Global Companion Diagnostics Industry

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Sep 28, 2016, 07:30 ET

LONDON, Sept. 28, 2016 /PRNewswire/ -- This report analyzes the worldwide markets for Companion Diagnostics in US$ Million. The Global market is further analyzed by the following Therapeutic Areas: Oncology, Neurology, and Others. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2015 through 2022. Also, a six-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 80 companies including many key and niche players such as -

Abbott Molecular Inc.
Beckman Coulter, Inc.
bioMérieux SA
Dako A/S
Foundation Medicine, Inc.

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I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1 Disclaimers.............. I-2 Data Interpretation & Reporting Level I-2 Quantitative Techniques & Analytics I-3 Product Definitions and Scope of Study I-3

II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW.............. II-1 Companion Diagnostics: Enhancing Drug Efficacy II-1 Companion Diagnostics: Challenging the One-Size-Fits-All Approach of the Pharmaceutical Industry II-1 Broader Scope and Applications II-1 Companion Diagnostics - Leading the Way to Personalized Medicine II-2 Herceptin Lays the Road for Companion Diagnostics II-3 Rise in Rx Companion Diagnostics II-4 Table 1: Rise in CDx Numbers Over the years - No. of FDA-Approved Drugs Requiring CDx in 1998, 2005, 2008 & 2016 (includes corresponding Graph/Chart) II-4 List of FDA-Approved Companion Diagnostic Devices (In-vitro and Imaging Tools): As of 2016 II-5 Current & Future Analysis..............II-6 US Leads the Companion Diagnostics Market, Asia-Pacific to Witness Fastest Growth..............II-7 Oncology and Neurology - Dominating Therapy Areas II-7 Table 2: Global Companion Diagnostic Drugs Market by Therapeutic Area (2015) - Percentage Share Breakdown of Revenue of CDx for Oncology, CNS Disorders, Gastrointestinal Disorders, Cardiovascular Diseases, and Others (includes corresponding Graph/Chart)..............II-8

Table 3: Oncology CDx Market by Cancer Type (2015) - Percentage Share Breakdown of Revenue of CDx for Breast, Colorectal, Lung, Melanoma, Gastric, and Other Cancers (includes corresponding Graph/Chart) II-8 Next-Generation Sequencing and Technological Innovations to Boost Market.............. II-8 Market Restraints.............. II-9

2. COMPETITIVE SCENARIO.............. II-10 Table 4: Global Companion Diagnostic-Associated Drug Market by Leading Product (2013) - Percentage Share Breakdown of Revenue for Erbitux, Gleevec, Herceptin, Iressa, Sprycel, Tarceva, Tasigna, & Others (includes corresponding Graph/Chart) II-11

3. MARKET TRENDS/GROWTH DRIVERS..............II-12 Growing Significance of Personalized Medicine Remains a Major Market Driver.............. II-12 Table 5: Drug Ineffectiveness for Select Therapeutic Categories as a Percentage of Patient Population (includes corresponding Graph/Chart)..............II-13 Rising Incidence of Cancer Propels the Need for Companion Diagnostics.............. II-14 Global Cancer Incidence on the Rise - Opportunity Indicators for Companion Diagnostics Market II-15 Table 6: Worldwide Incidence of Cancer in Millions: 2012, 2020 & 2030 (includes corresponding Graph/Chart) II-15

Table 7: World Cancer Incidence by Geographic Region and Gender (2012): Number of New Cancer Cases Reported (in Thousands) for Asia-Oceania, Europe, North America, Latin America & the Caribbean, and Africa (includes corresponding Graph/Chart).............. II-16

Table 8: New Cancer Cases in the World by Affected Site: 2012 (in Thousands) (includes corresponding Graph/Chart) II-17

Table 9: Global Cancer Incidence by Income Group: 2012 (in Thousands) (includes corresponding Graph/Chart) II-18 Growing Aging Population and Prevalence of Chronic Diseases Spurs Companion Diagnostics Demand II-18 Table 10: Global Population Statistics for the 65+ Age Group (2013) (includes corresponding Graph/Chart) II-19

Table 11: Elderly Population (65+ Years) as a % of Total Population (2000 & 2025) (includes corresponding Graph/Chart) II-20

Table 12: Percentage of Population Aged 65 and Above in EU-27 Countries, US and Japan (1960-2030) (includes corresponding Graph/Chart).............. II-20 Increasing Partnerships between Pharmaceutical and Diagnostics Players.............. II-21 Select Deals between Pharmaceutical and Diagnostic Companies: 2015 & 2016.............. II-21 Companion Diagnostics Augur Well for Pharmaceutical Companies with Diagnostics Capabilities II-22 Significant Role of Biomarkers in Companion Diagnostics II-22 List of US-FDA Approved Biomarkers for Cancer II-23 Companion Diagnostics Aid R&D Cost Reduction II-23 Table 13: Per-Capita Healthcare Expenditure in Select Regions (2013) (includes corresponding Graph/Chart) II-24

Table 14: Leading Countries with the Highest Healthcare Spending as a Percentage of GDP (2012) (includes corresponding Graph/Chart)..............II-25

4. REGULATORY SCENARIO..............II-26 Companion Diagnostics: What Various Stakeholders Expect? II-26 Pharmaceutical Company (Drug Manufacturer) II-26 Diagnostic Company (Companion Diagnostic Manufacturer) II-26 Patients.............. II-27 Physician/Healthcare Professional II-27 Payer.............. II-27 Revised Payer Strategy: Need of the Hour II-27 Regulatory Scenario in Leading Global Markets II-27 United States.............. II-27 Canada.............. II-28 Europe.............. II-28 List of Key Market Requirements for Companion Diagnostics across the World.............. II-29

5. PRODUCT OVERVIEW.............. II-30 Diagnostics in Personalized Medicine II-30 Genetic Tests.............. II-30 Companion Diagnostics..............II-30 Companion Diagnostics: What makes them work II-31 Techniques Used in Companion Diagnostics II-31 PCR Technology Proves to be of Significant Use in Companion Diagnostics.............. II-32 QuantaLife ddPCR™ System: A Breakthrough Innovation in the Field of Companion Diagnostics..............II-32 Biomarkers as Companion Diagnostics II-33 Herceptin and Vilazodone - References for Success of Biomarker Based Approach..............II-34 Applications of Companion Diagnostics at a Glance II-34 Role of Companion Diagnostics in the Drug Development Process II-34 Companion Diagnostics in Clinical Trials II-35 Companion Diagnostics in Select Therapeutic Areas II-35 Companion Diagnostics in Oncology II-35 Select Companion Diagnostics in Cancer II-36 Molecular Grade Index (MGISM) (bioTheranostics) II-38 Breast Cancer IndexSM (bioTheranostics) II-39 KRAS Testing.............. II-39 HER2 Testing for Herceptin Treatment in Breast Cancer II-40 Assays Used for HER2 Testing..............II-40 MammaPrint.............. II-40 The EGFRx™ Assay to Aid Cancer Treatment II-41 c-Kit pharmDx Assay to Aid Cancer Treatment (DakoCytomation) II-41 Companion Diagnostics in Inflammatory Diseases II-41 PROMETHEUS® IBD Serology 7 for Irritable Bowel Disease II-41 Companion Diagnostics in Infectious Diseases II-42 Trofile® Assay (Monogram Biosciences) to Aid in HIV Treatment II-42 Companion Diagnostics in Drug Metabolism II-42 AmpliChip® CYP450 Test..............II-42 HILOmet PhyzioType™ System (Genomas) II-42 Warfarin Sensitivity Test..............II-43 An Account of Companion Diagnostics Companies in the CNS Arena II-44

6. RECENT INDUSTRY ACTIVITY..............II-45 Avant Diagnostics Acquires Amarantus Diagnostics and Theranostics Health..............II-45 Thermo Fisher Enters Into Agreement with Novartis and Pfizer for CDx.............. II-45 R-Biopharm to Collaborate on Companion Diagnostics with Merck II-45 Myriad Genetics Expands CDx Research Collaboration with AbbVie II-45 QIAGEN Reaches Record Milestone in Collaboration Agreements for CDx.............. II-45 NanoString and Medivation Collaborate with Astellas for CDx Assay Development..............II-45 Ono Pharmaceutical to Develop Companion Diagnostic for its Cancer Drug Opdivo.............. II-45 Foundation Medicine and Mirati Collaborate to Develop CDx for NSCLS Drug Glesatinib..............II-46 Almac to Collaborate with Illumina on NGS-Based Companion Diagnostics.............. II-46 NeoGenomics to Acquire Clarient..............II-46 R-Biopharm to Take Over GeneWake II-46 Dako Announces FDA Approval of Companion Diagnostic for NSCLC II-46 BriaCell Therapeutics Launches R&D Program on Companion Diagnostic Product.............. II-46 Asuragen Enters into Agreement with Illumina for CDx Development II-46 Roche Submits CDx to FDA for Premarket Approval II-47 Shuwen Biotech and Jiangsu Enter into Collaboration for CDx Development.............. II-47 R-Biopharm AG and Apogenix Enter into R&D Collaboration II-47 Qiagen Receives FDA Approval for CDx with AstraZeneca's IRESSA II-47 Almac to Develop CDx for OncoMed's Novel Therapeutic Drug II-47 Halozyme Therapeutics and Ventana Enter into Agreement to Develop CDx for Pancreatic Cancer Drug II-47 AstraZeneca Collaborates with Abbott for Asthma CDx Tests II-47 Invivoscribe Technologies Enters Into CDx Agreement with Astellas II-48 Dako Announces Expanded Collaboration with Amgen on Companion Diagnostics.............. II-48 LabCorp Acquires Covance..............II-48 Roche to Acquire Stake in Foundation Medicine II-48 TESARO and Myriad Announce Collaboration on myChoice HRD CDx II-48 Qiagen Signs Collaboration Agreement with Novartis II-48 Qiagen Enters into Collaboration Agreement with Astellas II-48 Illumina Enters Into Collaborations with AstraZeneca, Janssen & Sanofi.............. II-49 AstraZeneca Launches Collaborations with Qiagen and Roche II-49 Illumina Acquires Myraqa..............II-49 Cancer Genetics to Acquire Gentris Corporation II-49 Biocartis and Abbott Announce Collaboration to Develop CDx II-49 Quest Diagnostics Introduces FDA-Approved THxID®- RAF test from bioMerieux.............. II-49 Roche's Ventana Launches CDx Prototype Assays II-49 AVEO and Biodesix Enter Into Development & Commercialization Agreement.............. II-50 Foundation Medicine and Clovis Oncology Expand Collaboration II-50 Illumina Enters into Agreement with Amgen to Develop CDx for Colorectal Cancer Drug..............II-50

7. FOCUS ON SELECT PLAYERS..............II-51 Abbott Molecular Inc. (US)..............II-51 Beckman Coulter, Inc. (US)..............II-51 bioMérieux SA (France)..............II-52 Dako A/S (Denmark)..............II-52 Foundation Medicine, Inc. (US) II-53 GE Healthcare Ltd. (UK)..............II-53 Clarient Diagnostic Services, Inc. (US) II-54 Laboratory Corporation of America® Holdings (US) II-54 Leica Biosystems Nussloch GmbH (Germany) II-55 Merck & Co. Inc. (US)..............II-56 Myriad Genetics, Inc. (US)..............II-56 QIAGEN N.V. (Netherlands)..............II-56 Quest Diagnostics, Inc. (US)..............II-57 Roche Diagnostics Corp. (US)..............II-58 Ventana Medical Systems, Inc. (US) II-59 Thermo Fisher Scientific Inc. (US) II-59

8. GLOBAL MARKET PERSPECTIVE..............II-61 Table 15: World Recent Past, Current & Future Analysis for Companion Diagnostics Market by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)..............II-61

Table 16: World 7-Year Perspective for Companion Diagnostics by Geographic Region - Percentage Breakdown of Dollar Revenues for US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets for Years 2016 & 2022 (includes corresponding Graph/Chart)..............II-62 By Application.............. II-63 Table 17: World Recent Past, Current & Future Analysis for Companion Diagnostics Market by Application Segment - Oncology, Neurology, and Others Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) II-63

Table 18: World 7-Year Perspective for Companion Diagnostics by Application Segment - Percentage Breakdown of Dollar Revenues for Oncology, Neurology, and Others Markets for Years 2016 & 2022 (includes corresponding Graph/Chart) II-64

III. MARKET

1. THE UNITED STATES.............. III-1 A.Market Analysis.............. III-1 Current & Future Analysis..............III-1 Table 19: Rise in CDx Numbers Over the years - No. of FDA-Approved Drugs requiring CDx in 1998, 2005, 2008 & 2016 (includes corresponding Graph/Chart) III-2

Table 20: Leading FDA-Approved CDx Drugs (2015): Percentage Share Breakdown for Erbitux/Vectibix, Exjade, Gilotrif, Gleevec, Herceptin, Herceptin/Perjeta, Lynparza, Mekinist/Tafinlar, Tarceva, Xalkori, and Zelboraf (includes corresponding Graph/Chart)..............III-2 List of FDA-Approved Companion Diagnostic Devices (In-vitro and Imaging Tools): As of 2016 III-3 Growing Cancer Incidence - An Opportunity Indicator for Companion Diagnostics..............III-4 Table 21: New Cancer Cases in the US by Gender and Affected Site: 2014 (includes corresponding Graph/Chart) III-5

Table 22: Incidence of Cancer for All Body Sites by Gender & Age Group in the US (2013): New Cancer Cases for Males & Females for the Age groups Under 45 years; 45 years and Above; Under 65 years; 65 years and Above (includes corresponding Graph/Chart)..............III-6

Table 23: The US Breast Cancer Incidence in Women by State (2013): New Cases of Breast Cancer in Leading 15 States (includes corresponding Graph/Chart) III-7 Pioneer in Development of Companion Diagnostics in Oncology III-7 Ageing Demographics: A Key Market Driver III-8 Table 24: North American Elderly Population by Age Group: 1975-2050 (includes corresponding Graph/Chart) III-8 Robust Personalized Medicine Market Offers Potential for CDx III-9 Biomarkers: A Novel Paradigm in Companion Diagnostics III-9 Regulatory Scenario..............III-9 Strategic Corporate Developments III-10 Focus on Select Key Players..............III-13 B.Market Analytics..............III-22 Table 25: The US Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-22

Table 26: The US Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) III-23

2. CANADA.............. III-24 A.Market Analysis.............. III-24 Current & Future Analysis..............III-24 Cancer Incidence in Canada: Opportunity Indicator for Companion Diagnostics..............III-24 Table 27: New Cancer Cases in Canada by Gender and Affected Site: 2014E (includes corresponding Graph/Chart) III-24

Table 28: New Cancer Cases in Canada by Province: 2014E (includes corresponding Graph/Chart) III-25

Table 29: New Cancer Cases in Canada by Age Group: 2014E (includes corresponding Graph/Chart) III-26 Regulatory Scenario..............III-26 B.Market Analytics..............III-27 Table 30: Canadian Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-27

3. JAPAN.............. III-28 A.Market Analysis.............. III-28 Graying Population Spurs Growth III-28 Table 31: Japanese Elderly (65+ Years) Population: 2000-2020 (includes corresponding Graph/Chart) III-28 Strategic Corporate Development III-28 B.Market Analytics..............III-29 Table 32: Japanese Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-29

Table 33: Japanese Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) III-30

4. EUROPE.............. III-31 A.Market Analysis.............. III-31 Current & Future Analysis..............III-31 Regulatory Scenario in Europe..............III-31 Personalized Medicine Market to Exhibit Robust Growth, Boding Well for CDx..............III-32 Cancer Incidence in Europe: An Opportunity Indicator for CDx III-32 Table 34: Number of New Cancer Cases in Europe: 2012-2030 (includes corresponding Graph/Chart) III-32 Ageing Population Drives the Demand for Companion Diagnostics III-33 Table 35: European Country-wise Statistics of 60+ Population as % of Total Population: 2013 (includes corresponding Graph/Chart)..............III-33 B.Market Analytics..............III-34 Table 36: European Recent Past, Current & Future Analysis for Companion Diagnostics Market by Geographic Region - France, Germany, Italy, UK, Spain, and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-34

Table 37: European Historic Review for Companion Diagnostics Market by Geographic Region - France, Germany, Italy, UK, Spain, and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) III-35

Table 38: European 7-Year Perspective for Companion Diagnostics by Geographic Region - Percentage Breakdown of Dollar Revenues for France, Germany, Italy, UK, Spain, and Rest of Europe Markets for Years 2016 & 2022 (includes corresponding Graph/Chart)..............III-36

4a. FRANCE.............. III-37 A.Market Analysis.............. III-37 Current & Future Analysis..............III-37 Change in IVD Reimbursement..............III-37 bioMérieux SA - A Key Player III-37 B.Market Analytics..............III-38 Table 39: French Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-38

Table 40: French Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) III-39

4b. GERMANY.............. III-40 A.Market Analysis.............. III-40 Current & Future Analysis..............III-40 Strategic Corporate Developments III-40 Select Key Players..............III-40 B.Market Analytics..............III-42 Table 41: German Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-42

Table 42: German Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) III-43

4c. ITALY.............. III-44 A.Market Analysis.............. III-44 Current & Future Analysis..............III-44 B.Market Analytics..............III-44 Table 43: Italian Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-44

Table 44: Italian Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) III-45

4d. THE UNITED KINGDOM..............III-46 A.Market Analysis.............. III-46 Current & Future Analysis..............III-46 Strategic Corporate Developments III-46 Key UK-Based Player - GE Healthcare Ltd. III-46 B.Market Analytics..............III-47 Table 45: UK Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-47

Table 46: UK Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) III-48

4e. SPAIN.............. III-49 A.Market Analysis.............. III-49 Current & Future Analysis..............III-49 B.Market Analytics..............III-49 Table 47: Spanish Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-49

Table 48: Spanish Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) III-50

4f. REST OF EUROPE.............. III-51 A.Market Analysis.............. III-51 Current & Future Analysis..............III-51 Strategic Corporate Developments III-51 Select Key Players..............III-52 B.Market Analytics..............III-55 Table 49: Rest of European Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) III-55

Table 50: Rest of Europe Historic Review for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart).............. III-56

5. ASIA-PACIFIC.............. III-57 A.Market Analysis.............. III-57 Current & Future Analysis..............III-57 B.Market Analytics..............III-57 Table 51: Asia-Pacific Recent Past, Current & Future Analysis for Companion Diagnostics Market by Geographic Region - China and Rest of Asia Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart).............. III-57

Table 52: Asia-Pacific 7-Year Perspective for Companion Diagnostics by Geographic Region - Percentage Breakdown of Dollar Revenues for China and Rest of Asia Pacific Markets for Years 2016 & 2022 (includes corresponding Graph/Chart) III-58

5a. CHINA.............. III-59 A.Market Analysis.............. III-59 Current & Future Analysis..............III-59 Breast Cancer CDx to Dominate..............III-59 Strategic Corporate Development III-59 B.Market Analytics..............III-60 Table 53: Chinese Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)..............III-60

5b. REST OF ASIA-PACIFIC..............III-61 A.Market Analysis.............. III-61 Current & Future Analysis..............III-61 B.Market Analytics..............III-61 Table 54: Rest of Asia-Pacific Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) III-61

6. LATIN AMERICA.............. III-62 A.Market Analysis.............. III-62 Current & Future Analysis..............III-62 B.Market Analytics..............III-62 Table 55: Latin American Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) III-62

7. REST OF WORLD.............. III-63 A.Market Analysis.............. III-63 Current & Future Analysis..............III-63 B.Market Analytics..............III-63 Table 56: Rest of World Recent Past, Current & Future Analysis for Companion Diagnostics Market Analyzed by Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) III-63

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 80 (including Divisions/Subsidiaries - 89)

The United States (53) Canada (2) Europe (28) - France (5) - Germany (4) - The United Kingdom (9) - Spain (1) - Rest of Europe (9) Asia-Pacific (Excluding Japan) (5) Middle East (1)
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