The Number of Drugs in Phase III Development Increased By 13% Representing the Largest Year Over Year Improvement Seen

While the Numbers are Promising the Amount of Innovations Remains Limited

NEW YORK, June 28, 2011 /PRNewswire/ -- Citeline, the world's leading research authority on pharmaceutical clinical trials and intelligence, recently completed its comprehensive year on year assessment of the pharmaceutical industry's drug development pipeline. Citeline's 2011 Annual Review of Trends in Pharmaceutical R&D released on June 24 found that the overall size and potential of the pharmaceutical industry, as judged by growth in its drug development pipeline, remained flat, although improvements were seen in certain specific trends, foretelling of possible better times ahead.

Ian Lloyd, Editorial Director of Citeline's Drug Information Service, commented that while overall drug development did not grow the number of drugs entering Phase III trials increased considerably as did the growth in biological drug development. "While the actual number of drugs in development seemed to plateau year over year at 9700, most promising was the number of drugs that successfully completed Phase II trials. This increase of 13% was the biggest increase on record."

The Number of Approved New Active Substances Less Than a Vintage Year

2010 saw the launch of 42 new drugs entering the market. This number is up slightly from the previous year's figure of 36 though this modest increase is somewhat flattened by the approval of nine new anti-infective launches mostly for the H1N1 influenza pandemic. Ian Lloyd commented "If we want to assess innovation we look at the number of new chemical entities, which this year was in the low twenties similar to last year and if we examine the list further for drugs with a new mechanism of action hitting the market for the first time we come up with only three. These three drugs, Amgen's Prolia for osteoporosis, Mitsubishi-Tanabe's Gilenya for relapsing and remitting multiple sclerosis and Santen's Diquas for dry eye syndrome, all represent first in class approvals with a novel mechanism of action. However, Diquas failed to secure approval in the US.

The proportion of drugs classified as 'Biotech' (biologicals) has also risen and now accounts for over a quarter of all pipeline drugs. Trends in individual therapeutic categories examined in the accompanying table were more stable with cancer, anti-infectives and analgesics dominating the top four positions.

Top 25 Therapeutic categories

Position 2011


No of R&D
products 2011


1  (1)

Anticancer, other

1488  (1465)


2  (2)

Anticancer, immunological

773  (769)


3  (4)

Prophylactic vaccine, anti-infective

544  (513)


4  (5)

Analgesic, other

535  (461)


5  (3)


507  (536)


6  (8)


410  (385)


7  (6)

Recombinant vaccine

399  (420)


8  (7)

Cognition enhancer

382  (408)


9  (9)

Antiviral, other

377  (374)

no change

10 (10)


351  (358)

no change

The rise in the number of drugs currently in Phase III trials could be a sign of the improving success rates of drugs completing Phase II, which is particularly important in the changing regulatory environment. Ultimately, it will only be successful drug launches and subsequent portfolio management which will refuel the industry.

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SOURCE Citeline