June 10, 2005 Volume 1, Number 3
 
 

Investing Time to Make Money: A PAT Implementation Perspective-By John E. Carroll
API Scale-Up During Research and Development-By Nandita P. Shetgiri, Mahesh S. Phansalkar, Sandeep Patil, and Rupesh Kelaskar
Outsourcing Outlook-Seeking a Fresh Start
Packaging Forum-New Systems for Counterfeit Protection and Quality Control
Washington Report-Drug Specifications Under Scrutiny
Contracts, Mergers, and Announcements
People
Calendar
Contact
 
   


Seeking a Fresh Start
Outsourcing Outlook
Seeking a Fresh Start (continued)
 
2005 starts
The strong revenue momentum that the pharmaceutical contract services business generated in 2004 carried into the first quarter of 2005. Most industry segments generated double-digit revenue growth for the quarter, and new contract signings remained strong.

Demand for early-development services, including preclinical and Phase I research, remained especially strong, and waiting times for capacity continued to stretch into the 3–6 month range. Several CROs brought on new Phase I capacity, including PPD's (Wilmington, NC, www.ppdi.com) 300-bed Austin, Texas, facility and Radiant Research's (Bellevue, WA, www.radiantresearch.com) 120-bed facility in Dallas, Texas. Substantial new preclinical capacity won't be available until late in 2005 or 2006, however.

A big driver of clinical CRO revenue was the growing strength in Phase II–III activity. Bookings for new late-development studies began growing in early 2004, and the revenue effect of those signings is being felt this year. Clinical CROs reported continued strength in new business signings, with the large public CROs benefitting from their ability to secure preferred provider relationships with major pharmaceutical companies.

The growth in late-stage development is especially good news for API and dose manufacturers as well as providers of analytical chemistry, formulation, and packaging services. Conversations with exhibitors at April's Interphex show confirmed that the nonclinical service providers are experiencing growing demand as well.

Prospects for the industry look good through the rest of the year. The only cloud on the horizon appears to be reduced funding opportunities for early-stage companies. The initial public offering window closed in the first quarter of the year, and several companies postponed their new public offerings or took a substantially lower price per share to seal their deals. Venture capital funding remained strong in the first quarter but dropped precipitously in April. The funding environment is a critical concern for nonclinical CROs and small clinical CROs because early-stage companies make up a large portion of their business. The large clinical CROs get a large and growing share of their business from major pharmaceutical companies, and they should benefit as Big Pharma enhances its new product pipeline with licensing deals and acquisitions. PT

 

 


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