US demand to exceed $251 billion in 2019

US demand for drug delivery products is forecast to grow 6.1 percent annually to $251 billion in 2019. Specialized dosage formulations that improve therapies for autoimmune, cancer, cardiovascular, neurological, viral, and other debilitating disorders will lead gains. Included in this group are human and humanized monoclonal antibodies, polymer-encapsulated medicines, and brachy therapy seeds. Among drug delivery devices, pen injectors and retractable prefillable syringes will record the fastest revenue growth based on safety, infection prevention, and ease-of-use advantages.

Demand for oral drug delivery products will benefit from bio availability and reduced dosing advantages, while controlled-release formulations will continue to dominate revenues. On the downside, patent expirations and generic competition will soften overall growth potential for this product segment.

Prefillable syringes to lead strong gains in parenteral drug delivery

US demand for parenteral drug delivery products is projected to post double-digit gains through 2019. Advances in monoclonal antibodies and polymer-encapsulated medicines will underlie growth. The use of new and existing therapies based on human and humanized monoclonal antibodies will improve the effectiveness of remedies against various forms of cancer and other long-term disorders, such as allergy-linked asthma, Crohn’s disease, rheumatoid and psoriatic arthritis, and wet age-related macular degeneration. Enhanced bioavailability and reduced toxicity advantages will boost applications for polymer-enhanced medicines in the treatment of conditions such as cancer complications, hepatitis B and C, and multiple sclerosis.

Among parenteral delivery devices, prefillable syringes will account for the largest and fastest expanding demand over the long term. Improvements in safety features such as automatic needle retraction, along with overall infection prevention and response time advantages, will benefit growth. Prefillable syringes will also broaden self-use applications based on advances in pen injectors and related apparatus.

Mixed outlook for inhalers

Demand for other drug delivery products is expected to surpass $34 billion in 2019. Dry powder and metered dose inhalers will account for more than three-fourths of revenues, reflecting upward trends in prevalence of asthma and chronic obstructive pulmonary disease (COPD). On the downside, growth prospects for inhalers will weaken gradually as patent expirations make several widely used respiratory therapies — such as ADVAIR, SPIRIVA and SYMBICORT — available to low cost generic competition.

Limited indications and competition from alternative therapies will hold down demand for transdermal drug delivery products. Within this product group, overactive bladder and estrogen replacement therapies will post the fastest revenue growth. Contraceptive inserts will draw the largest and fastest expanding revenues among implantable drug delivery products based on convenience and effectiveness advantages in birth control applications. Brachytherapy implants will also fare well in the marketplace, spurred by increasing use in cervical, prostate, breast, and skin cancer treatment. Im-plantable drug pumps will see moderate growth in demand as improvements in device safety broadens applications in the delivery of pain control and ophthalmic medication. Recent introductions and a rise in heart conditions will foster growth in the market for drug-eluting stents.

Company Profiles

Profiles of nearly 30 competitors in the US industry including AbbVie, Amgen, GlaxoSmithKline, Johnson & Johnson, Becton Dickinson & Roche Holding

Additional Information

This comprehensive study examines the US market for drug delivery products. The discussion covers specialized dosage formats and devices that improve the safety, effectiveness, and/or administration ease of pharmaceutical, biological, and other therapeutic agents. For purposes of analysis, this study divides drug delivery products into three major groups:

• oral (controlled-release, chewable, orally disintegrating, polymerbased, and transmucosal)
• parenteral (monoclonal antibodies, injectors and related devices, nanoparticulate formulations, and premixed IV solutions)
• other (inhalation, transdermal, and implantable)

Unless otherwise indicated, all statistics and forecasts represent demand for drug delivery products stated in current US dollars. The term “demand” is equivalent to “value of consumption” or “manufacturers’ sales” and correlates to the value of domestic production plus imports minus exports. Historical data (2004, 2009, and 2014) and forecasts for 2019 and 2024 are provided for drug delivery products by type and application. It should be noted that the value of demand presented for oral controlled-release and other specialized dosage formats, as well as for implantable products, prefilled inhalers, and premixed IV products, includes the cost of enclosed medication. By contrast, the value of demand presented for prefillable and hypodermic syringes, IV catheters, and related parenteral delivery devices reflects sales of devices without medication.

Table of Contents

Introduction X

I. Executive Summary 1

II. Market Environment 4
General 4
Economic Factors 5
Demographic Patterns 9
Healthcare Trends 12
Health Insurance Reforms 13
Medical Conditions 16
Acute Conditions 16
Chronic Conditions 17
National Health Expenditures 20
Spending Categories 21
Funding Sources 24
Medical Providers 27
Hospitals 28
Outpatient Facilities 29
Physicians 30
Skilled Nursing Homes 30
Patient Activity 31
Hospital Activity 32
Outpatient Activity 33
Surgical Procedures 33
Pharmaceutical Industry Overview 34
Regulation 35
Research & Development 38
Product Demand 38
Therapeutic Groups 39
Dosage Formulations 41
Regulatory Classes 43
Commercial Status 45

III. Drug Delivery Product Overview 49
General 49
Types of Drug Delivery Products 50
Historical Market Trends 53
US Trade 55
International Markets 57

IV. Oral Drug Delivery Products 59
General 59
Controlled-Release Formulations 61
Film-Coated Formulations 65
Diffusion Formulations 68
Reservoir Formulations 70
Chewable Tablets 72
Orally Disintegrating Tablets 74
Nanoparticulate Formulations 77
Transmucosal Formulations 81

V. Parenteral Drug Delivery Products 85
General 85
Therapeutic Monoclonal Antibodies 87
Technology 89
Products 91
HUMIRA (adalimumab) 91
REMICADE (infliximab) 92
RITUXAN (rituximab) 92
AVASTIN (bevacizumab) 92
HERCEPTIN (trastuzumab) 93
LUCENTIS (ranibizumab) 93
STELARA (ustekinumab) 94
XOLAIR (omalizumab) 94
TYSABRI (natalizumab) 95
Other Monoclonal Antibodies 95
New Products 99
Developmental Products 103
Encapsulated Parenteral Formulations 104
Polymer-Protected Formulations 105
PEG-Based Parenteral Therapies 106
Other Polymer-Protected Parenteral Therapies 110
Developmental Activities 111
Liposomes 112
Technology 113
Marketed Products 113
Developmental Activities 116
Infusion Products 117
IV Administration Sets 118
Premixed IV Solutions 120
Infusion Pumps 121
Other Infusion Products 123
Enteral Feeding Supplies 124
IV Accessories 124
Parenteral Devices 125
Prefillable Syringes 126
Injectors 127
Cartridge Systems 129
Hypodermic Syringes 132
IV Catheters 134
Other Parenteral Devices 135

VI. Other Drug Delivery Products 137
General 137
Inhalation Drug Delivery Products 138
Dry Powder Formulations 139
Metered Dose Formulations 142
Transdermal Drug Delivery Products 145
Transdermal Technologies 146
Central Nervous System Agents 148
Hormones & Related Agents 151
Cardiovascular Agents 154
Other Transdermal Patches 154
Implantable Drug Delivery Products 155
Drug Inserts 156
Drug-Eluting Stents 159
Other Implantable Drug Delivery Products 162
Brachytherapy Products 163
Implantable Drug Pumps 165

VII. Applications 168
General 168
Central Nervous System Agents 170
Controlled-Release Formulations 171
Other Oral Drug Delivery Products 173
Transdermal Formulations 174
Monoclonal Antibodies & Polymer Encapsulated Therapies 176
Liposomes 178
Other Drug Delivery Products 178
Hormones & Related Agents 179
Anticancer Monoclonal Antibodies 180
Encapsulated Polymers 185
Liposomes 186
Insulin Pen Injectors 188
Controlled-Release & Other Oral Drug Delivery Products 190
Transdermal Hormones & Related Agents 191
Other Drug Delivery Products 192
Respiratory Agents 194
Dry Powder Inhalers 195
Metered Dose Inhalers 197
Monoclonal Antibodies 199
Anti-Infective Agents 200
Cardiovascular Agents 202
Controlled-Release Formulations 203
Monoclonal Antibodies 204
Drug-Eluting Stents 205
Transdermal Patches 207
Gastrointestinal Agents 207
Nutritional Agents 210
Other Pharmaceuticals 212

VIII. Industry Structure 217
General 217
Market Share 219
Dosage Formulations 219
Devices 220
Competitive Strategies 222
Mergers & Acquisitions 224
Licensing & Related Agreements 227
Marketing & Distribution 233
Manufacturing 234
Company Profiles 235
Abbott Laboratories 236
AbbVie Incorporated 239
Actavis, see Allergan Adare Pharmaceuticals Incorporated 242
Allergan plc 246
Amgen Incorporated 251
Animas, see Johnson & Johnson Aptalis Pharma, see Allergan Aptalis Pharmaceutical Technologies, see Adare Pharmaceuticals AptarGroup Incorporated 255
AstraZeneca plc 258
Baxter International Incorporated 263
Becton, Dickinson, and Company 266
Boehringer Ingelheim GmbH 274
Braun (B.) Melsungen AG 278
Bristol-Myers Squibb Company 281
CareFusion, see Becton, Dickinson Evonik Industries AG 285
Forest Laboratories, see Allergan Genentech, see Roche Holding Genzyme, see Sanofi Gerresheimer AG 288
Gilead Sciences Incorporated 292
GlaxoSmithKline plc 295
Hospira, see Pfizer ImClone Systems, see Lilly (Eli) Janssen Pharmaceuticals, see Johnson & Johnson Johnson & Johnson 300
Lilly (Eli) and Company 306
MedImmune, see AstraZeneca Merck & Company Incorporated 311
Nitto Denko Corporation 316
Novartis AG 319
Novo Nordisk A/S 326
Pfizer Incorporated 330
Regeneron Pharmaceuticals, see Sanofi Roche Holding Limited 339
Sanofi 344
Teva Pharmaceutical Industries Limited 350
3M Company 355
Unilife Corporation 359
Vetter Pharma International GmbH 364
West Pharmaceutical Services Incorporated 366
Additional Companies in the Drug Delivery Product Market 370

List of Tables

Section I -- Executive Summary
Summary Table 3

Section II -- Market Environment
1 Macroeconomic Indicators 9
2 Resident Population by Age Group 12
3 Health Insurance Coverage of the US Population, 2004-2014 15
4 Acute Conditions by Type 17
5 Chronic Conditions by Type 20
6 National Health Expenditures by Spending Category 24
7 National Health Expenditures by Funding Source 27
8 Medical Providers by Type 28
9 Patient Activity by Type 32
10 Pharmaceutical Demand by Therapeutic Class 41
11 Pharmaceutical Demand by Dosage Formulation 43
12 Pharmaceutical Demand by Regulatory Classification 45
13 Pharmaceutical Demand by Patent Status 48

Section III -- Drug Delivery Product Overview
1 Drug Delivery Product Demand by Type 50
2 Drug Delivery Product Demand Patterns, 2004-2014 55
3 US Trade in Drug Delivery Products 56
4 World Drug Delivery Product Demand by Region 58

Section IV -- Oral Drug Delivery Products
1 Oral Drug Delivery Product Demand by Type 61
2 Controlled-Release Oral Drug Delivery Product Demand 64
3 Film-Coated Oral Drug Delivery Product Demand 68
4 Diffusion Oral Drug Delivery Product Demand 70
5 Reservoir Oral Drug Delivery Product Demand 72
6 Chewable Tablet Product Demand by Therapeutic Class 74
7 Orally Disintegrating Tablet Demand by Therapeutic Class 77
8 Oral Nanoparticulate Drug Delivery Product Demand by Therapeutic Class 81
9 Transmucosal Drug Delivery Product Demand by Therapeutic Class 84

Section V -- Parenteral Drug Delivery Products
1 Parenteral Drug Delivery Product Demand by Type 86
2 Therapeutic Monoclonal Antibody Demand by Therapeutic Class 88
3 Encapsulated Parenteral Product Demand by Type & Therapeutic Class 105
4 Infusion Product Demand by Type 118
5 Parenteral Device Demand by Type 126

Section VI -- Other Drug Delivery Products
1 Other Drug Delivery Product Demand by Type 138
2 Inhalation Drug Delivery Product Demand by Type 139
3 Dry Powder Inhaler Demand 142
4 Metered Dose Inhaler Demand 145
5 Transdermal Drug Delivery Product Demand by Therapeutic Class 146
6 Implantable Drug Delivery Product Demand by Type 156
7 Drug Insert Demand by Therapeutic Class 159
8 Drug-Eluting Stent Demand 162
9 Other Implantable Drug Delivery Product Demand by Type 163

Section VII -- Applications
1 Drug Delivery Product Demand by Therapeutic Class 169
2 Central Nervous System Drug Delivery Product Demand by Type 171
3 Hormone & Related Drug Delivery Product Demand by Type 180
4 Respiratory Drug Delivery Product Demand by Type 195
5 Anti-Infective Drug Delivery Product Demand by Type 201
6 Cardiovascular Drug Delivery Product Demand by Type 203
7 Gastrointestinal Drug Delivery Product Demand by Type 210
8 Nutritional Preparation Delivery Product Demand by Type 212
9 Other Application Drug Delivery Product Demand by Type 216

Section VIII -- Industry Structure
1 US Drug Delivery Product Sales by Company, 2014 218
2 Selected Acquisitions & Divestitures 225
3 Selected Cooperative Agreements 228

List of Charts

Section III -- Drug Delivery Product Overview
1 Drug Delivery Product Demand by Type, 2014 52

Section V -- Parenteral Drug Delivery Products
1 Parenteral Drug Delivery Product Demand by Type, 2014 87

Section VII -- Applications
1 Drug Delivery Product Demand by Therapeutic Class, 2014 170

Section VIII -- Industry Structure
1 Drug Delivery Formulations, US Market Share, 2014 220
2 Drug Delivery Devices, US Market Share, 2014 222