White Paper

Success Multiplied: Launch Excellence

for Multi-Indication Assets
How to capture the full potential of a pipeline in a product
MARKUS GORES, Vice President, EMEA Thought Leadership, IQVIA
KIRSTIE SCOTT, Consultant, EMEA Thought Leadership, IQVIA
Table of contents
Introduction 1

Multi-indication launches: Opportunities and challenges 2

Indication roll-out: Sequencing and speed 3

Performance consistency when launching multiple indications 10

Promotional investment strategies for multi-indication launches 12

How to achieve multi-indication launch success 14

References 17

About the authors 19

 Introduction
The concept of a ‘pipeline in a product’ emerged with the rise of specialty care
and has become firmly established since. Many specialty products are developed
for multiple potential indications, which is possible because their mechanisms of
action often target fundamental biological processes and pathways, such as the
immune cascade, which underlie a wide range of disease states.

Targeted immunology products launched over the versatility and have been expanding beyond their initial
past 25 years, for example, have an average of four indication in type 2 diabetes to treat heart failure and
indications, while some, like the TNF inhibitors, chronic kidney disease. Similarly, we are seeing several
have many more, with Humira amassing a total of products originally developed for type 2 diabetes expand
11 indications to date (see Figure 1). into obesity, e.g., liraglutide, semaglutide or tirzepatide.

Oncology is another therapy area where multi- Unlocking multi-indicationality is therefore critical to
indicationality is common. Twenty-six percent of all novel maximise the full potential of such assets. While multi-
cancer drugs launched in the U.S. between 2011 and 2021 indication assets offer unique commercial opportunities
to treat solid tumours were subsequently approved in to innovators, they also present formidable strategic and
multiple indications, while this was the case for 34% of all operational challenges.
haematological drugs. The checkpoint inhibitors are a 1
In this white paper, we will explore the specific challenges
case in point, e.g., with Tecentriq approved in 5 indications,
that multi-indication launches face, review the different
Opdivo in 10 and Keytruda in an astonishing 19.2–4
strategies such launches have pursued, and identify critical
Multi-indicationality is a relatively common feature success factors for maximising the value of multi-indication
among specialty products, however, it is worth noting assets. These insights are derived from a systematic
that it can also be found in non-specialty products. analysis of launches of targeted immunology products,
The SGLT-2 inhibitors, for example, have proven their complemented by selected checkpoint inhibitor launches.

Figure 1: Unlocking multi-indicationality is key to success in immunology

Number of indications, sales and year of market entry for targeted immunology therapies (MAT Q3/2022; US, EU4/UK, Japan)
14
(incl. approvals in US, EU4/UK, Japan)
Number of immunology indications

Bubble Size = Anti-TNF

US$5bn
12 2022 sales
Anti-IL-17
10
Anti-IL-23
adalimumab
8 infliximab
JAK inhibitor
golimumab mepolizumab
certolizumab pegol
6 etanercept tofacitinib ixekizumab Integrin inhibitor
secukinumab upadacitinib
anakinra tocilizumab brodalumab
4 Average: ~4
ustekinumab
PDE4 inhibitor
omalizumab apremilast dupilumab risankizumab
2 abatacept canakinumab baricitinib filgotinib Other anti-IL*
guselkumab
tildrakizumab
vedolizumab
0 belimumab sarilumab Other
1996 1998 2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 2022
Year of market entry

* Includes IL-1, IL-4/13, IL-6, IL-12/23

Source: IQVIA EMEA Thought Leadership; IQVIA MIDAS Sales by Disease MAT Q3 2022; SBD targeted therapies only, category of “other diseases” excluded
from indication count; all sales for the molecule are included (eg biosimilars).

iqvia.com | 1
Multi-indication launches: Opportunities and challenges
A ‘pipeline or portfolio in a product’ offers several relevant HCP specialty and the broader stakeholder
attractive benefits to innovators. Firstly, the inherent, audience, collectively, messages must be aligned to
total opportunity potential of multi-indication assets reinforce brand equity. This may also involve choosing
is typically sizable. As such, a single asset can sustain between a single brand name used across all indications
future revenue streams over a longer time horizon as its vs. different branding for different indications.
additional indications are successively launched.
Secondly, the scale of the combined revenue across • P
 ricing: The relative value of a multi-indication product

multiple indications provides leverage in payer typically varies considerably across its different

negotiations, for example, allowing innovators to offer indications, driven by a combination of differences in

attractive rebates to secure favourable formulary the product’s intrinsic clinical profile, different levels of

positions for all its indications. Finally, synergies unmet need and the current standard of care. Defining

can be realised during both the development and an optimal pricing strategy that maximises an asset’s

commercialisation of a pipeline in a product, e.g., value involves making some fundamental choices,

by developing a deep understanding of an asset’s e.g. setting a single price for the asset vs. indication-

mechanism of action or safety features which are based pricing, and it has strong interdependencies

applicable across multiple indications and help with a product’s indication sequencing.

accelerate development efforts; by benefitting from

• P
 erformance consistency: As we have shown
potential customer overlap between indications; or
in previous IQVIA Launch Excellence research5,
possibly by creating a ‘halo effect’ in the marketplace
complexity makes it hard to achieve consistency in
across indications to drive incremental brand
launch performance, and it is one of the main reasons
awareness spanning different HCP specialties and other
why launch excellence proves elusive for most.
stakeholders, thereby giving the asset a competitive edge.
Launching a multi-indication product is an inherently
complex endeavour, and the challenge innovators
However, compared to single-indication launches,
face is how to maintain organisational focus and
innovators of multi-indication assets face greater
momentum and execute consistently across the
strategic and operational complexity which manifests
launches of multiple indications.
itself in specific challenges:

• Resource allocation: Maximising the value of a multi-

• Indication sequencing: A key strategic choice for a
indication asset depends on optimally resourcing
multi-indication asset is the order in which to develop
each launch of its different indications.6 Practically,
and launch its different indications to maximise
this means competing for budgets and managing
its commercial potential. This involves a number
potentially conflicting priorities, while ensuring
of important considerations, e.g., selecting initial
customer engagement at competitive levels, sustaining
indications where a highly differentiated benefit can
a competitive Share of Scientific VoiceTM for evidence
be proven to secure an optimal price vs. gaining early
generation and dissemination7,8 and capturing synergies
access to the largest possible patient population.
at total brand level across all of its indications.
• Co-positioning: A product with multiple indications
Innovators must address all of these challenges and show
which are simultaneously promoted in the marketplace
enduring commitment to staying the course of what will
faces complexity in optimally positioning individual
inevitably be a ‘long launch’, which we elaborated on in
indications alongside each other. While messaging
our earlier publication IQVIA Launch Excellence VI9, to
needs to reflect a product’s specific benefits in each
indication and must be tailored to the needs of the unlock the full potential of a pipeline in a product.

2 | Success Multiplied: Launch Excellence for Multi-Indication Assets

Indication roll-out: Sequencing and speed
Defining the optimal sequence in which to launch its a favourable price for the initial indication that reflects
different indications is one of the first major strategic the superior outcomes, while budget impact is limited
decisions to make for a multi-indication asset. Innovators due to the small target patient population. As additional
have a fundamental choice between two sequencing indications are launched, this initial price provides a
strategy archetypes (see Figure 2): ‘narrow first’ vs. favourable reference point for any price negotiations of
‘broad first’. future indications.

Narrow first However, the flipside of this strategy is that the early
This sequencing strategy is based on the key premise commercial opportunity is limited by the small, initial
of achieving maximum differentiation by launching first target patient population, followed by a long road to
in an indication where the product shows the highest capture the full potential of the asset’s other, larger
benefit, supported by compelling clinical evidence, which indications. Furthermore, the launch environment is
is typically limited to smaller, well-defined patient (sub)- becoming increasingly unforgiving, which poses additional,
populations, especially when products are approved on competitive risks for a ‘narrow-first’ strategy. As recent
less mature data. IQVIA research10 has shown, over the past decade the
typical speed of competitors entering the market has
This approach has the benefit of reassuring regulators increased significantly, from one every three years to one
and payers by addressing concerns about both potential per year. Consequently, only the first three products in
outcomes and budget impact uncertainty, while allowing several major therapy areas now capture 10% or more of
to generate additional, supporting real-world evidence the market each, on average. Therefore, a ‘narrow first’
(RWE) along the way to substantiate the asset’s value strategy potentially risks being beaten to the market by
proposition. Furthermore, it allows innovators to secure competitors before it can seize the later, bigger prize.

Figure 2: Sequencing strategy archetypes for multi-indication launches

‘Narrow first’ ‘Broad first’
First launch in smaller sub-population(s) or indications First launch in the broadest population or indication possible
Cumulative patient opportunity

Cumulative patient opportunity

Ind. 4

Ind. 3
Sales

Sales

Ind. 2

Ind. 1
Ind. 1 Ind. 2 Ind. 3 Ind. 4

Time Time

• Focus on well-defined sub-population(s)*/indication in product’s • Launch first in the broadest patient population or indication
‘sweet spot’ to demonstrate superior outcomes possible, followed by smaller ones
• Reassures regulators, payers by addressing outcomes, budget • Maximises early revenue opportunity/NPV – in principle
impact uncertainty, esp if RCT data less mature • Requires limited outcomes uncertainty: proven effectiveness
• Superior outcomes create opportunity to lock in favourable price via RCTs, RWE
points for later indication expansion • Risk of challenge on price and access: budget impact,
• Enables HCPs to gain hands-on clinical experience inconsistency of patient outcomes due to size, heterogeneity
• Needs clear expansion strategy from the outset of patient population

* Eg via biomarker, CDx, clear clinical patient profile, can be identified in routine practice
Source: IQVIA EMEA Thought Leadership.

iqvia.com | 3
Case example: Keytruda’s narrow-first success Thus ‘narrow-first’, followed by strategic indication
Keytruda is a case in point for a tremendously successful expansion, provided the path towards broad use of
‘narrow first’ strategy, in which the PD-L1 biomarker Keytruda and, ultimately, its dominant market position
played a crucial role. When launching Keytruda, Merck
11
(see Figure 3).
chose a highly targeted approach, focussing on second-
Today, most multi-indication oncology products pursue a
line NSCLC patients with high PD-L1 expression who
narrow-first indication sequencing strategy, a reflection
should see the greatest benefit. Conversely, Opdivo
of the growing number of approvals based on less mature
launched with a broad strategy, targeting all second-line
data, an increasingly crowded and competitive oncology
NSCLC patients regardless of PD-L1 expression.
landscape which payers use to their advantage, and the
By demonstrating superior outcomes in its narrow initial reality of significant differences in products’ relative value
population, Keytruda secured subsequent approval for in different indications.
first-line NSCLC patients with tumours expressing high
levels of PD-L1, opening up the larger first-line market
opportunity. At the same time, the FDA expanded use of
Keytruda to all second-line NSCLC patients regardless of
level of PD-L1 expression.

Figure 3: Keytruda: a successful example of ‘narrow first’

Keytruda vs. Opdivo: Population and indication expansion

Keytruda Opdivo

2.5 NSCLC 2.5 NSCLC

Bladder cancer Kidney cancer

2.0 Melanoma 2.0
Melanoma

Head & neck Head & neck

Sales LCUS $ Bn

Sales LCUS $ Bn

1.5 1.5
Liver cancer Stomach cancer

All others All others

1.0 1.0

0.5 0.5

0.0 0.0
Q1 Q1 Q1 Q1 Q1 Q1 Q1 Q1 Q1 Q1
2015 2016 2017 2018 2019 2015 2016 2017 2018 2019

Source: IQVIA EMEA Thought Leadership, MIDAS Q1 2015 – Q1 2019, LCUS $, Global Sales.
Indication Split: IQVIA Oncology Dynamics Q1 2017-Q1 2019, Patient Level Oncology Survey, EU5, JP, CN, KR, Oncology Analyzer Q1 2015- Q1 2016, EU5,
JP, CN, KR *Patient Split from said countries applied globally to predict sales by Indication.

4 | Success Multiplied: Launch Excellence for Multi-Indication Assets

The findings of an analysis by Michaeli et al of 25 However, this rationale is somewhat simplistic for
multi-indication cancer drugs across 100 indications the harsh realities launches face today, for example,
corroborate the dominance of the narrow-first strategy budget and resource constrained health systems, post-
in oncology: pandemic macro-economic headwinds, a raft of cost
containment measures being put in place across many
For the sample of analysed products, the average
countries, and intense scrutiny of value by payers and
incremental quality adjusted life-years (QALYs) and life-
HTA bodies.13 Consequently, going broad first faces the
years (LYs) gained decreased for successive indications
risk of payer push back on price and restrictive market
launched, while the average disease prevalence increased
access, driven by budget impact concerns due to the size
for successive indications, clearly showing that multi-
of the potential target population and questions around
indication oncology products are first launched in small
the consistency of patient outcomes across a large,
indications with high clinical benefit, before expanding
typically heterogeneous patient pool.
into larger indications with comparatively lower benefit.12
Therefore, to be successful, a ‘broad first’ strategy
Broad first
requires the product to have proven, consistent
Conversely, launching first in the broadest possible
patient benefits in its initial launch indication, which
patient population or largest indication seeks to
are supported by strong and mature clinical trial data,
maximise the early revenue opportunity, and thus
further substantiated via RWE and compare favourably
asset NPV — in principle. Early focus on the largest
against both the standard of care and the broader
opportunity also minimises the risk of missing out on
competitive context.
an asset’s full potential by being beaten to the market
by competitors when only the early entrants tend to
capture a sizeable share.

Today, most multi-indication oncology products pursue a narrow-first

strategy, reflecting a lack of mature data at launch in an increasingly
crowded and competitive market and the reality of significant differences
in products’ relative value in different indications.

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 Case example: Targeted autoimmune therapies — In stark contrast, no such correlation between the order
going broad first of indication roll-out and relevant market size exists for
The order in which the different indications of targeted checkpoint inhibitors at the tumour-indication level.
autoimmune products were launched strongly correlates
with their respective market size, i.e., larger indications SPEED OF LAUNCHING ADDITIONAL INDICATIONS
were typically launched before smaller ones. This Once the indication sequence has been defined, the speed of
pattern applies across a basket of targeted autoimmune executing its roll-out represents the next degree of freedom
products comprising all major mechanisms of action for unlocking a pipeline in a product.
(MoA), including anti-TNF, IL-inhibitors, JAK inhibitors and
To understand how innovators have approached this
others, which were launched over the past two and a half
issue, we analysed the indication launch patterns of
decades. It has also endured over time and holds true
a basket of 18 leading multi-indication immunology
when we look at the subset of products with newer MoAs,
products in the U.S. Specifically, we focussed on three
excluding the TNF inhibitors (see Figure 4).
metrics: the time lag between the launch of successive
Interestingly, we found ‘broad first’ as the prevailing indications; the average number of indications launched
strategy for immunology assets at large. Leading multi- per year, defined as total number of all launched
indication products for treating allergic inflammation indications divided by the time from the first to the last
conditions, for example Dupixent or Nucala, also follow indication launched; and the number of indications on the
the indication roll-out pattern we observed for their market five years after the initial launch (see Figure 5).
autoimmune counterparts, starting with larger indications
followed by smaller ones.

Figure 4: Sequencing autoimmune indications: typically going ‘broad first‘

Basket of 16 autoimmune products* Basket of 11 autoimmune products — excluding anti-TNFs*

Top 7 market size by indication, (2022, in US$Bn)
Top 7 market size by indication, (2022, in US$Bn)

40 R2 = 0.69 40 R2 = 0.87
Rheumatoid Rheumatoid
arthritis arthritis
Psoriasis
30 30 Psoriasis

Crohn’s
disease

20 Crohn’s 20
disease Ulcerative
colitis Psoriatic
arthritis
Psoriatic Spondyloarthritis
10 arthritis 10 Ulcerative
Spondyloarthritis colitis
nr-axSpA** nr-axSpA**
Juvenile idiopathic arthritis Juvenile idiopathic arthritis
0 0
1 2 3 4 5 1 2 3 4 5
Average rank in indication roll-out sequence Average rank in indication roll-out sequence

*Includes abatacept, adalimumab, apremilast, baricitinib, certolizumab pegol, etanercept, golimumab, guselkumab, infliximab, ixekizumab,
risankizumab, secukinumab, tofacitinib, upadacitinib, ustekinumab, vedolizumab; the second analysis excludes the 5 TNF inhibitors from this group;
indication rank based on FDA approval dates. **Non-radiographic axial spondyloarthritis.
Source: IQVIA EMEA Thought Leadership; secondary research; FDA; market sizes according to IQVIA Forecast Link 2022.

6 | Success Multiplied: Launch Excellence for Multi-Indication Assets

Figure 5: Speed of indication roll-out

Indication roll-out patterns of multi-indication immunology products in U.S.

2.0

median: 1.7 yrs

Bubble Size = Number of
ind. 5yrs after 1st launch 2
Average number of indications launched p.a.
(total launched indications / time from first

Rinvoq*
1.5
to last launch; as at Dec 2022)

Simponi Dupixent Skyrizi*

1.0
Cosentyx

median: 0.65 ind./yr.

0.5
Taltz Humira
Stelara

0.0
0.0 1.0 2.0 3.0 4.0 5.0
Time lag between 1st and 2nd indication launched (years) Outperforming product
in class on sales / growth

* Product has been on the market for <5 years; total number of indications for bubble size estimated based on latest pipeline information
Note: Analysis based on a basket of 18 immunology products: abatacept, adalimumab, apremilast, baricitinib, certolizumab pegol, etanercept,
golimumab, guselkumab, infliximab, ixekizumab, risankizumab, secukinumab, tofacitinib, upadacitinib, ustekinumab, vedolizumab, dupilumab,
mepolizumab.
Source: IQVIA EMEA Thought leadership; FDA, company reports, press releases; IQVIA MIDAS Sales by Disease MAT Q2 2022.

Across our sample of leading immunology products, • I n contrast, fellow TNF-inhibitor Enbrel launched its
we found a median lag of 1.7 years between the launch second indication just half a year after its first, while
of first and second indication and a median of 0.65 for Simponi secured simultaneous approval of its first
the average number of indications launched per year. 3 indications.
Five years after the launch of their initial indication,
70% of the immunology products in our sample had 2–3 • R
 invoq, one of Humira’s key successors in AbbVie’s

indications on the market. immunology portfolio, has already amassed

6 indications within 3 years from initial launch,
Against those benchmarks, we observed great variation and it is poised to reach 8–9 indications after 5 years
in the indication roll-out patterns between individual on the market.
immunology products, for example:
A more detailed analysis of the speed of indication
• Stalwart Humira launched 5 indications during its first roll-out by mechanism of action (MoA) for a basket of
five years on the market, while adding, on average, leading autoimmune products found that the older class
2 new indications every 3 years over its entire lifecycle. of TNF inhibitors were faster than classes with newer
Humira sustained this rate over a remarkable 18-year MoAs, i.e., IL inhibitors, JAK inhibitors, in adding a second
period from its first to the most recent indication, but indication, taking a median of just 15 months vs. 33
it took comparatively long, just under 3 years, for its months and 48 months, respectively.
second indication to be launched.

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Figure 6: Speed of indication roll-out by MoA

Median time lag between FDA approvals of successive indications, by MoA

(for a basket of 15 multi-indication autoimmune products*; time lag in months)

1st to 2nd indication 2nd to 3rd indication 1st to 3rd indication

TNF inhibitors
15 52 65
(n=5)

Interleukin
inhibitors 33 20 41
(n=5)

JAK inhibitors
(n=3) 48 4 49

Other
(n=2) 19 107 137

Median (all) : 32 Median (all) : 32 Median (all) : 65

*Includes abatacept, adalimumab, apremilast, baricitinib, certolizumab pegol, etanercept, golimumab, guselkumab, infliximab, ixekizumab,
risankizumab, secukinumab, tofacitinib, upadacitinib, ustekinumab.
Source: IQVIA EMEA Thought Leadership; FDA; company reports, press releases.

Conversely, classes with newer MoAs were faster to This pattern also holds among checkpoint inhibitors, but
expand beyond their second indication, at a median the observed overall speed of indication roll-out is much
time lag of 20 months and 4 months between second faster. Specifically, outperforming products Keytruda
and third indication for IL inhibitors and JAK inhibitors, and Opdivo have launched an average of 3.3 and 2.1
respectively, compared to a median of 52 months for the indications per year, respectively, compared to a median
class of TNF inhibitors (see Figure 6). of 1.7 for the checkpoint inhibitor class, while the median
time lag for the class between first and second indication
Importantly, although faster indication roll-out alone launched is a mere 4 months.
does not guarantee greater overall commercial success,
we found that most outperforming immunology
products tend to launch an average number of
indications per year equal to or greater than the median
of 0.65 for our sample (see Figure 5).

While faster indication roll-out alone does not guarantee greater overall
commercial success, most outperforming immunology products launch an
average number of indications per year equal to or greater than 0.65,
the median for our sample.

8 | Success Multiplied: Launch Excellence for Multi-Indication Assets

KEY CONSIDERATIONS FOR DEFINING THE
INDICATION ROLL-OUT STRATEGY
Getting the indication roll-out right is of paramount
Getting the indication roll-out
importance and a major determinant of the overall right is of paramount importance
success of commercialising a multi-indication asset.
When defining their indication roll-out strategy,
and a major determinant of the
innovators must consider the following key questions: overall success of commercialising
• What is the level of unmet need in each indication? And
a multi-indication asset.
how does it compare between indications?

It is important to consider these questions in the

• How differentiated are the asset’s benefits in each
context of the broader healthcare system, because the
indication relative to the current SoC, and the
regulatory and policy environment matters.
broader competitive context, including likely future
therapy options? For example, the U.S. Inflation Reduction Act (IRA)
will have implications for manufacturers’ pipeline and
• How robust and compelling is the supporting evidence portfolio choices.14,15 Faced with potential Medicare price
to prove differentiated clinical benefits to both negotiations 9 years and 13 years post approval for small
regulators and payers? molecule drugs and biologics, respectively, innovators of
multi-indication cancer drugs may now choose to launch
• When will we have ‘good enough’ evidence in each the largest indication first. This way they avoid starting
indication that is sufficiently mature and compelling to the clock on when price negotiations could begin
convince key stakeholders? with a smaller, initial indication of limited commercial
potential, and thereby, to their detriment, limiting the
• What competitive intensity will we face in the
time available for capturing the full opportunity of
marketplace when launching each indication?
subsequent, larger indications.

• Will some indications take us into novel markets However, such change in indication sequencing in
where we don’t have any prior presence, experience or turn has profound ramifications for the go-to-market
stakeholder relationships vs. being a continuation of approach, for example in larger indications launches
our existing business? would face far greater competitive pressures and payer
scrutiny, precisely the kind of challenges that a ‘narrow
• What is the trade-off in patient population size/ first’ strategy seeks to avoid.
commercial opportunity between different indication
sequencing scenarios?

• Should all indications be launched under a single brand

name or would separate branding for some indications
maximise the opportunity?

iqvia.com | 9
Performance consistency when launching multiple indications
In our very first Launch Excellence publication16 in • V
 ariance in average market share attainment:
2007 we already identified wide variations in the local How does the market share average achieved across
performance across countries as a key challenge for the top 7 markets (US, EU4/UK, Japan) one year after
the vast majority of launches, which at the time were launch compare for a product’s first, second and third
predominantly single-indication products. indication, respectively?

As we elaborated earlier, launching a multi-indication • V

 ariance in local performance: How does each
product is considerably more complex and therefore indication perform in gaining market share in each of
compounds the challenge of delivering consistent the top 7 markets, measured as normalised variance in
performance across the multiple launches of its first year local market share, again for the first, second
different indications. and third indication, respectively? This metric is defined
as the nominal spread in local market share attainment
To systematically explore this challenge, we analysed
one year post launch between the highest and lowest
a basket of 12 multi-indication products, comprising
performing country for a given indication, divided by
immunology brands and PD-(L)1 inhibitors, using two
the average market share that indication achieved
metrics to assess their performance consistency:
across the top 7 countries at the year 1 time point.5

Figure 7: Performance consistency challenge for multi-indication launches

Variance in local performance Variance in average market share attainment Performance consistency ranking
Median normalised local market share Average market share achieved Distribution of products by launch
variance in year 1 between countries, in year 1 across top 7 countries, performance consistency across
by indication by indication indications

Indexed
Performance
= 100 consistency across
1.5 100 100% =
(nominal MS spread / average MS in top 7)

90 12 products ind’s. by product**

Normalised year 1 MS variance*

82
(INDEXED to 1st indication = 100)
Normalised year 1 MS achieved

High
80 17% Range =<+/-10 pts
1.04
1.0 Medium
0.84 60 25%
+/-10 pts< range
= <+/-20 pts
0.67
40
0.5
Low
58%
20 Range >+/- 20 pts

0.0 0
1st 2nd 3rd 1st 2nd 3rd Basket of
multi-indication
Indication roll-out sequence Indication roll-out sequence products

* Equals nominal market share spread between highest / lowest performing country divided by average market share achieved across all countries for a given
indication of a given product.
** Measured as range in average market share achieved by a brand in its 2nd / 3rd indication vs 1st, with 1st indication indexed to 100; range expressed as
points difference of high/low around indication average.
Notes: Error bars indicate interquartile ranges; launches have sales in at least 3 of the top 7 countries (US, EU4/UK, Japan); basket of multi-indication products
includes 8 immunology brands and 4 PD-(L)1 inhibitors.
Source: IQVIA MIDAS Sales by Disease; IQVIA Forecast Link 2022; IQVIA EMEA Thought Leadership.

10 | Success Multiplied: Launch Excellence for Multi-Indication Assets

Based on these measures, launch performance varies market access. We did not find any obvious or consistent
considerably across indications for our sample of patterns with regards to particular countries driving
products, while the consistency challenge increases with significant out- or under-performance that might explain
the number of indications launched (see Figure 7). the observed variance in launch performance.

Successive indications achieved lower average year 1 Ranking the multi-indication products in our basket by
market share compared to a product’s initial indication, launch performance consistency across their respective
at 90 and 82 index values for the second and third indications highlights the extent of the challenge: Only
indication launched, respectively, vs. 100 for the indexed 17% performed within a narrow range of less than 10
year 1 market share of the first indication. At the same points in average year 1 market share attainment between
time, the range of observed market share values for our first, second and third indication; 25% performed within
sample widens from first to third indication launched. a range of 10 to 20 points, while for a majority of 58% of
products the average year 1 market share values varied by
Furthermore, the variance in local performance that an
more than 20 points between their three indications.
indication launch achieved also widens for successive
indications, with the median value of the normalised Furthermore, achieving launch consistency is a challenge
local year 1 market share variance increasing from faced across the performance spectrum. We only
0.67 to 0.84 and 1.04 from first to second and third observed a soft correlation between a product’s overall
indication, respectively. sales and growth performance and greater consistency
across its individual indication launches. Out-performing
Importantly, this variance in market share is
products achieved moderately better consistency,
predominantly a reflection of companies’ launch
i.e., falling into both the high and medium categories
performance and not simply the result of differences
of launch performance consistency in our analysis,
between countries, such as different healthcare systems,
but even they still exhibited considerable variation in
HTA requirements or timelines for achieving favourable
performance across both indications and countries.

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 Promotional investment strategies for multi-indication launches
Launch success for any type of asset critically depends To allow cross-product comparisons, the spend profile
on optimal resourcing and investment, e.g., to ensure for each brand was normalised by indexing its first
effective market preparation and customer engagement indication to 100.
to establish a competitive presence.
The result is a surprisingly consistent promotional
Multi-indication assets face a number of additional investment profile across the five analysed PD-(L)1
complications, such as launches of their different inhibitors, with the average spend per indication
indications competing for budgets, managing following a downward sloping, almost exponential
potentially conflicting priorities, while maximising trendline along the indication roll-out sequence.
pan-indication synergies. Specifically, this finding implies that, on average,
promotional investment synergies of 21–29% were
For a sample of five, multi-indication PD-(L)1 inhibitors,
realised for each new indication added for this class of
we found that capturing synergies between indications
products (see Figure 8).
is indeed a hallmark of typical promotional investment
strategies for this class. To illustrate this point, we A more differentiated analysis of the promotional
compared the U.S. promotional investment profiles investment patterns for a basket of nine multi-indication
along each product’s indication roll-out sequence. immunology products highlights two different ways in
The underlying metric for this analysis was the total which cross-indication benefits may be realised:
promotional spend in the U.S. for each brand, excluding
• S
 ynergies, in the traditional sense, which arise
DTC, at the respective year 1 timepoint after each new
because of customer overlap between indications.
indication received FDA approval, divided by the number
For example, an autoimmune product approved for
of a brand’s approved indications at that point in time.
rheumatoid arthritis (RA), ankylosing spondylitis

Figure 8: Multi-indication promotional spend profiles: PD-(L)1 inhibitors

Average promotional spend per indication in U.S. for PD-(L)1 inhibitors

(indexed to 1st indication spend 1-yr post approval = 100; average for 5 products)

100
Normalised 1-year promotional spend

-29%
80

-23%
60
per indication*

-21%
-21%
40
-21%

20

-xx% Average synergies

0
1 2 3 4 5 6
Number of FDA-approved indications
Note: Error bars show min/max values;
* Total US promotional spend (USD) at year 1 timepoint after each new FDA indication approval, excluding DTC, divided by number of approved indications;
1st indication indexed to 100;.average products: n=5 for indications 1-3, n=3 for indication 4–6.
Source: IQVIA Channel Dynamics Jan 2023; IQVIA EMEA Thought Leadership.

12 | Success Multiplied: Launch Excellence for Multi-Indication Assets

 (AS) and non-radiographic axial spondyloarthritis To systematically explore this issue, we analysed
(nr-axSpA) shares the same prescriber specialty differences in the average promotional spend per
between its indications, i.e., they are all promoted to prescriber in the U.S. for relevant specialties, including
rheumatologists. rheumatologists, gastroenterologist and dermatologist,
at the respective year 1 timepoint after each new
• A ‘halo effect’, which results from spill-over of overall
indication received FDA approval for our sample of multi-
brand-level awareness and perceptions across different
indication immunology products.
prescriber specialties. Consequently, it manifests
itself between a product’s different indications which This analysis shows average synergies of 37% were
are promoted to different prescriber specialties. realised from customer overlap when a second
For example, an autoimmune product approved for indication was launched into the same prescriber
rheumatoid arthritis and Crohn’s disease would be specialty already targeted by a product’s first indication.
promoted to rheumatologists and gastroenterologist, When adding a third indication, incremental synergies of
respectively. Despite the absence of customer overlap 62% were realised on average (see Figure 9).
between its indications, the product may still see cross-
indication benefits which a single-indication product
would not, because seemingly unrelated promotional
efforts contribute to the overall brand equity.

Figure 9: Promotional synergies and ‘halo effect’: immunology launches

Synergies realised within same HCP specialty* ‘Halo effect’ observed across different HCP specialties**
Average U.S. promotional spend per HCP, by indication Average U.S. promotional spend per HCP, by indication
(Brands’ 1st indication indexed = 100; average for 9 products) (Brands’ 1st indication indexed = 100; range for 4 cases of
observed halo effect)

100 100
-5-12%
88-95
-37%

63

-62%

24

1st indication 2nd indication 3rd indication Standalone indication Indication in multi-
HCP specialty context
Indication roll-out sequence within same HCP specialty* • Brand’s 1st indication on the • Brand’s 1st ind. to be promoted
market and being promoted to a new HCP speciality
to a given HCP specialty • Brand has other indications on
the market, being promoted to
-XX% Average synergies different HCP specialties

Note: Average promotional spend per HCP equals U.S. promotional spend 1-yr post approval for each indication targeting a given HCP specialty, divided by
the universe size of that HCP specialty in U.S; 1:1 detailing channels only; brands’1st indication indexed = 100; values in chart are averages across products.
* Only includes a brand’s successively launched indications that share the same HCP specialty, eg RA, AS, nr-axSpA all promoted to rheumatologists.
** Based on a cross-brand comparison, looking at average spend per HCP benchmarks for 1st indications only targeting a given HCP specialty vs. later
indications targeting the same specialty but which are a brand’s first indication for that HCP specialty while the brand has other on market indications
promoted to different HCP specialties.
Source: IQVIA Channel Dynamics Jan 2023; IQVIA OneKey; IQVIA EMEA Thought Leadership.

iqvia.com | 13
The existence of a ‘halo effect’, as defined above, was
How to achieve multi-indication
more difficult to demonstrate. Its magnitude should be
launch success
expected to be smaller than traditional synergies from
customer overlap, due to its more indirect nature. In this white paper, we have focused on immunology
and oncology, the latter represented by checkpoint
Nevertheless, while not a universal pattern, we found
inhibitors. However, multi-indicationality extends well
a modest ‘halo effect’ among a select sub-set of
beyond those two therapy areas and has broader
immunology products in our sample, all with single
relevance for innovators. For example, products in
branding across their respective indications. When these
development for cardio-metabolic health may target
products launched an indication into a new prescriber
several of the associated conditions, e.g., diabetes,
specialty for the first time, while already having other
obesity, heart failure or NASH. Likewise, mental health
indications on the market which were promoted to
assets are often investigated in a number of illnesses,
different prescriber specialties, we observed a beneficial
e.g., depression, anxiety or PTSD, while the principles
‘halo effect’ of 5–12%. This manifested itself as lower
of multi-indicationality also apply to novel technology
promotional spend per prescriber compared to
platforms, such are RNA therapeutics, given
typical benchmarks for launching the same indication
their versatility.
standalone. Importantly, this benefit did not come at the
expense of launch success for these indications. As our research unequivocally demonstrates, innovators
of multi-indication assets face unique and formidable
Pan-indication benefits derived from both capturing
strategic and operational challenges. They must
traditional spend synergies and building overall brand
therefore focus on five critical priorities to achieve multi-
equity are an important lever for maximising the value
indication launch success (see Figure 10):
of multi-indication assets, which few brands exemplify as
strikingly as the $20 billion Humira mega-franchise.

Figure 10: Critical priorities for multi-indication launch success

Indication Pricing Compelling Adequate Focused

roll-out strategy evidence resourcing organisation

Optimal indication Innovative Sustained, synergistic Committing to Maintaining

sequencing strategy; approaches, e.g., evidence generation competitive organisational
indications launched multi-year-multi- and dissemination investment/resource momentum and focus
in rapid succession, indication over the product levels pre-/post through optimal
but without agreements, lifecycle/multi- launch, sustained structure, governance
overstretching the anticipating impact indication roll-out across all launches of and ways of working
organisation of future indication multiple indications to enable consistent
roll-out execution

Source: IQVIA EMEA Thought Leadership.

14 | Success Multiplied: Launch Excellence for Multi-Indication Assets

1. I ndication roll-out: Defining the optimal indication 5. Focused organisation: Maintaining an organisation’s
sequencing strategy reflecting asset- and TA/market- momentum and focus through optimal structure,
specific considerations; followed by swift execution to governance and ways of working, e.g., customer-
launch the different indications in rapid succession, centric go-to-market models, ringfenced and
but without overstretching the organisation. indication-dedicated teams, balanced with asset-level
planning, to enable the consistent execution across
2. Pricing strategy: Optimising price-volume trade-
the launches of multiple indications.5
offs, including exploring innovative approaches,
e.g., multi-year-multi-indication agreements17, which Multi-indication assets represent a tremendous
anticipate the relative value of future indications and commercial opportunity, but unlocking their full
their impact on volume/price, and thus budgets, to potential requires careful strategic choices, disciplined
accelerate market and patient access. execution and sustained organisational commitment to
staying the course of a long launch. Innovators blessed
3. C
 ompelling evidence: Sustaining synergistic
with a pipeline in a product have everything to play for.
evidence generation and dissemination over the
product lifecycle and multi-indication roll-out to
continuously polish an asset’s differential value
proposition18 and maintain a competitive Share of Multi-indication assets represent a
Scientific Voice .
tremendous commercial opportunity,
TM 7,8

4. Adequate resourcing: Committing to competitive but unlocking their full potential

investment and resource levels, pre- and post-launch,
requires careful strategic choices,
sustained across the launches of multiple indications
and reflecting TA/market-specific competitive disciplined execution and sustained
dynamics and intensity; while capturing cross- organisational commitment.
indication synergies.

iqvia.com | 15
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institute/reports/the-global-use-of-medicines-2022.
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papers/launch-excellence-escaping-the-complexity-trap
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medical-affairs-analytics-to-enhance-engagement-and-demonstrate-value/
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library/white-papers/launch-excellence-vi
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environment really more competitive now? | Pharmaphorum
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com/library/white-papers/in-the-eye-of-the-storm-pd-l-1-inhibitors-weathering-turbulence
12. Michaeli, D.T., Mills, M. & Kanavos, P. Value and Price of Multi-indication Cancer Drugs in the USA, Germany,
France, England, Canada, Australia, and Scotland. Appl Health Econ Health Policy 20, 757–768 (2022). https://doi.
org/10.1007/s40258-022-00737-w
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white-papers/overcoming-pharmas-launch-performance-problem
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white-papers/see-the-whole-board
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to oncology medicines with multiple indications in Europe. J Mark Access Health Policy. 2021 Aug 17;9(1):1964791.
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excellent-launches-are-winning-the-evidence-battle

16 | Success Multiplied: Launch Excellence for Multi-Indication Assets

About the authors
MARKUS GORES KIRSTIE SCOTT
Vice President, Consultant,
EMEA Thought Leadership, EMEA Thought Leadership,
IQVIA IQVIA

Markus has over 20 years of experience in life sciences, Kirstie is a consultant in IQVIA’s EMEA Thought
advising clients in all major geographies on a broad Leadership team, based in London. She has experience
range of topics, including real world evidence strategy, preparing white papers across a range of priority
launch readiness, go-to-market models, brand healthcare topics such as the availability of medicines,
and commercial strategies, and building enabling the impact of biosimilars in Europe and launch
organisational capabilities. excellence. A particular recent focus is how companies
with new launches can overcome the challenging
Markus is a frequent speaker on the latest industry post-pandemic environment to achieve launch success.
trends and regularly engages with senior leadership
teams of pharmaceutical companies. Kirstie has over 5 years’ experience in healthcare and
life sciences, previously working to support industry
Prior to his current role in Thought Leadership, he associations to influence health policy, and providing
has held leadership positions within IQVIA Real World clinical and commercial competitive insights for
Solutions and QuintilesIMS Consulting Services pharmaceutical companies. She holds a degree in
(formerly the IMS Consulting Group). Neuroscience from the University of Nottingham.

Markus holds a PhD in Pharmaceutical Chemistry

from the University of Hanover and has completed
post-doctoral research at the University of California.

iqvia.com | 17
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