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Monoclonal antibodies: 2009 update

Datamonitor
November 2, 2009
SKU: DFMN2500560

Abstract Table of Contents Related Reports

Introduction

The report provides a comprehensive financial and strategic analysis of the mAb market, forecasting its commercial evolution out to 2014 and assessing trends by product, company, therapy area, geography, technology and target type. It also provides an insight into the direction of mAb technology evolution and an analysis of pipeline dynamics.

Scope

Comprehensive financial strategic analysis of the mAb market out to 2014
Global sales forecasts to 2014 for marketed and Phase III mAb products
Analysis of market trends by product, company, geography, therapy area, technology and target type
Analysis of characteristics of key products and insight into direction of mAb technology evolution and pipeline dynamics

Highlights

The global prescription pharmaceutical market is expected to face a decline in sales over 2012 to 2013 as a result of the 'patent cliff'. The patent cliff will impact the small molecule market, in contrast, the mAb market segment will continue to record robust growth.

Over the forecast period monoclonal antibodies are predicted to enjoy double-digit growth while small molecule drugs face declining growth rates. The main barrier to sales growth for small molecules, and particularly in the US, is exposure to material generic competition, which Datamonitor believes will have no effect on mAbs out to 2014.

This attractive growth rate and sales return potential has made mAb companies a prime acquisition target in recent years, even during a period of economic uncertainty, with a number of key acquisitions made during 2008-09.

Reasons to Purchase

Assess the key products that will drive sales growth in the mAb market to 2014
Identify the key geographic regions of the global mAb market and the dynamics within these territories
Understand the challenges and barriers to entry for new players seeking to venture into the mAb market

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ABOUT DATAMONITOR HEALTHCARE: About the PharmaVitae team
Chapter 1 About this Sector Report: PharmaVitae Explorer database
Chapter structure
Executive summary: mAb technology overview; Market analysis; Pipeline analysis; Key products; Data sourcing; Sales data
Chapter 2 Executive summary: Key findings; Total prescription pharmaceutical market outlook; Monoclonal antibody market outlook; Introduction to the PharmaVitae company universe; The prescription pharmaceutical market to 2014; Prescription pharmaceutical market performance, 2008-14; Introduction to molecule type analysis; Small molecules; Therapeutic proteins; Monoclonal antibodies; Vaccines; Industry consequences of molecule type; Prescription pharmaceutical sales by molecule type, 2008-14; The monoclonal antibody market will deliver the biggest portion of sales growth across the entire pharmaceutical industry, at the fastest rate; The mAb market is forecast to increase at a double-digit growth rate; The monoclonal antibody market will deliver much-needed sales growth in order to offset US-centered small molecule sales collapse; Geographic sales growth: the US and 5EU lead the way; A raft of new mAbs expected to make it onto the market over 2008-14; ...but still only a few mAbs command the highest revenues; Introduction to the 'Big 5'; 'Big 5' dominance will remain, although their share will decline; Product analysis (size); Product analysis (growth); Company analysis; Big Pharma's hold on the mAb market; Recent M&A deals underline Pharma's 'bankable view' of mAbs; The mAb landscape: innovation driven by collaboration and M&A; Long term opportunities and threats; Long term threat of biosimilar mAbs?; The US offers the 'biggest biosimilar prize'; Price of mAb therapies a major resistor to growth, however, the collapse of the US branded small molecule market could 'free-up' payer resource to expand mAb purchasing; Drive for personalized medicine: the role of companion diagnostics, an opportunity for diagnostic and mAb players; Table of Contents; Table of figures
Chapter 3 MAb Technology Overview: Key findings; Introduction; The immune system; B lymphocytes and antibodies; Antibody structure; Hybridoma technique - the production of mAbs; Monoclonal antibodies as therapeutic agents; Targets; Target selection - the importance of an accessible epitope; Production of mAbs; Transgenic mice; Phage display; Future focus; Mode of action; mAb-focused oncology; The effect of the effector region; Blockade; MAbs as a delivery vehicle; Evolution of mAbs; Limitations associated with immunization; Murine; Chimeric and humanized antibodies; Chimeric; Humanized; Fully human; Fragments; Conjugated; Radiolabeled conjugated mAbs; Focus for antibody R&D - oncology immunotoxin drug conjugates; Naked mAbs still dominate; Systematic naming of monoclonal antibodies; The mAb timeline - technology evolution; Manufacturing; Time to market and manufacturing of monoclonal antibodies; Mammalian cell culture - still the most widely-used system
Chapter 4 Market analysis: Key findings; Introduction; The mAb market, overview of the fastest growing sector across the pharmaceutical industry; The mAb market: the double-digit growth market; Key global mAb products, 2002-14; Introduction to the 'Big 5'; MAb market: product analysis, 2002-14; Historical product analysis, 2002-08; Growth from a few; Rapid uptake from two key therapies; Growth continues from more established therapies; Forecast product analysis, 2008-14; Avastin to shape the mAb market future; Humira will be the biggest immunology & inflammation driver; Still growth left for the older brands; Exciting Amgen entrant to make an impact; Second generation anti-TNF to gain some ground on Humira...; ...at the expense of Remicade; Innovative Alzheimer's therapy attracts additional Big Pharma investment; Roche expands mAb interests away from oncology; MAb market: company analysis, 2002-14; Historical product analysis, 2002-08; 'Big 5' ownership highlights four key players; Genentech and Roche: the symbiotic partnership; Abbott Laboratories, growth through in-licensing; Schering Plough and Johnson & Johnson: Remicade centered growth; Forecast company analysis, 2008-14; Leading players will maintain standing, with few new entrants; Roche through Genentech maintains leading position; Abbott's Humira-centric growth; Amgen: the emerging player; Johnson & Johnson, recent deal boosts mAb interests; MAb market: therapy area analysis, 2002-14; Historical therapy area analysis, 2002-08; 'Big Three' drives oncology sales; Immunology & inflammation: two-product therapy area; Forecast therapy area analysis, 2008-14; Oncology: Genentech/Roche continue to lead the way; Immunology & inflammation delivers strong growth, despite Raptiva withdrawal; After a stuttering start central nervous system will emerge as a major mAb therapy area; Musculoskeletal; MAb market: geographic analysis, 2002-14; Historical geographic analysis, 2002-08; US growth centered on 'Big 5'; Herceptin drives 5EU sales; Japan: older therapies in an earlier life cycle stage; Forecast geographic analysis, 2008-14; The US and 5EU will contribute almost 80% of the global mAb market growth; The developing Japanese market will experience some major brand launches...; ... but the RoW will still generate more mAb sales; MAb market: technology analysis, 2002-14; Historical technology analysis, 2002-08; Humanized becomes the number one in 2008; Forecast technology analysis, 2008-14; Increasing human content the market driver; Avastin and key launch products will drive humanized sales; Human mAb sales growth centered on three products; The once dominant chimeric mAbs will slow in growth; Antibody fragments, the only other +$1 billion sales growth driver; MAb market: target analysis, 2002-14; Historical target analysis, 2002-08; Forecast target analysis, 2008-14; Avastin and Lucentis will drive VEGF sales; Well represented TNF alpha target will continue to grow; CD20: Rituxan remains dominant although GSK will make some headway; RANKL sales growth from highly anticipated first-in-class Prolia; Market withdrawal of Raptiva in 2009 ends CD11a sales growth
Chapter 5 Pipeline analysis: Key findings; Introduction; MAb pipeline overview; Company pipeline analysis; Late-stage company pipeline analysis; Early-stage company pipeline analysis; Change of direction driven by acquisition; Technology pipeline analysis; Therapy area pipeline analysis; Target pipeline analysis; Target crowding evident with the late-stage mAbs - with lifecycle management strategies being employed; Novel target early-stage candidates
Chapter 6 Key products: Key findings; Introduction; Oncology; Avastin; Overview; Sales forecast; Product overview; Additional indication approvals drives growth; Failure in adjuvant trial raises concerns; Competitive threats to future sales growth; Herceptin; Overview; Sales forecast; Product overview; Competitive threats to future sales growth; MabThera/Rituxan; Overview; Sales forecast; Product overview; Competitive threats to future sales growth; Erbitux; Overview; Sales forecast; Restrictive patient population impedes sales growth; Additional indications drive growth; Prolia (onco); Overview; Sales forecast; Prolia (oncology); Significant opportunity in oncology, targeting Zometa's market; Amgen initially seeking approval for treatment of bone loss in patients receiving hormone ablation chemotherapy; Biggest sales potential lies within the treatment and prevention of bone metastasis; Amgen announces positive late-stage bone metastases data; Vectibix; Overview; Sales forecast; Personalized medicine movement to boost sales?; Arzerra; Overview; Sales forecast; Genmab/GlaxoSmithKline are investigating Arzerra in the first-line follicular lymphoma setting; Genmab/GlaxoSmithKline's commercial strategy may improve Arzerra's chances of success in the non-Hodgkin's lymphoma market; Targeting underserved chronic lymphocytic leukemia patients may enhance Arzerra's uptake in the market; gains FDA approval; Immunology & inflammation; Humira; Overview; Sales forecast; First fully human anti-TNF alpha mAb; Aggressive indication broadening; Humira growth outstrips rivals Enbrel and Remicade; Significant dosing and delivery advantages help drive uptake; Further growth across all indications expected despite new launches; Remicade; Overview; Sales forecast; Remicade can be used at first-line without prior failure of methotrexate; Remicade is prescribed in patients who may have compliance problems; Unlike Enbrel and Humira, Remicade does not have the JIA indication; Remicade's sales will decrease from 2010 as patients shift to Simponi; Simponi; Overview; Sales forecast; Simponi will be positioned in multiple rheumatoid arthritis patient subgroups; Simponi and first-generation Remicade will compete in the same rheumatoid arthritis populations; Simponi offers dosing frequency advantages over other TNF inhibitors; Cimzia; Overview; Sales forecast; UCB's novel anti-TNF mAb finally gets green light; UCB faces a considerable promotional hurdle in recruiting physicians; Non-responder patient population and pricing offer key route to uptake; Actemra; Overview; Sales forecast; Product overview; Delay to launch in the US; Actemra has strong positioning potential as a result of impressive Phase III program; Product positioning; Future performance; Stelara; Overview; Sales forecast; Compared to Enbrel, Stelara shines in terms of efficacy; Dosing frequency distinguishes Stelara from marketed biologics; Central nervous system; Tysabri; Overview; Sales forecast; Product overview; Safety scare; Re-launch; Two new confirmed cases of PML rocks initially strong 2008 Tysabri uptake; Physician enrollment and patient numbers have increased strongly with each month through to July 2008; Long-term growth hinges on the incidence and management of new PML cases; Bapineuzumab; Overview; Sales forecast; Product overview; Campath (CNS); Overview; Sales forecast; Product overview; Phase II data show superior efficacy compared to Rebif; Safety concerns; Future market potential; Infectious diseases; Numax; Overview; Sales forecast; Product overview; Synagis; Overview; Sales forecast; Product overview; Respiratory; Xolair; Overview; Sales forecast; Musculoskeletal; Prolia; Overview; Sales forecast; First-in-class therapy; Not oral, but convenient dosing all the same; Strong clinical trial data, issues regarding safety; Initially positioned as a second-line therapy; GSK deal should provide Amgen with higher returns; Cardiovascular; ReoPro; Overview; Sales forecast; Other; Lucentis; Overview; Sales forecast; Fragment of Avastin has provided significant revenues; Strong clinical trial data has positioned Lucentis as the market leading treatment; Avastin off-label usage discouraged
Chapter 7 Appendix: References; Datamonitor reports; Abbreviations; Exchange rates; About Datamonitor; About Datamonitor Healthcare; Datamonitor consulting; Disclaimer
List of Tables: Table 1: PharmaVitae company coverage by peer set; Table 2: Molecule type definitions; Table 3: General characteristics of small molecule drugs vs. biologics; Table 4: Prescription pharmaceutical sales ($m) by molecule type, 2008-14; Table 5: The global small molecule market ($m), 2008-14; Table 6: The global mAb market ($m), 2008-14; Table 7: The 'Big 5' (annual revenues >$4 billion in both 2008 and 2014); Table 8: Overview of a selection of marketed mAbs: technology type and immunogenicity; Table 9: Infix nomenclature for mAbs; Table 10: Manufacturing cell lines for marketed mAbs; Table 11: Global top 5: 2002, 2008 & 2014 ($m); Table 12: The 'Big 5' (annual revenues >$4 billion in both 2008 and 2014); Table 13: Historical mAb product sales ($m), 2002-08; Table 14: Forecast mAb product sales ($m), 2008-14; Table 15: Historical mAb company sales ($m), 2002-08; Table 16: Forecast mAb company sales ($m), 2008-14; Table 17: Historical mAb therapy area sales ($m), 2002-08; Table 18: Forecast mAb therapy area sales ($m), 2008-14; Table 19: Historical mAb geography sales ($m), 2002-08; Table 20: Forecast mAb geography sales ($m), 2008-14; Table 21: Historical mAb technology sales ($m), 2002-08; Table 22: Forecast mAb technology sales ($m), 2008-14; Table 23: Historical mAb target sales ($m), 2002-08; Table 24: Forecast mAb target sales ($m), 2008-14; Table 25: MAb pipeline overview; Table 26: Count of marketed mAbs; Table 27: Count of Phase III mAb players; Table 28: Count of companies with multiple Phase I-II mAb candidates; Table 29: mAb count split by technology type; Table 30: mAb count split by technology type; Table 31: Detailed product/target analysis - late stage; Table 32: Novel late-stage targets; Table 33: Novel early-stage targets; Table 34: Avastin: overview; Table 35: Avastin: sales forecast ($m), 2008-14; Table 36: Herceptin: overview; Table 37: Herceptin: sales forecast ($m), 2008-14; Table 38: MabThera/Rituxan: overview; Table 39: MabThera/Rituxan: sales forecast ($m), 2008-14; Table 40: Erbitux: overview; Table 41: Erbitux: sales forecast ($m), 2008-14; Table 42: Prolia (onco): overview; Table 43: Prolia (onco): sales forecast ($m), 2008-14; Table 44: Vectibix: overview; Table 45: Vectibix: sales forecast ($m), 2008-14; Table 46: Arzerra: overview; Table 47: Arzerra: sales forecast ($m), 2008-14; Table 48: Humira: overview; Table 49: Humira: sales forecast ($m), 2008-14; Table 50: Remicade: overview; Table 51: Remicade: sales forecast ($m), 2008-14; Table 52: Simponi: overview; Table 53: Simponi: sales forecast ($m), 2008-14; Table 54: Comparison of the route of administration and dosing frequency of the anti-TNFs in rheumatoid arthritis; Table 55: Cimzia: overview; Table 56: Cimzia: sales forecast ($m), 2008-14; Table 57: Actemra: overview; Table 58: Actemra: sales forecast ($m), 2008-14; Table 59: Stelara: overview; Table 60: Stelara: sales forecast ($m), 2008-14; Table 61: Tysabri: overview; Table 62: Tysabri: sales forecast ($m), 2008-14; Table 63: Bapineuzumab: overview; Table 64: Bapineuzumab: sales forecast ($m), 2008-14; Table 65: Campath (CNS): overview; Table 66: Campath (CNS): sales forecast ($m), 2008-14; Table 67: Numax: overview; Table 68: Numax: sales forecast ($m), 2008-14; Table 69: Synagis: overview; Table 70: Synagis: sales forecast ($m), 2008-14; Table 71: Xolair: overview; Table 72: Xolair: sales forecast ($m), 2008-14; Table 73: Prolia: overview; Table 74: Prolia: sales forecast ($m), 2008-14; Table 75: ReoPro: overview; Table 76: ReoPro: sales forecast ($m), 2008-14; Table 77: Lucentis: overview; Table 78: Lucentis: sales forecast ($m), 2008-14; Table 79: Exchange rates, 2009
List of Figures: Figure 1: The PharmaVitae Explorer; Figure 2: The total pharmaceutical market outlook, sales ($m) and year-on-year growth rate (%), 2002-14; Figure 3: Change in annual sales from 2008-14 ($m) of PharmaVitae universe by molecule type; Figure 4: Compound annual growth rate (%) of PharmaVitae universe by molecule type; Figure 5: Total sales of the mAb market ($m), 2002-14; Figure 6: The US versus ex-US small molecule market sales growth ($m), (%), 2002-14; Figure 7: The US versus ex-US monoclonal antibody market sales growth ($m), (%), 2002-14; Figure 8: mAb market geographic analysis, total sales ($m), 2002-14; Figure 9: Total number of mAbs versus total mAb market sales ($m), 2002-14; Figure 10: Total mAb sales versus average price per mAb ($m), 2002-14; Figure 11: Sales proportion of the 'Big 5' vs the rest of the mAb market (%), 2002-14; Figure 12: mAb product sales ($m), 2002-14; Figure 13: Growth driver/resistor products of forecast revenue performance ($m), 2008-14; Figure 14: MAb company sales ($m), 2002-14; Figure 15: mAb ownership sales by peer set ($,%), 2002-14; Figure 16: Big Pharma's $74 billion worth of key mAb acquisitions over the past five years; Figure 17: The collaborative landscape of the mAb market key players; Figure 18: The structure of an antibody; Figure 19: Types of antibodies; Figure 20: Immunogenicity ranges; Figure 21: Number of marketed mAb technologies; Figure 22: Schematic illustration of antibody fragments; Figure 23: mAb timeline - technology shift; Figure 24: Total sales of the mAb market ($m), 2002-14; Figure 25: MAb product sales ($m), 2002-14; Figure 26: Growth driver/resistor products of historical revenue performance ($m), 2002-08; Figure 27: Growth driver/resistor products of forecast revenue performance ($m), 2008-14; Figure 28: MAb company sales ($m), 2002-14; Figure 29: Growth driver/resistor companies of historical revenue performance ($m), 2002-08; Figure 30: Growth driver/resistor companies of forecast revenue performance ($m), 2008-14; Figure 31: MAb therapy area sales ($m), 2002-14; Figure 32: Growth driver/resistor therapy areas of historical revenue performance ($m), 2002-08; Figure 33: Growth driver/resistor therapy areas of forecast revenue performance ($m), 2008-14; Figure 34: MAb geography sales ($m), 2002-14; Figure 35: Growth driver/resistor geographies of forecast revenue performance ($m), 2008-14; Figure 36: MAb technology sales ($m), 2002-14; Figure 37: Growth driver/resistor technologies of forecast revenue performance ($m), 2008-14; Figure 38: MAb target sales ($m), 2002-14; Figure 39: Growth driver/resistor targets of forecast revenue performance ($m), 2008-14; Figure 40: Count of marketed mAb players; Figure 41: Count of Phase III pipeline mAb players; Figure 42: Count of companies with multiple Phase I-II mAb candidates; Figure 43: Phase I-III pipeline count split by technology; Figure 44: The stepwise evolution of naked mAb technology; Figure 45: Overview of pipeline technology type Phase I-registration; Figure 46: Phase I-pre-reg mAb count split by therapy area; Figure 47: Count of the most popular targets in early-stage development

Monoclonal antibodies: 2009 update

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