New
INDs flat in 2004
One of the big stories of 2004 was the strong performance in
early
stage-development services, including preclinical and Phase I testing
and clinical trial material development and manufacturing. Growth in
those sectors exceeded 15%, and capacity constraints have forced
pharmaceutical companies to reserve CRO capacity 3–6 months in advance.
One would expect, in the face of robust early-development performance,
that the number of commercial investigational new drug (IND) filings
would have jumped in 2004. That does not seem to be the case, however.
According to data recently released by FDA, new IND filings were
essentially flat in 2004 when compared with 2003.
Various factors might explain the gap between accelerating
early
development spending and sluggish IND growth. First, companies are
spending more time and money per study than in the past. The growth in
safety pharmacology studies and specialty areas such as inhalation
toxicology is driving up the cost and time invested per study. As a
result, preclinical revenues and capacity usage may increase faster
than the number of candidates.
A further explanation is that much of the increased demand may be in
support of Phase II–III studies rather than for preparing for
first-in-man studies. CRO booking and backlog indicate that Phase
II–III studies are increasing, and companies often must do more
extensive testing to support longer or larger dosage regimes. In
addition, demand for long-term toxicity studies such as those for
carcinogenicity will pick up as candidates move beyond Phase I. Major
pharmaceutical companies are more likely to outsource those long-term
studies than the short-term studies conducted pre-Phase I.
Although new INDs were flat, the total number of active INDs grew
6%
from 4544 to 4827. Last year was a good one for financing small
bio/pharma companies, and it is likely that many compounds that were
stuck in early development began moving ahead again this past year,
which is reflected in the growing demand for Phase II–III services. The
market continues to offer plenty of good opportunities for contract
service providers. PT
