Rainer Krugmann, Global Director Sales at Fette Compacting, provides an outlook as to what trends Fette Compacting can anticipate in the production of solid formulations
Forecast for the worldwide distribution of medicine spending in 2020 (Source: IMS Health, Market Prognosis, September 2015)
According to current studies, pharmaceutical producers can look forward to growing demand in the years to come. Growth means that more people receive access to medical care on the one hand while special medication for rare diseases gains in importance on the other. This increases international requirements on flexibility and quality in production.Machine technology is obliged to offer the right solutions for each product and each requirement - increasingly in accordance with uniform global standards. In an interview, Rainer Krugmann, Global Director Sales at Fette Compacting, provides an outlook as to what trends Fette Compacting can anticipate in the production of solid formulations.
Rainer Krugmann, Global Director Sales, Fette Compacting
Projections indicate positive development over the next few years. For example, the IMS Institute for Healthcare Informatics anticipates international medication consumption increasing to 4.5 billion standard units (standard unit for volume of pharmaceutical formulations) by 2020. This complies with growth of 24 percent compared with 2015. The greatest drive is represented by the demand for generic drugs in so-called pharmerging markets. This demand is driven by improved access to medical care by broader sectors of the population. While only one-third of the world's population had access to pharmaceuticals in 2005, half of humanity is likely to have this access by 2020. Apart from the key growth markets of China, India and Brazil, the most important trends for this will also be set in future by markets such as Indonesia, the Middle East and North Africa - to date suffering from below-average supply.
At international level, pharmaceutical companies remain subject to high pressure on costs. Among the manufacturers of generic drugs, global competition will in fact increase this pressure. At the same time and as regulations become aligned at international level, quality requirements on the production of generic drugs will also increase. Although loss of sales through expiring patents is declining among researching pharmaceutical companies, pricing is increasingly being influenced by health systems and health insurance companies. But pricing is ultimately dependent on the effectiveness of a new drug which is why pharmaceutical companies will continue to increase their investments in new medication. So the financial pressure will remain high here, too.
The lion's share of expenditure on innovative medication can be anticipated in highly-industrialised regions, especially in the USA, Europe and Japan. In these markets, the focus is on therapies for non-contagious diseases such as cardiovascular ailments and cancer, for example. What's more, the increasing consumption of expensive "specialty medicines" for rare, chronic or genetic diseases leads to a cost-increasing effect.
Thanks to increased efficiency in developing new medication, they avail of robust product pipelines. New active ingredients even permit therapy of previously incurable diseases such as Hepatitis C. Most of the new active ingredients currently pending approval are highly-potent. In mature markets, the market segment for HPAPIs (High Potency Active Pharmaceutical Ingredients) is likely to grow by up to 14 percent - on average twice as fast as the market as a whole - making HPAPIs a growth driver which implies that mature markets will once again account for a higher share of overall international growth. Accordingly, the issue of containment plays a decisive role in pharmaceutical production.
Here too, the demand for high-potency active ingredients is increasing disproportionately, primarily driven by oncological drugs. Ultimately and in all regions, we are anticipating increasing demands for containment features which reliably prevent the release of dust. To this aim, Fette Compacting offers the appropriate solutions in all toxicity classes.
Many of the new ingredients are targeted toward rare diseases which is why smaller plants with short conversion times are increasingly gaining in importance. Within this context, we are anticipating a breakthrough in continuous manufacturing in the pharmaceutical sector over the medium term. Continuous plants are significantly more productive, especially in the manufacture of smaller volumes of expensive drugs. What is also important is that plant availability is increased in an effort to withstand the pressure on costs. Against this backdrop, the significance of machine manufacturers also grows in their capacity as consultants and service partners. This is even more applicable the more pharmaceutical companies reduce their own competencies in these areas for reasons relating to costs.
The requirements by the FDA and EMA approval authorities are increasingly affecting production standards all over the world. On the one hand, this is effected directly by monitoring all manufacturers exporting to the USA or the EU; on the other hand, indirectly as a template for national regulations. We regard these efforts as positive as they promote uniform international quality standards in production and automation. Over the medium term, we are anticipating a levelling cost effect which will reduce the price differences between countries with low production costs and high-wage countries. This will also increase the demand for highly-productive and safe production plants in pharmerging markets.
The issue of reducing costs through standardisation is in fact very interesting for practically all of our major customers. We advise them insofar as how they can reduce their complexity costs using standardised machinery and processes. Today, it is still often the case that a company's engineering teams draw up their own URS (User Requirement Specifications) depending on location and product. In other words, they keep reinventing the wheel! Standardised machine technology, however, dispenses with weeks or even months of project management and qualification work. At the same time, flexibility increases within the international production network. And an enormous savings potential can even be tapped for production which is already efficient.
Although new biopharmaceutical ingredients are often dispensed in liquid form, we still regard tablets and capsules as the undisputed leader among all dosage forms. This is primarily accounted for by the advantages associated with their easy handling, exact dosing of active ingredients and inexpensive production. Designers will continue to look for methods of manufacturing new medication in tablet or capsule form. Furthermore, apart from pharmaceutical solid formulations, nutrition supplements and natural products in solid form also represent an exciting growth market.