A brief description about opportunities in niche buster market which can be a alternative of blockbuster strategy..

1. Rhit Srivastava
IIHMR, JAIPUR
MBA-PM 05
BLOCKBUSTER VS.
NICHEBUSTER

2.  Market-driven blockbuster strategy of the
pharmaceutical industry is increasingly coming
under fire.
 Now industries are pushing them to the
Segmentation of patient populations, creating
niche populations.

3. Drawbacks of blockbuster drugs
 Enormous, fully capitalized development costs.
 Long development times: 8 - 12 years from the
laboratory to the pharmacy.
 High attrition rates: only 5 - 9 of 100 preclinical
substances reach the status of ‘new drug application’.
 Large clinical studies in order to demonstrate
statistically relevant effectiveness.
 The development of “me-too“ preparations and
generic drugs reduce the period in which the original
drugs generate high profit.
 The risk of severe side effects that are only
recognized when large patient numbers are involved
in the trials.

4.  Higher expenditures do not necessarily
lead to better drugs or to better
investment returns.
 Blockbuster strategy of the big
pharmaceutical companies, a ‘research-
driven’ strategy, which will be needed lots
of investment

5. Niche buster drugs
 Business model paradigm that involves following
the science of a disease to determine where a
drug can intervene along its pathway to create a
positive treatment for a low population of
patients.
 Drugs which are niche market where targeted
population is very low.
 Orphan drugs market is a niche market.
 Biotech industries are doing well in this market.
 All the big pharmaceutical companies are now
looking for it.
 They are motivating biotech research and also
going for the mergers and acquisitions with
biotech companies.

6. ADVANTAGES OF NICHE BUSTER
MODELS
 Reduced development costs; shorter
development times from the time of
discovery to market entry.
 smaller clinical studies are required for
testing the effectiveness of a certain drug
in the target population.
 A higher probability that the clinical test
substances will reach the market.
 A higher safety profile.

7.  Some governments are also supporting it, like
orphan drug act of america-1983 lowered
financial hurdles and tax relief.
 Less attractive by the generic makers.
 Classical example of niche buster drugs is
GLIVEC, a cancer drug
 Approved in 2001 for chronic myeloid leukemia.
 Specifically for small population but generated
2.2 bn in annual global sales in 2005.
 An eye opening moment for other companies.

8.  Drugs are prepared from biotech are called
as biologics .
 Very large market in 2012 it was carrying
160 mn market.
 Industries are looking forward to make
biologics for orphan disease so that they can
hit the niche market.
 Biggest plus point with biologics is that
regulatory requirements for making generics
for biologics are still unclear.
 Less attractive for generic makers so safer to
invest.

9. BIOTECHNOLOGY AS A DRIVER
 Biotechnology is a powerful tool for initiating
niche buster strategy.
 orphan drug market is now focused by
industries and biotechnology is a major diving
force to put innovation in this sector.
 As soon as blockbuster strategy is coming on fire
biotech has coming up to fill this innovation gap.
 Aimed at transforming the knowledge gained
from genomics, proteomics, pharmacogenomics
and systems biology into active substances for
the treatment .

10. Conclusion
 As industries have began to realize that a
market driven growth strategy is not it
self sufficient for future they are focusing
more towards this sector.
 This sector has proven that it has
potential and safe market.
 Regulatory authorities and market
dynamics is also supporting this sector.