TABLE 2 RECOGNIZED AND POTENTIAL AUTOIMMUNE DISEASES AND THE SYSTEMS THEY EFFECT,

Transcription

1 CHAPTER ONE: INTRODUCTION... 1 REASONS FOR DOING THE STUDY... 1 STUDY GOALS AND OBJECTIVES... 1 SCOPE OF REPORT... 2 INTENDED AUDIENCE... 2 METHODOLOGIES AND INFORMATION SOURCES... 2 ANALYST CREDENTIALS... 2 RELATED REPORTS... 3 BCC ONLINE SERVICES... 3 DISCLAIMER... 3 CHAPTER TWO: SUMMARY... 4 SUMMARY... 4 SUMMARY TABLE GLOBAL MARKET FOR AUTOIMMUNE TREATMENTS, THROUGH 2016 ($ MILLIONS)... 5 SUMMARY FIGURE GLOBAL MARKET FOR AUTOIMMUNE TREATMENTS BY GEOGRAPHICAL AREA, 2011 AND 2016 (%)... 5 SUMMARY FIGURE (CONTINUED)... 6 CHAPTER THREE: OVERVIEW OF AUTOIMMUNE DISEASE... 7 AUTOIMMUNITY AND THE AUTOIMMUNE SYSTEM... 7 COMPLEX HUMAN IMMUNE SYSTEM... 7 INNATE IMMUNE SYSTEM... 7 ADAPTIVE IMMUNE SYSTEM... 8 GENETICS AND AUTOIMMUNE DISEASES... 8 NEW GENETIC RESEARCH... 9 ROLES OF T CELLS, B CELLS, PHAGOCYTES, AND GRANULOCYTES... 9 T Cells B Cells Phagocytes and Granulocytes ROLE OF HUMAN LEUKOCYTE ANTIGEN ROLE OF CYTOKINES ROLES OF ANTIBODIES CAUSES OF AUTOIMMUNE DISEASES WOMEN AND AUTOIMMUNE DISEASE GENETIC DIFFERENCE IN AUTOIMMUNE DISEASES AFFECTS ON ETHNIC GROUPS ROLE OF THE ENVIRONMENT TABLE 1 INFECTIONS IN HUMANS ASSOCIATED WITH SELECTED AUTOIMMUNE DISEASES DIAGNOSING AUTOIMMUNE DISEASES SYSTEMIC AND LOCALIZED DISEASES MAJOR RECOGNIZED AUTOIMMUNE DISEASES... 15

2 TABLE 2 RECOGNIZED AND POTENTIAL AUTOIMMUNE DISEASES AND THE SYSTEMS THEY EFFECT, CHAPTER FOUR: MARKET FOR AUTOIMMUNE PHARMACEUTICALS TABLE 3 GLOBAL MARKET FOR PHARMACEUTICAL THERAPIES FOR LEADING AUTOIMMUNE DISEASES, THROUGH 2016 ($ MILLIONS) RHEUMATOID ARTHRITIS DEFINITION SYMPTOMS AND DIAGNOSIS TREATMENT Treatment (Continued) TABLE 4 AMERICAN COLLEGE OF RHEUMATOLOGY RECOMMENDATIONS FOR RA TREATMENTS, TABLE 5 GLOBAL MARKET FOR RHEUMATOID ARTHRITIS MEDICATIONS, THROUGH 2016 ($ MILLIONS) TYPE 1 DIABETES Definition Scope Symptoms and Diagnosis Treatment TABLE 6 GLOBAL MARKET FOR TYPE 1 DIABETES PHARMACEUTICAL PRODUCTS, THROUGH 2016 ($ MILLIONS) TABLE 7 MAJOR MANUFACTURERS OF DIABETES PRODUCTS, FIGURE 1 GLOBAL MARKET SHARE FOR TYPE 1 DIABETES INSULIN PRODUCTS BY MANUFACTURER, 2011 (%) LUPUS Definition Systemic Lupus Erythematosus Cutaneous Lupus Erythematosus Drug-induced and Neonatal Lupus Erythematosus Scope Treatment New Approval TABLE 8 PHARMACEUTICAL TREATMENTS FOR SYSTEMIC LUPUS ERYTHEMATOSUS BY CONDITION TYPE, TABLE 9 INVESTIGATIONAL TREATMENTS FOR SYSTEMIC LUPUS ERYTHEMATOSUS, TABLE 9 (CONTINUED) TABLE 10 GLOBAL MARKET FOR PHARMACEUTICALS TO TREAT LUPUS, THROUGH 2016 ($ MILLIONS) MULTIPLE SCLEROSIS Definition Scope... 30

3 Symptoms and Diagnosis Treatment TABLE 11 PHARMACOLOGICAL TREATMENTS FOR MULTIPLE SCLEROSIS BY NAME, MANUFACTURER, DOSAGE, AND APPROVAL DATE, TABLE 12 MARKET FOR MS PHARMACEUTICALS, THROUGH 2016 ($ MILLIONS) INFLAMMATORY BOWEL DISEASE TABLE 13 GLOBAL MARKET FOR IBD MEDICATIONS, THROUGH 2016 ($ MILLIONS) Ulcerative Colitis Definition Scope Symptoms and Diagnosis Treatment TABLE 14 MEDICATIONS TO TREAT ULCERATIVE COLITIS, TABLE 15 GLOBAL MARKET FOR MEDICATIONS TO TREAT ULCERATIVE COLITIS, THROUGH 2016 ($ MILLIONS) Crohn s Disease Definition Scope Symptoms and Diagnosis Treatment TABLE 16 CURRENT MEDICATIONS FOR THE TREATMENT OF CROHN S DISEASE BY MANUFACTURER, TABLE 17 GLOBAL MARKET FOR MEDICATIONS TO TREAT CROHN S DISEASE, THROUGH 2016 ($ MILLIONS) PSORIASIS Definition Symptoms and Diagnosis Treatment TABLE 18 SELECTED CURRENT MEDICATIONS FOR PSORIASIS, TABLE 18 (CONTINUED) TABLE 19 GLOBAL MARKET FOR PSORIASIS PHARMACEUTICALS, THROUGH, 2016 ($ MILLIONS) OTHER MAJOR AUTOIMMUNE DISEASES SCLERODERMA Scope Symptoms and Diagnosis Treatment ANKYLOSING SPONDYLITIS Definition Symptoms and Diagnosis... 42

4 Treatment GRAVES DISEASE Definition Scope Symptoms and Diagnosis Treatment CELIAC DISEASE Definition Scope Symptoms and Diagnosis Treatment SJÖGREN S SYNDROME Definition Scope Signs and Symptoms Treatment RECOGNIZED AUTOIMMUNE AND AUTOIMMUNE-RELATED DISEASES TABLE 20 RECOGNIZED AUTOIMMUNE AND AUTOIMMUNE- RELATED DISEASES* TABLE 20 (CONTINUED) TABLE 20 (CONTINUED) CHAPTER FIVE: GLOBAL AUTOIMMUNE PHARMACEUTICAL THERAPIES MARKET TABLE 21 GLOBAL AUTOIMMUNE PHARMACEUTICAL THERAPY MARKET BY REGION, THROUGH 2016 ($ MILLIONS) REGIONAL VARIATIONS RA AND MS PREVALENCE BY GEOGRAPHIC REGIONS TABLE 22 TOP 10 COUNTRIES IN WHICH MS IS MOST OR LEAST PREVALENT (PREVALENCE PER 100,00) DRIVERS OF AUTOIMMUNE TREATMENT MARKET FIGURE 2 GLOBAL MARKET SHARE FOR AUTOIMMUNE THERAPIES BY REGION, 2011 AND 2016 (%) U.S. MARKET SCOPE Celiac Disease in the U.S Pharmaceuticals Other Therapies TABLE 23 U.S. MARKET FOR U.S. AUTOIMMUNE PHARMACEUTICAL THERAPIES, THROUGH 2016 ($ MILLIONS) EUROPEAN MARKET SCOPE Type 1 Diabetes Pharmaceuticals... 56

5 TABLE 24 EUROPEAN MARKET FOR AUTOIMMUNE PHARMACEUTICALS, THROUGH 2016 ($ MILLIONS) JAPANESE MARKET SCOPE RA in Japan Type 1 Diabetes in Japan MS in Japan Pharmaceuticals TABLE 25 APPROVED DMARDS AND BIOLOGICALS FOR TREATMENT OF RA IN JAPAN AND THE U.S., TABLE 26 JAPANESE MARKET FOR AUTOIMMUNE PHARMACEUTICALS, THROUGH 2016 ($ MILLIONS) REST OF THE WORLD MARKET SCOPE Diabetes TABLE 27 REST OF THE WORLD MARKET FOR AUTOIMMUNE PHARMACEUTICALS, THROUGH 2016 ($ MILLIONS) AFFECTS OF HEALTHCARE REFORM U.S HEALTHCARE REFORM OUTSIDE THE U.S EMERGING TRENDS IN TREATMENTS TYPE 1 DIABETES CHANGES IN THE INDUSTRY TABLE 28 SELECTED MERGERS AND/OR ACQUISITIONS, ($ MILLIONS) CHAPTER SIX: AUTOIMMUNE DISEASE PHARMACEUTICAL MARKET BY PHARMACEUTICAL TYPE TYPES OF APPROPRIATE PHARMACEUTICALS TABLE 29 GLOBAL MARKET FOR AUTOIMMUNE PHARMACEUTICALS BY TYPE, THROUGH 2016 ($ MILLIONS) FIGURE 3 GLOBAL MARKET SHARE FOR AUTOIMMUNE PHARMACEUTICALS BY TYPE, 2011 AND 2016 (%) FIGURE 3 (CONTINUED) TUMOR NECROSIS FACTOR INHIBITORS TABLE 30 TNF INHIBITORS AVAILABLE IN THE U.S., E.U., AND JAPAN, METHOD OF ACTION FIGURE 4 GLOBAL MARKET SHARE FOR TNF PHARMACEUTICAL MARKET BY PRODUCT, 2011 (%) FIGURE 4 (CONTINUED) ADVERSE EFFECTS TABLE 31 TNF INHIBITORS FOR AUTOIMMUNE DISEASES, TABLE 32 GLOBAL MARKET FOR TNF INHIBITORS TO TREAT AUTOIMMUNE DISEASES, THROUGH 2016 ($ MILLIONS)... 68

6 B-CELL INHIBITORS METHOD OF ACTION ADVERSE EFFECTS T-CELL INHIBITORS METHOD OF ACTION ADVERSE EFFECTS TABLE 33 B-CELLAND T-CELL INHIBITORS FOR AUTOIMMUNE DISEASES, TABLE 34 GLOBAL MARKET FOR B-CELL AND T-CELL INHIBITORS, THROUGH 2016 ($ MILLIONS) INTERLEUKIN INHIBITORS METHOD OF ACTION ADVERSE EFFECTS CURRENT TREATMENTS TABLE 35 INTERLEUKIN INHIBITORS FOR AUTOIMMUNE DISEASES, MARKET FOR INTERLEUKIN INHIBITORS TABLE 36 MARKET FOR INTERLEUKIN PRODUCTS TO TREAT AUTOIMMUNE DISEASES, THROUGH 2016 ($ MILLIONS) IMMUNOSUPPRESSANTS TABLE 37 IMMUNOSUPPRESSANTS FOR AUTOIMMUNE DISEASES, METHOD OF ACTION Antimetabolites Antimetabolites Used in the Treatment of Type 1 Diabetes Calcineurin Inhibitors Anticytokines ADVERSE EFFECTS TABLE 38 GLOBAL MARKET FOR IMMUNOSUPPRESSANTS TO TREAT AUTOIMMUNE DISEASES, THROUGH 2016 ($ MILLIONS) BETA INTERFERONS METHOD OF ACTION ADVERSE EFFECTS TABLE 39 BETA INTERFERONS FOR AUTOIMMUNE DISEASES, TABLE 40 GLOBAL MARKET FOR BETA INTERFERONS, THROUGH 2016 ($ MILLIONS) INSULIN TABLE 41 GLOBAL MARKET FOR INSULIN, THROUGH 2016 ($ MILLIONS) OTHER DRUGS AND THERAPIES WITH DIFFERING METHODS OF ACTION COX II INHIBITORS... 78

7 SPHINGOSINE KINASE LEFLUNOMIDE GLATIRAMER INTRAVENOUS IMMUNOGLOBULIN PLASMAPHERESIS HORMONE REPLACEMENT THERAPY ENZYME REPLACEMENT THERAPY TABLE 42 OTHER PHARMACEUTICAL PRODUCTS WITH DIFFERING MECHANISMS OF ACTION TO TREAT AUTOIMMUNE DISEASES, TABLE 43 MARKET FOR OTHER DRUGS TO TREAT AUTOIMMUNE DISEASES, THROUGH 2016 ($ MILLIONS) OTHER MECHANISMS OF ACTION SPLEEN TYROSINE KINASE INHIBITORS PATENT EXPIRATIONS TABLE 44 PATENT EXPIRIES FOR PHARMACEUTICALS TO TREAT AUTOIMMUNE DISEASES, NEW DRUG APPROVALS IN 2009 AND TABLE 45 NEW DRUG APPROVALS FOR TREATMENT OF AUTOIMMUNE DISEASES, CHAPTER SEVEN: AUTOIMMUNE DIAGNOSTIC TESTING MARKET ENZYME-LINKED IMMUNOSORBENT ASSAY IMMUNOFLUORESCENCE ASSAY HLA TESTING MANUAL TESTING METHODS AUTOMATED TESTING METHODS TABLE 46 LEADING MANUFACTURERS OF AUTOMATED DIAGNOSTIC TESTING EQUIPMENT CURRENT DIAGNOSTIC TESTS FOR AUTOIMMUNE DISEASE TABLE 47 SELECTED MANUFACTURERS OF DIAGNOSTIC TESTS FOR AUTOIMMUNE DISEASES, SYSTEMIC AUTOIMMUNE DIAGNOSTIC TESTS Antinuclear Antibodies Anti-Neutrophil Cytoplasmic Anti-Double-Stranded DNA Extractable Nuclear Antigen Antibodies Panel Rheumatoid Factor Cyclic Citrullinated Peptide Antibody LOCALIZED AUTOIMMUNE DIAGNOSTIC TESTS Liver Kidney Thyroid Gastrointestinal Tract TABLE 48 TEST TYPE BY AUTOIMMUNE CONDITION,

8 MARKET FOR DIAGNOSTIC TESTS FOR AUTOIMMUNE DISEASE TABLE 49 GLOBAL MARKET FOR AUTOIMMUNE DIAGNOSTIC TESTS, THROUGH 2016 ($ MILLIONS) CHAPTER EIGHT: AUTOIMMUNE TREATMENT ASSISTIVE TECHNOLOGIES AUTOIMMUNE THERAPIES NUTRITION Affect of Vitamins Vitamin D and MS Beta-cell Autoimmunity in Children EXERCISE STRESS REDUCTION PHARMACEUTICAL MANAGEMENT ASSISTIVE PRODUCTS TABLE 50 GLOBAL MARKET FOR ASSISTIVE TECHNOLOGIES TO TREAT TYPE 1 DIABETES, THROUGH 2016 ($ MILLIONS) FIGURE 5 GLOBAL MARKET SHARE FOR BLOOD GLUCOSE MONITORS TO TREAT TYPE 1 DIABETES BY MANUFACTURER, 2011 (%) CHAPTER NINE: CURRENT RESEARCH AND EMERGING PHARMACEUTICALS THERAPEUTIC VACCINES STATINS PHARMACEUTICALS ANTARES PHARMA, INC RA 99 ARGENTIS Systemic Scleroderma RA 100 BIOGEN IDEC Dalfampridine BG Daclizumab Pegylated Interferon Beta-1a Dexpramipexole ELI LILLY BAFF Antibody Bl10773 and Linagliptin GENZYME/BAYER GLAXOSMITHKLINE Otelixizumab Horizant CCX

9 GSK IMMUNOMEDICS/UCB PHARMACEUTICALS SLE MERCK NATIONAL INSTITUTES OF HEALTH NOVO NORDISK PFIZER Halofuginone SANOFI-AVENTIS Teriflunomide SAR SAR TEVA PHARMACEUTICAL Laquinimod DIAGNOSTIC TESTING CHAPTER TEN: REGULATIONS AND PATENTS REGULATIONS U.S. REGULATIONS Pharmaceuticals EUROPEAN REGULATIONS Pharmaceuticals JAPANESE REGULATIONS Pharmaceuticals REST OF THE WORLD REGULATIONS Pharmaceuticals PATENTS PATENTS BY MANUFACTURER TABLE 51 PATENTS BY MANUFACTURER PATENTS BY DATE OF ISSUE TABLE 52 PHARMACEUTICAL PATENTS BY DATE OF ISSUE, PATENTS BY MANUFACTURER TABLE 53 PATENTS BY MANUFACTURER TABLE 53 (CONTINUED) COMPOUND PATENTS FOR AUTOIMMUNE APPLICATIONS TABLE 54 PATENT COMPOUNDS FOR AUTOIMMUNE TREATMENTS, TABLE 54 (CONTINUED) TABLE 54 (CONTINUED) PATENTS BY INDICATION TABLE 55 PATENTS BY INDICATION: RHEUMATOID ARTHRITIS, TABLE 56 PATENTS BY INDICATION: INFLAMMATORY BOWEL DISEASES,

10 TABLE 57 PATENTS BY INDICATION: TYPE 1 DIABETES, PATENTS FOR AUTOIMMUNE DISEASE TESTING TABLE 58 PATENT BY INDICATION: DIAGNOSTIC TESTING AND ASSAYS, CHAPTER ELEVEN: COMPANY DIRECTORY PHARMACEUTICAL COMPANIES ABBOTT LABORATORIES Business Overview Financials Products AMGEN Business Overview Financials Products ASTELLAS PHARMA, INC Business Overview Financial Information Products BAYER AG (MILES-BAYER) Business Overview Financials Products BIOGEN IDEC Business Overview Financials Products BOEHRINGER INGELHEIM GMBH Business Overview Financials Products BRISTOL-MYERS SQUIBB Business Overview Financials Products ELAN CORPORATION Business Overview Financials Products ELI LILLY Business Overview Financials Products EMD SERONO, INC Business Overview

11 Financials Products GENENTECH Business Overview Financials Products GLAXOSMITHKLINE Business Overview Financials Products JANSSEN BIOTECH, INC (CENTOCOR) Business Overview Financials Products KING PHARMACEUTICALS MERCK Business Overview Financials Products NOVARTIS AG Business Overview Financials Products NOVO NORDISK Business Overview Financials Products PFIZER Business Overview Financials Products PROCTER & GAMBLE PHARMACEUTICALS ROCHE PHARMACEUTICALS Business Overview Financials Products SALIX PHARMACEUTICALS Business Overview Financials Products SANOFI AVENTIS Business Overview Financials Products

12 SCHERING-PLOUGH SHIRE PLC Business Overview Financials Products TEVA PHARMACEUTICAL INDUSTRIES, LTD Business Overview Financials Products UCB PHARMA Business Overview Financials Products WARNER CHILCOTT Business Overview Financials Products DIAGNOSTIC TESTING COMPANIES ABBOTT LABORATORIES, DIAGNOSTICS DIVISION Business Overview Financials Products ALERE, INC Business Overview Financials Products BECKMAN COULTER Business Overview Financials Products BECTON DICKINSON COMPANY Business Overview Financials Products BIOMERIEUX, INC Business Overview Financials Products BIO-RAD LABORATORIES, INC Business Overview Financials Products DIASORIN SPA Business Overview

13 Financials Products IMMCO DIAGNOSTICS Business Overview Financials Products INOVA DIAGNOSTICS Business Overview Financials Products INVERNESS MEDICAL INNOVATIONS IVAX DIAGNOSTICS, INC Business Overview Financials Products LUMINEX CORPORATION Business Overview Financials Products MERIDIAN BIOSCIENCE, INC Business Overview Financials Products ORTHO CLINICAL DIAGNOSTICS Business Overview Financials Products PHADIA ROCHE DIAGNOSTICS Business Overview Financials Products SCIMEDX CORPORATION Business Overview Financials Products SIEMENS MEDICAL SOLUTIONS Business Overview Financials Products THERMO FISHER SCIENTIFIC, INC Business Overview Financials Products

14 TRINITY BIOTECH Business Overview Financials Products ZEUS SCIENTIFIC, INC Business Overview Financials Products ASSISTIVE TECHNOLOGY COMPANIES ABBOTT LABORATORIES Products LIFESCAN (JOHNSON & JOHNSON DIABETES CARE) Business Overview Financials Products ROCHE DIAGNOSTICS (DIABETES CARE) Products