Dec. 7st, 2016: GTAI Webinar Medical Biotechnology in Germany - Dr. Sabine Sydow, Head of vfa bio
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fotolia/euthymia
©© vfa (Impfausweis), fotolia/booka (DNA)
Dec. 7st, 2016: GTAI Webinar
Medical Biotechnology in Germany
Dr. Sabine Sydow, Head of vfa bio
Page 1
vfa: The Association of Research-Based
Pharmaceutical Companies in Germany
44 leading research-based pharmaceutical companies are
organized in the vfa
Together with their more than 100 subsidiaries and affiliated
companies, they employ nearly 80,000 people in Germany.
The vfa members represent more than two-thirds of the entire
German pharmaceutical market.
They guarantee therapeutic progress in pharmaceuticals and
ensure high-quality pharmaceutical therapy.
In Germany more than 18,000 of their employees work in the
field of research and development of pharmaceuticals. Here, the
research-based pharmaceutical companies invest EUR 5.2 billion
per year in pharmaceutical research.
vfa bio is the interest group biotechnology within the vfa
Page 2 © vfa | GTAI Webinar Dec. 7th, 2016 | Sydow
11 Biotech Reports since the foundation of vfa bio in 2006 Page 3 © vfa | GTAI Webinar Dec. 7th, 2016 | Sydow
The EU‘s centralized authorization procedure Compulsory for e.g. biopharmaceuticals, orphan drugs and advanced therapy medicinal products Manufacturer can obtain scientific advice from EMA experts Documents are submitted to the EMA (since 2006 risk management plans are mandatory obligation to conduct non-interventional/ observational studies after registration) Assessment by two rapporteurs (national regulatory institutions); if applicable recommendation („positive opinion“) of the EMA by the Committee for Medicinal Products for Human Use (CHMP) Final approval decision by the European Commission (publication in the Official Journal of the EU) More than 500 registrations in the EU since 1995 Page 4 © vfa | GTAI Webinar Dec. 7th, 2016 | Sydow
Centralized authorization procedure (EU)
Submission/ Day 80 Day 120
START
Validation of Dossier 2 Reports List of Questions
STOP
Company Rapporteur/
Co-Rapporteur CHMP
Answers
Day 150
Joined Report
Company Rapporteur/
Co-Rapporteur
List of
Questions Written answer or hearing
STOP / +
CHMP
Authorization decision
(60 days) by the
European Commission
positive
Rapporteur/ Day 210
Co-Rapporteur Votum
Day 180 CHMP
Joined Report Benefit-/Risk-Assessment
negative
Page 5 © vfa | GTAI Webinar Dec. 7th, 2016 | Sydow
Germany is at the top in Europe in the production
of biopharmaceuticals authorized in the EU
Number of produced biopharmaceutical active substances per country which have
been authorized in the EU (by country)1
52
23
9 4
5 9 SE
8
4 DK 1
UK LT 1
9 DE 2
US IE BE NL
9 1 JP
5 KR
5 1 HU 1
AT IN
SI 1 7
PR FR CH
2 1 HR
ES IT
SG
1
IL
1
AR
1. Analysis of 125 biopharmaceutical active substances authorized in the EU, whose production location is known. Of these, 28 drugs are manufactured at
several production locations; A total of 24 countries are represented; Source: http://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-
arzneimitteln/amzulassungen-gentec.html; Medical Biotechnology in Germany 2015, BCG/vfa bio
Page 6 © vfa | GTAI Webinar Dec. 7th, 2016 | Sydow
10-year comparison: Growing importance
of biopharmaceuticals in Germany
Marketing authorizations Market share of biopharmaceuticals
Well over 200 biopharmaceuticals on the market1 Market share of biopharmaceuticals on the total
pharmaceuticals market has almost doubled
+71
226 12% 22% (7.5 billion)
(€ 2.6 billion)
155
88% 78%
2005 2014 20062 2014
Pipeline Employment
Number of pipeline products has more than doubled Continuously increasing employment figures
+348 +11,295
604 37,715
Phase III 26,420
256 Phase II
Phase I
2005 2014 2005 2014
1. Includes biotechnologically and genetically manufactured vaccines 2. First itemisation in the Biotech Report 2007 for the calendar year 2006
Source: Medical Biotechnology in Germany 2015, BCG/vfa bio
Page 7 © vfa | GTAI Webinar Dec. 7th, 2016 | Sydow
15 newly authorized original biopharma-
ceuticals: More than ever before
Number of new marketing authorizations1
Share of bio-
23% 31% 25% 4% 27% 27% 12% 18% 29% 30% 30%
pharmaceuticals
49 50
47
44
11 15
40 11
36 11
8 34 3
3
1 4
10 2
27 28
1 1 5
22 22
Biopharmaceuticals:
5 5
1 35 33 35
30 32 30 Originals
25 26 Biosimilars
23
17 16
Other medicinal
products2
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
1. New authorizations in Germany/EU; new active substances or new combinations of known active substances including
biosimilars 2. With chemical and other active substances; Source: EMA; European Commission; vfa; BCG analysis;
Source: Medical Biotechnology in Germany 2016, BCG/vfa bio
Page 8 © vfa | GTAI Webinar Dec. 7th, 2016 | Sydow
Biopharmaceutical pipeline
sees double-digit growth in Phase I of clinical development
Pipeline 20151 – according Share of biosimilars
Pipeline 2005 to 20151 to active substance type in pipeline 20151
Change from
+3% +4% +8% +2% -6% -9% +2% +27%
previous year
627 387 585
604
587
+4%
+10% 132 72 100
115 127
460 Active
substances in:
88 -3%
+2% Phase III
243
143 243
244 250 Phase II
Phase I
2/3 of which
256 179 are
monoclonal
49
115 antibodies
+11% 104
105 ±0% 24
252 172 33 242
228 227
193 53
32
21 42
102 3
38 39 32
15 3
10
2005 2009 2013 2014 2015 Mono- Other Gene New active Bio-
clonal Vaccines2 recomb. therapy substances similars
antibodies proteins drugs
1. Number of new active substances in the most advanced phase 2. Biotechnologically and genetically manufactured
Comment: Phase I/IIa included in Phase I; Active substances in approval procedure included in Phase III; Active substances
in global studies conducted by companies operating in Germany; Source: EvaluatePharma; Citeline’s Pharmaprojects Pipeline
Service, Jan 2016; vfa; Company information; BCG analysis; Medical Biotechnology in Germany 2016, BCG/vfa bio
Page 9 © vfa | GTAI Webinar Dec. 7th, 2016 | Sydow
The importance of biopharmaceuticals
continues to increase
Sales and share of biopharmaceuticals in the total pharmaceuticals market1, 2
(net, Germany, in billion euros [€])
2014 2015
Chemical Chemical
and Biopharmaceuticals: and
Biopharma- Biopharma-
other 22.0% Change 2014 – 2015 other 22.9%
ceuticals ceuticals
active +9.7% growth active
€ 7.5 billion € 8.2 billion
substances substances
78.0% 77.1%
Total market:
Total: € 34.1 billion Change 2014 – 2015 Total: € 35.9 billion
+5.4% growth
1. Total net sales (pharmacy and hospital market in the statutory and private health insurance sectors) according to the ApU
(selling price of pharmaceutical companies) minus the statutory manufacturers' rebates 2. IMS Health
Comment: Biopharmaceuticals = medicinal products whose active substances are manufactured using genetically altered
organisms; Source: IMS Health; BCG analysis; Medical Biotechnology in Germany 2016, BCG/vfa bio
Page 10 © vfa | GTAI Webinar Dec. 7th, 2016 | SydowMore than two thirds of sales are in
immunology, oncology and metabolism
Sales1 of biopharmaceuticals in Germany 2015
Change
+10% +11% +12% +9% -9% +11% +6% +25%
2014 – 2015
million € 8,242 2,423
1,801
1,642
691
416
367
902
71% of sales
Total Immuno- Oncology Metabolism CNS Haema- Infection4 Other5
logy2 tology3
1. Total net sales (pharmacy and hospital market in the statutory and private health insurance sectors) according to the ApU
(selling price of pharmaceutical companies) minus the statutory manufacturers' rebates 2. Includes TNF-α inhibitors;
excludes multiple sclerosis (s. CNS) 3. Excludes haematological oncology 4. Includes vaccines and antiviral active
substances 5. Includes osteoporosis, eye and respiratory diseases; Source: IMS Health; BCG analysis;
Medical Biotechnology in Germany 2016, BCG/vfa bio
Page 11 © vfa | GTAI Webinar Dec. 7th, 2016 | SydowMedical biotechnology in Germany 2025:
Seven theses at a glance
Companies are investing continuously in the biopharmaceutical pipeline: High
1
number of development candidates in pipeline, share of new approvals around 30-40%
Benefits for more and more patients: New approvals and indication extensions will
2
enable more patients to be treated with biopharmaceuticals in the future
Unmet medical need: Biopharmaceuticals will become established in further areas of
3
application
Renaissance of vaccines: The importance of vaccines will increase, particularly with
4
the introduction of therapeutic vaccines
Personalized medicine a growing trend: The share of personalized/stratified
5
biopharmaceuticals will increase significantly
Biopharmaceutical advances thanks to new technologies: New analysis concepts
6
and therapeutic applications will continue to improve treatment options for patients
On the way from manufacturer to healthcare partner: Not only biopharmaceuticals
7
themselves but also the involvement in the provision of integrated healthcare will be
crucial
Source: Medical Biotechnology in Germany 2015, BCG/vfa bio
Page 12 © vfa | GTAI Webinar Dec. 7th, 2016 | SydowThank you very much for your attention!
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