In recent years, the outbreak of the new crown epidemic has attracted great attention to the pharmaceutical industry around the world. With the deepening of pharmaceutical and biomedical research, the research and development of new drugs has become increasingly complex, covering many fields such as biological products and gene drugs. These drugs place higher demands on packaging and delivery systems, requiring more stable storage conditions and more precise dosing.
As a disseminator of new pharmaceutical biotechnology technologies, Peptide Timedoo also deeply observes the complexity behind the pharmaceutical industry chain. Pharmaceutical packaging and drug delivery systems have long been an integral part of the pharmaceutical industry. The prescription drugs we use every day, the disposable devices needed for blood tests or blood donation, and even the cell and gene products that have attracted much attention in recent years are inseparable from the development and application of pharmaceutical packaging components and injection delivery systems.
Behind this huge industrial chain, there is an industry giant with a history of more than 70 years - Stevanato Group. Headquartered in Italy, Stevanato Group operates in more than 70 countries around the world, with factories in several countries, and in 2012 established a factory in China's Zhangjiagang Economic Development Zone to support the burgeoning Chinese pharmaceutical market.
Raffaele Pace, Senior Vice President, Asia Pacific, Stevanato Group
Timedoo interviewed Raffaele Pace, Senior Vice President of Stevanato Group Asia Pacific, to find out how the world's largest manufacturer of pre-sterilized vials (EZ-fills) and the world's second-largest manufacturer of prefillable syringes are innovating and deploying behind the pharmaceutical value chain.
Responding to market trends: Challenges and opportunities coexist
After the outbreak of the new crown epidemic, global pharmaceutical companies quickly launched a number of new crown vaccines. However, what is less well known is that even if a vaccine is successfully developed, it may not be possible to administer it on a large scale due to a shortage of glass vials, which are vaccine aids. Stevanato Group has provided primary packaging solutions, diagnostic kits, glass molding machines and light inspection machines at this critical juncture, and has participated in more than 90% of the world's COVID-19 vaccine and ** projects, making a great contribution to the fight against the global pandemic.
For emerging biopharma market trends, China is the second largest global pharmaceutical spending, with an annual growth rate of about 2% to 5%. Due to market changes such as an aging population, an increase in patients with chronic diseases, and an increase in new diseases due to the migration of people to large cities, more and more Chinese pharmaceutical companies are beginning to pay attention to biopharmaceuticals.
When it comes to the trend of the Chinese market, first of all, it is inseparable from the keyword "centralized purchasing". Since 2015, the competition for pharmaceuticals in China has become more intense, and pharmaceutical companies are facing greater cost pressures. Therefore, pharmaceutical companies need to look for opportunities in new growth areas, especially to develop more biologics and biosimilars to meet the growing market demand. Another key word is "CDMO", that is, contract development organization, and more and more domestic CDMO companies are focusing on the development of biologics and biosimilars. Their control of the entire process and the quality requirements of the best suppliers are very high, which reflects the urgent demand of the industry for high-quality products.
To address these challenges, Raffaele Pace said Stevanato Group offers a proven and complete set of solutions, and the EZ-FILL platform is one of the key products to meet the needs of emerging biopharmaceutical products. It's a fully integrated, pre-sterilized primary packaging solution that avoids tedious steps such as cleaning, depyrogenation, and sterilization for CDMOs and pharmaceutical companies, allowing them to start the filling process right away. This not only helps startups to increase their speed to market, but also improves the product quality level of established companies. RTU containers are aligned with current market trends such as the growth of complex biologics and biosimilars, stringent regulatory requirements in terms of quality and safety, and the pressure to deliver high-quality products while optimizing costs. This not only improves the quality of the entire drug product, reduces the number of links that the customer needs to deal with, but also meets the requirements of the regulations, and at the same time controls it from the perspective of overall cost, reduces the customer's investment in equipment and personnel, and reduces the cost.
Digitalization is one of the current trends in the global industry. Stevanato Group provides digital pharmaceutical inspection equipment, which effectively improves the accuracy of product inspection and reduces the false positive rate through artificial intelligence technology and big data analysis.
The quality of our products is consistent across the globe and we have local factories and offices to be closer to our customers and support the best chain. Raffaele Pace revealed that Stevanato Group can become a market leader, on the one hand, through organic growth, to expand its global presence and market shareOn the other hand, through strategic acquisitions, the Group will be able to cover the entire pharmaceutical value chain by enhancing new service capabilities, such as new drug delivery diagnostic systems and equipment solutionsAt the same time, we invest heavily in R&D and people to provide customers with the solutions they need.
As a comprehensive solutions provider of biopharmaceutical packaging materials and drug delivery system solutions, Stevanato Group creates cutting-edge solutions for pharmaceutical, biopharmaceutical and diagnostic customers, ranging from glass containers, analytical and testing services, drug delivery equipment, contract manufacturing, visual inspection, assembly and packaging equipment. By offering a complete end-to-end portfolio of products, processes and services, Stevanato Group can meet the full lifecycle needs of drugs from development and clinical trials to final commercial applications, effectively enhancing the capabilities of companies looking to expand in highly regulated markets or establish strong competitiveness in domestic markets, as well as start-ups looking to invest in high value-added medicines.
In the Chinese market, Stevanato Group has a clear growth strategy, by investing more resources to support local partners, simplify the ** chain, and provide high-quality solutions.
In the case of vials and cartridges, Stevanato Group plans to support the large-scale production of high-quality pharmaceutical packaging materials in China to meet the growing demand from domestic pharmaceutical companies. and meeting the needs of startups and large companies expanding in highly regulated markets with the EZ-FILL platform to accelerate the speed to market for new drugs.
Stevanato Group is unique in its ability to provide equipment for all steps from post-filling, from inspection and assembly to the secondary packaging line. Customers can rely on a single vendor to make the entire manufacturing process smoother and shorten the time it takes for a new drug to market.
"Our customers are the driving force behind us, and we don't just provide products, we work with them to find solutions to problems." Back in the late 90's, when we received a complaint about a defective appearance of a Japanese vial, we studied all the processes and worked closely with the customer to provide a solution that far exceeded the European quality standards of the time. Therefore, we would like to emphasize that our position in the industry stems from our commitment to always continuously improve and listen to the needs of our customers, actively responding to their needs by providing them with value-added solutions. ”
China is the world's second largest pharmaceutical market, and the market for diabetes drugs and vaccines will grow rapidly. Stevanato Group saw this opportunity and developed a series of smart strategic layouts to meet market demand.
Raffaele Pace told Timedoo that they offer pharmaceutical companies a convenient option to handle the entire pharmaceutical process through a single vendor, which not only saves time but also reduces risk. And, in addition to accelerating the time to market, pharmaceutical companies can also benefit from Stevanato Group's expertise, particularly in the manufacturing of diabetes products, services and equipment across the value chain.
When it comes to technical centers of excellence, they're like their tech home base, helping to analyze and test the relationships between drugs, containers, and drug delivery devices while pharmaceutical companies are still in the early stages of drug development. Stevanato Group not only has a lot of experience in primary packaging solutions, but also excels in testing.
In the Chinese market, Stevanato Group is not sitting still, as early as 2012, it built a factory in the Zhangjiagang Economic Development Zone, preparing for the rapid growth of China's pharmaceutical market. They are also planning to expand the facility, which is planned to cover approximately 7,500 square meters of new floor area, thereby increasing the capabilities of pharmaceutical primary packaging solutions, while enhancing the commissioning and after-sales service of processing lines and testing. This will not only support local pharmaceutical companies, but also create more local jobs.
Stevanato Group is also trying to adapt to the needs of its customers in the Chinese market, and it plans to increase its production capacity for high value-added solutions and invest more in research to meet the needs of customers for different product portfolios.
At the same time, the packaging and containers of drugs sold in direct contact with the Chinese market have been registered with the Center for Drug Evaluation (CDE) to ensure that they are linked to the relevant drug registration review. They actively comply with relevant regulations and ensure the compliance of products during the approval process.
Finally, Raffaele Pace emphasizes the need for innovative thinking to keep up with market demands. In order to do this, they maintain a vision for the future and are constantly reorienting their R&D to ensure that they are able to provide solutions that meet the needs of the market.
Reporter: Damon
Editor: Li Li.