Monoclonal antibodies: 2009 update

Published by: Datamonitor

Published: Nov. 2, 2009

Table of Contents

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

Abstract

• 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

• 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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