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Copyright © 2019 IQVIA. All rights reserved.
What are German companies looking for
in terms of open innovation and
technology in- licensing, R&D services
and clinical trials
Health Cluster Portugal, 30th September 2019
Opportunities in
Germany’s health market
Dr. Frank Wartenberg
President Central Europe
3
0%
5%
10%
15%
60
20
0
10
30
40
50
7065
46
20222014
59
52
2017 20182013 2015 2016 2019 2020 2021 2023
48
43 4447
55
61
68
Germany sales and market growth (2013-23) Bn US$Global Pharmaceutical sales in
Bn US$
Germany sales (Bn US$) YoY growth (%)
In 2019, Germany represents more than 4% of the total global pharma market with a predicted growth of ~ 4% per annum
Growth Drivers 2019-23
Recent and future
product launches
(mainly innovative
specialty products)
Generic competition
and Biosimilar entries
Changes to pricing and
reimbursement under
AMNOG
Reference price revision
Demographics
(flat/declining overall
vs. ageing population)
Opportunities in Germany’s health market, Health Cluster Portugal, September 2019
Note: Growth and CAGR calculated on LCD values
Source: IQVIA European Thought Leadership; MIDAS MAT Q2 2019; Rx only; Market Prognosis May 2019
Local payer/KV
influence
4%7%
15%
22%
10%
41%
2019
RoW
Pharmerging
Japan
GERMANY
EU4
US
$1.249bn
4Opportunities in Germany’s health market, Health Cluster Portugal, September 2019
Apothekenmarkt nach Segmenten, Apotheke (Offizin+VH), BRD-Gesamt
+/-% € z. VJ
4.703
1.406
778
151
Patient Care
(PAC)
Total market
Rx
Non-RX (OTCGMS)
Personal Care
(PEC)
Nutrition
(NUT)
30.392
23.354
4,1
5,0
1,7
0,2
0,0
4,4
74
62
14
476
1.007
382
-0,5
0,5
-0,9
-1,3
-1,8
-3,1
+/-% PCK z. VJSales Mio. € Volume Mn. PCK
YTD 06/19
Growth in the German market is driven by a trend to higher priced packs
Source: IMS® Consumer Report Apotheke, Rx aus IMS PharmaTrend® monatlich
5Opportunities in Germany’s health market, Health Cluster Portugal, September 2019
Hospital and Retail sale is driving the German market growth, volume remains stable
Source: IMS Dataview® Pharmaceutical Consumption (AMV) Database: Clinic data from IMS® Hospital Index (DKM®), sales in Euro at valued hospital prices, sales in counting units; IMS PharmaScope® National, sales in Euro at the selling price of the pharmaceutical company (ApU=refund amount for AMNOG products and list price for other products) without consideration of discounts and savings from discount agreements, sales in counting units, consideration of preparations, pharmacy sales including vaccines
+10,8 %
43,9 Bn. Euro 97,7 Bn. SU
+5,7 % +1,2 %
86%Retail
14%Hospital
91%Retail
9%Hospital +0,03 %
+4,9%+1,3%
Sales Volume Sales Volume
22,5 Bn. Euro 28,8 Bn. SU
+5,2 % -0,2 %
86%
14%
Retail
Hospital
92%
8%
Retail
Hospital
2018
7,1 %+0,4 %
+4,9 %-0,3 %
H1 / 2019
6Opportunities in Germany’s health market, Health Cluster Portugal, September 2019
4 out of 5 Top TAs are the same globally and in Germany
Oncology is the leading TA globally and in Germany while Diabetes is at #2 and #4 respectively
51%
14%
$47 bn
19%
8%
15%
22%
5%
Oncologics
5%8%
$44 bn
66%
68%
Antidiabetics
17%
12%
10%
14%
3%
4%14%
55%
Autoimmune
13% 11%
11%
35%
9%
Pain
12%
61%Respiratory Agents
7%
70%
15%27%
15%
8%
19%44%Anticoagulants
32%
11%
Antihypertensives
12%
16%
7%
45%
Antibacterials
4%1%
HIV
15%13%
4%
$136 bn
$93 bn
$82 bn
$41 bn
$37 bn
$36 bn
$33 bn
$32 bnMental Health
2019 Global Sales by Therapy Area and Region in Bn US$
Note: Growth in LCUS on YoY basis
Source: IQVIA MIDAS MAT Q2 2019, Rx only
US ROWEU5 JAPAN PHARMERGING
• Top 5 TA 39% of global value
• Top 3 with 69% of global growth
Top 5 TAs and Share
of 2018-19 Growth
1 Oncology 46%
2 Autoimmune 17%
3 Anticoagulants 10%
4 Antidiabetics 4%
5 Pain 0.2%
7Opportunities in Germany’s health market, Health Cluster Portugal, September 2019
L01G MAB ANTINEOPLASTICS21%
B01F DIRECT FACTOR XA INHIBITOR16%
L01H PROTEINKIN.HEMM.A.NEOPL.12%
L01X OTHER ANTINEOPLASTICS10%L04C INTERLEUKIN INHIBITORS
17%
M01C ANTI-INFLAMMATORY DRUGS, SPECIFIC
10%
R07X OTHER PREPARATIONS OF THE RESPIR. SYSTEMS
9%
ÜBRIGE5%
Half of the additional SHI expenditures for drugs in the first half of 2019 are attributable to various cancer therapeutics
In the first half of 2019, the statutory health insurance funds spent an additional 712 million euros* on drugs.
In total, around half of the additional expenditure (MAB antineoplastics, protein kinase inhibitors, antineoplastics) is attributable to various
innovative oncological drugs.
The group of interleukin inhibitors contributes 10 % to the increase in expenditure. The preparations are used for the targeted therapy of
autoimmune diseases. These include, for example, severe forms of rheumatic diseases or psoriasis. Innovative therapies for the
treatment of the hereditary disease cystic fibrosis (mucoviscidosis) contribute a further 9 % to growth.
Source: IMS PharmaScope® Polo, Basis: *Turnover in euro at pharmacy retail price (AVP) less compulsory discounts to be paid by manufacturers and pharmacies, less reported discounts from reimbursement amounts in accordance with §130 SGB V; without savings from discount agreements; sales in packaging units; without vaccine
+712Mn. Euro*
German 2018 Oncology Market
Rank Company Share
1 Roche 19%
2 BMS/Celgene 16%
3 Novartis 12%
4 J&J 11%
5 Pfizer 5%
8Opportunities in Germany’s health market, Health Cluster Portugal, September 2019
2018(Mn. Euro)
L01G MAB ANTINEOPLASTICS 1.534,3
B02D BLOOD COAGULATION 431,5
N07X ALLE AND.ZNS-WIRKS.PRAEP 326,2
J06C POLYVAL.IMMUNOGLOBUL.,I.V. 241,8
L04X OTHER IMMUNOSUPPRESENT 226,7
N07A PROD.G. MULTIPLE SCLEROSIS 138,5
L01B ANTIMETABOLITES 132,5
S01P OPH.ANTINEOVASCULAR.PROD 129,0
J02A ANTIMYKOTIKA, SYSTEMISCH 126,9
L04B ANTIMYCOTICS, SYSTEMIC 109,0
Total TOP 10 3.396,5
Total 6.298,6
14.0
-15.4
-0.4
164
35.8
3.8
19.5
10.8
71.0
-1.4
-20.6
17.7
In 2018, the sales volume in the hospital sector reached 6.3 billion euros. This corresponds to growth of 11%.
Sales of CNS-active preparations increased particularly strongly due to the launch of a new product. Spinraza is the first drug to treat the
rare hereditary disease spinal muscular atrophy (SMA)
Further growth groups are MAB* antineoplastics (+14 %) for cancer immunotherapy, blood coagulants (+4 %) and polyvalent
immunoglobulins (+20 %) for infection defence in patients with congenital immunodeficiency. Immunosuppressants increased by 36%. The
high rate of increase (+71 %) in preparations for multiple sclerosis
Systemic antimycotics (-15 %) and anti-TNF products (-21 %) posted declines in sales.
5 of the Top 10 ATC4 classes show double digit growth2018: YoY growth +/-%
Source: IMS Dataview® hospital, Umsatz in Mio. EUR bewertet * MAB: Monoklonale Antikörper (monoclonal antibody)
9® 2019 IQVIA Commercial – Health Cluster Portugal, Sep. 2019
In 2018, the pharmacy market recorded revenue growth of around 5 % and amounted to 35.9 billion euros. The lion's share of this is
accounted for by prescription preparations (86 %), whose turnover is rising by 6 %. Over-the-counter (OTC) products grew by only 3 %.
In a second perspective, the right part of the chart divides the market into the segments generics / biosimilars, protected and no longer
protected originals. Newer, still patent-protected preparations that are only just establishing themselves on the market will increase by 15
% in 2018. Products for which patent protection has expired are recording losses of 10 %. Sales of generics and biosimilars increased by
+7 %
* Others includes among others: Vaccines and test diagnostics as the top-selling categories,
also therapeutics that substitute or supplement the body's own substances
Selling price of the pharmaceutical company less manufacturer discounts
Growth drivers in the German market are patent-protected products (low double-digit) and biosimilars (high single-digit)
Source: IMS PharmaScope® Real, basis: sales in € million at the selling price of the pharmaceutical company (ApU=refund amount for AMNOG products and list price for other products) less manufacturer discounts and additional discount due to price moratorium, without savings from discount agreements §130a Para. 8 SGB V. Since July 2009, market information on the mail order business has been integrate
Originals + 2nd
supplier,
protected
Total
35.891
7.502
Generics +
Biosimilars
8.712
Originals + 2nd
supplier,
unprotected
Originale/
Zweitanbieter
geschützt+
ungeschützt
14.04221.544
5.635
Others*Non Rx
35.891
RxTotal
30.762
5.130
+5,2 % +5,5 % +3,4 % +5,2 % +7,2 % +14,7 % -9,8 % +4,8 % +3,9 %
10
European biosimilar market development (value, LC€)
The European biosimilar story started slowly but value is growing exponential
Enoxaparin Sodium
Adalimumab
Insulin Lispro
Trastuzumab
Epoetin
Rituximab
Etanercept
Filgrastim
Infliximab
Insulin Glargine
Follitropin Alfa
Somatropin
© 2019, IQVIA Commercial GmbH & Co. OHG
900Mn €0€Biosimilar value per country1
stw
ave
2n
dw
ave
3rd
waveMAT 6/2007
# Bs: 1
1 Mn €
MAT 6/2008
# Bs: 6
18 Mn €
MAT 6/2009
# Bs: 10
66 Mn €
MAT 6/2010
# Bs: 11
146 Mn €
MAT 6/2011
# Bs: 12
237 Mn €
MAT 6/2012
# Bs: 12
344 Mn €
MAT 6/2013
# Bs: 12
426 Mn €
MAT 6/2014
# Bs: 15
521 Mn €
MAT 6/2015
# Bs: 18
682 Mn €
MAT 6/2016
# Bs: 20
1,162 Mn €
MAT 6/2017
# Bs: 24
1,998 Mn €
MAT 6/2018
# Bs: 33
3,206 Mn €
Source: IQVIA; European Thought Leadership; MIDAS MAT Q4 2018; Rx only
MA
T
12
/20
13
MA
T
12
/20
11
MA
T
12
/20
10
MA
T
12
/20
07
MA
T
12
/20
08
MA
T
12
/20
09
MA
T
12
/20
12
MA
T
12
/20
14
MA
T
12
/20
15
MA
T
12
/20
16
MA
T
12
/20
17
MA
T
12
/20
18
MAT 12/2018
# Biosimilar: 43
4,655 Mn €
4
3
1
3
2
3
7
5
1
2
1
2
No. of Biosimilar products
11® 2019 IQVIA Commercial – Pharma Trends 2019
Large Pharma under pressure – What does it mean for Germany?
• Lower growth, less favorable operating margins
• Rising R&D and pipeline cost
• Higher commercial complexity for novel therapies
• Rising price pressure in key markets
Conclusions
• Germany remains a must win market
• Often launching into new and small but
highly competitive therapy segments
• With complexity around right pricing,
reimbursement, positioning and even
delivery to patients
• Having more limited launch budgets…
• … still facing high expectations from HQ
Source: IQVIA
12
Key events and trends
With digital progress,
RWE expands
at two ends
Primary care rises from
the ashes
Digitally supported
promotion reaches a
tipping point
Substantial biosimilar
savings impact
Pharma under pressure
to manage costs
(R&D, …)
Cell/gene therapies
search for the right
commercial model
Source: IQVIA Thought Leadership
14
DEMONSTRATING
VALUE
UNLOCKING
DIGITALNEW CHANNEL
STRATEGIES
Continued increase in cost
containment measures are driving
a need to work with public policy
makers and payers to enhance
product value propositions
beyond simple price cuts
Technology adoption to existing
processes/systems continues, with
the focus shifting to innovative
coordinated approaches to
increase engagement across the
value chain via technology
A shift of service delivery and touch
points for customer interaction due to
policy focus and a strengthening
retail segment, gives rise to change
in channel strategy
Source: IQVIA research & analysis © 2019, IQVIA Commercial GmbH & Co. OHG. All rights reserved
We see three potential starting points for growth supportive actions in Rx, medical devices and OTC markets
15
Real World Data are increasingly important and currently expanding at two ends: 2. Patient/Consumer
® 2019 IQVIA Commercial – Pharma Trends 2019
Lab/biomarkerdata
Genomicsdata
Patient apps
Wearables/devices
Real-World Data
PayerClaims
Medicalrecords
PatientRegistries
HospitalEHRs
Pharmacydata
High science Patient
Increasing volume of
individual body
composition data
Increasing volume of
patient-generated
data
Source: IQVIA
16
Novel strategies to boost maturing brands and to launch innovations successfully are needed
Opportunities in Germany’s health market, Health Cluster Portugal, September 2019
Source: IQVIA European Thought Leadership White Paper “Rising from the Ashes; Primary Care is Alive and Well” 2018
17
Draft legislation passed by the federal cabinet in July
The Minister of Health drives a digital agenda
• Health Apps can be prescribed by physicians and are
reimbursed under the condition that Apps have been evaluated
− BfArM evaluates safety, quality, functionality and data
protection & security before launch
− Payers reimburse without further evaluation for 1 year
− During 1st year, suppliers have to collect data that proves
positive effect on care
− Subsequent reimbursement to be negotiated with payer
association (GKV-Spitzenverband)
• Other changes: (1) deadlines and fines for delays re connection of
HCPs to telematic infrastructure, (2) ePrescription of “Heil &
Hilfsmittel”, (3) advertising eConsultation on physician websites
® 2019 IQVIA Commercial – Pharma Trends 2019
The worlds largest digital health market: these legal initiatives create an end to end market for digital applications in health care with a potential of 80 million people
Source: Tagesspiegel 10.7.2019
Jens Spahn
Federal Minister of Health
18
Payers have already moved forward supporting health apps
Opportunities in Germany’s health market, Health Cluster Portugal, September 2019
SHI-reimbursed app: “Online therapeutic” Selfapy
• Offers online therapy courses and personal coaching for various
diseases (depression, eating disorders, anxiety, chronic pain,…)
• Bridging waiting time for a therapy slot
• Proven clinical effectiveness
• Data gathering since 2016 to develop personalized treatment algorithm
ADA claims
• Artificial Intelligence, based on database with thousands of medical
cases from >100 physicians, plus information from studies & literature
• "Ada" knows several thousand diseases and symptoms
• 30,000 new cases per day added by users of the Ada app
• University of Essen and Giessen/Marburg intend to study whether
"Ada" can be used for better patient control in emergency departments
Source: IQVIA; TK https://www.tk.de/presse/mediathek/kuenstliche-intelligenz-fuer-eine-bessere-versorgung-2051404;
https://www.selfapy.de/?gclid=EAIaIQobChMIxKLR1d6k4AIVkNdkCh1hugc7EAAYASAAEgIj1vD_BwE#
Ada partners with TK: In 2019 patients can check
symptoms based on Artificial Intelligence via TK-Doc-App
19® 2019 IQVIA Commercial – BAH Mitgliederversammlung Sep. 2019
Sales teams can
optimize the impact of
multi-channel
promotional
investments by
analyzing the response
rates from past
campaigns. They can
focus on the right
healthcare professional
(HCP), segmenting them
into the right channel at
the right time
AI and ML transform the sales and marketing process – Pharma companies exploring new partnerships
Identify highly-
specific patient
populations
Customize digital
engagement
Predictive analytics can
provide insight into
prescribing patterns for
precision medicine
candidates through
patient genomics and
biological data. The
technology can identify
which patients should
start treatment. This
helps sales teams to
accurately target the
most relevant physicians
AI & ML powered digital
engagement solutions
can optimize channel
effectiveness,
recommending the
timing, frequency, and
content of email
messages. This
targeted approach at the
individual HCP level
reduces physician churn
rates and maximizes the
impact of digital
campaigns
Many drugs have
multiple indications and
are distributed through
multiple channels. AI &
ML-powered analytics
can paint a clearer
picture of how multi-
indication products are
used. Teams can track
product performance by
indication, specialty,
region and source of
business to inform their
future marketing efforts
Local retail pharmacy
sales analytics can
deliver precise targeting
lists highlighting
individual pharmacy
sales potential and
behavioral profiles that
prioritize marketing
and inform strategies
— i.e. offer discounts in
price-conscious markets
versus value-add
opportunities in high
sales shops
Multichannel
optimization
Leverage multi-
indication analyticsEnhance HCP
profiling,
segmentation and
targeting
Source: IQVIA European Thought Leadership, White Paper: Using AI & Machine Learning to Drive Commercial Success in the EU March 29, 2019
20
Industry challenges require more innovation in clinical trial design and execution
1 E. Miseta. Clinical Leader. July 13, 2015 2 Impact Report (2016) Tufts CSDD 18(1). 3 Impact Report (2013) Tufts CSDD 15(1) 4 Impact Report (2006) Tufts CSDD 8(5) 5 J. DiMasi. Tufts CSDD. October 2014
48%of sites miss
enrolment
targets2
49%of trial
participants
drop out
before study
ends3
10years
to bring a
new therapy
through
R&D4
<5%of patients
participate in
clinical
research1
57%of trials have
a
protocol
amendment3
21Opportunities in Germany’s health market, Health Cluster Portugal, September 2019
Germany scores favourable for conducting clinical trials, but cost are relatively high
• Size of market/ eligible
patients in region
• Speed of MoH*/Ethics
approvals
• Government financial/
tax incentives
• Cost of running trials in
relevant market
• Disease management
system/ networks
Investigator
drivenHospital
Environment
drivenCost
Source: IQVIA European Thought Leadership,; Marta Gehring et al. BMJ Open 2013;3:e002957, 2013 by British Medical Journal Publishing Group; appliedclinicaltrialsonline.com/selecting-study-appropriate-clinical-sites-3-steps; rcri-inc.com/clinical-trial-
site-selection-best-practices/;
• Investigator interest
• Previous experience in
similar studies
• Concurrent trial
workload
• Recruitment and
retention track record in
prior trials
• Publication track record
• Site personnel study
experience and training
• Site personnel
language capabilities
• Facilities (lab, imaging)
• Hospital quality
assurance process
• Hospital institutional
approval system/
contracts
• Cost of running a trial
in the relevant market
for phase II
• Cost of running a trial
in the relevant market
for phase III
• Germany and
Switzerland have the
highest cost in Europe
*MoH= Ministry of Health
22
Companies are therefore seeking support along three dimensions of clinical trials
IQVIA Proprietary and Confidential
• Validate protocols with real-world data
• Bring real-world and commercial insights into clinical development
planning, to find alternative paths that shorten timelines and
maximize asset value
• Pinpoint the patients who match your protocol, then select the right sites
• Streamline activation of only the right sites
• Look beyond known investigator pool
• Use site-level data to create action-oriented plans for each site and
empower CRAs
• Identify alternative recruitment channels at each site
Rethinking
design
More
effective
recruitment
Truly
targeted
site ID
23IQVIA Confidential. Not approved by management For internal use only.
Domain
Expertise
Transformative
Technology
Unparalleled
Data
Advanced
Analytics
+530m non-identified patient records
+800,000 data sources
+75b healthcare records
+85% of global drug sales covered
+1,100 Medical Doctors
+1,400 PhDs
+2,500 Statisticians
+850 Epidemiologists / RWI experts
+200 Patents and patents pending
+6,000 client engagements / yr
+100,000 users on our software platforms
24
▪ Demog. change leads to an increasing need for treatment with parallel reduction of existing care provision structures
▪ Economical aspects cause a shift from individual practices to larger units and the establishment of chains
▪ The interdisciplinary cooperation progresses, driven by the advancing possibilities in telemedicine. The general
practitioner is assumed to have a leading role in the coordination of the care pathwayRetail
▪ Sustained consolidation to larger units and increasing specialization, aiming at improving profitability and care quality
▪ The trend towards privatization continues, combined with enhanced vertical integration in surrounding care provision
structures
▪ Stronger coordinating role in regional outpatient care provision requiredClinics
Others
▪ Entry of new investors into the healthcare market increases, but remains limited due to regulatory elements
▪ Introduction of Advanced Therapies results in significant market adjustments, e.g. healthcare infrastructure
▪ Increasing relevance of data-based evidence, e.g. on the efficacy of new therapies, leads to additional requirements for
the collection and processing of data from health care research and to new stakeholders
Sector Outlook
Current market trends amplify cross-sectorally until 2025
Opportunities in Germany’s health market, Health Cluster Portugal, September 2019
For further information, contact
Dr. Frank Wartenberg
President Central Europe
+49 (0) 69 6604-0
@ FrankWartenberg
© 2019, IQVIA Commercial GmbH & Co. OHG
All rights reserved. The information may not be duplicated, stored, further processed, nor be made accessible in whole or in part to any third
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