What is driving growth in APIs and how is Dipharma positioned within this landscape?

RF: The API market is projected to reach US$350 billion by 2029, reflecting a 6% annual growth rate. Within this broader market, generic APIs—a key segment where Dipharma operates—play a crucial role. Several factors contribute to market expansion, i.e., chronic diseases like diabetes and cardiovascular conditions, together with an aging global population, driving the demand for cost-effective treatments, fueling generic API production. Small molecule drugs dominate pharmaceutical development, holding almost 60% of the market in 2024, and FDA approvals for small molecules are expected to stay strong. 

By leveraging well-established yet innovative manufacturing processes, Dipharma ensures the production of affordable generics while remaining nonetheless competitive. Dipharma is well-positioned for growth in the API market, backed again by strong regulatory achievements in 2024, including five CEP submissions and four DMF approvals. Since 1970, our Italian facilities have maintained a flawless record of positive inspections from global agencies like the FDA, AIFA, PMDA, KFDA, and more recently, ANVISA. Strengthening its presence in South America, the company strategically expanded in Brazil, where it received CADIFA for UDCA. With investments in facility upgrades and a dedicated unit for new generic APIs.

How does Dipharma support its clients in the evolving CDMO environment?

AC: Small and mid-sized companies increasingly outsource to CDMOs to streamline drug development, reduce costs, and increase flexibility. The CDMO market for small molecules, which represents Dipharma’s core segment, is growing at nearly 8% CAGR, projected to reach US$55 billion in 2025. This growth is driven by the increasing complexity of drug development and industry consolidation, with a need to focus on core competencies. 

We support clients throughout the entire lifecycle of their molecule, from preclinical studies to commercialization, providing tailored solutions to accelerate development. A clear example of our adaptability is a project started in 2021, with a pilot-scale batch for phase 2 clinical trials. The molecule’s clinical path advanced faster than expected, leading to back-to-back production campaigns up to 2024. We scaled up from a single 15 kg batch in 2021 to a full industrial campaign sizing 4 tons in just three years.

How does the US market shape Dipharma’s business strategy?

AC: The US market is a key driver for Dipharma’s business, contributing over 40% of total revenues. We strongly focus on this region, where one of our facilities is located. Dipharma acquired the Kalamazoo site in 2018 and transformed it into a GMP-compliant facility, successfully inspected by FDA in 2024. 

In recent years, in the US there has been a strong trend of bolt-on acquisitions, as well as a frequent in-licensing of early projects designed for lab scale, not fit for commercial production. To strengthen our position as the partner of choice, we excel in managing these processes by enhancing purification techniques, developing innovative analytical methods, and streamlining synthesis to efficiently scale up to commercial production.

How is Dipharma strengthening its commitment to ESG and sustainability?

AC: We evaluate our entire value chain and launch initiatives to control and reduce environmental impact, optimize chemical processes, and support employees’ safety and health. Over the past five years, we implemented technical and management solutions to cut hazardous waste by over 20%, surpassing our 15% reduction target. We tripled the ratio of hazardous waste sent for recycling or recovery instead of disposal and we reduced GHG emissions by 20%. 

How is Dipharma advancing continuous manufacturing?

RF: Flow chemistry has always been a key part of Dipharma’s identity, since its foundation on continuous processes for the manufacture of nitroglycerin. This expertise remains a cornerstone of our daily operations, and we advance our flow chemistry capabilities at both lab and pilot scale. A recent implementation is the continuous synthesis of a Nitro-alkyl reagent, where we optimized reaction conditions using a flow reactor and a real-time monitoring system, improving reliability and safety while reducing waste and ensuring yield and process control. Dipharma is also planning ahead by investing in a dedicated skid designed for industrial use. Continuous processing is not just a shift in design — it is a foundation of Dipharma’s sustainable, cutting-edge manufacturing approach.