By Peter Rosholm
What regulatory changes do you see affecting the pharmaceutical business?
Regulatory authorities are beginning to enforce strict quality measures on animal-based products in order to improve safety for the end user. Both the European Medicines Agency (EMEA) and the Center for Biologics Evaluation and Research (CBER) of the FDA have issued guidelines for the controlled use of animal-derived materials for pharmaceuticals. The contamination risk from pathogens when using animal-derived ingredients is driving companies toward animal-free alternatives. Animal-free products and technologies, designed and manufactured exclusively to support biopharmaceutical manufacturing, bypass many regulatory hurdles, while improving efficiency, consistency, and security of supply for commercial-scale production.
How has the biopharm market changed during the last decade?
The biopharm industry is reaching a crucial phase with manufacturers looking for the next pipelines of blockbuster drugs, which Novozymes Biopharma believes will come from biopharmaceuticals. This will result in further increasing regulatory pressures to eliminate animal-derived products to ensure patients are not exposed to any contamination risks from pathogens such as viruses. There will also be increased pressure for biopharmaceutical manufacturers to improve efficiency and time to market.
What new developments do you think will emerge in the market in the coming years?
Protein therapeutics is predicted to represent one of the most medically beneficial drug development areas of the next decade because of their high level of efficacy and efficiency.
How do you see the biomanufacturing sector evolving over the next decade? Can a number of companies continue to operate in the sector, or is the opposite situation likely, with consolidation in the sector occurring over the next few years? If you think there will be consolidation, then what types of companies do you expect will remain successful in the sector?
The biomanufacturing sector is incredibly exciting — there has been a significant shift towards biopharmaceutical production as the pipeline of classical blockbusters gradually erodes, and this trend will continue in the medium and long term. However, the bio industry relies heavily on investors, particularly in the United States, and the current economic climate suggests that, in the short term, we will see consolidation as companies struggle to raise necessary working capital. Add to that the rising cost of energy and fuel, and we should see some interesting, if not difficult, times ahead — especially for smaller biotechs. Only time will tell whether this occurs through mergers and acquisitions, natural attrition, or an increase in collaborations/alliances/joint ventures. The companies that will remain successful are the ones that can best anticipate the needs of tomorrow.
Long term, it’s difficult to say how the sector will develop over the next decade because it is constantly evolving. We will see many biotechs manufacturing several therapeutics to remain competitive, compared with the traditional model of focusing on one product; this in itself will bring about production and regulatory challenges. But, the outlook is very positive with many products coming to commercialization in the short and medium term.
The major markets will remain the United States and the EU, but you also need to see what’s happening in India and China to realize that there will be a huge demand for biopharmaceuticals in these two economies. It’s important the biopharm manufacturers continue to invest in developing countries as these will provide the best ROIs. The flip side is that, further down the line, an increase in biopharmaceuticals will also mean an increase in biogenerics, and we will have the same trends that we see occurring in the pharmaceutical industry at the moment — cheap copies and quality/regulatory issues from mercenary manufacturers.
We have seen regulatory bodies encourage the switch to animal-free products and processes, and this will see the elimination of animal-derived products in the long term as the public demands safer medicines. With levels of media coverage increasing on an almost daily basis, the public has access to a huge amount of information, and they will have a major say in what products are developed and launched and how they are manufactured.