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Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UK.

Ward DJ, Martino OI, Simpson S, Stevens AJ - BMJ Open (2013)

Bottom Line: There was no significant linear trend in the number of new drugs introduced into the UK from 1982 to 2011.This peak was followed by a decline to approximately 20 new drugs/year between 2003 and 2006, and another peak in 2010.Reports of declining innovation need to be considered in the context of their timescale and perspective.

View Article: PubMed Central - PubMed

Affiliation: NIHR Horizon Scanning Centre, University of Birmingham, Birmingham, UK.

ABSTRACT

Objective: To describe trends in new drugs launched in the UK from 1982 to 2011 and test the hypothesis that the rate of new drug introductions has declined over the study period. There is wide concern that pharmaceutical innovation is declining. Reported trends suggest that fewer new drugs have been launched over recent decades, despite increasing investment into research and development.

Design: Retrospective observational study. SETTING AND DATA SOURCE: Database of new preparations added annually to the British National Formulary (BNF).

Main outcome measures: The number of new drugs entered each year, including new chemical entities(NCEs) and new biological drugs, based on first appearance in the BNF.

Results: There was no significant linear trend in the number of new drugs introduced into the UK from 1982 to 2011. Following a dip in the mid-1980s (11-12 NCEs/new biologics introduced annually from 1985 to 1987), there was a variable increase in the numbers of new drugs introduced annually to a peak of 34 in 1997. This peak was followed by a decline to approximately 20 new drugs/year between 2003 and 2006, and another peak in 2010. Extending the timeline further back with existing published data shows an overall slight increase in new drug introductions of 0.16/year over the entire 1971 to 2011 period.

Conclusions: The purported 'innovation dip' is an artefact of the time periods previously studied. Reports of declining innovation need to be considered in the context of their timescale and perspective.

No MeSH data available.


Related in: MedlinePlus

New drugs launched in the UK from 1982 to 2011.
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BMJOPEN2012002088F1: New drugs launched in the UK from 1982 to 2011.

Mentions: Figure 1 shows the number of new drugs launched annually in the UK from 1982 to 2011. The mean number of new drugs introduced each year was 23.9 (SE 1.16). The lowest was 11 in 1985, and the highest was 34 in 1997 and again in 2010. These data suggest only a minor upward linear trend in the annual numbers of new drugs launched, a result that was not statistically significant (new drugs launched: y=− 291+0.16×year, r=0.22, p=0.25).


Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UK.

Ward DJ, Martino OI, Simpson S, Stevens AJ - BMJ Open (2013)

New drugs launched in the UK from 1982 to 2011.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC3585972&req=5

BMJOPEN2012002088F1: New drugs launched in the UK from 1982 to 2011.
Mentions: Figure 1 shows the number of new drugs launched annually in the UK from 1982 to 2011. The mean number of new drugs introduced each year was 23.9 (SE 1.16). The lowest was 11 in 1985, and the highest was 34 in 1997 and again in 2010. These data suggest only a minor upward linear trend in the annual numbers of new drugs launched, a result that was not statistically significant (new drugs launched: y=− 291+0.16×year, r=0.22, p=0.25).

Bottom Line: There was no significant linear trend in the number of new drugs introduced into the UK from 1982 to 2011.This peak was followed by a decline to approximately 20 new drugs/year between 2003 and 2006, and another peak in 2010.Reports of declining innovation need to be considered in the context of their timescale and perspective.

View Article: PubMed Central - PubMed

Affiliation: NIHR Horizon Scanning Centre, University of Birmingham, Birmingham, UK.

ABSTRACT

Objective: To describe trends in new drugs launched in the UK from 1982 to 2011 and test the hypothesis that the rate of new drug introductions has declined over the study period. There is wide concern that pharmaceutical innovation is declining. Reported trends suggest that fewer new drugs have been launched over recent decades, despite increasing investment into research and development.

Design: Retrospective observational study. SETTING AND DATA SOURCE: Database of new preparations added annually to the British National Formulary (BNF).

Main outcome measures: The number of new drugs entered each year, including new chemical entities(NCEs) and new biological drugs, based on first appearance in the BNF.

Results: There was no significant linear trend in the number of new drugs introduced into the UK from 1982 to 2011. Following a dip in the mid-1980s (11-12 NCEs/new biologics introduced annually from 1985 to 1987), there was a variable increase in the numbers of new drugs introduced annually to a peak of 34 in 1997. This peak was followed by a decline to approximately 20 new drugs/year between 2003 and 2006, and another peak in 2010. Extending the timeline further back with existing published data shows an overall slight increase in new drug introductions of 0.16/year over the entire 1971 to 2011 period.

Conclusions: The purported 'innovation dip' is an artefact of the time periods previously studied. Reports of declining innovation need to be considered in the context of their timescale and perspective.

No MeSH data available.


Related in: MedlinePlus