Mergers and acquisitions.
The trend for industry mergers, acquisitions, and other corporate consolidation at all scales continued in 2011. This is
particularly evident among large international companies that continue merging and purging (i.e., acquiring or merging companies
and then downsizing the merged company). Some companies, such as Merck & Co., are moving from mergers/acquisitions in favor
of more in-house and company-sponsored R&D. The continuing trend of pharmaceutical mergers, combined with off-shoring of certain
jobs and facilities, has resulted in relatively high bio/pharmaceutical industry unemployment rates in the US.
Patent litigation.
Patent-infringement suits can be expected to increase, particularly as a large number of biosimilars (and biobetters and
biogenerics) approach filing in the US and other major markets. Major test cases, such as Classen Immunotherapies versus Biogen Idec, involve whether business methods patents include coverage of methods for determining the optimal dose of a therapeutic.
Biopharmaceutical companies may soon need to consider yet another type of patent, in addition to those for composition-of-matter
(e.g., sequences), formulations, uses, bioprocessing, and reference standards.
Conclusion
The bio/pharmaceutical industry is emerging from the current global economic situation into 2012 with a positive outlook.
The industry is spending more, becoming more efficient, and, perhaps most importantly, expressing great optimism. With sales
growth of between 14 and 18% this year, we will likely continue to see additional spending in new technology, capital equipment,
and hiring.
Eric Langer is president of BioPlan Associates, tel. 301.921.5979, elanger@bioplanassociates.com
, and a periodic contributor to Outsourcing Outlook.
References
1. BioPlan Associates, 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production: A Survey of Biotherapeutic Developers
and Contract Manufacturing Organizations (Rockville, MD), April 2011.
2. BioPlan Associates, Top 1000 Global Biopharmaceutical Facilities Index,
http://www.top1000bio.com/index.asp/, accessed June 20, 2011.
3. R.A Rader, Biopharmaceutical Products in the US and European Markets (database), BioPlan Associates,
http://www.bioplanassociates.com/publications/pub_bpuseu.htm, accessed Jan. 16, 2012.
4. R. Rader, FDA Biopharmaceutical Product Approvals and Trends, Biotechnology Information Institute,
http://www.biopharma.com/approvals_2011.html, accessed Jan. 16, 2012.
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