The world drug delivery systems market is currently valued at $12 billion with an annual growth rate of 20%. Novel drug delivery systems are increasingly being employed to extend mature product lifetimes and to create solutions to unresolved therapeutic problems.

This new Scrip report focuses on cutting edge technologies for improved drug delivery including: dry-powder inhalers, buccal patches, needleless injection devices, osmotic implants, transdermal patches, liposomes, and oral controlled-release formulations. In addition, the report reviews the major issues driving developments in the field, for example the demand for injection-free delivery of genes, proteins and peptides such as insulin and calcitonin. The report assesses strategies for mutually beneficial alliances between drug delivery business and pharmaceutical companies, and provides a guide to the successful negotiation of regulatory requirements. In-depth analysis of the market potential of drug delivery products by design and therapeutic application is given.

The 25 companies profiled include: 3M; Alza; Cortecs; DepoTech; Dura; Elan; Inhale; Noven; Powderject; Scherer; Sequus; TheraTech.

PUBLICATION: MARCH 1998
REF: BS906E
PAGES: 150+
PRICE: £495/$1,040/¥119,000

SEE ALSO:
Liposomes in Drug Delivery and Diagnostics
Transdermal Patch Drug Delivery

ES.1 Why drug delivery?
ES.2 Strategies for successful alliances
ES.3 Innovations in oral delivery
ES.4 Future prospects for systemic inhalation delivery
ES.5 New technologies for expansion of transdermal delivery
ES.6 Routes to needle-free delivery
ES.7 Success with liposomal therapeutics
ES.8 The market place
ES.9 Market players

APPENDIX
A.1 Scope of the report
A.2 Sources of information
GLOSSARY AND ABBREVIATIONS

CHAPTER 1 INDUSTRY OVERVIEW
1.1 Definition of a drug delivery system
1.2 A growing industry
1.3 Why drug delivery?
1.3.1 Improvements in therapy
1.3.2 Increasing patient compliance
1.3.3 Adding competitive advantage
1.4 Industry drivers
1.4.1 Life cycle management
1.4.2 Cost of development
1.4.3 Macromolecule delivery
1.4.4 Patient compliance
1.5 Routes of delivery
1.5.1 Oral delivery
1.5.2 Parenteral delivery
1.5.3 Mucosal delivery
1.5.4 Transdermal delivery
1.5.5 Inhalation delivery
1.6 Therapeutic areas
1.6.1 Arthritis
1.6.2 Asthma
1.6.3 Cancer
1.6.4 Cardiovascular disorders
1.6.4.1 Hypertension
1.6.4.2 Angina
1.6.5 Diabetes
1.6.6 Hormone replacement therapy
1.6.7 Hypogonadism
1.6.8 Infectious diseases
1.6.9 Osteoporosis
1.6.10 Pain management

CHAPTER 2 LICENSING ISSUES
2.1 Successful strategies
2.1.1 Finding a partner
2.1.1.1 Selection of a drug delivery company
2.1.1.2 Selection of a pharmaceutical company
2.1.2 The negotiation
2.1.3 The agreement
2.1.3.1 Supply agreement
2.1.3.2 Purchase rights
2.1.3.3 Licensing deal
2.1.4 The solution
2.1.5 The joint venture
2.2 Regulatory affairs
2.2.1 Medical devices
2.2.1.1 The US
2.2.1.2 European Union
2.2.2 The drug component
2.2.1.1 NCEs
2.2.1.2 Mutual recognition in Europe
2.2.2.3 Generics
2.2.2.4 Patent litigation

CHAPTER 3 ORAL DELIVERY
3.1 Background
3.2 Macromolecule delivery
3.2.1 Barriers to oral delivery
3.2.2 Permeation enhancers
3.2.3 Colon targeting
3.3 Market players
3.3.1 Alza
3.3.1.1 OROS
3.3.2 Elan
3.3.2.1 BEODAS
3.3.3 Eurand
3.3.3.1 Microcaps
3.3.4 Andrx
3.4 New technologies
3.4.1 Macrosol - Cortecs
3.4.1.1 Macritonin
3.4.1.2 Macrulin
3.4.2 Carrier mediated oral delivery - Emisphere
3.4.3 Ceform - Fuisz Technologies
3.5 Buccal patches
3.5.1 TheraTech
3.5.2 Cydot -3M Pharmaceuticals
3.5.3 Noven Pharmaceuticals
3.6 Fast dispersing dosage forms

CHAPTER 4 INHALATION DELIVERY
4.1 Background
4.2 Device designs
4.2.1 Nebulisers
4.2.2 Metered dose inhalers
4.2.3 Dry powder inhalers
4.3 Marketed devices
4.3.1 Airomir/Proventil HFA - 3M
4.3.2 Market share by design
4.4 Macromolecule delivery
4.5 New technologies
4.5.1 SmartMist Asthma Management System - Aradigm
4.5.2 Spiros DPI - Dura Pharmaceuticals
4.5.3 Inhale Therapeutics - pulmonary delivery system
4.5.3.1 Diabetes
4.5.3.2 Osteoporosis
4.5.3.3 Emphysema
4.5.3.4 Viral infections
4.5.4 Andaris
4.5.5 AeroGen
4.5.5.1 AeroNeb
4.5.5.2 AeroDose
4.5.6 AERx Pulmonary Drug Delivery System - Aradigm
4.5.6.1 AERx Diabetes Management System
4.5.6.2 AERx Pain Management System
4.5.6.3 AERx Protein and Small Molecule Delivery System
4.5.6.4 AERx Pulmonary Diagnostic System

CHAPTER 5 TRANSDERMAL DELIVERY
5.1 Background
5.2 The transdermal route
5.2.1 Transdermal patches
5.3 Marketed products
5.4 Market players
5.4.1 3M Pharmaceuticals
5.4.2 Alza
5.4.2.1 Testoderm TTS
5.4.3 Elan
5.4.4 TheraTech
5.4.5 Noven
5.5 New technologies
5.5.1 Penetration enhancers
5.5.1.1 SEPA - MacroChem
5.5.1.2 Dermac - Pharmetrix (TCPI)
5.5.2 Counter-irritants
5.5.2.1 Celledirm - Cellergy Pharmaceuticals
5.5.2.2 Counter-sensitizers - ConvaTec
5.5.3 Iontophoretic patches
5.5.3.1 Becton Dickinson
5.5.3.2 E-TRANS - Alza
5.5.3.3 Panoderm - Elan
5.5.4 Electroporation
5.5.4.1 DermaPulse - Genetronics
5.5.5 Thermal microporation
5.5.5.1 Altea Technologies
5.5.6 Other approaches
5.5.6.1 Transfersome - IDEA

CHAPTER 6 NEEDLELESS DEVICES, INJECTABLE DEPOTS AND IMPLANTS
6.1 Background
6.2 Marketed products
6.2.1 Injectable depots
6.2.1.1 Contraceptives
6.2.1.2 Prostate cancer
6.2.2 Implants
6.2.2.1 Norplant - AHP
6.2.3 Needleless devices
6.3 Injectable depots
6.3.1 Therapeutic Implant - Matrix
6.3.1.1 AccuSite
6.3.1.2 IntraDose
6.3.1.3 Anhydrous delivery vehicle
6.3.2 ProLease - Alkermes
6.3.3 Atrigel - Atrix
6.3.4 MIDAS - Elan
6.3.5 PEG-technology - Enzon
6.4 Implants
6.4.1 DUROS - Alza
6.4.1.1 DUROS Leuprolide
6.4.2 CRIB technology - CytoTherapeutics
6.4.3 CNS targeting - Medtronic
6.4.3.1 SynchroMed
6.4.3.2 Model 8506 ICV
6.5 Needleless devices
6.5.1 Medi-Jector - Medi-Ject
6.5.2 Dermal and Oral PowderJect - PowderJect
6.5.3 Medipad - Elan

CHAPTER 7 LIPOSOMES
7.1 Background
7.2 Marketed products
7.2.1 AmBisome - NeXstar
7.2.2 Abelcet - The Liposome Co
7.2.3 Amphotec - Sequus
7.2.4 Comparisons of Amphotec, Abelcet and AmBisome
7.2.5 Cost comparisons
7.2.6 DaunoXome - NeXstar
7.3 New technologies
7.3.1 Stealth - Sequus
7.3.1.1 Doxil
7.3.1.2 Cisplatin (SPI-077)
7.3.2 DepoFoam - DepoTech
7.3.2.1 DepoCyt
7.3.2.2 DepoAmikacin
7.3.2.3 DepoMorphine
7.4 New developments
7.4.1 The Liposome Co
7.4.1.1 Evacet (TLC D-99)
7.4.1.2 Ventus
7.4.1.3 TLC ELL-12
7.4.1.4 Bromotaxol
7.4.2 NeXstar
7.4.2.1 MiKasome

CHAPTER 8 MARKET DATA
8.1 The global market
8.1.1 The pharmaceutical market
8.1.2 The drug delivery systems market
8.1.3 The biotechnology market
8.1.4 The generics market
8.2 Market by drug delivery route
8.2.1 Oral delivery
8.2.2 Transdermal delivery
8.2.3 Inhalation therapy
8.2.4 Other routes
8.2.4.1 Implants
8.2.4.2 Injectable depots
8.2.4.3 Liposomes
8.3 Market by therapeutic category
8.3.1 Cardiovasculars
8.3.2 Hormonal therapy
8.3.2.1 Female HRT
8.3.2.2 Male hypogonadism
8.3.3 Asthma
8.4 Future prospects
8.4.1 The global pharmaceutical market
8.4.2 The drug delivery systems market
8.4.3 Drug delivery companies

CHAPTER 9 COMPANY PROFILES
9.1 Alkermes
9.2 Alza
9.3 Andrx
9.4 Aradigm
9.5 Atrix
9.6 Becton Dickinson
9.7 Biovail
9.8 Cortecs
9.9 DepoTech
9.10 Dura
9.11 Elan
9.12 Emisphere
9.13 Enzon
9.14 Ethical
9.15 Eurand
9.16 Inhale Therapeutic Systems
9.17 3M Pharmaceuticals
9.18 Matrix
9.19 NeXstar
9.20 Noven
9.21 PowderJect
9.22 Scherer
9.23 Sequus
9.24 The Liposome Co
9.25 TheraTech

CHAPTER 10 DIRECTORY

REFERENCES

List of tables
Table 1.1 Peptide and protein candidates for alternative delivery systems
Table 1.2 Preferred administration routes for drug delivery
Table 1.3 Self-administration device requirements

Table 2.1 Selection criteria for successful partnerships
Table 2.2 Types of licensing agreements
Table 2.3 The terms of a licensing deal
Table 2.4 A strategy for successful collaboration
Table 2.5 AB-rated controlled-release products in the US

Table 3.1 Approaches to overcome the obstacles of oral delivery of macromolecules
Table 3.2 Products marketed using Alza's OROS technology
Table 3.3 Alza's OROS products in development, licensed-out or available for licence
Table 3.4 Elan's oral drug delivery technologies
Table 3.5 Elan's marketed oral drug delivery products
Table 3.6 Eurand's oral drug delivery technologies
Table 3.7 Products incorporating Eurand's Microcaps technology
Table 3.8 Andrx's oral drug delivery systems
Table 3.9 Andrx's generic product pipeline
Table 3.10 Properties of the ideal drug for a transmucosal drug delivery system
Table 3.11 Theratech's oral transmucosal system pipeline
Table 3.12 3M's development profile for the Cydot buccal patch system
Table 3.13 Fast dispersing dosage forms
Table 3.14 Marketed fast dispersing products

Table 4.1 Breath-actuated inhaler devices available in the UK
Table 4.2 Market share of existing pulmonary delivery systems
Table 4.3 Rate of absorption of pulmonary delivered peptide drugs
Table 4.4 Spiros commercialisation strategy
Table 4.5 Dura's product development timeline for Spiros technology products
Table 4.6 Inhale's inhalation therapy development programme

Table 5.1 Characteristics of transdermal patch designs
Table 5.2 Marketed transdermal patches
Table 5.3 Marketed products using Alza's D-TRANS technology
Table 5.4 Sano's transdermal product pipeline acquired by Elan
Table 5.5 TheraTech's TheraDerm patch product pipeline
Table 5.6 Worldwide transdermal drug delivery patents by category, 1994-1996
Table 5.7 Enhancement of drug permeation by Dermac (SR-38) from transdermal formulations
Table 5.8 Properties of peptides suitable for iontophoretic delivery
Table 5.9 Possible indications for iontophoresis

Table 6.1 Marketed injectable depot systems for prostate cancer
Table 6.2 Matrix's Therapeutic Implant clinical development programme
Table 6.3 Enzon's PEG-technology product pipeline
Table 6.4 Potential advantages of the PowderJect device

Table 7.1 Liposomal-based formulations of amphotericin B
Table 7.2 Comparative cost of treatment with liposomal-based preparations of amphotericin B
Table 7.3 DepoTech's development pipeline for DepoFoam technology

Table 8.1 Major pharmaceutical market sales ($ million)
Table 8.2 The worldwide biotechnology market
Table 8.3 Top biotechnology product sales in the US, 1996
Table 8.4 Generic drug delivery industry pipeline in the cardiovascular arena
Table 8.5 Distribution of the US market by drug delivery route
Table 8.6 Oral controlled-release drug delivery, industry pipeline
Table 8.7 Oral delivery for peptides and proteins, drug delivery industry pipeline
Table 8.8 Oral fast dispersing drug delivery industry pipeline
Table 8.9 Transdermal drug delivery, industry pipeline
Table 8.10 Inhalation therapy drug delivery industry pipeline
Table 8.11 Sales of injectable depot products in the US
Table 8.12 Injectable depot drug delivery industry pipeline
Table 8.13 Liposome drug delivery industry pipeline
Table 8.14 World pharmaceutical sales by therapeutic area, 1996-1997
Table 8.15 Oral controlled-release cardiovascular product sales in US
Table 8.16 Sales of nitroglycerin patches in the US, 1996
Table 8.17 Sales forecasts for selected transdermal oestradiol preparations
Table 8.18 Sales of testosterone patches in the US, 1996
Table 8.19 Sales of asthma products in the US, 1996
Table 8.20 The global pharmaceutical market, 1997-2001
Table 8.21 Forecast of the US drug delivery systems market, 1996-2005 ($ billion)

Table 9.1 Alkermes' financial results, 1995-1998 ($ thousand)
Table 9.2 Alza's products in development which are available for licensing
Table 9.3 Alza's financial results, 1993-1997 ($ million)
Table 9.4 Andrx's financial results, 1993-1997 ($ thousand)
Table 9.5 Aradigm's financial results, 1993-1997 ($ thousand)
Table 9.6 Atrix' product pipeline
Table 9.7 Atrix' financial results, 1994-1997 ($ thousand)
Table 9.8 BD's financial results, 1996-1997 ($ million)
Table 9.9 Biovail's financial results, 1993-1997 ($ thousand)
Table 9.10 Cortecs' financial results, 1996-1997 (� million)
Table 9.11 DepoTech's financial results, 1994-1997 ($ thousand)
Table 9.12 Dura's financial results, 1993-1997 ($ thousand)
Table 9.13 Sano's product pipeline acquired by Elan
Table 9.14 Elan's financial results, 1996-1997 ($ million)
Table 9.15 Emisphere financial results, 1993-1997 ($ thousand)
Table 9.16 Enzon's financial results, 1994-1997 ($ thousand)
Table 9.17 Ethical's financial results, 1993-1997 (� thousand)
Table 9.18 Inhale's financial results, 1996-1997 ($ thousand)
Table 9.19 3M's financial results, 1993-1997 ($ million)
Table 9.20 Matrix's financial results, 1993-1997 ($ thousand)
Table 9.21 NeXstar's financial results, 1994-1997 ($ thousand)
Table 9.22 Noven's financial results, 1993-1997 ($ thousand)
Table 9.23 PowderJect's drug delivery development pipeline
Table 9.24 PowderJect's financial data, 1995-1997 (� thousand)
Table 9.25 Scherer's financial results, 1994-1998 ($ million)
Table 9.26 Sequus' financial results, 1993-1997 ($ thousand)
Table 9.27 TLC's financial results, 1993-1997 ($ thousand)
Table 9.28 TheraTech's financial results, 1994-1997 ($ thousand)

List of figures
Figure 4.1 Market share of existing pulmonary delivery systems

Figure 5.1 Transdermal patch design
Figure 5.2 How the iontophoretic patch works

Figure 8.1 Major pharmaceutical market sales
Figure 8.2 Geographical distribution of the drug delivery systems market in 2000
Figure 8.3 The world biotechnology market, 1996
Figure 8.4 Distribution of the US market by drug delivery route
Figure 8.5 The global pharmaceutical market, 1997-2001
Figure 8.6 Forecast of the US drug delivery systems market, 1994-2005 by delivery route

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