New Drug Approvals

January 2017
Trends in US New Drug Approvals
2016 FDA New Drug Approvals (and Multi-Year Trends)
Key Findings
 In 2016, FDA approved only 19 new therapeutic drugs (new molecular entities or
“NMEs”) as compared to 45 approvals in 2015. (The official FDA count is 22 which
includes two new imaging agents and one antidote).
 Taking into account some “specific circumstances” such as 5 approvals in 2015 ahead of
PDUFA schedule and a high number of complete response letters in 2016 (12 as
compared to only 2 in in 2015), the drop in drug approvals appears not quite as
dramatic as headline numbers suggest.
 Most drug categories (which boosted approval numbers in the years before) had lower
approval numbers, including biologics (6 approvals in 2016 vs. 12 in 2015), orphan
drugs (7 vs. 21), cancer drugs (4 vs. 15) and diabetes/metabolic drugs (1 vs. 4). Drug
approvals in some other therapeutic areas were better, e.g. in immunology (3
approvals), CNS (2) and anti-virals (2).
 Worldwide peak sales potential from new drugs approved in 2016 was estimated to be
$27.3 billion (less than 50% of the $58.6 billion in cumulative peak sales estimated for
drugs approved in 2015). The average worldwide peak sales per new drug approved in
2016 is estimated at $1.4 billion, a similar number as in previous years. 11 new
prospective “blockbusters” were approved in 2016 (vs. 19 in 2015).
 A number of large pharma companies which did well in 2015 and the years before did
not receive any drug approvals in 2016, namely Novartis (4 approvals in 2015), Johnson
& Johnson (2), Bristol-Myers Squibb (2), AstraZeneca (2), GlaxoSmithKline (1) and
Takeda (1).

As in the years before, over 60% of new drugs approved in 2016 originated at smaller
biopharma companies, i.e. at companies outside of the 30 largest biopharma firms.
Additional key data on new drugs approved by the FDA since 2003 are available under
www.hbmpartners.com/en/industry-reports. The use of data and charts is permitted with reference to
“HBM Partners – Trends in New Drug Approvals”.
The authors of this report welcome any feedback or corrections:
Dr Ulrich Geilinger [email protected]
Dr Chandra P. Leo [email protected]
Dr Emil Bujak [email protected]
Nora Schweizer [email protected]
HBM Partners AG, CH-6300 Zug, Switzerland, www.hbmpartners.com phone +41 43 888 71 71
1
New Drug Approvals by FDA in 2016
Comment: The term “new drug” in this report is used for therapeutic new molecular entities (“NMEs”). This
includes new chemical entities (“NCEs”) and new biologics (classified by FDA as NMEs). It does not include (a)
new non-therapeutic agents such as imaging agents, preventive vaccines etc., some of which are included in
the FDA approval numbers and reports, (b) BLA approvals (by CBER) such as fractioned plasma products etc.
which are not classified as NMEs by FDA, (c) approvals of previously FDA-approved drugs for new indications,
(d) new combinations of previously approved NMEs and (e) biosimilars.
NMEs Approved by FDA 2006-2016 (NCEs & Biologics)
New Drug (NME) Approvals by FDA
# of New Drug Approvals by FDA
NCEs approved (FDA list)
New biologics approved (FDA list)
Therapeutic NMEs approved (HBM analysis)
40
45
45
41
39
24
35
30
24
20
18
17
20
21
10
0
26
26
20
30
28
27
33
22 21
24
33
30
22
19
24
25
15
16
16
2
3
2007
2008
6
6
6
6
2009
2010
2011
2012
11
12
2014
2015
2
2013
Source: FDA (www.fda.gov), HBM analysis
Source: FDA, HBM analysis / NME = new molecular entity, NCE = new chemcial entity, i.e. small molecule
Note: Biologics not yet in FDA statistics in 2003
6
2016
HBM Partners
2
2016a .
After a record 45 new drug approvals in 2015, FDA approved only 19 NMEs in
During 2016, the FDA
received 36 NME applications (NDAs and BLAs), a similar number as in previous years (40 in 2015, 41 in
2014 and 36 in 2013). Therefore, the drop in approvals for 2016 is not related to fewer compounds reaching
an approvable stage. John K. Jenkins, the departing Director of the Office of New Drugs, in a presentation in
December 2016, explained the main reasons for the very disappointing 2016 numbers as follows:

Five new drugs approved in 2015 had 2016 PDUFA dates, thus were approved faster than anticipated,
boosting the 2015 approval numbers.

In 2016, the FDA issued 12 complete response letters (CRLs) vs. only two in 2015. Four CRLs cited
efficacy issues, three safety and four manufacturing issues (in one case, the reasons were not disclosed).
We can assume that 4-6 of these initially rejected drugs will eventually be approved.
Assuming that the 5 approvals in 2015 ahead of schedule would have been approved in 2016 and adding
the 4-6 rejected drugs that will likely be approved later, 2016 drug approval numbers would not look all
that bad: i.e. about 30 approvals in 2016 vs 40 approvals in 2015.
Drug development is a long-term business and one has to be cautious to jump to conclusions from
disappointing approval numbers in any single year. Considering all the above information, we believe that
US drug approvals will continue to show a positive trend over the next years, despite the dip in 2016.
However, approval numbers of more than 40 NMEs per year, as seen in 2014-15, are not the “new normal”.
Please also check respective comments on the subject by Endpoints and FierceBiotech.
a
The official number of new drugs approved in 2016 is 22; but this includes two imaging agents and one antidote. The
number of new therapeutic molecular entities approved is therefore only 19.
HBM Report | Trends in US New Drug Approvals | 2
Peak Sales Estimates for New Drugs Approved in 2016
Comment: Estimated annual peak sales of NMEs approved were collected from analyst reports and other
sources (in most cases sales estimated 5 years after approval, in some cases later). In case of multiple differing
estimates, we calculated the averages. Please note that in our analysis, we use the worldwide peak sales of the
new drugs as estimated at the time of approval. Thus, we do not adjust the figures retrospectively when actual
sales figures or new
estimates become available. Our estimates do not take into account the impact of potential
New therapeutics NMEs only
future US policy changes regarding drug prices.
Peak Sales Potential of New Drugs Approved by FDA 2011-2016
Peak Sales Potential of NCEs and New Biologics Approved by FDA
Peak Sales Potential ($ billion)
60
58.6
50
40
Number of Therapeutic
NMEs approved
35
30
20
28
39
42.8
27.1
26.8
19
31.3
6.1
3.6
4.8
2011
2012
2013
-53%
27.3
24
10
0
45
36.0
30.4
22.5
16.5
43.2
19.5
16.1
15.8
2014
2015
7.8
WW Peak
Sales
Estimates
Peak Sales
NCEs
Peak Sales
Biologics
2016
HBM Partners
Source: FDA, HBM
Analysis
/ NME = new molecular entity
Source: FDA (www.fda.gov),
HBM
analysis
4
Expected cumulative worldwide peak sales of the new drugs approved in 2016 amounted to $27.3 billion
(compared to $58.6 billion for 2015 approvals). Peak sales estimates, both for NCEs and new biologics
approved in 2016, reached less than 50% of the respective 2015 numbers.
The chart below shows our worldwide peak sales estimates compared to sales estimates 5 years after
therapeutics
NMEs
launch for the New
US market
only
asonly
provided by EvaluatePharma.
Peak Sales Potential of New Drugs Approved by FDA 2011-2015
Peak Sales Potential of New Drugs (NMEs) Approved by FDA
58.6
Peak Sales Potential ($ billion)
60
50
Worldwide Peak
Sales Estimates
5+ Years After Launch
40
43.2
36.0
30.4
30
27.3
22.5
20
23.6
10
11.9
13.9
15.7
2011
2012
2013
30.7
15.0
0
Source: FDA, HBM
Analysis
Source: FDA (www.fda.gov),
HBM
analysis
2014
2015
US Peak Sales
Estimates
5 Years
After Launch
(EvaluatePharma)
2016
HBM Partners
3
HBM Report | Trends in US New Drug Approvals | 3
Number of Potential Blockbusters
New therapeutics NMEs only
Peak Sales Estimates of New Biologics (BLA) Approved by FDA
Number of New Potential Blockbusters and Average Peak Sales Potential for New Drugs Approved
Average Peak
Worldwide
Sales Potential
per NME
($ million)
Number of NMEs
Approved With
Expected
Blockbuster Status
(Peak Sales =>$1bn)
10
14
15
11
1'566
1'430
1'436
2015
2016
1'169
804
2011
Source: FDA, HBMHBM
Analysis
Source: FDA (www.fda.gov),
analysis
10
19
895
2012
2013
2014
HBM Partners
5
In 2016, 11 (i.e. more than half) of the new drugs approved had “blockbuster” potential, i.e. were expected
to reach sales of $1 billion or more per year. This number is lower than in the three previous years, but
similar to 2011 and 2012. The average peak sales potential per NME approved in 2016 amounted to
$1.4 billion.
Three potential blockbusters were approved in immunology (vs. one in 2015), two in cancer (six in 2015)
and two in anti-virals (two in 2015).
Potential new blockbusters approved in 2014-2016 are listed on the next page.
HBM Report | Trends in US New Drug Approvals | 4
List of New “Blockbuster” Drugs Approved 2014-2016
(i.e. worldwide peak sales estimate at time of approval ≥ $1 billion)
Year
2014
2015
2016
Worldwide
Peak Sales
Drug Name (Ingredient) / Drug Sponsor (Country) / Indication
Estimate
($bn)
Harvoni (ledipasvir/sofosbuvir) / Gilead Sciences (USA) / Hepatitis C
10.00
Opdivo (nivolumab) / Bristol-Myers Squibb (USA) / Skin cancer
4.50
Keytruda (pembrolizumab) / Merck & Co. (USA) / Skin cancer
2.72
Viekira Pak (ombitasvir, paritaprevir, ritonavir, dasabuvir) / AbbVie (USA) / Hepatitis C
2.33
Plegridy (peginterferon beta-1a) / Biogen (USA) / Multiple Sclerosis
1.83
Otezla (apremilast) / Celgene (USA) / Psoriasis
1.79
Sylvant (siltuximab) / Johnson & Johnson (USA) / Rare lymphatic system disease
1.45
Ofev (nintedanib) / Boehringer Ingelheim (Germany) / Idiopathic pulmonary fibrosis (IPF)
1.40
Cyramza (ramucirumab) / Eli Lilly (USA) / Stomach cancer
1.40
Esbriet (pirfenidone) / Roche (Switzerland) / Idiopathic pulmonary fibrosis (IPF)
1.35
Zydelig (idelalisib) / Gilead Sciences (USA) / Blood cancer
1.33
Trulicity (dulaglutide) / Eli Lilly (USA) / Diabetes type 2
1.27
Farxiga (dapaglifozin) / AstraZeneca (UK) / Diabetes type 2
1.23
Entyvio (vedolizumab) / Takeda (Japan) / Autoimmune disease
1.23
Zerbaxa (ceftolozane/tazobactam) / Merck & Co. (USA) / Bacterial infections
1.05
Entresto (sacubitril/valsartan ) / Novartis (Switzerland) / Chronic heart failure
6.40
Orkambi (lumacaftor 200 mg/ ivacaftor 125 mg ) / Vertex Pharmaceuticals (USA) / Cystic fibrosis
5.20
Ibrance (palbociclib ) / Pfizer (USA) / Breast cancer
4.40
Praluent (alirocumab ) / Sanofi (France) / Hypercholesterolemia (HeFH), artherosclerosis
3.50
Repatha (evolocumab ) / Amgen (USA) / Hypercholesterolemia (HeFH), artherosclerosis
3.15
Tresiba (insulin degludec injection) / Novo Nordisk (Denmark) / Diabetes type 1 and 2
3.05
Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide) / Gilead Sciences (USA) / HIV-1
3.00
Darzalex (daratumumab ) / Johnson & Johnson (USA) / Blood cancer
2.45
Tagrisso (osimertinib ) / AstraZeneca (UK) / Lung cancer
2.40
Alecensa (alectinib ) / Roche (Switzerland) / Lung cancer
2.20
Rexulti (brexpiprazole ) / Otsuka Pharmaceutical (Japan) / Schizophrenia, depression
2.20
Cosentyx (secukinumab ) / Novartis (Switzerland) / Psoriasis
2.00
Ninlaro (ixazomib ) / Takeda (Japan) / Multiple melanoma
1.70
Uptravi (selexipag ) / Actelion (Switzerland) / Pulmonary arterial hypertension
1.48
Nucala (mepolizumab ) / GlaxoSmithKline (UK) / Asthma
1.25
Daklinza (daclatasvir ) / Bristol-Myers Squibb (USA) / Hepatitis C
1.00
Kanuma (sebelipase alfa ) / Alexion (USA) / Enyzme replacement
1.00
Empliciti (elotuzumab) / Bristol-Myers Squibb (USA) / Multiple melanoma
0.99
Veltassa (patiromer for oral suspension ) / Relypsa (USA) / Hyperkalemia
0.97
Epclusa (sofosbuvir and velpatasvir) / Gilead Sciences (USA) / Hepatitis C
5.14
Tecentriq (atezolizumab) / Roche (Switzerland) / Bladder cancer
4.63
Venclexta (venetoclax) / Abbvie (USA) / Blood cancer
2.00
Xiidra (lifitegrast) / Shire (Ireland) / Dry eye disease
1.88
Zepatier (elbasvir and grazoprevir) / Merck & Co. (USA) / Hepatitis C
1.88
Ocaliva (obeticholic acid) / Intercept (USA) / Autoimmune disease
1.77
Spinraza (nusinersen) / Biogen (USA) / Genetic diseases
1.50
Eucrisa (crisaborole) / Pfizer (USA) / Atopic Dermatitis
1.37
Nuplazid (pimavanserin) / Acadia Pharmaceuticals (USA) / Parkinson's disease
1.33
Zinbryta (daclizumab) / Biogen (USA) / Multiple Sclerosis
1.23
Taltz (ixekizumab) / Eli Lilly (USA) / Psoriasis
0.98
Note: Drug sponsor = drug owner at time of approval
HBM Report | Trends in US New Drug Approvals | 5
NewApprovals
therapeutics NMEs by
only Therapeutic Area
New Drug
Number of New Drugs Approved by Therapeutic Area
Number of New Drugs (NMEs) Approved in 2016 by Therapeutic Area
# of NMEs approved 0
5
$7.5
4
Cancer
2
Infections viral
$7.0
3
Immunology
$4.0
2
Genetic
Ophthalmology
10
$2.1
1
# of NMEs - Average 2011-2015
$1.9
# of NMEs - 2016
2
CNS/Pain/Behaviour
Diabetes/Metabolic/Endocrinology
1
$1.6
NMEs 2016 - Peak sales estimates
$0.9
HBM Partners
Source: FDA
Source: FDA (www.fda.gov),
HBM analysis
6
Only 4 new cancer drugs were approved in 2016 (as compared to 15 in 2015 and an average of >10 during
the years 2011-15). By contrast, approval numbers in other therapeutics areas such as viral infections,
immunology, genetic disease or CNS were comparable to previous years.
The chart below provides a longer-term picture of approval numbers by major therapeutic area (i.e. for
New therapeutics
NMEs
only
therapeutic areas
with at least
10
new drug approvals 2007-2016).
New Drugs Approved by FDA 2003-2012 – By Location Of Drug Originator
Number of New Drugs (NMEs) Approved by Therapeutic Area for [2007-11] vs. [2012-16]
# of NMEs
Approved by FDA
2007-11 and
2012-16
40
2007-11
2012-16
Strong increase in drug approvals
Modest increase in drug approvals
30
Decrease in drug approvals
24 50
19
20
10
8
14
6
2 9
11
11
10
8
13
12
9
12
10
12
0
Source: FDA, HBM
Analysis
Source: FDA (www.fda.gov),
HBM
analysis
HBM Partners
8
Therapeutic areas: Cancer (incl. cancer-related conditions), diabetes/metabolic diseases/endocrinology, respiratory diseases, viral
infections, other infections (incl. bacterial, fungal and parasitic infections), cardiovascular/vascular diseases, genetic diseases,
immunology-related diseases & inflammation, CNS and behavioural diseases incl. pain.
HBM Report | Trends in US New Drug Approvals | 6
New Orphan Drugs Approved
The increasing number of orphan drug approvals since 2010 has been one of the main drivers for high drug
approval numbers in 2014 and 2015. In 2016, only 7 (!) orphan drugs were approved by FDA, the lowest
number seen since 2010. The drop in orphan drug approvals is, of course, closely related to fewer cancer
New therapeutics NMEs only
drugs approved
(as these often seek orphan status for their first approved indication).
New Orphan Drugs Approved by FDA 2003-2012
New Orphan Drugs Approved by FDA
# of New Orphan
Drugs Approved
by FDA
20
35%
15
35%
35%
7
4
38%
17
47%
4
37%
Other
31%
11
9
6
0
44%
39%
27%
10
5
21
% Share of All
Drugs Approved
2
6
7
7
11
4
12
9
7
2
8
2
2
2
3
2
2
3
2
3
2
2
1
2
2007
2008
2009
2010
2011
2012
2013
2014
3
5
Cancer
6
2
3
5
Genetic
2
2015
2016
HBM Partners
Source: FDA, HBM Analysis
Source: FDA (www.fda.gov),
HBM analysis
9
Despite the low number of orphan approvals in 2016, we expect the strong overall trend for more orphan
drugs submitted to and approved by FDA to continue.
“First-In Class” Drugs Approved
9 (or 47%) of the 19 new drugs approved in 2016 were classified by FDA as “first-in-class”, i.e. with a new
mechanism different from existing drugs. As mentioned in last year’s report, the relatively high proportion
(40-50%) of first-in-class compounds is encouraging and an indication that biopharma companies push
forward the development of genuinely new drugs.
2011
2012
2013
2014
2015
2016
# of new drugs approved
28
35
24
39
45
19
Thereof “first-in-class” drugs
13
19
9
16
16
9
“First in class” approvals in %
46%
54%
38%
41%
36%
47%
HBM Report | Trends in US New Drug Approvals | 7
New Drugs Approved by Location of Drug Sponsor/Owner and Drug
Originator
Definitions: The “Drug Sponsor/Owner” is the company that owns the drug at time of approval or has licensed
it for US or worldwide markets. “Location” is the location of the company’s headquarters. The “Drug
Originator” is the company that undertook the first serious pre-clinical or clinical development effort. Note:
therapeutics
Quite a numberNew
of new
drugsNMEs
wereonly
originally discovered at universities or research institutions.
New Drugs Approved by FDA 2003-2012 – By Location Of Drug Sponsor
New Drug Approvals (NMEs) by Location/Headquarter of Drug Sponsor/Owner
# of NMEs Approved by FDA
ROW
40
6
Japan
Europe
30
2
2
USA
2
1
3
20
1
2
5
8
9
1
2
12
14
2008
2009
15
10
9
1
4
9
11
10
9
2
2
22
12
1
5
25
24
16
13
8
7
0
2007
2010
2011
2012
2013
2014
2015
2016
HBM Partners
Source: FDA, HBM
Analysis
Source: FDA (www.fda.gov),
HBM
analysis
10
US companies increasingly dominate the US drug approval rankings. This was especially obvious in 2016,
when only 6 (out of 19) new drugs approved by FDA were “sponsored” by non-US companies and only 3 (!)
New therapeutics
NMEs from
only non-US companies.
new drugs approved
originated
New Drugs Approved by FDA 2003-2012 – By Location Of Drug Originator
# of NMEs Approved by FDA
New Drug Approvals (NMEs) by Location/Headquarter of Drug Originator
1
5
ROW (incl. Canada)
40
Japan
Europe
30
USA
7
20
2
10
11
7
1
2
9
11
1
5
3
3
3
4
7
3
13
12
9
21
13
8
8
8
7
2007
2008
2009
2010
16
7
3
26
23
16
9
0
Source: FDA, HBM
Analysis
Source: FDA (www.fda.gov),
HBM
analysis
2011
2012
2013
2014
2015
2016
HBM Partners
11
HBM Report | Trends in US New Drug Approvals | 8
New Drug Approvals by Company
The table below shows that several large pharma companies with a strong approval track record did not
receive any drug approvals in 2016, most notably Johnson & Johnson (2 approvals in 2015), Bristol-Myers
Squibb (2), GlaxoSmithKline, (1) Novartis (4), Takeda (1) and AstraZeneca (2).
Only Merck & Co., Biogen and Eli Lilly scored more than one approval in 2016 (as compared to 9 companies
with 2 or more approvals in 2015).
As mentioned previously, drug development is a long-term effort and a low (or high) number of drug
approvals in a single year is not a reliable indicator of a company’s strength in drug development.
New Drugs Approved by Company 2012-16 and 2016
2012-2016
Ranked
by Peak
Sales Company
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
Gilead Sciences
Roche
Johnson & Johnson
Bristol-Myers Squibb
Novartis
Pfizer
Biogen
Merck & Co.
GlaxoSmithKline
Vertex Pharmaceuticals
Sanofi
Takeda
AstraZeneca
Eli Lilly
Abbvie
Amgen
Novo Nordisk
Celgene
Boehringer Ingelheim
Actelion
Shire
Otsuka Pharmaceutical
2016
Peak Sales
Peak Sales
# of Drugs Estimates # of Drugs Estimates
Approved ($ billion) Approved ($ billion)
6
8
7
5
6
7
4
8
6
2
6
4
5
6
2
3
1
2
4
2
2
2
26.9
16.9
11.3
10.5
10.2
9.7
7.4
7.3
7.3
7.3
6.4
5.5
5.1
5.0
4.3
3.8
3.1
3.0
2.8
2.5
2.5
2.5
1
1
1
2
2
1
2
1
1
-
5.1
4.6
1.4
2.7
2.2
0.9
1.4
2.0
1.9
-
Source: FDA (www.fda.gov), HBM analysis
HBM Report | Trends in US New Drug Approvals | 9
New Drug Approvals by Company Size
Definitions:
“Top ten pharma companies” = Pharma companies ranked within the top ten worldwide by pharma sales.
“Other large pharma/biotech companies” =Biopharma companies ranked between 11 and 30 in terms of
worldwide sales (Note: Gilead is included in this group even though Gilead moved into the top ten recently).
“Smaller pharma/biotech companies” = Other (smaller) biopharma companies.
The “Drug Sponsor/Owner” is the company that owns the drug at time of approval or has licensed it for US or
worldwide markets.
New therapeutics NMEs only
New Drugs Approved by FDA 2006-2015 – By Size of Drug Sponsor
New Drugs (NMEs) Approved by Size of Drug Sponsor/Owner
Smaller pharma/biotech companies
Other large pharma/biotech companies
# of NME Approvals
45
Top ten pharma companies
40
35
16
53%
30
46%
25
10
5
0
36%
14
35%
20
15
Top 10 Pharma‘s
Share of Approvals
6
2
9
25%
13
2
5
13
4
9
13
18%
5
4
18
31%
6
4
10
11
4
13
10
9
11
42%
41%
16
33%
14
15
7
4
8
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Source: FDA, HBMHBM
Analysis
Source: FDA (www.fda.gov),
analysis
HBM Partners
12
The 42% share of 2016 approvals, accounted for by the top ten pharma companies, is above the long-term
share. Thus, Big Pharma cannot be “blamed” for the recent weakness in drug approvals. Mid-sized and
smaller companies saw a stronger drop in approval numbers.
As we show later in this report, only about 50% of all drugs approved during the last years were developed
in-house by the respective sponsor. About 30% of drugs approved were in-licensed and about 20% were
acquired through M&A (before such drugs were approved). Companies of all sizes are active on the “buy”
and “sell” side. Even though larger companies have a somewhat higher proportion of approved drugs that
were in-licensed or acquired (vs. developed in-house), this cannot be generalized.
Looking at the top ten pharma companies during the 10 years from 2007-2016, the share of internally
developed drugs among their approvals has fallen below 50%, while drugs acquired through M&A or inlicensing have become more important. For other company size categories, the trend is less clear.
HBM Report | Trends in US New Drug Approvals | 10
Originators of New Drugs Approved by Company Size
Definitions: The “Drug Originator” is the company that undertook the first serious pre-clinical or clinical
development effort. Note: Quite a number of new drugs were originally discovered at universities or research
institutions and then transferred to a biopharma company for further development.
New therapeutics NMEs only
New Drugs Approved by FDA 2006-2015 – By Size of Drug Sponsor
New Drugs (NMEs) Approved by Size of Drug Originator
Smaller pharma/biotech companies
% of New Drugs Approved
Originated from Smaller
Biopharma Companies
Other large pharma/biotech companies
Top ten pharma companies
# of NME Approvals
50
75%
45
68%
40
35
64%
63%
54%
30
25
20
15
29%
10
5
2
15
5
9
1
4
0
14
18
8
5
2
6
4
68%
51%
20
29
12
8
13
6
8
2
4
22
15
15
3
64%
63%
5
7
6
2
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Source: FDA, HBM HBM
Analysis
Source: FDA (www.fda.gov),
analysis
HBM Partners
13
The majority of new drugs approved by FDA in 2016 (and the years before) originated at smaller companies,
i.e. companies outside of the largest 30 biopharma firms. As these smaller companies often out-license their
drug candidates or get acquired before approval, the number of approvals under their name (16 in 2015
and 7 in 2016, see chart on last page) understates their important contribution to pharmaceutical
innovation. Of course, some smaller companies are also active licensors and acquirers in some cases.
HBM Report | Trends in US New Drug Approvals | 11
NMEsInnovation
only
InternalNew
vstherapeutics
External
New Drugs Approved by FDA 2006-2015 - Inhouse vs. External Development
New Drugs (NMEs) Approved – In-House Development vs. In-Licensed or Acquired Through M&A
45
# of NMEs Approved
40
35
Drugs acquired through M&A
80%
In-Licensed drugs
% of In-Licensed or
Acquired Drugs
50%
25
2
20
35%
15
2
4
5
11
5
4
41%
43%
4
8
13
11
2008
51%
13
9
43%
6
13
16
20
14
11
7
4
2007
10
2009
2010
2011
2012
2013
22
12
2014
47%
5
5
11
0
69%
13
6
30
10
71%
Inhouse development
4
10
2015
2016
HBM Partners
Source: FDA, HBM HBM
Analysis
Source: FDA (www.fda.gov),
analysis
14
About half of the drugs approved in 2016 were in-licensed or acquired through M&A. Interestingly,
internally developed drugs have done well with a higher percentage of approvals shown recently (mainly
in 2013, 2014 and 2015). However, there still seems to be a long-term trend towards more in-sourcing of
drugs, especially through M&A.
January 2017
Please address questions, comments or corrections to:
Dr Ulrich Geilinger [email protected]
About HBM Partners
HBM Partners is among the global leaders in healthcare-focused investing with approximately
$1.5 billion in assets under management. HBM focuses on development stage, growth and buy-out
financings of private and public biopharma, medical device and diagnostics companies.
Investments in private companies usually range between $10 million to $50 million.
HBM Partners advises HBM Healthcare Investments AG, HBM BioCapital as well as specialized
public equity funds. HBM Partners has been an active contributor to value creation in its portfolio
companies, generating over 50 trade sales and IPOs since its inception in 2001.
HBM Partners AG, CH-6300 Zug, Switzerland, www.hbmpartners.com, phone +41 43 888 71 71
HBM Report | Trends in US New Drug Approvals | 12

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