Commission européenne, DG COMP MERGER REGISTRY, 1049 Bruxelles, BELGIQUE  
Europese Commissie, DG COMP MERGER REGISTRY, 1049 Brussel, BELGIË  
 
Tel: +32 229 -91111. Fax: +32 229 -64301. E -mail: COMP -MERGER -REGISTRY@ec.europa.eu .  EUROPEAN COMMISSION  
Brussels,  22.04.2021  
C(2021 ) 2985 final  
PUBLIC VERSION   
 
 
Astorg Asset Management S.a.r.l.  
2 rue Albert Borschette  
L-1246 Luxembourg  
Grand Duchy of Luxembourg  
 
Nordic Capital IX Limited  
26 Esplanade, St Helier  
JE2 3QA  Jersey  
Channel Islands  
 
Novo Holdings A/S  
Tuborg Havnevej 19  
2900 Hellerup  
Denmark  
 
Subject : Case M. 10133 – Astorg/Nordic Capital/Novo/Bioclinica  
Commission decision pursuant to Article 6(1)(b) of Council Regulation 
No 139/20041 and Article  57 of the Agreement on the European Economic 
Area2 
 
                                                 
1  OJ L 24, 29.1.2004, p. 1 (the “Merger Regulation”). With effect from 1 December 2009,  the Treaty on the 
Functioning of the European Union (“TFEU”) has introduced certain changes, such as the replacement of 
“Community” by “Union” and “common market” by “internal market”. The terminology of the TFEU will 
be used throughout this decision . 
2  OJ L 1, 3.1.1994, p. 3 (the “EEA Agreement”).  
In the published version of this decision, 
some information has been omitted 
pursuant to Article 17(2) of Council 
Regulation (EC) No 139/2004 concerning 
non-disclosure of business secrets and other  
confidential information. The omissions are 
shown thus […] . Where possible the 
information omitted has been replaced by 
ranges of figures or a general description.  
2 Dear Sir or Madam,  
(1) On 16 March 2021 , the European Commission received notification of a proposed 
concentration pursuant to Article 4 of the Merger Regulation by which 
eResearchTechnology, Inc . (“ERT”, US) , jointly controlled by Astorg VII SLP (a 
fund managed by Astorg Asset Management S.à  r.l (“Astorg”, Luxembourg)), by 
affiliates of Nordic Capital IX Limited (“Nordic Capital”, Jersey, Channel Islands), 
and by an affiliate of Novo Holdings A/S (“Novo”, Den mark), acquires within the 
meaning of Article 3(1)(b) of the Merger Regulation control of Bioclinica Holding I 
LP (“Bioclinica”, US) (the “Transaction”). Astorg, Nordic Capital, and Novo are 
referred to as the “Notifying Parties” and, together with Bioclin ica, the “Parties”.  
1. THE  PARTIE S  AND THE  OPE RATION  
(2) Astorg  is a European private equity firm with activities focusing on Western Europe 
and North America.  
(3) Nordic Capital  is a European private equity firm with activities focusing on 
healthcare, technology & payments, financial services, and selectively, industrial & 
business services in Europe and globally.  
(4) Novo  is responsible for managing the assets of the Novo Nordisk Fo undation 
through strategic investments in the life sciences and related areas.  
(5) ERT is a provider of software -enabled clinical research solutions (“e -Clinical trial 
solutions”) . 
(6) Bioclinica  is a provider of e-Clinical trial solutions . Bioclinica is solely co ntrolled by 
Cinven,3 UK.  
(7) On 7 December 2020, Astorg, Nordic Capital, Novo, ERT, and Bioclinica entered 
into an agreement pursuant to which ERT will acquire all of the issued and 
outstanding equity interests of Bioclinica.  
(8) Currently , ERT is jointly control led by Astorg, Nordic Capital and Novo.4 Cinven 
will receive (cash and) ~ […]% of the share capital in the combined entity.5 Cinven 
will also have the right to […].6 Post-Transaction, each of Astorg and Nordic Capital 
will own ~ […]% of ERT. Novo will own ~ […]% of ERT. The rest of ERT’s capital 
(~[…]%) will be owned by ERT’s management.7 Post-Transaction, Cinven will not 
(solely or jointly) control the combined entity. The combined entity’s Board will 
consist of eleven members, of which, [Information about sh areholder’s rights to 
appoint certain board directors] .8 Each of Astorg, Nordic Capital and Novo will 
continue to have veto rights over several matters, including changes in the combined 
                                                 
3  Cinven  means, depending on the context, any of or collectively, Cinven Partnership LLP, Cinven 
Holdings Guernsey Limited, Cinven (Luxco 1) S.A. and their respective "associates" (as defined in the 
Compa nies Act 2006) and/or funds managed and/or advised by any of the foregoing.  
4  See Case COMP/ M.9633 – Astorg/Nordic Capital/Novo/ERT , decision of 20 March 2020, paragraph 1.  
5  Form CO, paragraph 44.  
6  Form CO, paragraph 44.  
7  Form CO, paragraph 45 and  table following.  
8  Form CO, paragraph 49.  
3 entity’s strategy, business plan and annual budget.9 On the contrary,  Cinven will not 
obtain any veto rights over strategic commercial decisions of the combined entity. 
Cinven’s veto rights will be limited, aiming only to protect its minority 
shareholding.10 Against this background, the combined entity will continue to be 
jointly controlled by Astorg, Nordic Capital, and Novo.  
2. EU DIME NSION  
(9) The undertakings concerned11,12 have a combined aggregate world -wide turnover of 
more than EUR 5 000 million13. Each of them has an EU -wide turnover in excess of 
EUR 250 million, but they do not achieve more than two -thirds of their aggregate 
EU-wide turnover within one and the same Member State. The Transaction therefore 
has an EU dimension.   
3. RE LE VANT MARKE TS  
(10) Both ERT and Bioclinica are active in the provision of e -Clinical trial solutions.  
e-Clinical trial solutions are software solutions used in clinical trials to collect and 
organise data, and evaluate the trial’s results. These solutions gather data on patien ts 
before, during and after a clinical trial, allowing researchers to monitor patients’ 
biometric data and overall health. e -Clinical trial solutions facilitate overall clinical 
trial management by increasing the efficacy and accuracy of data collection, a s well 
as enabling quick evaluation, analysis and reporting of collected data and trial 
outcomes.  
(11) There are two types of e -Clinical trial solutions where the activities of ERT and 
Bioclinica  overlap:  
(a) Cardiac safety services.  These services monitor the pat ients’ cardiac 
parameters in the course of a clinical trial. They aim to assess the risk that the 
new treatment may have negative (side -)effects on the heart. Cardiac safety is 
monitored in approximately 70% of all clinical trials; and  
(b) Medical imaging sol utions.  These solutions analyse medical images captured 
in clinical sites to assess drug safety and efficacy. Medical imaging is used in 
approximately one third of all clinical trials.  
(12) Customers , typically pharmaceutical companies or contract research org anisations 
(“CRO s”) carrying out clinical trials,  often purchase e -Clinical trial solutions from 
third parties (like ERT or Bioclinica) but they may also organise the same data 
                                                 
9  Form CO, paragraph 49.  
10  Form CO, paragraph 49.  
11  Astorg, Nordic Capital, and Novo are considered as undertakings concerned by this Transaction given 
their “ significant involvement […] in the initiation, organisation and financing of the operation ” (see 
Consolidated Jurisdictional Notice, OJ 2008/C 95/01, paragraph 147 and in line with Case T-380/17, 
HeidelbergCement and Schwenk  Zement, ECLI:EU:T:2020:471, paragraphs 97ff ). Bioclinica (the target) 
is also an undertaking concerned by the Transaction.  
12  The remainder of this decision focuses on ERT’s and Bioclinica’s activities. The activities of Astorg, 
Nordic Capital, and Novo do not give rise to any horizontal or vertic al links with the activities of 
Bioclinica.  
13  Turnover calculated in accordance with Article 5 of the Merger Regulation.  
4 management processes in -house. When sourced from third parties, e -Clinical tria l 
solutions are called “ centralised ”. When sourced in -house, e -Clinical trial solutions 
are called “de centralised ”.  
3.1. Market definition for e -Clinical trial solutions  
3.1.1.  Product market definition for e -Clinical trial solutions  
3.1.1.1.  The Commission’s precedents  
(13) The Commission has not considered in the past the product market definition for  
e-Clinical trial solutions.  
3.1.1.2.  The Notifying Part ies’ view 
(14) The Notifying Parties suggest that there is one broad market including all e -Clinical 
trial solutions, in view of the strong supply -side substitutability between cardiac 
safety solutions, medical imaging services, and other business lines.14 The Notifying 
Parties add that plausible markets for e -Clinical trial solutions or (more narrowly) for 
cardiac safety and medical ima ging should include both centralised  and de centralised  
services.15 Yet, the Notifying Parties submit that the precise product market 
definition in this case can be left open.16  
3.1.1.3.  The Commission’s assessment and conclusion  
(15) The Commission’s  investigation provid ed indications that separate relevant markets 
exist for (i) cardiac safety services and (ii) medical imaging solutions within the 
broader space of e -Clinical trial solutions.  In more detail:  
(a) Third -party market reports analyse  separately the competitive la ndscape in 
cardiac safety services17 and in medical imaging solutions;18 
(b) ERT internal documents report on ERT’s and Bioclini ca’s activities 
separate ly for cardiac safety services and medical imaging solutions;19  
(c) With the exception of ERT, Bioclinica, and BioTelemetry, different players 
are active in cardiac safety services and in medical imaging solutions;20 and  
(d) The vast majority  of respondents to the market investigation suggested that 
cardiac safety services do not compete in the same relevant product ma rket as 
medical imaging solutions .  
                                                 
14  Form CO, paragraph 102 . 
15  Form CO, paragraph 114 . 
16  Form CO, paragraph 123.  
17  E.g., reports by Orion Market Research, Marketsa ndMarkets, Transparency Market Research, 
Fiormarkets, and Reports And Data (see Form CO, paragraph 92).  
18  E.g., Grand View Research, MarketsandMarkets, The Insight Partners,  MarketWatch, and Data Bridge 
Market Research (see Form CO, paragraph 92).  
19  Form CO, Annex 14 -10, “ […]”, 5 June 2020 and Form CO, Annex 14 -13, “ […]”, 5 June 2020.  
20  See Tables 1 and 2.   
5 (16) The Commission’s investigation also provided indications that separate relevant 
markets exist including only centralised  solutions for each of (i) cardiac safety 
services and (ii) medical imaging solutions.  In more detai l:  
(a) [Internal documents]21,22,23 and 
(b) During the market investigation, competitors submitted that only some (not 
all) customers can source de centralised  services in -house.24 
(17) In any event, for the purpose of assessing the Transaction, the exact scope of the 
product market definition can be left open since none of the above -mentioned 
plausible alternative product market definitions  (namely, e -Clinical trial solutions 
(including centralised and decentralised solutions); e -Clinical trial solutions 
(including only centralised solutions); cardiac safety services (including centralised 
and decentralised solutions); cardiac safety services (including only centralised 
solutions); medica l imaging solutions (including centralised and decentralised 
solutions); and medical imaging solutions (including only centralised solutions)) 
affect s the outcome of the competitive assessment of the Transaction .  
3.1.2.  Geographic market definition  
3.1.2.1.  The Commissio n’s precedents  
(18) The Commission has not considered in the past the relevant geographic market for  
e-Clinical trial solutions or any of its sub -segments.  
3.1.2.2.  The Notifying Part ies’ view 
(19) The Notifying Parties take the view that the market for e -Clinical trial so lutions (and 
its sub -segmentations) are EEA-wide in scope.25 The Notifying Parties recall that 
these solutions are often offered as part of the offering of a CRO and in the past, the 
Commission defined the market for CRO services as EEA -wide.26 Yet, the Noti fying 
Parties also acknowledge that the internal documents of ERT and Bioclinica often 
consider the relevant markets on a global basis.27 In any event, the Notifying Parties 
submit that the precise geographic market definition in this case can be left open.28 
3.1.2.3.  The Commission’s assessment and conclusion  
(20) The Commission’s market investigation provided indications that the market for  
e-Clinical trial solutions and all its plausible sub -segmentations (listed in paragraph 
(17) above) are worldwide in scope.  As a competitor of ERT and Bioclinica  put it for 
cardiac safety services, “ competition  [...] takes place at worldwide level. [Our 
company], as one of the  smallest players in the field, still offers cardiac safety 
                                                 
21  Form CO, Annex 14 -7, “[…]”, 5 October 2020, page 19.  
22  Form CO, Annex 14 -7, “[…]”, 5 October 2020, page 21.  
23  Form CO, Annex 14 -13, “ […]”, 5 June 2020, page 2.  
24  Minutes of conference call with competitor , 30 March 2021, paragraph 5; minutes of conference call with 
competitor, 25 March 2021, paragraph 7.  
25  Form CO, paragraph 124 . 
26  Form CO, paragraph 126 . 
27  Form CO, paragraph 134 . 
28  Form CO, paragraph 133 . 
6 solutions to customers around the world  [...]”.29 Competitors in medical imaging 
solutions also indicated that competition takes place on a worldwide level.30  
(21) In any event, for the purpose of asses sing the Transaction, the exact scope of the 
geographic market definition can be left open since under all above -mentioned 
plausible alternative geographic market definitions  (namely, EEA -wide or 
worldwide) , since these plausible alternative market definit ions do not affect the 
outcome of the competitive assessment of the Transaction .  
4. COMPE TITIVE ASSE SSME N T 
(22) Both ERT and Bioclinica offer e -Clinical trial solutions, including cardiac safety 
solutions and medical imaging solutions.31 The Transaction results in the following 
horizontally affected markets:32  
(a) Worldwide market for cardiac safety services (including both centralised  and 
decentralised  services) ;  
(b) (Worldwide or EEA -wide) market for cardiac safety services (including only 
centralised services);  
(c) Worldwide market for medical imaging solutions (including both centralised  
and de centralised  services) ; and  
(d) (Worldwide or EEA -wide) market for medical imaging solutions (includ ing 
only centralised  services).  
                                                 
29  Minutes of conference call with competitor, 25 March 2021, paragraph 8.  
30  Minutes of conference call with competitor, 25 March 2021 , paragraphs 3, 6, and 7; m inutes of conference 
call with competitor, 2 6 March 2021 , paragraphs  13-14.  
31  The plausible relevant market for e -Clinical trial solutions  (including both decentralised and centralised 
services) would not be affected worldwide or in the EEA as the combined market share of ERT and 
Bioclinica would be in both cases below 20% (see Form CO, paragraphs 136 and  209). The plausible 
relevant market for e -Clinical trial solutions (including only centralised services) would not be affected 
worldwide or in the EEA as the combined market share of ERT and Bioclinica would be in both cases 
below 20% (see Form CO, footnote 64). In addition, the potential EEA -wide   market for cardiac safety 
services (including both centralised and decentralised services) would not be affected as the combined 
market share of ERT and Bioclinica would be be low 20%. The potential EEA -wide  market for medical 
imaging solutions (including both centralised and decentralised services) would not be affected as the 
combined market share of ERT and Bioclinica would be below 20%.   
32  ERT is jointly controlled (among others) by Novo, which also controls pharmaceutical companies Novo 
Nordisk, Stargazer, and Spruce Bio. Each of these companies purchased centralised e -Clinical trial 
solutions (including cardiac safety services and medical imaging solutions). However, thes e purchases do 
not give rise to a meaningful vertical relationship between Novo and Bioclinica because e -Clinical trial 
solutions (including cardiac safety services and medical imaging solutions) do not constitute an 
“important input ” for the markets of fi nished pharmaceutical products where Novo’s portfolio entities are 
active within  the meaning of paragraph 34 of the Commission’s Guidelines on the assessment of non -
horizontal mergers under the Council Regulation on the control of concentrations between un dertakings 
(“Non -Horizontal Merger Guidelines”), OJ C 265, 18.10.2008. This is because (i) e -Clinical trial solutions 
do not represent a significant cost factor related to the price of the development of a pharmaceutical 
product ([…]% according to Novo Nor disk’s estimates ); (ii) they are not a critical component to perform 
and complete the clinical trial (or for the market success of the finished pharmaceutical product); (iii) they 
do not represent a significant source of differentiation for finished pharma ceutical products; and (iv) 
customers can switch to alternative providers in the cont ext of subsequent  tenders.     
7 4.1. Legal framework for the Co mmission’s assessment of horizontal non -
coordinated effects  
(23) Article 2 of the Merger Regulation requires the Commission to examine whether 
notified concentrations are compatible with the internal market, by assessing whether 
they would significantly impede effective competition in the internal market or in a 
substantial part of it.  
(24) The Commission Guidelines on the assessment of horizontal mergers under the 
Merger Regulation (the "Horizontal Merger Guidelines")33 distinguish between two 
main ways in which mer gers between actual or potential competitors on the same 
relevant market may significantly impede effective competition, namely non -
coordinated effects and coordinated effects.  
(25) Non-coordinated effects may significantly impede effective competition by 
eliminating the competitive constraint imposed by each merging party on the other, 
as a result of which the merged entity would have increased market power without 
resorting to coordinated behaviour. According to recital (25) of the Merger 
Regulation, a signif icant impediment to effective competition can result from the 
anticompetitive effects of a concentration even if the merged entity would not have a 
dominant position on the market concerned. In this regard, the Horizontal Merger 
Guidelines consider not onl y the direct loss of competition between the merging 
firms, but also the reduction in competitive pressure on non -merging firms in the 
same market that could be brought about by the merger.34  
(26) The Horizontal Merger Guidelines list a number of factors which may influence 
whether or not significant non -coordinated effects are likely to result from a merger, 
such as the large market shares of the merging firms, the fact that the merging firms 
are close competitors, the limited possibilities for customers to swi tch suppliers, or 
the fact that the merger would eliminate an important competitive force. Not all of 
these factors need to be present for significant non -coordinated effects to be likely. 
The list of factors, each of which is not necessarily decisive in i ts own right, is also 
not an exhaustive list.35  
                                                 
33  OJ C 31, 05.02.2004, p. 5.  
34  Horizontal Merger Guidelines, paragraphs 24 and 25.  
35  Horizontal Merger Guidelines, paragraphs 26 -38. 

9 customers, there are only  […] customers  in common ;41 and that (v) ERT’s database 
of opportunities for customers in the EEA for the years 2016 -2020 shows that the 
competitors that ERT lost most often to in cardiac safety were […], while Bioclinica 
is only placed  […].42  
4.2.2.  The Commission’s assessment  
4.2.2.1.  Cardiac safety services (including centralised  and decentralised  services)  
(29) In the potential worldwide market for cardiac safety services (including both 
centralised  and de centralised  services), the combined share of ERT and Bioclinica 
would be [20-30]% (with a share increment of [0-5]% contr ibuted by Bioclinica). As 
such, the Transaction will only bring a negligible increment to ERT’s already 
modest market share, and the HHI delta would remain well below 150.43 As a result, 
the Transaction does not raise serious doubts as to its compatibility with the internal 
market in relation to the potential worldwide market for cardiac safety services 
(including both centralised  and de centralised  services).  
4.2.2.2.  Cardiac safety services (including only centralised  services)  
(30) In the potential worldwide  and EEA -wide market s for cardiac safety services 
(including only centralised  services ), the Transaction does not raise serious doubts as 
to its compatibility with the internal market for the following reasons:  
(31) First , while the combined market share of ERT and Biocli nica would be significant 
at a worldwide level ( [40-50]%), the share increment contributed by Bioclinica is 
limited at [0-5]%.44 As a result, the HHI increment would be equal to [200-300] 
(below [200-300] without rounding  in the market shares ), in a market where the 
post-merger HHI would be ~ [2000 -3000] . This suggests that the Transaction would 
not change meaningfully the competitive landscape in this market. As a customer put 
it, the Transaction would give rise to “very little overlap” between the activitie s of 
                                                 
41  Form CO, paragraph 173 . 
42  Form CO, paragraph 173 . 
43  Based on the Horizontal Merger Guidelines (paragraph 20), the Commission is unlikely to identify 
horizontal competition concerns in a merger concerning relevant markets wit h an HHI delta below 150 
(subject to certain caveat factors). In the markets that are relevant to this decision, none of these caveat 
factors apply.  
44  The Commission sought to confirm that the market share estimates provided by the Notifying Parties were  
reliable. The Notifying Parties submitted that ERT’s and Bioclinica’s market shares have been estimated 
by using (i) ERT’s and Bioclinica’s actual sales in 2019 and (ii) a total market size based on a model of 
the total sales  of cardiac safety services cr eated by LEK Consulting (Form CO, Annex 15.b, “[…]”).  The 
Notifying Parties submitted that ERT has commissioned this report since […] and uses it in the ordinary 
course of business (see email of outside counsel of the Notifying Parties to the case team dat ed 1 April 
2021). On the basis of this report, the Notifying Parties estimated that the total size of a plausible 
worldwide market for cardiac safety services (including only centralised services) in 2019 is USD [200 -
300] million (approximately EUR [200 -300] million).  This is in line with ERT internal documents (see 
Form CO, Annex 14 -3, “[…]”, 2020, page 4).  In the market investigation, several competitors estimated 
the total size of a plausible worldwide market for cardiac safety services (including only c entralised 
services) at USD 450 million (approximately EUR 378 million) or more (see minutes of conference call  
with competitor, 30 March 2021, paragraph 13; m inutes of con ference call with competitor, 26  March 
2021, paragraph 1 2; m inutes of conference call with competitor, 8 April 2021, paragraph 15).  This 
suggests that if anything, the market share data provided for the Parties in Table 1 above underestimate the 
total size of a plausible worldwide market for cardiac safety services  (including only centralised services). 
Thus, the Commission can rely to the market share estimates provided by the Notifying Parties in the 
competitive assessment of the Transaction in cardiac safety services (including only centralised services).  
10 ERT and Bioclinica in cardiac safety services.45 This is even more the case in the 
possible market for centralised  only cardiac safety services in the EEA, where the 
combined market share of ERT and Bioclinica is lower ( [20-30]%), and Bioclinica 
holds only a negligible market share ([0-5]%). In this market, the Transaction would 
result in an HHI delta below 150.   
(32) Second , post -Transaction, the combined entity will continue facing competitive 
constraints by several players who each hold a share higher tha n the increment 
brought by Bioclinica. These include IQVIA ( [20-30]% share globally and [10-20]% 
in the EEA) ; BioTelemetry ( [10-20]% globally and [0-5]% in the EEA) ; Banook ( [5-
10]% globally and [10-20]% in the EEA) ; Nabios ( [0-5]% globally and [0-5]% in the 
EEA) ; and Richmonds ( [0-5]% globally and [0-5]% in the EEA).  During the market 
investigation, a competitor estimated that there are 5 -10 players in the worldwide 
market for cardiac safety services (including only centralised  services).46 
(33) Third , ERT and Bioclinica are not the closest competitors in this market (worldwide 
and in the EEA). An internal document of ERT dated 5 June 2020 states that “ ERT is 
seen as the top provider for cardiac safety monitoring solutions, followed closely by 
[…]”. The same doc ument identifies […] as the closest competitor to ERT in terms 
of reputation and […] as the closest competitor to ERT in terms of product offering 
strength.47 In 2016 -2020, Bioclinica won only […] out of the […] cardiac safety 
opportunities that ERT lost in  the EEA to other providers of centralised  solutions.  
(34) Fourth, even if they are not part of a plausible market for cardiac safety services 
including only centralised  solutions, de centralised  cardiac safety services also exert 
competitive constraints on the  combined entity.  Both in the EEA and worldwide, 
between  2016  and 2020, when ERT lo st in a tender, in most cases […].48 There are 
several examples of a clinical trial sponsor switch ing from a centralised  to a 
decentralised  solution for cardiac safety services even in the context of one and the 
same clinical trial (i.e., from one phase to the next).  These examples cover 
pharmaceutical companies of all sizes, including […].49  
(35) Fifth , during the market investigation, all custom er respondents agreed that the 
Transaction does not raise competition concerns in the plausible worldwide or EEA -
wide markets for cardiac safety services (including only centralised  services) .50 One 
customer recogni sed that the Transaction could also result  in an increased choice of 
products and lower prices .51  
(36) By contrast, several competitors submitted that the Transaction does raise 
competition concerns in these plausible markets.52 In particular, competitors argued 
that the Transaction would reinforce ERT’s already strong position in the worldwide 
or EEA -wide markets for centralised  cardiac safety services, giving to the combined 
                                                 
45  Response of a customer of the Parties to question 3 of Q1 – Questions to customers . 
46  Minutes of conference call with competitor, 25 March 2021, paragraph 9.  
47  Form CO, Annex 14-10, “[…]”, 5 June 2020, pages 4  and 6.  
48  Form CO, paragraphs 167 and 211 and  RFI 3 reply, question 3, paragraph 5.  
49  Form CO, paragraph 170.  
50  Responses to questions 1.c and 1.d of Q1 – Questions to customers.  
51  Response of a customer of the Parties to question 4 of Q1 – Questions to customers . 
52  Responses to questions 1.c a nd 1.d of Q2 – Questions to competitors.  
11 entity pricing power and the ability to impose its sc ientific methodology for cardiac 
safety services on customers.53  
(37) However, the se claims are not  sufficiently cogent and substantiated to outweigh the 
body of evidence illustrated above and to cast doubt as to the Transaction’s 
compatibility with the interna l market  in cardiac safety services . This is so  for the 
following reasons:  
(a) In the market investigation, s ome of the competitors referred to ERT’s 
already strong position in the worldwide and EEA -wide markets for 
centralised  cardiac safety solutions but wi thout substanti ating merger -specific 
concerns.  The Commission notes that Bioclinica’s position in cardiac safety 
services remains limited (with a share of [0-5]% or less in 2019) . One 
competitor raising concerns acknowledged that “ Bioclinica alone currentl y 
[does not] represent [] an important competitive force in the provision of 
cardiac safety solutions ”.54 Another competitor raising concerns regarding 
the prevalence of ERT’s scientific methodology indicated that “ it does not 
have proof  [...] that there is anything special in Bioclinica’s scientific 
approach ”.55  
(b) Despite its significant market share  in the worldwide and EEA -wide markets 
for centralised  cardiac safety services , the combined entity would likely  face 
competitive pressure post -Transaction from its customers.56 Each of ERT and 
Bioclinica sell to a concentrated group of customers . ERT’s 15 largest 
customers represent […]% of its revenues in the worldwide market for 
cardiac safety services.  Bioclinica’s 15 largest customers represent […]% of 
its revenues in the worldwide market for cardiac safety services.  The 
customers of cardiac safety services are typically repeat customers  and they 
purchase services through tenders where several rivals can be invited to bid. 
The fact that no customer  raised concerns regarding the Transaction also 
suggests that the combined entity faces competitive constraints from 
customers in cardiac safety services.  
(38) In light of the above, the Commission concludes that the Transaction does not raise 
serious doubts a s to its compatibility with the int ernal market in relation to the 
market for cardiac safety services (including only centralised  services) worldwide or 
in the EEA .  
4.3. Medical imaging solutions  
(39) Both ERT and Bioclinica are active in the provision of medical imaging solutions. 
Set forth below are the market shares of ERT, Bioclinica, and their competitors in 
                                                 
53  Minutes of conference call with competitor, 25 March 2021, paragraphs 12ff and m inutes of conference 
call with competitor, 26 March 2021, paragraphs 9ff.  
54  Minutes of conference call with competitor, 30 March 2 021, paragraph 12.  
55  Minutes of conference call with competitor, 25 March 2021, paragraph 13.  
56  See Horizontal Merger Guidelines, paragraph 64, which reads: “[e] ven firms with very high market shares 
may not be in a position, post -merger, to significantly impede effective competition, in particular by acting 
to an appreciable extent independently of their customers, if the latter possess countervailing buyer 
power ”.  

13 ERT and Bioclinica have different focuses in medical imaging, with Bioclinica – 
along with its other major competitors – focusing particularly on oncology studies  
(which is the largest therapeutic area requiring medical imaging services), while 
ERT generates most of its medical i maging revenue from […], with less than […] % 
of its medical imaging revenues coming from oncology.64 
4.3.2.  The Commission’s assessment  
4.3.2.1.  Medical imaging solutions (including centralised  and decentralised  services)  
(41) In the potential worldwide market for medical imaging solutions (including both 
centralised  and de centralised  services), the combined share of ERT and Bioclinica 
would be [20-30]% (with a share increment of [0-5]% contributed by ERT). As such, 
the Transact ion will only bring a small increment to Bioclinica’s already modest 
market share, and the HHI delta would remain well below 150. As a result, the 
Transaction does not raise serious doubts as to its compatibility with the internal 
market in relation to the  potential worldwide market for medical imaging solutions 
(including both centralised  and de centralised  services).  
4.3.2.2.  Medical imaging solutions (including only centralised  services)  
(42) In the potential worldwide and EEA -wide markets for medical imaging solutions  
(including only centralised  services ), the Transaction does not raise serious doubts as 
to its compatibility with the internal market for the following reasons:  
(43) First, while the combined market share of ERT and Bioclinica would be moderate at 
a worldwide  level ( [30-40]%), the share increment contributed by ERT is limited at 
[0-5]%.65 As a result, the HHI increment would be [200-300], where the post -merger 
HHI would be ~[2000 -3000]  which is above, but not far from, [2000 -3000]  (<2500 ). 
This suggests that the Transaction would not change meaningfully the competitive 
landscape in this market. The same holds in  the market for medical imaging 
solutions including only centralised services in the EEA, where the combined market 
share of ERT and Bioclinica is even lower ( [20-30]%). As a result, the Transaction 
would bring about an HHI delta of 168 in a market where the post -Transaction HHI 
would be below [2000 -3000] .66 During the market investigation, a competitor stated 
                                                 
64  Form CO, paragraph s 200-203. 
65  The Commission sought to confirm that the market share estimates provided by the Notifying Parties were 
reliable.  The Notifying Parties submitted that ERT’s and Bioclinica’s market share have been estimated 
by using (i) ERT’s and Bioclinica’s actual sales in 2019 and (ii) a total market size based on a model of 
the total sales  of cardiac safety services created by LEK Consulting (Form CO, Annex 15.b, “ […]”). The 
Notifying Parties submitted that ERT has commissioned th is report since […] and uses it in the ordinary 
course of business (see email of outside counsel of the Notifying Parties to the case team dated 1 April 
2021).  On the basis of this report, the Notifying Parties estimated that the total size of a plausible 
worldwide market for medical imaging solutions (including only centralised services) is USD [500-600] 
million (approximately EUR [400-500] million).  In the market investigation, several competitors 
estimated the total size of a plausible worldwide market f or medical imaging solutions (including only 
centralised services) at USD 480 -550 million or more (approximately EUR 404 -463 million or more) (see 
minutes of conference call with competitor, 30 March 2021, paragraph 15, minutes of conference call with  
comp etitor, 8 April 2021, paragraph 11).  This suggests that the market share data provided for the Parties 
in Table 2 above are generally reliable.  
66  Based on the Horizontal Merger Guidelines (paragraph 20), the Commission is unlikely to identify 
horizontal c ompetition concerns in a merger with a post -merger HHI between 1 000 and 2 000 and a delta 
below 250 (subject to certain caveat factors). In the EEA -wide market for medical imaging solutions  
(including only centralised services) , none of these caveat facto rs apply.   
14 that it “ does not view ERT as a significant player in the [medical imaging] market.  
Thus, the Transaction would only marginally affect the competitive dynamics in the 
market”.67 A customer added that the Transaction would give rise to “very little 
overlap” between the activities of ERT and Bioclinica in medical imaging 
solutions .68  
(44) Second, post-Transaction, the combined entity will continue facing competitive 
constraints by several players who each hold a share higher than the increment 
brought by ERT. These include Parexel ( [20-30]% share globally and [20-30]% in 
the EEA), ICON ( [10-20]% globally and 17% in the EEA), and BioTelemetry ( [5-
10]% globally and [5-10]% in the EEA).  
(45) Third, Bioclinica and ERT are not close  competitors in these markets. According to 
the Notifying Par ties, between  2017  and 2020, Bioclinica participated globally in 
around […] ti mes as many medical imaging opportunities as ERT, which implies 
that, even if every ERT opportunity was also bid for by Bioclinica, ERT would be a 
competitor in at most […] o f Bioclinica’s opportunities.69 There is also limited 
overlap among the top customers of Bioclinica and ERT for medical imaging 
solutions worldwide.  There are only […] overlapping customers among the top 15 
medical imaging customers of Bioclinica and the top 15  medical imaging customers 
of ERT.70 
(46) The market investigation confirmed that ERT and Bioclinica do not compete closely 
in me dical imaging solutions.  Rather, Bioclinica competes most closely with […]. 
An internal document […] for Astorg and Nordic Capital identifies Bioclinica and 
[…] as the two Tier 1 players in this market while ERT features as a “ […]”.71 The 
same document explains: “ […]”.72 In the same vein, an internal document of ERT 
dated […] refers to […] as closer competi tors to Bioclinica ( […]) both in terms of 
reputation and strength of product offering.73  
(47) Fourth , during the market investigation, all customer respondents agreed that the 
Transaction does not raise competition concerns in the plausible worldwide or EEA -
wide markets for medical imaging solutions  (including only centralised  services).74  
(48) By contra st, several  competitors submitted that the Transaction does raise 
competition concerns in these plausible markets.  Specifically , competitors argued 
that post-Transaction, the combined entity  would be able to compete aggressively on 
price until it forces  rivals out of  the market .75, 76  
                                                 
67  Minutes of con ference call with competitor, 26  March 2021, paragraph 14.  
68  Response of a customer of the Parties to question 3 of Q1 – Questions to customers . 
69  Form CO, paragraph 205.  
70  Namely, […]. See Form CO, paragraph 201.  
71  Form CO, Annex 14 -6, “Project Bright”, page 5.  
72  Form CO, Annex 14 -6, “Project Bright”, page 8.  
73  Form CO, Annex 14 -13, “ […]”, 5 June 2020, page 6.  
74  Responses to questions 1.a and 1.b of Q1 – Questions to customers.  
75  Responses to questions 1.a and  1.b of Q2 – Questions to competitors.   
76  In the market investigation, o ne competitor respondent also claimed  that post -Transaction, ERT and 
Bioclinica would be able to combine their respective offerings in cardiac safety services and medical 
imaging solu tions and thus obtain “ preferred provider ” status from customers. According to this 
competitor, this would reduce the opportunities in medical imaging solutions for which rivals of the 
combined entity can bid ( minutes of con ference call with competitor, 9 April  2021, paragraphs 12ff ). 
 
15 (49) However, these claims are not sufficiently cogent and substantiated to outweigh the 
body of evidence illustrated above and to cast doubt as to the Transaction’s 
compatibility with the internal market in medical imaging solutions . This is so  for 
the following reasons:  
(a) Some of the competitors referred to Bioclinica’s already strong position in 
the worldwide and EEA -wide markets  for centralised  medical imaging 
solutions but without substantiating any merger -specific concerns. None of 
the competitor respondents raising concerns identified ERT as a significant 
competitive constraint to Bioclinica in medical imaging solutions.  In an y 
event, the Transaction does not materially change the incentives of the 
combined entity to adopt a hypothetical strategy of aggressively reducing 
prices to exclude competitors. If Bioclinica considered such a strategy to be 
profitable and viable, it is likely that it would have already implemented it  
irrespective of the Transaction. None of the competitor respondents provided 
evidence to that effect. Rather, a n internal document […] for Astorg and 
Nordic Capital states for medical imaging solutions: “ […]”.77  
(b) Despite its meaningful market share in the worldwide and EEA -wide markets 
for medical imaging solutions, the combined entity would likely face 
competitive pressure post -Transaction from its customers. Both ERT and 
Bioclinica sell to a concentrated group of customers . ERT’s 15 largest 
customers represent […]% of its revenues in the worldwide market for 
medical imaging solutions.  Bioclinica’s 15 largest customers represent […]% 
of its revenues in the worldwide market for medical imaging solutions. The 
customers of medical imaging solutions are typically repeat customers and 
they purchase services through tenders where several rivals can be invited to 
bid. An internal document […] for Astorg and Nordic Capital confirms this: 
“[…]”.78 The fact that no cus tomer raised concerns regarding the Transaction 
also suggests that the combined entity faces competitive constraints from 
customers in medical imaging solutions.  
(50) In light of the above, the Commission concludes that the Transaction does not raise 
serious d oubts as to its compatibility with the internal market in relation to the  
market for medical imaging solutions (including only centralised  services) 
worldwide or in the EEA.   
                                                                                                                                                      
These claims are however not sufficiently substantiated to raise serious  doubts as to the Transaction’s 
compatibility with the internal market in medical imaging solutions. The Commission considers that post -
Transaction, rivals will be able to continue competing against the combined entity for the vast majority of 
opportunitie s involving medical imaging solutions.  This is for the following reasons.  First , the competitor 
respondent raising concerns acknowledged that a customer can grant “ preferred provider ” status for one 
type of service only (e.g., medical imaging solutions) an d not always for a combination of services. 
Second , the same competitor recognised that even after granting “ preferred provider ” status the customer 
can still source some of the services required from third parties e.g., if the preferred provider is unable  to 
offer them. Third , the same competitor submitted that it sometimes bids itself “ together with other 
companies offering its specialized services as part of a combined proposal in selection processes for 
preferred providers ” (minutes of con ference call w ith competitor, 9 April  2021, paragraphs 13ff).   
77  Form CO, Anne x 14-6, “Project Bright”, page 29.  
78  Form CO, Anne x 14-6, “Project Bright”, page 104.  
16 5. CONCLUSION  
(51) For the above reasons, the European Commission has decided not to oppo se the 
notified operation and to declare it compatible with the internal market and with the 
EEA Agreement. This decision is adopted in application of Article 6(1)(b) of the 
Merger Regulation and Article 57 of the EEA Agreement.   
For the Commission  
 
 
(Signed)  
Margrethe VESTAGER  
Executive Vice -President