Industry Analysis & Industry Trends
The Australian Pharmaceutical Product Manufacturing industry has contended with several challenges over the past five years. Echoing trends on the global pharmaceutical stage, these challenges have included a changing regulatory and risk environment, a patent cliff that has seen manufacturers lose exclusive manufacturing rights to some of the most profitable drugs in the industry's history, and reform-driven pricing pressures. On the local front, ongoing reforms to the Pharmaceutical Benefits Scheme (PBS) have been particularly significant, as mandatory price disclosures have continued to reduce prices. Increased regulatory burden and heightened competitive pressures have added to the challenges that local industry players are currently facing... purchase to read more
Industry Report - Starting a New Business Chapter
Substantial barriers to entry to the industry exist, not least of which is the fact that the industry is becoming increasingly globalised, with the dominant major players operating on a large global scale. The high and rising costs of R&D, combined with declining R&D productivity pose another substantial obstacle. A new medicine can cost as much as US$2.6 billion to develop with a 10 to 15 year time frame before it makes it to market. Furthermore according to Medicines Australia, it can then take 22 months to get a new medicine listed on the PBS. High capital expenditure is also required at the onset to establish a manufacturing plant geared to producing high-cost, high-technology drugs.
Government policies can be significant barriers to entry... purchase to read more