Advanced Oral & Parenteral Drug Delivery Technologies Players, Products & Prospects to 2015

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Advanced Oral & Parenteral Drug Delivery Technologies Players,
Products & Prospects to 2015
Published on January 2011
Report Summary
This report provides a detailed insight into the current and future market for oral and parenteral 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 advanced delivery platforms
Examines new product developments from major specialist drug delivery companies, critically analysing their prospects
Allows ready comparison on different technologies within a company's portfolio.
A comprehensive examination of trends and advances in the two major drug delivery sectors
Unique sales forecasts to 2015 for key technology areas
Critical analyses of specialist developers driving the market onwards
The increasing number of new biological products, and the emergence of a biosimilars market has focused the industry's attention on
the development of novel and advanced drug delivery technologies which can deliver these new targeted products. However, oral and
parenteral drug administration still dominates the market, and technical innovation is ensuring these tried and tested routes of
administration continue to offer more compelling and effective methods of drug delivery.
The global pharmaceutical industry generated revenues of over US$800 billion in 2009, growing at around 7% per annum.
Oral formulations accounted for almost 60% of prescriptions, with the top 10 oral products accounting for nearly 10% of total global
pharmaceutical sales. The global market for oral drug delivery enhanced products (DDEPs) was estimated to be worth around US$51
billion in 2009, accounting for nearly 60% of the market share of the entire DDEP market; sustained-release formulations represented
over 95% of all oral DDEPs.
Parenteral drug delivery is the second largest segment of the market accounting for nearly 30% of the market share. It is presently
valued at US$27 billion and is expected to reach US$51 billion by 2015 driven primarily by the launch of new biologics; the uptake of
novel delivery platforms and the utilisation of controlled-release systems.
This report provides a detailed insight into the current and future market for oral and parenteral 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 advanced delivery platforms
Examines new product developments from major specialist drug delivery companies, critically analysing their prospects
Allows ready comparison on different technologies within a company's portfolio.
Use this report to...
Assess the strengths and weaknesses of competing products/technologies in the context of specific delivery sectors and development
Advanced Oral & Parenteral Drug Delivery Technologies Players, Products & Prospects to 2015 (From Slideshare) Page 1/15

companies
Identify and review licensing and collaborative partners
Understand the merits and applications of the main approaches being researched.
Quantify the commercial prospects for current and future products.
Volume I
Oral Delivery Technology
During the last 30 years, considerable advances have been made in drug delivery technologies, particularly in the field of
controlled-release delivery. However, there is an unremitting demand for products that achieve continuous release of therapeutic
agents over extended time periods. This has led to the development of a multitude of drug delivery platforms mainly involving either
multi-particulate dosage forms (e.g. pellets contained in gelatine capsules) or single-unit dosage forms (e.g. bilayer or multilayer
tablets), and a variety of release profiles.
Currently-marketed oral DDEPs encompass several therapeutic categories including cancer, cardiovascular, central nervous system,
musculoskeletal, metabolic diseases (diabetes) and respiratory conditions. Oral disintegrating tablets (ODTs) or melts have evolved
as an important delivery system for drugs that treat medical conditions vulnerable to a sudden onset of symptoms such as allergies,
migraine, reflux disease and schizophrenia. In addition, oral DDEP platforms have been utilised to reduce the abuse-resistance of
opioids and to prevent alcohol 'dose dumping.'
Oral DDEPs are widely used across the globe as patients migrate towards convenient dosage formulations. Controlled-release tablets
and capsules remain the main formulation platform although orally disintegrating, nanoparticle and combined technology formulations
are expected to broaden applications in the future.
Oral DDEPs use a variety of mechanisms to modify the controlled delivery of the molecule (drug) including: osmotic-driven drug
release, degradation-driven release, diffusion-controlled release or through a combination of delivery platforms. Advanced oral
DDEPs can be used to target release within specific regions of the GI tract such as Alizyme's Colal delivery system and Cosmo's
MMX technology. In addition, companies have developed pulsatile-release platforms that allow drug release to more closely follow
circadian rhythms, such as BTG's Pulsincap.
A vigorous research environment
Over 800 companies are currently involved in the development of oral drug delivery technologies from large pharma to specialty
delivering technologists. This report identifies 29 of the top movers and shakers in the oral delivery industry.
This report answer key questions
What % of the oral drug delivery market by value do emerging markets account for'
What is the current state of play with sustained, modified, chrono and pulsatile release technologies'
What are the leading products that utilise advanced oral delivery and in what therapeutic areas are they most commonly applied'
What research is being undertaken to develop novel drug delivery technologies for cancer'
Will oral delivery technology ever crack the large molecule problem'
Volume II
Parenteral Delivery Technology
Over the last 50 years, considerable technological advances have been made in the area of parenteral drug delivery to overcome the

many limitations associated with this route of delivery. This has led to the development of sophisticated systems that allow drug
targeting and the sustained or controlled release of parenteral medicines. Over the next ten years more than 30 new targeted-delivery
products are expected to be commercially released and more than 35 nano-enabled nucleic acid products could reach the market.
Improvements in parenteral delivery devices such as pre-filled syringes, pens, auto-injectors and needle-free devices continue to
alleviate the burden of self-administration and improve patient compliance. Meanwhile the explosion of biological therapies provides
additional challenges for drug delivery specialists seeking to develop ways of improving on standard injections for these products.
Widening therapeutic uses for parenteral delivery
The development of new and approved agents for oncology, infectious disease, endocrinology and inflammatory and immune-related
diseases continues to fuel the growth of injectable DDEPs. This market will be driven by the identification of novel drug targets and
the development of innovative immunotherapeutics that address areas of high unmet clinical need, a segment that has been
historically poorly treated with oral therapeutics. Parenteral DDEPs are widely used across the globe, but tend to be priced at a
premium due to the sophisticated delivery devices which often require administration from a healthcare professional.
Innovation from a vigorous research-based sector
Parenteral DDEPs apply to a variety of formulations and devices in which to modify the delivery of small and large molecule drugs.
Self-injection devices include pen injectors, auto-injectors, needle-free injectors and nasal spray devices while formulation-based
technologies range from liposomes and emulsions, PEGylation, microparticles and nanoparticles and dendrimers, either used alone
or in combination to optimise delivery and minimise off-target toxicities. Over 250 companies are currently involved in the
development of parenteral drug delivery technologies from large pharma to specialty delivery technologists, and this report analyses
24 of the leading players.
This report answers key questions
What trends are driving the parenteral delivery sector to double digit growth'
Which sector of the market is expected to grow by a CAGR of 15% to 2015'
Which companies are developing technologies for the delivery of poorly-soluble drugs'
What clinical benefits are there in the subcutaneous delivery of monoclonal antibodies'
What is the current state of play for auto injectors and insulin pumps for the treatment of diabetes'
Focusing on two key sectors that are igniting growth
VOLUME I ORAL DELIVERY | VOLUME II PARENTERAL DELIVERY
Table of Content
Volume 1
Table of Contents

EXECUTIVE SUMMARY.1
1 Mar ket Perspective 2
1.1 Revenues.3
1.1.1 Geographical.3
Figure 1.1.1: Geographical revenues of oral DDEPs, 2009.3
1.1.2 Technological3
Figure 1.1.2: Drug release profiles.4
1.1.3 Therapeutic.5
Table 1.1.1: Leading oral DDEPs.5
1.2 Market Trends.6
1.2.3 Therapeutic.6
2 Tec hnologica l Viewpoint8
2.1 Device-based delivery.8
2.1.1 O smotic-driven drug release.9
Figure 2.1.1: ALZA's Oros drug delivery technology .9
Figure 2.1.2: Alkermes Ringcap drug delivery technology9
Degradation-driven release.10
Figure 2.1.3: SkyePharma's Geomatrix drug delivery technology.10
Figure 2.1.4: Smartrix Technologies' drug delivery technology.10
2.1.3 Diffusion-controlled release 11
Figure 2.1.5: Labopharm's Contramid drug delivery technology11
Figure 2.1.6: Impax' CMDS drug delivery technology11
Figure 2.1.7: Elan's PRODAS drug delivery technology12
2.1.4 Combined delivery technologies 12
Figure 2.1.7: Flamel's Micropump drug delivery technology.12
2.1.5 Targeted delivery technologies. 13
2.1.6 O rally Disintegrating Tablets (ODTs) 13
Table 2.1.1: Leading proprietary technologies.14
2.1.7 Pulsatile drug delivery. 15
2.1.7.1 Single-unit systems15
Figure 2.1.8: BTG's Port drug delivery technology15
2.1.7.2 Pulsatile Delivery by Erosion of Membrane .16
2.1.7.3 Pulsatile Delivery by Membrane Rupture16
3 Therapeutic Releva nce 17
3.1 Cancer.17
Table 3.1.1: Leading Oral DDEP Products, 2000-2009.17
3.2 Cardiovascular18
Table 3.1.2: Leading Oral Cardiovascular DDEP Products18
3.3 CNS19
Table 3.1.3: Leading Oral CNS DDEP Products.19
3.4 Musculoskeletal System20
Table 3.1.4: Leading Oral Musculoskeletal DDEP products20
3.5 Cancer.21
3.6 Diabetes.22
Figure 3.1.1: Access Pharmaceuticals' Cobalamin delivery technology.22
Figure 3.1.2: Emisphere's Eligen delivery technology23

4 Pri ncipa l Delivery Specia lists 24
4.1 Leading Companies.24
Table 4.1.1: Leading oral delivery companies & technologies .24
4.2 Company Profiles 27
4.2.1 Access Pharmaceuticals27
Overview 27
Oral Delivery Technologies.27
Figure 4.1.1: Access Pharmaceutical's delivery technology.27
Commercialised Products. 28
Deals, Alliances, M&A 28
4.2.2 Acura Pharmaceuticals Inc.28
Overview . 28
Oral Delivery Technology. 28
Figure 4.1.2: Acura Aversion Technology28
4.2.3 Akina29
Overview . 29
4.2.4 Alizyme plc.30
Overview . 30
Oral Delivery Technologies 30
4.2.5 AlphaRx Inc30
Overview . 30
Commercialised Products31
Deals, Partnerships, M&A31
4.2.6 ALZA Corporation.31
Overview 31
Table 4.2.1: ALZA's oral products32
Deals, Alliances, M&A.32
4.2.7 BTG.32
Overview 32
Oral Delivery Technology32
4.2.8 Biovail Corporation.33
Overview 33
Commercialised products 34
Deals, Partnerships, M&A. 34
4.2.9 Camurus AB.34

Overview . 34
4.2.10 Catalent Pharma Solutions35
Overview 35
4.2.11 Cipher Pharmaceuticals36
Overview . 36
4.2.12 Cosmo Pharmaceuticals S.p.A.36
Overview . 36
Oral Delivery Technology 37
4.2.43 Depomed Technologies37
Overview 37
Commercialised Oral Products 38
4.2.14 Durect Corporation.38
Overview . 38
Commercialised Oral Products.39
4.2.15 Elan Corporation.39
Overview 39
Commercialised Products 40
Table 4.2.2: Elan's oral products.40
4.2.16 Egalet Ltd.40
Overview . 40
Deals, Alliance, M&A 40
4.2.17 Elite Pharmaceuticals.41
Overview 41
4.2.18 Emisphere Technologies41
Overview 41

4.2.19 Ethypharm SA42
Overview 42
Table 4.2.3: Ethypharm's oral products in R&D43
4.2.20 Eurand .43
Overview . 43
Table 4.2.4: Eurand's oral products44
4.2.21 Flamel Technologies 45
Overview . 45
Figure 4.1.1: Flamel's Micropump technology45
4.2.22 K V Pharmaceuticals, Inc . 46
Overview . 46
4.2.23 Labopharm. 46
Overview . 46
4.2.24 L avipharm SA 47
Overview 47
Table 4.2.5: Lavipharm's oral products48
4.2.25 Penwest Pharmaceuticals. 48
Overview . 48
4.2.26 SCOL R Pharma, Inc. 49
Overview . 49
4.2.27 Shire Plc .50
Overview . 50

4.2.28 SkyePharma Plc 51
Overview 51
Table 4.2.5: SkyePharma's oral products.52
4.2.29 W atson Pharmaceuticals .52
Overview 52
Controlled-Release Technologies53
Immediate-release Technology53
Sustained-release Technology.53
Delayed-release Technology.53
Formulation delivery systems53
Table 4.2.6: Watson's oral products.54
5 Analysis & Conclusi ons 55
5.1 Analysis. 55
Table 5.1.1: Top 10 leading oral drugs, 200955
5.1.1 O ral DDEP Market.55
Table 5.1.1: Global revenues pharmaceutical & DDEP market 2009-2015.55
Table 5.1.1: Top 60 oral DDEPs sales forecasts 2009, 2010, 201556
Table 5.1.2: Oral DDEPs in development, sales forecasts, 2009, 2010, 201557
5.2 Technology. 58
5.2.1. Fundamental Technologies.58
5.2.2 Coating Technologies.58
5.2.3 Matrix Technologies.58
5.3 Novel Technologies. 59
5.3.1 Fast-Dissolving Oral Dosage Forms.59
5.3.2 O ral Delivery of Large Molecules.60
Figure 5.3.1: Merrion's Oral Insulin GIPET delivery technology61
5.4 Therapeutic 62
5.4.1 Frontrunners.62
5.4.2 Alliances.63
5.5 Conclusions..64
6 GLO SSARY. 65
7 AUTHO R BIOGRAPHIES. 67
8 BIBLIOGRAPHY. 68
Volume 2
Contents
EXECUTIVE SUMMARY.1
1 MARKET PERSPECTIVES.2
Figure 1.1.1: Routes of parenteral administration.2
Table 1.1.1: Advantages and disadvantages of parenteral delivery3
1.1 Revenues.4

Figure 1.1.2: Geographical revenues of parenteral DDEPs, 20094
1.1.3 Therapeutic.5
1.2 Market Trends.6
1.2.3 Therapeutic.7
2 Tec hnologica l Viewpoint8
2.1 Device-based delivery.8
2.1.1 Syringe, vial & ampoule8
2.1.2 Pre-filled syringes.9
Figure 2.1.1: Syringes pre-filled with Interferon 2b.9
2.2 Self-Injection Devices10
2.2.1 Pen injectors10
Figure 2.2.1: Pen Injector and refills10
2.2.2 Auto-injectors.10
Figure 2.2.2: EpiPen Auto-injector10
2.2.3 Auto-Injector Pros and Cons 11
2.3 Needle-Free Injection12
2.3.1 Improvements in Needle-Free Delivery. 12
Figure 2.2.3: Glide SDI (Solid Dose Injector).12
Figure 2.2.4: Medi-Jector Vision13
2.4 Nasal spray delivery.14
Figure 2.3.1: Pfeiffer Bidose Nasal Spray14
Figure 2.1.5: Insulin Pump15
2.5 Formulation-based technologies16
2.5.1 L iposomes and Emulsions16
2.5.2 PEGylation 17
Table 2.4.1: Marketed PEGylated products .17
2.5.3 Microparticle-based depot product18
2.6 Nano-Enhanced Parenteral Drug Delivery.20
2.6.1 Polymeric nanoparticles20
Figure 2.1.4: Abraxane structure20
2.6.2 Nanovectors 21
Table 2.5.1: Marketed nano-enabled products 21
2.7 Dendrimers .22
3 Therapeutic Releva nce 23
3.1 Oncology.23
Table 3.1.1: Leading Oncology Parenteral DDEPs24
3.2 Inflammation and Immune-related diseases.25
Table 3.1.2: Leading Inflammatory & Immune-related Parenteral DDEPs.25
3.3 Anti-infectives.25
3.4 Diabetes.26
3.4.1 N ew-generation insulin pens26
Table 3.1.3: Insulin Delivery Devices26
3.4.2 Insulin pumps27
Table 3.1.4: Insulin Pumps27
3.4.3 Advanced Insulin Pump: Paradigm (Medtronic).27

Figure 3.1.1 MiniMed Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System 28
3.4.4 N eedle-free Insulin Delivery28
3.4.5 SQ-Pen (Bespak Medical Devices)29
Figure 3.1.2 Bespak Medical Devices' SQ-Pen29
4 Pri ncipa l Delivery Specia lists . 30
4.1 Leading Companies 30
Table 4.1.1: Leading oral delivery companies and technologies 30
4.2 Company Profiles 33
4.2.1 Abraxis Biosciences.33
Overview 33
Parenteral Delivery Technology.33
Deals, Partnerships, M&A33
4.2.2 Access Pharmaceuticals33
Overview 33
Parenteral Delivery Technologies33
4.2.3 Alkermes34
Overview . 34
Parenteral Delivery Technologies. 34
4.2.4 Antares Pharma.34
Overview . 34
Parenteral Delivery Technologies. 34
4.2.5 Becton Dickinson35
Overview 35
Parenteral Delivery Devices35
4.2.6 Bespak Pharmaceuticals35
Overview 35
Parenteral Delivery Devices35
4.2.7 BioGeneriX AG.36
Overview . 36
Parenteral Delivery Technology 36
4.2.8 Bioject Medical Technologies 36
Overview . 36
Parenteral Delivery Devices. 36
4.2.9 Biophan Technologies37

Overview 37
4.2.10 Camurus AB.37
Overview 37
Figure 4.1.1: Camurus' FluidCrystal injectable depot technology.38
4.2.11 CyDex Pharmaceuticals38
Overview . 38
4.2.12 Enzon Pharmaceuticals39
Overview 39
4.2.13 Genzyme Corporation39
Overview 39
4.2.14 Glide Pharmaceutical Technologies 40
Overview . 40
Parenteral Delivery Devices. 40
4.2.15 L ipoxen.40
Overview . 40
4.2.16 Mountain View Pharmaceuticals .41
Overview 41
4.2.17 N ektar Therapeutics.42
Overview 42
4.2.18 Novavax .42
Overview 42

4.2.19 O ctoPlus N.V43
Overview . 43
4.2.20 PolyTherics 43
Overview . 43
4.2.21 pSivida Corporation. 44
Overview . 44
4.2.22 QLT 44
Overview . 44
4.2.23 Starpharma Holdings 44
Overview . 44
4.2.24 SurModics 45
Overview . 45
5 Analysis & Conclusi ons 46
5.1 Analysis.46
Table 5.1.1: Top 10 leading parenteral drugs, 2009.46
5.1.1 Parenteral DDEP Market 46
Table 5.1.2: Global revenues pharmaceutical & parenteral DDEPs 2009-2015.46
Table 5.1.3: Growth areas for inflammatory & immune related parenteral DDEPs.47
Table 5.1.4: Global revenues of parenteral DDEPs 2009-2015.47
5.2 Technology.48
5.2.1 Prolong Activity. 48
5.2.2 Cancer . 48
5.2.3 Poorly soluble drugs . 48
5.2.4 Targeted drug delivery 48
5.2.5 Monoclonal Antibodies. 48
5.3 Therapeutic 49
5.3.1 Frontrunners.49
5.3.2 Alliances.50
5.4 Conclusions 51

6 GLO SSARY. 52
7 AUTHO R BIOGRAPHIES. 55
8 BIBLIOGRAPHY. 56

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