Nucleic Acid Drug Delivery Technologies: Players, products & prospects to 2018 (Volume III)

Date: June 22, 2009
Pages: 110
Price:
US$ 1,040.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: NCB7D63AC4FEN
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Nucleic Acid Drug Delivery Technologies: Players, products & prospects to 2018 (Volume III)
Nucleic Acid Delivery

The nucleic acid delivery market is maturing with over 1,450 clinical trials underway worldwide. The majority of these are in early clinical development (approximately 60%) with just over 3% in Phase III trials. Our analysis indicates that up to 35 novel nucleic acid products could reach the market within our forecasting period (2008-2018). However the harsh economic environment may force companies to place promising drugs on hold as they focus on lead projects rather than multiple programmes. To date, only a handful of nucleic acid-based products have been approved for human prescription and these products rely on delivery technologies in one shape or form. We estimate the nucleic acid market was worth just over US$80 million globally in 2008.

By 2018 we anticipate the nucleic acid technology market will have matured as many of the late-stage clinical programmes come to fruition and drug delivery companies continue to overcome issues surrounding its safety and efficiency. The development of nucleic acid delivery systems will help to improve specificity whilst the development of novel polymers and lipopolymer complexes will help to carry larger DNA payloads in order to target cells and make multigene targeting a reality. We forecast that nucleic acid products in development from 11 key companies could generate additional sales of nearly US$2.3 billion by 2018. These products utilise a range of delivery platforms including viral to non-viral delivery systems, and cover gene therapies, gene agents and DNA vaccines for a variety of targets including cancer, cardiovascular and infectious diseases.

Catalysts for change

Improvements in our understanding into the underlying genetic causes of disease as well as the uptake of new mechanisms of modulating DNA such as RNA interference which will help to fuel market growth.

The development of a new generation of DNA vaccines that will provoke strong immunogenic responses and will help to determine whether this has been a sound investment for the pharma industry.

Launch of the first siRNA-based therapeutics (although progress has been dampened following the recent termination of Opko Health’s leading eye treatment at the Phase III development stage). We anticipate companies will pursue other conditions such as infectious diseases and cancer where robust preclinical studies have already been performed and where drug delivery platforms have been adopted rather than the use of naked siRNAs.

This report is part of a major new 4-volume strategic analysis

Drug Delivery Technologies:
Players, Products & Prospects to 2018

Focusing on the sectors that are driving growth

VOLUME I
CONTROLLED- RELEASE

VOLUME II
NANOTECHNOLOGY

VOLUME III
NUCLEIC ACID DELIVERY

VOLUME IV
TARGETED DELIVERY


CONTENTS
EXECUTIVE SUMMARY & INTRODUCTION


- Overview of delivery technologies for genetic material: past, present & future
- Leading technology platforms for the delivery of genetic material
- Nucleic acid delivery: motivators & resistors

ADVANCED NUCLEIC ACID DELIVERY TECHNOLOGIES

- Types of nucleic acid-based products under development by the pharma industry
- Viral vector delivery of nucleic acids
- Bacterial vector delivery of nucleic acids
- Non-viral vector delivery of nucleic acids
- Chemical Technologies
- Physical Technologies
- Current therapeutic applications for the viral and non-viral delivery of nucleic acids
- Leading nucleic acid-based products in development
- Future commercial applications & opportunities

STRATEGIES OF DRUG DELIVERY COMPANIES

- Leading nucleic acid drug delivery companies
- Strategic developmental & commercialisation partnerships
- Mergers, acquisitions & joint ventures
- Intellectual Property

THE VIRAL AND NON-VIRAL VECTOR DELIVERY MARKET

- Now 2009: Approved nucleic acid product sales
- Future 2018: Novel nucleic acid product sales and Global nucleic acid product sales

COMPETITOR ANALYSIS

Detailed analysis of leading companies covering:
- Proprietary delivery technology
- Applications in the pharma industry
- Management/technical expertise
- Competition within the delivery technology sector
- Products in development/approved utilising the delivery technology
- Sales forecasts of products utilising the delivery technology
- Competitor ratio analysis

Companies analysed

- Alnylam Pharmaceuticals, Inc.
- AlphaVax, Inc.
- Altea Therapeutics, Inc.
- AP Pharma, Inc.
- ArmaGen Technologies, Inc.
- BioDelivery Sciences International, Inc.
- Calando Pharmaceuticals, Inc.
- Cequent Pharmaceuticals, Inc.
- Copernicus Therapeutics, Inc.
- Diatos SA, Inc.
- DOR BioPharma, Inc
- Expression Genetics, Inc
- Inovio Biomedical Corporation
- MaxCyte, Inc
- Nanotherapeutics, Inc.
- NeoPharm, Inc.
- Novagali Pharma, S.A.
- Oxford Biomedica, Plc.
- PCI Biotech ASA.
- Silence Therapeutics, Plc.
- Targeted Genetics Corporation
- TissueGene, Inc.
- Vical, Inc.
- Zosano Pharma, Inc.

APPENDICIES

- Global nucleic acid approved drug sales 2008-2018
- Global nucleic acid development drug sales 2008-2018
- Key nucleic acid delivery companies by 2018

Unique company & technology evaluation

It is vital that management information is reliable, current and insightful. Today, product and company assessment must be seen in a wider competitive and market environment.

In this report we present a précis on each of the leading delivery specialists and potential new delivery platforms and have identified their key attributes, based on a number of criteria including:
  • Proprietary delivery technology
  • Applications of the delivery technology within the pharmaceutical industry
  • Management/technical expertise of the delivery specialist
  • Competition within the delivery technology sector
  • Products in development/approved utilising the delivery technology

We have established a competitor ratio analysis based on each of the criteria mentioned above. Each criterion attracts an award of up to 10 points, with a maximum score of 50, thus enabling the establishment of an Espicom “ranking table” in each segment of the market, dependent on their relative attributes.

Multi-point evaluation and scoring assessment

Pharma drugs that utilise drug delivery systems have been evaluated based on a number of parameters, including:
  • The technology
  • Comparison of delivery platforms within each area including: activated, degradation or diffusion for controlled-release systems; nano-engineered (nanocrystals, nanoparticle, nanosuspension) or nanocarriers (carbon/ceramic, dendrimer, liposome, micelle, polymeric nanoparticles) for nano-enabled delivery; viral or non-viral platforms for nucleic acid delivery and active or passive platforms for targeted delivery systems
  • The application of the technology within a number of therapy areas
  • Route of delivery (oral, parenteral, transdermal, implantable), delivery of small molecules/macromolecules and vaccines, additional features such as bioerodible materials etc
  • The current status of the technology in clinical development or following approval
  • Number of approved and marketed products, clinical or preclinical development candidates, single or multiple products.
  • Competition within the technology arena
  • Alternative drug delivery systems to technologies under evaluation, advantages and disadvantages over competitors.
  • The drug delivery specialist’s expertise
  • Number of drug delivery systems in development, strategic alliances, financial position, marketing presence.
  • The product portfolio
  • Drug delivery systems under evaluation, products in development, commercialisation/development partnerships.
  • Potential drug sales
  • Based on key events such as market, competition, patent expiry, time of entry into the market.

About the Author

Dr Cheryl Barton is a highly regarded independent consultant with over 16 years research and business analysis experience. Following her senior research positions in academia and seven years with Merck, in which she was responsible for research projects ranging from Alzheimer’s disease to schizophrenia. Dr Barton subsequently joined Dutch investment bank ABN Amro NV as a senior equity analyst where she was lead analyst on major pharmaceutical companies such as Roche and Sanofi-Synthélabo, and assessed the potential impact of new drug development on European Stocks.

In 2002, Dr Barton founded a consulting business (www.Pharmavision.co.uk) to provide independent, tailor-made, pharmaceutical thematic research to investment houses and pharmaceutical companies. The research reports combine independent scientific analysis with patient-based models to forecast the potential sales growth of key drugs in clinical development.
EXECUTIVE SUMMARY

INTRODUCTION

Overview of delivery technologies for genetic material: past, present & future
Leading technology platforms for the delivery of genetic material
Nucleic acid delivery: motivators & resistors
Nucleic acid technology motivators
Motivators
Nucleic acid technology resistors
Resistors

ADVANCED NUCLEIC ACID DELIVERY TECHNOLOGIES

Types of nucleic acid-based products under development by the pharma industry
Viral vector delivery of nucleic acids
Schematic of gene therapy utilising an AAV vector
Schematic of gene therapy utilising HVJ envelope - virosome
Bacterial vector delivery of nucleic acids
Non-viral vector delivery of nucleic acids
Chemical Technologies
Stable nucleic acid-lipid particles
Targeted nanoparticles
Physical Technologies
Schematic of Zosano Pharma’s Patch Technology
Electroporation technology – PassPort Delivery System
Advantages and disadvantages of nucleic acid platforms
Current therapeutic applications for the viral and non-viral delivery of nucleic acids
Leading nucleic acid based products in development
Nucleic acid-based approved/filed drugs
Selection of gene therapies in clinical development
Selection of RNA therapeutics in clinical development
Selection of DNA vaccines in clinical development
Future commercial applications & opportunities

STRATEGIES OF DRUG DELIVERY COMPANIES

Leading nucleic acid drug delivery companies
Leading nucleic acid drug delivery specialists
Partnerships & acquisitions
Strategic developmental & commercialisation partnerships
Mergers, acquisitions & joint ventures
Recent partnerships & acquisitions in the nucleic acid field
Intellectual Property
Nucleic acid patents

THE VIRAL AND NON-VIRAL VECTOR DELIVERY MARKET

Now 2009
  Approved nucleic acid product sales
Future 2018
  Novel nucleic acid product sales
  Global controlled release product sales

COMPETITOR ANALYSIS

Movers & Shakers: Cutting edge or losing their grip
Movers & shakers in nucleic acid drug delivery systems
COMPANY PROFILES
Alnylam Pharmaceuticals
  Proprietary delivery technology
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  Alnylam’s product pipeline
  Sales forecasts of products utilising the delivery technology
  Alnylam’s sales forecasts
  Competitor Ratio Analysis
AlphaVax, Inc.
  Proprietary delivery technology
  The alphavaccine platform system
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  AlphaVax’ product pipeline
  Sales forecasts of products utilising the delivery technology
  AlphaVax’ sales forecasts
  Competitor Ratio Analysis
Altea Therapeutics, Inc
  Proprietary delivery technology
  Altea Therapeutics’ Passport Patch
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  Altea Therapeutics’ product pipeline
  Sales forecasts of products utilising the delivery technology
  Competitor Ratio Analysis
AP Pharma, Inc
  Proprietary delivery technology
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  AP Pharma’s product pipeline
  Sales forecasts of products utilising the delivery technology
  Competitor Ratio Analysis
ArmaGen Technologies
  Proprietary delivery technology
  ArmaGen’s BBB delivery technology
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  ArmaGen Technologies’ product pipeline
  Sales forecasts of products utilising the delivery technology
  Competitor Ratio Analysis
BioDelivery Sciences International
  Proprietary delivery technology
  Bioral Technology
  Direct membrane fusion
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  BDSI’s product pipeline
  Sales forecasts of products utilising the delivery technology
  Competitor Ratio Analysis
Calando Pharmaceuticals
  Proprietary delivery technology
  Schematic of cyclodextrin polymeric nanoparticles
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  Calando’s product pipeline
  Sales forecasts of products utilising the delivery technology
  Calando’s sales forecasts
  Competitor Ratio Analysis
Cequent Pharmaceuticals
  Proprietary delivery technology
  Application in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  Cequent’s product pipeline
  Sales forecasts of products utilising the delivery technology
  Cequent’s sales forecasts
  Competitor Ratio Analysis
Copernicus Therapeutics (www.cgsys.com)
  Proprietary delivery technology
  Uptake and trafficking of condensed nanoparticle DNA
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  Copernicus’ product pipeline
  Sales forecasts of products utilising the delivery technology
  Competitor Ratio Analysis
Diatos SA
  Proprietary delivery technology
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  Diatos’ product pipeline
  Sales forecasts of products utilising the delivery technology
  Competitor Ratio Analysis
DOR BioPharma, Inc (www.dorbiopharma.com)
  Proprietary delivery technology
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  DOR’s product pipeline
  Sales forecasts of products utilising the delivery technology
  Competitor Ratio Analysis
Expression Genetics, Inc
  Proprietary delivery technology
  TheraPlas Technology Platform
  TheraSilence Technology Platform
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  EGEN’s product pipeline
  Sales forecasts of products utilising the delivery technology
  EGEN’s sales forecasts
  Competitor Ratio Analysis
Inovio Biomedical Corporation
  Proprietary delivery technology
  Inovio’s gene delivery platform
  Inovio’s MedPulser DNA Delivery System
  VGX’ Cellectra Technology
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  Inovio’s product pipeline
  Sales forecasts of products utilising the delivery technology
  Inovio’s sales forecasts
  Competitor Ratio Analysis
MaxCyte, Inc
  Proprietary delivery technology
  MaxCyte’s GT exvivo cell loading system
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  MaxCyte’s product pipeline
  Sales forecasts of products utilising the delivery technology
  Competitor Ratio Analysis
Nanotherapeutics
  Proprietary delivery technology
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  Nanotherapeutics’ product pipeline
  Sales forecasts of products utilising the delivery technology
  Competitor Ratio Analysis
NeoPharm
  Proprietary delivery technology
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  NeoPharm’s product pipeline
  Sales forecasts of products utilising the delivery technology
  Competitor Ratio Analysis
Novagali Pharma SA
  Proprietary delivery technology
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  Novagali’s product pipeline
  Sales forecasts of products utilising the delivery technology
  Competitor Ratio Analysis
Oxford Biomedica
  Proprietary delivery technology
  Oxford Biomedica’s LentiVector system
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  Oxford Biomedica’s product pipeline
  Sales forecasts of products utilising the delivery technology
  Oxford Biomedica’s sales forecasts
  Competitor Ratio Analysis
PCI Biotech
  Proprietary delivery technology
  PCI enhances siRNA’s gene silencing effect and improves gene delivery
  Applications in the pharma industry
  Potential applications for improving the delivery of a range of drug types
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  PCI’s product pipeline
  Sales forecasts of products utilising the delivery technology
  Competitor Ratio Analysis
Silence Therapeutics plc
  Proprietary delivery technology
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  Silence Therapeutics’ product pipeline
  Sales forecasts of products utilising the delivery technology
  Silence Therapeutics’ sales forecasts
  Competitor Ratio Analysis
Targeted Genetics Corporation
  Proprietary delivery technology
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  TGEN’s product pipeline
  Sales forecasts of products utilising the delivery technology
  Targeted Genetics sales forecasts
  Competitor Ratio Analysis
Tekmira Pharmaceuticals Corporation
  Proprietary delivery technology
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  Tekmira’s product pipeline
  Sales forecasts of products utilising the delivery technology
  Tekmira’s sales forecasts
  Competitor Ratio Analysis
TissueGene, Inc
  Proprietary delivery technology
  Manufacturing TissueGene-C cell mediated gene therapies
  Applications in the pharma industry
  Application of TissueGene-C cell mediated gene therapy in orthopaedics
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  TissueGene’s product pipeline
  Sales forecasts of products utilising the delivery technology
  Competitor Ratio Analysis
Vical, Inc.
  Proprietary delivery technology
  Schematic of p-DNA delivery and utilisation in DNA vaccines
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  Vical’s product pipeline
  Sales forecasts of products utilising the delivery technology
  Vical’s sales forecasts
  Competitor Ratio Analysis
Zosano Pharma, Inc
  Proprietary delivery technology
  ZP Patch Technology
  Applications in the pharma industry
  Management/technical expertise
  Competition within the delivery technology sector
  Products in development/approved utilising the delivery technology
  Zosano Pharma’s product pipeline
  Sales forecasts of products utilising the delivery technology
  Competitor Ratio Analysis

APPENDIX 1

Global nucleic acid approved drugs sales 2008-2018

APPENDIX 2

Global nucleic acid developmental drugs sales 2008-2018

APPENDIX 3

Competitor Ratio Analysis Criteria
Key Nucleic acid delivery companies by 2018

GLOSSARY

ACRONYMS

ENDNOTES
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