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Pharmaceuticals Pharma 2020: The vision Which path will you take?* *connectedthinking pwc Pharma 2020: The vision #
Table of contents Introduction 1 A growth market 2 Emerging opportunities 3 Compound crisis 5 External barriers to innovation 8 Mixed signals 9 The bill for every ill 10 Washington blues 12 Blurring healthcare boundaries 14 Pay-for-performance 16 Medicines for different markets 18 Healthy habits and fab jabs 19 Sticking to the rules 21 What’s in a name? 24 The need for a dynamic new approach 27 Access to basic research 28 Pharmaceutical research 29 Pharmaceutical development 31 Regulation 33 The supply chain 36 Sales and marketing 38 Conclusion 40 Acknowledgements 42 References 43 # `PricewaterhouseCoopers
Introduction
Demand for effective medicines is At the start of the decade, many
rising, as the population ages, new people thought that science would
medical needs emerge and the come to the industry’s rescue and
disease burden of the developing that molecular genetics would reveal
world increasingly resembles that numerous new biological targets,
of the developed world. The E7 but the human genome has proved
countries – Brazil, China, India, even more complex than anyone
Indonesia, Mexico, Russia and first envisaged. It is no longer the
Turkey – are also becoming much speed at which scientific knowledge
more prosperous, with real gross is advancing so much as it is the
domestic product (GDP) projected healthcare agenda that is dictating
to triple over the next 13 years. By how Pharma evolves.
2020, the E7 could account for as
much as one-fifth of global sales. The first part of our report highlights
a number of issues that will have a
Yet the biopharmaceutical sector major bearing on the industry over
(Pharma) will find it hard to capitalise the next 13 years. The second part
on these opportunities unless it covers the changes we believe
can change the way in which it will best help pharmaceutical
functions. Its core problem is lack companies:
of productivity in the lab. Several
• operate in this new milieu
external factors have arguably
exacerbated the industry’s • realise the potential the future
difficulties, but the inescapable holds; and
truth is that it now spends far more
• enhance the value they provide
on research and development
shareholders and society alike.
(R&D) and produces far fewer new
molecules than it did 20 years ago.
The shortage of good medicines
in the pipeline underlies many
of the other challenges Pharma
faces, including its increasing
expenditure on sales and marketing,
deteriorating financial performance
and damaged reputation.
Pharma 2020: The vision 1A growth market strains of some existing illnesses.
The US Centers for Disease Control
and Prevention (CDC) estimates
The bottom line: Demographic, epidemiological and
economic shifts are transforming that more than 70% of US hospital
The global market the pharmaceuticals market. infections are resistant to at least one
of the antibiotics most commonly
The population is growing and
for medicines is aging; new areas of medical need used to treat them.5 And medical
research has exposed problems
growing, although are emerging; and the diseases
from which people in developing that were previously unidentified
demand is moving countries suffer are increasingly – including risk factors like metabolic
like those that trouble people living syndrome and conditions like
to different in the developed world. These chronic fatigue syndrome, which
therapeutic areas, changes will generate some huge
opportunities for Pharma.
recent evidence suggests is linked
to changes in gene expression in the
a shift that global The global population is projected
white blood cells.6
warming could to rise from 6.5 billion in 2005 to
7.6 billion in 2020. It is also aging
Meanwhile, new diseases, including
mutated forms of old diseases, are
accelerate rapidly; by 2020, about 719.4m surfacing. Urbanisation and greater
people – 9.4% of the world’s mobility have contributed to the
inhabitants – will be 65 or more, introduction of new pathogens,
compared with 477.4m (7.3%) two some of which spread very fast
years ago.1 Older people typically and are very difficult to treat. SARS
consume more medicines than moved from Asia to North America
younger people; four in five of and Europe in a matter of days.
those aged over 75 take at least Similarly, the H5N1 avian flu virus
one prescription product, while has spread from China and South
36% take four or more.2 So the East Asia to the Middle East. The
grey factor will boost the need for human cost has been tiny so far, but
medicines dramatically. the impact of an avian flu pandemic
Clinical advances will reinforce this could be enormous.
trend. The improvements of the Global warming could also have
past few decades have already a major effect on the world’s
converted some previously terminal health. In February 2007, the
illnesses into chronic conditions, thus Intergovernmental Panel on Climate
increasing long-term demand for Change (IPCC) reported that the
therapies to manage such diseases. global average temperature had
The number of deaths from heart increased by about 0.2°C per
attacks has declined by over 50% in decade between 1990 and 2005.
most industrialised countries since The IPCC projects that the average
the 1960s,3 for example, while five- temperature will increase by another
year survival rates for US patients 0.2°C per decade for the next two
with cancer (expressed as an average decades, even if the concentration
for all sites) have risen from 53% in
of all greenhouse gases remains
the mid-1980s to 66% today.4
constant at year 2000 levels, and
Demand for new anti-infectives that it will “very likely” increase
is also mounting, with the still more, if mankind’s output of
development of drug-resistant greenhouse gases continues to rise.7
2 PricewaterhouseCoopersIt is currently impossible to predict Emerging opportunities
the full impact of a change in India’s insulin dependence
global weather patterns, or even The markets of the developing world The number of Indians with diabetes is
to be absolutely certain that man- are altering even more radically than projected to reach 73.5m in 2025. The
made pollutants are causing the those of the developed world. At direct and indirect costs of treating such
change. But many scientists believe one time, infectious diseases were patients are currently about $420 per
that global warming could bring the biggest killers. This is still true of person per year. If these costs remained
diseases such as malaria, cholera, the same as they are now, India’s total bill
sub-Saharan Africa and South Asia.
diphtheria and dengue fever to for diabetes would be about $30 billion by
But, elsewhere, chronic diseases are
2025. But as its economic wealth grows
more developed regions. Cases of now the leading cause of death,11 and standards of care improve, treatment
malaria have now been reported in a pattern that will become even costs are likely to rise.
Azerbaijan, Corsica, Georgia and stronger as the population of the
Turkey, where the disease was developing world gets older, fatter The US spends an average $10,844 per
eradicated after World War II.8 year on each patient with diabetes. If
and less physically active.
India’s per capita expenditure rose to just
Specialists argue that most vector- Two specific instances illustrate just one-tenth of this level, the total cost of
borne diseases are unlikely to how much the epidemiological profile treating all patients with diabetes would
become a major threat in North is shifting. In 2004, an estimated be $79.7 billion by 2025. The value of
America or Western Europe, where prophylaxis in India alone would thus
639m people living in developing
the climate is cooler and better be substantial; preventing 10% of the
countries suffered from hypertension. population from developing diabetes
preventative measures are in place. By 2025, the number is forecast to would save nearly $8 billion a year.
The greater danger in such regions reach at least one billion – more than
is an increase in respiratory illnesses twice the projected rate of increase
like asthma and bronchitis, since in that same population over the
higher levels of greenhouse gases same timeframe.12 The picture is very
are expected to boost the pollen similar when it comes to diabetes.
production of ragweed and other The number of people with diabetes
common allergens.9 in developing countries is expected
But numerous other medical to rise from 84m in 1995 to 228m
problems could also emerge in 2025, with India, the Middle East
everywhere, because even a small and South East Asia bearing the
rise in temperature accelerates worst of the burden (see sidebar,
the proliferation of many common India’s insulin dependence).13
bacteria. The replication rate of Demand for medicines that treat
Salmonella increases by 1.2% illnesses formerly associated almost
per degree above minus 10°C, for exclusively with the developed world
example, while the replication rates is thus expanding in the developing
of Campylobacter (one of the most world, at the same time that some
common causes of gastroenteritis) countries are becoming increasingly
and E. coli increase by 2.2% and affluent.
6%, respectively.10 The E7 countries look especially
In short, all these changes are attractive. Our economic modelling
creating new openings for Pharma. suggests that the real GDP of the
Some of them may be in different E7 countries will triple from US
therapeutic areas. But demand for $5.1 trillion in 2004 to $15.7 trillion
innovative medicines for old and in 2020, whereas that of the G7
new conditions alike is growing, not countries will grow by just 40%, from
shrinking.
Pharma 2020: The vision 3Figure 1: The E7 economies will treble their real GDP by 2020
The bottom line: 18,000 G7 Countries E7 Countries
GDP (US$ Billions)
16,000
The diseases of 14,000
the developing 12,000
10,000
world increasingly 8,000
resemble those 6,000
4,000
of the developed 2,000
0
world, and greater
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2004 2020 forecast
some countries Source: PricewaterhouseCoopers Macro Economic Consulting Group
much more Notes: 2004 estimates based on World Bank World Development Indicators database (except China,
which was adjusted for a later large data revision); 2020 projections based on our model
attractive markets
$25.8 trillion to $36.1 trillion.14 Their However, this is probably too
wealth relative to that of the G7 will conservative an estimate. The richer
rise from 19.7% to 43.4% over the countries become, the more they
same period (see Figure 1). tend to spend on healthcare. The
E7 populations are also aging faster
In 2004, the E7 countries spent than those of the G7; by 2020,
0.94% of their GDP on prescription 338m of the people living in the E7
medicines (although the precise countries will be at least 65 years of
percentage varied from one state age, compared with 152.8m of the
to another). They collectively people living in the G7 countries.16
accounted for 8% of the $518 But the G7 countries will still be
billion global market.15 The G7 more than twice as wealthy as the
countries, by contrast, spent 1.31% E7 countries, and better able to
of their GDP on medicines and afford the higher healthcare costs
accounted for 79% of all sales. associated with an aging population.
So, if all 14 countries continue So it is likely that both the G7
to spend the same proportion of and the E7 countries will spend a
their GDP on medicines as they larger proportion of their GDP on
do now (and if their GDP grows medicines than they do now. But the
as we have projected), the global rate of growth in the G7 economies
pharmaceuticals market will be will almost certainly be much slower
worth about $800 billion in 2020, than it is in the E7 economies – and
and the E7 countries will account that disparity could eventually make
for about 14% of sales. a significant difference.
4 PricewaterhouseCoopersSuppose, for instance, that the G7 industry’s total shareholder returns is still struggling to apply the
pharmaceutical markets grew by (TSRs) would plummet, unless it insights it has gleaned from the
between 5% and 7% a year, while could “industrialise” its R&D.17 Our molecular sciences – genomics,
the E7 markets grew by between forecasts were borne out by 2002, proteomics, metabonomics and the
10% and 15% a year, for the next with the publication of “Pharma like – to improve its performance.
13 years. By 2020, the global 2010: The threshold of innovation”.
In 2006, North American spending
pharmaceuticals market would be The Pharma 2010 report contended
on biopharmaceutical R&D reached
worth about $1.3 trillion, with the E7 that the industry’s best hope of
a record $55.2 billion (and the US
countries accounting for about 19% earning higher returns lay in the
accounts for about three-quarters
of sales. China would be the second development of packages of
of global expenditure in this area).
or third biggest market in the world, products and services targeted
The member companies of the
and Turkey and India might well be at patients with specific disease
Pharmaceutical Research and
in the top 10. subtypes and that, if it was to make
Manufacturers of America (PhRMA)
such “targeted treatments”, it
One thing is clear from these spent an estimated $43 billion, while
would have to start by focusing on
broad-brush calculations; the non-member companies spent
diseases rather than compounds.18
financial clout of the E7 countries another $12.2 billion.19 But the US
is improving significantly. The However, the human genome has Food and Drug Administration (FDA)
economic, demographic and proved more complex and less approved only 22 new molecular
social changes of the next decade amenable to mechanistic analysis entities (NMEs) and biologics, a far
will make them very much more than many scientists anticipated, cry from the 53 it approved in 1996
appealing places in which to make when the draft map was completed when R&D expenditure was less than
and market pharmaceuticals. in 2001. Hence the fact that Pharma half the sum it is now (see Figure 2).20
Compound crisis
Yet Pharma will not be in a strong Figure 2: R&D spending has soared but the number of NMEs and biologics
position to capitalise on these approved by the FDA is down
opportunities, unless it can change
50,000 60 No. of NMEs and Biologics Approved
the way in which it operates. Its
R&D Spending (US$ Millions)
core problem is lack of innovation 45,000
50
in making effective new therapies 40,000
for the world’s unmet medical 35,000
40
needs. Medicines have helped many 30,000
individuals enjoy longer, healthier 25,000 30
lives. But, as the global population 20,000
becomes older and more prosperous, 15,000
20
people’s expectations are rising – and
10,000
the industry is finding it increasingly 10
difficult to fulfil their hopes. 5,000
0 0
We predicted that this would 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004* 2005* 2006*
happen when we published “Pharma * includes Biologics
2005: An Industrial Revolution” in R&D Spending NMEs and New Biologics Approved
1998. We argued that the safety,
efficacy and cost-effectiveness
Sources: FDA/CDER Data, PhRMA data, PricewaterhouseCoopers analysis
of new medicines would attract Note: Data on R&D spending for non-PhRMA companies are not included here, because they are not
growing scrutiny, and that the available for all 11 years
Pharma 2020: The vision 5Figure 3: Only five of the top Pharma companies generate more than 10% of Even allowing for inflation, the
their revenues from products that were launched in the last five years industry is investing twice as much
in R&D as it was a decade ago
35 to produce two-fifths of the new
30
medicines it then produced.21
25
Moreover, only nine of the new
treatments launched in the US in
% Sales
20 2006 came from the labs of the
13 companies that comprise the
15
Big Pharma universe,22 a pattern
10 that has changed very little over
the past few years. Our analysis
5
shows that, in 2006, only two Big
0 Pharma companies earned more
ABT AZN BMY GSK JNJ LLY MRK NVS PFE ROG SGP SNY WYE than 10% of their revenues from
% Sales in last 3 Years % Sales in last 5 Years “major”products that are less than
three years old.23 Worse still, those
Sources: IMS Health and PricewaterhouseCoopers analysis 38 products generated only $10
billion of the $316 billion Big Pharma
earned from its entire medicines
portfolio.
Figure 4: Big Pharma delivered weighted average total shareholder returns of The situation is little better over a
-2.4% per annum between January 2001 and March 2007 five-year timeframe. In 2006, only
five Big Pharma companies earned
more than 10% of their revenues
80 from major products launched
Total Return (%) Jan 2001- Mar 2007
after 2001, and those 65 products
60
generated sales of only $30.4
40 billion (see Figure 3). Thus more
than 90% of Big Pharma’s total
20 Avg. Weighted pharmaceutical revenues came
Return
0 from medicines that have been on
the market for more than five years.
-20 Yet the patents on many of these
-40 products are due to expire quite
shortly, exposing an estimated $157
-60 PFE GSK SNY NVS AZN JNJ ROG MRK WYE BMY ABT LLY SGP billion worth of sales (measured in
2005 terms) to generic erosion.24
Sources: Yahoo!Finance, PricewaterhouseCoopers analysis
Note: Total returns have been calculated for the period January 2, 2001- March 30, 2007, with the
exception of Sanofi (now sanofi-aventis) where the total return has been calculated from February 7, 2002.
The weighted average return is based on the market capitalisation in 2001
6 PricewaterhouseCoopersThe revenues the industry leaders Industry (ABPI), have also launched
generate have also come at a very new codes of practice imposing
high price. Between 1995 and 2005, much tighter rules on the promotion
the percentage of total corporate of medicines.28 And, in late 2003, The bottom line:
spending accounted for by R&D
rose from 15% to 17.1%, while
Spain’s Autonomous Regions
introduced restrictions on the Pharma must
the percentage accounted for by
sales and general administration
number of promotional visits sales
representatives can make.29
improve its R&D
rose from 28.7% to 33.1%. Sales
In short, Pharma’s lack of R&D productivity, if it is
and marketing is by far the biggest
corporate expense.25
productivity lies at the root of many
of the other difficulties it is now to meet the world’s
This increasing expenditure on
sales and marketing could be
experiencing – difficulties that are
reflected in its poor financial record
unmet medical
seen as yet another sign of the over the past few years. Between needs and capitalise
paucity of innovative medicines 1985 and 2000, the industry’s
reaching the market, since it is market value increased 85-fold, on the market
arguable that products for which far outpacing the stock market as
there is real demand do not need a whole.30 But in the six years to opportunities now
to be heavily promoted. However, March 30, 2007, the FTSE Global
it has generated considerable Pharmaceuticals Index rose just emerging
criticism, too. In a survey of 1.3%, while the Dow Jones World
industry stakeholders conducted Index rose by 34.9%. Big Pharma’s
by the PricewaterhouseCoopers TSRs followed the same downward
Health Research Institute, 94% path; between January 2001 and
of the respondents said that March 2007, it delivered weighted
pharmaceutical companies spent average TSRs of -2.4% a year (see
too much money on advertising.26 Figure 4).
Six US states have now passed “gift
laws” requiring all pharmaceutical
companies to disclose how much
they give doctors, hospitals and
pharmacists each year, while
another 15 states have similar bills
in the offing.27 Several European
trade bodies, including the
Prescription Medicines Code of
Practice Authority of the Association
of the British Pharmaceutical
Pharma 2020: The vision 7External barriers to The international laws governing
innovation intellectual property rights have
compounded this conservatism. At
The bottom line: Pharma’s R&D processes have present, all patents last 20 years,
The legal framework become so complex – even regardless of the quality of the
intellectual property they protect.
cumbersome, indeed – that it is
in which Pharma hardly surprising its productivity has But if prophylactics and novel
products serving an unmet medical
tumbled. Nevertheless, several
operates must be political, legal and financial factors need were granted longer patent
have arguably contributed to the lives, while me-too medicines and
altered to promote problem. Most pharmaceutical new formulations were granted
shorter patent lives, pharmaceutical
innovation and companies use internal valuation
mechanisms to assess the clinical companies would have a direct
incentive to become more
discourage imitation and commercial potential of the
compounds in their pipelines, innovative.32
and select the ones they want to Determining which therapies were
pursue. In other words, like other worthy of longer patent lives might
organisations that are answerable sometimes be difficult. If, say, 20
to shareholders, they “follow the new cancer treatments reached the
money”. market within a few months of each
But when they start developing other, it might be hard to decide
a new medicine, they do not which were the most deserving
know whether it will be eligible – let alone who should make that
for reimbursement if it reaches judgement. But, given the typical
the market, unless it addresses product lifecycle, we estimate
a disease for which there is no that an extra five years of patent
existing treatment or looks likely life would increase the cash flows
to prove much better than any from a truly innovative medicine by
comparable therapies. And, in most between 50% and 100%, depending
countries, they are not allowed to on how vulnerable it is to generic
seek guidance from the relevant erosion.33
government agencies. That, in turn, would furnish
Many firms therefore try to minimise governments with much stronger
their risks by “playing it safe”. The grounds for arguing that the prices
Centre for Medicines Research of such products should be reduced
International reports that, in 2004, and thus brought within reach of
more than 20% of the money many more patients, since the
10 of the largest pharmaceutical industry would have a longer period
companies invested in R&D went in which to recover its investment.
on line extensions and other work, Indeed, there may even be a case
as distinct from new development for extending the patent lives of
projects. In smaller companies, the groundbreaking vaccines like
percentage was over 40%.31 Gardasil to 50 years or more, on the
understanding that they are priced at
levels which are universally affordable.
8 PricewaterhouseCoopersMixed signals three NMEs a year. Most companies value when its pipeline is valued
subsequently acknowledged that differently by different analysts. And
The political and legal framework these aspirations were completely it is more tempting to maximise the
in which Pharma operates has thus unattainable. But, in repeatedly number of candidate molecules in
deterred it from taking some of the altering the targets they then set Phase III, even though it would be
risks that are required to produce themselves, they have failed to better to weed some of them out
genuinely innovative new therapies. give the investment community at an earlier and cheaper stage of
Its communications with the capital a clear idea of what to expect. development.
markets may have muddied the Attrition rates in Phase II have also
These are by no means the only
waters still further. The preliminary deteriorated significantly over the
problems. Analysts also look for
results of some research we recently same period.34 The variations in the
evidence of sustainable returns. But
conducted show that there are value different analysts place on
most pharmaceutical companies’
significant variations in the value pipelines are entirely understandable
revenues are becoming much
the top city analysts accord R&D in light of these conflicting signals,
more cyclical, as the billion-dollar
pipelines, and that most analysts as is their reluctance to attribute any
blockbusters in their portfolios
focus mainly on the quality of the value to molecules whose fate still
come off patent and they struggle
molecules in Phase III. Two major remains extremely doubtful.
to develop new medicines that can
changes during the past decade
However, in sending the capital replace this income. Research by
help to explain why.
markets such mixed messages, investment management firm AXA
In the mid-1990s, the leading Pharma has also made life harder for Framlington shows the scale of the
pharmaceutical companies itself. It is more difficult to determine challenge (see Table 1).
announced plans to launch two or how best to increase a company’s
Table 1: The leading pharmaceutical companies will lose between 14% and 41% of their existing revenues as a result
of patent expiries
Share of
Company 2010 2011 2012 Revenues (%)
AstraZeneca Arimidex ($2.2bn)* Seroquel ($4.7bn) Symbicort ($3.7bn) 38**
BMS US Plavix ($4.8bn) Abilify ($2.1bn) 30
Avapro ($1.3bn)
GSK Advair ($3.8bn) Avandia ($2.5bn) 23
Eli Lilly Zyprexa ($4.8bn) 22
Merck Cozaar/ ($3.2bn) Singulair ($4.5bn) 22
Hyzaar
Novartis Femara ($1.1bn) Diovan ($6.0bn) 14
Pfizer Aricept ($800m) Lipitor ($12.1bn) Viagra ($1.7bn) 41
Xalatan ($1.6bn) Detrol ($860m)
Geodon ($1.1bn)
sanofi-aventis Taxotere ($2bn) US Plavix ($3.8bn) Lovenox ($3.1bn) 34
Avapro ($2.1bn)
Source: AXA Framlington
Notes: * Estimate of global sales in 12 months prior to patent signing
** Value of products losing patent protection as a percentage of total company sales over next five years
Pharma 2020: The vision 9Many pharmaceutical companies The bill for every ill
face a serious dilemma, then. For
the past 20 years, they have “sold”
The bottom line: The themselves on their ability to develop
The same features that will ensure
Pharma’s market continues to
investment model blockbusters, but they now have to
alter their story without forfeiting the
expand have also exposed the
limitations of the current approach
used by the capital confidence of the capital markets.
They also have to meet short-term
to healthcare funding: namely, that
most of the world’s pharmaceutical
markets does not earnings targets (from quarterly spending goes on the treatment of
reporting or other, more subtle disease rather than its prevention.
work very well for pressures) that may be at odds with This is partly because some
their long-term aspirations – and they diseases are so complex that
an industry that have to do these things at a time when scientific understanding of their
competition for funding is getting
works to timelines more intense, thanks to the revival of
pathology is still very limited, and
developing cures or prophylactics
of 10 years or more, interest in the biotech sector. for such illnesses is therefore
In the US, where the sector is extremely difficult. In addition, the
and is unlikely to do relatively mature, the cycles of risks associated with preventing
investment in Pharma and biotech disease in healthy people are quite
so unless Pharma have converged. But, elsewhere, different from those associated with
treating people who are already sick.
“re-sets” market there is still a major disjunction
between the two. So, if the biotech However, most countries invest
expectations sector’s charms grow over the next
couple of years, as some investors
much less in public health than they
do in other forms of healthcare;
predict, Pharma could find itself out the OECD average is just 2.9% of
in the cold. total health expenditure.35 In effect,
society’s spending priorities are
back-to-front. A specific example
shows the full extent of the bias.
Gardasil, Merck’s breakthrough
vaccine for cervical cancer, sells for
just $360 in the US, compared with
an average annual wholesale price
of $19,289 for Betaseron, $22,875
for Rebif and $28,400 for Tysabri, all
products that modify the symptoms
of multiple sclerosis but cannot cure
or prevent it.36
As the global population grows
and ages, and demand for better
healthcare management increases,
this emphasis on treatment rather
than prevention will become
increasingly unsustainable. Older
10 PricewaterhouseCooperspeople consume more healthcare Figure 5: Older people consume more healthcare than younger people do
than young people everywhere,
although there are some huge
national discrepancies. In Spain and
Patients Relative to Those in 50-64 Age Group
Sweden, for example, the average
Increase in Healthcare Costs of Older
level of healthcare spending on 35
patients aged 80 or older is twice 30
as much as it is on patients aged
50-64; in the US, by contrast, it is 25
11.5 times more (see Figure 5). 20
We estimate that, by 2020, the
OECD countries, excluding the US, 15
will spend 16% of their GDP on 10
healthcare, while the US will spend a
5
huge 21%. In all, they will spend $10
trillion on healthcare (see Figure 6).37 0
So, governments everywhere will US Canada UK Australia Japan Germany Spain Sweden
have to reverse their approach. Age Group 50-64 65-69 70-74 75-79 80+
They will have to devote a much Source: Laurence Kotlikoff & Christian Hagist, “Who’s Going Broke?” National Bureau of Economic
larger proportion of their healthcare Research, Working Paper No. 11833, December 2005
expenditure to preventative Note: Ratio of average spending on individuals in each age group in each country relative to an individual
aged 50-64 in the same country. Numbers rounded
measures, and reward the
development of vaccines and cures
more highly than they do palliative
medicines. Without such a change
of strategy, no country will be able
Figure 6: Health expenditure as a percentage of GDP is increasing rapidly in the
to fund the healthcare needs of its OECD countries
inhabitants by 2020.
21
The aging of the population,
together with dietary changes 19
and more sedentary lifestyles,
will also increase the burden of 17
chronic disease. The World Health
% GDP
Organisation (WHO) estimates that 15
60% of all the deaths that took
13
place in 2005 could be attributed
to chronic conditions, and predicts 11
that the number of deaths from
chronic diseases will increase by 9
17% over the next 10 years.38
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
The toll is highest in developing
20
20
20
20
20
20
20
20
20
20
20
20
20
20
20
countries, which account for 80% of
all mortalities from chronic diseases US OECD ex-US
and where the onset of disease is Source: PricewaterhouseCoopers Health Research Institute
Pharma 2020: The vision 11often much earlier than it is in the Washington blues
developed world. In the US, for
example, only 12% of deaths from
The bottom line: cardiovascular disease (CVD) occur
The extent of the problem with
healthcare funding is particularly
Pharma will have in working-age people, compared
with 28% in Brazil, 35% in India and
apparent in the US, Pharma’s
biggest and most profitable market.
to participate in 41% in South Africa.39 As an article recently published in
But the developed world is also The New York Times put it: “What is
the debate on paying dearly. One recent study the most pressing problem facing the
[US] economy? A good case can be
healthcare funding puts the cost of CVD in the
European Union (EU) alone at made for the developing healthcare
crisis.”41 The impact on the
and demonstrate about €169 billion ($226.1 billion) a
year.40 And though the developed automotive manufacturing industry
the value of its countries have been very successful has already been well documented.
In 2006, General Motors and Ford
in pushing some chronic diseases
products or risk up the age ladder, increasing spent about $5.9 billion and $2.9
billion, respectively, on healthcare
longevity will force more people to
coming under work longer. Most of these changes – a bill that adds more than $1,380 to
– like the raising of the retirement the cost of producing each car.42
huge pressure to age in Belgium and the UK – will In fact, administrative costs are
cut the prices of take place after 2020. However, the
overall direction is clear; a bigger
responsible for between 20% and
31% of US healthcare spending.43
many mass-market percentage of the population of the
developed world will still be working
Hospital spending accounts for
nearly 33% of all expenditure,
medicines at the point at which chronic and prescription products for just
diseases kick in. 10.1%.44 But governments often
These trends have several focus on the prices of medicines
implications for Pharma. As because they are a relatively easy
healthcare rises up the political target, and many people believe the
agenda, the industry will have to medicines bill is much higher than
engage in the debate on how it is it really is. In a survey conducted
funded and play its part in helping by the PricewaterhouseCoopers
to control costs. The social and Health Research Institute, 97%
economic value of good medicines of consumers estimated that
for chronic diseases will rise with the prescription medicines accounted
extension of working life around the for at least 15% of overall US
globe – and many such medicines healthcare costs, while 63% put the
already exist, as falling mortality and figure between 40% and 79%.45
morbidity rates in the developed Moreover, with the Democrats
world demonstrate. But there will now in the ascendant on Capitol
simply not be enough money in Hill, Pharma could find itself much
the pot to cover the world’s future more exposed. Two measures, in
healthcare needs, unless Pharma particular, are worth discussing
can cut its operating costs and in further detail: the proposal
margins on these products. to introduce a national health
insurance scheme; and the bill to
give the federal government the
12 PricewaterhouseCooperspower to negotiate medicine prices even bigger financial impact on the Human Services estimates that
for Medicare Part D, the medicine industry, if they are ever translated the average level of discounts and
benefit programme for the elderly. into practice. In January 2007, the rebates in 2006 was about 27%.51
House of Representatives approved But research by the Congressional
Some 16% of the 300m people
a bill requiring the government to Budget Office shows that average
living in the US currently have no
negotiate Medicare prescription discounts for the six federal
medical cover, and the Democrats
drug prices, rather than having each programmes which negotiate prices
are keen to redress the situation
plan provider deal directly with directly with manufacturers range
by introducing a universal health
manufacturers, as is now the case.48 from 51% to 59%.52 If the government
system. However, such a move
President Bush has said that he will were to secure similar discounts for
would be very expensive. In 2005,
veto the Medicare Prescription Drug Medicare Part D, its net expenditure
the US spent almost $2 trillion on
Price Negotiation Act if it passes the on medicines under the programme
healthcare, about $50-60 billion of
which went on providing medical Senate.49 And, even if the Act does would therefore fall from $794 billion
treatment for the indigent. It is become law, it makes no provision to $532.9 billion – a total saving of
extremely difficult to calculate the for altering a government programme $261.1 billion – by 2017 (see Figure 7).
additional cost of covering the that is administered by third parties.
But the Democrats argue that In practice, it is doubtful that the
uninsured population as a whole, US government would introduce
but one study suggests that it could negotiating medicine prices centrally
could produce substantial savings. So quite such draconian price controls.
be between $125 billion and $150 Critics claim that the programme
billion a year, depending on the what sort of sums might be involved?
administered by the Department
particular model that is used.46 The net federal cost of Medicare of Veteran Affairs offers a relatively
Some public-policy researchers part D is currently projected at $794 narrow range of treatment options in
argue that the cost of restricting billion for the period 2007-2017.50 many classes of therapies, and that
access to healthcare for the The US Department of Health and patients and physicians accustomed
uninsured, measured in terms of
shorter lives and poorer productivity,
could be as much as $130 billion a Figure 7: If the US government negotiated drug prices for Medicare
Part D directly, Pharma’s revenues could drop
year, and that the introduction of a
federal healthcare programme for
the uninsured would ultimately be 140
revenue-neutral.47 But even if this 120
proved true, the initial investment
would be many billions of dollars, 100
US$ Billions
and the government would find it
80
difficult to raise such a sum. The
introduction of a national health 60
system in the US would thus
40
increase the number of people who
had access to modern medicines, 20
but it might also result in more
widespread use of treatment 0
protocols, generics and over-the-
17
07
08
09
10
11
12
13
14
15
16
counter (OTC) medications, making
20
20
20
20
20
20
20
20
20
20
20
life more difficult for research-based
Projected Net Federal Cost of Medicare Part D
pharmaceutical companies.
Projected Net Federal Cost With Average Discount of 51%
The Democrats’ proposed changes
to Medicare Part D could have an
Source: PricewaterhouseCoopers
Pharma 2020: The vision 13to a much wider range of choices to electronic pedigrees, DNA
under private health plans would be labelling and the like. A growing
unlikely to accept such restrictions.53 number of governments are also
The bottom line: Nevertheless, it is clear which way using prices in other countries to
Pharma cannot rely the wind is blowing – and, if the
Democrats have their way, Pharma
benchmark the prices they pay.
There may thus come a time when
on the US market to will come under huge pressure to
cut its prices.
many medicines command a
regional or even global price.
bail it out. Nor can Moreover, if price controls are
it assume that it will introduced, their impact will not be
confined to Medicare Part D. By
Blurring healthcare
boundaries
always be able to January 2010, the US government
will pay for 37% of all prescription
charge a lot more drug expenditure under Medicare Changes in the way healthcare is
delivered will arguably play an even
and Medicaid. Employers will pay
for its products in for another 39% under private bigger role in shaping the industry’s
future. The primary-care sector is
insurance programmes.54 Given the
some markets than extent to which rising healthcare expanding and becoming more
costs have already impaired the regimented, as general practitioners
in others competitiveness of US industry, it perform more minor surgical
seems reasonable to assume that procedures and healthcare payers
any price controls the government increasingly mandate the treatment
adopted would soon spill over into protocols they must follow, including
the private sector. the drugs they can prescribe.
Conversely, the secondary-care
So Pharma cannot continue to sector is contracting, as clinical
rely on the US to bail it out of its advances render previously terminal
current difficulties. Indeed, it may diseases chronic; healthcare
ultimately be unable to count on providers like Clinovia in the UK, and
differential pricing in any market Gentiva in the US, deliver secondary
whatever. The Internet has already care at home; and hospitals focus
eroded geographical variations in on the specialist care that cannot be
the prices of consumer electronics, supplied anywhere else.
for example, and the European The self-medication sector is
Commission recently threatened also growing, as more and more
to fine Apple for charging higher products that would once have
prices to download music in some been available only on prescription
European countries than in others.55 are sold in OTC formats. Most
Buying medicines on the Internet medicines that acquire OTC status
is currently much more dangerous, are used for non-chronic conditions
of course, unless the supplier which are relatively easy to self-
is a reputable company with an diagnose and have little potential
established track record. But, by to cause harm, if abused. But, in
2020, the problem of counterfeiting May 2004, the UK Medicines and
should be largely resolved, thanks Healthcare products Regulatory
14 PricewaterhouseCoopersAgency (MHRA) broke with this set up retail medicine outlets staffed conceivable that patients will be
convention by reclassifying by nurse practitioners who provide able to use web-based receiving
simvastatin 10mg as an OTC basic medical care, including writing algorithms to establish whether they
medicine.56 prescriptions.60 An increasing have a condition that will sort itself
number of surgical procedures are out without recourse to prescription
Meanwhile, Australia’s Therapeutic
performed in ambulatory surgery drugs. This would eliminate a
Goods Administration approved the
centres rather than hospitals. And substantial number of consultations,
weight-management therapy Orlistat
the FDA has said that it hopes to since self-limiting diseases are
for OTC use in October 2003.57 The
boost the number of medicines it thought to account for about 85% of
FDA followed suit in February 2007,58
switches to OTC status by 50% a all visits to primary-care physicians.63
and Boots, the British pharmacy chain,
year.61 The American Pharmacists Any patient who needed additional
introduced a trial scheme to sell Viagra
Association is also advocating diagnostic tests or treatments would
over the counter only a few days
the introduction of a “behind-the- then see a nurse practitioner, and
afterwards.59 The definitions of primary
counter” option such as already would only be referred to a doctor if
and secondary care are thus blurring,
exists in some European countries his or her case were more complex
as some forms of care that were
and the FDA has endorsed the idea, or required surgical intervention.
traditionally delivered by secondary-
care providers are transferred to a although any such move would These changes in the healthcare
primary-care setting, and some forms require congressional approval.62 system have obvious benefits for
of primary care are transferred to the A better understanding of the healthcare payers; healthcare is
patient (see Figure 8). cheaper, the more it is planned
taxonomy of disease, together
and the closer it is delivered to the
This trend is particularly pronounced with better diagnostic tools and
patient’s home. But they have huge
in the UK, but it is taking place in monitoring devices, will provide
ramifications for Pharma as well.
other countries, too. In the US, the means with which to bring
for example, some large discount healthcare delivery even closer First, as treatment protocols replace
stores and pharmacy chains have to the patient. By 2020, it is quite individual prescribing decisions and
Figure 8: The provision of healthcare is moving closer to the patient
Healthcare Delivery in 2007 Healthcare Delivery in 2020
Secondary Care
Secondary Care
Emergency room, Diagnostics
Intensive care, Minor surgery, Emergency room
Major surgery, Other out-patient services Intensive care
Major surgery
Primary Care
Initial
Complex diagnosis
diagnostics
Prescriptions Patient
& treatments Primary Care
Routine checks
Minor surgical procedures
Complex diagnostics & treatments
Minor surgical procedures Patient
Basic diagnostics & prescribing by nurse
practitioners
Self-Care “Life checks”
OTC drugs
-
Basic medical advice Self-Care
Web based self-diagnostics
OTC drugs self
Web-based for chronic & non-chronic
diagnostics
conditions
OTC drugs for chronic & non--
““Wellness”
Wellness”services
services
Source: PricewaterhouseCoopers
Pharma 2020: The vision 15technology improves the ability to Pay-for-performance
diagnose conditions, the decision-
making authority is gradually moving
The bottom line: from doctors to healthcare policy-
The provision of healthcare is not
all that is changing; so is the way
Pharma’s target makers and payers. However, the
criteria policy-makers and payers
in which it is measured. Several
countries have set up agencies
audience is use for adopting new medicines
are different from those physicians
specifically to compare the safety
and efficacy of different forms of
changing, as use; payers typically focus on risk intervention and promote the use of
and cost-effectiveness,64 whereas evidence-based medicine. The US
healthcare policy- doctors put safety and efficacy Agency for Healthcare Research and
before cost.65 Quality is one such body, as is the
makers and payers Second, the sales and marketing UK Centre for Health Technology
increasingly control model on which the industry has Evaluation – a division of the
National Institute for Clinical Health
historically relied is becoming
the prescribing increasingly obsolete.There is little and Effectiveness (NICE) – although
the latter also considers economic
point in sending out a large sales
decision force to influence primary-care performance.
practitioners who do not choose The Australian Pharmaceutical
which medicines they prescribe. Benefits Advisory Committee,
Lastly, with the erosion of New Zealand Pharmaceutical
the conventional boundaries Management Agency and Finnish
between self-care, primary care Office for Health Care Technology
and secondary care, the needs Assessment (to name just a few)
of patients are shifting. Where also conduct pharmacoeconomic
treatment is migrating from the evaluations of new medicines,
doctor to ancillary staff or self-care, devices and procedures. But there
for example, patients will require is as yet no systematic process
more comprehensive information for measuring cost-benefit ratios,
about the medicines they take, more and the volume of outcomes data
advice and more surveillance. Where these agencies can analyse is still
treatment is migrating from the relatively small – a restriction that
hospital to the primary-care sector, will end during the next decade
they will require new services such with the widespread adoption of
as home delivery. electronic medical records (EMRs).
Thus Pharma should be focusing The US aims to develop a national
on the provision of a full range of health information network by
products and services spanning 2014.66 The EU has also called for
the healthcare spectrum, and using every member state to create an
different channels to distribute EMR,67 and several countries have
different kinds of products and already made considerable headway.
services. In fact, some companies Denmark now has a comprehensive
are already beginning to use health data network,68 while the
different distribution channels in British system is expected to be
the US – a trend we shall discuss in operational by 2012, despite the
more detail further on. many problems that have dogged
16 PricewaterhouseCoopersit.69 Thus, by 2020, some countries data would expose those instances
will have between six and eight in which a medicine works well for
years’ worth of longitudinal data. one patient population and not for
This may not be enough to assess others. And if the industry succeeds The bottom line:
the impact of treatments for
diseases that progress quite slowly,
in changing its approach to R&D,
and launching many more drugs Pharma will have to
but it will certainly be sufficient to
evaluate the clinical and economic
with individually smaller revenues, it
would also be spreading its risk to a
prove to healthcare
performance of many therapies. much greater extent. payers increasingly
The effect on Pharma is likely
to be two-fold. First, healthcare
Second, the price any therapy
can command will be based on interested in
policy-makers and payers will use
outcomes data to determine best
its performance, not what the
manufacturer thinks it should fetch.
establishing best
practice. They will include medicines This is essentially what the UK medical practice
that are particularly safe, efficacious Office of Fair Trading proposed
and cost-effective in their treatment in its recent review of the British that its products
protocols, and exclude those that medicines pricing scheme. It
are not – as recently happened recommended that the current really work and
in the UK, when NICE ruled that “profit cap and price cut” scheme
Aricept, Exelon and Reminyl should be replaced with a value-based provide value for
only be prescribed for people with
moderate to severe symptoms
pricing system in which the prices
of products are set by comparing money
of Alzheimer’s disease because their clinical value with that of other
they “did not make enough of a treatments for the same condition.72
difference” to justify the cost of
When a new therapy is launched,
giving them to patients in earlier
the manufacturer will also be
stages of the disease.70
expected to assume a much greater
It is impossible to predict just how share of the financial risk. At least
many medicines will fail to pass one such deal already exists; in
muster. But in one recent analysis of September 2006, GlaxoSmithKline
45 frequently cited studies claiming struck an agreement with two
that certain treatments worked, European governments under which
nearly a third of the original findings the prices of two new medicines
proved wrong.71 If this were true will be increased or reduced,
of all the medicines on the market, once enough data are available to
and the industry were still reliant on judge their true efficacy and cost-
blockbusters in 2020, the impact effectiveness.73 In future, such
would be punitive; Big Pharma had risk-sharing arrangements will be
273 major products with average commonplace.
sales of $963m apiece in 2006,
The remit of healthcare payers is
suggesting that the fate of about 85
growing, then. They are not just
medicines with aggregate revenues
negotiating prices, they are starting
of about $82 billion (in today’s
to stipulate best medical practice –
terms) would be in question.
and access to extensive amounts of
That said, the failure rate itself might outcomes data will give them much
not be so high. Extensive outcomes more ammunition. By 2020, Pharma
Pharma 2020: The vision 17will have to prove that its products Medicines for different of affluence differs considerably
really work, provide value for money markets both among and within countries.
and are better than alternative forms Mexico’s per capita gross national
of intervention. It will have to charge The changing global epidemiological income (measured in international
much lower prices for new therapies profile has yet other implications. dollars) is over 10 times higher
or formulations offering only minor We have already discussed the than India’s, for example, while
improvements on treatments that extent to which demand for the wealthiest 20% of the Brazilian
already exist, and even when it is medicines for chronic diseases is population enjoy incomes that are
marketing medicines that represent spreading to the developing world. over 30 times higher than those of
a genuine breakthrough, it will have But differences in ethnic origin, the poorest 20% (see Table 3).
to be much more flexible in its diet and environmental factors In short, the markets of the
approach to pricing such therapies. have produced marked variations developing world possess very
Lastly, it will have to build very in the nature and incidence of the different clinical and economic
much better relationships with the disease subtypes from which these attributes – and these are by
agencies that perform the health populations suffer (see Table 2). no means the only features that
technology assessments on which Ethnic origins likewise play a large separate them. They vary in their
many healthcare payers will rely, part in determining how people use of traditional medicines, the
since it currently has very little input respond to particular therapies. robustness of their laws governing
into such evaluations.
The rate at which the E7 populations the protection of intellectual
are aging – and thus likely to suffer property, their healthcare
from the diseases of aging – also infrastructure and so forth. Any
varies substantially. By 2020, 15.2% company that wants to serve these
of the Russian population will be 65 markets successfully will therefore
or older, compared with just 7% of have to devise strategies that are
those living in India.74 And the level tailored to their individual needs.
Table 2: There are marked variations in the incidence of the disease subtypes from which the E7 populations suffer
Cancer site Brazil China India Indonesia Mexico Russia Turkey
Oesophagus 6.4 26.2 5.5 0.4 1.4 8.4 1.7
Stomach 15.5 39.9 4.2 2.5 9.0 44.4 9.6
Colon & rectum 11.0 13.3 3.6 8.9 5.6 32.7 7.4
Liver 2.6 37.9 1.7 8.4 3.3 5.6 2.1
Pancreas 3.1 3.8 1.1 1.4 3.1 9.5 2.0
Larynx 6.5 1.5 4.5 1.5 3.6 9.8 6.4
Lung 15.8 40.7 6.6 14.2 11.2 80.4 37.3
Skin melanoma 2.1 0.2 0.3 0.3 1.0 3.0 0.8
Prostate 37.1 1.5 3.1 4.7 19.2 15.6 6.1
Testis 1.5 0.5 0.6 0.9 3.3 2.2 1.4
Kidney etc. 2.6 2.0 0.9 1.4 3.7 12.6 1.7
Bladder 6.6 3.6 2.3 2.9 3.8 15.3 8.6
Leukaemia 5.2 5.7 2.8 3.8 5.6 8.6 5.1
Source: International Agency for Research on Cancer, Globocan 2002 database
Note: Crude rate of cancer in males in the E7 countries (incidence per 100,000 people)
18 PricewaterhouseCoopersTable 3: The level of affluence varies substantially both among and within the E7
countries
Per Capita
Percentage Share of Income
or Consumption The bottom line:
Country GNI (PPP$) Lowest 20% Highest 20% The markets of the
Brazil 3,000 2.6 62.1
developing world
China 1,500 4.7 50.0
India 630 8.9 43.3 are heterogeneous,
Indonesia 1,130 8.4 43.3 and Pharma must
Mexico 6,930 4.3 55.1
Russia 3,410 6.1 46.6 understand their
Turkey 3,750 5.3 49.7 specific needs
Source: World Bank Development Indicators 2006
Healthy habits and Similarly, some countries are waging
fab jabs war against the world’s spreading
waistlines, although recent research
A growing number of governments suggests that genes play a major
in both developed and developing role, too (see sidebar, Fat is an FTO
countries are also trying to shift issue).76 Australia, the US and Chile
the focus from the treatment of have all launched national anti-
disease to its prevention. At least 18 obesity initiatives, for example,77 while
countries have already introduced Europe’s health ministers recently
nationwide bans on smoking in approved the world’s first charter to
enclosed public places, as have a fight fat.78 The Chinese government
number of US states.75 is battling the juvenile bulge by
requiring students to exercise or play
Fat is an FTO issue sports for an hour a day at school.79
And, in 2006, the British government
Researchers at the Peninsula Medical
announced plans to introduce
School and Oxford University recently
found evidence that people with two
“Life Checks”, as well as providing
copies of a particular variant of the FTO more support services for keeping
gene have a 70% higher risk of obesity physically and mentally well.80
than those with none, and weigh an
Most of these initiatives are far
average 3kg more. Those with one copy
too small to make a fundamental
of the variant (which differs from the other
allele by a single mutation in the DNA difference to mankind’s
sequence) have a 30% higher risk of being health, despite all the political
obese. They estimate that half of all white grandstanding that accompanies
Europeans carry one copy of the variant, them. The amount of money
and one in six has two copies. The team governments invest in such
hopes that further research to understand measures is still just a fraction of
the gene may help unravel the basic the sums they spend on healthcare
biology of obesity and pave the way for as a whole. Nevertheless, they
the development of medicines that can are indicative of the direction in
prevent it.
which the world is slowly moving.
Pharma 2020: The vision 19Social and economic pressures are major players – GlaxoSmithKline,
gradually causing a sea-change in Merck, sanofi-aventis, Wyeth
attitudes towards healthcare. and Novartis (via its acquisition
The bottom line: The of Chiron) – have traditionally
Fears about bio-terrorism and a flu
increasing emphasis pandemic have also kick-started
dominated the field, but a number of
smaller pharmaceutical companies
a new wave of public investment
on prevention in vaccines, while philanthropic
have also entered the fray.
institutions like the Bill & Melinda Moreover, the range of indications
of disease will Gates Foundation are funding they are researching is surprisingly
provide Pharma research into vaccines for malaria
and other tropical diseases.81
varied. It includes vaccines for
cocaine addiction, diabetes,
with new business And the success of Gardasil has
demonstrated that it is possible to
hypertension, Alzheimer’s disease,
psoriasis, food allergies, rheumatoid
opportunities make a profit from such products. arthritis and nicotine withdrawal.
The US, German, French, Italian But oncology is by far the most
and Austrian health authorities have significant new therapeutic area;
recommended that every girl be according to IMS, there are 90
vaccinated with Gardasil,82 and the therapeutic (as distinct from
US public programme to vaccinate prophylactic) vaccines for cancer in
all minors will generate at least $2 the pipeline, and more than two-
billion of sales alone.83 thirds of them are in late-stage
development (see Figure 9).86
The vaccines sector is growing
rapidly, then; there are now 245 However, conventional vaccines are
pure vaccines and 11 combination very different from other therapies
vaccines in clinical development,84 in several respects. They usually
and some industry experts estimate require very large safety and efficacy
that the market could be worth as trials using healthy volunteers;
much as $42 billion by 2015.85 Five long-term surveillance to ensure
Figure 9: Many of the new vaccines in the pipeline depart from the conventional
vaccines model
100
90
No. of Vaccines in Development
80
70
60
50
40
30
20
10
0
er
za
en C
tis
y
ia
a
S m is
ox
He s
x
S
V
An s
rg
ru
e
ra
oe
HI
os
R
ar
nc
rp
or
gi
en
lp
th
SA
vi
le
al
h
ul
in
al
Ca
Al
u
r
B
M
ile
ar
rc
He Infl
is
tN
Di
be
M
t it
Tu
es
pa
W
Big Five Others
Source: IMS Knowledgelink, January 2007
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