating diabesity.
​With a ~15% spend on R&D and average cost of goods at ~25 % pharma invests around USD 650 Billion in R&D and operations with as much as half outsourced to a broad range of organisations including CROs (contract research organisations) for R&D and CDMOs (contract development & manufacturing organisations) for manufacturing. Overall, outsourcing is a key activity for pharma and their supply chains have become global and complex. With more outsourcing, new modalities, and novel ways to reach patients, it is critical to ensure that outsourcing networks are robust and can withstand shocks.

​The platform product approach to self-injection devices

​The platform approach for injectable drug delivery emerged through the use of prefilled syringes for the injection of heparins and vaccines and prefilled cartridges for insulin and dental lidocaine. Many of these innovations were introduced in parallel to the development and growth of the markets for these molecules in the 1980s. During the 1980s the self-injection market developed with more bespoke, dedicated devices as insulin and human growth hormone (hGH) were developed and needed to be dosed using an accurate pen mechanism for frequent, typically daily, injections.
​​In the 1990s and 2000s, the development of interferons and monoclonal antibodies (mAbs) led to the introduction of spring-driven automated autoinjectors for less frequent injections based on fixed doses. Until 2006, when the first handheld prefilled autoinjectors were launched, there were few self-injection devices on the market. At that time the market was dominated by the pens from insulin manufacturers like Novo Nordisk, Lilly and Sanofi and the first prefilled autoinjectors for the two anti-tumour necrosis factor (TNF) antibodies adalimumab (Humira®) and etanercept (Enbrel®).
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​The 2000s were transformational for both pens and autoinjectors with the introduction of platform-based business models and a growing number of drug product launches in the 2010s. Platform products refer to self-injection standardised device technologies supplied from common manufacturing infrastructure. Already established in other industries, platforms serve to de-risk and accelerate the development and manufacture of a variety of customised product iterations. In contrast to bespoke devices designed for individual drugs, platforms are versatile and accommodate different drug requirements, such as primary packaging configuration, dose volume or drug viscosity.
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​There has been a notable shift recently toward customising platforms to create a spectrum of drug-device combinations, resulting in a simplified access to advanced drug-device combination products for a wide range of biopharmaceutical customer segments, including small biotechnology innovators, emerging biosimilar manufacturers and global big pharma - the latter often adopting a platform-in-platform approach to further streamline the serial launch of injectable drug-device combination products with proven supply chains, partnerships and manufacturing infrastructures.

​Ypsomed’s platform product partnership strategy

​Pharma has developed four key elements to improve supply-chain resilience for their drug products:

• ​Mapping of its suppliers with end-to-end transparency to fully understand the supply chain and identify potential vulnerabilities.
• ​Performing routine stress-testing and reassessment which often entails regular audits of critical suppliers.
• Reduction in exposure to shocks through multi-sourcing and striking a balance between just-in-time and just-in-case inventory levels.
• ​Ensuring that supply-chain risk and resilience is embedded in the pharma organisations’ strategic planning and day-to-day execution, with structured governance to ensure that decisions are made and acted on at the right level and time.

​All of these aspects are mirrored within Ypsomed’s Delivery Systems structures and processes which are designed to develop long-lasting and trusting partnerships with pharma customers. Of these points, end-to-end transparency, and structured governance, are important aspects within the strategic partner networks of suppliers that Ypsomed maintains to benefit both pharma clients and patients alike. Ypsomed’s approach to both customer and networking partnerships are elaborated below.

More about Ypsomed's Platform Strategy

​Collaborative partnerships and regular audits

​Ypsomed supports a wide range of small biotech, mid-size pharma and big pharma customers around the globe. The complexity of the pharma supply chain demands an open exchange on technical, logistical as well as commercial topics. Ypsomed’s cross-industry expertise in drug delivery is highly valued by our customers. Our specialists have guided numerous customers through the design and development of innovative self-injection devices, and through the compilation and review of data required for product registration. Throughout all project phases, such as customisation to individual design requirements, human factor studies, clinical supply, or regulatory filing, all competencies are centred at Ypsomed headquarters in Burgdorf, Switzerland. This enables an efficient dialogue among experts, supports rapid learning processes across specialist fields, and helps to both establish and sustain effective risk management programmes.

​Building a global manufacturing network

​Over the last 10 years Ypsomed has manufactured more than 25 million reusable pens and 1 billion prefilled pens. In addition, over 100 million prefilled autoinjectors have been supplied since the 1st launch of YpsoMate in 2018. To accommodate the growing volume demand and new product launches, Ypsomed is expanding manufacturing in Switzerland, Germany, China and North America. The two high-volume platform products, UnoPen and YpsoMate 1.0 mL, are manufactured at multiple sites today and this will be extended to the new sites in China and North America.
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​To free up manufacturing space and focus on core platform products, Ypsomed has announced the discontinuation of existing contract manufacturing and pen needle manufacturing at its large manufacturing site in Solothurn, Switzerland. In addition, Ypsomed’s in-house toolmaking located in Burgdorf will be mirrored at the Solothurn site over the next 1-2 years. Higher cavity tooling and larger subassembly lines are being installed to increase manufacturing efficiency. This is reflected in the annual investments in fixed assets of CHF 120 million in the 2023/24 business year which will increase to a total of CHF 1,500 million for the next 5 years. The ability to supply platform products from multiple sites globally significantly reduces risks for our pharma partners and their largest drug franchises and manufacturing close to the end market is more efficient and sustainable.

​Serving all customers

Ypsomed serves all therapy areas and customer segments with its platform products. Each customised product version is therefore supplied on a non-exclusive basis. Shared development and manufacturing infrastructure/ resources benefits all customers. Today over 70 separate drug products based on Ypsomed platforms are on the market around the world with a further 150 projects moving through clinical trials or being prepared for commercial launch. YpsoMate autoinjectors have now been launched for 20 different branded drug products with growing numbers of launches anticipated over the coming years. The largest number of projects are in the autoinjector space for treating autoimmune and rare diseases followed by pens and autoinjectors for the insulin and GLP-1 franchises.
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​For projects serving high-volume commercial quantities Ypsomed supplies initial volumes through its shared platform product infrastructure and expands its manufacturing capacities in line with customer forecasts. Dedicated manufacturing lines for individual customers are also considered for the largest drug franchises. In order to reduce dependencies for such franchises, third-party contract manufacturing may also be considered under a royalty scheme.

​40 years of strategic network partnerships – extending the platform beyond the device 

For 40 years Ypsomed has built up a network of trusted strategic partners, that just like Ypsomed, serve as key suppliers to our pharma customers. Over the last 20 years these relationships have moved from cartridge-based peptide therapies for pens to include syringe-based autoinjector therapies to serve pharma and patient needs for antibody-based therapies. While Ypsomed strives to be best in class in the development and manufacture of self-injection devices, we partner with all key suppliers to make sure the drug-device combination product is supplied fast, on-time and fulfils both pharma and patient needs. By nurturing these strategic partnerships, pharma customers profit from best-in-class systems which lead to reduced costs and shorter timelines during the clinical, approval and commercial phases for each drug product. A recent example is how Ypsomed has entered into a strategic partnership with Interface Analysis Associates LLC (IAA), a leading HF service provider with long-standing expertise in supporting the pharmaceutical industry along the full combination product development journey.

More about Strategic Partner Network

​Primary container compatibility specialist

The starting point for every injection drug-device combination product is the primary drug container, the cartridge or pre-filled syringe. These containers are typically glass, may be polymer-based, but only function as a container system in combination with the elastomeric components that seal the drug in the container, e.g. a bilayer combi-seal, a needle-shield or a plunger. Understanding the primary drug container system and its interfaces with the injection device are key. Ypsomed collaborates and consults with both the customer and involved networking partners throughout the whole project to ensure that the selected drug container is fully compatible with the Ypsomed platform product whether the device is a pen injector, autoinjector or patch injector.
​Ypsomed collaborates with over 15 different glass and elastomer manufacturers worldwide and tests the container variant prior to and during each and every project. When a primary drug container does not yet exist for a new platform injector, Ypsomed collaborates with leading suppliers to define and develop new industry standards as is the case for the recent platform product developments YpsoMate 5.5 mL and YpsoDose 10 mL.

​Final assembly equipment and CDMOs

​Final assembly of the drug with the prefilled pen injector, autoinjector or patch injector device is fundamental to the success of drug-device combination products. The development of easy to assemble platform products led Ypsomed to collaborate with a group of leading assembly equipment manufacturers. These companies supply scalable assembly solutions for both clinical and commercial supply based on clearly specified ready-to-order equipment. This extends to process aspects such as functional release testing, labelling and final packaging. If a pharma customer is considering final assembly, Ypsomed is at hand to make recommendations and facilitate the selection based on its established global network of fill/finish and final assembly CDMOs (contract development and manufacturing organisations). For YpsoDose, Ypsomed not only collaborates with SCHOTT Pharma for the 10 mL cartridge, but also with ten23 to harness their formulation and process development, filling, assembly, and testing (QC) of the final product.

Fill/finish and other networking specialists

​Understanding the cartridge or pre-filled syringe dimensions is important, but understanding the filling process and the filled container as a system are critical to completing successful ISO verification testing for each combination product. Ypsomed collaborates with sterile filling equipment manufacturers to keep up to date with the latest filling process developments. Their equipment is located within pharma manufacturing and within the global network of CDMOs which are involved in more than 50 % of all projects. With over 130 active customers, Ypsomed is a proactive and fully integrated player in the global pharma and CDMO manufacturing network.
​Whether pharma customers are looking to establish contact within the global drug-device consulting network, or to source trainer devices, or other specialist know-how, Ypsomed is always available to make recommendations from its rich partner network.

​Strategic networking is part of our DNA

Drug-device development and manufacturing is complex and more demanding than just understanding the device itself. Ypsomed has been at the heart of the combination product ecosystem for 40 years. Ypsomed’s comprehensive pen and autoinjector platform portfolio, including UnoPen and YpsoMate, and its partner network, are ideally positioned to support the burgeoning demand for self-injection devices.