Reportlinker Adds Stem Cell Therapeutics for Oncology: Technologies and Global Markets
NEW YORK, May 3, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Stem Cell Therapeutics for Oncology: Technologies and Global Markets
The global stem cell anticancer therapeutics market was valued at $859 million in 2010. This market is expected to increase at an 11.3% compound annual growth rate (CAGR) to reach nearly $1.5 billion in 2015.
Latin and South America represent one of the faster-growing geographical segments for stem cell anticancer therapies. This region was valued at nearly $55 million in 2010 and is expected to increase at a 15.1% compound annual growth rate (CAGR) to reach $110 million.
The North American market for stem cell anticancer therapeutics was valued at $346 million in 2010. This region is expected to increase at an 8% compound annual growth rate (CAGR) to reach $509 million in 2015.
INTRODUCTION
STUDY GOALS AND OBJECTIVES
BCC's goal in conducting this study was to determine the current status of the global marketplace for stem cell therapies utilized in oncology settings and to assess this niche marketplace's growth potential for the 5-year period from 2010 through 2015.
At present, stem cell based therapies in oncology are primarily of the hematopoietic variety, although at the research level there is significant development with embryonic, pluripotent and other stem cell therapies. Conservatively speaking there are, presently, no FDA approved stem cell biologics, however there are a few FDA approved therapies that are utilized adjunctively as part of an oncology regimen. These therapies have either a tissue regenerative effect, a tissue protective effect, or an anti-cancer effect and are stem or progenitor cell based depending on which theory of cellular biology is employed. In 2009 President Obama issued executive order 13505, which further empowered new stem cell lines, and ultimately gives scientists larger pools of new data to explore, and brightens both the near term and long term future of stem cell research.
The majority of the revenues reflected in this report are based on the industrial research from incorporated entities providing second- and third-party research where the key data is excerpted from public sources such as annual reports, press releases, and other key public data, as it relates to a conservative definition of stem cell based therapeutics. Generally speaking, research at this level is not profitable, so the revenues reflected in this report represent some of the more innovative companies and organizations with the savvy to produce revenue streams in the millions of dollars range at a time when most organizations are having great difficulty keeping pace.
Our key objective with this report is to produce an intensive analysis of the current stem cell therapeutics oncology market in cancers such as multiple myeloma, leukemia, lymphoma, prostate, breast and lung cancers, and to explore the future direction of these markets. These are the primary cancers being studied for applications relating to stem cell based therapies. We have included a section on natural derived products with antitumor effects that are part of a stem cell therapeutic-based regimen.
We have specifically excluded any analysis of non-oncology uses of stem cells, stem cells in diagnostics, or any use of stem cells that are outside the scope of anti-tumor therapeutics, protection of healthy tissues in oncology settings, or healthy tissue development in individuals with cancer. Also our selection of stem cell based therapeutics has been carefully selected to include therapeutics that are denoted in primary sources as stem cell therapeutics, not those of progenitor cells, or of growth factors, proteins, cell mobilizers that are later in cell development cycle than stem cells. There will be further discussion of this in Chapter Four
REASONS FOR DOING THIS STUDY
Malignant tumors, particularly those that are advanced, often are incurable and recurrent. Their etiology is based on a host of factors ranging from genetics, radiation exposure, to a chemical and/or biological carcinogen, or any combination of the above. To further complicate treatment, there are issues of drug-resistance, proper early diagnosis, and our treatments of the disease doing less harm than the cancer itself in humans with these often invasive neoplasms. It is estimated that nearly 1 out of 2 men and 1 out of 3 women at some point in their lifetime will have a form of cancer. To further complicate matters, there is good statistical source material that denotes as much as a 50% death rate attributed to stem cell transplants in oncology settings due to the side effects of the transplant including graft vs. host disease being a key issue.
Nonetheless, as cancer is presently incurable in its advanced state, biologics hold a fantastic amount of potential and a growing market share in the oncology therapeutics marketplace and stem cells, should we resolve the regulatory and safety issues. As such, BCC was particularly interested in examining the oncology market of the stem cell therapies in all venues that they present.
INTENDED AUDIENCE
This report was prepared as a study of the global oncolytic stem cell therapeutic marketplace for use in humans.
Information is presented on the oncology industry in general including a specific focus on the various market segments including autologous or allogeneic, stem cell transplants, therapeutics that produce healthy stem cells or inhibit tumor stem cells, both alone and in adjunctive settings.
This study will be of significant interest to hospitals, pharmacies, pharmaceutical companies, biopharmaceutical researchers, pharmaceutical company marketing executives, contract research organizations (CROs), chemists, physicians, nurses, physician assistants, pharmaceutical directors, product managers and representatives, all manner of institutional directors ranging from nursing homes and schools, to those in long term care situations both public and private. It will also be of interest to investment bankers in the biotechnology and pharmaceutical sectors, insurance executives and oncology product marketing managers alike.
SCOPE OF REPORT
This study examines the human applications both marketed and in development of anti-cancer and tissue protective therapies and stem cell therapies for oncology conditions. BCC extensively analyzes each market segment, presents its current market status and presents various forecasts for growth over the next 5 years. Other factors such as Food and Drug Administration (FDA) restrictions, government legislation, a cancer's drug resistance to therapeutics, and/or natural and alternative remedies are also highlighted, where they meet the criteria of what this report is defining as a stem cell based therapeutic. Our financial and sales analysis focuses on the available figures from 2007 through 2009 with estimates for the years 2010 through 2015, including compound annual growth rates (CAGRs).
METHODOLOGY
Through an extensive industry survey BCC was able to compile data to present our analysis of the oncology stem cell based therapeutics, by market segment. Research included online database searches of industry specific data sources coupled with financial, trade, government, and marketing database sources as well as interviews via correspondence or telephone with independent sources comprising companies, government agencies, and academic experts.
CHAPTER ONE: INTRODUCTION
STUDY GOALS AND OBJECTIVES
REASONS FOR DOING THIS STUDY
INTENDED AUDIENCE
SCOPE OF REPORT
METHODOLOGY
INFORMATION SOURCES
ANALYST CREDENTIALS
RELATED BCC REPORTS
BCC ONLINE SERVICES
DISCLAIMER
CHAPTER TWO: SUMMARY
SUMMARY TABLE GLOBAL MARKET REVENUE FORECAST FOR STEM CELL THERAPEUTIC REGIMENS IN ONCOLOGY, THROUGH 2015 ($ MILLIONS)
SUMMARY FIGURE GLOBAL MARKET REVENUE FORECAST FOR STEM CELL THERAPEUTIC REGIMENS IN ONCOLOGY, 2008-2015 ($ MILLIONS)
CHAPTER THREE: OVERVIEW
HISTORY AND CURRENT STATE OF ONCOLOGY, AND CORE CONCEPTS OF STEM CELL BASED THERAPEUTICS AND REGENERATIVE MEDICINE
HISTORY OF ONCOLOGY
HISTORY OF STEM CELLS IN ONCOLOGY
A BRIEFING ON THE HISTORY OF STEM CELLS AS THERAPEUTICS, AND A FEW KEY ISSUES TO KEEP IN MIND
OTHER RELEVANT HISTORY
TYPES OF CANCER
TABLE 1 TYPES OF CANCER INCLUDED IN THIS REPORT
TABLE 2 COMMON TYPES OF LYMPHOMA
DEFINITION OF THE INDUSTRY
IMPORTANCE OF THE INDUSTRY
PRODUCT LIFE CYCLES
TABLE 3 DRUG DEVELOPMENT LIFECYCLE FOLLOWING DISCOVERY OF NEW DRUG
DEVELOPMENT OF STEM CELLS IN ONCOLOGY
TABLE 4 HISTORICAL PIPELINE OF FDA APPROVED THERAPEUTICS RELATING TO STEM AND PROGENITOR CELLS
HUMAN CLINICAL DEVELOPMENT
NEW DRUG ACTIVITY
FUTURE DEVELOPMENTS
SIGNIFICANT "NEW" CLINICAL DEVELOPMENTS 2008 TO PRESENT
TABLE 5 KEY PHASE III AND IV STEM CELL CLINICAL TRIALS WITH ESTIMATED COMPLETION DATES BETWEEN 2008 AND 2019
WITH AN EYE TOWARD THE FUTURE
CHAPTER FOUR: TYPES OF APPLICATIONS: AUTOLOGOUS, ALLOGENEIC, HEALTHY STEM CELL PROMOTER, TUMOR STEM CELL INHIBITOR
TYPES OF APPLICATIONS: AUTOLOGOUS…
HUMAN CANCERS
TABLE 6 REVENUES OF STEM CELL ONCOLOGY REGIMENS BROKEN DOWN BY CANCER INDICATION, THROUGH 2015 ($ MILLIONS)
FIGURE 1 REVENUES OF STEM CELL ONCOLOGY REGIMENS BROKEN DOWN BY CANCER INDICATION, 2008-2015 ($ MILLIONS)
RISK FACTORS FOR DEVELOPING CANCERS
TABLE 7 RISK FACTORS ASSOCIATED WITH HUMAN CANCERS
TABLE 8 INCIDENCE ASSOCIATED WITH HUMAN CANCERS IN MEN
TABLE 9 INCIDENCE ASSOCIATED WITH HUMAN CANCERS IN WOMEN
TABLE 10 HUMAN CANCER SURVIVAL STATISTICS BY ETHNIC BACKGROUND (%)
TABLE 11 ESTIMATED HUMAN CANCER TRENDS, 2008-2015
BREAST
TABLE 12 BREAST CANCER: SIGNS AND SYMPTOMS
TABLE 13 BREAST CANCER: RISK FACTORS
TABLE 14 KEY GENETIC FACTORS ASSOCIATED WITH BREAST CANCER
TABLE 15 CLINICAL TRIALS THAT INCLUDE STEM CELL-BASED THERAPEUTICS FOR BREAST CANCER
RECTUM AND COLON
TABLE 16 COLON AND RECTUM CANCERS: SIGNS AND SYMPTOMS
TABLE 17 COLON AND RECTUM CANCERS: RISK FACTORS
TABLE 18 KEY GENETIC FACTORS ASSOCIATED WITH CANCERS OF THE COLON AND RECTUM
TABLE 19 CLINICAL TRIALS THAT INCLUDE STEM CELL-BASED THERAPEUTICS FOR COLON OR RECTAL CANCERS
TABLE 20 REVENUES FOR STEM CELL BASED REGIMENS FOR COLORECTAL CANCER BY GEOGRAPHICAL REGION, THROUGH 2015
LYMPHOMA
TABLE 21 LYMPHOMAS: SIGNS AND SYMPTOMS
TABLE 22 LYMPHOMAS: RISK FACTORS
TABLE 23 KEY GENETIC FACTORS ASSOCIATED WITH LYMPHOMAS
TABLE 24 REVENUES FOR STEM CELL BASED REGIMENS FOR LYMPHOMAS BY GEOGRAPHICAL REGION, THROUGH 2015 ($ MILLIONS)
TABLE 25 CLINICAL TRIALS THAT INCLUDE STEM CELL-BASED THERAPEUTICS FOR LYMPHOMA
LUNG
TABLE 26 LUNG CANCERS: SIGNS AND SYMPTOMS
TABLE 27 LUNG CANCERS: RISK FACTORS
Non-small Cell Lung Cancer
Small Cell Lung Cancer
TABLE 28 KEY GENETIC FACTORS ASSOCIATED WITH LUNG CANCERS
TABLE 29 CLINICAL TRIALS THAT INCLUDE STEM CELL-BASED THERAPEUTICS FOR LUNG CANCERS
TABLE 30 REVENUES FOR STEM CELL BASED REGIMENS FOR LUNG CANCER BY GEOGRAPHY, THROUGH 2015 ($ MILLIONS)
LEUKEMIA
TABLE 31 LEUKEMIA: SIGNS AND SYMPTOMS
TABLE 32 LEUKEMIA: RISK FACTORS
TABLE 33 KEY GENETIC FACTORS ASSOCIATED WITH LEUKEMIAS
TABLE 34 CLINICAL TRIALS THAT INCLUDE STEM CELL-BASED THERAPEUTICS FOR LEUKEMIAS
TABLE 35 REVENUES FOR STEM CELL BASED REGIMENS FOR LEUKEMIA BY GEOGRAPHY, THROUGH 2015 ($ MILLIONS)
PROSTATE CANCER
TABLE 36 PROSTATE CANCER: SIGNS AND SYMPTOMS
TABLE 37 PROSTATE CANCER: RISK FACTORS
TABLE 38 KEY GENETIC FACTORS IN PROSTATE CANCERS
TABLE 39 CLINICAL TRIALS THAT INCLUDE STEM CELL-BASED THERAPEUTICS FOR PROSTATE CANCERS
SPONSORS: M.D. ANDERSON CANCER CENTER; CELGENE CORPORATION
MULTIPLE MYELOMA
TABLE 40 REVENUES FOR STEM CELL BASED REGIMENS FOR MULTIPLE MYELOMA BY GEOGRAPHICAL REGION, THROUGH 2015 ($ MILLIONS)
TABLE 41 CLINICAL TRIALS THAT INCLUDE A STEM CELL-BASED THERAPEUTICS FOR MULTIPLE MYELOMA
GASTRIC
TABLE 42 KEY GENETIC FACTORS IN GASTRIC CANCERS
TABLE 43 CLINICAL TRIALS THAT INCLUDE STEM CELL BASED THERAPEUTICS FOR GASTRIC CANCERS
SKIN CANCER
TABLE 44 SKIN CANCER: SIGNS AND SYMPTOMS
TABLE 45 SKIN CNACER: RISK FACTORS
TABLE 46 KEY GENETIC FACTORS IN SKIN CANCERS
TABLE 47 REVENUES FOR STEM CELL-BASED REGIMENS FOR SKIN CANCERS BY GEOGRAPHY, THROUGH 2015 ($ MILLIONS)
TABLE 48 CLINICAL TRIALS THAT INCLUDE STEM CELL BASED THERAPEUTICS FOR SKIN CANCERS
CHAPTER FIVE: STEM CELL-BASED THERAPIES IN HUMAN ONCOLOGY SETTINGS
STEM CELL-BASED THERAPIES…
TABLE 49 ONCOLYTIC STEM CELL REVENUES BY DEVELOPMENT/APPROVAL STATUS: ALL PRODUCT TYPES, THROUGH 2015 ($ MILLIONS)
THERAPEUTIC OR ADJUVANT REVENUES AND PRODUCTS
TABLE 50 ONCOLOGY STEM CELL BASED THERAPEUTICS REVENUES BY THERAPY TYPE, THROUGH 2015 ($ MILLIONS)
FIGURE 2 ONCOLOGY STEM CELL BASED THERAPEUTICS REVENUES BY THERAPY TYPE, THROUGH 2015 ($ MILLIONS)
ALLOGENEIC THERAPEUTICS
TABLE 51 REVENUES AND FORECAST OF ALLOGENEIC THERAPEUTICS BROKEN DOWN BY GEOGRAPHICAL REGION, THROUGH 2015 ($ MILLIONS)
Revlimid
StemEx
AUTOLOGOUS THERAPEUTICS
TABLE 52 REVENUES AND FORECAST OF AUTOLOGOUS THERAPEUTICS BROKEN DOWN BY GEOGRAPHICAL REGION, THROUGH 2015 ($ MILLIONS)
StemEx
Mozobil
Genzyme's - Mozobil
TUMOR INHIBITOR THERAPEUTICS
TABLE 53 REVENUES AND FORECAST OF TUMOR INHIBITOR THERAPEUTICS BROKEN DOWN BY GEOGRAPHY, THROUGH 2015 ($ MILLIONS)
IPI-926
VGX-3100
XL139
GDC-0449
CELL MOBILIZER THERAPEUTICS
TABLE 54 REVENUES AND FORECAST OF HEALTHY CELL MOBILIZER THERAPEUTICS BROKEN DOWN BY GEOGRAPHICAL REGION, THROUGH 2015 ($ MILLIONS)
Wyeth (now Pfizer) Neumega
THERAPEUTIC OR ADJUVANT BY CANCER INDICATION
TABLE 55 ONCOLOGY STEM CELL BASED THERAPEUTIC UTILIZED BY STAGE OF CANCER BROKEN DOWN BY CANCER INDICATION
ALLOGENEIC THERAPEUTIC
TABLE 56 REVENUES AND FORECAST OF ALLOGENEIC STEM CELL TRANSPLANT ANTICANCER THERAPEUTICS BY INDICATION THROUGH 2015 ($ MILLIONS)
TABLE 57 REVENUES AND FORECAST OF ALLOGENEIC STEM CELL TRANSPLANT ANTICANCER THERAPEUTICS BY INDICATION, FDA APPROVED, 2008 THROUGH 2015 ($ MILLIONS)
TABLE 58 REVENUES AND FORECAST OF ALLOGENEIC STEM CELL TRANSPLANT ANTICANCER THERAPEUTICS BY INDICATION, PHASE III APPROVED, 2008 THROUGH 2015 ($ MILLIONS)
AUTOLOGOUS THERAPEUTICS
TABLE 59 REVENUES AND FORECAST OF AUTOLOGOUS STEM CELL TRANSPLANT ANTICANCER THERAPEUTICS BY INDICATION THROUGH 2015 ($ MILLIONS)
TABLE 60 REVENUES AND FORECAST OF AUTOLOGOUS STEM CELL TRANSPLANT ANTICANCER THERAPEUTICS BY INDICATION, FDA APPROVED, THROUGH 2015 ($ MILLIONS)
TABLE 61 REVENUES AND FORECAST OF AUTOLOGOUS STEM CELL TRANSPLANT ANTICANCER THERAPEUTICS BY INDICATION, PHASE III, THROUGH 2015 ($ MILLIONS)
TUMOR INHIBITORS
TABLE 62 REVENUE AND FORECAST OF STEM CELL BASED TUMOR INHIBITORS BY INDICATION, THROUGH 2015 ($ MILLIONS)
TABLE 63 REVENUE AND FORECAST OF STEM CELL BASED TUMOR INHIBITORS BY INDICATION PHASE III, THROUGH 2015 ($ MILLIONS)
TABLE 64 REVENUE AND FORECAST OF STEM CELL BASED TUMOR INHIBITORS BY INDICATION RESEARCH, THROUGH 2015 ($ MILLIONS)
HEALTHY STEM CELL MOBILIZER/STIMULATORS
TABLE 65 REVENUE AND FORECAST OF STEM CELL BASED HEALTHY CELL MOBILIZERS BY INDICATION, THROUGH 2015 ($ MILLIONS)
TABLE 66 REVENUE AND FORECAST OF STEM CELL BASED HEALTHY CELL MOBILIZERS BY INDICATION, FDA APPROVED, THROUGH 2015 ($ MILLIONS)
TABLE 67 REVENUE AND FORECAST OF STEM CELL BASED HEALTHY CELL MOBILIZERS BY INDICATION, RESEARCH PHASE, THROUGH 2015 ($ MILLIONS)
CHAPTER SIX: TRADITIONAL MEDICINES
A BRIEF HISTORY OF NATURAL MEDICINES
MORE CURRENT FDA APPROVALS OF NATURAL MEDICINES
NATURAL PRODUCTS IN CLINICAL TRIALS
TABLE 68 CLINICAL TRIALS OF STEM CELL RELATED THERAPEUTICS THAT HAVE A NATURALLY DERIVED ANTITUMOR ADJUVANT
CHAPTER SEVEN: GOVERNMENT REGULATORY AGENCIES AND PROFESSIONAL ASSOCIATIONS
GOVERNMENT AGENCIES
FOOD AND DRUG ADMINISTRATION
BIOLOGICS
ONCOLOGY ADJUVANTS
STATE LEVEL RESEARCH
TABLE 69 STATES IN THE U.S. THAT PERMIT STEM CELL RESEARCH
TABLE 70 STATES IN THE U.S. THAT PROHIBIT STEM CELL RESEARCH
CALIFORNIA
TEXAS
INTERNATIONAL STEM CELL RESEARCH
TABLE 71 COUNTRIES PRODUCING STEM CELL RESEARCH
PROFESSIONAL ASSOCIATIONS
AMERICAN ASSOCIATION FOR CANCER RESEARCH
AMERICAN SOCIETY OF CLINICAL ONCOLOGY (ASCO)
CHAPTER EIGHT: MAJOR ONCOLYTIC STEM CELL MANUFACTURERS
STEM CELL MANUFACTURERS
TABLE 72 MAJOR STEM CELL ONCOLOGY HUMAN PHARMACEUTICAL MANUFACTURERS
FIGURE 3 PERCENTAGE OF ONCOLOGY STEM CELL THERAPEUTICS PHARMACEUTICAL MANUFACTURERS BY COUNTRY (%)
MAJOR PHARMACEUTICAL MANUFACTURER PROFILES
CELGENE
COMBINATRIX CORPORATION
CURIS, INC.
EXELIXIS, INC
F. HOFFMANN-LA ROCHE LTD
GERON CORPORATION
GENZYME
INOVIO BIOMEDICAL CORPORATION
MERCK
MICROMET, INC.
PFIZER, INC.
TEVA PHARMACEUTICAL INDUSTRIES LTD
CHAPTER NINE: ONCOLYTIC STEM CELL THERAPEUTICS INDUSTRY
ONCOLOGIC STEM CELL MARKET TRENDS: HUMAN HEALTHCARE
ACCELERATING STEM CELL THERAPIES IN ONCOLOGY
LEUKEMIA
LYMPHOMA
MULTIPLE MYELOMA
TABLE 73 NEW PRESCRIPTION ONCOLOGY STEM CELL THERAPEUTICS, 2008
TABLE 74 ONCOLOGY STEM CELL THERAPEUTIC REGIMENS IN THE CLINICAL TRIAL PIPELINE, 2009
NEED TO INCREASE USE AND ACCEPTANCE OF NEWER DRUGS .... 101
CHAPTER TEN: PATENT ANALYSIS
PURPOSE OF A PATENT ANALYSIS
DUE CARE IN REVIEWING THE PATENT ANALYSIS
NEW ONCOLOGY STEM CELL THERAPEUTIC PATENTS ISSUED
TABLE 75 ONCOLOGY STEM CELL THERAPEUTIC PATENT TRENDS, 1990-2009
FIGURE 4 ONCOLOGY STEM CELL THERAPEUTICS PATENT TRENDS 1990-2009
TABLE 76 PATENTS BY ONCOLOGY STEM CELL - THERAPY TYPE 2007-2009
TABLE 77 NEW ANTI-TUMOR THERAPIES RELATING TO STEM CELLS PATENTS ISSUED, 2007-2009
TABLE 78 ASSIGNEES OF TWO OR MORE PATENTS FOR ONCOLOGY STEM CELL THERAPEUTICS, 2007-2009
TABLE 79 NEW STEM CELL THERAPAUTIC ONCOLOGY PATENT APPROVALS BY COUNTRY, 2007-2009 (NO./%)
FIGURE 5 NEW STEM CELL THERAPAUTIC ONCOLOGY PATENT APPROVALS BY COUNTRY, 2007-2009 (%)
TRENDS IN PATENT APPLICATIONS
TABLE 80 NEW STEM CELL THERAPAUTIC ONCOLOGY PATENT APPLICATIONS BY YEAR, 2001 THROUGH 2009 (NO./%)
FIGURE 6 NEW STEM CELL THERAPAUTIC ONCOLOGY PATENT APPLICATIONS, BY YEAR, 2001-2009 (%)
TABLE 81 PATENT APPLICATIONS BY ONCOLOGY NEW STEM CELL THERAPAUTIC THERAPY TYPE, 2007-2009 (NO./%)
FIGURE 7 PERCENTAGE OF PATENT APPLICATIONS BY ONCOLOGY NEW STEM CELL THERAPAUTIC MARKET SEGMENT, 2007-2009 (%)
TABLE 82 NEW PATENT APPLICATIONS, 2007-2009
TABLE 83 RECENT TRENDS IN PATENT APPLICATIONS FOR ONCOLOGY STEM CELL THERAPEUTICS BY MARKET SEGMENT, 2007-2009 (NO./%)
TABLE 84 ONCOLOGY STEM CELL THERAPEUTICS PATENT APPLICATIONS BY COUNTRY, 2007-2009 (NO./%)
FIGURE 8 ONCOLOGY STEM CELL THERAPEUTICS PATENT APPLICATIONS BY COUNTRY, 2007-2009 (%)
PATENT EXPIRATIONS
TABLE 85 PATENT EXPIRATIONS
CHAPTER ELEVEN: APPENDIX
TABLE 86 COMPANIES
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: Stem Cell Therapeutics for Oncology: Technologies and Global Markets
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Nicolas Bombourg
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