AdvaMedDx.org 4

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

EDMS has become GDMS (Global Diagnostics Manufacturer Statistics) 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

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 250 Instruments / Consumables / After Sales / Software 5 Sample Containers 11 Clinical Chemistry 12 Immunochemistry 13 Hematology 14 Microbiology Culture 15 Infectious Immunology 16 Genetic Testing 2 Instruments / Consumables 3 After Sales Service/Spare Parts 4 Supporting Software

GIVD Classification- Four Classification Levels Example: GIVD code for Salmonella Antigen Detection Level 1 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 All companies report sales in local currency at parameter/product level 4

Here you can find the GIVD: 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

GLOBAL DIAGNOSTIC MANUFACTURERS STATISTICS - USA 17

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 18

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 19

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 20

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 21

CIP INTERNATIONAL STUDIES WHO DO WE WORK WITH? In Vitro Diagnostics Orthopaedics Animal Health In Vitro Diagnostics Medical Nutrition * Project under discussion In Vitro Diagnostics Animal Health * Project under discussion In Vitro Diagnostics * Project under agreement In Vitro Diagnostics In Vitro Diagnostics 22

TABLE OF CONTENT 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 23

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. 24

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 25

INPUT & OUTPUT DATA Sales audits are based on the invoiced sales* to INPUT DATA end-users for IVD medical devices and services *Units are not taken into account OUTPUT DATA Turnover / Sales Trend / Growth Market Share Ranking Quarter MAT (Rolling 4 quarters) YTD (from January) 26

GIVD CLASSIFICATION 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. CODE CLASS or PARAMETER 6 Total IVD Market 1 Reagents 2 Instruments 3 Services (After Sales) 4 Supporting Software 5 Sample Containers 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) 27

RULES OF CONFIDENTIALITY RED FLAG SYSTEM* 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 (*) 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. 28

REPORTING PROCESS Manufacturer Manufacturer Manufacturer All participating manufacturers report to CIP : A B C Their net invoiced sales Data Input Excel Files In US $ Based on the Global IVD classification Data consolidated by CIP Using a unique declaration form (provided by CIP) Data Output Excel Files Manufacturer Manufacturer Manufacturer Each participating company receives their individual reports A B C 29

CONTROL & VALIDATION OF THE REPORTED DATA INPUT 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 OUTPUT DATA Flagging of data deviations in final report such as in red +/- 10% variations and member is new or left statistics 30

TABLE OF CONTENT 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 31

COMPETITORS DISPLAY REPORT LAYOUT 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 sales Vs. All company sales My company growth rate Vs. All company growth rates My company market share My company market position - My company - All companies Company ranking: - Numbers of competitors reporting -Listing of each individual competitors with their market rank (Not market share) 32

COMPETITORS DISPLAY REPORT EXAMPLE (1/8) Company Code : Country: ITALY Périod : Q4/2007 Currency : EUR Thousand OVERVIEW SURVEY OF SALES STATISTICS IN VITRO DIAGNOSTICS EDMA Code QUARTER YEAR TO DATE MOVING ANNUAL TOTAL Year TURNOVER VAR MKT SHR TURNOVER VAR MKT SHR TURNOVER VAR Market Share (+/-%) % 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 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 BEC PHA RAD TOS 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 BAY BEC PHA RAD AWD TOS OXO CIS DEL BAX Tumour Markers 1203 All Company 17.726 3,93 71.875 1,81 70.597 71.875 1,81 2007 2006 14 ROC ABB MSY SIE SOR AWD BIO BEK TOS CIS RAD DAS ORT ILA 14 ROC MSY ABB SOR SIE AWD BIO TOS CIS BEK RAD DAS ORT ILA 14 ROC MSY ABB SIE SOR AWD BIO TOS BEK CIS RAD DAS ORT ILA 14 ABB ROC MSY SOR SIE AWD BIO TOS CIS BEK RAD DAS ORT ILA CEA 12030131 All Company 2.043-0,27 8.538 0,22 8.518 8.538 0,22 2007 2006 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 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 33

COMPETITORS DISPLAY REPORT EXAMPLE (2/8) Company Code : Périod : Q4/2007 Currency : EUR Thousand OVERVIEW EDMA Code QUARTER SURVEY OF SALE Year TURNOVER VAR MKT SHR (+/-%) % Rk Period (quarter or semester) TOTAL IVD MARKET 6 Currency (000) Company 70.000 2 All Company 369.445 2,97 2007 2006 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 BEC PHA RAD TOS AWD BAY OXO CIS DEL BAX Tumour Markers 1203 All Company 17.726 3,93 2007 2006 14 ROC ABB MSY SIE SOR AWD BIO BEK TOS CIS RAD DAS ORT ILA 14 ROC MSY ABB SOR SIE AWD BIO TOS CIS BEK RAD DAS ORT ILA 34

COMPETITORS DISPLAY REPORT EXAMPLE (3/8) Company Code : Périod : Q4/2007 Currency : EUR Thousand OVERVIEW EDMA Code QUARTER SURVEY OF SALE Year TURNOVER VAR MKT SHR (+/-%) % Rk TOTAL IVD MARKET 6 Company 70.000 3 2 All Company 369.445 2,97 2007 2006 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 BEC PHA RAD TOS AWD BAY OXO CIS DEL BAX Tumour Markers 1203 All Company 17.726 3,93 2007 2006 14 ROC ABB MSY SIE SOR AWD BIO BEK TOS CIS RAD DAS ORT ILA 14 ROC MSY ABB SOR SIE AWD BIO TOS CIS BEK RAD DAS ORT ILA 35

COMPETITORS DISPLAY REPORT EXAMPLE (4/8) Company Code : Périod : Q4/2007 Currency : EUR Thousand OVERVIEW EDMA Code QUARTER SURVEY OF SALE Year TURNOVER VAR MKT SHR (+/-%) % Rk TOTAL IVD MARKET 6 Company 70.000 3 2 All Company 369.445 2,97 2007 2006 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 BEC PHA RAD TOS AWD BAY OXO CIS DEL BAX Tumour Markers 1203 All Company 17.726 3,93 2007 2006 14 ROC ABB MSY SIE SOR AWD BIO BEK TOS CIS RAD DAS ORT ILA 14 ROC MSY ABB SOR SIE AWD BIO TOS CIS BEK RAD DAS ORT ILA 36

COMPETITORS DISPLAY REPORT EXAMPLE (5/8) Company Code : Périod : Q4/2007 Currency : EUR Thousand OVERVIEW EDMA Code QUARTER SURVEY OF SALE Year TURNOVER VAR MKT SHR (+/-%) % Rk TOTAL IVD MARKET 6 Company 70.000 3 19 2 All Company 369.445 2,97 2007 2006 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 BEC PHA RAD TOS AWD BAY OXO CIS DEL BAX Tumour Markers 1203 All Company 17.726 3,93 2007 2006 14 ROC ABB MSY SIE SOR AWD BIO BEK TOS CIS RAD DAS ORT ILA 14 ROC MSY ABB SOR SIE AWD BIO TOS CIS BEK RAD DAS ORT ILA 37

COMPETITORS DISPLAY REPORT EXAMPLE (6/8) Company Code : Périod : Q4/2007 Currency : EUR Thousand OVERVIEW EDMA Code QUARTER SURVEY OF SALE Year TURNOVER VAR MKT SHR (+/-%) % Rk TOTAL IVD MARKET 6 Company 70.000 3 19 2 All Company 369.445 2,97 2007 2006 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 BEC PHA RAD TOS AWD BAY OXO CIS DEL BAX Tumour Markers 1203 All Company 17.726 3,93 2007 2006 14 ROC ABB MSY SIE SOR AWD BIO BEK TOS CIS RAD DAS ORT ILA 14 ROC MSY ABB SOR SIE AWD BIO TOS CIS BEK RAD DAS ORT ILA 38

COMPETITORS DISPLAY REPORT EXAMPLE (7/8) Company Code : Périod : Q4/2007 Currency : EUR Thousand OVERVIEW EDMA Code QUARTER SURVEY OF SALE Year TURNOVER VAR MKT SHR (+/-%) % Rk TOTAL IVD MARKET 6 Company 70.000 3 19 2 All Company 369.445 2,97 Rankings 2007 2006 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 BEC PHA RAD TOS AWD BAY OXO CIS DEL BAX Tumour Markers 1203 All Company 17.726 3,93 2007 2006 14 ROC ABB MSY SIE SOR AWD BIO BEK TOS CIS RAD DAS ORT ILA 14 ROC MSY ABB SOR SIE AWD BIO TOS CIS BEK RAD DAS ORT ILA 39

COMPETITORS DISPLAY REPORT EXAMPLE (8/8) Company Code : Périod : Q4/2007 Currency : EUR Thousand OVERVIEW EDMA Code QUARTER SURVEY OF SALE Year TURNOVER VAR MKT SHR (+/-%) % Rk TOTAL IVD MARKET 6 Company 70.000 3 19 2 All Company 369.445 2,97 2007 2006 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 BEC PHA RAD TOS AWD BAY OXO CIS DEL BAX Tumour Markers 1203 Company All Company 17.726 3,93 Rankings 2007 2006 14 ROC ABB MSY SIE SOR AWD BIO BEK TOS CIS RAD DAS ORT ILA 14 ROC MSY ABB SOR SIE AWD BIO TOS CIS BEK RAD DAS ORT ILA 40

9-QUARTERS DISPLAY REPORT EXAMPLE Company Code : Périod : Q3/2013 Currency : USD Thousand Country: USA SURVEY OF SALES STATISTICS IN VITRO DIAGNOSTICS OVERVIEW Class Code Turnover/Sales TU_Q3_2011 TU_Q4_2011 TU_Q1_2012 TU_Q2_2012 TU_Q3_2012 TU_Q4_2012 TU_Q1_2013 TU_Q2_2013 TU_Q3_2013 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 & POC 110 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 41

CONTACT DETAILS ADVAMED DX Tharini Sathiamoorthy Vice President tsathiamoorthy@advameddx.org 202-434-7279 Annika Larsson Market Research Coordinator a.larsson@edma-ivd.eu +32 (2)777 02 74 CIP Krim Amrouche Director International Studies & Strategic Partnerships Krim.amrouche@cpclub.org +33 (1)49 09 62 53 42

Questions?