Accelerated Time for Review and Approval of Novel Medications Hint at Good Growth Prospects for Global Pharma Market in 2016


Published Date : Jan 05, 2016

2015 showed both high as well as tremendous lows to the global pharmaceutical industry. When at one point, some highly popular, generic medicines saw record increase in their prices (Turing Pharmaceutical’s newly acquired Daraprim saw more than 5,000% hike in price), numerous innovative medicines also hit the market.

The U.S. Food and Drug Administration approved 45 novel medicines in 2015, four more than the number of novel medicines approved a year before and the most since the record 53 that the pharma world witnessed in 1996. On the other part of the globe, the European Medicines Agency also approved a good number of novel medications, 93, including generics, up from a good 82 the previous year.

But despite the excellent statistics and growth prospects for the year 2016, there are some challenges before the pharmaceuticals industry that it needs to tackle for a smooth journey ahead, such as the rising political focus on medicine prices that has severely affected valuations of biotech and specialty pharmaceuticals.

The pharmaceutical industry is considered more a sacred ground for doing business: satisfaction of the end-user is the foremost concern, more than any other industry, and innovations are seen from the perspective of their benefits to the end-user than the innovator itself. Ways to rein in costs are constantly sought-after and the confidence in the industry’s profitability is a factor that is either constantly ignored or usually taken for granted.

For big pharmaceutical companies that traverse several specialty areas and are constantly investing millions and billions in research and development of new and more effective drugs, are still struggling to get good returns on the vast amount of money spent annually on R&D activities. Many new medicines are also projected to give relatively modest returns.

Moreover, getting a strong launch for new medicines, which have to compete against a whole array of cheap generic medicines, is also a tough battle for pharma companies as healthcare providers strongly push back against the high prices of novel medications.

The rapid pace at which approval of newer medications is happening on a global front reflects hastened review times on the side of regulators, who are keen to present before the world life-saving treatment, especially for a number of cancers, and an improved understanding of diseases.

The scenario is projected to continue in 2016 as well, and further enhancements are expected to occur in the field of cancer treatments that work by boosting the body’s immune system. Many companies also have promising products in their portfolios that are awaiting approval for diseases such as cancers, rheumatoid arthritis, psoriasis, chronic lung disease, and hepatitis C.