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Pipeline Insight: Molecular Targeted Cancer Therapies Can Anything Else Revolutionize The Market?

Published by: Datamonitor

Published: Oct. 23, 2007 - 434 Pages


Table of Contents


About the PharmaVitae team

CHAPTER 1 EXECUTIVE SUMMARY

Key findings

Introduction to the PharmaVitae universe

The outlook for the market is challenging

Market performance is shaped by key ATC classes

The three fundamental dimensions of pharma space

Dimension one: molecule type analysis

MAbs and therapeutic proteins to provide the greatest overall sales growth

Generic erosion wipes out small molecule drug sales

mAbs driven by 'core' sales

Dimension two: therapy area analysis

Oncology and AIID products drive growth across 2006-12

GI and CV particularly badly hit in 2012

Targets provide a missing link between drugs and disease

Target classification

Dimension three: target family analysis

ECS target family set for superior performance

Only the ECS target family will see growth between 2011-12 (the 'patent cliff')

Position within the three fundamental dimensions of pharma space influences commercial outlook

Introduction

Novel targets offer reduced competitive pressures

Superior commercial outlook with increasing target novelty

New technologies allow expansion into novel target space

Market growth driven by biologics acting on ECS targets

Biologics offer insulation from generic erosion

ECS shielded from generics

Lifecycle stage dictates performance of small molecule drugs

Areas of high unmet need facilitate commercial success

Biologics more warranted in areas of high unmet need

Certain areas already saturated by cheap options

Perfomance relates to the balance of key characteristics

Commercial attractiveness characteristics

Not all volumes of pharma space are biologically viable

Mechanism of disease dictates the pharmacologically useful targets

Small molecule drugs cannot modulate ECS targets

Biologics cannot access the targets relating to certain diseases

ATC performance is driven by key characteristics

Segment 1: High growth biologics

Segment 2: Declining small molecule drugs

Segment 3: High growth small molecule drugs

Considerations beyond 2012

The need for new technologies

DNA/RNA therapies hit the central dogma of biology

Gene therapy

RNA therapies

CHAPTER 2 MARKET ANALYSIS

Key findings

Introduction

Total market overview

Growth drivers and resistors

Top 25 growth drivers across 2006-12

Top 25 growth resistors across 2006-12

Top 25 growth drivers 2012

Top 25 growth resistors 2012

Molecule type analysis

Small molecule drugs account for the bulk of sales

Generic substitution is greater where more generic alternatives are available

Products satisfying high unmet needs are more likely to gain market share

Biologic products will make a greater contribution to growth

Therapy area analysis

Therapy area growth drivers and resistors

Oncology and AIID drive growth

CV and GI set to decline overall

2006-11 performance

2012 performance

LCE profile

CHAPTER 3 TARGET FAMILY CLASSIFICATION

Key findings

Introduction

Targets are a key dimension of pharma space

The druggable genome

Druggability by small molecules-the Rule of Five.

Target family classification

GPCR target family

Introduction

Structure and function

Subfamilies

Ion channel target family

Introduction

Structure and function

Subfamilies

Nuclear receptor target family

Introduction

Structure and function

Subfamilies

Enzyme target family

Introduction

Structure and function

Subfamilies

Extracellular signaling (ECS) target family

Introduction

Structure and function

Subfamilies

Non-human

Other

Mixed

Unclassified

CHAPTER 4 MARKET ANALYSIS BY TARGET FAMILY

Key findings

Overview

Target family performance

ECS target family driving overall market growth

Enzyme and GPCR target families take the greatest hit in 2012

Therapy area analysis: satisfaction of unmet needs drives success

GPCR targets take the largest share of the CV and CNS sales

CV therapy area set for 'boom and bust'

Without target innovation, CNS products struggle to offset expiries

ECS targets drive growth of the oncology and AIID therapy areas

Falling sales of enzyme modulators bring down GI

Molecule type analysis

Monoclonal antibody (mAb) sales are driven by ECS targets

Therapeutic protein analysis

Small molecule drugs are highly susceptible to generic erosion

Vaccine sales are entirely derived from non-human targets

LCE analysis

Launch

Core

Expiry

CHAPTER 5 NUCLEAR RECEPTOR AND ION CHANNEL TARGET FAMILIES

Key findings

Overview: nuclear receptor and ion channel target families

Contribution to total market sales is set to diminish further

Ranked amongst the smallest target families by sales

Forecast to experience the fastest rate of decline

Scope for expansion is restricted

Small number of possible nuclear receptor target types

Nuclear receptors are not readily targeted by biologics

Ion channels offer significant potential, but are limited by their high association with CNS disorders

Therapy area analysis: key areas dictate overall performance

Diabetes & endocrinology pulls down nuclear receptor-related sales

Diabetes sales are pulled down by genericization of just one target type

Women's health products generate growth for the nuclear receptor target family

Growth despite limited target innovation

Tougher times ahead?

CNS pulls down ion channels

CNS is the largest ion channel therapy area by sales

New launches are not sufficient to overcome the decline of older products

Competition high due to lack of target innovation

Products not revolutionizing the satisfaction of unmet needs

Molecule type analysis: exclusively small molecule

LCE analysis: expiries drag sales into decline

CHAPTER 6 EXTRACELLULAR SIGNALLING PROTEIN (ECS) TARGET FAMILY

Key findings

Overview: ECS target family

Fastest rate of growth over 2006-12

Only target family to see growth in 2012

Therapy area analysis: driving growth of AIID & oncology

AIID sales growth is entirely reliant on ECS targets

Sales are largely derived from products acting on TNF-á

Novel targets generate growth as anti-TNF market slows

Novel ECS targets drive oncology growth

Success drawn from 'locking competitors out' of key targets

Molecule type analysis: new technologies opened up ECS targets

MAb technology has allowed novel ECS targets to be exploited

Unique position compared to other target families

Potential small molecule threat?

LCE analyis: growth across all LCE components

Expansion through novel targets

Free from declining 'expiry' sales

CHAPTER 7 ENZYME AND GPCR TARGET FAMILIES

Key findings

Overview: enzyme and GPCR target families

The largest target families by sales

Forecast to see the greatest decline over 2011-12

Therapy area analysis: novel targets drive growth

Enzyme sales growth wiped out by declining therapy areas.

Novel targets drive oncology sales and the enzyme target family

Transferase targets drive oncology therapy area growth

Tyrosine kinase inhibitors exemplify novel target value

Tyrosine kinase inhibitors account for the bulk of enzyme target family gains

GI and CV sales hit by loss of patents on key classes

Heavily reliant on ageing PPIs, GI sales are set decline

HMG-CoA reductase inhibitors erode enzyme target family growth

GPCR sales growth across all therapy areas but eroded in 2012

Angiotensin II receptor antagonists drive CV growth but hit by genericization

New CNS launches do little to replace the loss of 'blockbusters'

Diabetes sales driven by novel targets

Molecule type analysis: almost entirely small molecule

LCE analysis: expiries offset growth

Significant 'launch' gains driven by availability of novel targets

Massive 'expiry' loss in 2012

CHAPTER 8 APPENDIX

Target sub-sub-families

GPCR sub-sub-families

Nuclear receptor sub-sub-families

Enzyme sub-sub-families

Details of mixed and unclassified

Avandia

References

Journals

Websites

Abbreviations

Abstract

Introduction

Approaches to cancer treatment continue to incorporate molecular targeted therapies into standard treatment regimens. With an increasing number of candidates gaining approval, and with a dynamic developmental pipeline, further clinical, commercial and strategic challenges are continuing to emerge.

Scope

Research and analysis of the MTT pipeline with in-depth clinical and commercial assessment of Phase III candidates Seven major pharmaceutical market sales forecasts to 2016 for key pipeline candidates incorporating product specific assumptions and events Segmentation and examination of product pipeline by developmental phase, class, mode of action, indication and developer Insight and analysis of market potential including commercial opportunity, commonalities across cancers and discussion of unmet needs

Highlights

329 different pipeline candidates have been identified of which 24 are in late-phase development. These identified candidates have a forecast sales potential of up to $6.03 billion in the seven major pharmaceutical markets by 2016. Among agents with the greatest commercial potential are the angiogenesis inhibitors Recentin (cediranib; AstraZeneca), aflibercept (VEGF-Trap; Regeneron/Sanofi-Aventis) and pazopanib (GlaxoSmithKline). Other candidates holding particular promise include the only preregistered agent Novartis's Gleevec-follow-on Tasigna (nilotinib), Novartis's mTOR inhibitor Certican (everolimus), and Biogen Idec's anti-CD23 monoclonal antibody, lumiliximab.

Reasons to Purchase

Acquire a detailed appreciation and impartial perspective of the entire molecular targeted therapies developmental pipeline Identify the key products in late-phase development based on sales forecasts to 2016 and Datamonitor's drug assessment methodology Assess the shifting oncology market dynamic and how future treatment of many cancers will incorporate pipeline products

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