PowerPoint Presentation - AdvaMed = Category Infectious Immunology Level 2 15.01 = Group Bacteriology Level 3 15.01.10 = Subgroup Salmonella Level 4 15.01.10.01 = Parameter Salmonella

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AdvaMedDx.org 4

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EDMA and its Market Intelligence

Activities

EDMA Statistics Evolution

Up to the late 80‘s no harmonized IVD market

statistics

National trade associations in Europe

established their own IVD product categories

IVD industry statistics varied by country,

inconsistent sales reporting by the companies

EDMA to Take Action

Defined that the major Western European countries

need to report in the same layout and quarterly

Essential to have a structured IVD classification to

report sales correctly

Implement a dedicated EDMA market research

committee with IVD product knowledge and market

statistics expertise from the industry

Commitment by the major IVD suppliers and

national trade associations to support the process

EDMA Market Research Committee

Established in the late 80s

IVD company delegates from national or HQ offices / national

association members (market researchers,

marketing/product/sales or scientific affairs managers)

Current active members are from Abbott, Bayer, Beckman

Coulter, Biomerieux, Bio-Rad, Diasorin, Instrumentation

Laboratory, Ortho, Roche, Siemens and Sysmex

Major tasks- 1) continuously improve the statistical programs

in order to provide companies with good and reliable market

data 2) yearly update the Global IVD Classification

EDMS Launched in 1991

European Diagnostics Manufacturer Statistics

(EDMS) was created within one year

• A common IVD classification was key to secure

reporting

• CIP* proposed by the French IVD association as the

European partner to handle the IVD market audit

First countries coming on board were Belgium, NL,

Germany and France in 1991 - 1993

*CIP, Club Inter Pharmaceutique- a non-profit data handling organisation located in Paris

Stakeholders: pharmaceutical industry, wholesalers, pharmacies, hospitals and other HC providers

GDMS available in:

- Europe through the NAMs (14 countries-

Austria, Belgium, Czech Republic, Denmark,

France, Germany, Italy, Netherlands, Poland,

Portugal, Slovakia, Spain, Switzerland, UK)

- Canada (through MEDEC)- since 2011

- USA (through AdvaMedDx)- since 2013

- South Africa and Australia- coming 2014

EDMS has become GDMS (Global Diagnostics Manufacturer Statistics)

http://www.google.be/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&docid=0JPtxhrwshuUvM&tbnid=O1yGKh4LXRD_bM:&ved=0CAUQjRw&url=http://commons.wikimedia.org/wiki/File:A_large_blank_world_map_with_oceans_marked_in_blue.PNG&ei=MvjgUqXEMomS0QXO7oE4&bvm=bv.59568121,d.d2k&psig=AFQjCNHlDylqxzQsU9uJ0WVjZfIotlVxrg&ust=1390561621995326

The GIVD Classification

The statistics are based on the GIVD classification

(formerly EDMA classification)

The classification was generated by members of

the market research committee in the late 80s

Yearly updated – with the IVD products on the

market

Over 1000 product lines- divided by testing area

and disease group

GIVD Classification

6 Total IVD Market

1 Reagents

11 Clinical

Chemistry

12 Immuno- chemistry

13 Hematology

14

Microbiology Culture

15 Infectious

Immunology

16 Genetic Testing

250

Instruments / Consumables /

After Sales / Software

2 Instruments / Consumables

3 After Sales

Service/Spare Parts

4 Supporting Software

5 Sample

Containers

GIVD Classification- Four Classification Levels

15 = Category Infectious Immunology

Level 2 15.01 = Group Bacteriology

Level 3 15.01.10 = Subgroup Salmonella

Level 4 15.01.10.01 =

Parameter

Salmonella Antigen Detection

Example: GIVD code for Salmonella Antigen Detection

All companies report sales in local currency at parameter/product level 4

Level 1

Here you can find the GIVD:

• http://www.edma-ivd.eu/index.php?page=Global-

IVD-Classification

http://www.edma-ivd.eu/index.php?page=Global-IVD-Classification








Benefits to Participating Companies

Track the IVD market

Understand company performance versus competitors (e.g. company growth in-line with market growth?)

Reliable basis for strategy development activities,

planning and budgeting

Quarterly and timely data (GDMS data is usually available 6-8

weeks after end of quarter)

GDMS same reporting structure around the globe

CIP and EDMA/AdvaMedDx expertise available to support

new companies joining to allocate their products

correctly during process implementation

Lobbying activities

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GLOBAL DIAGNOSTIC MANUFACTURERS STATISTICS - USA

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TABLE OF CONTENTS

CIP

GDMS-USA Overview

Objective

Participants

Input & Output Data

GIVD Classification

Confidentiality Rules of the “Red Flag System”

Reporting Process

Control & Validation of the Reported Data

Delivered Reports

“Competitors Display” Report

“9-Quarters Display” Report

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TABLE OF CONTENTS

CIP

GDMS-USA Overview

Objective

Participants

Input & Output Data

GIVD Classification


Reporting Process


Delivered Reports



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CIP – WHERE DID WE COME FROM?

Club Inter Pharmaceutique

Not-for-profit organization founded in 1964 by the key stakeholders of

the pharmaceutical industry operating in France:

Manufacturers

Distributors & Wholesalers

Professional bodies representing pharmacists, hospitals & biologics

A network of 211 Members

CIP International Studies

A dedicated in-house team for international project developments

Reliable IT partners

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CIP – WHAT DO WE DO?

Core business in 4 major areas:

Product coding (CIP & ACL Codes – UCD Hospital Codes) - France only

Drug information databases (Up to SKUs level) – National & International

Statistics & Market Research - International

Training & Education – International

Trusted third party for the following associations:

CEESA (Animal Health – 1997) with 45 countries

EDMA (IVD - 1998) with 14 EU National Associations (GDMS) and 35 countries (MIS)

EMNS (Medical Nutrition – 2011) with 22 EU countries

MEDEC (IVD & Orthopaedics – 2011 & 2012) Canada

ADVAMEDDX (IVD – 2013) USA

SALDA (IVD – 2014) South Africa

IVD AUSTRALIA (IVD – 2014) Australia

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CIP INTERNATIONAL STUDIES – WHO DO WE WORK WITH?

Animal Health In Vitro Diagnostics Medical Nutrition In Vitro Diagnostics

Orthopaedics

In Vitro Diagnostics

In Vitro Diagnostics

* Project under discussion

* Project under discussion

* Project under agreement

Animal Health

In Vitro Diagnostics In Vitro Diagnostics

Projets/EMNS/Résultats version test.xltm

http://www.medec.org/en

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TABLE OF CONTENT

CIP

GDMS-USA Overview

Objective

Participants

Input & Output Data

GIVD Classification


Reporting Process


Delivered Reports



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OBJECTIVE

GDMS-USA stands for “Global Diagnostic Manufacturers Survey USA”.

GDMS-USA is based on the current IVD Sales Surveys processed in

Europe, Canada, South Africa and soon Australia by CIP but dedicated

to the American Diagnostic Manufacturers.

The objective of GDMS-USA is to provide a comprehensive and

continuing estimate of the US In Vitro Diagnostic Market.

The sales audit is based on the invoiced sales to end-users for IVD

medical devices and services.

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PARTICIPANTING COMPANIES (Last updated: January 2014)

1. Abbott

2. Alere

3. Becton Dickinson

4. Beckman Coulter

5. Biomerieux

6. Cepheid

7. Hologic GenProbe

8. Diasorin

9. Instrumentation Laboratory

10. Ortho Clinical Diagnostics

11. Qiagen

12. Roche

13. Siemens

14. Stago

15. Sysmex

16. The Bindingsite

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Sales audits are based on the invoiced sales* to

end-users for IVD medical devices and services

*Units are not taken into account

Turnover / Sales

Trend / Growth

Market Share

Ranking

INPUT DATA

OUTPUT DATA

INPUT & OUTPUT DATA

Quarter

MAT (Rolling 4 quarters)

YTD (from January)

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GIVD CLASSIFICATION

CODE CLASS or PARAMETER

6 Total IVD Market

1 Reagents

2 Instruments

3 Services (After Sales)

4 Supporting Software

5 Sample Containers

Between 200 – 400 Assay level market sizes depending on the size of the country and number of reporting companies NAT is available as independent testing area excluding other infectious diseases. Instrument market sizes for the major disease areas such as Clinical Chemistry, Immunochemistry, Coagulation, microbiology and Other. Service and Spare Parts market.

EXAMPLE OF CLASSES & SUB-CLASSES

Free Prostatic Specific Antigen (fPSA)

Level 1: Category Immunochemistry Reagents

Level 2: Group

Tumour Markers

Level 3: Subgroup Cancer Antigens

Level 4: Parameter

Free Prostatic Specific Antigen (fPSA)

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RULES OF CONFIDENTIALITY – “RED FLAG SYSTEM*”

(*) The criteria for the Red Flag System may be modified as deemed necessary or permissible by Outside Antitrust Counsel. Participants will be notified by AdvaMedDx if any parameters of the Red Flag System

change.

To ensure that the reports provided under the Service are compliant with

U.S. antitrust laws and to maximize the permissibly reported Statistics, the

following thresholds will identify a data set as a Red Flag Data Set:

• Only trigger a red flag if any three companies exceeded 90% AND any

one of those companies constituted over 50% of the reported sales

• If three players have approximately the same sales (e.g. 35%, 30%,

25%), it may be harder to discern competitively sensitive information

• However, when there are only three companies reporting, do not identify

the survey participants

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REPORTING PROCESS

Data consolidated by CIP

Data Output – Excel Files

Manufacturer

A

Manufacturer

B

Manufacturer

C

Each participating company

receives their individual

reports

All participating

manufacturers report to CIP :

Their net invoiced sales

In US $

Based on the Global IVD

classification

Using a unique declaration

form (provided by CIP)

Manufacturer

A

Manufacturer

B

Manufacturer

C

Data Input – Excel Files

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CONTROL & VALIDATION OF THE REPORTED DATA

Companies receive prior to final publication highlighted in red their

sales with +/- 10% deviations versus previous quarter

Companies need to check accuracy and report back to CIP their

approval

INPUT DATA

Flagging of data deviations in final report such as in red +/- 10%

variations and member is new or left statistics

OUTPUT DATA

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TABLE OF CONTENT

CIP

GDMS-USA Overview

Objective

Participants

Input & Output Data

GIVD Classification


Reporting Process


Delivered Reports



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By Quarter or MAT or YTD

Turnover/Sales Growth rate

% Market share

% Rank

CATEGORY (e.g. Immunochemistry)

GROUP (e.g. Tumour Markers)

Sub-GROUP (e.g. Cancer Antigens)

PARAMETER (e.g. fPSA) - My company - All companies

My company sales Vs.

All company sales

My company growth rate

Vs. All company growth rates

My company market share

My company market position

Company ranking:

- Numbers of competitors reporting

-Listing of each individual competitors with their market rank

(Not market share)

“COMPETITORS DISPLAY” REPORT – LAYOUT

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“COMPETITORS DISPLAY” REPORT – EXAMPLE (1/8)

Company Code : Country: ITALY

Périod : Q4/2007Currency : EUR Thousand

OVERVIEW

Year TURNOVER VAR MKT SHR TURNOVER VAR MKT SHR VAR

(+/-%) % Rk (+/- %) % Rk Previous Current (+/- %) Prev Curr

TOTAL IVD MARKET 6

Company 2 3

All Company 369.445 2,97 1.495.675 3,20 1.449.159 1.495.675 3,20

2007

2006

Tumour Markers 1203

All Company 17.726 3,93 71.875 1,81 70.597 71.875 1,81

2007

2006

CEA 12030131

All Company 2.043 -0,27 8.538 0,22 8.518 8.538 0,22

2007

2006

Total PSA 12030132

All Company 4.310 5,96 16.793 0,88 16.646 16.793 0,88

2007

2006

13 MSY ABB ROC SIE BIO BEK TOS SOR CIS DAS RAD ORT ILA 13 MSY ABB ROC SIE BIO TOS BEK SOR CIS DAS RAD ORT ILA

13 MSY ABB ROC SIE BIO TOS BEK SOR DAS CIS RAD ORT ILA 13 MSY ABB ROC SIE BIO TOS SOR BEK DAS CIS RAD ORT ILA

12 ABB ROC SIE MSY TOS BIO BEK SOR DAS ORT RAD CIS 12 ABB ROC SIE MSY TOS SOR BIO BEK DAS ORT RAD CIS

12 ABB ROC SIE MSY TOS SOR BIO BEK DAS ORT RAD CIS 13 ABB ROC SIE MSY SOR TOS BIO BEK DAS ORT RAD CIS ILA

14 ROC ABB MSY SIE SOR AWD BIO BEK TOS CIS RAD DAS ORT

ILA

14 ROC MSY ABB SIE SOR AWD BIO TOS BEK CIS RAD DAS ORT

ILA

14 ROC MSY ABB SOR SIE AWD BIO TOS CIS BEK RAD DAS ORT

ILA

14 ABB ROC MSY SOR SIE AWD BIO TOS CIS BEK RAD DAS ORT

ILA

22 ROC ABB SIE ORT MEN ILA MSY BIO DAS BEK SOR BIR PHA

BEC TOS RAD AWD BAY OXO CIS DEL BAX

22 ROC SIE ABB ORT MEN ILA MSY BIO DAS BEK SOR BIR PHA

BEC RAD TOS AWD BAY OXO CIS DEL BAX

22 ROC SIE ABB ORT MEN ILA MSY BIO DAS BEK SOR BIR BEC

PHA RAD TOS AWD BAY OXO CIS DEL BAX

22 ROC SIE ABB ORT MEN ILA MSY BIO DAS BEK SOR BIR BAY

BEC PHA RAD AWD TOS OXO CIS DEL BAX

SURVEY OF SALES STATISTICS IN VITRO DIAGNOSTICS

TURNOVER

EDMA Code YEAR TO DATE MOVING ANNUAL TOTALQUARTER

Market Share

34



OVERVIEW



TOTAL IVD MARKET 6

Company 2 3

All Company 369.445 2,97 1.495.675 3,20 1.449.159 1.495.675 3,20

2007

2006

Tumour Markers 1203

All Company 17.726 3,93 71.875 1,81 70.597 71.875 1,81

2007

2006

CEA 12030131

All Company 2.043 -0,27 8.538 0,22 8.518 8.538 0,22

2007

2006

Total PSA 12030132

All Company 4.310 5,96 16.793 0,88 16.646 16.793 0,88

2007

2006






ILA


ILA


ILA


ILA










TURNOVER


Market Share

70.000

Period (quarter or semester) Currency (000)


35



OVERVIEW



TOTAL IVD MARKET 6

Company 2 3

All Company 369.445 2,97 1.495.675 3,20 1.449.159 1.495.675 3,20

2007

2006

Tumour Markers 1203

All Company 17.726 3,93 71.875 1,81 70.597 71.875 1,81

2007

2006

CEA 12030131

All Company 2.043 -0,27 8.538 0,22 8.518 8.538 0,22

2007

2006

Total PSA 12030132

All Company 4.310 5,96 16.793 0,88 16.646 16.793 0,88

2007

2006






ILA


ILA


ILA


ILA










TURNOVER


Market Share

70.000 3


36



OVERVIEW



TOTAL IVD MARKET 6

Company 2 3

All Company 369.445 2,97 1.495.675 3,20 1.449.159 1.495.675 3,20

2007

2006

Tumour Markers 1203

All Company 17.726 3,93 71.875 1,81 70.597 71.875 1,81

2007

2006

CEA 12030131

All Company 2.043 -0,27 8.538 0,22 8.518 8.538 0,22

2007

2006

Total PSA 12030132

All Company 4.310 5,96 16.793 0,88 16.646 16.793 0,88

2007

2006






ILA


ILA


ILA


ILA










TURNOVER


Market Share

70.000 3


37



OVERVIEW



TOTAL IVD MARKET 6

Company 2 3

All Company 369.445 2,97 1.495.675 3,20 1.449.159 1.495.675 3,20

2007

2006

Tumour Markers 1203

All Company 17.726 3,93 71.875 1,81 70.597 71.875 1,81

2007

2006

CEA 12030131

All Company 2.043 -0,27 8.538 0,22 8.518 8.538 0,22

2007

2006

Total PSA 12030132

All Company 4.310 5,96 16.793 0,88 16.646 16.793 0,88

2007

2006






ILA


ILA


ILA


ILA










TURNOVER


Market Share

70.000 3 19


38



OVERVIEW



TOTAL IVD MARKET 6

Company 2 3

All Company 369.445 2,97 1.495.675 3,20 1.449.159 1.495.675 3,20

2007

2006

Tumour Markers 1203

All Company 17.726 3,93 71.875 1,81 70.597 71.875 1,81

2007

2006

CEA 12030131

All Company 2.043 -0,27 8.538 0,22 8.518 8.538 0,22

2007

2006

Total PSA 12030132

All Company 4.310 5,96 16.793 0,88 16.646 16.793 0,88

2007

2006






ILA


ILA


ILA


ILA










TURNOVER


Market Share

70.000 3 19


39



OVERVIEW



TOTAL IVD MARKET 6

Company 2 3

All Company 369.445 2,97 1.495.675 3,20 1.449.159 1.495.675 3,20

2007

2006

Tumour Markers 1203

All Company 17.726 3,93 71.875 1,81 70.597 71.875 1,81

2007

2006

CEA 12030131

All Company 2.043 -0,27 8.538 0,22 8.518 8.538 0,22

2007

2006

Total PSA 12030132

All Company 4.310 5,96 16.793 0,88 16.646 16.793 0,88

2007

2006






ILA


ILA


ILA


ILA










TURNOVER


Market Share

70.000 3 19

Rankings


40



OVERVIEW



TOTAL IVD MARKET 6

Company 2 3

All Company 369.445 2,97 1.495.675 3,20 1.449.159 1.495.675 3,20

2007

2006

Tumour Markers 1203

All Company 17.726 3,93 71.875 1,81 70.597 71.875 1,81

2007

2006

CEA 12030131

All Company 2.043 -0,27 8.538 0,22 8.518 8.538 0,22

2007

2006

Total PSA 12030132

All Company 4.310 5,96 16.793 0,88 16.646 16.793 0,88

2007

2006






ILA


ILA


ILA


ILA










TURNOVER


Market Share

70.000 3 19

Rankings

Company


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“9-QUARTERS DISPLAY” REPORT – EXAMPLE

Company Code :

Périod : Q3/2013

Currency : USD Thousand

Country: USA

OVERVIEW

Total IVD Market 6

Company 0 0 0 0 0 0 0 0 0

All Company 2 670 089 2 757 026 2 592 615 2 661 589 2 605 032 2 747 472 2 829 065 2 759 895 2 778 625

REAGENTS 1

Company 0 0 0 0 0 0 0 0 0

All Company 2 123 931 2 172 266 2 129 168 2 183 567 2 126 565 2 261 980 2 274 144 2 254 353 2 219 775

CLINICAL CHEMISTRY 11

Company 0 0 0 0 0 0 0 0 0

All Company 481 138 521 626 525 039 570 492 525 831 606 856 513 518 569 191 520 520

Clinical Chemistry excl Rapid Test &

POC110

Company 0 0 0 0 0 0 0 0 0

All Company 204 432 204 296 214 123 218 149 211 569 211 307 207 534 204 760 200 125

TU_Q1_2013 TU_Q2_2013 TU_Q3_2013


Class Code Turnover/Sales

TU_Q3_2011 TU_Q4_2011 TU_Q1_2012 TU_Q2_2012 TU_Q3_2012 TU_Q4_2012

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CONTACT DETAILS

ADVAMED DX

CIP

Annika Larsson Market Research Coordinator

[email protected] +32 (2)777 02 74

Tharini Sathiamoorthy Vice President [email protected] 202-434-7279

Krim Amrouche Director International Studies & Strategic Partnerships [email protected] +33 (1)49 09 62 53

Questions?

Documents

PowerPoint Presentation - AdvaMed = Category Infectious Immunology Level 2 15.01 = Group Bacteriology Level 3 15.01.10 = Subgroup Salmonella Level 4 15.01.10.01 = Parameter Salmonella