Convegno Science Generation
Bioscienze ed economia
Vittorio Chiesa
Università degli studi di Milano-Bicocca
FAST
Milano, 14 marzo 2003
Vittorio Chiesa, 2003
Index
 The healthcare context
 The role of biotech
 A worldwide overview on biotech industry
 The Italian situation
Vittorio Chiesa, 2003
Index
 The healthcare context
 The role of biotech
 A worldwide overview on biotech industry
 The Italian situation
Vittorio Chiesa, 2003
The healthcare context
• Increasing level of competition
• Patent expiration
• Industry performance indicators decline
Vittorio Chiesa, 2003
Increasing level of competition
Inderall®1965
6
Tagamet®1977
5
Capoten® 1980
10 Lopresor® 1975
Zantac®1983
Vasotec® 1985
Hismanial®1989
AZT® 1987
4
4
Mevacor® 1987
4
Pravachol® 1991
Prozac® 1988
4
Zoloft® 1992
Seldane ®1985
2
Dillucan® 1990
Recombinate® 1992
Invirase® 1995
Celebrex® 1999
Videx® 1991
Sporanox® 1992
1
Kogenale® 1993
Norvi® 1996
0,25
0,25
Vioxx® 1999
years of exclusivity
Vittorio Chiesa, 2003
Patent expiration
 Generic products strongly penetrate
(50% of prescription drugs in US)
 Revenues decrease by 75% in three months since
outpatenting
 40 bln $ of revenues will disappear in the next 5 years
2001
53
Vittorio Chiesa, 2003
Number of expiring patents
2002 41
2003 58
2004
46
Performance indicators decline
Although R&D expenses grow continuously
1992
1997
2001
11 bln$
18 bln$
35 bln$
• New drug approval decreases
• Post-marketing product withdrawals grow
• Sales growth declines
(9% in the ‘90ies vs. 5.3% foreseen in the first decade of
the 2000)
Vittorio Chiesa, 2003
The traditional paradigm is over
• Development of blockbusters (at least 1bln$ of
revenues)
• General-purpose products
• Aggressive marketing
Vittorio Chiesa, 2003
A new paradigm is required:
targeted treatments
• Disease-centric approach to drug discovery
• Cover of secondary care
• Combination of products and services (selfdiagnosis, patient training and education, disease
management)
• Targeted marketing
Vittorio Chiesa, 2003
The new paradigm means
stronger market pressure
• Earlier contacts with regulatory authorities
• Continuous evaluation and stringent reviews
• Shifting balance of power (to MCO)
• Pricing fixed on the basis of medical results
Vittorio Chiesa, 2003
The new paradigm is challenging
• Higher costs of development (clinical trials)
• Lower selling volumes per drug
• Lower price
but
• Higher number of new and more effective drugs
Vittorio Chiesa, 2003
Index
 The healthcare context
 The role of biotech
 A worldwide overview on biotech industry
 The Italian situation
Vittorio Chiesa, 2003
The new paradigm means
a new approach to R&D
R&D
Approval
Drug
Drug
Discovery
Development
Understanding the
disease at molecular
level in drug discovery
Vittorio Chiesa, 2003
Modeling and
simulation in drug
development
Production
&
Commercialization
The new paradigm means a great opportunity for
biotech companies
Small Biotech
Big Biotech
Big Pharma
Drug
Discovery
Drug
Production
Approval
&
Development
Commercialization
Enabling technology providers
Vittorio Chiesa, 2003
Midsize Pharma
Index
 The healthcare context
 The role of biotech
 A worldwide overview on biotech industry
 The Italian situation
Vittorio Chiesa, 2003
The biotech industry in US and EU
Revenues
Sales
R&D expenses
Profits (Losses)
Number of companies
Number of public
companies
Number of employees
Data 2001 in millions $
Vittorio Chiesa, 2003
USA
28.500
20.700
15.700
(6.900)
1.457
342
191.000
Europe
13.730
n.a
7.480
(1.520)
1.879
104
87.182
Biotech in Europe
Germania
Uk
Francia
Svezia
Israele
Finlandia
Svizzera
Paesi Bassi
Belgio
Danimarca
Italia
Irlanda
Private Companies
Public Companies
Norvegia
Altri Paesi
0
50
100
150
200
250
Number of Companies
Vittorio Chiesa, 2003
300
350
400
Biotech clusters in Europe
Vittorio Chiesa, 2003
What is a cluster
• A cluster is “a geographical concentration of
actors in vertical and horizontal relationships,
showing a clear tendency of co-operating and of
sharing their competences, all involved in a
localized infrastructure of support”
• In a cluster co-exist small biotech firms, R&D labs
of large firms, universities and research centres,
financial institutions, service companies, public
support structures
Vittorio Chiesa, 2003
Advantages from clustering
• Sharing of knowledge, competencies and practices
• Availability of skills
• Collaboration
• Support infrastructure
Vittorio Chiesa, 2003
Growth mechanisms of a cluster
Excellent
Scientific Base
The trigger is facilitating
the generation of new
science-based companies
Vittorio Chiesa, 2003
Generation of
Start-ups and
Spin-offs
Growth of the
scientific base
Establishment
of large firm
sites
Reinforcement
of relations
between
Industry and
Science
How clusters were born
• In US and UK, there were the conditions for the
growth of a cluster:
– excellent scientific base
– strong enterpreneurial culture
– propensity of finance to risky investments
• In other countries (Germany, France, Scandinavian
area) the public support helped create the conditions
for the growth of a cluster
Vittorio Chiesa, 2003
Index
 The healthcare context
 The role of biotech
 A worldwide overview on biotech industry
 The Italian situation
Vittorio Chiesa, 2003
Biotech industry in Italy and Lombardy
Number of biotech
firms
(no academic
spin-offs)
Number of
employees
Average number of
employees
Number of public
companies
Number of pharma
companies
LOMBARDY
ITALY
14 (48,3%)
29
532 (71.8%)
735
38
25
3
3
36 (41.3%)
87
614
-
(source: Farmindustria)
Number of biotech
researchers
Vittorio Chiesa, 2003
What is missing for a biotech cluster
in Lombardy
Scientific
Base
Biodevelopment
Companies
International cases
• BiomAG in Munich
• Genopole in Evry (France)
• Scientific and Technology Park in
Heidelberg
• Innovation Agencies and University
Liaison Offices in Scandinavian
countries
Vittorio Chiesa, 2003
Generation of
Start-ups and
Spin-offs
Mission
of a Biodevelopment Company
• supporting researchers willing to
found a new company
• supporting the management of the
project
• attracting funds
• hosting the companies in their
embryonic phase
What we are doing
• A EU funded project (Cleverbio) to study growth
mechanisms and practices of biotech clusters and
make a feasibility study for a biodevelopment
company
• A project funded by Fondazione Cariplo to build a
network of bioincubators (University of MilanoBicocca, Parco Tecnologico Padano, European
Institute for Oncology - IFOM)
Vittorio Chiesa, 2003