DNA/RNA Therapies: Translating the Genome into a $1.2bn Market by 2010

Published by: Datamonitor

Published: Feb. 22, 2005 - 162 Pages

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

Scope

Datamonitor’s insight into the DNA/RNA market in 2004

The DNA/RNA market is forecast to generate $1.2bn by 2010, using a riskadjusted

market forecast, of which 45% is set to be generated by Pfizer/Eyetech’s

ophthalmic aptamer Macugen (pegaptanib). This product is set drive the overall

growth of the market, and it represents the optimal business development and

innovation profile.

Macugen’s strong revenue-generating potential means that the ophthalmology

franchise and the aptamer platform will dominate the focus of the DNA/RNA

market, in terms of sales. Behind ophthalmology, oncology will dominate the

therapeutic focus of the DNA/RNA market, and is set to generate 31.2% of 2010

sales.

After aptamers, antisense and gene therapies represent the leading technological

focus of products set to launch by 2010 in terms of sales, together generating 46%

of 2010 sales.

The biggest challenge for companies operating in the DNA/RNA market is to

demonstrate that they can deliver products beyond Phase III that represent a good

alternative to those products already marketed. The principal focus of these

companies should therefore be to validate their platform technology with large

pharmaceutical or biotech companies.

CHAPTER 2 BUSINESS MODEL DYNAMICS

Introduction

Where is the DNA/RNA market currently?

DNA/RNA market evolution

DNA/RNA company and market analysis

Drivers and resistors to DNA/RNA market evolution: a PESTEL analysis

Political, Ethical and Social issues

Economics: Pharmacoeconomic issues

Legal: Intellectual Property and Regulatory Approval

DNA/RNA market and company strategy

Alliance strategies - licensing and R&D collaboration

Mergers and acquisitions

Product development strategy

Winning strategies

CHAPTER 3 TECHNOLOGICAL AND THERAPEUTIC

EVOLUTION

Classifying the DNA/RNA market

Gene therapy

Evolution of vector development

Market dynamics of vector choice

Market leaders

Antisense

Evolution

Antisense market dynamics

RNAi, aptamers, ribozymes and DNA

Categories

RNAi, aptamers, ribozymes and DNA market dynamics

Delivery modality

Delivery modality profiles of products set to launch by 2010

Innovative delivery modalities in development

Therapeutic diversification

Key therapeutic development trends across the DNA/RNA market

Technological diversification

Key technological development trends across the DNA/RNA market

Productivity leaders

Technological focus of DNA/RNA productivity leaders

Therapeutic focus of DNA/RNA market leaders

CHAPTER 4 PORTFOLIO AND PIPELINE ANALYSIS

Active DNA/RNA programs overview, 2004

Methodology of analysing and forecasting products set to launch by 2010

DNA/RNA market, 2004

The DNA/RNA market to 2010

Total and risk adjusted DNA/RNA market forecast to 2010

Gene therapies

Products scheduled to launch by 2010

Gendicine

DS-992

Advexin (INGN-201)

ANG1 (VEGF gene therapy)

Cerepro (EG009)

BioBypass (AdGVVEGF121.10)

tgAAVCF

Gene therapy products not scheduled to launch by 2010

Antisense therapies

Products scheduled to launch by 2010

E2F decoy (edifoligide, CGT-003, E2F-D)

Genasense (oblimersen sodium)

AP 12009

Resten-NG (AVI-4126)

ProMune (CPG 7909)

Kappaproct

Vitravene (fomivirsen)

ISIS14803

Alicaforsen (ISIS2302)

ISIS104838

Antisense therapy products not scheduled to launch by 2010

RNAi, aptamers, ribozymes and DNA

Products scheduled to launch by 2010

Macugen (pegaptanib)

Ampligen (polyI:polyC12U)

RNAi, aptamer, ribozyme and DNA products not scheduled to launch by 2010

CHAPTER 5 APPENDIX : SUPPORTING DATA

Financial data

Exchange rates

Methodology for therapy area forecasting

LIST OF TABLES

Table 1: Patenting activity of most active DNA/RNA companies

Table 2: Drivers and resistors of collaborations in the DNA/RNA market

Table 3: Key deals of most productive DNA/RNA companies, 1996-2003

Table 4: Winning strategies in the DNA/RNA market

Table 5: Main characteristics of commonly investigated gene therapy vector

types

Table 6: Main characteristics of commonly investigated antisense platform

types

Table 7: DNA/RNA market, 2004

Table 8: Market potential of each product set to launch by 2010

Table 9: Scoring of each product forecast to be launched by 2010, to create a

percentage probability of successful launch

Table 10: Exchange rates, 2003

LIST OF FIGURES

Figure 1: The structure of Datamonitor’s analysis of the DNA/RNA market, 2004

Figure 2: Risk-adjusted total DNA/RNA market forecast, to 2010

Figure 3: Total number of active DNA/RNA programs, split by therapeutic focus

Figure 4: Total number of active DNA/RNA programs, split by technological

focus

Figure 5: Balance between business development and innovation for products

set to be launched between 2005-2010

Figure 6: Technology focus for active gene therapy programs, 2004

Figure 7: New gene therapy trials approved by year, 1989-2003

Figure 8: Vector focus of most active gene therapy players, 2004

Figure 9: Pipeline development focus of antisense subclasses, 2004

Figure 10: Platform focus of most productive antisense players, 2004

Figure 11: Pipeline development focus of RNAi, aptamers, ribozymes and DNA

products, 2004

Figure 12: Technology focus of most active RNAi, aptamers, ribozymes and DNA

players, 2004

Figure 13: Commercial and developmental therapeutic focus of the DNA/RNA

market, 2004

Figure 14: Commercial and developmental technological focus of the DNA/RNA

market, 2004

Figure 15: Technological focus of most active DNA/RNA players, 2004

Figure 16: Therapeutic focus of most active DNA/RNA players, 2004

Figure 17: Timeline of forecast DNA/RNA product launches to 2010

Figure 18: Unadjusted total DNA/RNA market forecast, to 2010

Figure 19: Risk-adjusted total DNA/RNA market forecast, to 2010

Figure 20: Biotech sector sales growth, 2003-2008

Figure 21: Gene therapy programs set to launch by 2010, split by technology

focus and therapy

Figure 22: Early clinical gene therapy programs, split by therapy and technology

focus

Figure 23: Preclinical gene therapy programs, split by therapy and technology

focus

Figure 24: Antisense therapy programs set to launch by 2010, split by technology

focus and therapy

Figure 25: Early clinical antisense therapy programs, split by therapy and

technology focus

Figure 26: Preclinical antisense programs, split by therapy and technology focus 150

Figure 27: Early clinical RNAi, aptamers, ribozymes and DNA therapy programs,

split by therapy and technology focus

Figure 28: Preclinical RNAi, aptamers, ribozymes and DNA therapy programs,

split by therapy and technology focus

Abstract

• Benchmarking of the current and future DNA/RNA market, by technology and therapeutic focus, in terms of number of projects and dollar value
• Analysis of market trends and future opportunities for both biotech and pharmaceutical players
• Investigation of the steps that the industry's emerging players are taking to increase innovation in their businesses and improve strategic position
• Full profiles of 19 DNA/RNA programs set to launch by 2010, encompassing product development and company strategy

• Forecast how advances in science and changes in the commercial environment will offer new opportunities to benefit from DNA/RNA therapies
• Identify key pipeline products for in-licensing opportunities as well as areas of unmet need
• Benchmark your position within the DNA/RNA market and identify the optimum strategy for future success

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