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SUMMARY
Introduction
Monoclonal antibodies (MAbs) are very hot commodities in today's
pharmaceutical marketplace, and in recent years, the growth in the number of
MAbs under development has far outpaced the growth of other types of drugs.
With expert insight from our Decision Resources analysts, we look at
approximately 70 MAbs in latestage development, identify promising MAbs, and
discuss four developing trends in MAb markets.
Get the Answers You Need to Shape Your Strategy
- Monoclonal antibodies are one of the fastest growing segments of the
pharmaceutical industry. Will the intense competition in this market lead
to saturation in some segments? Which classes could get crowded if new MAbs in
development successfully enter the market?
- MAbs are highly sought after by the pharmaceutical industry to fi ll
sparse pipelines with new biologics. Which companies are looking to ramp up
their MAb production? Who will be the key players in this arena going
forward?
- MAb markets are becoming complex, and companies with emerging MAbs need to
carefully consider how best to position their products. Which factors will
be the most important to ensuring market success for new MAbs? What strategies
are companies pursuing?
Scope
- A review of the evolving biologics market: the role of MAbs, sales
fi gures, market leaders.
- MAbs in development in ten different drug classes: their stage of
development and the companies developing them.
- Four interesting trends in MAb markets: developments that are
adding new layers of complexity to the MAb landscape, trends to be carefully
considered when entering or competing in today's evolving MAb markets,
implications for stakeholders.
- Expert insight from Decision Resources analysts: comparison of the
relative merits of MAbs now in development, by the following analysts:
- Madhuri Borde, Ph.D., analyst, Immune and Infl ammatory Disorders
- Sylvia Eash, Ph.D., analyst, Infectious Disease
- Clair Gricks, Ph.D., analyst, Onkos
- Neil Grubert, M.A., director of pricing and reimbursement, Spectrum,
Pharmacoeconomics, Pricing, and Reimbursement
- Bethany A. Kiernan, Ph.D., analyst, Cognos
- Joanna Kim, M.Ed., analyst, Immune and Infl ammatory Disorders
- Nitasha Manchanda, Ph.D., analyst, Cognos
- Jennifer Moniz Carpenter, M.B.A., program manager, Spectrum, Therapy
Markets and Emerging Technologies
- Mohamed Muhsin, M.Sc., analyst, Onkos
- Alice von Loesecke, Ph.D., senior director, New Products
TABLE OF CONTENTS
- Executive Summary
- Strategic Considerations
- Trends and Their Implications for Stakeholders
- Evolving Biologics Market
- Alzheimer's Disease and Anti-Amyloid Antibodies
- Elan/Wyeth's AAB-001 (Bapineuzumab)
- MAbs in Early-Stage Clinical Development for Alzheimer's Disease
- Anti-Integrin Antibodies
- Biogen Idec/Elan's Tysabri (Natalizumab)
- Anti-Integrin Antibodies in Early-Stage Clinical Development
- Biogen Idec/PDL BioPharma's M-200 (Volociximab)
- Johnson & Johnson/Centocor/Medarex's CNTO-95
- Millennium's MLN-0002
- Selective T-Cell Co-Stimulation Antagonists
- Superagonist Debacle
- Bristol-Myers Squibb's Orencia (Abatacept)
- Three Phase III Contenders
- Bristol-Myers Squibb's LEA29Y (Belatacept)
- Medarex/Bristol-Myers Squibb's MDX-010 (Ipilimumab)
- Pfi zer's CP-675,206 (Tremelimumab)
- Complement and Complement Receptor Antibodies
- HIV Antibody Therapies
- Blocking Immune Cell Migration to Infl ammation Sites
- Cytotoxicity-Enhanced CCR4 Antibody
- B-Cell-Targeted Therapies: Anti-CD20 Antibodies
- Biogen Idec/Genentech/Roche/Chugai/Zenyaku's Rituxan/MabThera (Rituximab)
- Anti-CD20 Antibodies in Clinical Development
- Biogen Idec/Genentech/Roche's R-1594/PRO-70769 (Ocrelizumab)
- GlaxoSmithKline/Genmab's HuMax-CD20 (Ofatumumab)
- Immunomedics' IMMU-106 (Veltuzumab)
- Next-Generation Engineered Antibodies
- Radioimmunotherapy
- T-Cell-Targeted Therapies
- Anti-CD3 Antibodies
- Agents in Development for Recent-Onset Type 1 Diabetes
- Agents in Development for Infl ammatory Bowel Diseases
- CD4-Targeting Antibodies
- Novel Interleukin-6 Receptor Antagonist Class
- Tumor Necrosis Factor-Alpha Inhibitors
- EGFR-Targeted Therapies
- Bristol-Myers Squibb/ImClone Systems /Merck Serono's Erbitux (Cetuximab)
- Amgen's Vectibix (Panitumumab)
- EGFR Antagonists in Clinical Development
- Oncoscience/YM Bioscience/Daiichi Sankyo's TheraCIM h-R3/Theraloc
(Nimotuzumab)
- Genmab's HuMax-EGFR (Zalutumumab)
- Merck Serono/Takeda's EMD-72000 (Matuzumab)
- Bristol-Myers Squibb/ImClone Systems' IMC-11F8
- Anti-VEGF Angiogenesis Inhibitors
- Genentech/Roche/Chugai's Bevacizumab (Avastin)
- Drug Resistance and Combination Therapies
- Genentech/Novartis's Lucentis (Ranibizumab)
- ThromboGenics/BioInvent's TB-403
- Four Developing Trends
- Trend 1
- Trend 2
- Trend 3
- Trend 4
Tables:
- 1. Alzheimer's Disease and Anti-Amyloid Antibodies
- 2. Anti-Integrin Antibodies
- 3. Selective T-Cell Co-Stimulation Antagonists
- 4. Select Complement Receptor Antibodies
- 5. Anti-CD20 Antibodies
- 6. Anti-CD3 Antibodies
- 7. Anti-CD4 Antibodies
- 8. Tumor Necrosis Factor Alpha (TNF-α) Antibodies
- 9. Anti-EGFR Antibodies
- 10. Anti-VEGF Angiogenesis Inhibitors
Figures:
- 1. Evolving Pharmaceutical Market Segments Based on Technology, 2000-2012
- 2. Top-Selling Monoclonal Antibodies, 2007
- 3. Amyloid Plaques and Neurofi brillary Tangles in Alzheimer's Disease
- 4. Mechanisms of T-Cell Co-Stimulation
- 5. The Life Cycle of HIV-1
- 6. EGFR Family
- 7. The Angiogenic Process
- 8. TNF-Alpha Inhibitors, 2006-2016: Market Share
Decision Resources, Inc., Analysts Featured
- Madhuri Borde, Ph.D., analyst, Immune and Infl ammatory Disorders
- Sylvia Eash, Ph.D., analyst, Infectious Disease
- Clair Gricks, Ph.D., analyst, Onkos
- Neil Grubert, M.A., director of pricing and reimbursement, Spectrum,
Pharmacoeconomics, Pricing, and Reimbursement
- Bethany A. Kiernan, Ph.D., analyst, Cognos
- Joanna Kim, M.Ed., analyst, Immune and Infl ammatory Disorders
- Nitasha Manchanda, Ph.D., analyst, Cognos
- Jennifer Moniz Carpenter, M.B.A., program manager, Spectrum, Therapy
Markets and Emerging Technologies
- Mohamed Muhsin, M.Sc., analyst, Onkos
- Alice von Loesecke, Ph.D., senior director, New Products
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