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Coagulation Disorders Market to 2017 by GBIResearch

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Coagulation Disorders Market to 2017 - Hemophilia A, the Largest Segment, to Witness a Decline in Growth Rate due to Patent Expiries and Weak Pipeline Summary GBI Research, the leading business intelligence provider, has released its latest research, “Coagulation Disorders Market to 2017 - Hemophilia A, the Largest Segment, to Witness a Decline in Growth Rate due to Patent Expiries and Weak Pipeline”, provides in-depth analysis of unmet needs, drivers and barriers that impact the global coagulation disorders market. The report analyzes the markets for coagulation disorders in the US, the top five countries in Europe (the UK, Germany, France, Italy and Spain) and Japan. Market size, annual cost of therapy and treatment usage patterns are forecast until 2016 for the key geographies, as well as the leading therapeutic segments which includes hemophilia A, hemophilia B and von Willebrand Disease. Furthermore, the report provides competitive benchmarking for the leading companies and analyzes the mergers, acquisitions and licensing agreements that shape the global coagulation disorders market. Scope The scope of this report includes - - Annualized market data for the coagulation disorders market from 2002 to 2010, forecast forward to 2017. - Analysis of the leading therapeutic segments, including hemophilia A, hemophilia B, and von Willebrand’s disease (vWD). - Analysis of the coagulation disorders market in the leading geographies of the world, which include the US, the UK, Germany, France, Italy, Spain and Japan. - Market characterization of the coagulation disorders market, including market size, annual cost of therapy and treatment usage patterns. - Key drivers and barriers that have a significant impact on the market. - Coverage of pipeline molecules in various phases of drug development. - Competitive benchmarking of leading companies. The key companies studied in this report are Baxter International Inc, Bayer AG, Novo Nordisk A/S, Pfizer I

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									  Coagulation Disorders Market to 2017 - Hemophilia A, the
 Largest Segment, to Witness a Decline in Growth Rate due to
             Patent Expiries and Weak Pipeline
 Reference Code: GBIHC074MR                                                                                         Publication Date: September 2011


                                     GBI Research’s analysis indicates that the global coagulation disorders market has been one of the
                                     fastest growing markets from 2002-2010. However, the market growth is expected to slow down in
                                     the future due to various restraints, such as the expiry of key drug patents across all disease
                                     segments, generic substitution, biosimilar penetration, and the decreasing annual cost of disease
                                     treatment in major markets such as the US, Japan and the top five countries in Europe.
                                     Nevertheless, the global coagulation disorders market is still forecast to grow at a moderate rate
                                     over the next seven years.
                                     The Global Coagulation Disorders Market is Forecast to Slow Down Due to a Series of
                                     Patent Expiries
By 2017, the global                  In 2010, the global coagulation disorders market was estimated to be worth $5.6 billion,
coagulation disorders                representing a compound annual growth rate (CAGR) of 6.7% between 2002 and 2010. By 2017,
market is estimated to               the global coagulation disorders market is estimated to reach $8.3 billion, indicating a CAGR of
grow at a CAGR of 5.7%               5.7% between 2010 and 2017. The major reason for the reduced growth rate is the expected
from 2010 as leading                 decline in the annual cost of treating coagulation disorders after 2010.
drugs are set to lose
                                     The global coagulation disorders market is expected to witness a series of patent expiries between
patent protection between
                                     2010 and 2017, which includes most of the top selling blockbuster drugs in the hemophilia disease
2010 and 2017.
                                     markets. The major drugs that are set to lose patent protection between 2010 and 2017 include
                                     NovoSeven (2010), ReFacto (2010), BeneFIX (2011) and Kogenate FS in the US (2014).
                                     While the current coagulation disorders pipeline does offer some promising products, the revenues
                                     generated from these products are not expected to completely offset the revenue lost due to the
                                     patent expiries. Therefore, the overall market growth of the global coagulation disorders market is
                                     expected to slow down in the future.

                                       Coagulation Disorders Therapeutics Market, Global, Revenue Forecasts ($bn), 2002-2017

                                                                 9                                     CAGR (2010-2017): 5.7%


                                                                 8

                                                                     CAGR (2002-2010): 6.7%
                                                                 7


                                                                 6
                                                 Revenue ($bn)




                                                                 5


                                                                 4


                                                                 3


                                                                 2


                                                                 1


                                                                 0
                                                                       2002                         2010                          2017


                                       Source: GBI Research, GBI Research’s Internal Database, Company Annual Reports, Clinical Trials.gov, NHF, WFH
                                       Note: Phase in Hemophilia have been classified into Hemophilia A,, Hemophilia B and Hemophilia




Coagulation Disorders Market to 2017 - Hemophilia A, the                                                                 GBIHC074MR /Published SEP 2011
Largest Segment, to Witness a Decline in Growth Rate due to
Patent Expiries and Weak Pipeline                                                                                                                      Page 1
                                                                                    © GBI Research. This is a licensed product and is not to be photocopied
                                     The Global Coagulation Disorders Pipeline is Dominated by Early-Stage Development
                                     Products
                                     The current coagulation disorders market scenario demands substantial output from the research
                                     and development (R&D) departments of pharmaceutical companies. With a series of patent
                                     expiries expected in the next seven years, disease indications such as hemophilia A and
                                     hemophilia B are set to lose billions of dollars of revenue from the market as a result.
                                     The current pharmaceutical pipeline for coagulation disorders does provide some promising drugs.
                                     However, the drugs are not expected to completely replace the revenue losses experienced due to
                                     the patent expiry of the current blockbuster drugs, such as Kogenate FS, NovoSeven, BeneFIX and
                                     others.

                                       Hemophilia Therapeutics Market, Global, R&D Pipeline by Phase (%), Jul 2011

                                                                                                  NDA Filed
                                                                                   Discovery        2%
                                                                                      4%
                                                                                                                             Phase I
                                                                                                                              20%




                                                       Pre-Clinical
                                                          34%




                                                                                                                                   Phase II
                                                                                                                                    24%




                                                                                     Phase III
                                                                                       16%

                                       Source: GBI Research, GBI Research’s Internal Database, Company Annual Reports, Clinical Trials.gov, NHF, WFH
                                       Note: Phase in Hemophilia have been classified into Hemophilia A,, Hemophilia B and Hemophilia




                                     The hemophilia pipeline is largely dominated by early stage development projects. In the
                                     hemophilia pipeline, early stage development, which includes the discovery, preclinical and Phase I
                                     stages, accounts for 54% of the total projects. The preclinical stage in the hemophilia pipeline
                                     accounts for approximately 34% of the total R&D programs, the largest of all the stages. This is
                                     followed by Phase II programs, which account for approximately 24% of the total R&D programs,
                                     while Phase III programs account for 16%. The discovery stage accounts for 4% of the pipeline,
                                     while NDA filed projects form 2%. The primary focus of the pipeline has remained finding a cure for
                                     hemophilia A, which is approximately five times as common as hemophilia B.
                                     The current coagulation disorders pipeline focuses on three major indications: hemophilia A,
                                     hemophilia B and von Willebrand disease. Approximately 89% of the current coagulation disorders
                                     pipeline concentrates on hemophilia A and hemophilia B as its major indications. About 54% of the
                                     coagulation disorders pipeline is in the early stages of development for hemophilia.




Coagulation Disorders Market to 2017 - Hemophilia A, the                                                               GBIHC074MR /Published SEP 2011
Largest Segment, to Witness a Decline in Growth Rate due to
Patent Expiries and Weak Pipeline                                                                                                                      Page 2
                                                                                © GBI Research. This is a licensed product and is not to be photocopied
                                     About 34% of the total projects for hemophilia A and hemophilia B are in the preclinical stage,
                                     which suggests that the future hemophilia market can expect some novel drugs. The vWD disease
                                     market is comparatively smaller than the markets for hemophilia A and hemophilia B. With less
                                     market opportunities available, pharmaceutical companies do not make these indications their top
                                     priorities. vWD accounts for 11% of the current coagulation disorders pipeline, with a total of eight
                                     projects.
                                     Large Number of Licensing Deals in the Coagulation Disorders Market Focused on the US
                                     and Europe
                                     A large number of licensing deals in the coagulation disorders market are focused on the US and
                                     Europe. The US witnessed the most licensing activity with 41%, followed by deals focused on the
                                     US, Europe, Asia-Pacific, Middle East and Africa at 31%. Deals specific to Europe accounted for
                                     17% of the total agreements, while Asia-Pacific witnessed 4% of the licensing activity at a global
                                     level.




Coagulation Disorders Market to 2017 - Hemophilia A, the                                                   GBIHC074MR /Published SEP 2011
Largest Segment, to Witness a Decline in Growth Rate due to
Patent Expiries and Weak Pipeline                                                                                                      Page 3
                                                                        © GBI Research. This is a licensed product and is not to be photocopied
                                     1         Table of Contents
                                     1   Table of Contents ........................................................................................................................ 4
                                         1.1    List of Tables..................................................................................................................... 6
                                         1.2    List of Figures ................................................................................................................... 7
                                     2   Introduction .................................................................................................................................. 9
                                         2.1    GBI Research Report Guidance ....................................................................................... 9
                                     3   Coagulation Disorders Therapeutics Market: Market Overview ................................................. 10
                                         3.1    Introduction ..................................................................................................................... 10
                                         3.2    Revenue Forecasts for the Global Coagulation Disorders Market .................................. 11
                                            3.2.1    Revenue .................................................................................................................. 11
                                            3.2.2    Annual Cost of Therapy ........................................................................................... 12
                                            3.2.3    Treatment Usage Pattern ........................................................................................ 13
                                         3.3    Coagulation Disorders Market Drivers ............................................................................ 19
                                            3.3.1    Steady Increase in the Prevalence Population, Particularly in the Top Five Countries
                                                     in Europe ................................................................................................................. 19
                                            3.3.2    Rapid Uptake of Recombinant Products due to Better Efficacy, Safety and
                                                     Convenient Dosing .................................................................................................. 19
                                            3.3.3    Increase in the Prescription Population due to Patent Expiries of Expensive Biologic
                                                     Drugs, Making Them More Affordable ..................................................................... 20
                                         3.4    Coagulation Disorders Market Restraints ....................................................................... 21
                                            3.4.1    Low Diagnosed Population as Mild and Moderate Forms of Coagulation Disorders
                                                     Go Undiagnosed...................................................................................................... 21
                                            3.4.2    Patent Expiries of Major Blockbusters Including Kogenate FS, BeneFIX,
                                                     NovoSeven, and ReFacto Pose a Threat to Leading Players in the Market ............ 21
                                            3.4.3    Sluggish Growth in the Annual Cost of Therapy for Coagulation Disorders is
                                                     Expected to Drive Down the Growth Rate ............................................................... 21
                                     4   Global Coagulation Disorders Market: Geographical Landscape .............................................. 22
                                         4.1    Geographical Break-up ................................................................................................... 22
                                         4.2    The US ............................................................................................................................ 24
                                            4.2.1    Revenue .................................................................................................................. 24
                                            4.2.2    Annual Cost of Therapy ........................................................................................... 25
                                            4.2.3    Treatment Usage Patterns ...................................................................................... 26
                                         4.3    Top Five Countries in Europe ......................................................................................... 29
                                            4.3.1    Revenue .................................................................................................................. 29
                                            4.3.2    Annual Cost of Therapy ........................................................................................... 30
                                            4.3.3    Treatment Usage Pattern ........................................................................................ 31
                                         4.4    Japan .............................................................................................................................. 34
                                            4.4.1    Revenue .................................................................................................................. 34
                                            4.4.2    Annual Cost of Therapy ........................................................................................... 35
                                            4.4.3    Treatment Usage Patterns ...................................................................................... 36
                                     5   Coagulation Disorders Therapeutics Market: Therapeutic Landscape ...................................... 38
                                         5.1    Hemophilia A Market....................................................................................................... 38
                                            5.1.1    Introduction .............................................................................................................. 38
                                            5.1.2    Revenue .................................................................................................................. 41
                                            5.1.3    Annual Cost of Treatment........................................................................................ 45
                                            5.1.4    Treatment Flow Algorithm ....................................................................................... 46
                                            5.1.5    Treatment Usage Pattern ........................................................................................ 47
                                         5.2    Hemophilia B Market....................................................................................................... 50
                                            5.2.1    Introduction .............................................................................................................. 50
                                            5.2.2    Revenue .................................................................................................................. 53
                                            5.2.3    Annual Cost of Treatment........................................................................................ 56
                                            5.2.4    Treatment Flow Algorithm ....................................................................................... 57
                                            5.2.5    Treatment Usage Pattern ........................................................................................ 58
                                         5.3    von Willebrand Disease (vWD) Market ........................................................................... 60
                                            5.3.1    Introduction .............................................................................................................. 60

Coagulation Disorders Market to 2017 - Hemophilia A, the                                                                                GBIHC074MR /Published SEP 2011
Largest Segment, to Witness a Decline in Growth Rate due to
Patent Expiries and Weak Pipeline                                                                                                                                               Page 4
                                                                                        © GBI Research. This is a licensed product and is not to be photocopied
                                            5.3.2    Revenue .................................................................................................................. 65
                                            5.3.3    Annual Cost of Treatment........................................................................................ 68
                                            5.3.4    Treatment Flow Algorithm ....................................................................................... 69
                                            5.3.5    Treatment Usage Pattern ........................................................................................ 70
                                     6   Coagulation Disorders Therapeutics Market to 2017: Pipeline Analysis.................................... 73
                                         6.1    Introduction ..................................................................................................................... 73
                                            6.1.1    Research and Development Pipeline – Hemophilia................................................. 74
                                            6.1.2    Research and Development Pipeline – von Willebrand Disease (vWD) .................. 77
                                         6.2    Profiles of Key Late-Stage Drugs in the Coagulation Disorders Market .......................... 78
                                            6.2.1    NecLip-pdFVIII......................................................................................................... 78
                                            6.2.2    Long Acting rFactor VIII ........................................................................................... 78
                                            6.2.3    OBI-1 ....................................................................................................................... 79
                                            6.2.4    Recombinant Factor IX Fc Fusion Protein (rFIXFc) ................................................. 80
                                            6.2.5    NN7008 ................................................................................................................... 81
                                            6.2.6    Human-cl rhFVIII ..................................................................................................... 81
                                            6.2.7    BAX 326 .................................................................................................................. 82
                                            6.2.8    IB1001 ..................................................................................................................... 83
                                            6.2.9    NNC-0156-0000-0009 ............................................................................................. 84
                                            6.2.10 Biostate ................................................................................................................... 84
                                            6.2.11 Long Acting rFactor IX ............................................................................................. 85
                                     7   Global Coagulation Disorders Market: Competitive Landscape ................................................ 87
                                         7.1    Competitive Profiling ....................................................................................................... 87
                                            7.1.1    Baxter International Inc............................................................................................ 87
                                            7.1.2    Novo Nordisk A/S .................................................................................................... 89
                                            7.1.3    Pfizer Inc.................................................................................................................. 91
                                            7.1.4    CSL Behring LLC..................................................................................................... 93
                                            7.1.5    Bayer AG ................................................................................................................. 94
                                            7.1.6    LFB .......................................................................................................................... 95
                                            7.1.7    Grifols ...................................................................................................................... 96
                                            7.1.8    Biotest ..................................................................................................................... 99
                                            7.1.9    Bio Product Laboratory .......................................................................................... 100
                                            7.1.10 Octapharma ........................................................................................................... 101
                                     8   Global Coagulation Disorders Market: Strategic Consolidations ............................................. 104
                                         8.1    Overview ....................................................................................................................... 104
                                            8.1.2    Deals by Geography .............................................................................................. 106
                                            8.1.3    Deals by Value ($) ................................................................................................. 107
                                     9   Global Coagulation Disorders Market: Appendix ..................................................................... 108
                                         9.1    Market Definitions ......................................................................................................... 108
                                         9.2    Abbreviations ................................................................................................................ 108
                                         9.3    Research Methodology ................................................................................................. 109
                                            9.3.1    Coverage ............................................................................................................... 109
                                            9.3.2    Secondary Research ............................................................................................. 109
                                            9.3.3    Primary Research .................................................................................................. 110
                                         9.4    Therapeutic Landscape ................................................................................................ 110
                                            9.4.2    Market Size by Geography .................................................................................... 112
                                         9.5    Geographical Landscape .............................................................................................. 113
                                         9.6    Pipeline Analysis ........................................................................................................... 113
                                         9.7    Competitive Landscape ................................................................................................ 113
                                            9.7.1    Expert Panel Validation ......................................................................................... 113
                                         9.8    Contact Us .................................................................................................................... 113
                                         9.9    Disclaimer ..................................................................................................................... 113
                                         9.10 Sources ......................................................................................................................... 114




Coagulation Disorders Market to 2017 - Hemophilia A, the                                                                              GBIHC074MR /Published SEP 2011
Largest Segment, to Witness a Decline in Growth Rate due to
Patent Expiries and Weak Pipeline                                                                                                                                           Page 5
                                                                                       © GBI Research. This is a licensed product and is not to be photocopied
                                     1.1     List of Tables
                                     Table 1:    Coagulation Disorders Market, Global, Revenue ($bn), 2002–2010 .............................. 11
                                     Table 2:    Coagulation Disorders Market, Global, Revenue ($bn), 2010–2017 .............................. 11
                                     Table 3:    Coagulation Disorders Market, Global, Annual Cost of Therapy ($), 2002–2010 ........... 12
                                     Table 4:    Coagulation Disorders Market, Global, Annual Cost of Therapy ($), 2010–2017 ........... 12
                                     Table 5:    Coagulation Disorders Market, Global, Treatment Usage Patterns (thousands), 2002–
                                                 2010 ............................................................................................................................... 13
                                     Table 6:    Coagulation Disorders Market, Global, Treatment Usage Patterns (thousands), 2010–
                                                 2017 ............................................................................................................................... 14
                                     Table 7:    Coagulation Disorders Market, Global, Sales Value by Geography ($bn), 2002–2010 . 22
                                     Table 8:    Coagulation Disorders Market, Global, Sales Value by Geography ($bn), 2010–2017 . 23
                                     Table 9:    Coagulation Disorders Market, The US, Revenue ($bn), 2002–2010 ............................ 24
                                     Table 10:   Coagulation Disorders Market, The US, Sales Value ($bn), 2010–2017 ....................... 24
                                     Table 11:   Coagulation Disorders Market, The US, Annual Cost of Treatment ($), 2002–2010 ...... 25
                                     Table 12:   Coagulation Disorders Market, The US, Annual Cost of Treatment ($), 2010–2017 ...... 25
                                     Table 13:   Coagulation Disorders Market, The US, Treatment Usage Pattern (thousands), 2002–
                                                 2010 ............................................................................................................................... 27
                                     Table 14:   Coagulation Disorders Market, The US, Treatment Usage Pattern (thousands), 2010–
                                                 2017 ............................................................................................................................... 27
                                     Table 15:   Coagulation Disorders Market, Top Five Countries in Europe, Revenue ($bn), 2002–
                                                 2010 ............................................................................................................................... 29
                                     Table 16:   Coagulation Disorders Market, Top Five Countries in Europe, Revenue ($bn), 2010–
                                                 2017 ............................................................................................................................... 29
                                     Table 17:   Coagulation Disorders Market, Top Five Countries in Europe, Annual Cost of Treatment
                                                 ($), 2002–2010 ............................................................................................................... 30
                                     Table 18:   Coagulation Disorders Market, Top Five Countries in Europe, Annual Cost of Therapy
                                                 ($), 2010–2017 ............................................................................................................... 30
                                     Table 19:   Coagulation Disorders Market, Top Five Countries in Europe, Treatment Usage Pattern
                                                 (thousands), 2002–2010 ................................................................................................ 31
                                     Table 20:   Coagulation Disorders Market, Top Five Countries in Europe, Treatment Usage Pattern
                                                 (thousands), 2010–2017 ................................................................................................ 32
                                     Table 21:   Coagulation Disorders Market, Japan, Revenue ($m), 2002–2010................................ 34
                                     Table 22:   Coagulation Disorders Market, Japan, Revenue ($m), 2010–2017................................ 34
                                     Table 23:   Coagulation Disorders Market, Japan, Annual Cost of Treatment ($), 2002–2010 ........ 35
                                     Table 24:   Coagulation Disorders Market, Japan, Annual Cost of Treatment ($), 2010–2017 ........ 35
                                     Table 25:   Coagulation Disorders Market, Japan, Treatment Usage Pattern (thousands), 2002–
                                                 2010 ............................................................................................................................... 36
                                     Table 26:   Coagulation Disorders Market, Japan, Treatment Usage Pattern (thousand), 2010–2017
                                                 ....................................................................................................................................... 37
                                     Table 27:   Hemophilia A Therapeutics Market, Global, Revenue ($bn), 2002–2010 ...................... 42
                                     Table 28:   Hemophilia A Therapeutics Market, Global, Revenue ($bn), 2010–2017 ...................... 42
                                     Table 29:   Hemophilia A Therapeutics Market, Global, Annual Cost of Treatment ($), 2002–2010 45
                                     Table 30:   Hemophilia A Therapeutics Market, Global, Annual Cost of Treatment ($), 2010–2017 45
                                     Table 31:   Hemophilia A Therapeutics Market, Global Treatment Usage Pattern (thousand), 2002–
                                                 2010 ............................................................................................................................... 48
                                     Table 32:   Hemophilia A Therapeutics Market, Global, Treatment Usage Pattern (thousand), 2010–
                                                 2017 ............................................................................................................................... 48
                                     Table 33:   Hemophilia B Therapeutics Market, Global, Revenue ($m), 2002–2010 ....................... 53
                                     Table 34:   Hemophilia B Therapeutics Market, Global, Revenue ($m), 2010–2017 ....................... 53
                                     Table 35:   Hemophilia B Therapeutics Market, Global, Annual Cost of Treatment ($), 2002–2010 56
                                     Table 36:   Hemophilia B Therapeutics Market, Global, Annual Cost of Treatment ($), 2010–2017 56
                                     Table 37:   Hemophilia B Therapeutics Market, Global, Treatment Usage Pattern (thousand), 2002–
                                                 2010 ............................................................................................................................... 58
                                     Table 38:   Hemophilia B Therapeutics Market, Global, Treatment Usage Pattern (thousand), 2010–
                                                 2017 ............................................................................................................................... 59
                                     Table 39:   vWD Therapeutics Market, Global, Revenue ($m), 2002–2010 ..................................... 65
                                     Table 40:   vWD Therapeutics Market, Global, Revenue ($m), 2010–2017 ..................................... 65
                                     Table 41:   vWD Therapeutics Market, Global, Annual Cost of Treatment ($), 2002–2010 ............. 68
                                     Table 42:   vWD Therapeutics Market, Global, Annual Cost of Treatment ($), 2010–2017 ............. 68
                                     Table 43:   vWD Therapeutics Market, Global, Treatment Usage Pattern (thousand), 2002–2010 70
                                     Table 44:   vWD Therapeutics Market, Global, Treatment Usage Pattern (thousand), 2010–2017 71
                                     Table 45:   Hemophilia Therapeutics Market, Global, R&D Pipeline by Phase, 2011 ...................... 75

Coagulation Disorders Market to 2017 - Hemophilia A, the                                                                                GBIHC074MR /Published SEP 2011
Largest Segment, to Witness a Decline in Growth Rate due to
Patent Expiries and Weak Pipeline                                                                                                                                               Page 6
                                                                                      © GBI Research. This is a licensed product and is not to be photocopied
                                     Table 46: vWD Therapeutics Market, Global, R&D Pipeline by Phase .......................................... 77
                                     Table 47: Coagulation Disorders Market, Global, Major M&A Deals, 2008-2010......................... 105


                                     1.2       List of Figures
                                     Figure 1:  Coagulation Disorders Market, Global, Drivers and Restraints, 2010 ............................ 10
                                     Figure 2:  Coagulation Disorders Market, Global, Revenue ($bn), 2002–2017 .............................. 11
                                     Figure 3:  Coagulation Disorders Market, Global, Annual Cost of Therapy ($), 2002–2017 ........... 12
                                     Figure 4:  Coagulation Disorders Market, Global, Treatment Usage Pattern (thousands), 2002–
                                                2017 ............................................................................................................................... 13
                                     Figure 5: Coagulation Disorders Market, Global, Diseased Population (thousands), 2002–2017 15
                                     Figure 6: Coagulation Disorders Market, Global, Treatment Seeking Population (thousands),
                                                2002–2017 ..................................................................................................................... 16
                                     Figure 7: Coagulation Disorders Market, Global, Diagnosed Population (thousands), 2002–2017
       
								
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