Abstract
There are hundreds of drugs in Phase III clinical trials, of which almost 200 of them may gain market approval from the FDA in the coming 5 years. Which drugs will make it and how these drugs impact existing pharmaceutical markets in terms of overall size and competitive share is one of the most difficult forecasting projects in market research.
In this nearly 500-page analysis, Kalorama Information has compiled all the relevant information about the candidates, their value, and their likely impact. And we've made some predictions and estimates of the changing market scenarios in five therapeutic areas.
In particular, this report examines over 500 drugs in Phase III clinical trials and how these new products are expected to perform and affect existing markets. The report looks at five therapeutic categories:
- Cardiovascular disease,
- Neuropsychotherapeutic disorders,
- Infectious disease,
- Cancer, and
- Others.
Market opportunity revenues are provided in each segment for approvals anticipated from 2006 to 2010 with specific information related to likely 2006 approvals. For each segment, the report includes an
- Overview,
- Descriptions of products in phase III development,
- Number of approvals expected each year through 2010 by indication within the segment,
- Market forecasts for those likely to be approved,
- Which major brands and marketers who are currently active the segment will be affected by these likely new entrants, and
- What share of the segments these new drugs are likely to take.
This report is the only analysis of its kind available in syndicated form and contains vital intelligence for strategic planners within the industry and analysts and investors interested in the competitive dynamics in the years ahead.
Table of Contents
Chapter One: Executive Summary
- Scope and Methodology
- Potential Market Opportunity
- Issues and Trends Affecting Market
- Leading Competitors
Chapter Two: Introduction Drugs in Phase III Development
- Introduction
- Drug Development Overview
- Phases of Drug Development
- Benefits and Risks of Phase III Development
- Benefits
- Risks
- Randomization
- Clinical Trial Protocol
- Orphan Drugs
- Fast Track Drug Status
- Biotechnology Drug Development
- Mergers, Acquisitions, and Collaborations
- Contributors To R&D Success
- R&D Spending
- Contract Research Organizations
Chapter Three: Cardiovascular Drugs: Phase III Development Analysis
- Overview
- Heart
- Circulatory System
- Cardiac Cycle
- Isovolumic Contraction
- Ventricular Ejection
- Isovolumic Relaxation
- Coronary Circulation
- Cardiac Myocytes
- o
- Contraction
- Calcium Role in Contraction
- Relaxation
- Cardiac Energy Metabolism
- Cardiac Output
- Conditions
- Angina Pectoris
- Arrhythmia
- Atherosclerosis
- Congestive Heart Failure
- Coronary Artery Disease
- Hypertension
- Myocardial Infarction
- Incidence of Conditions
- Products in Development
- AGI-1067
- Alfimeprase
- Ambrisentan
- Angiomax
- Atrixra
- Azimilide
- Celacade
- Clevelox
- Conivaptan
- CP-529, 414 (Torcetrapib/Atorvastatin)
- Dabigatran Extexilate
- Darusentan
- Dronedarone
- Exanta
- Enoximone capsules
- Idraparinux
- Integrilin
- Lercanidipine (Zanidip)
- OPC-41061
- Pexelizumab
- Prasugrel
- Propiony-l-carnitine
- Ranexa
- Resten NG
- RSD 1235 IV
- Simdax
- SPP101
- Tecadenoson
- Tedisamil (Pulzium)
- Thelin
- Market Size and Growth
- Competitive Analysis
Chapter Four: Neuropsychotherapeutic Drugs: Phase III Development Analysis
- Overview
- Structural Organization of the Neurological System
- Types of Neuropsychotherapeutic Diseases and Disorders
- Alzheimer's Disease and Dementia
- Traumatic Brain Injury
- Cerebrovascular Disease and Stroke
- Ischemic Stroke
- Hemorrhagic Stroke
- Cerebral Palsy
- Parkinson's Disease
- Huntington's Disease
- Myasthenia Gravis
- Tic and Tourette's Syndrome
- Periodic Limb Movement Disorder and Restless Leg Syndrome
- Seizures
- Generalized Seizures
- Partial Seizures
- Aura/Prodrome
- Multiple Sclerosis
- Amyotrophic Lateral Sclerosis
- Spinal Cord Injury
- Guillian-Barre Syndrome
- Bell's Palsy
- Anxiety Disorders
- Panic Disorder
- Post-traumatic Stress Disorder
- Specific and Social Phobias
- Attention Deficit Hyperactivity Disorder
- Bipolar Disorder
- Cyclothymic Disorder
- Borderline Personality Disorder
- Depression
- Eating Disorders
- Anorexia Nervosa
- Bulimia Nervosa
- Obsessive-Compulsive Disorder
- Schizophrenia
- o
- Sleep Disorders
- Insomnia
- Narcolepsy
- Parasomnia
- Substance Abuse
- Alcohol Abuse
- Drug Abuse
- Incidence of Conditions
- Products in Development
- AERx Inhaled Morphine
- Alcar
- ALGRX 3268
- Alzhemed
- Ampligen
- Antegren
- Aquavan
- Asenapine
- Bicifadine
- Bifeprunox
- CEP 1347
- Cerovive
- Chronogesic
- Citicoline
- Corlux
- DAS-431
- DU 127090
- DVS-223
- Dynastat
- Fampridine
- Flurizan
- Gaboxadol
- Iloperidone
- Indiplon
- KW-6002
- Lacosamide
- Miraxion
- MT 100
- MT 300
- Mylinax
- Neurodex
- NGX-4010
- NRP104
- Nuvigil
- ONO-2506
- Org 25969
- Oxytrex
- Pagoclone
- Phenserine
- PRX-00023
- Rapinyl
- Rasagiline
- Remoxy
- ReoPro
- Requip CR
- Rotigotine CDS
- Saredutant
- SGS111
- Silenor
- SLV308
- SPD 503
- Spheramine
- SR58611
- Teriflunomide
- Tramadol
- Trexima
- Xaliproden
- Zelpar
- Market Size and Growth
- Competitive Analysis
Chapter Five: Infectious Disease: Phase III Development Analysis
- Overview
- Conditions
- Fungi
- Viruses
- Hepatitis
- Hepatitis A
- Hepatitis B
- Hepatitis C
- Hepatitis D
- Hepatitis E
- Hepatitis G
- Herpes Simplex
- Epstein-Barr Virus (Mononucleosis)
- Influenza
- Other Significant Viruses
- Human Papilloma Virus
- Cytomegalovirus
- Respiratory Syncytial Virus
- Hantavirus
- Yellow Fever
- Rotavirus
- Parvovirus
- Incidence of Conditions
- Products in Development
- ABT-773
- ACAM2000
- Amoxicillin PULSYS
- Anidulafungin
- Aplaviroc
- AzaSite
- Aztreonam Lysinate
- Buffer Gel
- Ceftobiprole (BAL5788)
- Cervarix
- Cubicin (daptomycin for injection)
- Dalbavancin
- Doripenem
- Extina
- Faropenem daloxate
- Gardasil
- Garenoxacin
- Helicide
- Hyphanox
- IFN-alpha Lozenge
- Influvac TC
- Iseganan
- Interferon Alfacon/Ribaviron Combination
- Macrotac
- ME-609
- Maraviroc
- Multiferon
- MX-226 (CPI-226)
- Neuprex
- Noxafil
- Oracea
- Oritavancin
- PolyphenonE Ointment
- PRO 2000
- Ramoplanin
- Retapamulin
- Rotarix
- SAVVY
- Simplirix
- SPO1A
- StaphVAX
- Streptorix
- T-3811
- Telavancin
- Telbivudine
- Tifacogin
- Tolevamer
- Tripranavir
- Ushercell
- Veronate
- Viramidine
- Zadaxin
- Market Size and Growth
- Competitive Analysis
Chapter Six: Cancer Drugs: Phase III Development Analysis
- Overview
- Biochemistry of Cancer Cells
- Carcinogen Metabolism
- Causes of Cancer Growth
- Environmental Factors, DNA, RNA
- Cellular Oncogenes
- Tumor Suppressor Genes
- Types of Cancer
- Bladder/Urinary Cancer
- Breast Cancer
- Cervical Cancer
- Colorectal Cancer
- Endometrial (Uterine) Cancer
- Esophageal Cancer
- Head and Neck
- Kidney
- Leukemia
- Liver
- Lung Cancer
- Lymphoma
- Melanoma
- Multiple Myeloma
- Neuroblastoma
- Ovarian Cancer
- Pancreatic Cancer
- Prostate Cancer
- Stomach Cancer
- Incidence of Conditions
- Products in Development
- Acapodene
- Advexin
- Allovectin-7
- Alvocidib
- AMD-3100 (Mozobil)
- Arzoxifene
- Atamestane
- Avastin
- Avicine
- Biovaxid
- Canvaxin
- Ceplene
- Cintredekin besudotox (IL13-PE38)
- Cloretazine
- CoFactor
- Cotara
- DCVAX -Prostate
- Doxil
- DTI 015
- Edotecarin
- Efaproxyn
- FavId
- Genasense
- Glufosfamide
- GMK Therapeutics Vaccine
- GVAX Prostate
- HuMax CD4
- IGN101
- Insegia
- Ixabepilone
- Javlor
- Junovan
- Lapatinib
- Lasofoxifene
- MDX-010
- MyVax
- Neovastat
- Nexavar (previously BAY 43-9006) (Sorafinib)
- NOV-022
- Onconase
- Oncophage
- OncoVax
- Orathecin
- OvaRex
- Panitumumab
- Panvac-VF
- Rencarex
- Satraplatin
- Sipuleucel-T (Provenge)
- STR
- Tavocept
- Taxoprexin
- Telcyta
- Temsirolimus
- TheraCIMhR3(Nimotuzunab)
- Thymitaq
- TransMID-R
- Vatalanib
- Vinorelbine IV
- Xcytrin
- Xerecept
- XL119
- Xorane
- XRP9881
- Xyotax
- Yondelis
- Zactima
- Zarnestra
- ZYC101a
- Market Size and Growth
- Competitive Analysis
Chapter Seven: Other Drugs: Phase III Development Analysis
- Overview
- Conditions
- Types of Conditions, Diseases and Disorders
- Diabetes
- Irritable Bowel Syndrome /Crohn's Disease
- Psoriasis
- Rheumatoid Arthritis
- Osteoporosis
- COPD/Asthma
- Incidence of Conditions
- Products in Development
- 406381
- Aclasta
- Acomplia
- AERx iDMS
- Alicaforsen
- Alista
- Allermist
- Alprox TD
- Alvesco
- ALX-0600
- AMG 162 (Denosumab)
- Aridol
- Arxxant
- Arformoterol
- Asoprisnil
- Axokine
- Bazedoxifene
- Belatacept
- Bio-E-Gel
- Biopten
- Bronchitol
- CDP 870
- Ceprotin
- Chrysalin
- Cilansetron
- Cimzia
- Cordase
- CS-917
- Dapoxetine
- Daxas
- DE-085
- Dexloxiglumide
- DPP4 Inhibitor Oral(Saxasliptin)
- E2/DNG Pill
- Eculizumab
- Evamist
- Exanatide
- Exubera
- FC Patch
- Ferumoxytol
- Fersterodine
- FIBRILLEX
- Formoterol HFA ( Fordil Certihaler)
- Fortigel
- Galida
- Human Growth Hormone
- ICA-17043
- IoGen
- ISV-205
- Itax
- LAF237
- Lasofoxifene (Oporia)
- LEA29Y
- LibiGel
- Librel
- Livial
- Lucentis
- Menopausal Levonorgestrel System
- Mepolizumab
- Methylnaltrexone
- MK-0431(Sitagliptin)
- Muraglitazar (Pargluva)
- NovoMix 50 and 70
- Onercept
- OPC-6535
- Oral Calcitonin
- OrBec
- Oxygent
- Pennsaid Topical Solution
- Phenoptin
- PhotoPoint
- PHP
- Posurdex
- PREOS
- Prexige
- Primolux
- PTI-901
- QAB149
- Rebamipide
- ReFacto AF
- Retanne
- SPD 476
- SPI-0211/RU0211 (Lubiprostone)
- SR 121463
- Stannsoporfin (Stanate)
- Starlix and Diovan
- Tanaproget
- Teduglutide
- Terlipressin
- Tolevamer
- Tostrelle
- VP002
- XP12B
- YAZ
- Zelnorm
- Market Size and Growth
- Competitive Analysis
