8/2/2019 Januvia Success Story
1/16
Launch Evolution AcrossPharmerging MarketsIMS LEAP STUDY 2010
8/2/2019 Januvia Success Story
2/16
Headline
The dynamic, high-potential pharmerging
markets offer tremendous opportunities
for pharmaceutical manufacturers facing
mounting pressures in the mature
markets. But as more companies embrace
these new growth drivers in their long-
term strategic plans, they face the
challenge of a new and very different
environment for launching a global brand;
complex, demanding and changing fast.
8/2/2019 Januvia Success Story
3/16
IMS HEALTH LAUNCH EVOLUTION ACROSS PHARMERGING MARKETS 1
IMS LEAP Study 2010Launch Evolution Across Pharmerging Markets
The dynamic, high-potential pharmerging markets offer
tremendous opportunities for pharmaceutical manufacturers facing
mounting pressures in the mature markets. But as more
companies embrace these new growth drivers in their long-term
strategic plans, they face the challenge of a new and very different
environment for launching a global brand; complex, demanding
and changing fast. What guidance can they draw from the historic
performance of previous launches in these markets? Where is the
greatest potential for product success today? And what does it
mean for the launch planning process at the global and local
levels? In a major analysis of launch evolution in pharmerging
markets, the IMS LEAP Study 2010 brings much-needed
answers to these important questions with unparalleled insights
into the key dynamics, developing trends, and changing drivers of
launch success.
Despite the global economic downturn, the paradigm shift
in pharmaceutical growth away from the established drivers
of old to a group of high-potential pharmerging markets
has continued to gather momentum. Collectively, the IMS
Tier 1, Tier 2 and Tier 3 pharmerging markets1 have been
steadily gaining share at the expense of the U.S. and top five
Europe (France, Germany, Italy, UK and Spain), accounting
for close to 34% of global growth in 2009 (Figure 1).
Traditionally, pharmerging markets have been something
of a postscript for global pharma, with many
multinationals preferentially launching in the major
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010(f) 2011(f) 2012(f) 2013(f) 2014(f)
Rest of World*Tier 3 PharmergingTier 2 PharmergingTier 1 Pharmerging
8% 13% 16% 19% 26% 20% 26% 41% 34% 41% 40% 52% 47% 49%
% Contribution from pharmerging (Tiers 1-3)
Source: IMS Health Market Prognosis March 2010. Market size rankings in constant US$. * ROW: includes mature markets and other non-pharmerging markets.
FIGURE 1: PHARMERGING MARKETS CONTRIBUTION TO GLOBAL GROWTH HAS STEADILY INCREASED
1. Pharmerging Shake-up, IMS Health, 2010. Tier 1 (China);Tier 2 (Brazil, Russia,India);Tier 3 (Venezuela, Poland, Argentina, Turkey, Mexico, Vietnam, S.Africa,Thailand, Indonesia, Romania, Egypt, Pakistan, Ukraine).
8/2/2019 Januvia Success Story
4/16
2 IMS HEALTH LAUNCH EVOLUTION ACROSS PHARMERGING MARKETS
mature markets before even considering opportunities in
the emerging sector. Today, with eight pharmerging
countries among the top 20 world pharmaceutical
markets and China on the brink of achieving top three
status, (Figure 2), more companies are reassessing the
focus of their global launch plans.
Some of the worlds leading pharmaceutical
multinationals are already achieving more than a quarter
of their growth from the pharmerging markets; mosthave called them out as a key strategic priority; and all of
the top 15 players2 are accelerating efforts to strengthen
their presence within them either through research
investments, licensing deals, co-marketing arrangements,
buy-outs, or similar.
Among a flurry of recent announcements in this area are
Abbotts acquisition of Piramal Healthcare in India - a deal
that could make the U.S. giant the number one player in
this country; GSKs and Lillys commitment to double
revenue in emerging markets by 2015; Pfizers discount-
card system in Russia offering drug price cuts of up to
50%; and the purchase of Medley, Brazils third largest
pharmaceutical company, by Sanofi-Aventis, to name
but a few.But, as the launch environment has continued to evolve in
pharmerging markets, along with the competitor profile,
Tier 3 PharmergingTier 2 PharmergingTier 1 Pharmerging
2004 Rank 2009 Rank 2014(f) Rank1 United States 1 United States 1 United States
2 Japan 2 Japan 2 Japan
3 France 3 Germany 3 China
4 Germany 4 France 4 Germany
5 United Kingdom 5 China 5 France
6 Italy 6 Italy 6 Brazil
7 Spain 7 Spain 7 Italy
8 Canada 8 United Kingdom 8 Spain
9 China 9 Canada 9 United Kingdom
10 Mexico 10 Brazil 10 Canada11 Brazil 11 Russia 11 India
12 Australia 12 Mexico 12 Venezuela
13 South Korea 13 India 13 Russia
14 India 14 Turkey 14 South Korea
15 Netherlands 15 South Korea 15 Turkey
16 Turkey 16 Australia 16 Greece
17 Belgium 17 Greece 17 Australia
18 Greece 18 Venezuela 18 Poland
19 Russia 19 Poland 19 Mexico
20 Poland 20 Belgium 20 Netherlands
Source: IMS Health MIDAS, Market Prognosis March 2010; Market size ranking in constant US$.
FIGURE 2: THE PHARMERGING MARKETS ARE REDEFINING THE ESTABLISHED WORLD ORDER
2. Pharmaceutical companies with sales of more than US$15bn in 2009.
8/2/2019 Januvia Success Story
5/16
IMS HEALTH LAUNCH EVOLUTION ACROSS PHARMERGING MARKETS 3
have the rules for successful engagement also now
changed? What sort of launch trajectory can be expected
today? How much time do companies have to get it
right? And what does it all mean for their launch plans at
the global and local level?
A MAJOR LEAP FORWARD
To answer these important questions, IMS Health has
conducted a major study into the evolution of launch
performance across the pharmerging markets. Building
on the heritage of our groundbreaking research into the
elements of launch excellence across therapy areas in the
mature markets3, the IMS LEAP Study 2010 brings
unprecedented insights into the changing dynamics, key
drivers and evolving priorities for launch success in the
critical pharmerging sector.
In this first instance, we have focused on the IMS Tier 1
(China) and Tier 2 (Brazil, Russia, India) pharmerging
markets1 the four leading emerging economies in
terms of absolute GDP and anticipated pharmaceutical
market value growth through 2013 (however, this is not
to suggest that the opportunity is not just as favorable in
Tier 3 markets).
Drawing on gold standard, audited pharmaceutical sales
data from the IMS Health MIDAS database4, the study
evaluated over 260 NCEs and branded generics
launched into the Tier 1/Tier 2 pharmerging markets
since 1998 and which fulfilled the following key criteria:
Minimum global sales of US$250m and US$4m in
Tier 1/Tier 2 pharmerging markets in 2009
Launched in at least one Tier 1/Tier 2pharmerging market and one Top 8 mature market
The study considered only products first launched
globally post-1998; products launched globally
before this date but later on in pharmerging
markets have not been analyzed
For comparative purposes, products were segmented
according to their global launch date into three waves of
four years each:
Wave I: 1998-2001
Wave II: 2002-2005
Wave III: 2006-2009
The key findings that emerged from the study are
discussed in the following sections.
GROWING CONTRIBUTION OF LAUNCHES INPHARMERGING MARKETS
New launches are positioned to play an increasinglyimportant role in the expansion of pharmerging markets.
Products launched within the last four years (Wave III)
were responsible for 19.9% of sales in the Tier 1/Tier 2
pharmerging markets, compared to 15.5% in the Top 8
mature markets. They already account for an average 6.5%
share of growth in the sector (10.9% in China) versus
4.1% in the Top 8 mature a contribution that is set to
continue rising as more companies recognize the value of
these markets as a major source of revenue growth.
CLOSING TIME GAP
Positive developments in the pharmerging markets,
including greater government investment in healthcare,
rising demand for drugs to treat typically Western
diseases and a strengthening of regulatory and IP
requirements in some cases, have increased the ability
and willingness of multinational players to launch in
pharmerging markets. Many have been quickening the
pace at which they do so: for products already launched
in at least one mature and one Tier 1/Tier 2
pharmerging country (and which fit the study criteria),
our analysis reveals a halving in time to market between
first global launch and first launch in a pharmergingmarket over the last decade, from 2.5 years in Wave I to
1.25 years in Wave III (Figure 3).
Notwithstanding this finding, it is important to bear in
mind that our analysis considers only products that have
launched in at least one Tier 1/ Tier 2 pharmerging
market in addition to a mature market, and that overall,
only a third of all global NCEs introduced since 1998
have reached the former. Furthermore, in many cases
the first pharmerging launch is in Brazil and rarely in
the Tier 1 market China, where it can take two years
longer to register a product versus some of the mature
countries. However, the trend is clear: products are
launching earlier in pharmerging markets than they were
over a decade ago.
3. Defining Global Launch Excellence, IMS Health, 2007; Achieving Global Launch
Excellence, IMS Health, 2008 & Searching For Global Launch Excellence,IMS Health, 2009.
4. The IMS Health MIDAS database includes sales in audited pharmaceuticalsegments in more than 70 countries, amounting to over 94% of the globalpharmaceutical universe. Retail and hospital channels are included whereavailable. Data reported for India are derived from the Secondary Sales Audit (SSA)
8/2/2019 Januvia Success Story
6/16
4 IMS HEALTH LAUNCH EVOLUTION ACROSS PHARMERGING MARKETS
SHIFTING EMPHASIS TO SPECIALIST CARE
Not only are companies launching much sooner into the
pharmerging sector than they have done in the past (even
though no major product has yet launched earlier in a
pharmerging market), they are also changing the nature
of the drugs that they launch. The traditional strategy of
entering these markets with products focused mainly on
primary care is giving way to much stronger emphasis
on specialist launches5. Our study shows that specialist
products now account for 55% of launches in China,Brazil, Russia and India compared to only 47% in Wave I.
Furthermore, drugs in the specialist sector have
experienced the greatest reduction in time to market
versus those in primary care, with an average time lag of
only 1.5 years now compared to 3 years a decade ago.
The greatest decline overall can be seen among oral
anti-diabetics, which are now reaching the first Tier
1/Tier 2 pharmerging market on average 1 year after
first global launch compared to 3 years in Wave I; and
CNS drugs which have experienced a similar reduction
in time to market. The fastest pharmerging Tier 1/Tier 2launches in these therapy areas have been MSDs Januvia
(sitagliptin) in Brazil and J&Js Invega (paliperidone) in
Russia - only 2 and 3 quarters, respectively, following
the first global launch.
Overall, we believe this to be a function of improving
infrastructure, selective company strategies and the
opening up the regulatory environments.
CHANGING RULES FOR INNOVATIVE DRUGS
To better understand these findings and determine what
kind of launch investment has the greatest potential to
positively impact the pharmerging markets, we
considered therapy classes according to type, using an
IMS segmentation6 based on the level of patent
protection and an objective measure of innovation to
come up with three key market segments:
1. DIFFERENTIATED: Classes characterized by significant
product innovation. There are often no generics
available and payers exert little influence on treatment
decisions.
2. COMMODITY: Classes with products that are minimally
differentiated, other than by price. Payers, potentially,
have a great stake in prescribing decisions.
Wave IIIWave IIWave I
Pharmerging Tiers 1-2
Average number of quarters delay in first pharmerging Tier 1/2 launch vs. first global launch
Primary Care
Specialist Care
Oral Anti-diabetics
CNS drugs
10
9
7
5
12
8
6
12
5
4
11
4
3
8
5
Source: IMS Health MIDAS 2009
FIGURE 3: THE TIME TO FIRST LAUNCH IN A TIER 1/TIER 2 PHARMERGING MARKET HAS HALVEDIN THE LAST DECADE
5. IMS Health definition based on positioning of dynamic market in terms ofprimary care vs specialist physicians6. Understanding New Commercial Models in the Pharmaceutical Industry, IMSHealth Special Report, 2009. Segmentation covers Top 8 markets (U.S., Japan,France, Germany, U.K., Italy, Spain and Canada).
8/2/2019 Januvia Success Story
7/16
IMS HEALTH LAUNCH EVOLUTION ACROSS PHARMERGING MARKETS 5
3. TRANSITIONAL: Classes that fall between the above two
extremes and are likely to undergo significant change.
When time to market is considered within the context
of these three market segments, it can be seen that the
largest reduction in time to market is apparent in the
differentiated category, i.e. products associated with a
high degree of innovation (Figure 4).
The traditional perception of pharmerging markets as
home to tail-end, typically commoditized products, thus
appears to be changing, reflecting improvements in
access to healthcare, rising demand for innovative
medicines, a growing, more affluent middle class with
greater purchasing power, and broader public and private
healthcare coverage. These markets may still represent
largely lower-cost bases with continued relevance for
low price primary care products, but government
programs and healthcare initiatives are clearly opening
up new opportunities for companies to increasingly
deploy their specialist and differentiated portfolios.
VARIABLE UPTAKE
Despite sharing many similar characteristics, there are
significant distinctions both within and across the
pharmerging markets that clearly set these markets apart
both from each other and from mature markets - in the
way they are structured, the way they operate and in the
various hurdles to market access they present. These
differences are manifested in highly variable uptake curves
within the countries studied, compared to those observed
in mature markets (Figure 5).
Products launched in India, for example, tend to follow a
shallow uptake curve that plateaus quite quickly. Here,
faster genericization due to poor IP protection and a
strong presence of local players has created a fragmented
market where a high share is difficult to achieve.
Conversely, in Brazil - where launches are often linked
with U.S. market entry - rates of uptake are more in line
with those of the mature markets in terms of the higher
share that products can expect to achieve within their
given therapeutic area. It is important to note that
Brazil has included many innovative drugs in its
reimbursement list.
Wave IIIWave IIWave I
Average number of quarters delay in first pharmerging Tier 1/2 launch vs. first global launch
Differentiated
Transitional Commodity
9
8
5
11
10
7
8
5
6
Source: IMS Health MIDAS 2009
FIGURE 4: THE BIGGEST DECLINE IN TIME TO MARKET CAN BE SEEN IN DIFFERENTIATED SEGMENTS
8/2/2019 Januvia Success Story
8/16
8/2/2019 Januvia Success Story
9/16
Wave IIIWave I
% of product launches able to improve their
performance by at least 1 decile 6 months after launch
RussiaBrazil IndiaTier 1/2 China
Source: IMS Health MIDAS 2009, in constant US $
16.1
11.0
16.5
13.0
10.4
8.3
20.9
11.1
18.2
12.5
20%
Overall, fewer than 20% of launches see significant changes
to their launch trajectories after these first, critical six months.
This window of opportunity is also apparent in the
pharmerging markets, where, again, the success (or
otherwise) of a launch can largely be determined within
the first six months: in Wave I, only 16% of brands were
able to improve on their initial launch trajectory
(defined as moving up at least one decile six months
after launch) (Figure 7).
Moreover, it appears that opportunities for a second
chance are becoming more scarce: in Wave III only
11.0% of Tier 1/2 brands showed an improvement after
the first six months, suggesting a toughening ofconditions in these markets. While common to all four
countries, this decline was greatest in Russia.
IMS HEALTH LAUNCH EVOLUTION ACROSS PHARMERGING MARKETS 7
CommodityTransitionalDifferentiated
Mature Markets
Average country launch uptake curves by market segment
0 1 2 3 4 5 6 7 8 9 10 11 12
40
30
20
10
0
China
Quarter After Launch
%V
alueMark
etShare
%V
alueMark
etShare
%V
akueMarket
Share
Quarter After Launch
Quarter After Launch
0 1 2 3 4 5 6 7 8 9 10 11 12
40
30
20
10
0
Brazil
0 1 2 3 4 5 6 7 8 9 10 11 12
40
30
20
10
0
Companies have a higher chance of successin launching a differentiated product in
pharmerging (even steeper & deeper curvesvs. mature markets); conversely, commod-itized & transitional products fare worse
FIGURE 6: VARIATIONS ARE ALSO APPARENT IN THE BEHAVIOUR OF DIFFERENTIATED AND COMMODITIZEDPRODUCTS VERSUS THE MATURE MARKETS
FIGURE 7: THE SIX-MONTH WINDOW OF
OPPORTUNITY EXISTS IN PHARMERGING MARKETS
Source: IMS Health 2009, in constant US $
8/2/2019 Januvia Success Story
10/16
WHAT DOES THIS MEAN FOR THE PHARMACEUTICAL
INDUSTRY?
One clear, overriding conclusion from our analysis isthat the rules of the launch game in pharmergingmarkets have changed. As companies press ahead withtheir plans to drive growth in this critical sector, theability to adapt to a fundamental shift in the launchenvironment with well-planned, fully-integrated
strategies for market entry, will be essential for theirlong-term success. Four key considerations should beplaced at the forefront of their decision making:
1. LAUNCH EARLIER IN PHARMERGING MARKETS - POTENTIALLY
AHEAD OF MATURE
With a clear trend towards faster launch into China,Brazil, Russia and India, the imperative to addressthese key growth markets during the creation ofinitial global launch plans is critical - the long-timestrategy of focusing first and foremost on the majormature markets no longer holds good.
Global players that do not extend their drugdevelopment and launch planning to include early andthorough consideration of opportunities in the Tier1/Tier 2 pharmerging markets run the risk of leavingsignificant untapped revenue potential on the table. Incertain cases, companies should even considerlaunching earlier in pharmerging than in maturemarkets: some branded generics may encounter moreattractive markets in the pharmerging sector; evencertain innovative products may be able to capitalizeon greater growth potential and tap into anunsaturated market early on, creating the chance to
achieve higher market share a challenge that isbecoming increasingly difficult in mature markets3.
This will call for a rebalancing and restructuring ofglobal launch plans to address many newconsiderations over and above those required for atraditional focus on the U.S., Top 5 Europe and Japan.The impact goes beyond the commercial organizations:R&D need to understand the requirements for launchin pharmerging markets and build capabilities toleverage the opportunity; corporate functions,including regulatory affairs, must develop a clear
understanding of market access requirements inpharmerging countries; and local organizations needto power up their operations to meet the demands ofthis new agenda.
2. DONT UNDERESTIMATE THE POTENTIAL FOR INNOVATIVE LAUNCHES
Behind the greater variation in the pattern of uptakein the pharmerging markets is the higher probabilityof gaining significant market share when launchingdifferentiated products rather than those incommoditized or transitional therapy areas.
Our findings suggest that it is possible to achieve highermarket share with an innovative product in pharmergingmarkets in differentiated therapy areas. With strong and
continued investment in market conditioning, companiesmay thus have a greater chance of establishing aleadership position than they would in saturated maturemarkets. All Tier 1/Tier 2 pharmerging markets havestated plans to extend their coverage, either of thepopulation or of the number of drugs reimbursed.Countries like Brazil, which already boasts highcoverage of its population, plans to increase the numberof drugs covered, with particular emphasis on innovativedrugs (the plan is to increase the number of innovativemolecules reimbursed from 107 to 144 by the end of2010), while other countries will focus on extending
population cover with more commoditized drugs. It istherefore imperative that the opportunity for innovativedrugs is assessed at a country-by-country level, and thatthis knowledge is used to focus on understanding howto optimize the value of their portfolio and developstrategies that better support the high growth opportunities.
3. PLAN TO MAXIMIZE THE 6-MONTH LAUNCH WINDOW
The extreme importance of the first six monthsmeans that strategies for launching into thepharmerging markets must be built well in advancewith careful planning of pre-launch activities toensure optimal readiness across all relevant functions.
New capabilities and commercial models may berequired to penetrate high growth segments, and earlyestablishment of KPIs will be essential to measuringinitial performance against plans. Paramount will begreater and earlier investment in launch preparation atboth an international and local level.
A compelling example of planning ahead is thelaunch of BMS Hepatitis-B product Baraclude inChina7. 18 months prior to expected approval, BMScarried out detailed pre-launch market research andstarted building the required infrastructure, including alarge and well-trained sales force to help educate
physicians. Full alignment across global, regional andlocal entities allowed BMS to achieve a truly excellentlaunch that not only became market leader (c.20% share
8 IMS HEALTH LAUNCH EVOLUTION ACROSS PHARMERGING MARKETS
7. Sowing the Seeds of a Blockbuster Launch in China, IMS Health, 2009
8/2/2019 Januvia Success Story
11/16
of the whole Hepatitis antiviral market) but also managedto grow the overall Hepatitis-B market in China.
4. ADDRESS THE COMPLEXITIES
The highly variable uptake of launches within therapyareas across the Tier 1/Tier 2 pharmerging countriesunderscores the extremely diverse nature of thesemarkets and the very different patterns of behaviourthat they display. And while healthcare reforms may becreating new opportunities, they are also shaping a
launch environment that is becoming increasinglyfragmented. Companies need to understand thedifferences, navigate the complexities and tailor theirapproaches accordingly. Strategies must be adapted tothe specific requirements of each individual countryin terms of portfolio, commercial models, businessmodel, systems, structure, and people, with earlyattention to such key issues as:
AFFORDABILITY: With generally lower levels of incomeand greater emphasis on out-of-pocket or privatepayment for healthcare, affordability is an importantconsideration for launching in pharmerging markets.
Many multinational companies are implementingdiscounted price schemes to overcome this potentialhurdle. At the same time, our analysis has shown thatwhile many transitional and commodity products aresubstantially cheaper than in the mature markets,differentiated products appear able to still commanda premium price. These factors should be taken intoaccount when sizing market potential and pricingnew brands.
ACCESS: Healthcare access can be a challenge forpopulations living outside the major cities inpharmerging markets. Companies that are able to
successfully penetrate more rural areas may benefitsignificantly from being first to market in tapping thepotential of large, under-treated populations.Novartis and Sanofi-Aventis, for example, haveworked to promote healthcare access in rural Indiaover the past few years to extend their patientoutreach, alongside a $19.5bn government programto improve healthcare for over 700m Indian villagers.However, targeting rural areas may not be theoptimal approach for all products, particularly in thedifferentiated/premium segment where affordabilityand access to specialist care will become an issue(examples of both approaches illustrated in
Diabetes: A Case in Point on page 10).
LOCAL NUANCES: In addition to fulfilling global launchrequirements, companies must adapt their approachto the market conditions of each individual country
and use their knowledge of the anticipated launchtrajectory to ensure an early focus on the segmentsof greatest potential. It is important to rememberthat many therapy areas are under-developed inthese countries, and simply launching a first-to-market product will be no guarantee of success,even in the face of seemingly considerable patientpotential. In many cases, upfront investment inmarket conditioning and a continuing focus onphysician and patient education will be key. In allcases, it will be important to ensure that the criticalquestions for a successful launch have beenaddressed. For example: Have you built acomprehensive plan for city/rural rollout? Are youprepared with the right distribution strategy?
THE FUTURE MODEL?
The Tier 1/Tier 2 pharmerging markets offer majoropportunities for launching new drugs and more globalplayers are shaping their long-term strategies to secure aslice of the rapidly expanding pie. As they do so, theywill need to be extremely clear about their approach to
driving a successful launch. Faced with the challengesand complexities of the changing landscape, thedecisions they make on the right portfolio for thesehigh growth markets must be determined not on thebasis of todays environment but in anticipation of theone to come. At an international level, early integrationof pharmerging markets into global launch plans will becritical, based on a detailed understanding of how tomaximize the opportunities within them. Locally,success will be dependent on appropriate adaptation ofthe full pre-launch strategy.
Our study has revealed four key considerations for
companies in search of a successful launch in theTier1/Tier 2 pharmerging markets:
1. Launch earlier in pharmerging markets -
potentially ahead of mature
2. Dont underestimate the potential for innovative
launches
3. Plan to maximize the 6-month launch window
4. Address the complexities
As conditions continue to toughen in the maturemarkets, optimizing performance in the pharmergingsector will be increasingly important for global successand sustainable competitive edge. Companies planningtheir global launch strategies with an eye on maximizinggrowth must do so in the knowledge that pharmergingmarkets are now an essential front-end priority not anoptional late-stage reserve.
IMS HEALTH LAUNCH EVOLUTION ACROSS PHARMERGING MARKETS 9
8/2/2019 Januvia Success Story
12/16
Diabetes is today one of the worlds most challenging
and costly healthcare problems. A major cause of
premature illness and mortality, it is growing to
pandemic proportions and is one of several chronic
diseases called out by the WHO for global action. Of
particular concern is the rise in Type 2 diabetes.
Traditionally a disorder of the middle-aged and
elderly, this is now affecting people at a much younger
age. It is also becoming increasingly common inrapidly developing economies, particularly China and
India, fuelled by the combined effect of mass
urbanization, increasingly Westernized diets and a
general decrease in levels of physical activity. At the
same time, additional risks, epitomized by the global
rise of overweight and obesity, have become more
prominent.
EARLIER ENTRY, STRONGER COMPETITION
In response to the increased significance of diabetes in
developing countries, a large number of global anti-
diabetics have been launched into the Tier 1/Tier 2
pharmerging markets. The picture is broadly similar to
the mature markets we saw twelve years ago, but
includes several innovative product classes (GLP-1s
and DPP-IVs), higher share of insulins, slightly lower
share of traditional products and very low share of
glitazones (Figure 9). Overall, competition is
increasing and the launch space is changing fast as
more multinationals include these markets at an earlier
stage in their global launch plans.
Of all the leading therapy areas, the newer generationanti-diabetes sector8 has experienced one of the
largest reductions in time to market from global to
pharmerging launch (in China): in Wave I, Actos
(pioglitazone) was on the global market for approx
5.75 years prior to its first pharmerging launch; in
Wave III, Januvia (sitagliptin) was launched (in Brazil)
just 6 months after its first global entry.
STUDIES IN STRATEGIC PLANNING
The importance of achieving the steepest and deepestmarket penetration curve possible within the six-
month window of each country places heavy
demands on the planning and execution of every
launch. Two recent examples in the diabetes area
illustrate the power of an informed, fully-integrated
strategic plan in achieving this goal, albeit by taking a
different approach to the market:
TARGETED, PREMIUM, DIFFERENTIATED APPROACH IN THE
INDIAN MARKET:
One of the greatest pharmaceutical success stories
in Indias recent history, is the game-changing
launch of Januvia/Janumet (sitagliptin) that
revolutionized the local, low-cost diabetes market
with a premium price approximately five times
greater than that of alternative new-generation
anti-diabetics.8
Success was gained through the relentless pursuit of
a focused scientific promotional strategy that was
based on a highly targeted approach leveraging
in-depth knowledge of the Indian market.
By positioning the product with targeteddoctors/diabetologists in specified geographical
10 IMS HEALTH LAUNCH EVOLUTION ACROSS PHARMERGING MARKETS
Diabetes: A case in point
100%
Traditional
anti-diabetics
Glitazones
DPP-IVs
and GLP-1s
Insulins
Source: IMS Health MIDAS 2009, in constant US $
5%
8%
17%
24%
14%
50%
14%
45%
35%
46%41%
Pharmerging(Today)
Developed(Today)
Developed(12 yrs ago)
FIGURE 8: VALUE SHARE OF DIABETES BYTREATMENT TYPE
8. Defined as glitazones, DPP-IVs, GLP-1s
8/2/2019 Januvia Success Story
13/16
areas the company ensured that marketing efforts
were directed at high ROI segments while
competitors continued employing a mass market
approach. With an accompanying integrated disease
management program strengthening the value
proposition and an external strategy of pricing
Januvia at c.25% of the average price in the Top 8
mature markets (high for India), the Januvia
franchise currently boasts a 10.4% share (in quarter1 2010) among the new-generation anti-diabetics8
in just over a year since launch, compared to only
1.3% share for a key competitor (in the same time-
period) which discounted its price to as low as 7%
of the price in mature markets. In addition, the
drug also benefited from Indias recently improved
IP protection laws, which is creating an increasingly
favorable environment for innovative launches.
MARKET CONDITIONING ACROSS PHARMERGING COUNTRIES:
An alternative, but equally successful approach by
Novo Nordisk has focused on more of a blanketstrategy, mostly in commoditized segments in
diabetes (e.g. insulins, biguanides) to get access to
the vast Tier 1/ Tier 2 market populations.
Successful players have launched their entire
diabetes portfolio in emerging markets, offering a
wide range of product options, building strong
physician loyalty with heavy emphasis on education
and promotion, and successfully targeting and
penetrating areas beyond the large urban centers.
Spurred by first mover advantage and continuing
high investment, the company has established an
exceptional reputation in the diabetes arena in such
pharmerging markets as China, where it hassecured a high market share within some of the
countrys more remote regions, and in India and
Russia, where it has achieved major reach with
physician and patient disease awareness programs
including a diabetes bus and mobile test centers
(in Russia).
Conversely, lack of investment has reaped poor
rewards for some companies. For one major player
in the newer generation sector8, a high turnover of
reps and middle management, lack of continuity,
limited attempts at trust-building and nocommitment to continuous investment resulted in
recourse to a co-promotional deal in China and a
low position/success despite the product being
highly successful in mature markets.
IMS HEALTH LAUNCH EVOLUTION ACROSS PHARMERGING MARKETS 11
8/2/2019 Januvia Success Story
14/16
KEY FINDINGS
CLOSING TIME GAP: For drugs launched in at least one
pharmerging country, the time lag between first
global launch and the first entry into a pharmerging
market has halved in the past decade, from 2.5 years
to 1.25 years. Although the first launch country
continues to be Brazil in many cases, the other Tier
1/Tier 2 pharmerging markets are also now rising to
the forefront. The decline is greatest for specialist-driven and differentiated products and for the key
areas of oral anti-diabetics and CNS drugs. With
more companies quickening the pace of their
outreach to the pharmerging sector, the need to
reprioritze these markets in global launch strategies is
more important than ever. Those that fail to do so
run the risk of leaving significant untapped revenue
potential on the table.
CHANGING RULES: There is a noticeable and higher
variation in average launch uptake among the
different pharmerging markets studied compared to
the rates observed in the mature markets. Launches in
India typically follow a very shallow uptake curve;
those in Brazil are more typically in line with average
uptake in the mature markets. Companies looking to
expand in the pharmerging sector must focus on
understanding how to optimize the value of their
portfolio within the context of these variable patterns
and invest in market conditioning.
Differentiated products have a greater chance of
achieving higher market share in China and Brazil,the two largest pharmerging markets, than in mature
therefore it may be easier for companies to establish
leadership positions in these unsaturated markets.
Conversely, the potential benefit from launching a
transitional product in some therapy areas is more
limited than in mature and the dynamics at launch
appear more in line with commoditized products.
NARROW WINDOW: Fewer than 20% of launches in the
pharmerging markets are able to significantly improve
their launch trajectory after six months a finding
that is consistent with the Top 8 mature markets3. It
appears hardest to do so in Brazil, where less than
10% of Wave III launches were able to improve on
their initial uptake compared to 17.6% in India. Steep
and rapid penetration of the pharmerging markets is
therefore essential. With such a narrow windowavailable for launches to make their mark, the
imperative for early and full launch preparation -
including contingency planning and the establishment
of KPIs is greater than ever.
It is becoming increasingly apparent that companies
need to conquer the pharmerging markets if they
want to succeed globally. The findings of the IMS
LEAP 2010 Study point to four key implications for
the pharma industry to do this successfully:
1. Launch earlier in pharmerging markets -potentially ahead of mature
2. Dont underestimate the potential forinnovative launches
3. Plan to maximize the 6-monthlaunch window
4. Address the complexities
FOR FURTHER DETAILS ON THIS STUDY 2010AND HOW THIS AFFECTS YOUR BUSINESS,
PLEASE CONTACT:
Yosh Tarapore, Thought Leadership, IMS Health
Eva Casal, Management Consulting, IMS Health
David Campbell, Global Lead Pharmerging Markets,
IMS Health [email protected]
12 IMS HEALTH LAUNCH EVOLUTION ACROSS PHARMERGING MARKETS
The IMS LEAP Study 2010
8/2/2019 Januvia Success Story
15/16
IMS HEALTH LAUNCH EVOLUTION ACROSS PHARMERGING MARKETS 13
8/2/2019 Januvia Success Story
16/16
HeadlineABOUT IMS
Operating in more than 100 countries, IMS Health is
the worlds leading provider of market intelligence to
the pharmaceutical and healthcare industries
With $2.2 billion in 2009 revenue and more than 50
years of industry experience, IMS offers leading-edge
market intelligence products and services that are
integral to clients day-to-day operations, including
product and portfolio management capabilities;
commercial effectiveness innovations; managed care and
consumer health offerings; and consulting and services
solutions that improve productivity and the delivery of
quality healthcare worldwide. Additional information is
available at http://www.imshealth.com
IMS HEALTH
CORPORATE HEADQUARTERS
IMS Health
901 Main Avenue, Suite 612
Norwalk, CT 068511187, USA
Tel: 203.845.5200
REGIONAL HEADQUARTERS
The Americas
Plymouth Meeting
Executive Campus660 W. Germantown Pike
Plymouth Meeting, PA
19462-0905, USA
Tel: 610.834.5000
EUROPE / MIDDLE EAST / AFRICA
7 Harewood Avenue
London NW1 6JB, UK
Tel: +44 (0)20 3075 5888
www.imshealth.com
ASIA PACIFIC
10 Hoe Chiang Road
Keppel Towers #23-01/02
Singapore 089315
Tel: 65 6227 3006
JAPAN
Toranomon Towers
4-1-28 Toranomon
Minato-ku, Tokyo 105-0001
Japan
Tel: 81 03 5425 9000
Top Related