Drug Delivery Technologies: Innovations and market challenges

Drug Delivery Technologies: Innovations and market challenges

Therapeutic

Drug Delivery is one of the fastest growing healthcare sectors, with sales of drugs incorporating drug delivery systems increasing at an annual rate of 15%. By 2003, the US drug delivery market alone will be worth $24 billion.

With these facts in mind, Scrip Reports brings you this comprehensive review of drug delivery, describing how advances in biotechnology and delivery technology will become vital to pharmaceutical commercial success.

This authoritative study answers the following questions:

What are the innovations in drug delivery technologies and how do they work?
What synergy is there between established products and new drug delivery technologies?
How will the new drug delivery technologies affect the current and future markets?
Which companies have suitable drug delivery technologies for licensing?

New drug delivery technologies are revolutionising the pharmaceutical industry - why not let Scrip Reports help revolutionise your company?

Published: May 2001
Pages: 231
Ref: BS1086E
Price: £595/$1,250/¥143,000

For further information about this report, please contact our Customer Helpdesk on:
Tel: +44 (0)20 8332 8965 / 66
Fax: +44 (0)20 8332 8992
E-mail: [email protected]

CONTENTS
LIST OF TABLES
LIST OF FIGURES
EXECUTIVE SUMMARY
ABBREVIATIONS

SCOPE AND METHODOLOGY
SM1 Background
SM2 Objectives of the report
SM3 Methodology
SM4 Boundaries of the report
SM5 Exchange rates

CHAPTER 1 INTRODUCTION TO DRUG DELIVERY TECHNOLOGY
1.1 Development perspective of drug delivery
1.1.1 Advantages of drug delivery technologies
1.2 Biological barriers to drug delivery
1.2.1 Cellular and subcellular barriers
1.2.2 Site of administration
1.2.3 Chronotherapeutics
1.2.4 Ocular drug delivery � challenging the biological barriers
1.3 Historical approaches to solving the problems of drug delivery
1.3.1 Profile of the drug delivery industry since 1985
1.4 Factors influencing the development of the drug delivery industry
1.4.1 Generic competition
1.4.2 Prolonging the patent
1.4.2.1 Reformulation
1.4.3 Patent extension strategies
1.4.3.1 Eli Lilly � Prozac
1.4.3.2 AstraZeneca � Losec
1.4.4 Franchise extensions and drug delivery based reformulation
1.5 Product development strategies utilising drug delivery technologies
1.5.1 Drug delivery to differentiate products in a saturated market
1.5.2 Expanding the indication
1.5.3 Salvaging abandoned drugs through drug delivery technology
1.5.3.1 Improving pharmacokinetics
1.5.4 Macromolecule drug delivery
1.6 External factors influencing drug delivery developments
1.6.1 Demands from patients and practitioners
1.6.2 Drug reimbursement issues
1.6.3 The demands of novel therapies
1.6.3.1 Novel drug delivery � revolutionising the insulin market
1.7 The drug delivery industry environment

CHAPTER 2 INNOVATIONS IN DRUG DELIVERY TECHNOLOGIES
2.1 Routes of Drug Delivery
2.2 Oral drug delivery
2.2.1 Targeted oral delivery
2.2.2 Modified-release formulations
2.2.3 Carrier mediated oral drug delivery
2.3 Drug delivery by injection
2.3.1 Safety issues of delivering drugs by injection
2.3.2 Needleless drug delivery technologies
2.3.2.1 PowderJect's needleless injector
2.3.2.2 Medi-Ject
2.3.2.3 Weston's Intraject
2.3.2.4 Equidyne's INJEX
2.4 Transdermal drug delivery
2.4.1 History of transdermal delivery
2.4.2 Skin structure and permeability
2.4.3 Benefits and limitations of transdermal drug delivery
2.4.3.1 Benefits
2.4.3.2 Limitations
2.4.4 Enhancers
2.4.5 Microparticulate drug carriers
2.4.5.1 Liposomes
2.4.5.2 Niosomes
2.4.5.3 Nanoparticles
2.4.5.4 Transfersomes
2.4.6 Polymer implants
2.4.7 Phonophoresis
2.4.8 Electroporation
2.4.9 Iontophoresis
2.5 Mucosal drug delivery
2.5.1 Sites for mucosal drug delivery
2.5.2 Oral mucosal drug delivery
2.5.2.1 Anatomical aspects of oral mucosal drug delivery
2.5.3 Nasal mucosal delivery
2.5.4 Intravaginal delivery
2.5.5 Urethral mucosal delivery
2.5.6 Rectal mucosal delivery
2.5.7 Ocular delivery
2.5.7.1 Posterior ocular drug delivery
2.5.7.2 Oculex � Surodex
2.6 Pulmonary drug delivery
2.6.1 History of drug delivery by inhalation
2.6.2 The lungs as a site for drug delivery
2.6.2.1 Barriers to drug delivery by inhalation
2.6.3 Inhalation devices
2.6.3.1 Nebulisers
2.6.3.2 Dry powder inhalers
2.6.3.3 Pressurised metered dose inhalers
2.7 Gene therapy
2.7.1 What is gene therapy?
2.7.2 Challenges of gene therapy
2.7.2.1 Risks of gene therapy
2.7.3 The delivery of genes into target cells
2.7.3.1 Viral vectors

CHAPTER 3 MARKETED DRUGS UTILISING DRUG DELIVERY TECHNOLOGIES
3.1 Introduction
3.2 Anti-infectives
3.2.1 Oral delivery drugs
3.2.1.1 Tamiflu
3.2.1.2 Fortovase
3.2.2 Transdermal topical drug delivery
3.2.2.1 Crystabase
3.2.2.2 Crystacide/Microcid
3.2.3 Carrier delivery
3.2.3.1 PEG-Intron
3.2.3.2 AmBisome
3.3 Cancer
3.3.1 Injectable/implantable drug delivery
3.3.1.1 DepoCyt
3.3.1.2 Doxil/Caelyx
3.3.1.3 DaunoXome
3.3.2 Enhancement technologies
3.3.2.1 ONCASPAR
3.4 Cardiovascular disease products
3.4.1 Controlled-release oral antihypertensive/angina products
3.4.1.1 Procardia XL
3.4.1.2 Covera HS
3.4.1.3 Cardura XL
3.4.1.4 Verelan
3.4.1.5 Verelan PM
3.4.1.6 Cartia XT
3.4.1.7 Diltia XT
3.4.2 Controlled-release oral cardiovascular disorders products
3.4.2.1 Dilacor XR
3.4.2.2 Diffutab isosorbide dinitrate SR
3.4.2.3 Isosorbide-5-mononitrate SR capsules
3.4.2.4 Cardizem
3.4.2.5 Monicor
3.4.3 Transdermal drug delivery
3.4.3.1 Nitroderm TTS/Transderm-Nitro
3.4.3.2 Catapres TTS
3.4.3.3 Deponit
3.4.4 Enhancement technologies
3.4.4.1 Nifelan
3.5 Central nervous system
3.5.1 Oral delivery
3.5.1.1 Concerta
3.5.1.2 Madopar DR
3.5.1.3 Carbatrol
3.5.2 Transmucosal delivery
3.5.2.1 Zydis apomorphine
3.5.2.2 Zydis selegiline
3.6 Gastrointestinal disorders
3.6.1 Oral delivery
3.6.1.1 Gaster OD
3.6.1.2 Pentasa
3.7 Metabolic diseases
3.7.1 Oral delivery
3.7.1.1 Glucotrol XL
3.8 Oral delivery
3.8.1 Oruvail and generic Voltaren
3.8.1.1 Neprelan
3.8.1.2 Diclofenac-ratiopharm-uno
3.8.2 Transdermal drug delivery
3.8.2.1 Pennsaid Topical Lotion
3.9 Oral disease
3.9.1 Injectable/implantable technologies
3.9.1.1 ATRIDOX
3.9.2 Oral delivery
3.9.2.1 PerioChip and Periosense
3.10 Pain relief
3.10.1 Injectable/implantable technologies
3.10.1.1 Fresofol
3.10.2 Oral delivery
3.10.2.1 VOLTFAST
3.10.2.2 Zomig rapimelt
3.10.2.3 Ethypharm oral products
3.10.2.4 MicroMask ibuprofen
3.10.2.5 Advil Liqui-Gel
3.10.3 Transmucosal delivery
3.10.3.1 Actiq
3.10.3.2 Stadol NS
3.10.3.3 DentiPatch
3.10.4 Transdermal delivery
3.10.4.1 Duragesic
3.10.4.2 Numby stuff and IONTOCAINE
3.11 Respiratory disease
3.11.1 Oral delivery
3.11.1.1 Volmax
3.11.1.2 Theo-Dur
3.12 Urological disorders and female health
3.12.1 Oral delivery
3.12.1.1 Cystrin
3.12.1.2 Ditropan XL
3.12.2 Transmucosal delivery
3.12.2.1 Crinone, Advantage-S and Replens
3.12.3 Transdermal drug delivery
3.12.3.1 Estraderm and Testoderm
3.12.3.2 Vivelle, Vivelle-Dot and CompiPatch/Estalis
3.12.3.3 Alora and Androderm
3.13 Miscellaneous
3.13.1 Transmucosal delivery
3.13.1.1 Nascobal
3.13.1.2 Benadryl FASTMELT tablets

CHAPTER 4 DRUGS IN DEVELOPMENT UTILISING INNOVATIVE DELIVERY TECHNOLOGIES
4.1 Introduction
4.2 Infectious diseases
4.2.1 Carrier/encapsulation delivery
4.2.1.1 Liposomal formulations
4.2.1.2 Lipopeptidic formulation
4.2.1.3 Flamel's Medusa technology
4.2.1.4 Flamel's micropump technology
4.2.1.5 Biovector light-based products
4.2.1.6 Helix BioPharma's BIPHASIX technology
4.2.2 Injectable/implantable delivery
4.2.2.1 Dexemel based intraperitoneal delivery
4.2.2.2 SkyePharma's DepoFoam
4.2.3 Site-specific/targeted delivery
4.2.3.1 Gyne-Rx
4.2.3.2 Oramed
4.2.3.3 DP-v100/v200 series
4.2.4 Transdermal delivery
4.2.4.1 ES-Gel topical system
4.2.4.2 Dimethaid's transdermal delivery system
4.2.4.3 Helix BioPharma's interferon cream
4.2.4.4 Transcutaneous Immuno Modulation
4.2.4.5 Soft Enhancement of Percutaneous Absorption
4.2.4.6 NexACT penetration enhancers
4.2.4.7 Topical Matrix
4.2.5 Transmucosal delivery
4.2.5.1 Advantage-S
4.2.5.2 Nasal interferon-a
4.3 Cancer
4.3.1 Carrier/encapsulation delivery
4.3.1.1 Stealth technology
4.3.1.2 Atragen (tretinoin liposome formulation)
4.3.1.3 Aroplatin
4.3.1.4 Annamycin
4.3.1.5 Biovector-based anticancer products
4.3.1.6 Medusa formulation of interferon-a
4.3.1.7 DaunoXome
4.3.1.8 BIPHASIX formulation of interferon-a for cervical cancer
4.3.1.9 Onco TCS
4.3.1.10 INX-3280
4.3.1.11 NeoPharm's liposome technology platform
4.3.1.12 Liposome Encapsulated Paclitaxel
4.3.1.13 Liposome Encapsulated Doxorubicin
4.3.1.14 Liposome Encapsulated Mitoxantrone and Epirubicin
4.3.1.15 Liposomal Encapsulated Antisense c-Raf Oligonucleotide
4.3.1.16 Chimeric Protein and Exotoxin IL13-PE38
4.3.1.17 Mesothelin Chimeric Protein and Exotoxin (SS1(dsFv)-PE38)
4.3.1.18 Pep:trans technology
4.3.2 Gene delivery
4.3.2.1 VP22 technology
4.3.2.2 VP22 Protein Vectosomes
4.3.2.3 Valentis' cationic lipid delivery system
4.3.2.4 Naked DNA technology
4.3.3 Injectable/implantable delivery
4.3.3.1 Viadur implant
4.3.3.2 ATRIGEL leuprolide injection
4.3.3.3 5-Fluorouracil microspheres
4.3.3.4 Dexemel based intraperitoneal delivery
4.3.3.5 DepoCyt
4.3.3.6 Paclitaxel emulsion
4.3.4 Oral delivery
4.3.4.1 Lobradimil plus carboplatin
4.3.4.2 Nobex' oral delivery technology
4.3.5 Site-specific/targeted delivery
4.3.5.1 D-RAP technology
4.3.5.2 IntraDose (cisplatin/epinephrine) Injectable Gel
4.3.5.3 FMdC
4.3.5.4 Perio's Colonic Delivery System
4.3.6 Transdermal delivery
4.3.7 Transmucosal delivery
4.4 Cardiovascular disease
4.4.1 Gene delivery
4.4.1.1 Restenosis
4.4.1.2 Vascular endothelial growth factor
4.4.1.3 Naked DNA
4.4.2 Oral delivery
4.4.2.1 Andrx' oral drug delivery technologies
4.4.2.2 Biovail's oral controlled-release technology
4.4.2.3 CeNeS' OSAT technology
4.4.2.4 Emisphere's oral heparin
4.4.2.5 Ethypharm's multiparticulate technologies
4.4.2.6 Eurand's controlled-release ISMN
4.4.2.7 Oligomer-conjugate technology
4.4.2.8 EnSoTrol formulation of nifedipine
4.4.2.9 Geomatrix oral drug delivery technology
4.4.3 Transdermal delivery
4.4.4 Transmucosal delivery
4.4.4.1 Soft-bite product formulations
4.4.4.2 Lingual spray formulation of nitroglycerin
4.5 Central nervous system
4.5.1 Gene delivery
4.5.2 Injectable/implantable delivery
4.5.2.1 Medisorb Naltrexone
4.5.2.2 Risperidone (Risperdal)
4.5.3 Oral delivery
4.5.3.1 Andrx' controlled-release technology
4.5.3.2 Biovail's controlled-release technology
4.5.3.3 Ethypharm
4.5.3.4 Eurand's controlled-release products
4.5.3.5 Shire's SLI 381
4.5.3.6 SkyePharma's Geomatrix technology
4.5.4 Pulmonary/inhalational delivery
4.5.4.1 Inhalable interferon-b
4.5.5 Site-specific/targeted delivery
4.5.5.1 D-RAP formulation of valproic acid
4.5.6 Transdermal delivery
4.5.6.1 Interferon Transfersomes
4.5.6.2 Transcutaneous Immuno Modulation
4.5.6.3 Methylphenidate MethyPatch
4.5.7 Transmucosal delivery
4.6 Dermatological diseases
4.6.1 Transdermal delivery
4.6.1.1 Dapsone topical gel
4.6.1.2 DermaStick system
4.6.1.3 Crystalip system
4.6.1.4 Corticosteroids in Transfersomes
4.7 Gastrointestinal disorders
4.7.1 Chronotherapeutic delivery
4.7.2 Oral delivery
4.7.2.1 SPDS formulation of omeprazole
4.7.2.2 Controlled-release trimebutine
4.7.2.3 Mesalazine prodrug
4.7.3 Site-specific/targeted delivery
4.8 Metabolic and hormonal conditions
4.8.1 Carrier/encapsulation delivery
4.8.1.1 Basulin
4.8.2 Injectable/implantable delivery
4.8.2.1 Nutropin Depot
4.8.2.2 Self-regulating insulin delivery
4.8.2.3 AndroJect (testosterone)
4.8.3 Oral delivery
4.8.3.1 Metformin osmotic tablet
4.8.3.2 Controlled-release metformin
4.8.3.3 Multiparticulate hypoglycaemic
4.8.3.4 Oral insulin
4.8.4 Pulmonary/inhalational delivery
4.8.4.1 AeroDose insulin
4.8.4.2 AIR pulmonary delivery system
4.8.4.3 AERx pulmonary drug delivery system
4.8.4.4 Spiros pulmonary delivery system
4.8.4.5 Inhale's inhalable insulin
4.8.4.6 Quadrant's inhaled insulin
4.8.5 Transdermal delivery
4.8.5.1 3M's Latitude/Latitude Duo
4.8.5.2 Combi-Patch, Combi-Gel
4.8.5.3 BIPHASIX insulin patch
4.8.5.4` Transfersulin
4.8.5.5 Micellar Nanoparticles
4.8.5.6 Watson's transdermal matrix products
4.8.6 Transmucosal delivery
4.8.6.1 Buccal testosterone tablet
4.8.6.2 17-ß-Oestradiol spray
4.8.6.3 ORALIN oral insulin
4.9 Musculoskeletal disorders
4.9.1 Oral delivery
4.9.1.1 Extended-release naproxen sodium
4.9.1.2 High-dose ibuprofen
4.9.1.3 Oral calcitonin
4.9.1.4 Ethypharm osteoporosis compound
4.9.1.5 Nobex' oral delivery technology
4.9.1.6 Geomatrix formulation of naproxen
4.9.1.7 Unigene's oral calcitonin
4.9.2 Transdermal delivery
4.9.2.1 Pennsaid topical diclofenac lotion
4.9.2.2 TIM products for rheumatoid arthritis
4.9.2.3 Noven's transdermal osteoporosis products
4.9.2.4 Watson's osteoporosis products
4.10 Ophthalmic disease
4.10.1 Ocular delivery
4.10.1.1 DDS technology
4.10.1.2 Anti-angiogenic compounds
4.11 Pain/analgesia
4.11.1 Carrier/encapsulation delivery
4.11.1.1 Asacard
4.11.1.2 Pep:trans technology
4.11.2 Injectable/implantable delivery
4.11.2.1 DepoMorphine
4.11.2.2 DepoBupivacaine
4.11.3 Oral delivery
4.11.3.1 OROS formulation of hydromorphone
4.11.3.2 Immediate-release diclofenac
4.11.3.3 Controlled-release ibuprofen
4.11.3.4 Controlled-release tramadol
4.11.3.5 CeNeS's OSAT technology
4.11.3.6 Ethypharm's sustained-release analgesics
4.11.3.7 Eurand's controlled-release analgesics
4.11.3.8 Contramid formulation of tramadol
4.11.3.9 Dirame
4.11.4 Pulmonary/inhalational delivery
4.11.4.1 AERx Pain Management System
4.11.5 Transdermal delivery
4.11.5.1 Fentanyl patch
4.11.5.2 Crystalip system
4.11.5.3 Dexamethasone sodium phosphate (Iontodex)
4.11.5.4 Hydromorphone
4.11.5.5 Soft Enhancement of Percutaneous Absorption
4.11.5.6 NexACT formulations of ibuprofen and ketoprofen
4.11.5.7 Ketoprofen patch
4.11.6 Transmucosal delivery
4.11.6.1 Anesta's OTS technology
4.11.6.2 Bioerodible Mucoadhesive technology
4.11.6.3 Moraxen spray
4.11.6.4 RapidMist formulation of morphine
4.11.6.5 Intranasal analgesia
4.11.6.6 Transmucosal ketoprofen
4.11.6.7 Perio's SLP technology
4.11.6.8 Watson's oral transmucosal technology
4.11.6.9 Chitosan nasal drug delivery technology
4.11.6.10 Zentrans bioadhesive delivery technology
4.12 Respiratory disease
4.12.1 Oral delivery
4.12.1.1 Xopenex (levalbuterol or racemic-albuterol)
4.12.1.2 Pulmonary/inhalational delivery
4.12.1.3 AERx pulmonary delivery system
4.12.1.4 Spiros inhaler system
4.13 Genitourinary/women's health products
4.13.1 Carrier/encapsulation delivery
4.13.1.1 NP9-Novasomes
4.13.2 Chronotherapeutic delivery
4.13.2.1 Chronotopic-SYS oestradiol
4.13.3 Oral delivery
4.13.3.1 Contramid oxybutynin
4.13.3.2 Geomatrix alfuzosin
4.13.4 Site-specific/targeted delivery
4.13.4.1 SAVVY
4.13.5 Transdermal delivery
4.13.5.1 Topiglan
4.13.5.2 Alprox-TD
4.13.5.3 Femprox
4.13.5.4 Noven's transdermal hormone products
4.13.5.5 ALISTA
4.13.5.6 Watson's transdermal matrix products
4.13.6 Transmucosal delivery
4.13.6.1 Terbutaline gel
4.13.6.2 Lingual spray formulation of progesterone
4.13.6.3 Intranasal apomorphine
4.13.6.4 Intranasal leuprolide
4.14 Miscellaneous
4.14.1 Carrier/encapsulation delivery
4.14.1.1 Ionic amphiphile Biovector-based products
4.14.2 Gene delivery
4.14.2.1 Valentis' PINC technology
4.14.2.2 PEGylated proteins
4.14.3 Injectable/implantable delivery
4.14.3.1 ATRISORB-DOXY
4.14.3.2 DepoFoam formulations
4.14.4 Oral delivery
4.14.4.1 OROS methylphenidate
4.14.4.2 Pelletised potassium supplement
4.14.4.3 Controlled-release bupropion
4.14.4.4 Liquid oral heparin
4.14.4.5 Prednisolone liquid solution
4.14.4.6 Controlled-release potassium
4.14.4.7 Contramid formulations
4.14.4.8 Oligomer-conjugated delivery
4.14.4.9 Geomatrix formulation of Pfizer compound
4.14.5 Pulmonary/inhalational delivery
4.14.5.1 AERx for gene therapy
4.14.5.2 Inhaled antibiotics for cystic fibrosis
4.14.5.3 Inhaled a-1 proteinase inhibitor
4.14.6 Site-specific/targeted delivery
4.14.6.1 D-Pharm's Tag platform
4.14.7 Transdermal delivery
4.14.7.1 ES-Gel topical system
4.14.7.2 Interferon Transfersomes
4.14.7.3 Scopolamine patch
4.14.8 Transmucosal delivery
4.14.8.1 OT-nicotine (nicotine)
4.14.8.2 Other OTS products
4.14.8.3 Aerosol products for addiction
4.14.8.4 Flemington's lingual spray formulations
4.14.8.5 Intranasal metoclopramide
4.14.8.6 SLP oral mucosal delivery
4.14.8.7 Nicotine lozenge
4.14.8.8 Zentrans growth hormone releasing factor

CHAPTER 5 DRUG DELIVERY SYSTEMS MARKET
5.1 Global drug delivery market
5.1.1 Market size, valuations, and growth prospects
5.2 Market drivers
5.3 Market conditions and barriers to entry
5.4 Drug delivery markets by route of delivery
5.4.1 Oral delivery market
5.4.1.1 Market opportunities
5.4.1.2 Calcitonin
5.4.1.3 Heparin
5.4.2 Inhalational/pulmonary market
5.4.3 Injectable/implantable delivery market
5.4.3.1 Injectable protein/peptide drug market
5.4.4 Needleless injection market
5.4.5 Transmucosal drug delivery
5.4.5.1 Intranasal mucosal drug delivery sector
5.4.5.2 Transrectal delivery market
5.4.6 Transdermal drug delivery market
5.4.6.1 Hormone replacement therapy market
5.4.7 Liposomal delivery market
5.4.8 Gene delivery market
5.4.8.1 Secreted proteins
5.5 Drug delivery markets by territory
5.5.1 US drug delivery market
5.5.1.1 The insulin market opportunity in the US and worldwide
5.5.1.2 Inhaled insulin
5.5.2 European drug delivery market
5.5.2.1 European market by therapeutic segment
5.5.3 Asian drug delivery markets
5.5.3.1 Japan
5.6 Drug delivery markets by therapeutic categories

REFERENCES

EXECUTIVE SUMMARY
The drug delivery industry is emerging from the shadow of the mainstream pharmaceutical industry to become an influential force. Drug delivery companies are now at the forefront of innovation and this once small niche market is now well positioned to become a major and significant driver of global pharmaceutical growth in the 21st century. Products incorporating innovative drug delivery systems hold the promise of rich rewards and exciting opportunities.

Drug delivery systems have come along way from just simple reformulation with limited application. Delivery technologies have evolved into innovative platforms that will positively impact the global pharmaceutical industry in every therapeutic category. To-date, the applications of drug delivery technologies are immense, offering unrivalled opportunities to combat diseases more effectively than ever before. Drug delivery systems can improve a product's medicinal value by providing pharmacological superiority over conventional products on the market. Furthermore, the right drug delivery system can boost a product's market value by reducing compliance issues, such as multiple applications, side-effects and tolerability. Drug delivery technologies have also become an integral part of a product's life-cycle management � extending a drug's exclusivity and profitability.

The advances in drug delivery technologies have gone hand in hand with the new era of drug discovery and development. Gene based therapies, for example, which utilise drug delivery technologies to stabilise large active protein molecules, will eventually provide novel treatments for diseases such as cancer, infectious diseases and metabolic disorders to name but a few. Additionally, new drug delivery systems including nasal sprays, extended-release oral formulations, topical creams, transdermal patches, and inhalational compounds have the capacity to expand the market for therapeutic peptides � a largely untapped pharmaceutical market with immense potential. Most of these compounds are either administered by injection only or are abandoned because of poor bioavailability and/or solubility. Novel drug delivery technologies offer new capabilities to revive the market potential for these compounds by providing new solutions to old problems.

Medical practice is not the only beneficiary of these new drug delivery-based products that aim to improve drug efficacy, reduce dosing frequency, enhance patient compliance and improve on their quality of life. The drug delivery companies themselves and pharmaceutical companies who partner them are poised to reap the rewards of the estimated $40 billion drug delivery market, which is forecast to grow to $70 billion by 2005.

Developing new and improved pharmaceuticals utilising drug delivery technologies has allowed drug delivery companies to offer viable solutions to pharmaceutical companies' key products which face patent expiration, thus expanding product line shelf-life and sustaining revenue for these best-sellers.

Major multi-national R&D and generics companies are fast recognising the strategic advantages of drug delivery technologies, which can be used to reformulate existing products and protect them, in the case of patented drugs, from generic erosion. Additional indications can also be applied to new formulations, which offer considerable economic advantages over the R&D efforts to bring New Chemical Entities to market.

The drug delivery arena is highly research intensive � in this report alone, the collective product pipeline for drug delivery based products exceeds 350 products across 10 routes of delivery including oral, transmucosal, transdermal, inhalational, carrier/liposomal, injectable/implantable, targeted/site-specific, chronotherapeutic, gene delivery, and ocular delivery.

This report discusses all of these product sectors relative to the global drug delivery market. It also aims to inform the reader on the current status of the global drug delivery industry by discussing current products on the market that utilise drug delivery technologies and products in development that utilise drug delivery technologies. The product-related chapters also discuss technological strengths of marketed products and allow the reader to gain insight into which drugs have the potential to become leading products in their therapeutic class. The report also discusses market values, market divisions, provides forecasts for sub-sectors of the drug delivery market to 2005, and details emerging market opportunities.

In Chapter 1, drug delivery is discussed generally in terms of development and its application to the pharmaceutical industry. It documents the many problems facing drug delivery technologies, including biological barriers that inhibit pharmaceutical development and difficulties in developing drugs to achieve desired pharmacological activity. Additionally, this chapter discusses the factors that influence the development of drug delivery technologies, such as generic competition and patent protection issues. Patent extension strategies through reformulation are also included in Chapter 1, highlighting line extensions that can be achieved through drug delivery technologies.

Innovations in the drug delivery technology arena are discussed in Chapter 2. Routes of delivery are detailed to provide an overview of the advantages and disadvantages of each discrete delivery route. Novel systems are introduced giving an insight into the potential market opportunities that lie ahead. The main areas of focus include oral drug delivery, injectable delivery, transdermal and transmucosal delivery, pulmonary delivery, and drug delivery based gene therapy.

Chapter 3 contains information on marketed pharmaceutical products that incorporate drug delivery systems. Products are categorised by therapeutic area to indicate the intensity of developed products for particular disease states; this also allows the reader to recognise unmet needs in the marketed drug delivery based product market. Products that have benefited from drug delivery technologies are profiled, thus providing an indication of the potentials afforded by innovative delivery systems.

Chapter 4 contains an extensive review of over 100 pipeline drug delivery based products categorised by route of delivery. Selected products are discussed in terms of development through proprietary technologies in addition to potential market opportunities for these products. The products are also sub-divided by therapeutic area to provide the reader with an insight into unmet pharmaceutical needs or research focus for future development strategies.

Drug delivery market data is detailed in Chapter 5. This highlights the differences in market estimations and provides a realistic estimate of the global drug delivery market. The valuations and projections are divided by US, Europe, Asia, and the Rest of the World with estimates to 2005. Also detailed are market estimations by route of delivery. Emerging markets and sub-sectors of the market that are earmarked for high growth are also documented. The chapter also provides and overview of market drivers and market influences on drug delivery development including barriers to entry.