Reportlinker Adds Drug Delivery Technologies: Players, Products & Prospects to 2018

NEW YORK, May 4 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Drug Delivery Technologies: Players, products & prospects to 2018

http://www.reportlinker.com/p0192401/Drug-Delivery-Technologies-Players-products--prospects-to-2018.html

Providing...

Critical analyses and competitive ratings for major specialist developers

Unique sales forecasts to 2018 for key current and new products utilising drug delivery technologies

A comprehensive examination of the 4 major and compelling drug delivery sectors

While pharmaceutical sales have risen steadily over the last five years generating over US$720 billion in 2008, analysts are forecasting sales growth will slow over the next five years due to an unprecedented level of patent expiration compounded by the downturn in the global economy. At the same time, the global drug delivery market has undergone rapid growth from an estimated US$26 billion in 2000 to approximately US$74 billion in 2008.

This market has been driven by a number of factors:

Advances in new delivery technology (microencapsulation, nanotechnology);

Development and cost-effective manufacture of new delivery materials (dendrimers, lipid formulations and biodegradable polymers);

Emergence of new delivery specialists expanding the availability of delivery platforms e.g. siRNA delivery;

Patent expiration of leading brands forcing the pharmaceutical industry to evaluate ways to maximise product lifecycles through new formulations, combinations and repositioning;

Renewed interest in the development of novel biologics and vaccines requiring specialised delivery technologies;

Dramatic growth reflected in the evolution of an array of delivery vehicles and hybrid platforms that are increasingly being used to deliver approved and novel therapeutic agents.

Within this market there are areas of advanced drug delivery which have attracted the attention of the pharmaceutical industry and the investment community.

Focusing on the sectors that are driving growth!

VOLUME I

CONTROLLED- RELEASE

VOLUME II

NANOTECHNOLOGY

VOLUME III

NUCLEIC ACID DELIVERY

VOLUME IV

TARGETED DELIVERY

Few sectors of the pharmaceutical industry will be as resistant to the global economic downturn

Drug Delivery Technology: Assessing its potential

The time when advanced drug delivery was merely a means for profitable product life extension has gone. Drug delivery is now a major component of the pharmaceutical industry's future and critical to bringing novel therapies to market.

Indeed, without the ability to effectively deliver targeted drugs in therapeutically significant quantities, many of the gene-based agents in research would not be viable. Despite the importance of the sector, the pharmaceutical industry has not always been quick to embrace the full range of potential technologies and opportunities on offer.

With so many companies pursuing a wide range of research strategies, it is difficult for industry and commercial executives to get a balanced and independent overview of the competitive landscape.

That is why this major new 4-volume report, Drug Delivery Technologies: Players, Products and Prospects to 2018, is essential reading for everyone in the field, from niche technology specialists through to the investment community and the pharmaceutical industry itself.

By 2018 sales of products using the novel drug delivery technology assessed in this report could exceed US$58 billion

This report provides a detailed insight into the current and future market for drug delivery technology and...

Provides an overview of the marketplace, outlining current thinking on the technologies being researched and employed;

Appraises currently available products which utilise drug delivery technology and assesses their future;

Examines new product developments from major specialist drug delivery companies, critically analysing the prospects at the product level and forecasting sales;

Allows ready comparison on different technologies within a company's portfolio;

Provides a unique window on the sector's product launch timetable;

Includes detailed appendices which allow at-a-glance reviews of the competitive landscape for both new and up and coming products.

Use this report to...

Assess the strengths and weaknesses of competing products/technologies in the context of specific delivery sectors and development companies;

Identify and review licencing and collaboration partners;

Understand the merits and applications of the main approaches being researched;

Quantify the commercial prospects for current and future products.

Volume I

Controlled-release Delivery

The controlled-release market was worth nearly US$21 billion globally in 2008. The sector is dominated by the launch of oral controlled-release formulations in key therapeutic areas such as the central nervous system, cardiovascular, metabolic and respiratory diseases. The growth of controlled-release delivery continues to be fuelled by line extensions helping to offset the impact of generic erosion. We estimate there are around 60 approved controlled-release products which will generate global sales of over US$21.5 billion in 2009, peaking at around US$29.5 billion in 2017 as products mature and face patent expiration leading to a decline in mature product sales to US$28.9 billion by 2018. In addition, we forecast that controlled-release products in development from 17 key companies could generate additional sales of over US$5.1 billion by 2018.

Impact on product lifecycles

Controlled-release technologies, possibly more than any other approved delivery systems, have been an important tool for pharmaceutical companies to protect their branded franchises from the ever increasing and competitive generic market. These formulations play a critical role in establishing a balanced portfolio of solid dosage products and may lead to enhanced efficacy and improved patient compliance. This leads to reductions in patient costs and extending product life-cycle management for both branded and generic pharmaceuticals.

In the past, pharmaceutical companies have tended to develop controlled-release formulations as immediate-release counterparts near patent expiration. This trend is reversing and companies are developing controlled-release formulations earlier in the product life-cycle and often launching multiple formulations (immediate release, controlled release/

modified release, and delayed release) in parallel to expand the potential addressable patient population and gain a significant share of competitive market places.

This report answers key questions...

Who will have launched novel products by 2018 and what technologies could they be using?

Can market leaders such as ALZA and Elan maintain their status in controlled release in the face of growing competition?

What obstacles must companies overcome to achieve full market potential?

What strategies are proving most productive and for which companies?

What will the product/company landscape look like in 2018?

Volume II

Nano-enabled Delivery

The true value of nanotechnology lies in its potential to improve the solubility and enhance the efficiency of product delivery. It has been successfully applied to the commercialisation of more than 30 drugs. Regulators have published numerous white papers on the topic and established Task Forces to monitor the progress and application of this technology although there are presently no regulations specific to nanomedicine or nano-enabled medical devices.

As the field of nanotechnology gains momentum and nano-enabled platforms emerge to address the industry's need for therapeutic, bioavailable and less toxic products, this market is expected to grow significantly over the next decade. Proof of concept data with novel compounds is accumulating and new formulations of old chemotherapeutic drugs offer the promise to revolutionise cancer therapies.

The potential of future applications:

Tissue specific delivery – targeting the delivery of small and macro molecules across biological membranes such as the blood brain barrier for CNS drugs;

Gene and vaccine delivery – non-viral delivery of genetic materials in nanohydrogels and nanocarriers with a high degree of efficiency and expression;

Controlled-release devices – design of new nanoporous, bioerodible membranes;

Increased biocompatibility – design of artificial surfaces engineering for medical and dental implants to by-pass unwanted inflammatory response;

Improved drug bioavailability and solubility – through the engineering of drugs and reagents by nanostructuring;

Applied diagnosis, etiology, prognosis and therapy (ADEPT) technology for the safe targeted delivery of toxic therapeutic drugs.

By 2018, the market could exceed US$13 billion

By 2018 the established nanotechnology product market will be US$10.2 billion. The market will mature as the number of marketed nano-enabled products doubles and second generation nanomedicines begin to emerge. These agents will address areas of high unmet clinical need and result in the formulation of approved and novel drugs which are safer, less toxic and more efficacious than first generation products.

By 2018 these second generation nanomedicines could generate sales of nearly US$2.9 billion and establish nanotechnology as an important tool in the industry's delivery armoury. A range of proprietary delivery platforms will utilise CaP technologies, FluidCrystals, micelles and polymeric nanoparticles to target a number of therapy areas such as CNS disorders, oncology and infectious diseases.

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.

Which companies and products will dominate?

This volume will tell you!

Volume IV

Targeted Delivery

By 2018, over 30 new products will be launched resulting in a global market for advanced targeted delivery products worth over US$8.5 billion.

Despite considerable advances in drug delivery technologies, there continues to be a high unmet clinical need for safer and better-tolerated drugs. Sub-optimal compliance and failure to persist with drug treatments are important determinants of therapeutic non-response and are of significant cost to healthcare providers. Advanced targeted drug delivery technologies will help to overcome some of these issues by improving pharmacokinetics, increasing tolerability and reducing dose-limiting off-target effects.

The need for targeted delivery platforms is increasing as patients and drug regulators seek to meet these challenges.

Current and future applications

Whilst the majority of targeted delivery systems under evaluation incorporate passive carrier systems, there will be a shift towards the use of actively targeted carriers to increase the therapeutic index of existing and new products. There are significant opportunities for future commercial developments within the pharmaceutical industry. These include:

Cost-effective production of antibodies and antibody fragments for drug targeting;

Development of new polymers and biopolymers that may be utilised in the safe and efficient targeted delivery of drugs and pro-drugs into host cells;

Development and selective targeting of macromolecules to improve intracellular uptake and tissue specificity;

Development of inactive pro-drugs for tissue specific release;

Extended product life-cycles through the development of targeted formulations;

Identification of new targeting ligands to improve the targeted delivery of small molecules and macromolecules;

Utilisation of multiple targeting ligands to address the needs of patient sub-types;

Combined technology platforms to develop targeted therapeutics and diagnostics in a single molecule.

A new generation of targeted delivery systems is under development to meet these needs which should provide greater control over the selective targeting of tissue, either with active moieties or inactive moieties which may be activated within the tissue by biological (enzymes), chemical (pH) or physical means (light, ultrasound) in order to release the active agent. The multitude of delivery platforms will lend themselves to the delivery of both small molecules and macromolecules and to a variety of target sites and delivery routes.

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.

EXECUTIVE SUMMARY.... 9

INTRODUCTION....... 10

Overview of controlled-release delivery: past, present & future. 10

Leading controlled-release technology platforms & characteristics...10

Controlled delivery profiles.. 11

Drug release profiles........12

Controlled-release delivery: motivators & resistors..... 12

Motivators......13

Controlled-Release technology motivators..13

Resistors14

Controlled-Release technology resistors......14

Controlled-release delivery: impact on product lifecycles.. 15

Impact of reformulation on product life-cycle......15

CONTROLLED-RELEASE DELIVERY....... 16

Types of controlled-release delivery used by pharma industry .. 16

Activated controlled-release delivery...16

Activated controlled-release delivery – ALZA's OROS systems...16

Degradation controlled-release delivery......17

Degradation controlled-release delivery – SkyePharma's GEOMATRIX ..17

Diffusion controlled-release delivery...18

Monolithic diffusion controlled-release delivery – LaboPharm's Contramid ...18

Reservoir diffusion controlled-release delivery – Impax' CMDS.18

Combined controlled-release delivery – Flamel's Micropump...19

Advantages and disadvantages of controlled-release platforms........20

Current therapeutic application of controlled-release in drug delivery.20

Leading brands that utilise controlled-release delivery...... 21

Leading controlled-release approved drugs21

Future commercial applications & opportunities 21

STRATEGIES OF DRUG DELIVERY COMPANIES...... 23

Leading controlled-release drug delivery companies.23

Leading controlled-release drug delivery companies....23

Partnerships & acquisitions..27

Strategic developmental & commercialisation partnerships.......27

Merger & acquisitions27

Recent partnerships & acquisitions in the controlled-release field......28

Intellectual Property.....30

Controlled-Release patents ..31

THE controlLed-releas e MARKET . 32

Now 2009..32

Approved controlled-release product sales .32

Future 2018........32

Global controlled-release product sales ......33

Novel controlled-release product sales........33

COMPETITO R ANALY SIS 34

Movers & Shakers: Cutting edge or losing their grip....34

Movers & shakers in controlled-release drug delivery systems..35

COMPANY PROFILES......36

AlphaRx Corporation (www.alpharx.com).... 36

Proprietary delivery technology...36

Applications in the pharma industry36

Management/technical expertise36

Competition within the delivery technology sector....37

Products in development/approved utilising the delivery technology..37

AlphaRx' product pipeline....37

Sales forecasts of products utilising the delivery technology.....37

AlphaRx' drug delivery sales.38

Competitor Ratio Analysis.....38

ALZA Corporation (www.alza.com) 39

Proprietary delivery technology...39

Applications in the pharma industry40

Management/technical expertise40

Competition within the delivery technology sector....40

Products in development/approved utilising the delivery technology..40

ALZA's product pipeline...41

Sales forecasts of products utilising the delivery technology.....41

ALZA's drug delivery sales.....41

Competitor Ratio Analysis.....42

Antares Pharma, Inc. (www.antarespharma.com)...... 43

Proprietary delivery technology...43

Applications in the pharma industry43

Management/technical expertise44

Competition within the delivery technology sector....44

Products in development/approved utilising the delivery technology..44

Antares' product pipeline44

Sales forecasts of products utilising the delivery technology.....44

Antares' drug delivery sales..45

Competitor Ratio Analysis.....45

Biovail Corporation (www.Biovail.com)........ 46

Proprietary delivery technology...46

Applications in the pharma industry46

Management/technical expertise46

Competition within the delivery technology sector....47

Products in development/approved utilising the delivery technology..47

Biovail's product pipeline48

Sales forecasts of products utilising the delivery technology.....48

Biovail's drug delivery sales ..48

Competitor Ratio Analysis.....48

Camurus AB (www.camurus.se)...... 49

Proprietary delivery technology...49

Camurus' FluidCrystal CR technology..49

Applications in the pharma industry50

Management/technical expertise50

Competition within the delivery technology sector....50

Products in development/approved utilising the delivery technology..50

Camurus AB's product pipeline......50

Sales forecasts of products utilising the delivery technology.....51

Camurus AB's drug delivery sales...51

Competitor Ratio Analysis.....51

Cerulean Pharma Inc (www.ceruleanrx.com).52

Proprietary delivery technology...52

Applications in the pharma industry52

Management/technical expertise52

Competition within the delivery technology sector....52

Products in development/approved utilising the delivery technology..52

Cerulean's product pipeline...52

Sales forecasts of products utilising the delivery technology.....53

Competitor Ratio Analysis.....53

Cipher Pharmaceuticals, Inc. (www.cipherpharma.com).... 54

Proprietary delivery technology...54

Applications in the pharma industry54

Management/technical expertise54

Competition within the delivery technology sector....54

Products in development/approved utilising the delivery technology..54

Cipher's product pipeline55

Sales forecasts of products utilising the delivery technology.....55

Cipher's drug delivery sales...55

Competitor Ratio Analysis.....55

Debiopharm Group (www.debio.com). 56

Proprietary delivery technology...56

Applications in the pharma industry56

Management/technical expertise56

Competition within the delivery technology sector....57

Products in development/approved utilising the delivery technology..57

Debiopharm's product pipeline.....57

Sales forecasts of products utilising the delivery technology.....57

DebioPharm's drug delivery sales..57

Competitor Ratio Analysis.....58

DelSite Biotechnologies, Inc. (www.delsite.com)....... 59

Proprietary delivery technology...59

Applications in the pharma industry59

Management/technical expertise59

Competition within the delivery technology sector....60

Products in development/approved utilising the delivery technology..60

DelSite's product pipeline60

Sales forecasts of products utilising the delivery technology.....60

Competitor Ratio Analysis.....60

Depomed, Inc. (www.depomedinc.com)........61

Proprietary delivery technology...61

Applications in the pharma industry62

Management/technical expertise62

Competition within the delivery technology sector....62

Products in development/approved utilising the delivery technology..62

Depomed's product pipeline.63

Sales forecasts of products utilising the delivery technology.....63

Depomed's product sales63

Competitor Ratio Analysis.....63

Durect Corporation (www.Durect.com)........ 64

Proprietary delivery technology...64

Applications in the pharma industry65

Management/technical expertise65

Competition within the delivery technology sector....65

Products in development/approved utilising the delivery technology..65

Durect's product pipeline66

Sales forecasts of products utilising the delivery technology.....66

Durect's product sales.....66

Competitor Ratio Analysis.....67

Elan Corporation (www.elan.com). 68

Proprietary delivery technology...68

Applications in the pharma industry68

Management/technical expertise68

Competition within the delivery technology sector....68

Products in development/approved utilising the delivery technology..69

Elan's product pipeline....69

Sales forecasts of products utilising the delivery technology.....69

Elan's drug delivery sales70

Competitor Ratio Analysis.....70

Elite Pharmaceuticals, Inc. (www.elitepharma.com)...71

Proprietary delivery technology...71

Applications in the pharma industry71

Management/technical expertise71

Competition within the delivery technology sector....71

Elite's product pipeline....72

Sales forecasts of products utilising the delivery technology.....72

Elite's product sales72

Competitor Ratio Analysis.....72

Endo Pharmaceuticals, Inc. (www.endo.com).... 73

Proprietary delivery technology...73

Applications in the pharma industry73

Management/technical expertise73

Competition within the delivery technology sector....74

Products in development/approved utilising the delivery technology..74

Endo's product pipeline...74

Sales forecasts of products utilising the delivery technology.....74

Endo's product sales........74

Competitor Ratio Analysis.....75

Ethypharm SA (www.ethypharm.com).76

Proprietary delivery technology...76

Applications in the pharma industry76

Management/technical expertise76

Competition within the delivery technology sector....77

Products in development/approved utilising the delivery technology..77

Ethypharm's product pipeline........77

Sales forecasts of products utilising the delivery technology.....77

Ethypharm's product sales....77

Competitor Ratio Analysis.....78

Eurand (www.eurand.com).... 79

Proprietary delivery technology...79

Applications in the pharma industry79

Management/technical expertise79

Competition within the delivery technology sector....80

Products in development/approved utilising the delivery technology..80

Eurand's product pipeline.....80

Sales forecasts of products utilising the delivery technology.....81

Eurand's product sales....81

Competitor Ratio Analysis.....81

Flamel Technologies, Inc. (www.flamel.com) 82

Proprietary delivery technology...82

Flamel's Medusa technology 82

Flamel's Micropump technology ...83

Applications in the pharma industry83

Management/technical expertise83

Competition within the delivery technology sector....83

Products in development/approved utilising the delivery technology..83

Flamel's product pipeline84

Sales forecasts of products utilising the delivery technology.....84

Flamel's product sales.....84

Competitor Ratio Analysis.....85

Glycologic, Ltd (www.glycologic.co.uk) 86

Proprietary delivery technology...86

Applications in the pharma industry86

Management/technical expertise86

Competition within the delivery technology sector....87

Products in development/approved utilising the delivery technology..87

Glycologic's product pipeline.87

Sales forecasts of products utilising the delivery technology.....87

Competitor Ratio Analysis.....87

KV Pharmaceuticals, Inc (www.kvpharmaceutical.com)..... 88

Proprietary delivery technology...88

Applications in the pharma industry88

Management/technical expertise88

Competition within the delivery technology sector....88

Products in development/approved utilising the delivery technology..89

KV's product pipeline......89

Sales forecasts of products utilising the delivery technology.....89

Competitor Ratio Analysis.....89

Labopharm, Inc. (www.labopharm.com)....... 90

Proprietary delivery technology...90

Applications in the pharma industry90

Management/technical expertise90

Competition within the delivery technology sector....90

Products in development/approved utilising the delivery technology..91

Labopharm's product pipeline.......91

Sales forecasts of products utilising the delivery technology.....91

Labopharm's product sales...91

Competitor Ratio Analysis.....91

Lavipharm SA (www.lavipharm.com)....92

Proprietary delivery technology...92

Applications in the pharma industry92

Management/technical expertise92

Competition within the delivery technology sector....93

Products in development/approved utilising the delivery technology..93

Lavipharm's product pipeline........93

Sales forecasts of products utilising the delivery technology.....93

Competitor Ratio Analysis.....94

Nano Interface Technology (www.nanointerfacetech.com)........ 95

Proprietary delivery technology...95

Applications in the pharma industry95

Management/technical expertise95

Competition within the delivery technology sector....95

Products in development/approved utilising the delivery technology..95

NITI's product pipeline.....96

Sales forecasts of products utilising the delivery technology.....96

Competitor Ratio Analysis.....96

OctoPlus N.V. (www.octoplus.nl).... 97

Proprietary delivery technology...97

Applications in the pharma industry97

Management/technical expertise97

Competition within the delivery technology sector....98

Products in development/approved utilising the delivery technology..98

OctoPlus' product pipeline....98

Sales forecasts of products utilising the delivery technology.....98

OctoPlus' product sales...98

Competitor Ratio Analysis.....99

Penwest Pharmaceuticals (www.penw.com).... 100

Proprietary delivery technology 100

Applications in the pharma industry.......101

Management/technical expertise...101

Competition within the delivery technology sector..101

Products in development/approved utilising the delivery technology101

Penwest's product pipeline.102

Sales forecasts of products utilising the delivery technology...102

Penwest's product sales102

Competitor Ratio Analysis...102

SCOL R Pharma, Inc. (www.scolr.com). 103

Proprietary delivery technology.103

Applications in the pharma industry.......103

Management/technical expertise.. 104

Competition within the delivery technology sector. 104

Products in development/approved utilising the delivery technology........ 104

SCOLR's product pipeline...104

Sales forecasts of products utilising the delivery technology...105

SCOLR's drug delivery sales.105

Competitor Ratio Analysis...105

Shire, Plc (www.shire.com)... 106

Proprietary delivery technology.106

Applications in the pharma industry.......106

Management/technical expertise...106

Competition within the delivery technology sector..107

Products in development/approved utilising the delivery technology107

Shire's product pipeline.107

Sales forecasts of products utilising the delivery technology...107

Shire's leading drug delivery product sales108

Competitor Ratio Analysis...108

Skinvisible, Inc. (www.skinvisible.com)....... 109

Proprietary delivery technology.109

Applications in the pharma industry.......109

Management/technical expertise...109

Competition within the delivery technology sector..109

Products in development/approved utilising the delivery technology110

Skinvisible's product pipeline.......110

Sales forecasts of products utilising the delivery technology...110

Competitor Ratio Analysis...110

SkyePharma (www.skyepharma.com)111

Proprietary delivery technology.111

Applications in the pharma industry.......111

Management/technical expertise...112

Competition within the delivery technology sector..112

Products in development/approved utilising the delivery technology112

SkyePharma's product pipeline... 113

Sales forecasts of products utilising the delivery technology...113

SkyePharma's product sales........ 113

Competitor Ratio Analysis...114

Spherics (www.spherics.com)........115

Proprietary delivery technology.115

Applications in the pharma industry.......115

Management/technical expertise...115

Competition within the delivery technology sector..115

Products in development/approved utilising the delivery technology115

Spheric's product pipeline...116

Sales forecasts of products utilising the delivery technology...116

Spheric's product sales..116

Competitor Ratio Analysis...116

Watson Pharmaceuticals (www.watson.com)...117

Proprietary delivery technology.117

Applications in the pharma industry.......118

Management/technical expertise...118

Competition within the delivery technology sector..118

Products in development/approved utilising the delivery technology118

Watson's product pipeline..119

Sales forecasts of products utilising the delivery technology...119

Watson's drug delivery sales........119

Competitor Ratio Analysis...119

APPENDIX 1.. 120

Global controlled-release approved drugs sales 2008-2018 (US$million)......120

APPENDIX 2.. 122

Global controlled-release developmental drugs sales 2008-2018 (US$million)...122

APPENDIX 3.. 124

Competitor Ratio Analysis Criteria...124

Key Controlled-release delivery companies by 2015....125

BIBLIOGRAPHY ..... 127

GLOSSARY.... 127

Acronyms ... 129

Endnotes.... 132

Drug Delivery Technologies: Nanotechnology

EXECUTIVE SUMMARY 137

INTRODUCTION..... 138

Overview of nanotechnology: past, present & future........138

Multifunctional nanotechnology platform ........139

Nanotechnology: motivators & resistors.......139

Motivators....139

Nanotechnology motivators .......139

Resistors...... 140

Nanotechnology resistors....141

Nanomedicines, formulations and product regeneration. 141

Failure rates at each stage of clinical drug development.141

NANOTECHNOLOGY IN DRUG DELIVERY.... 143

Core nanotechnology used by the pharma industry 143

Nano-engineered drugs...143

Nano-carriers...143

Dendrimer structure......144

Liposome structure .......144

Micelle structure...145

Polymeric nanoparticle structure - Abraxane.....146

Current therapeutic applications of nanotechnology in drug delivery.147

Leading brands that utilise nanotechnology delivery........147

Nanotechnology-enabled approved drugs........147

Future commercial applications & opportunities.......149

STRATEGIES OF DRUG DELIVERY COMPANIES.... 150

Leading nanotechnology drug delivery companies..150

Leading nanotechnology-enabled drug delivery companies...150

Partnerships & acquisitions153

Strategic development & commercialisation partnerships and joint ventures...153

Mergers, acquisitions, start ups & spin offs..153

Recent partnerships & acquisitions in the nanotechnology field......154

Intellectual Property156

Nanotechnology patents ....156

THE NANOTECHNOLOGY MARKET ..... 158

Now 2009158

Leading approved nano-enabled product sales 158

Leading companies developing nano-enabled product sales .159

Future 2018......159

Novel nano-enabled product sales ..160

Global nano-enabled product sales .160

COMPETITOR ANALYSIS........ 161

Movers & Shakers: Cutting edge or losing their grip..161

Movers & shakers in nanotechnology drug delivery systems...162

COMPANY PROFILES....163

Abraxis Bioscience (www.abraxisbio.com).. 163

Proprietary delivery technology.163

Abraxis Protosphere - nab technology.......163

Applications in the pharma industry.......163

Management/technical expertise...163

Competition within the delivery technology sector..163

Products in development/approved utilising the delivery technology........ 164

Abraxis' product pipeline....164

Sales forecasts of products utilising the delivery technology.. 164

Abraxis' sales forecasts..164

Competitor Ratio Analysis.. 164

Access Pharmaceuticals (www.accesspharma.com). 165

Proprietary delivery technology.165

ProLindac nanoparticulate prodrug.165

Cobalamin coated nanoparticulates166

Applications in the pharma industry.......166

Management/technical expertise...166

Competition within the delivery technology sector..167

Products in development/approved utilising the delivery technology167

Access Pharmaceuticals product pipeline..167

Sales forecasts of products utilising the delivery technology...167

Access' sales forecasts....167

Competitor Ratio Analysis...168

AlphaRx Corporation (www.alpharx.com).. 169

Proprietary delivery technology.169

Nanoparticle targeted delivery & uptake...169

Applications in the pharma industry.......169

Management/technical expertise...170

Competition within the delivery technology sector..170

Products in development/approved utilising the delivery technology170

AlphaRx' product pipeline..170

Sales forecasts of products utilising the delivery technology...170

AlphaRx' pharmaceuticals sales ..171

Competitor Ratio Analysis...171

ALZA Corporation (www.alza.com).....172

Proprietary delivery technology.172

Applications in the pharma industry.......172

Management/technical expertise...172

Competition within the delivery technology sector..172

Products in development/approved utilising the delivery technology172

Sales forecasts of products utilising the delivery technology...172

ALZA's drug delivery sales ..172

Competitor Ratio Analysis...173

Aphios Corporation (www.aphios.com)........174

Proprietary delivery technology.174

Applications in the pharma industry.......174

Management/technical expertise...174

Competition within the delivery technology sector..174

Products in development/approved utilising the delivery technology174

Aphios' product pipeline.....175

Sales forecasts of products utilising the delivery technology...175

Competitor Ratio Analysis...175

APR Applied Pharma Research (www.apr.com)176

Proprietary delivery technology.176

Applications in the pharma industry.......176

Management/technical expertise...176

Competition within the delivery technology sector..176

Products in development/approved utilising the delivery technology177

APR's product pipeline..177

Sales forecasts of products utilising the delivery technology...177

Competitor Ratio Analysis...177

BioSante Pharmaceuticals (www.biosantepharma.com)..178

Proprietary delivery technology.178

Applications in the pharma industry.......178

Management/technical expertise...178

Competition within the delivery technology sector..179

Products in development/approved utilising the delivery technology179

BioSante's CaP product pipeline...179

Sales forecasts of products utilising the delivery technology...180

BioSante's drug delivery sales......180

Competitor Ratio Analysis...180

Calando Pharmaceuticals (www. calandopharma.com)....181

Proprietary delivery technology.181

Schematic of cyclodextrin polymeric nanoparticles....181

Applications in the pharma industry .......181

Management/technical expertise...181

Competition within the delivery technology sector..182

Products in development/approved utilising the delivery technology182

Calando's product pipeline..182

Sales forecasts of products utilising the delivery technology...182

Calando's sales forecasts.....182

Competitor Ratio Analysis...182

Camurus AB (www.camurus.se).... 183

Proprietary delivery technology.183

Applications in the pharma industry.......183

Management/technical expertise...183

Competition within the delivery technology sector..183

Products in development/approved utilising the delivery technology183

Camurus AB's product pipeline....184

Sales forecasts of products utilising the delivery technology...184

Camurus AB's drug delivery sales.184

Competitor Ratio Analysis...184

Cerulean Pharma Inc (www.ceruleanrx.com)... 185

Proprietary delivery technology.185

Applications in the pharma industry.......185

Management/technical expertise...185

Competition within the delivery technology sector..185

Products in development/approved utilising the delivery technology185

Cerulean's product pipeline.185

Sales forecasts of products utilising the delivery technology...186

Competitor Ratio Analysis...186

CytImmune Sciences Inc (www.cytimmune.com)..... 187

Proprietary delivery technology.187

CytImmune's Colloidal Gold Nanoparticle Delivery.....187

Applications in the pharma industry .......187

Management/technical expertise...187

Competition within the delivery technology sector..188

Products in development/approved utilising the delivery technology188

CytImmune's' product pipeline....188

Sales forecasts of products utilising the delivery technology...188

CytImmune's sales forecasts188

Competitor Ratio Analysis...189

Elan Corporation (www.elan.com)..... 190

Proprietary delivery technology.190

Applications in the pharma industry.......190

Management/technical expertise...190

Competition within the delivery technology sector..190

Products in development/approved utilising the delivery technology191

Elan's NanoCrystal product portfolio191

Sales forecasts of products utilising the delivery technology...191

Elan's drug delivery sales....192

Competitor Ratio Analysis...192

Enzon Pharmaceuticals, Inc. (www.enzon.com)193

Proprietary delivery technology.193

Applications in the pharma industry.......193

Management/technical expertise...193

Competition within the delivery technology sector..193

Products in development/approved utilising the delivery technology193

Enzon's product pipeline.....194

Sales forecasts of products utilising the delivery technology...194

Enzon's targeted product sales.....194

Competitor Ratio Analysis...194

Gilead Sciences (www.gilead.com)..... 195

Proprietary delivery technology.195

Applications in the pharma industry.......195

Management/technical expertise...195

Competition within the delivery technology sector..195

Products in development/approved utilising the delivery technology195

Gilead Sciences' product pipeline.195

Sales forecasts of products utilising the delivery technology...196

Gilead Sciences' drug delivery sales...196

Competitor Ratio Analysis...196

Introgen Therapeutics (www.introgen.com)....197

Proprietary delivery technology.197

Applications in the pharma industry .......197

Management/technical expertise...197

Competition within the delivery technology sector..197

Products in development/approved utilising the delivery technology197

Introgen's product pipeline.198

Sales forecasts of products utilising the delivery technology...198

Introgen's sales forecasts....198

Competitor Ratio Analysis...198

Mersana Therapeutics (www.mersana.com).... 199

Proprietary delivery technology.199

Applications in the pharma industry .......199

Management/technical expertise...199

Competition within the delivery technology sector..199

Products in development/approved utilising the delivery technology199

Mersana's product pipeline199

Sales forecasts of products utilising the delivery technology.. 200

Mersana's sales forecasts....200

Competitor Ratio Analysis.. 200

Nano Interface Technology (www.nanointerfacetech.com)...... 201

Proprietary delivery technology.201

Applications in the pharma industry.......201

Management/technical expertise...201

Competition within the delivery technology sector..201

Products in development/approved utilising the delivery technology201

NITI's product pipeline...202

Sales forecasts of products utilising the delivery technology...202

Competitor Ratio Analysis...202

Nano S Biotechnology GmbH (www.nano-s.com).... 203

Proprietary delivery technology 203

S-Layer Technology Platform.......203

Applications in the pharma industry...... 203

Management/technical expertise.. 203

Competition within the delivery technology sector. 204

Products in development/approved utilising the delivery technology........ 204

Nano S' product pipeline.....204

Sales forecasts of products utilising the delivery technology.. 204

Competitor Ratio Analysis.. 204

NanoBio Corporation (www.nanobio.com). 205

Proprietary delivery technology 205

Applications in the pharma industry...... 205

Management/technical expertise.. 205

Competition within the delivery technology sector. 205

Products in development/approved utilising the delivery technology........ 205

NanoBio's product pipeline.206

Sales forecasts of products utilising the delivery technology.. 206

NanoBio's drug delivery sales......206

Competitor Ratio Analysis.. 206

NanoBioMagnetics (www.nanobmi.com).... 207

Proprietary delivery technology.207

Applications in the pharma industry.......207

Management/technical expertise...207

Competition within the delivery technology sector..207

Products in development/approved utilising the delivery technology........ 208

NanoBioMagnetics' product pipeline........208

Sales forecasts of products utilising the delivery technology.. 208

Competitor Ratio Analysis.. 208

Nanobiotix (www.nanobiotix.com).... 209

Proprietary delivery technology 209

Applications in the pharma industry...... 209

Management/technical expertise.. 209

Competition within the delivery technology sector. 209

Products in development/approved utilising the delivery technology........ 209

Nanobiotix' product pipeline.......209

Sales forecasts of products utilising the delivery technology...210

Competitor Ratio Analysis...210

NanoCarrier (www.nanocarrier.co.jp).211

Proprietary delivery technology.211

Micellar Nanoparticles..211

Applications in the pharma industry.......211

Management/technical expertise...212

Competition within the delivery technology sector..212

Products in development/approved utilising the delivery technology212

NanoCarrier's product pipeline....212

Sales forecasts of products utilising the delivery technology...212

NanoCarrier's drug delivery sales.213

Competitor Ratio Analysis...213

Nanotechnology Victoria, Ltd (www.nanovic.com)...214

Proprietary delivery technology.214

Applications in the pharma industry.......214

Management/technical expertise...214

Competition within the delivery technology sector..214

Products in development/approved utilising the delivery technology214

NanoVic's product pipeline.215

Sales forecasts of products utilising the delivery technology...215

Competitor Ratio Analysis...215

NanoMaterials Technology (www.nanomt.com).......216

Proprietary delivery technology.216

High Gravity Controlled Precipitation (HCGP) of nanomaterials........216

Applications in the pharma industry.......216

Management/technical expertise...216

Competition within the delivery technology sector..217

Products in development/approved utilising the delivery technology217

NanoMaterial's product pipeline.217

Sales forecasts of products utilising the delivery technology...217

Competitor Ratio Analysis...217

Nanotherapeutics (www.nanotherapeutics.com).....218

Proprietary delivery technology.218

Applications in the pharma industry.......218

Management/technical expertise...218

Competition within the delivery technology sector..219

Products in development/approved utilising the delivery technology219

Nanotherapeutics' product pipeline.219

Sales forecasts of products utilising the delivery technology...219

Nanotherapeutics' drug delivery sales.......220

Competitor Ratio Analysis.. 220

Novavax (www.novavax.com)....... 221

Proprietary delivery technology.221

Applications in the pharma industry.......221

Management/technical expertise...221

Competition within the delivery technology sector. 222

Products in development/approved utilising the delivery technology........ 222

Novavax's product pipeline.222

Sales forecasts of products utilising the delivery technology.. 223

Novavax's drug delivery sales......223

Competitor Ratio Analysis.. 223

SkyePharma (www.skyepharma.com)........ 224

Proprietary delivery technology.224

Applications in the pharma industry.......224

Management/technical expertise...224

Competition within the delivery technology sector. 225

Products in development/approved utilising the delivery technology........ 225

SkyePharma's product pipeline...225

Sales forecasts of products utilising the delivery technology.. 225

SkyePharma's product sales........226

Competitor Ratio Analysis.. 226

Spherics (www.spherics.com)....... 227

Proprietary delivery technology.227

Applications in the pharma industry.......227

Management/technical expertise...227

Competition within the delivery technology sector..227

Products in development/approved utilising the delivery technology227

Spheric's product pipeline...228

Sales forecasts of products utilising t

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Drug Delivery Technology Industry: Drug Delivery Technologies: Players, products & prospects to 2018

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Nicolas Bombourg

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