Drug Delivery Products Market

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Drug Delivery Products Market

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US demand to rise 7.2% annually through 2015

US demand for drug delivery products is forecast to expand 7.2 percent annually to $133 billion in 2015. The best growth opportunities will emerge in specialized pharmaceutical formulations and administration devices that advance the nature of therapy for autoimmune conditions, cancer, heart disease, neurological disorders and other debilitating health problems. Included in this group are human monoclonal antibodies, polymer encapsulated nanomedicines and transdermal patches for breakthrough pain management. Infusion products and parenteral delivery devices with improved safety, infection prevention and ease-of-use features will also fare well in the marketplace. Among these devices are retractable syringes, needleless injectors, premixed IV systems and smart infusion pumps. Based on the complex nature of therapy and the high frequency of dosing requirements, central nervous system, respiratory and hormonal indications will command the largest and fastest growth by drug delivery products.

Chewable and orally disintegrating tablets to see good growth

Demand for oral drug delivery products will increase 4.3 percent annually to over $52 billion in 2015. Controlled-release formulations will command the largest share of sales, but will lose some growth momentum due to patent expirations on several large-selling sustained-release therapies. Chewable and orally disintegrating tablets, nanoparticulate medicines and transmucosal therapies will realize faster growth in demand spurred by new product introductions and the high valueadded nature of indications served.

Monoclonal antibodies to pace parenteral products

Demand for parenteral drug delivery products will reach $54.7 billion in 2015, up eleven percent annually from 2015. Monoclonal antibodies will lead gains as advances in biotechnologies contribute new and improved therapies for autoimmune disorders, cancer and various rate debilitating diseases. Polymer-encapsulated medicines will also see fast rising demand based on contributions to the improved bioavailality and reduced toxicity of advanced parenteral compounds. Safety-engineered prefillable syringes and IV catheters, along with bag/ vial infusion systems, will command the best growth opportunities among parenteral infusion products and delivery devices due largely to infection prevention advantages.

Patches to lead gains among other drug delivery systems

Other drug delivery products will post demand of $26.1 billion in 2015, up 6.6 percent annually from 2010. Prefilled dry powder and metered dose inhalers will retain the largest share of sales, spurred largely upward trends in prevalence of asthma and chronic obstructive pulmonary disease (COPD). Less favorably, growth opportunities for these devices will decelerate as patent expirations open up several widely prescribed inhalation therapies, including sales leader ADVAIR, to generic competition. Led by new next-generation drug-eluting stents with thinner struts and enhanced safety profiles, implantable drug delivery systems will generate rebounding demand in angioplasty procedures, reversing a recent sharp sales drop. Transdermal patches will realize the fastest growth among other drug delivery systems as new therapies for breakthrough pain and various central nervous system disorders replace less effective oral medicines.

Study coverage

This upcoming industry study, Drug Delivery Systems, presents historical demand data (2000, 2005, 2010) plus forecasts for 2015 and 2020 by material, application and type. The study also considers market environment factors, assesses industry structure, evaluates company market share and profiles industry players.

TABLE OF CONTENTS INTRODUCTION xi I. EXECUTIVE SUMMARY 1 II. MARKET ENVIRONMENT 4

General 4Economic Factors 5Demographic Patterns 8Health Care Trends 11Health Insurance 12Medical Conditions 14Acute Conditions 15Chronic Conditions 16National Health Expenditures 19Medical Providers 22Hospitals 23Skilled Nursing Homes 23Outpatient Facilities 23Physicians 24Patient Activity 24Hospital Activity 26Surgical Procedures 26Outpatient Consultations 26Pharmaceutical Market Overview 28Regulation 29Research & Development 30Demand Patterns 32Therapeutic Classes 32Dosage Formulations 34Distribution Classification 37Commercial Status 38

III. DRUG DELIVERY EXCIPIENTS 42

General 42Polymers 43Polyethylene Glycol 44Acrylic Polymers 46Carbomers 46Methacrylate Copolymers 47Polyethylene Oxide 48Polyvinyl Alcohol 49Other Synthetic Polymers 49Cellulose Excipients 50Ethyl Cellulose 51Hydroxypropyl Methylcellulose (HPMC) 52Other Cellulose Excipients 53Minerals 54Mineral Hydrocarbons 55Petrolatum 55Mineral Oil 56Waxes 57Other Minerals 57Attapulgite 57Calcium Carbonate 58Calcium Silicate 59Electrolytes 59Other Excipients 59Sterile & Purified Waters 60Starch Compounds 62Cyclodextrins 62Dextrates 62Dextrin 63Maltodextrin 63Sugars & Polyols 63Sucrose 63Sorbitol 64Lactose 65Mannitol 65Natural Gums 66All Other Excipients 66

IV. DRUG DELIVERY PRODUCTS OVERVIEW 68

General 68Types of Drug Delivery Products 70Historical Market Trends 72Regulation 75Research & Development 76US Trade 77International Markets 78

V. ORAL DRUG DELIVERY PRODUCTS 81

General 81Controlled-Release Formulations 83Coated Products 86Diffusion Products 89Reservoir Products 91Chewable Tablets 93Nanoparticulate Formulations 96Orally Disintegrating Tablets (ODT) 99Transmucosal Formulations 101

VI. PARENTERAL DRUG DELIVERY PRODUCTS 105

General 105Therapeutic Monoclonal Antibodies 107Types of Monoclonal Antibodies 109Marketed Products 111Therapeutic Monoclonal Antibodies in Development 130Encapsulated Parenteral Drug Delivery Products 135Polymer-Protected Products 136PEG-Based Parenteral Therapies 137Other Polymer-Protected Parenteral Therapies 140Developmental Activities 141Liposomes 143Marketed Products 144Developmental Activities 145Infusion Products 146IV Administration Sets 147Premixed IV Solutions 149Infusion Pumps 150Other Infusion Products 152Enteral Feeding Supplies 152IV Accessories 153Parenteral Drug Delivery Devices 154Prefillable Syringes 155Injectors 155Cartridges 157

Hypodermic Syringes 160

IV Catheters 161

Other Parenteral Delivery Devices 163 VII. OTHER DRUG DELIVERY PRODUCTS 165

General 165Inhalation Drug Delivery Products 167Dry Powder Formulations 168Types of DPIs 170Developmental Activities 171Metered Dose Formulations 1723M Drug Delivery Systems 173Other Producers 174Implantable Drug Delivery Products 176Drug-Eluting Stents 177Other Implantable Drug Delivery Products 181Drug Inserts 182Brachytherapy 183Drug Pumps 186Transdermal Drug Delivery Products 187Transdermal Technologies 189Central Nervous System Agents 190Other Transdermal Therapies 193Hormones & Related Agents 193OXYTROL 195Cardiovascular Agents 195Nicotine Patches 196Scopolamine 197

VIII. APPLICATIONS 198

General 198Central Nervous System Agents 200Respiratory Agents 203Hormones & Related Agents 206Gastrointestinal Agents 211Cardiovascular Agents 213Anti-Infective Agents 217Nutritional Agents 219Genito-Urinary Agents 221Other Pharmaceuticals 223

IX. INDUSTRY STRUCTURE 227

General 227Market Share 230Competitive Strategies 232Mergers & Acquisitions 234Licensing & Related Agreements 238Marketing & Distribution 244Manufacturing 245Company Profiles 247Abbott Laboratories 248Amgen Incorporated 251Aptalis Pharma Incorporated 254AptarGroup Incorporated 258AstraZeneca plc 261Aveva Drug Delivery Systems, see Nitto DenkoAxcan Intermediate Holdings, see Aptalis PharmaBaxa, see Baxter InternationalBaxter International Incorporated 265Becton, Dickinson and Company 268Boehringer Ingelheim GmbH 273Boston Scientific Corporation 276Braun (B.) Melsungen AG 277Bristol-Myers Squibb Company 280Cephalon, see Teva Pharmaceutical IndustriesConor Medsystems, see Johnson & JohnsonCordis, see Johnson & JohnsonEurand, see Aptalis PharmaEvonik Industries AG 283Facet Biotech, see Abbott LaboratoriesGenentech, see Roche HoldingGenzyme, see Sanofi-AventisGlaxoSmithKline plc 286Hospira Incorporated 290ImClone Systems, see Lilly (Eli)Janssen Pharmaceuticals, see Johnson & JohnsonJohnson & Johnson 295Lilly (Eli) and Company 300Medingo, see Roche HoldingMerck & Company Incorporated 303Nitto Denko Corporation 307Novartis AG 310Novo Nordisk A/S 314Ortho-McNeil-Janssen Pharmaceuticals, see Johnson &JohnsonPfizer Incorporated 316Roche Holding Limited 318Sanofi-Aventis 322Teva Pharmaceutical Industries Limited 3263M Company 329Unilife Corporation 332West Pharmaceutical Services Incorporated 335

LIST OF TABLES

SECTION I -- EXECUTIVE SUMMARY Summary Table 3 SECTION II -- MARKET ENVIRONMENT

2 Population by Age Group 11

3 Health Insurance Coverage of the US Population 14

4 Acute Conditions by Type 16

5 Chronic Conditions by Type 19

6 National Health Expenditures by Type 21

7 Medical Providers by Type 22

8 Patient Activity by Type & Volume 25

9 Pharmaceutical Demand by Therapeutic Class 34

10 Pharmaceutical Demand by Dosage Formulation 36

11 Pharmaceutical Demand by Distribution Classification 38

12 Pharmaceutical Demand by Commercial Status 39

SECTION III -- DRUG DELIVERY EXCIPIENTS

2 Polymer Drug Delivery Excipient Demand by Type 44

3 Cellulose Drug Delivery Excipient Demand by Type 51

4 Mineral Drug Delivery Excipient Demand by Type 55

5 Other Drug Delivery Excipient Demand by Type 60

SECTION IV -- DRUG DELIVERY PRODUCTS OVERVIEW

2 Drug Delivery Product Demand, 2000-2010 75

3 US Trade in Drug Delivery Products 78

4 World Drug Delivery Product Demand by Region 80

SECTION V -- ORAL DRUG DELIVERY PRODUCTS

2 Oral Controlled-Release Drug Delivery Product Demand

by Type, Mode of Action & Application 85

3 Oral Coated Drug Delivery Product Demand 89

4 Oral Diffusion Drug Delivery Product Demand 91

5 Oral Reservoir Drug Delivery Product Demand 93

6 Chewable Tablet Demand by Therapeutic Class 95

7 Oral Nanoparticulate Product Demand by Application 98

8 Orally Disintegrating Tablet (ODT) Demand by Application 101

9 Transmucosal Product Demand 104

SECTION VI -- PARENTERAL DRUG DELIVERY PRODUCTS

2 Therapeutic Monoclonal Antibody Demand by Application 109

3 Therapeutic Monoclonal Antibodies Approved for US Sale 113

4 Encapsulated Parenteral Product Demand by Type

& Application 136

5 Infusion Product Demand by Type 147

6 Parenteral Delivery Device Demand by Type 154

SECTION VII -- OTHER DRUG DELIVERY PRODUCTS

2 Inhalation Drug Delivery Product Demand by Type 168

3 Dry Powder Inhaler (DPI) Product Demand 170

4 Metered Dose Inhaler (MDI) Product Demand 173

5 Implantable Drug Delivery Product Demand by Type

& Application 177

6 Drug-Eluting Stent Demand 180

7 Other Implantable Drug Delivery Product Demand by Type 181

8 Transdermal Product Demand by Application 189

SECTION VIII -- APPLICATIONS

2 Central Nervous System (CNS) Drug Delivery Product

Demand by Type 203

3 Respiratory Drug Delivery Product Demand by Type 206

4 Hormone & Related Drug Delivery Product Demand by Type 211

5 Gastrointestinal Drug Delivery Product Demand by Type 213

6 Cardiovascular Drug Delivery Product Demand by Type 217

7 Anti-Infective Drug Delivery Product Demand by Type 219

8 Nutritional Drug Delivery Product Demand by Type 221

9 Genito-Urinary Drug Delivery Product Demand by Type 223

10 Drug Delivery Product Demand in Other Pharmaceuticals

by Type 226

SECTION IX -- INDUSTRY STRUCTURE

2 Selected Acquisitions & Divestitures 236

3 Selected Cooperative Agreements 240

LIST OF CHARTS SECTION IV -- DRUG DELIVERY PRODUCTS OVERVIEW

SECTION V -- ORAL DRUG DELIVERY PRODUCTS

1 Oral Drug Delivery Product Demand by Type, 2010 83

2 Oral Controlled-Release Drug Delivery Product Demand

by Type, 2010 86

SECTION VI -- PARENTERAL DRUG DELIVERY PRODUCTS

1 Parenteral Drug Delivery Product Demand by Type, 2010 107

SECTION VII -- OTHER DRUG DELIVERY PRODUCTS

1 Other Drug Delivery Product Demand by Type, 2010 167

SECTION VIII -- APPLICATIONS

1 Drug Delivery Product Demand by Application, 2010 200

SECTION IX -- INDUSTRY STRUCTURE

1 Drug Delivery Dosage Formulations, US Market Share, 2010 231

2 Drug Delivery Devices, US Market Share, 2010 232

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