[Report] DNA & RNA Therapies Market Research, Trends, Analysis TOC

CHAPTER 1 EXECUTIVE SUMMARY

Scope

Datamonitors insight into the DNA/RNA market in 2004

The DNA/RNA market is forecast to generate $1.2bn by 2010, using a risk-adjusted market forecast, of which 45% is set to be generated by Pfizer/Eyetechs ophthalmic aptamer Macugen (pegaptanib). This product is set to drive the overall growth of the market, and it represents the optimal business development and innovation profile.

Macugens 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.

A critical step for emerging DNA/RNA therapeutics players before reaching full integraration will be to show they are capable of advancing with confidence a number of products beyond Phase III. Vital to this process will be their pipelines validation through strategic alliances with leading biopharma players.

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
Will gene therapy be limited to severe, life-threatening indications with a high unmet need?
Is it right to delay future gene therapy trials while we wait for safer vectors?
Are there any issues that are relevant for ex-vivo gene therapy versus in-vivo gene therapy?
Will gene therapy be limited to somatic gene therapy, rather than germline gene therapy?
Conclusion
Recommendation
Economics: Pharmacoeconomic issues
Acute vs. chronic treatments
Drug development
Physician mentality
Company business plan flexibility
Pricing and logistical issues
Recommendation
Legal: Intellectual Property and Regulatory Approval
Gene therapy
Antisense
RNAi, aptamers, ribozymes and DNA
Most active DNA/RNA companies
Conclusion
Regulatory issues
Recommendation
DNA/RNA market and company strategy
Alliance strategies - licensing and R&D collaboration
Originator collaborations
Development/commercialization collaborations
Drivers and resistors of collaborations
FIPCO/FIBio collaborations
Collaborations with earlier-stage companies
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
DNA viral vectors
RNA viral vectors
Non-viral vectors
Market dynamics of vector choice
Current state of the gene therapy market
Future gene therapy market dynamics
Market leaders
Antisense
Evolution
First-generation antisense and immunomodulatory antisense
Second-generation antisense
Further evolution of antisense technology
Antisense market dynamics
Current state of the antisense market
Future antisense market dynamics
Market leaders
RNAi, aptamers, ribozymes and DNA
Categories
RNAi
Aptamers
Ribozymes
DNA
RNAi, aptamers, ribozymes and DNA market dynamics
Current state of the antisense market
Future RNAi, aptamer, ribozyme and DNA market dynamics
Market leaders
Delivery modality
1. Vectors
2. Direct delivery
Delivery modality profiles of products set to launch by 2010
Innovative delivery modalities in development
RASONs
Gene pill
Pathway IV
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
1. First-year sales and impacting sales and marketing collaborations
2. Absolute and risk-adjusted market forecasting
3. Sourcing information
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
Innovation
Business development
DS-992
Innovation
Business development
Advexin (INGN-201)
Innovation
Business development
ANG1 (VEGF gene therapy)
Innovation
Business development
Cerepro (EG009)
Innovation
Business development
BioBypass (AdGVVEGF121.10)
Innovation
Business development
tgAAVCF
Innovation
Business development
Gene therapy products not scheduled to launch by 2010
Antisense therapies
Products scheduled to launch by 2010
E2F decoy (edifoligide, CGT-003, E2F-D)
Innovation
Business development
Genasense (oblimersen sodium)
Innovation
Business development
AP 12009
Innovation
Business development
Resten-NG (AVI-4126)
Innovation
Business development
ProMune (CPG 7909)
Innovation
Business development
Kappaproct
Innovation
Business development
Vitravene (fomivirsen)
Innovation
Business development
ISIS14803
Innovation
Business development
Alicaforsen (ISIS2302)
Innovation
Business development
ISIS104838
Innovation
Business development
Antisense therapy products not scheduled to launch by 2010
RNAi, aptamers, ribozymes and DNA
Products scheduled to launch by 2010
Macugen (pegaptanib)
Innovation
Business development
Ampligen (polyI:polyC12U)
Innovation
Business development
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 Datamonitors 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
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

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