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Peter Soelkner is Managing Director of Vetter Pharma International GmbH, Germany.
Keeping abreast of the latest industry trends and retaining flexibility are key to maintaining a strong market position.
The pharmaceutical and biotechnology industries have received a fair amount of attention in recent years. For companies to be successful and maintain their position in the market, keeping abreast of industry trends is imperative.
But what are some of these trends and how have they affected the industry today? What can the industry expect in the future? From a contract development and manufacturing organization’s perspective, one can see a rapidly changing pharmaceutical and biotechnology market primarily due to a variety of factors.
On the macro level, the industry is witnessing the combination of digital health with mobile lifestyles, which includes using more convenient technology to deliver medication and information to patients and healthcare providers. This is a significant trend because approximately two-thirds of the world’s population already own a ‘smart’ mobile phone.
From a therapy perspective, breakthrough therapies for medical needs are quickly on the rise. Looking at the injectables market, in particular, nearly 40% of breakthrough therapies are monoclonal antibodies (mAbs), most of which are used to treat cancer and orphan diseases. Additionally, diseases such as diabetes are also on the rise worldwide, leading to an increased number of patients that require access to parenteral therapies.
What do the outlined market developments mean as a consequence for pharmaceutical service providers? Service providers are advised to adhere to the following practices in order to continue market success:
Looking at the injectable market, a ResearchAndMarkets report estimates that the global injectable drug delivery market is expected to grow from US$404.14 billion in 2017, reaching nearly US$1200 billion by 2026, with a Compound Annual Growth Rate (CAGR) of 12.8% (1). In geographical terms, North Americais still estimated to be the holder of the largest share for the market during the forecasted period. This growth is attributed to the rising dominance of chronic diseases, as well as the number of companies that are focused on collaboration and partnerships that enable the availability of high-value products.
With venture capital funding accelerating in 2017, smaller biotech companies are in good financial shape and have the ability to maintain their pace of outsourcing expenditure. It helps that the injectable share of all therapeutic New Drug Application (NDA) and Biologic License Application (BLA) approvals has increased in recent years, with further positive development expected until 2024. The orphan drug sector will also double in size by 2024 with venture capital funding taking aim at oncology, rare diseases, and high prevalent chronic diseases.
Various digitalization activities are widespread in our market as well. This involves primarily pharma and biotech companies, but also their partners and suppliers. The earlier the suppliers engage themselves in digitalization projects, the quicker they can act as a valuable partner at ‘eye level’. Sample digitalization activities in the drug product manufacturing process include efforts in the field of electronic batch recording and, in general, establishing paperless processes. Overall, being active in connected health initiatives is a core trend as the healthcare industry is focusing on patient-monitoring as well as supporting patient engagement and adherence through software services connected to medical devices (Figure 1).
From an indication perspective, the industry is also experiencing that the ‘mainstream approach of molecules that are simple to manufacture is becoming more and more outdated’. This is due to the fact that more and more drugs are targeted to small, specific subgroups, and that ever-more therapeutic biologics have been approved in the market over the past few years. By their very nature, these compounds are complex to handle. Vetter is also receiving project inquiries with minimal filling volume requests, for example, products that are administered via an injection into the eye. Vetter estimates RNA and DNA therapeutics to increase in the future, with Big Pharma investing heavily in these forms of gene therapy solutions (Figure 2).
An increasing number of parenterals are being supplied in more patient friendly drug-delivery systems, such as prefilled syringes or auto-injectors. Additionally, many component suppliers are providing ready-to-use components that offer advantages to manufacturers.
Nevertheless, this still requires tight oversight of the involved suppliers. Overall, thesupply chain of a drug product is increasingly challenging due to the global nature of the business. Active ingredients, components, and excipients, for example, often come from many various suppliers around the world.
Obviously, there is a huge difference between a therapy that treats thousands of patients and one that treats a few. Nevertheless, both blockbusters and personalized therapies will continue to be needed in the future. The entire industry, including both pharma and biotech companies along with their partners in the supply chain, must retain the flexibility to discover, develop, manufacture, and market therapies in both fields.
There have always been a wide variety of trends that have influenced our industry. Most likely, this will continue into the future as well. As an industry, we will always do our best to meet these needs successfully. And, we will be able to master the future with the support of industry experts and their promising solutions, be they analogous or digital.
1. Reuters, “Injectable Drug Delivery Market Size, Share, Report, Analysis, Trends & Forecast to 2026,” reuters.com
Peter Soeklner is managing director at Vetter Pharma-Fertigung GmbH & Co. KG and Vetter Pharma International GmbH.