This report provides an analytical snapshot of the current state of the vaccine industry, its development efforts, and an outlook to 2020, examining:
- Vaccines for prevention of infectious diseases including hepatitis, influenza, polio, rabies, tropical viruses, and HIV
- Therapeutic vaccines that target HIV, HCV, asthma and allergy, type 1 diabetes, multiple sclerosis, psoriasis, arthritis, atherosclerosis, transplant rejection, Alzheimer's disease, periodontitis, substance abuse, obesity, cachexia, and age-related macular degeneration
- Therapeutic cancer vaccines, including all cancer vaccines currently known to be in Phase III clinical trials and an overview of products that are in Phase I or II
- Perspectives for vaccine development, the direction the markets are likely to take to 2020, and estimates for market growth
- Results of a four-part survey offering unique insights into industry sentiment concerning vaccine development to 2020
- Advances in vaccine design, formulation, and delivery
- Company profiles of large pharmaceutical players in the vaccine business and small vaccine specialist companies
New Trends in Preventive and Therapeutic Vaccines: R&D Activities and Commercial Prospects begins by dealing with the major task of vaccines: prevention of infectious diseases. A thorough overview of vaccine-preventable diseases is given, with a special focus on human immunodeficiency virus (HIV), hepatitis C, and influenza. We use the case of a potential HIV vaccine for an analysis of how the first vaccine for a previously "unvaccinable" major infectious disease could fare, on the market and in terms of epidemiological impact, assuming several scenarios. The major corporate players on the market, and vaccine specialist companies including those developing or selling vaccines for "weaponized" biological agents such as anthrax, are reviewed as are the international organizations and the charities, which play the dominant role in making standard vaccines accessible to the developing nations. Attention is given to emerging tropical viral diseases (such as Dengue and West Nile virus), which are increasingly spreading to the temperate zones of the globe. A special section is devoted to the challenge of tropical parasitic diseases. Opposition to vaccination is also discussed.
We then turn to therapeutic vaccines that target chronic infectious diseases, but also non-infectious conditions with massive immune system involvement. A special section addresses efforts to develop therapeutic vaccines for conditions that most people would not consider targets for this type of intervention. Therapeutic cancer vaccines are covered in a separate chapter. This part of the report reviews the paradigms of active immune intervention in cancer and the problems it faces, as well as discusses cancer vaccines in clinical development. Standardized cancer vaccines, which work by harnessing the patient's immune system, should offer a completely new therapeutic angle. Most importantly, they would be best suited to prevent tumor recurrence once a complete remission has been achieved by initial therapy-which would open an entirely new perspective for cancer survivors, and a completely new market as well.
Insight Pharma Reports conducted a four-part online survey in late September/early October 2011, which covered preventive vaccines for infectious diseases in general, influenza vaccines, HIV and HCV vaccines, and cancer vaccines. Analyses of the responses can be found throughout this report.
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- Executive Summary
- Chapter 1
- INTRODUCTION
- 1.1. Before the Cure There Was Protection
- 1.2. Mechanisms of Immunity
- 1.3. The Universe of Vaccines
- Chapter 2
- PREVENTIVE VACCINES
- 2.1. The Infectious Disease Vaccine Industry: Special in Every WayHow Vaccines Are Different
- 2.2. The Main Types of VaccinesDNA Vaccines: The Third Generation
- 2.3. Regulatory Handling of VaccinesVaccine Testing and Approval in the United States
- Vaccine Regulation in Europe
- No Generics with Vaccines
- 2.4. Diseases and the State of Available VaccinesBacterial Infections
- Viral Infections
- Hepatitis
- Influenza
- Poliomyelitis
- Rabies
- Spreading Tropical Viruses
- Japanese Encephalitis Virus
- Human Immunodeficiency Virus and AIDS
- Malaria
- 2.5. The Corporate PlayersLarge Pharmaceutical Players in the Vaccine Business
- Baxter Vaccines
- GlaxoSmithKline Vaccines
- Johnson & Johnson Center for Vaccines
- Novartis Vaccines and Diagnostics GmbH & Co. KG
- Pfizer Vaccines
- Sanofi Pasteur MSD
- Small Vaccine Specialist Companies
- AlphaVax
- Bavarian Nordic
- Bionor Pharma
- ChronTech Pharma
- DynPort Vaccine Company
- Emergent BioSolutions
- EpiVax
- Genocea Biosciences
- GenVec
- Inovio Pharmaceuticals
- Intercell
- Medicago
- MedImmune Vaccines
- Mymetics
- Novavax
- Sinovac Biotech
- Synthetic Genomics Vaccines
- VaxInnate
- Vical
- 2.6. Global InitiativesThe WHO Initiative for Vaccine Research (IVR)
- The Global Alliance for Vaccines and Immunization (GAVI)
- The Bill & Melinda Gates Foundation
- The United Nations Children's Fund (UNICEF)
- Pediatric Vaccines: A Multivalent Universe
- 2.7. The Market for Infectious Disease VaccinesIntellectual Property and the Vaccine Market
- Mixed Prospects for an HIV Vaccine
- 2.8. Opposition to Vaccination: A Persistent PhenomenonThe Coalition for Vaccine Safety (CVS)
- 2.9. Vaccine Design, Formulation, and DeliveryGenetic Engineering and Rational Design of Antigens
- Increasing Efficacy of DNA Vaccines
- The Adjuvant Revolution: Nanoparticulate Vaccines and ISCOM Technologies
- Intradermal and Needle-Free Transdermal Delivery
- Oral Vaccines: From Niche Toward Mainstream
- 2.10. Infectious Disease Vaccines in a Globalized WorldInternational Travel, Migration, and Climate Change Drive New Vaccine Demands
- SARS: A Model Event for an Emerging Pandemic Virus
- Influenza: The Big Pandemic Continues to Loom
- Planning and Logistics of Modern Mass Vaccination Campaigns
- Bioterrorism and Biowarfare: Countermeasures for "The Next Very Bad Thing"
- 2.11. The Challenge of the ParasitesWhy Vaccination Against Parasites Is Difficult
- The Quest for a Malaria Vaccine
- Schistosomiasis
- Neglected Tropical Diseases and the Major Pharma Markets
- Chapter 3
- THERAPEUTIC VACCINES
- 3.1. A Continuum with Immunotherapies
- 3.2. Postexposure Therapy for Viral DiseasesHepatitis C: Therapeutic Hopes in the Absence of Protection
- AIDS: Still the Hotbed for Therapeutic Vaccine Development
- 3.3. Potential Vaccination Targets Outside the Mainstream: Autoimmune Diseases and BeyondAsthma and Allergy
- Autoimmune Conditions: Type 1 Diabetes, Psoriasis, Arthritis, Multiple Sclerosis, and Transplant Rejection
- Type 1 Diabetes
- Multiple Sclerosis
- Rheumatoid and Psoriatic Arthritis
- Atherosclerosis
- Periodontitis
- Transplant Rejection
- Alzheimer's Disease
- 3.4. The Most Unlikely Vaccine TargetsDrug Abuse and Smoking
- Limited Hopes for Obesity
- Cachexia
- Macular Degeneration
- Chapter 4
- CANCER VACCINES
- 4. 1. Objectives and Criteria for a Cancer VaccineProphylaxis and Therapy Rolled into One
- Therapeutic Cancer Vaccines: Breaking Immune Tolerance
- Cancer Vaccines and Regulatory Authorities
- 4.2. The Status Quo: Cancer Vaccines Approved in the United States and ElsewhereGardasil and Cervarix to Prevent Cervical Cancer
- Provenge for Prostate Adenocarcinoma
- OncoVAX to Prevent Colon Cancer Recurrence
- Melacine for Melanoma
- Oncophage
- CimaVax EGF
- 4.3. Cancer Vaccines in Clinical Developmentgp100:209-217(210M) (National Cancer Institute)
- Lucanix (Belagenpumatucel-L) (NovaRx Corp.)
- GVAX (BioSante Pharmaceuticals [formerly Cell GeneSys])
- Stimuvax (Emepepimut-S) (Merck KGaA/Oncothyreon)
- TroVax (MVA-5T4) (Oxford BioMedica)
- GSK1572932A (GlaxoSmithKline)
- Prostvac-VF/TRICOM (BN Immunotherapeutics)
- OPT-822 (Optimer Biotechnology)
- IMA901 (Immatics Biotechnologies GmbH)
- GV1001 (KAEL-GemVax)
- Candidates to Enter Phase III
- TG-4010 (Transgene SA)
- Rindopepimut (CDX-110) (Avant Immunotherapeutics)
- Selected Phase I/II Candidate Vaccines
- ONY-P (VaxOnco)
- DPX-0907 and DPX-Survivac (Immunovaccine)
- ADXS11-001 (Advaxis)
- IDM-2101 (BioTech Synergy)
- VGX-3100 (Inovio Pharmaceuticals)
- SCIB1 (Scancell Holdings)
- HyperAcute Vaccines (NewLinkGenetics Corp./Ochsner Health System)
- PEP-223/CoVaccine HT (Pepscan Systems BV)
- ImMucin (Vaxil BioTherapeutics)
- GI-4000 and GI-6207 (GlobeImmune)
- PEV-6A (Pevion Biotech and Bio Life Science)
- 4.4. Market Potential for Cancer Vaccines
- Chapter 5
- VACCINE PERSPECTIVES TO 2020
- 5.1. Bioinformatics, Simulations, and In Silico Vaccinology
- 5.2. Toward the "Universalization" of Vaccines?
- 5.3. The Future of Vaccine Patenting
- 5.4. Commercial Scenarios for Vaccines
- 5.5. Summary
- References
- Company Index
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