Hovione’s Strategy for Complexity, Speed, and Regional Supply Chains

The landscape of small molecule manufacturing is rapidly evolving, according to Marcio Temtem, vice president, Strategic Business Development, Hovione, who provides an expert look into how his firm is evolving their approach as the industry changes. With 17 years of experience at Hovione, a family-owned CDMO with a 66-year legacy, Temtem identifies three pivotal trends currently shaping the industry: increased complexity, accelerated development speed, and the regionalization of supply chains.

Temtem observes that small molecules have grown significantly in size and complexity, often requiring multiple chemical steps and high-potency handling. This shift necessitates a specialized "toolbox" to overcome modern bioavailability challenges. Highlighting Hovione's technical approach to these hurdles, Temtem states, "We use a platform called amorphous solid dispersions, produced by spray drying to address this challenge of bioavailability.” This platform represents a core area in which Hovione maintains global leadership, utilizing innovative tools to scale processes efficiently while minimizing the use of APIs.

Temtem also mentions the increased influence of AI in drug discovery and deployment, which requires CDMOs to bridge the gap from grams to tons at a much faster pace than in previous years. He further addresses the trend of regionalization, noting the rise of countries such as the US and China prioritizing regional supply chain strategies. He explains that Hovione is uniquely positioned to navigate these new challenges with supply chains through its FDA-inspected sites across three continents.

Central to Hovione’s competitive advantage is their integrated manufacturing offer, which combines drug substance and drug product expertise at a single location. Temtem emphasizes the value of this model, stating, “The company… has been investing in an integrated offer, bridging the problems of chemists and formulators all at the same shop.” To support this integration, the company continues to pioneer advanced manufacturing avenues, including continuous flow for drug substances and continuous tableting for drug products.

Transcript:

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

I’m Marcio Temtem. I'm currently vice president for strategic business management at Hovione. I've been in the company for 17 years. Hovione is a CDMO for pharmathat has been in the business for 66 years. Still a family-owned business that supports small molecule synthesis, production of drug product intermediates, and drug product, for pharma clients. First, and my answer will focus on the small molecule side, and I will try to cover three big trends. One of the trends that we see today is the increased complexity. Small molecules, they are not so small anymore. These days, they have come to a size and to a complexity, that require multiple chemical steps and that very often require high potency. They also require, on the formulation side of things, not just on the chemistry, but on the formulation side of things they also require a new toolbox. A new toolbox to address some of the challenges related with bioavailability. In our case at Hovione, we use a platform called amorphous solid dispersions, produced by spray drying to address this challenge of bioavailability. One other trend that we see happening as we speak relates with acceleration speed. I think it reach a different definition in 2025. There's a need to develop new molecules, new candidates at a faster pace. AI, it's booming all over the place, in the deployment of new molecules. And with this, new way of synthesizing molecules also comes complexity, bridging to what I said before. But it also requires companies like Hovione to develop the CMC section, to develop the process that will take the program from grams to tons at a much faster pace. So that's the second trend. The third trend is that there is an increased concern with the regionalization of the supply chains. You see a big trend in US for US, China for China. In our case, we look at this as an opportunity. Hovione has sites in three continents. In Asia, China, Macau, in Europe, Portugal, and Ireland, and the US. And we believe that, all these sites, they are FDA-inspected, I could say. And we believe that this is also an opportunity for Hovione to continue serving as it has been doing so far, all these markets. I would like to highlight two of our platforms. One of the platforms, I already touched before, that relates with the addressing solubility, bioavailability challenges through the making of amorphous solid dispersions. This is an area where Hovione has, today, the global leadership. And not just over 2025, but over the last years, we have been developing a number of tools, that allow to scale up the process, to develop the formulation with minimum use of API, and with a high probability of success. This is one element where innovation has played an important role to us in 2025. One other aspect to it is that the company, Hovione, has been investing in an integrated offer, bridging the problems of chemists and formulators all at the same shop. And when I say at the same shop, at the same site, which is something very, very unique in the CDMO environment. And in order to do so, we have also been developing new ways of manufacturing. I can tell you that, for instance, in the drug substance space, we have been exploring new avenues, such as, continuous flow, or on the drug product manufacturing, we have been exploring new ways of manufacturing, such as continuous targeting, in order to accelerate, in order to address some of these needs that clients today, bring to our shop.