|
INTRODUCTION |
xx |
|
CONTRIBUTION OF THE STUDY AND FOR WHOM |
xx |
|
OBJECTIVES AND GOALS OF THE STUDY |
xx |
|
STUDY SCOPE AND FORMAT |
xxi |
|
METHODOLOGY |
xxii |
|
INFORMATION SOURCES |
xxii |
|
AUTHOR'S CREDENTIALS |
xxii |
|
RELATED BCC WORK CREDENTIALS INCLUDING WORK DONE BY OTHER AUTHORS |
xxii |
|
BCC ONLINE SERVICES |
xxiii |
|
DISCLAIMER |
xxiv |
|
EXECUTIVE SUMMARY |
xxv |
|
Summary Table:
GLOBAL MARKET FORECAST FOR IMMUNOTHERAPIES TO TREAT CANCER, THROUGH 2012 ($ MILLIONS) |
xxvi |
|
Summary Figure:
GLOBAL MARKET FORECAST FOR IMMUNOTHERAPIES TO TREAT CANCER, 2005-2012 ($ MILLIONS) |
xxvi |
|
OVERVIEW |
1 |
|
DEFINITION AND ETIOLOGY OF CANCER |
1 |
|
CANCER STATISTICS |
2 |
|
Table 1 PROBABILITY OF DEVELOPING SELECTED INVASIVE CANCERS, BY SEX, BASED ON CANCER CASES DIAGNOSED IN 2000 AND 2002 (%) |
2 |
|
Table 2 INCIDENCE, MORTALITY AND SURVIVAL RATES FOR COMMON CANCERS IN THE U.S., 2006 |
3 |
|
Table 3 CANCER PREVALENCE RATES IN THE U.S., 2003* |
3 |
|
Table 3 (CONTINUED) |
4 |
|
IMMUNOTHERAPY OF CANCER |
5 |
|
TYPES OF CANCER FOR WHICH IMMUNOTHERAPY TREATMENTS EXIST OR ARE LIKELY TO BE INTRODUCED BY 2012 |
5 |
|
BREAST CANCER |
5 |
|
COLORECTAL CANCER |
6 |
|
HEAD AND NECK CANCER |
6 |
|
KIDNEY CANCER |
6 |
|
LEUKEMIAS |
6 |
|
Leukemias (Continued) |
7 |
|
LIVER CANCER |
8 |
|
LUNG CANCER |
8 |
|
MALIGNANT MELANOMA |
9 |
|
MULTIPLE MYELOMA |
9 |
|
NONHODGKIN'S LYMPHOMA |
10 |
|
OSTEOSARCOMA |
10 |
|
OVARIAN CANCER |
10 |
|
PANCREATIC CANCER |
11 |
|
PROSTATE CANCER |
11 |
|
STOMACH CANCER |
12 |
|
CURRENT METHODS OF TREATMENT |
12 |
|
SURGERY |
12 |
|
RADIATION THERAPY |
13 |
|
PHARMACEUTICAL THERAPY |
13 |
|
IMMUNOTHERAPY |
14 |
|
INFLAMMATORY RESPONSE |
14 |
|
Cell-Mediated Immunity |
14 |
|
Humoral Immunity |
15 |
|
Macrophage Processing |
15 |
|
Nonspecific Immunity |
15 |
|
CYTOKINES |
16 |
|
Two Types of Cytokines |
16 |
|
MONOCYTES |
16 |
|
PHAGOCYTES |
17 |
|
SPECIFIC IMMUNITY |
17 |
|
Lymphocytes |
17 |
|
B-Cells |
18 |
|
T-Cells |
18 |
|
NK Cells |
18 |
|
CLINICAL APPROACHES TO IMMUNOTHERAPY |
18 |
|
Passive Cellular Immunotherapy |
19 |
|
Dealing with Significant Toxicity |
19 |
|
Passive Humoral Immunotherapy |
19 |
|
Active Specific Immunotherapy |
19 |
|
Nonspecific Immunotherapy |
20 |
|
TYPES OF IMMUNOTHERAPY PRODUCTS |
20 |
|
Biological Response Modifiers |
20 |
|
Table 4 COLONY STIMULATING FACTORS AND ERYTHROPOIETIN, THEIR NATURAL SOURCES AND MAJOR EFFECTS |
21 |
|
Table 5 INTERFERONS, THEIR NATURAL SOURCES AND MAJOR EFFECTS |
21 |
|
Table 6 INTERLEUKINS, THEIR NATURAL SOURCES AND MAJOR EFFECTS |
22 |
|
Table 6 (CONTINUED) |
23 |
|
Table 7 TUMOR NECROSIS FACTORS, THEIR NATURAL SOURCES, AND MAJOR EFFECTS |
24 |
|
Colony Stimulating Factors |
24 |
|
Treating Neutropenic Fevers |
24 |
|
A Justified Expense |
25 |
|
Interferons |
25 |
|
A Family of Small Proteins |
26 |
|
Anticancer Effects |
26 |
|
Side Effects |
27 |
|
Production of Interferon |
27 |
|
Interferon-alpha |
27 |
|
Interferon-beta |
28 |
|
Interferon-Beta-1a |
28 |
|
Interleukins |
28 |
|
Interleukin-2 |
28 |
|
Other Infection-Fighting Cells |
29 |
|
Side Effects |
29 |
|
Tumor Necrosis Factor |
30 |
|
ANTIBODIES |
30 |
|
ANTIBODY FORMS IN PRODUCTS |
31 |
|
Abtides |
31 |
|
Antibody Conjugates |
31 |
|
Antiserums |
32 |
|
Bispecific Antibodies |
32 |
|
Camouflaged Antibodies |
32 |
|
Chimeric Antibodies |
33 |
|
Humanized Antibodies |
34 |
|
Fully Human Antibodies |
35 |
|
Progenitor Stem Cells |
35 |
|
Single-Chain Antibodies |
36 |
|
Synthetic Antibodies |
37 |
|
VACCINES |
38 |
|
ANTIGENS: THEIR ROLE IN CANCER VACCINES |
38 |
|
VACCINE DEVELOPMENT STRATEGIES |
38 |
|
A SUMMARY OF TWO APPROACHES: LOW-TECH VS. HIGH-TECH |
39 |
|
TECHNOLOGY ADVANCES |
39 |
|
PRODUCTS AND APPLICATIONS |
40 |
|
IMMUNOTHERAPY PRODUCTS FOR THE TREATMENT OF CANCER INTRODUCED IN 2004, 2005 AND 2006 |
40 |
|
Table 8 IMMUNOTHERAPY PRODUCTS FOR THE TREATMENT OF CANCER INTRODUCED IN 2004, 2005 AND 2006 |
40 |
|
MECHANISM OF ACTION OF SELECTED IMMUNOTHERAPY PRODUCTS |
41 |
|
Table 9 MOLECULAR TARGET(S), MECHANISM(S) OF ACTION AND CANCER(S) TARGETED BY LEADING IMMUNOTHERAPY PRODUCTS |
41 |
|
BIOLOGICAL RESPONSE MODIFIERS |
41 |
|
THE MARKET FOR BIOLOGICAL RESPONSE MODIFIERS TO TREAT CANCER |
42 |
|
Table 10 GLOBAL MARKET FORECAST FOR BIOLOGICAL RESPONSE MODIFIERS TO TREAT CANCER, THROUGH 2012 ($ MILLIONS) |
42 |
|
Figure 1 GLOBAL MARKET FORECAST FOR BIOLOGICAL RESPONSE MODIFIERS TO TREAT CANCER, 2005-2012 ($ MILLIONS) |
42 |
|
COLONY STIMULATING FACTORS |
43 |
|
MARKETED BRM PRODUCTS FOR THE TREATMENT OF CANCER |
43 |
|
Table 11 COLONY-STIMULATING FACTOR PRODUCTS ON THE MARKET FOR THE TREATMENT OF CANCER |
43 |
|
Aranesp |
44 |
|
Granocyte |
44 |
|
Leukine |
44 |
|
Neorecormon |
44 |
|
Neulasta/Neupopeg/Neupogen/Granulokine |
45 |
|
Neumega |
46 |
|
Procrit |
46 |
|
Stemgen |
46 |
|
The Market for Colony Stimulating Factors |
47 |
|
Table 12 GLOBAL MARKET FORECAST FOR COLONY STIMULATING FACTORS IN CANCER TREATMENT BY PRODUCT, THROUGH 2012 ($ MILLIONS) |
47 |
|
The Market for Colony Stimulating Factors to Treat Cancer |
48 |
|
Table 13 GLOBAL MARKET FORECAST FOR COLONY STIMULATING FACTORS TO TREAT CANCER, THROUGH 2012 ($ MILLIONS) |
48 |
|
Figure 2 GLOBAL MARKET FORECAST FOR COLONY STIMULATING FACTORS TO TREAT CANCER, THROUGH 2012 ($ MILLIONS) |
48 |
|
Colony Stimulating Factors in Development |
49 |
|
INTERFERONS |
49 |
|
Interferon-Alpha |
49 |
|
Interferon Alpha-2b Products |
49 |
|
Marketed Interferon Products for the Treatment of Cancer |
50 |
|
Table 14 INTERFERON PRODUCTS ON THE MARKET FOR THE TREATMENT OF CANCER |
50 |
|
Infergen |
50 |
|
Intron A and PEG-Intron/Rebetron |
50 |
|
PEG-Intron vs. Intron A |
51 |
|
Multiferon |
52 |
|
Roferon-A |
52 |
|
Interferon-Gamma |
53 |
|
Actimmune/ Imukin |
53 |
|
The Market for Interferon Products Used in the Treatment of Cancer |
53 |
|
Table 15 GLOBAL MARKET FORECAST FOR INTERFERON ALPHA AND GAMMA PRODUCTS* USED IN THE TREATMENT OF CANCER BY PRODUCT, THROUGH 2012 ($ MILLIONS) |
53 |
|
THE MARKET FOR interFErons TO TREAT CANCER |
54 |
|
Table 16 GLOBAL MARKET FORECAST FOR INTERFERONS TO TREAT CANCER, THROUGH 2012 ($ MILLIONS) |
54 |
|
Figure 3 GLOBAL MARKET FORECAST FOR INTERFERONS TO TREAT CANCER, THROUGH 2012 ($ MILLIONS) |
54 |
|
INTERLEUKINS |
55 |
|
Marketed Interleukin Products for the Treatment of Cancer |
55 |
|
Table 17 INTERLEUKIN PRODUCTS ON THE MARKET FOR THE TREATMENT OF CANCER |
55 |
|
ONTAK |
55 |
|
PROLEUKIN |
56 |
|
The Market for Interleukin Products for the Treatment of Cancer |
56 |
|
Table 18 GLOBAL MARKET FORECAST FOR INTERLEUKINS IN THE TREATMENT OF CANCER, BY PRODUCT, THROUGH 2012 ($ MILLIONS) |
57 |
|
TUMOR NECROSIS FACTOR INHIBITORS |
57 |
|
BIOLOGICAL RESPONSE MODIFIERS IN DEVELOPMENT FOR THE TREAMENT OF CANCER |
57 |
|
Table 19 SELECTED BIOLOGICAL RESPONSE MODIFIERS IN PHASE III OR LATER DEVELOPMENT |
58 |
|
Actimmune |
58 |
|
Cintrekedin Besudotox |
59 |
|
Multikine |
59 |
|
Clinical Trial Results |
59 |
|
A Coca-Cola Formula |
60 |
|
PEG-Intron |
60 |
|
PRX321 |
60 |
|
Virulizin |
60 |
|
COMBINATION CYTOKINE-ANTIBODY TECHNOLOGY IN DEVELOPMENT |
61 |
|
MONOCLONAL ANTIBODY PRODUCTS |
62 |
|
Table 20 MARKETED MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF CANCER: U.S. |
62 |
|
Table 20 (CONTINUED) |
63 |
|
MARKETED MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF CANCER |
63 |
|
Avastin |
63 |
|
Avastin (Continued) |
64 |
|
Avastin (Continued) |
65 |
|
The Avastin Advantage |
66 |
|
Medicare Reimbursement Law Supports Use of Avastin |
66 |
|
Bexxar |
67 |
|
Bexxar (Continued) |
68 |
|
Campath/ MabCampath |
69 |
|
Erbitux |
70 |
|
Table 21 RANGE OF EGFR EXPRESSION IN SOLID TUMORS |
70 |
|
Table 22 EGFR IN PROGNOSIS FOR SELECTED TUMOR TYPES |
71 |
|
Erbitux (Continued) |
72 |
|
Herceptin |
73 |
|
Mylotarg |
74 |
|
Panorex |
75 |
|
Rituxan/MabThera |
75 |
|
Rituxan/Mabthera (Continued) |
76 |
|
Vectibix |
77 |
|
Zevalin |
78 |
|
First Radioimmunotherapeutic Drug |
78 |
|
Results of Trials |
79 |
|
Sales of Zevalin |
80 |
|
THE MARKET FOR MONOCLONAL ANTIBODY PRODUCTS FOR ALL INDICATIONS |
80 |
|
Monoclonal Antibody Sales by Technology |
81 |
|
Table 23 GLOBAL MARKET FORECAST FOR THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS BY TECHNOLOGY, THROUGH 2012 ($ MILLIONS) |
81 |
|
Figure 4 GLOBAL MARKET FORECAST FOR THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS BY TECHNOLOGY, 2005-2012 ($ MILLIONS) |
82 |
|
Monoclonal Antibody Sales by Target |
82 |
|
Table 24 GLOBAL MARKET FORECAST FOR THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS BY TARGET, THROUGH 2012 ($ MILLIONS) |
83 |
|
THE MARKET FOR THERAPEUTIC MONOCLONAL ANTIBODIES TO TREAT CANCER |
83 |
|
Table 25 GLOBAL MARKET FORECAST FOR MONOCLONAL ANTIBODY PRODUCTS FOR CANCER TREATMENT, THROUGH 2012 ($ MILLIONS) |
83 |
|
Table 25 (CONTINUED) |
84 |
|
THE EUROPEAN MARKET FOR THERAPEUTIC MONOCLONAL ANTIBODIES |
84 |
|
Table 26 MONOCLONAL ANTIBODY PRODUCTS ON THE EUROPEAN MARKET FOR THE TREATMENT OF CANCER |
84 |
|
Table 27 EUROPEAN MARKET FOR MONOCLONAL ANTIBODY PRODUCTS FOR CANCER TREATMENT, THROUGH 2012 ($ MILLIONS) |
85 |
|
Figure 5 EUROPEAN MARKET FOR MONOCLONAL ANTIBODY PRODUCTS FOR CANCER TREATMENT, 2005-2012 ($ MILLIONS) |
85 |
|
MONOCLONAL ANTIBODY PRODUCTS IN DEVELOPMENT FOR THE treatment of cancer |
86 |
|
Table 28 SELECTED MONOCLONAL ANTIBODY PRODUCTS IN PHASE III OR LATER DEVELOPMENT FOR THE TREATMENT OF CANCER |
86 |
|
Table 28 (CONTINUED) |
87 |
|
Table 28 (CONTINUED) |
88 |
|
Abegrin (formerly Vitaxin) |
89 |
|
Avastin |
89 |
|
Campath/MabCampath |
90 |
|
CP-675,206 |
90 |
|
Denosumab |
90 |
|
Herceptin |
90 |
|
HuMax-CD4 |
90 |
|
HuMax-CD20 |
90 |
|
HuMax-EGFr |
90 |
|
MDX-010 |
91 |
|
Nimotuzumab |
91 |
|
OvaRex |
91 |
|
Pemtumomab |
92 |
|
Rencarex |
92 |
|
Rituxan/MabThera |
92 |
|
VACCINES |
93 |
|
Table 29 TUMOR ANTIGENS USED IN CANCER VACCINES |
94 |
|
TYPES OF CANCER VACCINES |
95 |
|
Whole-cell Vaccines |
95 |
|
Antigen/Adjuvant Vaccines |
95 |
|
Idiotype Vaccines |
95 |
|
Autologous versus Allogenic Vaccines |
95 |
|
Dendritic Cell Vaccines |
96 |
|
Synthetic Cell Protein Antigens |
96 |
|
Gangliosides |
97 |
|
Heat Shock Proteins |
97 |
|
CANCER VACCINES ON THE WORLDWIDE MARKET |
97 |
|
Gardasil |
98 |
|
M-Vax |
98 |
|
Melacine |
99 |
|
OncoVax |
99 |
|
THE MARKET FOR CANCER VACCINES |
99 |
|
Table 30 ESTIMATED U.S. MARKET FOR CANCER VACCINES BY INDICATION |
100 |
|
Table 31 GLOBAL MARKET FORECAST FOR CANCER VACCINES, BY TECHNOLOGY, THROUGH 2012 ($ MILLIONS) |
100 |
|
Figure 6 PERCENTAGE OF GLOBAL MARKET HELD BY AUTOLOGOUS VERSUS ALLOGENEIC CANCER VACCINES, 2007 AND 2012 (%) |
101 |
|
CANCER VACCINES IN DEVELOPMENT |
101 |
|
Table 32 SELECTED CANCER VACCINES IN PHASE III OR LATER TRIALS |
102 |
|
Table 32 (CONTINUED) |
103 |
|
Table 33 TYPES OF VACCINES IN DEVELOPMENT FOR CANCER TREATMENT |
104 |
|
Allovectin-7 |
104 |
|
Allovectin-7 (Continued) |
105 |
|
BiovaxID |
106 |
|
Cervarix |
106 |
|
DCVax-Brain |
107 |
|
DCVax-Prostate |
107 |
|
GMK |
108 |
|
GVAX Prostate Vaccine |
109 |
|
IGN101 |
110 |
|
Insegia |
110 |
|
Insegia (Continued) |
111 |
|
Insegia (Continued) |
112 |
|
M-Vax |
113 |
|
Melacine |
114 |
|
MyVax Personalized Immunotherapy |
114 |
|
Myvax Personalized … (Continued) |
115 |
|
Oncophage |
116 |
|
OncoVax |
117 |
|
Panvac-VF |
118 |
|
Sipuleucel-T |
119 |
|
Stimuvax |
120 |
|
TG 4001 |
121 |
|
TG 1042 |
122 |
|
Theratope |
122 |
|
OTHER IMMUNOTHERAPY PRODUCTS FOR THE TREATMENT OF CANCER |
123 |
|
MARKETED PRODUCTS |
123 |
|
Gleevec |
123 |
|
Iressa |
124 |
|
Nexavar |
124 |
|
Revlimid |
125 |
|
Sprycel |
125 |
|
Sutent |
126 |
|
Tarceva |
127 |
|
Thalomid |
127 |
|
Velcade |
127 |
|
The Market for Other Immunotherapy Products for the Treatment of Cancer |
128 |
|
Table 34 GLOBAL MARKET FORECAST FOR OTHER CANCER TREATMENT IMMUNOTHERAPY PRODUCTS, THROUGH 2012 ($ MILLIONS) |
128 |
|
PRODUCTS IN DEVELOPMENT FOR THE TREATMENT OF CANCER |
128 |
|
Table 35 OTHER IMMUNOTHERPAY PRODUCTS IN PHASE III OR LATER DEVELOPMENT FOR THE TREATMENT OF CANCER |
129 |
|
Table 28 (CONTINUED) |
130 |
|
Table 28 (CONTINUED) |
131 |
|
Advexin |
131 |
|
BAY 43-9006 |
131 |
|
Ceplene |
132 |
|
Dacogen |
132 |
|
Efaproxyn |
132 |
|
Genasense |
133 |
|
Hycamptin |
133 |
|
INGN 241 |
134 |
|
Junovan |
134 |
|
Nexavar |
134 |
|
Onconase |
134 |
|
Orathecin |
135 |
|
Pixantrone |
135 |
|
PTK787 |
135 |
|
Telcyta |
136 |
|
Thymitaq |
136 |
|
Torisel |
136 |
|
Tykerb/Tycerb |
137 |
|
Velcade |
137 |
|
Zarnestra |
137 |
|
Zarnestra (Continued) |
138 |
|
INDUSTRY |
139 |
|
BLOCKBUSTER DRUGS ON THE WORLDWIDE PHARMACEUTICAL MARKET APPROACH 100 |
139 |
|
U.S. PHARMACEUTICAL INDUSTRY GROWTH TO INCREASE SLIGHTLY |
140 |
|
MORE MERGERS, ACQUISITIONS AND LICENSING |
140 |
|
MORE MERGERS, ACQUISITIONS AND … (Continued) |
141 |
|
BIOGENERICS-THE NEXT REVOLUTION |
142 |
|
BIOGENERICS-THE NEXT … (Continued) |
143 |
|
COMPANY PROFILES |
144 |
|
ABGENIX, INC. |
144 |
|
BUSINESS OVERVIEW |
144 |
|
FINANCIAL INFORMATION |
144 |
|
PRODUCTS |
144 |
|
XenoMouse and XenoMax Technologies |
145 |
|
Technology Advantages |
146 |
|
Technology Advantages (Continued) |
147 |
|
CORPORATE STRATEGY |
148 |
|
ALFACELL CORPORATION |
149 |
|
BUSINESS OVERVIEW |
149 |
|
FINANCIAL INFORMATION |
149 |
|
PRODUCTS |
149 |
|
CORPORATE STRATEGY |
150 |
|
AMGEN, INC. |
150 |
|
BUSINESS OVERVIEW |
150 |
|
FINANCIAL INFORMATION |
151 |
|
PRODUCTS |
151 |
|
Table 36 AMGEN'S PRODUCTS IN PHASE II OR LATER DEVELOPMENT |
151 |
|
CORPORATE STRATEGY |
152 |
|
ANTIGENICS INC. |
152 |
|
BUSINESS OVERVIEW |
152 |
|
FINANCIAL INFORMATION |
153 |
|
PRODUCTS |
153 |
|
Table 37 ANTIGENICS' PRODUCT PIPELINE |
153 |
|
CORPORATE STRATEGY |
153 |
|
AVAX TECHNOLOGIES, INC. |
154 |
|
BUSINESS OVERVIEW |
154 |
|
PRODUCTS |
154 |
|
CORPORATE STRATEGY |
155 |
|
BIOGEN IDEC, INC. |
156 |
|
BUSINESS OVERVIEW |
156 |
|
FIN
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