Summary
In Europe consolidation has been the order of the day throughout 2006, with many mid-sized companies being acquired - Bayer acquiring Schering AG, Schwarz bought by UCB to name a few. The implications of these and other mergers will be seen in the coming year in company strategy. On the regulatory front, Europe has been getting to grips with the additional requirements placed on the pharmaceutical companies as well as the regulatory agencies by the 2005 revisions of the EU pharmaceutical legislation coming into force.
During 2006 Japan has been facing increased healthcare costs due to its ageing population. There has also been renewed support for changes to the regulatory process for new medicines to allow new drugs to be available to market sooner, as well as calls for drug pricing to be reviewed annually instead of the current system of a review every two years. However, critics have questioned the effect this could have on the country's competitiveness in the pharmaceutical market.
By contrast, 2006 has been a year of rapid growth in China. It is now seen by the rest of the world as the place to build new research and manufacturing facilities; companies such as Pfizer and Eli Lilly, for example, have moved all their R&D development to China. However, China is, like Japan and the west, seeing rising costs in healthcare, which the government has been attempting to offset with price cuts in order to balance healthcare expenditure.
In the US the implications of increasing pressure to regulate drug prices, especially by the way of the Medicare drug benefit programme for the elderly (Part D), along with increased pressure to allow drugs to be reimported into the country, particularly by individuals via the internet, and attempts by the legislator to regulate companies' postmarketing activities have culminated in a tough year for the pharma industry.
Turning to drug development, 2006 has seen many products entering the market, many of which have been aimed at diseases which, at present, have been inadequately treated. One example is the multitargeted kinase inhibitors reaching the market - Pfizer's Sutent (sunitinib malate) and Bayer's Nexavar (sorafenib tosylate) for various cancers, Bristol-Myers Squibb's Sprycel (dasatinib) for leukaemia, Merck & Co/CSL's prophylactic cervical cancer vaccine Gardasil and Genentech/Roche's Lucentis (ranibizumab) in wet age-related macular degeneration. 2006 also saw Merck & Co's Januvia (sitagliptin) become the first dipeptidylpeptidase IV inhibitor to be launched in diabetes.
However, 2006 highlighted with disastrous consequences how much the industry still relies on clinical trials involving human volunteers, The events surrounding the Phase I human volunteer trail of the monoclonal antibody, Tegenero's TGN-1412 as already lead to recommendations being made to improve the way clinical trials using humans are regulated.
Most recently the report by a group of eminent experts, the independent Expert Scientific Group, established by the UK Secretary of State for Health to make recommendations for improving the safety of Phase 1 clinical trials, has published its final report on the TeGenero tragedy. The Group made 22 recommendations covering the following matters: the need for scientific advice from independent experts before trials of high risk substances are approved; information about unpublished clinical trials and adverse reactions occurring in trials; the conduct and environment of clinical trials; the clinical trial application process; the skills and future specialist training needs of those conducting clinical trials; and the location of trial units and the provision of adequate medical back up in case of problems arising.
Scrip Yearbook 2007 charts the progress of the pharmaceutical industry as reported in Scrip World Pharmaceutical News over the 12 months up to the end of November 2006.
The Scrip Yearbook 2007 is split into three sections. The first section focuses on the activities of key companies throughout 2006 - the top 20 pharmaceutical companies, the top 10 biotechnology companies and the top five generic companies, as defined in the Scrip Yearbook's sister report Scrip Pharmaceutical Company League Tables 2006. It looks at their financial progress, strategic decisions and product development during 2006. Also under this section we look at the merger and acquisition activity of these major companies and the reasons behind the decisions.
The second section focuses on developments in the top 40 major markets around the world and charts the regulatory and policy development and market trends in each.
The third section, under the general heading of 'Therapeutics', covers issues of disease prevalence (by A to Z), clinical trials conducted during the year as recorded by PharmaProjects and the major drug delivery methods as outlined by our sister newsletter, Target, which focuses on world drug delivery news and which drugs have been approved in 2006.
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