"Blick in die Glaskugel": Vortrag Dr. Frank Wartenberg, President Central Europe, IQVIA™ auf der...
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Transcript of "Blick in die Glaskugel": Vortrag Dr. Frank Wartenberg, President Central Europe, IQVIA™ auf der...
Copyright © 2017 IQVIA. All rights reserved.
Was ist nach den Wahlergebnissen in
Deutschland, Europa und USA zu erwarten
29. November 2017, Steigenberger Hotel Berlin
Dr. Frank Wartenberg – President Central Europe
Der Blick in die
Glaskugel
1© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
2
When human science meets data scienceHuman Data Science
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
Worldwide clinical and
real-world experience
informed by deep
scientific expertise
across every major
therapy area
Leading healthcare
“big data” and
technologies fueled
by commercial
expertise to find
unparalleled insights
Solutions to
help clients
drive healthcare
forward
IQVIA mobilizes unparalleled data, analytics, technology, and expertise through solutions connecting stakeholders to improve health
© IQVIA 2017. All rights reserved.
© IQVIA 2017. All rights reserved.
5
Where is Pharma headed in the next years?
Geopolitical challenges
and influences
Global and regional
market prognosis
Key market drivers and
innovations
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
6
Higher than region CAGR
On par with region CAGR
Lower than region CAGR
-4%
-2%
0%
2%
4%
6%
8%
10%
0,0
0,2
0,4
0,6
0,8
1,0
1,2
1,4
1,6
2016 2017 2018 2019 2020 2021
Global sales (2016-21), Trillions of constant USD
EU5
US
Pharmerging
Japan
CAGR 2016-21
Developed 2-5%
US 2-5%
Japan (-2)-1%
Germany 2-5%
UK* 2-5%
France 1-4%
Italy 2-5%
Spain 2-5%
Canada 2-5%
Pharmerging 6-9%
Pharmerging US$ 5-8%
China 6-9%
Brazil 6-9%
India 9-12%
Russia 6-9%
Turkey 11-14%
Mexico 3-6%
Gro
wth
Notes: *Subject to PPRS rebate; Ex-manufacturer price levels, not including rebates and discounts. Contains Audited + Unaudited data; Growth considered on par
if the there is overlap between country and region CAGR ranges Source: IQVIA, IMS Market Prognosis September 2017
The pharmaceutical market grows to $1.4 trillion by 2021, with a CAGR of 3-6%
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
7
Regional contribution to growth 2021 regional market share
44%
$285 bn
9%3%
9%
10%
19%
7%
2016-21
$256 bn
43%
9%
-2%
11%
16%
12%
11%
2011-16
China
BRI
Pharmerging
Tier 3
RoW
US
EU5
Japan
12%
Japan
14%
13%
7%
Pharmerging T3
RoW
7%
EU5
42%US
BRI
6%
China
Notes: *Subject to PPRS rebate; Ex-manufacturer price levels, not including rebates and discounts. Contains Audited + Unaudited data; Growth considered on par if
the there is overlap between country and region CAGR ranges Source: IQVIA, IMS Market Prognosis September 2017
USA to continue to dominate growth and sales whereas China and Japan expected to slow down
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
8
46% of the current global sales are in the USA
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
-5%
0%
5%
10%
15%
20%600
500
400
300
200
100
0
568
20
531
19
500
18
478
17
467
16
459
15
436
14
389
13
343
12 21
327
2011
332
Previous Q3 2016 forecastYoY growth (%)
Changes in
forecast
• List price increases
lower than anticipated
• Fewer novel drug
approvals and
product launches in
2016
• Decline in HCV sales
not balanced out by
new HCV products
• Threat to ACA, tax
credit and subsidy
reform, wider use of
Health Savings
Accounts
US sales and market growth (2011-21), Billions of USDGlobal sales
Billons of USD
US
MAT 06/2017
$1,046bn
43%
14%
7%
19%
16%
Japan
EU5Pharmerging
ROW
Notes: *Subject to PPRS rebate; Ex-manufacturer price levels, not including rebates and discounts. Contains Audited + Unaudited data; Growth considered on par if the
there is overlap between country and region CAGR ranges Source: IQVIA, IMS Market Prognosis September 2017
9
NASDAQ Biotechnology Index (IBB)
“I’m going to bring down
drug prices. I don’t like
what’s happened with
drug prices.”
– President Elect
Trump, Dec 7
“Our drug industry
has been disastrous
[…] they’re getting
away with murder.”
– President Elect
Trump, Jan 11
Every tweet or
statement
about drug
pricing raises
industry
concerns
President Trump has also openly targeted pharma and risingdrug costs, which has affected industry stock
Source: IQVIA, US & EU5 Market Trends; : iShares NASDAQ Biotechnology Index (ETF), Google Finance, Yahoo Finance, MSN Money
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
10
Patient Cost Exposure Distribution
20% 22% 25% 26%
66% 65% 64% 63%
7%8% 1%1%2%2%
20142013 20162015
5% 1%6%
1%1% 1%
4%4%
4%4%
Generics $0 Copay
Brands Paid >$50 Brands Paid $0.01-$50
Generics Paid >$50 Generics Paid $0.01-$50
Brands $0 Copay
24% of drug
spending
without patient
out of pocket
cost
30% of drug
spending
without patient
out of pocket
cost
OBAMACARE
The introduction of ACA shows first achievements: The share of zero patient out of pocket cost is constantly increasing
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
Source: IQVIA; Medicine Use and Spending in the U.S, IQVIA Institute
11
“We’re going to have
insurance for everybody…
There was a philosophy in
some circles that if you can’t
pay for it, you don’t get it… It
will be in a much simplified
form. Much less expensive
and much better.”
– President Elect Trump,
Washington Post, Jan 15
However, frustration with quality and affordability of care drove popularity of “Repeal and Replace” of the ACA
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
Source: IQVIA, US & EU5 Market Trends
12© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
Source: http://marketbusinessnews.com/bregret-regret-voting-brexit-spreading/138359
13
Brexit could decelerate UK pharma growth over the next 5 years
35
30
25
20
15
10
5
0
21
30
20
28
19
27
18
26
17
26
16
26
15
28
14
28
13
24
12
23
2011
23
20%
15%
10%
5%
0%
Downside of Brexit
pharma forecast
growth ~1% slower
by 2021
Further critical
factors in forecast
• Pre-PPRS rebate
and other
discounts/rebates
• Patient access
schemes
UK sales and market growth (2011-21), Billions of USDGlobal sales
Billons of USD
UK
MAT 06/2017
$1,046bn
43%
12%
2%7%
19%
16%
US
Rest of EU5
Japan
Pharmerging
ROW Brexit downsideUK sales/Brexit base caseBrexit upside
YoY growth/Brexit downside YoY growth/Brexit upside
YoY growth/Brexit base case
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
Notes: At ex-manufacturer price levels, not including rebates and discounts. Contains Audited + Unaudited data; *YoY growth in GBP; Source: IQVIA, IMS Market Prognosis Q3 2017; IMS MIDAS 09/2017
14
Ranks 6th in Europe for manufacturing; total
pharma employment is in decline
Justified reputation as a poor launch market
Nur hinter USA, Japan und Deutschland bei # von
Pharma HQs
In den Top 10 der Anzahl Pharmamitarbeiter
weltweit
Führend bei Pharma Forschungsausgaben
Führend im Bereich HTA und RWE
Innovationshochburg?
So where does Brexit leave the UK?
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
Die UK ist ein wichtiger Markt zur Kommerzialisierung …
2% Weltweiter
Pharma-ausgaben
1% NAS
Umsatz Jahr 1
nach Launch
…UK ist ein schwacher Umsatztreiber
Quelle: ABPI; IMS Midas MAT Q4 2016
15
Four key areas of UK pharma industry are affected by Brexit
Trade Scientific
CommercialRegulatory
Relocation of EMA & retention of regulatory personnel
EEA regulatory network relationship
Distribution, pharmacovigilance & clinical trials
Scientific funding
Freedom of movement
International research and policy cooperation
Freedom of movement
Harmonisation of infrastructure
UK as launch market & business base
Sterling as reporting currency
Change in import/export balance
Supply chains crossing UK-EU borders
Knock-on effects of regulatory disruption
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
Source: IQVIA Thought Leadership
16
• £25 million of research support for start ups/SMEs
• £13 million competition to establish a new Medicines Manufacturing Innovation Centre
• £12 million to expand the Cell and Gene Therapy Manufacturing Centre in Stevenage
Commercial growth and infrastructure
• £14 million investment in 11 medical technology research centres
• £30 million to establish the Advanced Therapies Treatment Centre
• £66 million for a major vaccines lab to prepare country for emergency epidemics
NHS Collaboration
Goals in the government’s life sciences strategy
£ 160 Mio
“These measures will provide confidence for global companies to invest in the UK during and beyond Brexit.” – Mike Thompson, ABPI
Government reinforces commitment to strengthens UKs attractiveness for pharma industry
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
Source: IQVIA Thought Leadership
17
0%
2%
4%
6%
8%
10%
12%70
60
0
10
20
30
50
40
48
13
46
12
42
2011
45
18 19
43
52
4749
20 2117
45
16
44
1514
54
Critical factors in
forecast
• 30 new products
expected to launch in
2017
• Aging population leads
to increase in volume
• Patent expiries
increase rebate
contracts and generic
volume
• Extension of the price
moratorium
• Sick funds discount
contracts expansion,
esp. in acute diseases
Germany sales and market growth (2011-21), Billions of USDGlobal sales
Billons of USD
16%
19%
7%4%Germany
10%
43%
$1,046bn
MAT 06/2017
US
Rest of EU5
Japan
Pharmerging
ROW
YoY growth (%)Germany sales
Launch and admission to reimbursement of innovative specialty products drive German market growth
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
Notes: At ex-manufacturer price levels, not including rebates and discounts. Contains Audited + Unaudited data; YoY growth in LCUS$, Source: iQVIA; IMS Market Prognosis Q3 2017; IMS MIDAS 09/2017
18
65%Des Wachstums kommt
von 3 Therapiegebieten
(Krebs, Autoimmun, NOAC)
Trends und wichtige Fakten für den deutschen Pharma Markt
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
225Markteinführungen neuer
Substanzen 2016-2020
16%Marktanteil von AMNOG-
Produkten am deutschen
Gesamt-Rx Markt
Deutschland bleibt
Hauptzielmarkt für
neue innovative
Markteinführung und
etablierte Produkte
1%Versandhandelsanteil am
Gesamt-Rx Markt (MAT 7/17)
4,357€ Mrd. OTC Markt mit einem
Wachstum von 3,8% (MAT7/2017)
2,398€ Mrd. Einsparungen durch
Erstattungspreise und Rück-
forderungen im 1. -3- Quartal
2017
1%Anteil der Biosimilars am
Gesamt-Rx Markt (MAT 7/17)2-5%Wachstumsprognose in
etablierten Märkten inkl.
Deutschland 2016 – 2020
43%der globalen Pipeline sind
Biologika auch für Alzheimer,
Asthma, Schmerz, …
59% vom europäischen Wachstum
resultiert aus
Spezialtherapeutika
19
In May 2017 the AMVSG was enforced – Key Points
Physician information
system about
AMNOG outcomes
Price moratorium
continues until
end of 2022
Provision to keep the
negotiated prices
confidential was set aside
Principle of free pricing in
the first year after launch
is kept
EU payers continue to focus on cost containment.The May 2017 AMVSG did not change that for Germany
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
Source: IQVIA, http://www.bundestagswahl-bw.de
20
• The G-BA has rarely restricted to sub-populations even though it is
legally able to do so
• AMVSG does not explicitly change this
• However, the fact that this was debated politically, and the precedent
case of PCSK9i restriction, makes this an area to watch for future
submissions
Restrictions to sub populations?
• GKV negotiations have been able to consider volume in the past, but the
focus has been on simple rebates
• With AMVSG, it will be important to consider how the negotiation
dynamic may change
Impact of price-volume
negotiation?
• Physicians may fear financial penalties if they cannot justify use in
populations where the drug did not show any additional benefit
• Conversely, drugs may be preferentially used in populations where the
drug showed an added benefit
AMNOG dossiers included in
physicians’ software: Effect on
prescribing?
Looking ahead, we can think of at least three key trends or open questions to watch for Germany
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
Source: IQVIA, US & EU5 Market Trends
21
What drives key markets growth? The shift towards specialty medicine
Share of absolute
growth by region
Forecast 2016-2021 88%
12%
Traditional Share of Growth 2016-21
Specialty Share of Growth 2016-21
31%
69%
94%
6%
41%59%
85%
15%
LATAMLC$ 23Bn Growth
EuropeLC$ 36Bn Growth
AFMELC$ 25Bn Growth
Asia/Aust./NZLC$ 86Bn Growth
North AmericaLC$ 203Bn Growth
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
Source: IQVIA, IMS Market Prognosis Q3 2016; at ex-manufacturer price levels, not including rebates and discounts. Contains Audited + Unaudited data; IHII analysis; Turkey included in AFME, Russia in Asia/Aust./NZ
22
Absolute one year growth MAT 06/2017 (Top 10 TAs, Mio LCU$)
1,000600 800200 4000
Immunosuppressants
814
52
Lipid Regulators 64
Vaccines 65
Multiple Sclerosis 66
Respiratory 69
Diabetes 72
Ocular Antineovascularisation 74
Anticoagulants 253
Autoimmune 475
Oncology
Share of total
positive growth
MAT 06/2017
34%
20%
11%
3%
3%
3%
3%
3%
2%
2%
Top 5
represent
71% of
growth
In Germany, over 70% of growth comes from five TAs, three of them being specialty
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
Source: IQVIA, IMS MIDAS MAT Q2 2017, Rx only
23
Phase II–Registered Percent of Pipeline
28%31%
3%
4%
4%6%
6%7%
11%
Oncology Other
Mental Disease
Respiratory
Diabetes
Autoimmune
Cardiovascular &
Haematology
CNS
Infectious disease
39%30%
13%
11%
15%
30%
3%
6%
11%8%
Phase II-III
2,212
4%4%
5%6%
Pre-Reg/Reg
272
3%5%
4%
4%
The pipeline is also full of specialty, almost half of drugs in late stage are within Oncology, Antivirals & CNS
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
Source: IQVIA, IMS R&D Focus. Sept 2017, active phase only
24
Past/current situation
Proportion of Globally Excellent Launches by
Primary care / specialty
Future situation
Rising areas
Launch
Excellence V
(2011-2015)
13%
87%
Launch
Excellence 1
(1995-2003)
82%
18%
Primary CareSpecialty Care
Launches
typically for
diseases/
conditions with
global patient
pops in Bn-
100s m range
Launches
typically for
diseases/
conditions with
global patient
pops in 10ms-
<1m range*
Personalised
Medicine
Gene therapy
Cell therapies
Large patient
populations,
high unmet need
Orphan drugs
Alzheimer’s?
Excellent launches strengthen companies performance; specialty products are also here in focus
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
Source: IQVIA Thought Leadership on Launch Excellence, Launch Excellence V, *Sole specialty exception: Hepatitis C
25
1
2
Pipeline candidates 10/2017
CAR T-cells
4
27Phase II
3Phase III
Pre-reg./ Reg.
Approved
Preclin./
Phase I27
RNAi
15
44
CRISPR
25
Patisiran - Amyloidosis (Sanofi/Alnylam)SYL 1001 - Dry eye (Sylentis)QPI 1007 - Ophthalmological disorder (Biocon/Quark)Teprasiran - Transplant rejection (Alnylam)
Kymriah - Leukemia (Novartis, FDA 08/2017)
tisagenlecleucel-T - Leukemia, Lymphoma (Novartis)Axi-cel – Non-Hodgkin lymphoma (Kite Pharma/Gilead)
First advanced cell therapy received market approval, RNAi and CRISPR technologies are in earlier trial stages
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
Source: IQVIA Thought Leadership analysis, IMS R&D Focus October 2017; Nature news
26
Where is Pharma headed in the next years?
Specialty
products and
TAs are the key
drivers of
developed
market growth
Cell and gene
therapies could
change the
current
definitions of
pharmaco-
therapy
German pharma
sales is growing
solidly; patient
centric
approaches and
closure of
supply gaps are
in focus of
politicians
The implications
of Brexit for
pharma remain
uncertain but will
affect regulatory,
trade,
commercial, and
scientific areas
Regulator/ payer
discussions on
drug pricing and
ACA will
influence pharma
business in the
US
Global pharma
contibutes to
grow to $1.4tn
by 2021;
US remains the
main growth
driver
© IQVIA 2017. All rights reserved. – Der Blick in die Glaskugel – Dr. Frank Wartenberg
Source: IQVIA
Für Fragen stehe ich Ihnen gerne zur Verfügung
Dr. Frank Wartenberg
President Central Europe
+49 69 6604-4315
@FrankWartenberg