There are a number of interesting market dynamics in play within the pharmaceutical industry; in the traditional markets, such as Europe, the US and Japan, we’ve recently witnessed the largest number of submitted patents for new molecular entities (NMEs) for more than 10 years. And, although some of those NCEs were targeted at low volume/high value solid dosage forms, the majority were new biological entities (NBEs) for liquid forms. Drug producers need a certain type of process solution to manufacture final dosage forms, so I see the traditional market focusing on high value, small volume products that require agile, efficient and flexible production processes. An additional area of growth is branded over-the-counter drugs (OTCs).
In the “pharmerging” regions, including India, China, Southeast Asia, Latin America and Russia, most of the growth is being driven by large volume generic products: some liquid dosage products, such as insulin, but primarily solid dosage forms. A number of large plants for high volume applications, such as Metformin, have been built, as well as facilities for low volume, high value “niche” products targeting areas such as oncology.
Clearly, one of the main growth areas in the pharmaceutical solid dosage area will come from the pharmerging regions. The end-market gross figures in most of these areas are double digit compared with the traditional markets. Most of the traditional market growth will come from liquid dosage forms and the agile solid dosage form arena.
In terms of production, particularly in the pharmerging regions, growth will come from technologies that go beyond conventional batch processing and deliver high volume throughputs and productivity, integrated “end-to-end” solutions and the increased use of multi-purpose process technologies that deliver value added performance in areas such as Multiple Unit Pellet System (MUPS), Metformin, oncology and hormone applications.
In the traditional markets, continuous processing will continue to play a significant role; it meets the industry’s needs for small, agile solutions and is perfectly suited for research and development work. It is also very cost-efficient. With liquid dosage forms, technologies such as fermentation, mechanical separation and freeze drying will continue to be fundamental production techniques, and there is a lot of potential for specialized liquid formulations — such as blood plasma fractionation — in the near future.
In summary, as we approach 2020, there is a definite trend towards large molecules as new molecular entities (NMEs); there is a notable transition from solid to liquid dosage forms and, where you do have NMEs for solid dosage forms, these will be targeted towards specific therapeutic areas wherein there’s a requirement for small volume flexibility, fast product changeovers and accurate process control.
The pharmerging market will be the key area of growth up to 2020 and beyond. Growth will be driven by localised production, which will require local process assistance, end-to-end solutions and strong service support capabilities to address the requirements of seamless high volume production. Our “technology leading” batch processing solutions and process know-how will have a major role to play, complemented by our regionalized supply chains delivering price-performance solutions.