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The Global Market for Pain Management Drugs and Devices

  • September 2015
  • -
  • BCC Research
  • -
  • 243 pages

This study focuses on the market for pain management, consisting of drugs and devices. It provides an overview of products included in this market, and detailed analyses of markets and competitive environments. The study includes information about significant products, players, issues and trends, regulatory issues and other information affecting the pain management industry.

REPORT HIGHLIGHTS

Market for global pain management pharmaceuticals and devices by revenue at manufacturers’ sales levels is projected to grow from $36.6 billion in 2014 to nearly $37.8 billion in 2015 and $44.3 billion in 2020, with a compound annual growth rate (CAGR) of 3.2% between 2015 and 2020.

This report provides:

- An overview of the global market for pain management drugs, which will address acute vs. chronic pain, treatments, and issues facing healthcare workers.
- Analyses of global market trends, with data from 2013 and 2014; estimates for 2015, and projections of CAGRs through 2020.
- Examination of product categories, use of products, and the competitive landscape.
- Coverage of several significant market trends, including undertreatment issues, professional issues, managed care pain issues, trends in new therapies, product pipelines, generic participation, pain research, drug delivery, and patent expirations.
- Discussion of new regulatory requirements.
- Comprehensive company profiles of major players in the industry.

SCOPE AND FORMAT

This BCC Research report is designed to be a helpful business tool that will provide a thorough evaluation of the markets for pain management. The geographical scope of this study is global. This study will address acute versus chronic pain, treatments and regulatory issues facing healthcare workers. Also provided is detailed information based on product categories, use of products, forecasts and competitive analyses.
The report identifies two general segments of pain management:
- Pharmaceuticals
- Devices.
Within the pharmaceuticals segment several sub-segments are discussed in detail, including:
- Narcotic pain management.
- Non-narcotic pain management.
- Antimigraine treatments.
- Anesthetics.
- Other drugs (including fibromyalgia treatments).

The device segment covers several product lines and specifically targets the largest product segments including:

- Electrotherapy stimulators.
- Spine stimulators.
- Other products (including electromagnetic therapies and other treatments).

For each market segment detailed information is provided based on product categories, product use, forecasts and competitive analyses.

Table Of Contents

The Global Market for Pain Management Drugs and Devices
CHAPTER 1 INTRODUCTION 2
STUDY GOALS AND OBJECTIVES 2
REASONS FOR DOING THE STUDY AND INTENDED AUDIENCE 2
SCOPE AND FORMAT 2
METHODOLOGY AND SOURCES OF INFORMATION 3
ANALYST'S CREDENTIALS 3
RELATED BCC RESEARCH REPORTS 3
BCC RESEARCH WEBSITE 4
DISCLAIMER 4
CHAPTER 2 SUMMARY 6
OVERVIEW 6
GENERAL PAIN TERMINOLOGY 6
MAJOR MARKETS SUMMARY 7
SUMMARY TABLE MARKET FOR GLOBAL PAIN MANAGEMENT PHARMACEUTICALS
AND DEVICES BY REVENUE AT MANUFACTURERS' SALES LEVELS, THROUGH 2020
($ MILLIONS)8
SUMMARY FIGURE MARKET FOR GLOBAL PAIN MANAGEMENT PHARMACEUTICALS
AND DEVICES BY REVENUE AT MANUFACTURERS' SALES LEVELS, 2012-2020 ($
MILLIONS)8
MARKET TRENDS 9
UNDERTREATMENT ISSUES 9
PROFESSIONAL PAIN TREATMENT ISSUES 9
ACCESS TO CARE 9
FDA APPROVAL REQUIREMENTS FOR PAIN THERAPIES 10
DRUG DELIVERY SYSTEMS 10
CHAPTER 3 INDUSTRY OVERVIEW 12
HISTORY OF PAIN AND PAIN TREATMENT 12
THE PERCEPTION OF PAIN 13
Types of Pain 13
Acute Pain 14
Chronic Pain 14
ASSESSMENT OF PAIN 14
Subjective 14
Objective 15
TABLE 1 OBJECTIVE SIGNS OF PAIN 15
HOW PAIN IS DIAGNOSED 15
HOW PAIN IS TREATED 16
FIGURE 1 PAIN-MANAGEMENT TECHNIQUES 16
DEMOGRAPHICS AND AGING POPULATIONS 21
Global Demographic Overview 21
TABLE 2 GLOBAL POPULATION BY SELECTED COUNTRY, THROUGH 2015 (MILLIONS) 22
FIGURE 2 GLOBAL POPULATION BY SELECTED COUNTRY, 2010 AND 2015
(MILLIONS) 22
The Aging Population 23
TABLE 3 ESTIMATED GLOBAL POPULATION BY SELECTED AGE GROUP AND
SELECTED YEARS, THROUGH 2030 (MILLIONS) 24
FIGURE 3 ESTIMATED GLOBAL POPULATION BY SELECTED AGE GROUP AND
SELECTED YEARS, 2000-2030 (MILLIONS) 24
Global Life Expectancy 25
TABLE 4 GLOBAL LIFE EXPECTANCY AT BIRTH BY SELECTED COUNTRY, 1980-2015
(YEARS) 25
FIGURE 4 GLOBAL LIFE EXPECTANCY AT BIRTH BY SELECTED COUNTRY, 1980-2015
(YEARS) 25
THE NEED FOR PAIN MANAGEMENT 26
Developments in Treating Neuropathic Pain 26
MIGRAINE HEADACHE PAIN MANAGEMENT 27
CANCER PAIN MANAGEMENT 28
Pain Management in Cancer 29
FIGURE 5 CAUSES OF CANCER PAIN 29
TABLE 5 CANCER PAIN MEDICATIONS 30
Developments in Breakthrough Cancer Pain 31
ORTHOPEDIC PAIN MANAGEMENT 31
Osteoarthritis 32
Rheumatoid Arthritis 32
Ankylosing Spondylitis 32
Fibromyalgia 33
Gout 33
Scleroderma 33
Lupus 33
Bursitis and Tendonitis 33
TABLE 6 ESTIMATED* PREVALENCE/INCIDENCE OF ORTHOPEDIC CONDITIONS BY
COUNTRY, AVERAGE FIGURE, 2010-2013 (MILLIONS) 34
FIGURE 6 ESTIMATED* PREVALENCE/INCIDENCE OF ORTHOPEDIC CONDITIONS BY
COUNTRY, AVERAGE FIGURE 2010-2013 (MILLIONS) 34
HIV/AIDS RELATED PAIN 35
BURN PAIN 35
Stages of Burn Healing 36
Challenges Associated with Burn Pain 37
Burn Pain Management 38
FIGURE 7 APPROACH TO BURN PAIN MANAGEMENT 38
DENTAL PAIN 39
Treatment for Dental Pain 39
OBSTETRICS PAIN 39
TABLE 7 BIRTH RATES AND BIRTHS BY COUNTRY, 2015 (THOUSANDS) 40
FIGURE 8 BIRTH RATES AND BIRTHS BY COUNTRY, 2015 (THOUSANDS) 40
SURGICAL PAIN 41
GENDER AND PAIN 42
TABLE 8 PEOPLE WHO REPORTED PAIN BY SELECTED CATEGORY AND GENDER IN
THE 18+ U.S. POPULATION*, 1997-2010 (THOUSANDS) 42
OTHER INFLUENCES DETERMINING HOW PAIN IS FELT AMONG
INDIVIDUALS 42
Objective Pain Measurement 43
PEDIATRIC PAIN 43
CHAPTER 4 INDUSTRY TRENDS 46
OVERVIEW 46
UNDERTREATMENT ISSUES 46
PAIN IN OLDER PATIENTS 46
PAIN IN YOUNGER PATIENTS 48
TREATMENT OF PAIN AND ISSUES FACING THE PROFESSIONAL SEGMENT 48
TABLE 9 AVAILABILITY OF EDUCATION IN PAIN MANAGEMENT BY SELECT
REGION/COUNTRY 51
PRESCRIPTION DRUG MONITORING PROGRAMS 52
TABLE 10 NUMBER OF AGENCIES RESPONSIBLE FOR PDMP IN EACH STATE, BY
TYPE 52
TABLE 11 BENEFITS OF PRESCRIPTION MONITORING PROGRAMS FOR MEDICAL
BOARDS 53
TABLE 12 DRUGS MONITORED BY PDMPS 53
TABLE 13 STATES WITH ELECTRONIC PRESCRIPTION MONITORING PROGRAMS 54
FIGURE 9 NUMBER OF STATES WITH ELECTRONIC PRESCRIPTION MONITORING
PROGRAMS BY YEAR OF ENACTMENT 55
TABLE 14 NURSE CONTINUING EDUCATION REQUIREMENTS FOR PAIN
MANAGEMENT BY REQUIRING STATE 57
ACCESS TO CARE 58
ACCESS TO PALLIATIVE CARE 58
Assessing the Need for Palliative Care 59
FIGURE 10 NUMBER OF DEATHS, BY CAUSES OF MORTALITY AND POTENTIAL NEED
FOR PALLIATIVE CARE (MILLIONS) 59
AVAILABILITY OF MEDICATIONS 61
TABLE 15 WHO ESSENTIAL MEDICINES LIST (ADULTS) FOR PAIN MANAGEMENT 61
TABLE 16 AVAILABILITY OF INJECTABLE MORPHINE BY REGION 62
TABLE 17 AVAILABILITY OF ORAL MORPHINE IN HOSPICE-TYPE SETTINGS, BY
REGION 64
International Narcotics Control Board and Obstacles to Availability 65
FIGURE 11 FACTORS AFFECTING AVAILABILITY OF OPIOIDS FOR MEDICAL NEEDS,
2010 65
GOVERNMENT INTERVENTION 66
Drug Supply 66
FDA Drug Shortages for Pain Therapies 66
TABLE 18 FDA ANALGESIA DRUG SHORTAGES BY REPORTING COMPANY, JULY 2015 66
Single Convention on Narcotic Drugs 79
Government Subsidies 80
PREVENTING OPIOID-INDUCED CONSTIPATION AND REDUCED COMPLIANCE 80
PUBLIC HEALTHCARE SYSTEMS AROUND THE WORLD 81
TABLE 19 WORLD HEALTH ORGANIZATION TOP 50 RANKING OF HEALTHCARE
SYSTEMS, 2000 81
RISING HEALTHCARE COSTS 83
TABLE 20 HEALTH EXPENDITURES AS PERCENTAGE OF GDP BY COUNTRY,
1980-2015 (%) 83
FIGURE 12 HEALTH EXPENDITURES AS PERCENT OF GDP BY COUNTRY, 1980-2015
(%) 83
AVERAGE LENGTH OF STAY 84
MANAGED CARE PAIN MANAGEMENT ISSUES 84
FDA APPROVAL REQUIREMENTS FOR PAIN THERAPIES 85
FDA APPROVAL REQUIREMENTS FOR PAIN DEVICES 86
510(K) EXEMPTIONS 87
TABLE 21 PARTS 862-892 OF 21 CFR 87
RISK EVALUATION AND MITIGATION STRATEGY (REMS) 88
TABLE 22 LIST OF EXTENDED-RELEASE AND LONG-ACTING OPIOID BRAND-NAME
PRODUCTS REQUIRED TO HAVE AN OPIOID REMS, MAY 2015 89
TABLE 23 LIST OF EXTENDED-RELEASE AND LONG-ACTING OPIOID GENERIC
PRODUCTS REQUIRED TO HAVE AN OPIOID REMS, MAY 2015 89
TABLE 24 TRANSMUCOSAL IMMEDIATE-RELEASE FENTANYL PRODUCTS REQUIRED
TO HAVE TIRF REMS ACCESS PROGRAM 91
ACETAMINOPHEN AND FDA CHANGES 91
TABLE 25 MARKETED ACETAMINOPHEN-CONTAINING PRESCRIPTION PRODUCTS 92
CODEINE IN COUGH AND COLD MEDICATIONS 95
NON-ASPIRIN NSAIDS LINKED TO INCREASED RISK OF HEART ATTACK OR
STROKE 95
TABLE 26 NON-ASPIRIN NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) 96
DRUG DELIVERY SYSTEMS 96
ORAL AND EXTENDED RELEASE 97
TOPICAL AND TRANSDERMAL 97
INTRAVENOUS 97
INTRANASAL 97
PATIENT-CONTROLLED ANALGESIA 98
IONTOPHORESIS 98
TABLE 27 ADVANTAGES AND DISADVANTAGES OF IONTOPHORETIC DRUG
DELIVERY 98
ELECTROMECHANICAL TRANSPORT 99
CHAPTER 5 TREATING PAIN 101
OVERVIEW 101
PHARMACEUTICAL PAIN MANAGEMENT 101
PRESCRIPTION PAIN MANAGEMENT PRODUCTS 101
TABLE 28 RECENT FDA APPLICATIONS/APPROVALS, JANUARY 2010-JULY 2015 101
Analgesic Drugs 104
Non-Narcotics 104
Narcotics 105
Full and Partial Agonists 107
Agonist-Antagonists 107
Nonsteroid Anti-inflammatory Drugs 109
Antimigraine Drugs 110
Antidepressant, Anticonvulsants and Other Pain Relieving Drugs 111
Anesthetics 111
General Anesthesia 112
TABLE 29 MOST COMMONLY USED GENERAL ANESTHETIC AGENTS 112
Local/Regional 113
Topical 113
OVER-THE-COUNTER PAIN MANAGEMENT PRODUCTS: OVERVIEW 114
ANALGESIC DRUGS 114
TABLE 30 OTC ACETAMINOPHEN AND ACETAMINOPHEN COMBINATION PRODUCTS 114
NONSTEROID ANTI-INFLAMMATORY DRUGS 115
Aspirin Products and Aspirin Combination Products 116
TABLE 31 OTC ASPIRIN AND ASPIRIN COMBINATION PRODUCTS 116
Ibuprofen and Ibuprofen Combination Products 116
TABLE 32 OTC IBUPROFEN AND IBUPROFEN COMBINATION PRODUCTS 116
Ketoprofen Products 117
TABLE 33 OTC KETOPROFEN PRODUCTS 117
Naproxen Compounds 117
TABLE 34 OTC NONSTEROID ANTI-INFLAMMATORIES 117
ANTIMIGRAINE DRUGS 118
TABLE 35 OTC ANTIMIGRAINE PRODUCTS 118
TOPICAL ANESTHETIC DRUGS 118
TABLE 36 OTC TOPICAL ANESTHETIC PRODUCTS 118
PAIN MANAGEMENT DEVICES 119
STIMULATION THERAPY 119
Electrotherapy 119
Neuromuscular Stimulators 121
Pain TEM 122
Spine Stimulation 122
COMBINATION PAIN MANAGEMENT DEVICES 124
LASER DEVICES 124
ELECTROMAGNETIC THERAPY DEVICES 124
INTRATHECAL DEVICES 125
OTHER PAIN DEVICES AND METHODS 125
PAIN MANAGEMENT PROCEDURES: STEROIDS, ENDOSCOPY AND FLUOROSCOPY 126
ALTERNATIVE METHODS OF PAIN MANAGEMENT 127
PHYSICAL PAIN TREATMENT MODALITIES 128
Acupuncture/Acupressure 128
Ice (Cryotherapy) 130
Joint Mobilization 130
Manipulation 130
Massage 130
Traction 130
Radiation Therapy 131
Radio Frequency Neuroablation, Epiduroscopy 131
Surgery 132
Whirlpool Bath (Thermotherapy) 132
PSYCHOLOGICAL PAIN THERAPIES 132
Biofeedback 133
Hypnosis 133
Behavior Modification/Operant Conditioning 134
Relaxation and Stress Management Training 134
Imagery 135
Autogenic Training 135
Psychosocial Interventions 135
Distraction and Reframing 135
TRACKING THE DEVELOPMENT OF COMPLEMENTARY AND ALTERNATIVE
PAIN CONTROL METHODS 136
TABLE 37 ADULTS 18 YEARS AND OVER IN THE U.S. WHO USED COMPLEMENTARY
AND ALTERNATIVE MEDICINE (CAM) IN THE PAST 12 MONTHS BY THERAPY TYPE,
2002-2015 (THOUSANDS)
136
FIGURE 13 ADULTS 18 YEARS AND OVER IN THE U.S. WHO USED COMPLEMENTARY
AND ALTERNATIVE MEDICINE (CAM) IN THE PAST 12 MONTHS BY THERAPY TYPE,
2002-2015 (THOUSANDS)
137
PAIN MANAGEMENT SERVICES AND ORGANIZATIONS 138
HOME CARE 138
HOSPICE 139
FIGURE 14 NUMBER OF HOSPICE PATIENTS SERVED BY YEAR, 2009-2013 139
TABLE 38 STATISTICS FOR HOSPICE PATIENTS BY CHARACTERISTIC, 2009-2013 (%) 140
FIGURE 15 PERCENTAGE OF HOSPICE PATIENTS BY GENDER, 2009-2013 (%) 141
FIGURE 16 PERCENTAGE OF HOSPICE PATIENTS BY AGE GROUP, 2009-2013 (%) 141
TABLE 39 STATISTICS OF HOSPICE PATIENTS BY PRIMARY DIAGNOSIS
(THOUSAND/%) 142
FIGURE 17 PERCENTAGE OF HOSPICE PATIENTS BY PRIMARY DIAGNOSIS,
2009-2013 (%) 143
NATIONAL HOSPICE AND PALLIATIVE CARE ORGANIZATION 144
TABLE 40 NHPCO COMMITTEES 144
HOSPITALS 145
TABLE 41 NUMBER OF REGISTERED HOSPITALS BY COUNTRY, 2010 145
TABLE 42 NUMBER OF REGISTERED U.S. HOSPITALS BY TYPE, 2013 146
Hospital Departments 146
Emergency Rooms 146
Critical Care Units 147
PAIN CLINICS 147
TABLE 43 NUMBER OF REGISTERED PAIN CLINICS IN THE U.S. BY STATE, 2015 148
TABLE 44 NUMBER OF REGISTERED PAIN CLINICS, BY COUNTRY 149
SKILLED NURSING FACILITIES 150
CHAPTER 6 PHARMACEUTICAL PAIN MANAGEMENT MARKET SIZE AND ANALYSIS 152
TOTAL MARKET 152
PRESCRIPTION PAIN MARKETS BY PRODUCT TYPE 152
TABLE 45 MARKET FOR GLOBAL PRESCRIPTION PAIN MANAGEMENT
PHARMACEUTICALS AT MANUFACTURERS' SALES LEVELS BY CATEGORY, THROUGH
2020 ($ MILLIONS)
153
FIGURE 18 MARKET FOR GLOBAL PRESCRIPTION PAIN MANAGEMENT
PHARMACEUTICALS AT MANUFACTURERS' SALES LEVELS BY CATEGORY,
2012-2020 ($ MILLIONS)
153
NARCOTIC ANALGESICS 154
TABLE 46 GLOBAL MARKET FOR NARCOTIC ANALGESICS BY REGION, THROUGH
2020 ($ MILLIONS) 154
FIGURE 19 GLOBAL MARKET FOR NARCOTIC ANALGESICS BY REGION, 2012-2020
($ MILLIONS) 154
NON-NARCOTIC ANALGESICS 155
TABLE 47 GLOBAL MARKET FOR NON-NARCOTIC ANALGESICS BY REGION,
THROUGH 2020 ($ MILLIONS) 156
FIGURE 20 GLOBAL MARKET FOR NON-NARCOTIC ANALGESICS BY REGION,
2012-2020 ($ MILLIONS) 156
ANTIMIGRAINE AGENTS 156
TABLE 48 GLOBAL MARKET FOR ANTIMIGRAINE AGENTS BY REGION, THROUGH
2020 ($ MILLIONS) 157
FIGURE 21 GLOBAL MARKET FOR ANTIMIGRAINE AGENTS BY REGION, 2012-2020
($ MILLIONS) 157
ANESTHETICS 158
TABLE 49 GLOBAL MARKET FOR ANESTHETICS BY REGION, THROUGH 2020 ($
MILLIONS) 158
FIGURE 22 GLOBAL MARKET FOR ANESTHETICS BY REGION, 2012-2020 ($
MILLIONS) 158
OTHER DRUG CLASSES 159
TABLE 50 GLOBAL MARKET FOR OTHER CNS ANALGESICS BY REGION, THROUGH
2020 ($ MILLIONS) 159
FIGURE 23 GLOBAL MARKET FOR OTHER CNS ANALGESICS BY REGION, 2012-2020
($ MILLIONS) 160
MARKET PARTICIPANTS 160
NARCOTIC/NON-NARCOTIC MARKET SHARE 160
TABLE 51 GLOBAL MARKET FOR PRESCRIPTION NARCOTIC AND NON-NARCOTIC BY
MANUFACTURER, 2015 ($ MILLIONS/%) 161
FIGURE 24 GLOBAL MARKET FOR PRESCRIPTION NARCOTIC AND NON-NARCOTIC
BY MANUFACTURER, 2015 ($ MILLIONS) 161
MIGRAINE TREATMENT MARKET SHARE 161
TABLE 52 GLOBAL MARKET FOR PRESCRIPTION ANTIMIGRAINE DRUG BY
MANUFACTURER, 2015 ($ MILLIONS/%) 162
FIGURE 25 GLOBAL MARKET FOR PRESCRIPTION ANTIMIGRAINE DRUG BY
MANUFACTURER, 2015 (%) 163
ANESTHETIC MARKET SHARE 163
TABLE 53 GLOBAL MARKET FOR PRESCRIPTION ANESTHETIC BY MANUFACTURER,
2015 ($ MILLIONS/%) 163
FIGURE 26 GLOBAL MARKET FOR PRESCRIPTION ANESTHETIC BY MANUFACTURER,
2015 (%) 163
FUTURE MARKET ANALYSIS 164
CHAPTER 7 PAIN MANAGEMENT DEVICE MARKET SIZE AND ANALYSIS 166
INTRODUCTION 166
TOTAL PAIN MANAGEMENT DEVICE MARKET 166
FIGURE 27 GLOBAL PAIN MANAGEMENT DEVICE MARKET AT MANUFACTURERS'
SALES LEVELS, 2012-2020 ($ MILLIONS) 166
PAIN MARKETS BY PRODUCT TYPE 167
ELECTROTHERAPY 167
SPINE STIMULATORS 167
OTHER PAIN TREATMENT DEVICES 168
TABLE 54 GLOBAL PAIN MANAGEMENT DEVICE MARKET AT MANUFACTURERS'
SALES LEVELS BY PRODUCT TYPE, THROUGH 2020 ($ MILLIONS) 168
FIGURE 28 GLOBAL PAIN MANAGEMENT DEVICE MARKET BY PRODUCT TYPE,
2012-2020 ($ MILLIONS) 168
TABLE 55 GLOBAL MARKET FOR PAIN MANAGEMENT DEVICES BY REGION,
THROUGH 2020 ($ MILLIONS) 169
FIGURE 29 GLOBAL MARKET FOR PAIN MANAGEMENT DEVICES BY REGION,
2012-2020 ($ MILLIONS) 169
MARKET PARTICIPANTS 169
TABLE 56 GLOBAL MARKET FOR NEUROMUSCULAR
STIMULATOR/ELECTROTHERAPY DEVICES BY MANUFACTURER, 2015 ($
MILLIONS/%)
170
FIGURE 30 GLOBAL MARKET SHARE FOR NEUROMUSCULAR
STIMULATOR/ELECTROTHERAPY DEVICES BY MANUFACTURER, 2015 (%) 170
TABLE 57 GLOBAL MARKET FOR SPINE STIMULATORS BY MANUFACTURER, 2015 ($
MILLIONS/%) 171
FIGURE 31 GLOBAL MARKET SHARE FOR SPINE CORD STIMULATORS BY
MANUFACTURER, 2015 (%) 171
FUTURE MARKET ANALYSIS 171
CHAPTER 8 TOTAL MARKET SUMMARY 173
TOTAL PAIN MANAGEMENT MARKET 173
TABLE 58 GLOBAL MARKET FOR PAIN MANAGEMENT PHARMACEUTICALS AND
DEVICES BY REVENUE AT MANUFACTURERS' SALES LEVELS, THROUGH 2020 ($
MILLIONS)
173
FIGURE 32 GLOBAL MARKET FOR PAIN MANAGEMENT PHARMACEUTICALS AND
DEVICES BY REVENUE AT MANUFACTURERS' SALES LEVELS, 2012-2020 ($
MILLIONS)
173
MARKET PERCENTAGE BY PRODUCT TYPE 174
TABLE 59 GLOBAL PAIN MANAGEMENT MARKET BY SEGMENT, 2015 ($ MILLIONS/%) 174
FIGURE 33 GLOBAL PAIN MANAGEMENT MARKET SHARE BY SEGMENT, 2015 (%) 174
MARKETS BY GLOBAL REGION 175
TABLE 60 GLOBAL MARKET FOR PAIN MANAGEMENT PHARMACEUTICALS AND
DEVICES BY REGION, THROUGH 2020 ($ MILLIONS) 176
FIGURE 34 GLOBAL MARKET FOR PAIN MANAGEMENT DEVICES BY REGION,
2012-2020 ($ MILLIONS) 176
CHAPTER 9 INDUSTRY DEVELOPMENTS 178
TIMELINE OF RECENT EVENTS AND DEVELOPMENTS 178
THE PHARMACEUTICAL PIPELINE 181
TABLE 61 MANUFACTURERS' PAIN-MANAGEMENT DRUG PIPELINES 181
FIGURE 35 PAIN MANAGEMENT DRUG PIPELINE, BY DEVELOPMENT STATUS 189
FIGURE 36 PAIN MANAGEMENT DRUG PIPELINE, BY PRIMARY INDICATION 190
PATENT ANALYSIS 191
NUMBER OF PATENTS ISSUED FOR PAIN 192
TABLE 62 NUMBER OF PAIN FOCUS PATENTS ISSUED, BY ABSTRACT DESCRIPTION 192
TABLE 63 NUMBER OF U.S. PATENTS FOR PAIN-FOCUSED INVENTIONS BY YEAR,
JANUARY 2000-JULY 2015 193
FIGURE 37 NUMBER OF U.S. PATENTS FOR PAIN-FOCUSED INVENTIONS BY YEAR,
JANUARY 2000-JULY 2015 193
DRUG PATENTS FOR SELECTED THERAPIES 193
TABLE 64 U.S. PATENT EXPIRATION DATES FOR SELECTED PAIN DRUGS 194
IMPACT OF GENERIC PARTICIPATION 194
TABLE 65 FIRST-TIME PRESCRIPTION GENERIC PAIN MANAGEMENT AND
APPROVALS, APRIL 2005-JULY 2015 195
PAIN DEVICE CLINICAL TRIALS 199
TABLE 66 SELECTED PAIN MANAGEMENT DEVICE TRIALS 199
FIGURE 38 NUMBER OF PAIN MANAGEMENT DEVICES IN DEVELOPMENT, BY
GENERAL STATUS 200
FUTURE OF PAIN RESEARCH 200
TABLE 67 PAIN OR PAIN-RELATED CLINICAL TRIALS, BY REGION, 2015 203
FIGURE 39 PERCENTAGE OF PAIN-FOCUSED CLINICAL TRIALS FOR ALL AGES, BY
REGION (%) 203
PAIN RESEARCH - PEDIATRIC POPULATIONS 204
FIGURE 40 PERCENTAGE OF PAIN-FOCUSED CLINICAL TRIALS FOR PEDIATRICS, BY
REGION (%) 204
PATIENT OUTCOMES RESEARCH 205
SELECTED PAIN-RELATED ACQUISITIONS AND ALLIANCES 205
CHAPTER 10 COMPANY PROFILES 208
PHARMACEUTICAL AND DEVICE PAIN MANAGEMENT MANUFACTURERS 208
ABBVIE INC. 208
ASTRAZENECA 208
DEPOMED INC. 209
DJO GLOBAL INC. 209
ELI LILLY and CO. 210
ENDO INTERNATIONAL 210
GLAXOSMITHKLINE 211
HISAMITSU PHARMACEUTICAL CO. INC. 211
JOHNSON and JOHNSON 212
MEDTRONIC INC. 212
NOVARTIS INTERNATIONAL AG 213
PFIZER 213
PURDUE PHARMACEUTICALS LP 214
ST. JUDE MEDICAL INC. 214
CHAPTER 11 APPENDIX I 217
PAIN MANAGEMENT PHARMACEUTICAL MANUFACTURERS AND DEVELOPERS 217
CHAPTER 12 APPENDIX II 236
2015-2016 STATE CONTROLLED SUBSTANCES SCHEDULING AUTHORITIES AND
OTHER HELPFUL CONTACT PERSONS 236
ALABAMA 236
ALASKA 236
ARIZONA 236
ARKANSAS 237
CALIFORNIA 237
COLORADO 237
CONNECTICUT 238
DELAWARE 238
DISTRICT OF COLUMBIA 238
FLORIDA 238
GEORGIA 239
HAWAII 239
IDAHO 239
ILLINOIS 240
INDIANA 240
IOWA 241
KANSAS 241
KENTUCKY 241
LOUISIANA 241
MAINE 242
MARYLAND 242
MASSACHUSETTS 242
MICHIGAN 243
MINNESOTA 243
MISSISSIPPI 243
MISSOURI 244
MONTANA 244
NEBRASKA 245
NEVADA 245
NEW HAMPSHIRE 245
NEW JERSEY 246
NEW MEXICO 246
NEW YORK 246
NORTH CAROLINA 247
NORTH DAKOTA 247
OHIO 247
OKLAHOMA 248
OREGON 248
PENNSYLVANIA 248
RHODE ISLAND 249
SOUTH CAROLINA 249
SOUTH DAKOTA 249
TENNESSEE 250
TEXAS 250
UTAH 250
VERMONT 251
VIRGINIA 251
WASHINGTON 252
WEST VIRGINIA 252
WISCONSIN 252
WYOMING 253
CHAPTER 13 APPENDIX III 255
U.S. PAIN SOCIETIES AND ASSOCIATIONS 255
CHAPTER 14 APPENDIX IV 257
INTERNATIONAL ASSOCIATIONS AND ORGANIZATIONS 257
SUMMARY TABLE MARKET FOR GLOBAL PAIN MANAGEMENT PHARMACEUTICALS
AND DEVICES BY REVENUE AT MANUFACTURERS' SALES LEVELS, THROUGH 2020 ($
MILLIONS)
8
TABLE 1 OBJECTIVE SIGNS OF PAIN 15
TABLE 2 GLOBAL POPULATION BY SELECTED COUNTRY, THROUGH 2015 (MILLIONS) 22
TABLE 3 ESTIMATED GLOBAL POPULATION BY SELECTED AGE GROUP AND
SELECTED YEARS, THROUGH 2030 (MILLIONS) 24
TABLE 4 GLOBAL LIFE EXPECTANCY AT BIRTH BY SELECTED COUNTRY, 1980-2015
(YEARS) 25
TABLE 5 CANCER PAIN MEDICATIONS 30
TABLE 6 ESTIMATED* PREVALENCE/INCIDENCE OF ORTHOPEDIC CONDITIONS BY
COUNTRY, AVERAGE FIGURE, 2010-2013 (MILLIONS) 34
TABLE 7 BIRTH RATES AND BIRTHS BY COUNTRY, 2015 (THOUSANDS) 40
TABLE 8 PEOPLE WHO REPORTED PAIN BY SELECTED CATEGORY AND GENDER IN
THE 18+ U.S. POPULATION*, 1997-2010 (THOUSANDS) 42
TABLE 9 AVAILABILITY OF EDUCATION IN PAIN MANAGEMENT BY SELECT
REGION/COUNTRY 51
TABLE 10 NUMBER OF AGENCIES RESPONSIBLE FOR PDMP IN EACH STATE, BY TYPE 52
TABLE 11 BENEFITS OF PRESCRIPTION MONITORING PROGRAMS FOR MEDICAL
BOARDS 53
TABLE 12 DRUGS MONITORED BY PDMPS 53
TABLE 13 STATES WITH ELECTRONIC PRESCRIPTION MONITORING PROGRAMS 54
TABLE 14 NURSE CONTINUING EDUCATION REQUIREMENTS FOR PAIN MANAGEMENT
BY REQUIRING STATE 57
TABLE 15 WHO ESSENTIAL MEDICINES LIST (ADULTS) FOR PAIN MANAGEMENT 61
TABLE 16 AVAILABILITY OF INJECTABLE MORPHINE BY REGION 62
TABLE 17 AVAILABILITY OF ORAL MORPHINE IN HOSPICE-TYPE SETTINGS, BY REGION 64
TABLE 18 FDA ANALGESIA DRUG SHORTAGES BY REPORTING COMPANY, JULY 2015 66
TABLE 19 WORLD HEALTH ORGANIZATION TOP 50 RANKING OF HEALTHCARE
SYSTEMS, 2000 81
TABLE 20 HEALTH EXPENDITURES AS PERCENTAGE OF GDP BY COUNTRY,
1980-2015 (%) 83
TABLE 21 PARTS 862-892 OF 21 CFR 87
TABLE 22 LIST OF EXTENDED-RELEASE AND LONG-ACTING OPIOID BRAND-NAME
PRODUCTS REQUIRED TO HAVE AN OPIOID REMS, MAY 2015 89
TABLE 23 LIST OF EXTENDED-RELEASE AND LONG-ACTING OPIOID GENERIC
PRODUCTS REQUIRED TO HAVE AN OPIOID REMS, MAY 2015 89
TABLE 24 TRANSMUCOSAL IMMEDIATE-RELEASE FENTANYL PRODUCTS REQUIRED
TO HAVE TIRF REMS ACCESS PROGRAM 91
TABLE 25 MARKETED ACETAMINOPHEN-CONTAINING PRESCRIPTION PRODUCTS 92
TABLE 26 NON-ASPIRIN NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) 96
TABLE 27 ADVANTAGES AND DISADVANTAGES OF IONTOPHORETIC DRUG DELIVERY 98
TABLE 28 RECENT FDA APPLICATIONS/APPROVALS, JANUARY 2010-JULY 2015 101
TABLE 29 MOST COMMONLY USED GENERAL ANESTHETIC AGENTS 112
TABLE 30 OTC ACETAMINOPHEN AND ACETAMINOPHEN COMBINATION PRODUCTS 114
TABLE 31 OTC ASPIRIN AND ASPIRIN COMBINATION PRODUCTS 116
TABLE 32 OTC IBUPROFEN AND IBUPROFEN COMBINATION PRODUCTS 116
TABLE 33 OTC KETOPROFEN PRODUCTS 117
TABLE 34 OTC NONSTEROID ANTI-INFLAMMATORIES 117
TABLE 35 OTC ANTIMIGRAINE PRODUCTS 118
TABLE 36 OTC TOPICAL ANESTHETIC PRODUCTS 118
TABLE 37 ADULTS 18 YEARS AND OVER IN THE U.S. WHO USED COMPLEMENTARY
AND ALTERNATIVE MEDICINE (CAM) IN THE PAST 12 MONTHS BY THERAPY TYPE,
2002-2015 (THOUSANDS)
136
TABLE 38 STATISTICS FOR HOSPICE PATIENTS BY CHARACTERISTIC, 2009-2013 (%) 140
TABLE 39 STATISTICS OF HOSPICE PATIENTS BY PRIMARY DIAGNOSIS (THOUSAND/%) 142
TABLE 40 NHPCO COMMITTEES 144
TABLE 41 NUMBER OF REGISTERED HOSPITALS BY COUNTRY, 2010 145
TABLE 42 NUMBER OF REGISTERED U.S. HOSPITALS BY TYPE, 2013 146
TABLE 43 NUMBER OF REGISTERED PAIN CLINICS IN THE U.S. BY STATE, 2015 148
TABLE 44 NUMBER OF REGISTERED PAIN CLINICS, BY COUNTRY 149
TABLE 45 MARKET FOR GLOBAL PRESCRIPTION PAIN MANAGEMENT
PHARMACEUTICALS AT MANUFACTURERS' SALES LEVELS BY CATEGORY, THROUGH
2020 ($ MILLIONS)
153
TABLE 46 GLOBAL MARKET FOR NARCOTIC ANALGESICS BY REGION, THROUGH
2020 ($ MILLIONS) 154
TABLE 47 GLOBAL MARKET FOR NON-NARCOTIC ANALGESICS BY REGION, THROUGH
2020 ($ MILLIONS) 156
TABLE 48 GLOBAL MARKET FOR ANTIMIGRAINE AGENTS BY REGION, THROUGH 2020
($ MILLIONS) 157
TABLE 49 GLOBAL MARKET FOR ANESTHETICS BY REGION, THROUGH 2020 ($
MILLIONS) 158
TABLE 50 GLOBAL MARKET FOR OTHER CNS ANALGESICS BY REGION, THROUGH
2020 ($ MILLIONS) 159
TABLE 51 GLOBAL MARKET FOR PRESCRIPTION NARCOTIC AND NON-NARCOTIC BY
MANUFACTURER, 2015 ($ MILLIONS/%) 161
TABLE 52 GLOBAL MARKET FOR PRESCRIPTION ANTIMIGRAINE DRUG BY
MANUFACTURER, 2015 ($ MILLIONS/%) 162
TABLE 53 GLOBAL MARKET FOR PRESCRIPTION ANESTHETIC BY MANUFACTURER,
2015 ($ MILLIONS/%) 163
TABLE 54 GLOBAL PAIN MANAGEMENT DEVICE MARKET AT MANUFACTURERS'
SALES LEVELS BY PRODUCT TYPE, THROUGH 2020 ($ MILLIONS) 168
TABLE 55 GLOBAL MARKET FOR PAIN MANAGEMENT DEVICES BY REGION, THROUGH
2020 ($ MILLIONS) 169
TABLE 56 GLOBAL MARKET FOR NEUROMUSCULAR STIMULATOR/ELECTROTHERAPY
DEVICES BY MANUFACTURER, 2015 ($ MILLIONS/%) 170
TABLE 57 GLOBAL MARKET FOR SPINE STIMULATORS BY MANUFACTURER, 2015 ($
MILLIONS/%) 171
TABLE 58 GLOBAL MARKET FOR PAIN MANAGEMENT PHARMACEUTICALS AND
DEVICES BY REVENUE AT MANUFACTURERS' SALES LEVELS, THROUGH 2020 ($
MILLIONS)
173
TABLE 59 GLOBAL PAIN MANAGEMENT MARKET BY SEGMENT, 2015 ($ MILLIONS/%) 174
TABLE 60 GLOBAL MARKET FOR PAIN MANAGEMENT PHARMACEUTICALS AND
DEVICES BY REGION, THROUGH 2020 ($ MILLIONS) 176
TABLE 61 MANUFACTURERS' PAIN-MANAGEMENT DRUG PIPELINES 181
TABLE 62 NUMBER OF PAIN FOCUS PATENTS ISSUED, BY ABSTRACT DESCRIPTION 192
TABLE 63 NUMBER OF U.S. PATENTS FOR PAIN-FOCUSED INVENTIONS BY YEAR,
JANUARY 2000-JULY 2015 193
TABLE 64 U.S. PATENT EXPIRATION DATES FOR SELECTED PAIN DRUGS 194
TABLE 65 FIRST-TIME PRESCRIPTION GENERIC PAIN MANAGEMENT AND APPROVALS,
APRIL 2005-JULY 2015 195
TABLE 66 SELECTED PAIN MANAGEMENT DEVICE TRIALS 199
TABLE 67 PAIN OR PAIN-RELATED CLINICAL TRIALS, BY REGION, 2015 203

LIST OF FIGURES
SUMMARY FIGURE MARKET FOR GLOBAL PAIN MANAGEMENT PHARMACEUTICALS
AND DEVICES BY REVENUE AT MANUFACTURERS' SALES LEVELS, 2012-2020 ($
MILLIONS)
8
FIGURE 1 PAIN-MANAGEMENT TECHNIQUES 16
FIGURE 2 GLOBAL POPULATION BY SELECTED COUNTRY, 2010 AND 2015 (MILLIONS) 22
FIGURE 3 ESTIMATED GLOBAL POPULATION BY SELECTED AGE GROUP AND
SELECTED YEARS, 2000-2030 (MILLIONS) 24
FIGURE 4 GLOBAL LIFE EXPECTANCY AT BIRTH BY SELECTED COUNTRY, 1980-2015
(YEARS) 25
FIGURE 5 CAUSES OF CANCER PAIN 29
FIGURE 6 ESTIMATED* PREVALENCE/INCIDENCE OF ORTHOPEDIC CONDITIONS BY
COUNTRY, AVERAGE FIGURE 2010-2013 (MILLIONS) 34
FIGURE 7 APPROACH TO BURN PAIN MANAGEMENT 38
FIGURE 8 BIRTH RATES AND BIRTHS BY COUNTRY, 2015 (THOUSANDS) 40
FIGURE 9 NUMBER OF STATES WITH ELECTRONIC PRESCRIPTION MONITORING
PROGRAMS BY YEAR OF ENACTMENT 55
FIGURE 10 NUMBER OF DEATHS, BY CAUSES OF MORTALITY AND POTENTIAL NEED
FOR PALLIATIVE CARE (MILLIONS) 59
FIGURE 11 FACTORS AFFECTING AVAILABILITY OF OPIOIDS FOR MEDICAL NEEDS,
2010 65
FIGURE 12 HEALTH EXPENDITURES AS PERCENT OF GDP BY COUNTRY, 1980-2015
(%) 83
FIGURE 13 ADULTS 18 YEARS AND OVER IN THE U.S. WHO USED COMPLEMENTARY
AND ALTERNATIVE MEDICINE (CAM) IN THE PAST 12 MONTHS BY THERAPY TYPE,
2002-2015 (THOUSANDS)
137
FIGURE 14 NUMBER OF HOSPICE PATIENTS SERVED BY YEAR, 2009-2013 139
FIGURE 15 PERCENTAGE OF HOSPICE PATIENTS BY GENDER, 2009-2013 (%) 141
FIGURE 16 PERCENTAGE OF HOSPICE PATIENTS BY AGE GROUP, 2009-2013 (%) 141
FIGURE 17 PERCENTAGE OF HOSPICE PATIENTS BY PRIMARY DIAGNOSIS, 2009-2013
(%) 143
FIGURE 18 MARKET FOR GLOBAL PRESCRIPTION PAIN MANAGEMENT
PHARMACEUTICALS AT MANUFACTURERS' SALES LEVELS BY CATEGORY, 2012-2020
($ MILLIONS)
153
FIGURE 19 GLOBAL MARKET FOR NARCOTIC ANALGESICS BY REGION, 2012-2020 ($
MILLIONS) 154
FIGURE 20 GLOBAL MARKET FOR NON-NARCOTIC ANALGESICS BY REGION,
2012-2020 ($ MILLIONS) 156
FIGURE 21 GLOBAL MARKET FOR ANTIMIGRAINE AGENTS BY REGION, 2012-2020 ($
MILLIONS) 157
FIGURE 22 GLOBAL MARKET FOR ANESTHETICS BY REGION, 2012-2020 ($ MILLIONS) 158
FIGURE 23 GLOBAL MARKET FOR OTHER CNS ANALGESICS BY REGION, 2012-2020
($ MILLIONS) 160
FIGURE 24 GLOBAL MARKET FOR PRESCRIPTION NARCOTIC AND NON-NARCOTIC BY
MANUFACTURER, 2015 ($ MILLIONS) 161
FIGURE 25 GLOBAL MARKET FOR PRESCRIPTION ANTIMIGRAINE DRUG BY
MANUFACTURER, 2015 (%) 163
FIGURE 26 GLOBAL MARKET FOR PRESCRIPTION ANESTHETIC BY MANUFACTURER,
2015 (%) 163
FIGURE 27 GLOBAL PAIN MANAGEMENT DEVICE MARKET AT MANUFACTURERS'
SALES LEVELS, 2012-2020 ($ MILLIONS) 166
FIGURE 28 GLOBAL PAIN MANAGEMENT DEVICE MARKET BY PRODUCT TYPE,
2012-2020 ($ MILLIONS) 168
FIGURE 29 GLOBAL MARKET FOR PAIN MANAGEMENT DEVICES BY REGION,
2012-2020 ($ MILLIONS) 169
FIGURE 30 GLOBAL MARKET SHARE FOR NEUROMUSCULAR
STIMULATOR/ELECTROTHERAPY DEVICES BY MANUFACTURER, 2015 (%) 170
FIGURE 31 GLOBAL MARKET SHARE FOR SPINE CORD STIMULATORS BY
MANUFACTURER, 2015 (%) 171
FIGURE 32 GLOBAL MARKET FOR PAIN MANAGEMENT PHARMACEUTICALS AND
DEVICES BY REVENUE AT MANUFACTURERS' SALES LEVELS, 2012-2020 ($ MILLIONS) 173
FIGURE 33 GLOBAL PAIN MANAGEMENT MARKET SHARE BY SEGMENT, 2015 (%) 174
FIGURE 34 GLOBAL MARKET FOR PAIN MANAGEMENT DEVICES BY REGION,
2012-2020 ($ MILLIONS) 176
FIGURE 35 PAIN MANAGEMENT DRUG PIPELINE, BY DEVELOPMENT STATUS 189
FIGURE 36 PAIN MANAGEMENT DRUG PIPELINE, BY PRIMARY INDICATION 190
FIGURE 37 NUMBER OF U.S. PATENTS FOR PAIN-FOCUSED INVENTIONS BY YEAR,
JANUARY 2000-JULY 2015 193
FIGURE 38 NUMBER OF PAIN MANAGEMENT DEVICES IN DEVELOPMENT, BY
GENERAL STATUS 200
FIGURE 39 PERCENTAGE OF PAIN-FOCUSED CLINICAL TRIALS FOR ALL AGES, BY
REGION (%) 203
FIGURE 40 PERCENTAGE OF PAIN-FOCUSED CLINICAL TRIALS FOR PEDIATRICS, BY
REGION (%) 204

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