Data states IND applications up from 2004
industry submitted 542 commercial Investigational New Drug (IND)
applications in 2004, increasing by more than a third from the
previous year.
Commenting on the findings, Mark Mathieu, director of Publications for Barnett Educational Services, a division of Parexel International, said: "Although the number of US clinical drug trials that have been initiated, measured by the number of commercial IND submissions, had been in a slow but steady decline since the late 1990s, this year's analysis uncovered a new record of IND submissions." The previous record of 441 INDs was set in 1998.
The latest edition of US contract research organisation Parexel International's Pharmaceutical R&D Statistical Sourcebook, indicated that the biotechnology/pharmaceutical industry's USA-based clinical research activity for drugs climbed 6.1 per cent last year.
At the end of 2004, 4,227 commercial INDs for drug products were held at the Centre for Drug Evaluation and Research versus 3,984 at the end of the prior year, which represented an approximate 30 per cent rise over the 3,243 recorded in 1993.
The boost in clinical research activity indicates that companies are actively researching more new drugs, indicated by the increased number of active commercial INDs,. Although active commercial INDs for drug products have risen throughout the 1990s, over recent years INDs have been on a slower but steady climb.
The research also agreed that the pharmaceutical sector's sales, R&D spending, and new product introductions had shifted from Europe to the United States. It said that Europe's pharmaceutical industry "faces the challenge of declining competitiveness as compared to the US, where the environment is more attractive for R&D investment and more supportive of pharmaceutical innovation,"
Of the 31 new molecular (chemical and biological) entities launched on the world market in 2003, 14 were launched by US-based firms, ten by European firms, three by Japanese firms, and four by companies based in other countries. According to one projection released by The European Federation of Pharmaceutical Industries and Associations (EFPIA), "fewer than 10 per cent of first [new medicine] launches are projected to occur in Europe by 2010."
The sourcebook quoted the world pharmaceutical market's value at an estimated €550 billion (€456 billion) in 2004. Over the past decade, the North American market (US and Canada) has grown the fastest and remained the world's largest, with a 48 per cent share (up from a 31.3 per cent share in 1990 and a 43 per cent share in 2000). This remains well ahead of Europe, which has a 30 per cent share, down from 37.8 per cent in 1990.
The sourcebook identified the resurgence in preclinical development, which appeared to be preceding the reaccelerating in R&D spending. While late-stage compound growth is moderating, growth in both the preclinical compounds and R&D spending appeared steady.
In 2004, PhRMA member companies invested an estimated $38.8 billion in researching and developing new medicines-an increase of 12.6 per cent over the previous year. When factoring in research and development by American biotechnology firms that are not PhRMA members-often supported through business ventures and funding from PhRMA member companies-an estimated $49.3 billion was invested in biopharmaceutical R&D in 2004. This is the first time PhRMA has reported an industry-wide R&D figure.
Analysis of monthly trends suggested that the relative strength in preclinical and early development was continuing. Although growth in global preclinical and Phase I compounds has been steady over the last three years, with CAGRs of 9.2 per cent and 8.1 per cent, respectively, recent trends suggest total compounds in development haveremained relatively stable since the beginning of the year.
