Opportunities for Monoclonal Antibodies: Where Companies Are Spending Their Antibody Dollars

Technological advances are exploding in the design of new and improved antibodies.
Therapeutic monoclonal antibodies (MAbs) represent one of the most lucrative sectors of drug development and commercialization, and biosimilar and biobetter MAbs are right around the corner. This report analyzes more than 100 MAbs on the market or in clinical development to assess potential market opportunities and where companies might best spend their precious resources for antibody development and commercialization (i.e., antibody dollars). The report investigates technologies to enhance the efficacy of antibodies or to make them safer drugs and specifically analyzes five key antibody technologies: antibody drug conjugates, Fab fragments, Fc engineering/glycoengineering, bispecific antibodies, and radioimmunotherapies.

Questions Answered in this Report

- MAbs have experienced great clinical success, and recent data for Herceptin show that MAb therapy can give long-term benefits. What is the size of MAb markets? What MAbs are on the market and in clinical development pipelines?

- The efficacy of MAbs needs to be improved, and they need to be associated with fewer adverse reactions. What black box warnings and Risk Evaluation and Mitigation Strategy (REMS) programs are in place for MAbs? What technologies are in development to improve MAb activities? Why does the FDA want to withdraw Avastin’s approval for breast cancer?

- MAb technology is a hot area for pharmaceutical dealmaking. What is the status of small antibody technology platforms? What antibody-enhanced products are in development and at what level? What recent antibody deals have occurred?

- Biosimilars represent a significant commercial opportunity given the size of the markets that have been created by certain MAbs that are soon to go off patent. What do surveyed hematologist- oncologists say will drive their uptake of biosimilar Rituxan/MabThera? Which large and domestic companies are developing a biosimilar Rituxan/MabThera?

- Biobetter MAbs represent an even better commercial opportunity. What antibody improvement technologies have matured to the point that biobetter MAbs are likely to enter the market in the near term?

Scope of the report:

- Pharmaceutical market sectors: Monoclonal antibodies (MAbs), synthetic peptides, small-molecule drugs, vaccines, recombinant proteins (i.e., protein therapies), market size, growth, major antibody franchises.

- Antibodies: Monoclonal antibody (MAb), 26 marketed antibodies, blockbusters, antibodies in clinical development, crowded antibody markets for non-Hodgkin’s lymphoma and chronic lymphocytic leukemia (NHL/CLL), International Nonproprietary Name (INN) guidelines, Fab fragment, Fc region, immunoglobulin subclass, effector function, most expensive drug in the world based on price per patient per year, single-chain Fv fragment (ScFv), diabody (also called a bibody), triplebody, tribody, TriFab.

- Antibody technologies: Chimeric, fully human, humanized, pegylation, Fab fragment, Fc engineering, glycoengineering, antibody drug conjugate (ADC), bispecific antibody, naked antibody, pretargeted radioimmmunotherapy (PT-RAIT), cell-killing agents, cytotoxic agent, toxin, tumor-targeted superantigens (TTS), antibody-dependent cell-mediated cytotoxicity (ADCC) enhancing, complement-dependent cytotoxicity (CDC) enhancing, inhibiting and activating Fc receptors, defucosylation, isotype chimerism, production systems, glycosidase inhibitors, sugar engineering, Fab arm switching or Fab crossover, trifunctional, bispecific T cell engager (BiTE), dual-variable-domain immunoglobulin (DVD-Ig), TandAb, dock and lock (DNL) technology, dual-affinity re-targeting (DART).

- Commercial issues: Indication expansion, nine Risk Evaluation and Mitigation Strategy programs for MAbs, black box warnings on 18 MAb labels, premium pricing, market entry of biosimilars, prospects for biobetters, emerging markets, dealmaking, contingency payments.

- Primary data: Data from a survey of 251 European hematologist-oncologists; attitudes toward naked, radiolabeled, and toxin-conjugated MAbs, and biosimilars.

- Expert insight: Andrew Merron, Ph.D., provides survey data and insights into biosimilar Rituxan/MabThera and the commercial prospects of new MAbs aiming to gain market share in crowded MAb markets. Dr. Merron is a senior oncology analyst at Decision Resources. He received his Ph.D. in molecular oncology from the University of London SHOW LESS READ MORE >

Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Introduction

International Nonproprietary Name Guidelines for MAbs
- Global Protein Therapy Markets
- Market Size
- MAb Blockbusters
- Major MAb Franchises
- Other Marketed MAbs

Threat of Market Saturation
- Crowded Biologics Markets
- Survey of European Hematologist-Oncologists

Imminent Threat of Biosimilar Rituxan/MabThera in Europe

Antibody Toxicities and Risks
- Risk Evaluation and Mitigation Strategy Programs
- Black Box Warnings

Antibody Drug Conjugates
- ImmunoGen
- Seattle Genetics
- Select Antibody Drug Conjugates in Clinical Development

Fab Antibody Fragments

Fc Engineering and Glycoengineering
- Alexion Pharmaceuticals
- Eureka Therapeutics
- Kyowa Hakko Kirin
- Roche Glycart
- Tolerx
- University of Texas
- Xencor

Cell Culture Glycosylation Methodologies
- Emergent BioSolutions
- Seattle Genetics

Bispecific Antibodies
- Trion Pharma/Fresenius Biotech
- Micromet
- Other Companies Developing Early-Stage Bispecific Antibody Technology

Radioimmunotherapy
- Attitudes About Naked, Radiolabeled, and Toxin-Conjugated MAbs
- GlaxoSmithKline
- Immunomedics and Pretargeted Radioimmunotherapy
- Spectrum Pharmaceuticals

Market Outlook
- About the Author
- About the Expert

- 4-Antibody
- Abbott Laboratories
- Active Biotech
- Active Biotech Research
- Affimed Therapeutics
- Agenus (formerly Antigenics)
- Alexion Pharmaceuticals
- Amgen
- Astellas Pharma
- AstraZeneca
- Bayer Healthcare
- Bayer Schering Pharma
- Biocon
- Biogen Idec
- BioMarin Pharmaceutical
- Biosynexus
- Biotecnol Pharmaceuticals
- Biotest
- BioWa
- Boehringer Ingelheim
- Bradmer Pharmaceuticals
- Bristol-Myers Squibb
- BTG
- Celldex Therapeutics
- Cephalon
- Cerimon Pharmaceuticals
- Chugai Pharmaceutical
- Daiichi Sankyo
- Dr. Reddy’s Laboratories
- Eisai
- Elan
- Eli Lilly
- Emergent Biosolutions
- Eureka Therapeutics
- Fresenius Biotech
- F-star Biotechnologische Boehringer Ingelheim
- Genentech
- Genmab
- Genzyme
- GlaxoSmithKline
- Helmholtz Zentrum München
- Human Genome Sciences
- IBC Pharmaceuticals ImmunoGen
- Immunomedics
- Johnson & Johnson
- KaloBios Pharmaceuticals
- Kyowa Hakko Kirin
- Lonza
- MacroGenics
- MedImmune
- Mentrik Biotechnology
- Merck & Co.
- Merck KGaA
- Merck Serono
- Micromet
- Mitsubishi Tanabe Pharma
- MorphoSys
- Morphotek (subsidiary of Eisai)
- Neurimmune Therapeutics
- Novartis
- Novartis Ophthalmics
- Nycomed
- OSI Pharmaceuticals
- Otsuka
- Parexel International
- Pfizer
- Pierre Fabre
- Progenics
- Quintiles
- Regeneron Pharmaceuticals
- Roche
- Roche Glycart
- Samsung
- Sandoz (the generic arm of Novartis)
- Sanofi-Aventis
- Sanofi Pasteur
- Seattle Genetics
- Shire
- Spectrum Pharmaceuticals
- Takeda Pharmaceutical
- TenX Biopharma
- Teva Pharmaceutical Industries
- Tolerx
- Trion Pharma
- Trubion Pharmaceuticals
- U.S. FDA
- UCB
- University of Texas
- Viropro
- Wilex
- World Health Organization
- Xencor
- Xoma
- Zyngenia