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TRANSCRIPT
Pharma Facts 2015
INNOVATION
7RESEARCH AND DEVELOPMENT
23
COSTS AND REVENUES
35
Pharma Facts 2015
4 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 5
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.
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.
Preface
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.
Nefarma >
6 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 7
Thanks to research and the innovations coming out of it,
we possess many new medicines and treatment methods.
INNOVATION#1 Cause of death:
cardiovascular diseases cancerwoman men
Almost 60% of the mortality in the Nether-lands is caused by cancer or cardiovascular diseases.
healthcare programes
188
Trough morethan
pharmaceutical companies contribute to better health in developing countries.
Source: The Developing World Health Partnerships Directory, IFPMA, 2012
Source: Gezondheid en zorg in cijfers 2013 (Health and healthcare in figures 2013), CBS
Source: PhRMA, 2011
Pharmaceutical companies have more than
biological medicinesfor different infectious diseases in the pipeline
250
= 1 year
averagePeak
average
1970 - 1989 1990 - 2009
8 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 9
3rd phaseclinicalresearch833
2nd phaseclinical
research2329
1st phaseclinical
research2164
New medicinesin the pipeline
Source: PhRMA, Analysis Group, 2013Source: DiMasi,Tufts Centre for the study of drug development, FDA
INNOVATION
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.
INNOVATION IS PROCEEDING
INNOVATION
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.
MORE NEW MEDICINES
10 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 11
Respiratorysystem
infections
Cancer
Neuro-psychiatricdisorders
Cardio-vascular
disorders
Diabetes
Respiratory system
disorders
Medicines available,R&D focused on challenges such as combating resistance in patients, etc.
Medicines unavailable,R&D focused on development of active drug.
Source: Nefarma, 2015
Medicines available,R&D focused on improving usability and reduction of side effects etc.
Prevention
Treatment
Cure
HIV/Aids
Hepatitis
Malaria
Childhooddiseases
INNOVATION
The status of drug development for several diseases.
PREVENTION, TREATMENT & CUREComplete 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.
1995 2000 2005 2010 201420120
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
Source: PhRMA, 2013
Genetic disorders
Eye disorders
Digestive disorders
Diabetes relateddisorders
Blood diseases
Autoimmunediseases
Cardiovascular diseases
Musculoskeletal disorders
Infectious diseases
Neurological disorders
Respiratory disorders
Skin disorders
Transplantations
Other diseases
Cancer
Number of biological medicinesunder development by disease
INNOVATION
TREND: MORE BIOLOGICAL MEDICINES
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Source: Axon Pharius, 2013
turnoverbiotech
turnovernon-bio-
tech
Growth of turnover for biotech and non-bio-tech medicines, in billion €
INNOVATION
INCREASE IN TURNOVER OF BIOLOGICAL MEDICINESThe turnover figures from recent years show clearly that the number of biotech products is gaining an ever-larger proportion of the total number of medici-nes arriving on the Dutch market.
Millions of patients currently profit from biological medicines that are based on human or animal proteins, which are manufactured in mi-cro-organisms. In recent years it has become obvious that the number of biological medicines is becoming an increasingly larger proportion of the total.
The absolute life expectancy inThe Netherlands (years)
Source: Statistics Netherlands, 2013
INNOVATION
MEDICINES EXTEND OUR LIVES
Through their continuous search for new medicines, pharmaceutical companies have made a major contri-bution to increasing the life expectation of the Dutch population.
14 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 15
400,000
300,000
200,000
100,000
Percentages of five-year survival rates of various cancers.1989-1993 compared to 2008-2012
16 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 17
The estimated number of deaths from polio,worldwide per year
Source: Bill & Melinda Gates Foundation, 2011
Cervical cancer
Skin cancer /melanoma
Breast cancer
Period2008-2012
Period1989-1993
All types ofCancer
Small-celllung cancer
Source: Nederlandse Kankerregistratie (The Netherlands cancer registration) – www.cijfersoverkanker.nl
Not small-cell lung cancer
Colon cancer
Prostate cancer
Lung cancer
INNOVATION
POLIO ALMOST ERADICATEDWhile 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.
INNOVATION
CANCER SURVIVAL RATES ON THE RISEAlthough 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.
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(2000, 2001, 2003)for the treatment of particular symptoms
Source: PhRMA, 2012
approvals
101 attempts, no breakthrough as yet
Source: Statistics Netherlands (CBS), 2013
Number of patientswho died from aids
Number of newaids patients
INNOVATION
THE FIGHT AGAINST ALZHEIMER’S
Total number of medicines against Alzheimer’s the develop-ment of which has been stopped.
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! Pharmaceu-tical companies manufacturers still have, in total, over 70 potential treatments in the pipeline.
INNOVATION
DECREASE IN THE NUMBER OF DEATHS FROM AIDS IN THE NETHERLANDSThrough 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.
20 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 21
2000
2001
2002
2003
20042005
2006
2007
2008
2009
1995
1996
1997
1998
1999
2010
2011
2012
2013
2014
‘95‘96‘97‘98‘99‘00‘01‘02‘03‘04‘05‘06‘07‘08‘09‘10‘11‘12‘13‘14
5.5%5.1%
5.6%
6.7%6.8%
0.7%
0.7%
0.8%
0.7%0.4%
6.9%
6.7%
5.5%
5.1%
5.8%5.2%
4.2%
3.2%
1.9%
1.2%
9
6
4
5
7
8
2
3
4
5
2
0
1
3
Prescribed doses (DOT) in billions
Five years or shorter on the market
Longer than 5 years on the market
2000
2001
2002
2003
20042005
2006
2007
2008
2009
1995
1996
1997
1998
1999
2010
2011
2012
2013
2014
‘95‘96‘97‘98‘99‘00‘01‘02‘03‘04‘05‘06‘07‘08‘09‘10‘11‘12‘13‘14
5.5%5.1%
5.6%
6.7%6.8%
0.7%
0.7%
0.8%
0.7%0.4%
6.9%
6.7%
5.5%
5.1%
5.8%5.2%
4.2%
3.2%
1.9%
1.2%
9
6
4
5
7
8
2
3
4
5
2
0
1
3
Source: Farminform, 2014
Sales in billions of euros AIP
INNOVATION
NEWEST MEDICINES PRESCRIBED EVER LESS OFTENDutch 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
22 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 23
Pharmaceutical companies worldwide spend many billions of euros every year on research into and development of medicines.
RESEARCH AND DEVELOPMENT
13% of the Dutch population have three or more long-term conditions. In those over 75, this proportion is
750,000 to 1.000.000 Those over 65 use five drugs or more every day
In
of elderly people with a mental limitation, errors are made in the prescription of medicines.
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
Source: Gezondheid en zorg in cijfers 2013 (Health and healthcare in figures 2013), CBS
Source: Research by A.D.M. van der Kaaij, et al. (2012) in PW Wetenschappelijk Platform, 2012;6;a1240
24 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 25
of own turnover
General industryLeisure products
TelecommunicationHealthcare equipment & services
Oil and gas exploration
FoodBanks
Other sectors
Source: European Committee, EU Industrial R&D Investment Scoreboard, 2013
Technology hardware & equipment
Pharma & biotechnology,over € 91 billion per year
Automotive industry
Software & computers
Electronic engineering
Machine industry
Aerospace
Chemical industry
RESEARCH AND DEVELOPMENT
Share by sector in total worldwi-de R&D investments, in percen-tages of the total.
PHARMACEUTICAL SECTOR AT NO. 1
26 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 27
Pharma & biotechnologySoftware & computers
Technology hardware &equipmentLeisure products
Electronic engineering
Healthcare equipment& services
Automotive industryAerospaceChemical industryMachine industry
TelecommunicationGeneral industry
FoodOil and gas exploration
Investment of own turnover in R&D worldwide, per sector, in
RESEARCH AND DEVELOPMENT
The pharmaceutical and biophar-maceutical sector invests a grea-ter proportion of its own turnover in R&D than do other sectors.
REINVESTMENT OF REVENUES
Source: Europese Commissie, EU Industrial R&D Investment Scoreboard, 2013
28 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 29
Source: Nefarma
Patent-application
Preclinicalresearch
Clinicalresearch
Registra- tion &
reimburse-ment
Remainingpatentperiod
Supplementary Protection Certificate
(SPC)
Patent- expiration
YEAR YEAR
The number of registered medicines with new active ingredients in the US
R&D investment in billion dollars
Source: DiMasi, Tufts Centre for the study of drug development, FDA, 2010
YEAR YEAR YEAR
RESEARCH AND DEVELOPMENT
The average duration in years of the development and patenting period of a medicine.
The average duration of the development and patent period of a drug (years)
PATENT TURNAROUND
RESEARCH AND DEVELOPMENT
INVESTMENTS VERSUS NEW MEDICINESThe growth in the number of registrations of medi-cines with a new active constituent displaysa rising trend. This growth is notable because the development costs are in fact rising.
International spending on R&D by the U.S.pharmaceutical industry over the past 30 years
30 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 31
Total
(1st half year)
Source: European Medicines Agency, 2014
Blood and blood-for-ming organs
Nervous system
Total
Digestive system and metabolism
Oncology and immunology
Urinary and reproductive system
Miscellaneous
Skin conditions
Anti-infective drugs
Cardiovascular system
Hormonal preparations
Respiratory system
Source: European Medicines Agency, 2014
RESEARCH AND DEVELOPMENT
MEDICINES IN RESEARCH PHASE1,307 medicines in the test phase have obtained a ‘designa-tion 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.
RESEARCH AND DEVELOPMENT
In total, 93 orphan drugs for various rare conditions have appeared on the European market in recent years.
ORPHAN DRUGS BY INDICATION AREA
32 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 33
Monitoring side effects and
effects in the longer term with users
Gaining marketing authorisa-tion based
on research files submit-
ted
Clinical research Registration &
compensa-tion
Usage
Determining dose, sa-fety and effectiveness
in patients with the condition concerned
Gaining deeper insight into the effectiveness,
advantages and possible side effects with hund-
reds to thousands of test subjects who have the condition concerned
OtherInvestigating the effect of
new, possibly active sub-
stances in the laboratory
Pre-clinicalresearch
Investigating how the new medicine is tolerated
by the body in a limited number of healthy
volunteers
Source: PhRMA & CCMO, 2013, Nefarma, 2014
RESEARCH AND DEVELOPMENT
MOST RESEARCH FUNDS FOR CLINICAL TEST PHASE
Distribution of investments over the different phases of medicine research.
The largest part of the expenditure in the development of a new medicine goes to the last phase of the clinical research.
34 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 35
Rising costs are a current theme in the healthcare debate; it is also important to look at revenues.
COSTS AND REVENUES
In 2040 the avarage family will spend almost
People in the lowest income group cost
In 2010, health insurers reimbursed for care under the basic cover.
as much in terms of healthcare as people in the highest income groups
Half of their gross income on healthcare
That is time more than now.2
1.5 times
Source: Economic Policy Analysis (CPB), 2013
Source: Statistics Netherlands (CBS), 2013
Source: Statistics Netherlands (CBS), 2013
€ 2100 per person
Medicines were responsible for of this total.15%
36 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 37
Source: Foundation for Pharmaceutical Statistics (SFK), 2014
CHE
Annual spending on medicines per capital
DEU FRA IRL FIN BEL AUT
SWE NED ESP ITA DNK PRT GBR
CHEDEUIRL FIN BEL AUTFRA NEDESP DNKPRT GBRITA SWE
of the total GDP in The Netherlands went to healthcare in 2003.
of the total GDP in The Netherlands went to healthcare in 2013.
9%
€ 42.9 billion
€ 72.1 billion
12%
Total healthcare expenditure in The Netherlands 2003-2013
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
COSTS AND REVENUES
THE NETHERLANDS IN EUROPE
Proportion of expenditure on phar-maceutical care in total care budget by country in 2012.
Compared with other countries, the Netherlands spends relatively little on pharmaceutical care.
COSTS AND REVENUES
Healthcare costs are rising: the bill is higher every year and it is absorbing an ever greater amount of the Gross Domestic Product.
RISING HEALTHCARE COSTS
16,245 4,505 3,367 2,369 2,215 2,038 1,473
38 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 39
GDP per country in billion $healthcare share 2011healthcare share 2004
2000 - 8%of $ 610 billion GDP
2012 - 12%of $ 714 billion GDP
Total healthcare spending per country as % GDP
Source: OECD, 2013
(*Data from 2011, as 2012 is not yet available)
COSTS AND REVENUES
HEALTHCARE COSTS COMPAREDHow 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.
USA NLDJPN BELDEU CHEFRA AUTGBR SWEITA PRTESP DNK FIN IRL
* Amounts are based on pharmacy purchase prices.The actual market price is the result of negotiations between the parties in the field.
Intramural turnover on drugs in euros
Extramural turnover on drugs
in euros
Total turnover on medicines in billions of euros*
Source: Farminform, 2015
TURNOVER ON MEDICINESThe total annual turnover for prescription drugs has fal-len 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.
COSTS AND REVENUES
40 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 41
Source: Dutch National Budget VWS for 2014, Dutch Budget day (Prinsjesdag), 2014
of all public health expenditure (71.3 billion euros) in 2015 is going to extramural medicines
Primary
Long-term care
Hospitals, medical specialist and other curative care
Other
COSTS AND REVENUES
Only a limited part of the total healthcare expenditure in the Netherlands may be attributed to medicine costs.
MEDICINES WITHIN HEALTHCARE
42 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 43
Prescription-drugs price index
Consumer price index compared to the price index for prescription medicines (1996 = 100)
Housing, Water and EnergyTransportation
EducationTotal Expeniture
Food
Health
Transition agreement
(Individual)Preference policy
Introductionfree pricing
Source: Foundations for Pharmaceutical Statistics (2014), FarmInform (2014), CBS (2014)
IntroductionMedicines Pricing
Act (WGP) Introductionclaw back
Introductiontemporary measure
“De Geus”
Claw back increaseAgreement
VWS - KNMP
Start contract period
Various measures and agreements have
contributed to the decrease in the price
of medicines.
COSTS AND REVENUES
AGAINST THE TREND: PRICES OF MEDICINES FALLThe average price of medicines has fallen sharply in recent years. Various reasons lie behind this fall, which started halfway through the nineties.
Turnover total
Turnover generic
Turnoverspecial
in billion euro’s*standard daily doses in billions
VolumeTotal
volumegeneric
volumespecial
44 | PHARMA FACTS 2015 PHARMA FACTS 2015 | 45
... TURNOVER FALLING* 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
VOLUME GROWING ...
COSTS AND REVENUES
VOLUME AND TURNOVERThe 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 ge-neric drugs, the volume is growing, but the turnover remains more or less stable.
46 | PHARMA FACTS 2015
In the Netherlands, approx. 14,000 people every year die from a rare disease.
This corresponds to approx.
of all mortality caused by illness.
10%Source: PhRMA, 2011
According to predictions, our life expectancy will continue to incre-ase 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
Source: Marc Pomp, Een beter Nederland, De Gouden Eieren van de gezondheidszorg, 2010 (Two reports for VWS)
Every euro invested inhealthcare yields return
euro return
1.30euro