Pharma Facts 2015 - vereniginginnovatievegeneesmiddelen.nl€¦ · Source: Research by A.D.M. van...

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 >


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


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


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


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.


400,000

300,000

200,000

100,000

Percentages of five-year survival rates of various cancers.1989-1993 compared to 2008-2012


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.


(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.


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


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


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


Share by sector in total worldwi-de R&D investments, in percen-tages of the total.

PHARMACEUTICAL SECTOR AT NO. 1


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


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


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


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


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


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


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.


In total, 93 orphan drugs for various rare conditions have appeared on the European market in recent years.

ORPHAN DRUGS BY INDICATION AREA


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


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.


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



€ 2100 per person

Medicines were responsible for of this total.15%


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


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*


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


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


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


... TURNOVER FALLING* Amounts are based on

pharmacy purchase prices. The actual market price is the result of negotiations between the parties in the field.


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

Pharma Facts 2015 - vereniginginnovatievegeneesmiddelen.nl€¦ · Source: Research by A.D.M. van...

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