Download Pharma Facts 2015

Pharma Facts
2015
Pharma Facts
2015
INNOVATION
7
RESEARCH AND
DEVELOPMENT
COSTS AND
REVENUES
23
35
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Preface
Nefarma >
This is the new edition of Pharma Facts (Farmafeiten), an overview of
information about pharmaceutical care in the Netherlands and the role
in this of innovative medicines. A number of improvements have been
implemented since the last edition: new information, shorter texts and
clearer illustrations. Based on reader reactions, it has been decided to
bring out a printed edition this year too, although all the illustrations
can also be found online in the Feitenzaal of our virtual Farmahuis
(www.farmahuis.nl). It is possible to download these, so you can use the
illustrations for your own presentations, printed material or website.
If during the course of the year new information becomes available,
this will be included there immediately.
Nefarma, the association for innovative medicines
in The Netherlands, represents pharmaceutical
companies engaged in the development and
marketing of new and innovative medicines. These
are medicines that have been developed in response
to new insights in the treatments of diseases and
medical conditions for which there were previously
no therapeutic options.
This printed edition of Pharma Facts is also available in Dutch. Do you
have suggestions for further improvements or any observations or
remarks? Then do please let us know ([email protected]). We would be
glad to benefit from them.
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Trough more
than
250 healthcare programes
pharmaceutical
companies contribute
to better health in
developing countries.
Source: The Developing World Health Partnerships Directory, IFPMA, 2012
#1 Cause of death:
woman
cardiovascular diseases
INNOVATION
men
cancer
60%
Almost
of the mortality in the Netherlands is caused by cancer or cardiovascular diseases.
Source: Gezondheid en zorg in cijfers 2013 (Health and healthcare in figures 2013), CBS
188 biological medicines
Pharmaceutical companies have more than
for different infectious
diseases in the pipeline
Source: PhRMA, 2011
Thanks to research and the
innovations coming out of it,
we possess many new medicines
and treatment methods.
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INNOVATION
INNOVATION
MORE NEW MEDICINES
INNOVATION IS PROCEEDING
During the last 20 years, more new
medicines have come into existence than
previously. The average increased from
20 to 27 registrations of drugs with a
new active constituent.
Worldwide, biopharma companies have over
5400 new medical products in development,
including many new drugs for rare diseases.
Every year, an average of 140 such products
are added to these.
Peak
average
average
1st phase
New medicines
in the pipeline
clinical
research
2164
2nd phase
clinical
research
2329
= 1 year
1970 - 1989
Source: DiMasi,Tufts Centre for the study of drug development, FDA
1990 - 2009
3rd phase
clinical
research
833
Source: PhRMA, Analysis Group, 2013
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INNOVATION
PREVENTION, TREATMENT & CURE
Complete cures are sometimes possible using medicines.
Patients also remain alive more frequently with an acceptable
quality of life without feeling ill. In many areas a lot has already
been achieved, but it is still important to maintain full progress
on innovation of medicines.
Childhood
diseases
The status of drug
development for
several diseases.
Hepatitis
HIV/Aids
Malaria
Cardiovascular
disorders
Cancer
Respiratory
system
infections
Neuropsychiatric
disorders
Respiratory
system
disorders
Diabetes
Prevention
Treatment
Cure
Medicines available,
R&D focused on improving usability and
reduction of side effects etc.
Source: Nefarma, 2015
Medicines available,
R&D focused on challenges such as
combating resistance in patients, etc.
Medicines unavailable,
R&D focused on development of
active drug.
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INNOVATION
INNOVATION
TREND: MORE BIOLOGICAL MEDICINES
Millions of patients currently profit from biological medicines that are
based on human or animal proteins, which are manufactured in micro-organisms. In recent years it has become obvious that the number
of biological medicines is becoming an increasingly larger proportion
of the total.
Number of biological medicines
under development by disease
INCREASE IN TURNOVER OF
BIOLOGICAL MEDICINES
The turnover figures from recent years show clearly
that the number of biotech products is gaining an
ever-larger proportion of the total number of medicines arriving on the Dutch market.
Growth of turnover for biotech and non-biotech medicines, in billion €
4.5
Autoimmune
diseases
4.0
Cancer
3.5
Blood diseases
Diabetes related
disorders
Digestive disorders
Eye disorders
Genetic disorders
3.0
Cardiovascular diseases
Musculoskeletal
disorders
Infectious diseases
Neurological disorders
Respiratory disorders
Skin disorders
2.5
2.0
turnover
non-biotech
1.5
turnover
biotech
1.0
0.5
0
1995
2000
2005
2010
2012
2014
Transplantations
Other diseases
Source: PhRMA, 2013
Source: Axon Pharius, 2013
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INNOVATION
MEDICINES EXTEND OUR LIVES
Through their continuous search for new medicines,
pharmaceutical companies have made a major contribution to increasing the life expectation of the Dutch
population.
The absolute life expectancy in
The Netherlands (years)
Source: Statistics Netherlands, 2013
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INNOVATION
INNOVATION
CANCER SURVIVAL RATES ON THE RISE
POLIO ALMOST ERADICATED
Although many millions of people worldwide continue
to die of cancer, in recent decades, there has been major
progress in its treatment. Life-lengthening and life-saving
treatments are now entirely possible.
While at the end of the 80s hundreds of
thousands of people worldwide still died of polio,
in ten years, that number was minimised. In the
90s the number of polio deaths had stabilised at a
total of less than 2000 per year.
Percentages of five-year survival rates
of various cancers.
1989-1993 compared to 2008-2012
Period
1989-1993
The estimated number of deaths from polio,
worldwide per year
All types of
Cancer
400,000
Period
2008-2012
Prostate
cancer
Breast cancer
Colon cancer
Skin cancer /
melanoma
Not small-cell
lung cancer
Small-cell
lung cancer
Cervical cancer
300,000
200,000
100,000
Lung cancer
Source: Nederlandse Kankerregistratie (The Netherlands cancer registration) – www.cijfersoverkanker.nl
Source: Bill & Melinda Gates Foundation, 2011
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INNOVATION
INNOVATION
DECREASE IN THE NUMBER OF DEATHS
FROM AIDS IN THE NETHERLANDS
THE FIGHT AGAINST ALZHEIMER’S
The desired breakthrough against Alzheimer disease is still awaited. The
development of 101 hopeful potential medicines had to be stopped
between 1998 and 2011. But the researchers keep going! Pharmaceutical companies manufacturers still have, in total, over 70 potential
treatments in the pipeline.
Through improved medicines, the patients do not
become so ill and they remain alive longer. The
medicines have in the meantime been improved so
that they only need to be taken once a day.
Total number of medicines
against Alzheimer’s the development of which has been stopped.
Number of new
aids patients
101 attempts, no
breakthrough as yet
Number of patients
who died from aids
approvals
(2000, 2001, 2003)
for the treatment of
particular symptoms
Source: Statistics Netherlands (CBS), 2013
Source: PhRMA, 2012
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INNOVATION
NEWEST MEDICINES PRESCRIBED
EVER LESS OFTEN
Dutch doctors are becoming ever more cautious in the
prescription of medicines that have just come on to the
market. This is discernible in both the sales and in the
number of doses of medicines prescribed.
Five years or shorter on the market
Longer than 5 years on the market
Sales in
billions of
euros AIP
Prescribed doses
(DOT) in billions
20
5 .1
19
96
19
7
%
0. 7 1 3
5.
0.
20
%
11
0. 7
20
2 01 0
6 .7
%
20
01
20
01
6 .7
%
07
02
02
5 . 8%
%
5. 1
5.
2%
3.
5.2%
2004
3
20
2005
5%
3.
.2%
0
20
20
5%
2 01 0
0.7%
0.7%
2000
6.9%
%
0. 7
20
11
20
‘95‘96‘97‘98‘99‘00‘01‘02‘03‘04‘05‘06‘07‘08‘09‘10‘11‘12‘13‘14
Source: Farminform, 2014
1999
20
20
06 the market
Longer than 5 years4 on
0
2
%
1.9
07
Five years1or2%
shorter on the market
‘95‘96‘97‘98‘99‘00‘01‘02‘03‘04‘05‘06‘07‘08‘09‘10‘11‘12‘13‘14
3
08
20
%
1.9
08
20
1
0
4
6.8%
2
19
2
5
2009
1 . 2%
2009
1 . 2%
3
5.
%
6.7 98
1999
3
19
6
6.8%
2
4
%
97
3
4
5 .1
19
96
6%
19
4
1995
7
1
%
6.7 98
5
5
9
8
8% 2
6
5
2014
20
97
1
5.5%
0.4%
%
6%
0.
1995
8
8% 2
20
9
2000
2014
6.9%
5.5%
0.4%
%
0. 7 1 3
20
06
4 .2
%
20
2005
5.2%
2004
5 . 8%
03
5. 1
%
5.
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750,000 to 1.000.000
Those over 65 use five drugs or more every day
16,000 elderly people
end up in hospital annually
as a result of erroneous use.
Source: RIVM, ‘Polyfarmacie bij kwetsbare ouderen’ (Polypharmacy in vulnerable elderly people), 2013
RESEARCH AND
DEVELOPMENT
13% of the Dutch population have three or more
long-term conditions. In those over 75, this proportion is
Source: Gezondheid en zorg in cijfers 2013 (Health and healthcare in figures 2013), CBS
In
of elderly people with a mental limitation, errors are
made in the prescription of medicines.
Source: Research by A.D.M. van der Kaaij, et al. (2012) in PW Wetenschappelijk Platform, 2012;6;a1240
Pharmaceutical companies
worldwide spend many billions of
euros every year on research into
and development of medicines.
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RESEARCH AND DEVELOPMENT
PHARMACEUTICAL
SECTOR AT NO. 1
Share by sector in total worldwide R&D investments, in percentages of the total.
of own
turnover
Pharma & biotechnology,
over € 91 billion per year
Automotive industry
Software & computers
Banks
Oil and gas exploration
Electronic engineering
Telecommunication
Chemical industry
Aerospace
Healthcare equipment & services
General industry
Leisure products
Technology hardware
& equipment
Machine industry
Source: European Committee, EU Industrial R&D Investment Scoreboard, 2013
Food
Other sectors
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RESEARCH AND DEVELOPMENT
REINVESTMENT OF
REVENUES
The pharmaceutical and biopharmaceutical sector invests a greater proportion of its own turnover
in R&D than do other sectors.
Pharma & biotechnology
Software & computers
Technology hardware &
equipment
Leisure products
Healthcare equipment
& services
Electronic engineering
Investment of own turnover
in R&D worldwide,
per sector, in
Source: Europese Commissie, EU Industrial R&D Investment Scoreboard, 2013
Automotive industry
Aerospace
Chemical industry
Machine industry
General industry
Telecommunication
Food
Oil and gas exploration
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RESEARCH AND DEVELOPMENT
RESEARCH AND DEVELOPMENT
INVESTMENTS VERSUS NEW
MEDICINES
PATENT TURNAROUND
The average duration in years of
the development and patenting
period of a medicine.
The growth in the number of registrations of medicines with a new active constituent displays
a rising trend. This growth is notable because the
development costs are in fact rising.
The average duration of the
development and patent period
of a drug (years)
International spending on R&D by the U.S.
pharmaceutical industry over the past 30 years
R&D investment in
billion dollars
The number of registered medicines with
new active ingredients in the US
Preclinical
research
Clinical
research
Registration &
reimbursement
YEAR
YEAR
YEAR
Patent-application
Source: DiMasi, Tufts Centre for the study of drug development, FDA, 2010
Remaining
patent
period
YEAR
Supplementary
Protection
Certificate
(SPC)
YEAR
Patent- expiration
Source: Nefarma
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RESEARCH AND DEVELOPMENT
RESEARCH AND DEVELOPMENT
ORPHAN DRUGS BY
INDICATION AREA
MEDICINES IN RESEARCH PHASE
1,307 medicines in the test phase have obtained a ‘designation as orphan drug’ since 2000 in Europe. To date around
10 per cent of these have appeared on the market. Many
hundreds of potential orphan drugs are therefore still in the
pipeline or have fallen by the wayside in the process.
In total, 93 orphan drugs for various
rare conditions have appeared on the
European market in recent years.
Total
Digestive system and
metabolism
Oncology and immunology
Total
Urinary and
reproductive system
Nervous system
Blood and blood-forming organs
Miscellaneous
Cardiovascular system
Skin conditions
Hormonal preparations
Anti-infective drugs
Source: European Medicines Agency, 2014
Respiratory system
(1st half year)
Source: European Medicines Agency, 2014
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RESEARCH AND DEVELOPMENT
MOST RESEARCH FUNDS
FOR CLINICAL TEST PHASE
The largest part of the expenditure in
the development of a new medicine
goes to the last phase of the clinical
research.
Pre-clinical
research
Registration
&
compensation
Clinical research
Distribution of investments over
the different phases of medicine
research.
Investigating
the effect of
new, possibly
active substances in the
laboratory
Source: PhRMA & CCMO, 2013, Nefarma, 2014
Investigating how the
new medicine is tolerated
by the body in a limited
number of healthy
volunteers
Determining dose, safety and effectiveness
in patients with the
condition concerned
Gaining deeper insight
into the effectiveness,
advantages and possible
side effects with hundreds to thousands of test
subjects who have the
condition concerned
Gaining
marketing
authorisation based
on research
files submitted
Usage
Monitoring
side effects and
effects in the
longer term
with users
Other
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In 2040 the avarage family will spend almost
Half of their gross income
on healthcare
That is
2
time more than now.
Source: Economic Policy Analysis (CPB), 2013
COSTS
AND REVENUES
People in the lowest income group cost
1.5 times
as much in terms of healthcare
as people in the highest income
groups
Source: Statistics Netherlands (CBS), 2013
In 2010, health insurers reimbursed
for care under
per person the basic cover.
€ 2100
Medicines were responsible for
of this total.
15%
Source: Statistics Netherlands (CBS), 2013
Rising costs are a current theme in
the healthcare debate; it is also
important to look at revenues.
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COSTS AND REVENUES
COSTS AND REVENUES
RISING HEALTHCARE COSTS
THE NETHERLANDS
IN EUROPE
Healthcare costs are rising: the bill is
higher every year and it is absorbing
an ever greater amount of the Gross
Domestic Product.
Compared with other
countries, the Netherlands
spends relatively little on
pharmaceutical care.
Proportion of expenditure on pharmaceutical care in total care budget
by country in 2012.
Total healthcare expenditure in The Netherlands
2003-2013
€ 72.1 billion
€ 42.9 billion
9%
of the total GDP in
The Netherlands
went to healthcare
in 2003.
12%
of the total GDP in
The Netherlands
went to healthcare
in 2013.
Source: Gross BKZ (Budgetary Healthcare Framework): Financial Picture of Healthcare from the Annual Report of
VWS (Ministry of Health Welfare and Sport)/Gross Domestic Product: CBS (Statistics Netherlands), 2014
PRT
FRA
IRL
DEU ESP
FIN
ITA
BEL
AUT
CHE SWE
NED GBR DNK
Annual spending on medicines per capital
CHE
DEU
FRA
IRL
FIN
BEL
AUT
SWE
NED
ESP
ITA
DNK
PRT
GBR
Source: Foundation for Pharmaceutical Statistics (SFK), 2014
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COSTS AND REVENUES
HEALTHCARE COSTS COMPARED
How heavily do the care costs weigh on the
budgets in each country? For this, we look at
the Gross Domestic Product (GDP) insofar as
these are known to the OECD.
2012 - 12%
of $ 714 billion GDP
2000 - 8%
of $ 610 billion GDP
Total healthcare
spending per country
as % GDP
USA
JPN
DEU FRA
GBR
ITA
ESP
16,245 4,505 3,367 2,369 2,215 2,038 1,473
(*Data from 2011, as 2012 is not yet available)
Source: OECD, 2013
NLD
BEL
CHE
AUT
SWE
PRT
DNK
FIN
IRL
GDP per country
in billion $
healthcare share 2011
healthcare share 2004
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COSTS AND REVENUES
COSTS AND REVENUES
MEDICINES WITHIN
HEALTHCARE
TURNOVER ON MEDICINES
The total annual turnover for prescription drugs has fallen slightly in recent years. The turnover for medicines
in hospitals is rising. This may partly be explained by
the transfer (since 2012) of certain groups of medicine
to the hospital budgets.
Only a limited part of the
total healthcare expenditure
in the Netherlands may be
attributed to medicine costs.
Total turnover on medicines in billions of euros*
Primary
Long-term care
of all public health
expenditure (71.3
billion euros) in
2015 is going
to extramural
medicines
Extramural
turnover on drugs
in euros
Other
Intramural turnover
on drugs in euros
Hospitals, medical specialist and
other curative care
Source: Dutch National Budget VWS for 2014, Dutch Budget day (Prinsjesdag), 2014
* Amounts are based on pharmacy purchase prices.
The actual market price is the result of negotiations between the parties in the field.
Source: Farminform, 2015
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COSTS AND REVENUES
AGAINST THE TREND:
PRICES OF MEDICINES FALL
The average price of medicines has fallen
sharply in recent years. Various reasons
lie behind this fall, which started halfway
through the nineties.
Consumer price index compared to the price
index for prescription medicines (1996 = 100)
Housing, Water
and Energy
Transportation
Various measures
and agreements have
contributed to the
decrease in the price
of medicines.
Education
Total Expeniture
Introduction
Medicines Pricing
Act (WGP)
Introduction
claw back
Food
Health
Start contract period
(Individual)
Preference policy
Claw back increase
Agreement
VWS - KNMP
Source: Foundations for Pharmaceutical Statistics (2014), FarmInform (2014), CBS (2014)
Introduction
free pricing
Introduction
temporary measure
“De Geus”
Transition agreement
Prescriptiondrugs price index
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COSTS AND REVENUES
VOLUME AND TURNOVER
The total use of prescription drugs in the Netherlands is increasing every year,
partly due to the ageing population. Despite this volume growth, manufacturers’
total earnings are falling. Manufacturers of branded or trademarked drugs have
experienced a decrease in both their turnover and volume in recent years. For generic drugs, the volume is growing, but the turnover remains more or less stable.
Volume
Total
volume
generic
standard daily doses in billions
volume
special
Turnover
total
Turnover
generic
Turnover
special
in billion euro’s*
VOLUME
GROWING ...
* Amounts are based on
pharmacy purchase prices.
The actual market price is the
result of negotiations between
the parties in the field.
Source: Farminform, 2015
... TURNOVER
FALLING
46 | PHARMA FACTS 2015
In the Netherlands, approx. 14,000 people every year
die from a rare disease.
This corresponds to approx.
10%
of all mortality
caused by illness.
Source: PhRMA, 2011
According to predictions, our life
expectancy will continue to increase in the coming decades:
by 2040 men will reach an
average age of 88 years and
women an average age of 90 years.
Source: The Developing World Health Partnerships Directory, IFPMA, 2012
Every euro invested in
healthcare yields return
1.30
euro
euro
return
Source: Marc Pomp, Een beter Nederland,
De Gouden Eieren van de gezondheidszorg, 2010 (Two reports for VWS)