HPAPI & high potent isolators

The attention of the pharmaceutical market towards HPAPI (High Potent Active Pharmaceutical Ingredients), namely the high potency pharmacologically active prime matters, keeps rising. The processing of these substances for the production of drugs requires specialized approaches in structure design, equipment selection and productive processes in order to reach the desired containment levels, reducing at minimum the operator exposure and ensuring worker’s safety and protection. Confirmed by the recent publication of the iHealtcareAnalyst report, Global HPAPIs Market $31.5 Billion by 2029, this trend in the interest of sector’s players made itself evident in the feedback gathered in the recent international event CPHI Frankfurt 2022.

The trend: API High-Potent require high containment systems

“During the Frankfurt event we found a significantly high interest towards HPAPI from pharmaceutical companies”, comments Francesco Sicuro, Product manager of Nicomac Europe systems. “This type of production must follow specific process standards to ensure operators safety. Manufacturers have therefore an increasing need of systems under isolator for the production of oral solid forms and for liquid drugs filling. Nicomac Europe from over 10 years supplies world level companies with entire granulation lines under isolator, thanks to the partnership with first-party companies specialized in systems not quite of its competence and proposing itself as single referent and interlocutor of the whole project. In this type of production it is essential that the design of process equipment follows precise standards to ensure the effective integration of the containment system. “As widely confirmed by the pharmaceutical industry, not all productive systems are suited to safely manage HPAPI”, specifies Sicuro. “Nicomac Europe can ensure as requested to obtain productive excellence under isolator and, furthermore, has always had as a strength point its competency and ability to supply help to the client on the manufacturing process and product formulative development. A combination that is giving us important results and very positive feedbacks by our clients, thanks to whom we keep improving our approach towards this type of production.”

HPAPI, the growing numbers

In the Global HPAPIs Market $31.5 Billion by 2029 report the iHealtcareAnalyst analysts estimate that the global HPAPI market will reach 31,5 billions of dollars within 2029, with an composite annual growth rate (CAGR) of 6,0% in the estimated period. This trend is dragged by the expiry of successful drugs patents and by the growing trends in pharmaceutical outsourcing in developed regions.

High potency and minimum dosages, High-Potent API for manufacturers represent a highly profitable segment, but they require highly sophisticated structures and specialized technical abilities. This, according to analysts, will create new and great business opportunities during the next five years.

The HPAPI demand has rapidly grown in the last ten years, mainly as a result of the progresses in clinical pharmacology and oncological research. “While in the 2000-2010 decade to characterize the market were the cardiovascular system benefit drugs, today it is ever more important for pharma companies to integrate a productive line of antitumoral drugs”, confirms Francesco Sicuro, of Nicomac Europe. Over a quarter of all the drugs in the world now contains HPAPI, since they proved more effective than other API. The pharmaceutical production that uses them requires lower doses of active ingredients and brings less collateral effects for patients, but at the same time opens new productive challenges: management, containment, costs and safety.

Many contract manufacturers in the world are building new structires designed specifically for HPAPI production, investing millions of dollars more compared to tradictional GMP productive structures. Europe and North America represent the major quote of the total high potency API market, as written in the report by iHealtcareAnalyst. Even in the Pacific-Asian region many are the API production leaders that are adopting measures to improve the use of equipments, product output, reduction of processing times and nocive emissions and increasing recycle and reutilization. In the same way, Latin American countries are becoming an important destination for the third-party pharmaceutical production, prospecting themselves as possible quick growth markets even for the HPAPI segment.

Nicomac Europe is ready to answer even HPAPI market requests, proposing itself as a single referent and interlocutor of turn-key systems for the production under isolator and high containment.