Vaccines in the new millennium: a view from Mexico a view from

Transcripción

Vacunas para la Salud Pública
Vaccines in the new millennium:
a view from Mexico
S
Samuel
l Ponce
P
de
d León
L ó R.
R MD,
MD MSc
MS
1
Samuel Ponce de Leon R.
Disclosure:
Director General de Biológicos y Reactivos de México.
Empresa paraestatal de la Secretaria de Salud.
Invitado p
por Sanofi Pasteur.
Birmex es socio de Sanofi Pasteur y tiene convenios
comerciales con otros productores de vacunas.
La única percepción económica que recibo es la
correspondiente a mi cargo en el gobierno de México
(incluye SNI).
Agenda
1.
Vaccines
att th
the XXI century
market
1 V
i
t
k t
2. Overview of opportunities
3. Challenges & Perspectives
Vacunas en el siglo XXI
La intervención médica más efectiva y con mejor costo-beneficio de la medicina
moderna.
Erradicación de la viruela, poliomielitis (hemisferio occidental), y drástica disminución
de sarampión, tétanos, difteria y tosferina. Prevención de Ca hepático, disminución de
la mortalidad por neumococo en niños.
El Programa
g
Expandido
p
de inmunizaciones OMS en 1985 cubrió al 80% de la población
p
infantil mundial vs 5% en 1974. Hoy globalmente la cobertura es mayor.
El mejor logro de Salud Pública en México con coberturas muy altas. Por arriba del
95% (infancia).
La biotecnología moderna permite imaginar vacunas para casi cualquier agente
patógeno, incluso otras entidades.
Vacunología 2008
Sucesos recientes
Dos infecciones se incorporan a las prevenibles con
vacunas (Herpes Zoster y Papiloma humano)
La vacuna contra rotavirus esta de regreso
Nuevas presentaciones para meningococo y difteria
Se liberó nueva vacuna cuadruple (Sar./Pap./Rub./Var.)
El CaCu puede evitarse con vacuna
Enfasis actual en vacunación de adolescentes
Costo vs Impacto
Medicina curativa
Medicina preventiva
Costo relativo de la
salud
Población
beneficiada
Tres grandes tendencias para la industria
f
farmacéutica
é ti
Primera:
P
i
Reducción de utilidades por el
crecimiento de los genéricos y el
poder de negociación de los
grandes compradores
Segunda:
C d vez es más
Cada
á difícil
difí il y costoso
t
encontrar nuevos tratamientos.
Tercera:
La industria gasta grandes
cantidades en mercadotecnia y la
investigación pública ha visto
reducidos
d id
sus presupuestos
t
en
los EEUU.
El renacimiento de las vacunas
((Beyond
y
the egg.
gg The economist,, marzo,, 2007))
The growth in value and in volume has accelerated
since 2004
10 730 M€
World Vaccine Global Market Evolution
• Total Market growth in value of 41 % since 2002
+24%
• Total Market growth in volume of 35 % since 2002
6 725 MDs
6 502 MDs
• Exchange rate USD/EUR effect between 2002 and 2004
6 116 MDs
8 626 M€
5 797 MDs
-2%
2%
+18%
-2%
7 620 M€
7 461 M€
7 294 M€
4 978 MDs
2002
2003
2004
2005
Source : sanofi pasteur World Market Analysis 2006
2006
40% of global growth in 2006 has been made by new
products* . . .
Menactra
HPV
MMRV
Rotavirus
Flu Pandemic
Zoster
OPV Mono T1
Meningo Cj C Hib
+788M€
. . . Even if Flu vaccine is still a major contributor
to g
growth
Flu market has doubled in 5 years (+ 1b€)
*Products lunched after 2002
Challenges & Perspectives
The mission for the vaccine industry is straightforward :
1
Ensure access to existing vaccines for all
2
Develop vaccines against new target diseases
3
Improve existing vaccines
Challenges and Perspectives: The mission for the vaccine goverment
programs is not so straightforward
Delineate the best cost-benefit/cost-efficacy scenario to
include a new/improved vaccine in a specific country
considering the local epidemiology and adjusted to the
existent budget
To decide if the new is really better
To work to expand
rationally
p
y the national vaccination
program
Nuevo esquema
q
de vacunación en México,, 2007
N
Nuevo
esquema d
de vacunación,
ió 2007
Programa del adulto mayor.
HITOS DE LA VACUNACIÓN ANTIPOLIOMIELÍTICA CASOS DE POLIOMIELITIS Y DOSIS APLICADAS. México, 1937 –
2006
1990
Ultimo
caso
2 000
2,000
1985
Días
NV
1,800
50
1994
Certif.
1,600
45
40
1,400
35
1962
Uso
OPV
1,200
1979
Cartill
a NV
30
1,000
25
800
20
600
400
1
15
1955
Uso
de IPV
10
200
5
0
0
2003 2006
1937 1941 1945 1949 1953 1957 1961 1965 1969 1973 1977 1981 1985 1989 1993 1997 2001
DOSIS
CASOS
Impacto de las cobertura de vacunación en la protección inmunológica y la morbilidad por sarampión, México 19851985-2005
2000
Encuesta
Nacional
de Salud
1985
Encuesta Nacional
Seroepidemiológica
1.7%
%
4.7%
70000
90%
23.8%
80%
Cobertura
Casos
50000
40000
34 6%
34.6%
60%
Proporción
Susceptibles
Inmunidad natural
30000
Inmunidad vacunal
93.6%
50%
40%
30%
20000
10000
70%
20%
31.6%
10%
0
0%
Año
Fuente: Lancet, noviembre 2006
Coberttura de
vacunac
ción (%)
Número
o de casos
60000
100%
OMS. Plan Estraté
Estratégico de Vacunació
Vacunación
2006--2009
2006
 El nivel de desarrollo de las investigaciones prevé el siguiente horizonte de
disponibilidad de vacunas.
Disponibilidad de vacunas y número de defunciones
TB
Vacunas en
Perspectiva
Malaria
HIV/AIDS
HPV
Nueva
generación de
vacunas
Encefalitis japonesa
(SA 14 14 2)
Pneumococo
g
A
Meningococo
Vacunas
disponibles
subutilizadas
Vacunas
Tradicionales
+ hep B
Tifoidea
Influenza
Rotavirus
Fiebre amarilla
Encefalitis japonesa
Hib
Polio
Tétanos Sarampión
1960
1970
Hepatitis B
1980
1990
2000
2010
Fuente: OMS:Strategic Plan 2006-2009. El tamaño de cada circulo representa el número de defunciones;
Current and future vaccines and technologies
Current vaccines
•
BCG a
•
Cholera (inactivated and live) b
•
DTP and DTP - based combinations
•
Haemophilus influenzae type b a
•
Hepatitis A a
•
Hepatitis B a
•
Influenza a
•
P li (OPV and
Polio
d IPV) a
•
Pseudomonas b
•
Rabies b
•
Rift Valley fever b
•
Rubella a
•
Tetanus toxoid a
•
Tick-borne
Tick
borne encephalitis b
•
Typhoid b
•
Varicella a
•
Yelllow fever a
a
live) b
•
Japanese encephalitis (inactivated and
•
Measles a
•
Meningococcus (polysaccharide and conjugate) a
•
Mumps a
•
Pneumococcus (polysaccharide and conjugate) a
a
b
Avalable for inmmediate use in routine immunization.
Available for specific regions or circumstances
Current and future vaccines and technologies
N
New
or iimproved
d vaccines
i
anticipated
ti i t d by
b 2015
•
Dengue d
•
New combinations of existing vaccines d
•
DT P ((with
DTaP
i h two P antigens)
i
)d
•
Enterotoxigenic Escherichia coli (ETEC) d
•
Group A streptococcus d
•
Human papilloma virus c
Influenza for pandemic response
•
•
Polio (monovalent OPV type 1) d
Japanese encephalitis (improved) c
•
•
Respiratory syncytial virus d
Malaria d
•
•
Rotavirus c
Measles (aerosol) c
•
•
Severe acute respiratory syndrome (SARS) d
Meningococcus A (multi-serotype conjugate) c
•
•
Shi ll d
Shigella
•
Typhoid (conjugate) d
•
West Nile fever d
Pneumococcus (improved conjugate or proteinbased) c
•
Polio
•
(inactivated vaccines based on Sabin strains) c
Developed countries are still the main market place
i terms off sales.
l
in
Top 10 products, Developed vs Developing Countries
Developed*
Countries
M€
1 418
F lu Inj ( A d )
1 340
Pno C j
Developing
Countries
Sales : 8 204 M€
Growth: 24%
335
R ab ies
MMR
309
Hep B ( A d )
281
273
OPV
V aricella
D TacP_ Hib _ IPV
333
F lu
l Inj
I j ( Ad)
190
172
147
D T wcP_ Hib _ Hep B
113
M go Cj ACW Y
242
MMR
D T acP_ IPV _ Hep B
234
Hep A ( Pd )
103
Hep B ( A d )
233
Pno C j
100
T d _ acP
230
Hib
D T acP_ Hib _ IPV _ Hep B
230
V aricella
98
72
*Developed: US, Canada, EU before 2004,Japan,Australia, Korea
Source : sanofi pasteur - World Market Analysis 2006
Sales : 2 526 M€
Growth: 25%
The vaccine market is very concentrated, with 5
manufacturers representing more than 80% of the market
Vaccine Market Competitive Situation in 2006
Worldwide
Others
North America
Others
Others
Others
The local players are mainly concentrated in Asia
Geographical position of 30 major
local manufacturers on a total of 100
Immunopreparat
Viron (Tomsk)
CNBC ( Public
Consortium)
Beijing
ChangChun
ChengDu
LanZhou
Shanghai
Wuhan
+ Kunming
Denka
Kaketsuken
Kitasato
Institute
About 21 private producers
in 2006 (16 in 2004)
CIGB/Heber
Biotech
7 small producers
Takeda
Biken
The largest:
Changshen
Finlay
RUSSIA
KOREA
JAPAN
EASTERN
EUROPE
Birmex
CUBA
CHINA
INDIA
GCC
MEXICO
INDONESIA
LG Life Sciences
+ 4 other
producers
Butantan
Fiocruz /
BioManguihos
BRAZIL
Serum Institute of India
Shantha Biotechnics
AUSTRALIA
Biofarma
Panacea
Bharat
Biological E
+ 10 other producers
CSL
Birmex tiene un posicionamiento
estratégico
g
bipolar
p
Es una empresa que se
encuentra dentro de
un sector g
global
dominado por
multinacionales
Reto de gestión
estratégica para Birmex:
Posicionamiento en dos
entornos muy diferentes
Es una empresa pública
dentro del Sector Salud
con una misión trascendente
hacia la sociedad
Vision: A world in 2015 in which:
•
•
•
•
•
•
•
Immunization is highly valued;
Every child
child, adolescent and adult has equal access to immunization as
provided for in their national schedule;
More people are protected against more diseases;
Immunization an related interventios are sustained in conditions of diverse
social values, changing demographics and economies, and evolving
diseases;
Immunization is seen as crucial for the wider strengthening of health
system and a major element of efforts to attain the Millennium Development
Goals;;
Vaccines are put to best use in improving health and security globally; and
Solidary among the global community guarantees equitable access for all
people to the vaccines they need.
There is no other industry for which
public interest
can match to such an extend with
business interest
1
Ensure access to existing vaccines far all
Set up capacity in order to meet demand and secure supply
Secure cost control while coping with quality requirements
Respond to political e
expectations
pectations in terms of locali
localization
ation
Make optimal use of available funding
EPI & GAVI Programs
Polio Eradication
Flu Pandemic Preparedness
2
Develop vaccines against new target diseases
So far, only accessible to multinational companies
Innovation available through biotechs
One “new target” vaccine every 3 to 5 years
Dengue, Meningo B
Malaria ,Tuberculosis, HIV
Oncology
+
_
Improve existing vaccines
“Paradox” of vaccination calling for improved safety
Convenience and ease of use
Better use of antigens capacities
Dose sparing
p
g : microinjections
j
& adjuvant
j
Combinations
3
Available but underused immunization supportive technologies
•
Pre-filled injections devices
•
Vaccine vial monitors on all vaccines
New immunization supportive technologies anticipated
by 2015
•
Jet injectors
•
Thermostable vaccines
•
Vaccine aerosols
•
Vaccine nasal sprays
•
Vaccine patches
C
In a late stage of development.
b
Licensing expected in 2010-2015
Agenda
1.
World
1 W
ld vaccine
i market
k t
2. Overview of competition
3 Challenges
3.
Ch ll
& Perspectives
P
ti
Global vaccine market in 2006 is worth more than 10.7
billion € and is dominated by North America
Vaccine Global Market in 2006
Worldwide
10,7 billion €
+24,40% compare to 2005
North America
Europe
International
4,9 billion €
2,5 billion €
3,3 billion €
Europe
24%
International
zone
31%
North
America
45%
The local players are mostly present in the international
zone, representing 42.3% of this market.
International market in 2006 with a focus on local
manufacturers
Panacea Biotec;
China Others;
13%
Solvay
(Duphar)
1,0%
Baxter
0,5%
7%
SII;; 9%
BioFarma; 3%
Others
42,3%
Merck
2,6%
CSL; 3%
Virion (Tomsk);
3%
Novartis
4,9%
Wyeth
5,4%
Fiocruz; 2%
Other Local
producers; 27%
sanofi pasteur
20,7%
Immunopreparat;
2%
GSK
22,6%
India Others; 2%
International Zone
Total Sales :3 275M €
Japan Others;
30%
The strategies may vary significantly from one
f
h
manufacturer
to another.
Market positioning in 2006
Geographical
Coverage*
Co
e age
sanofi
fi pasteur
t
GSK
Global
Merck
Novartis
Wyeth
Solvay (Duphar)
Medium
SII
Baxter
Berna
SSI
Local
CSL
LG
GCVC
Cuba
Shanta
IP Dakar
Europe
Biotech
Latin Am
Panacea
Immunopreparat Changchun
Virion (Tomsk)
Biotec
Ind
BioFarma
J
Japanese
Chi
Chinese
Asia Other
E.EuropeThail/Viet
Bharat
ia
RAZI
Biotech
Biological E
Low
Medium
High
Portfolio
diversity**
*Geographical coverage = Nb of countries where the competitor is present/Total NB of countries
**Portfolio diversity = Nb of Competitor’s products/ Total Number of products on the market

Vaccines in the new millennium: a view from Mexico a view from

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