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Anesthesia Markets

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March 2012

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ONE: EXECUTIVE SUMMARY ......................................................................................................... 1

Introduction ......................................................................................................................... 1
Scope and Methodology ...................................................................................................... 1
Size and Growth of the Market .......................................................................................... 3
Issues and Trends Affecting Market.................................................................................. 6
Leading Competitors ........................................................................................................... 6
TWO: INTRODUCTION THE WORLD ANESTHESIA DRUG MARKET .................................. 9

Introduction and History to Anesthesia Drugs ................................................................. 9


Types of Anesthesia ........................................................................................................... 11
General Anesthesia.......................................................................................................... 11
Local Anesthesia ............................................................................................................. 12
Adjunctive Therapies in Anesthesia ................................................................................ 12
Routes of Administration .................................................................................................. 13
Inhalation......................................................................................................................... 13
Mask Inhalation ...................................................................................................................... 14
Laryngeal Mask ...................................................................................................................... 14
Endotracheal Administration .................................................................................................. 14
Controlled Respiration ............................................................................................................ 14

Intravenous ...................................................................................................................... 16
Topical Application ......................................................................................................... 17
Transdermal/Transmucosal Application ......................................................................... 17
Distribution Channels ....................................................................................................... 18
Demographics and Statistics ............................................................................................. 19
Medical Procedures by Type ........................................................................................... 21
Complications in Anesthesia ........................................................................................... 25
AnesthesiologyWork Force ......................................................................................... 25
THREE: GENERAL ANESTHESIA ................................................................................................. 29

Overview............................................................................................................................. 29
Stages of General Anesthesia .......................................................................................... 30
Induction ................................................................................................................................. 30
Excitement .............................................................................................................................. 30
Surgical Anesthesia ................................................................................................................. 30
Overdose ................................................................................................................................. 31

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Table of Contents
ii
Description of Products ..................................................................................................... 31
Brevital.................................................................................................................................... 31
Diprivan .................................................................................................................................. 31
Ethrane .................................................................................................................................... 31
Forane ..................................................................................................................................... 32
Halothane ................................................................................................................................ 32
Ketalar ..................................................................................................................................... 32
Lusedra.................................................................................................................................... 33
Pentothal ................................................................................................................................. 33
Suprane ................................................................................................................................... 33
Ultane/Sevorane ...................................................................................................................... 33

Generic Drug Impact and Availability ............................................................................ 34


Research and Development .............................................................................................. 36
Market Size and Growth................................................................................................... 37
Total Market .................................................................................................................... 37
Market by Delivery Method ............................................................................................ 39
Market by Geographical Region ..................................................................................... 40
Competitive Analysis ......................................................................................................... 42
FOUR: LOCAL ANESTHESIA ......................................................................................................... 45

Overview............................................................................................................................. 45
Techniques of Administration ......................................................................................... 47
Topical Application................................................................................................................. 47
Transdermal/Transmucosal ..................................................................................................... 47
Simple Local Infiltration ......................................................................................................... 48
Regional Injections ................................................................................................................. 48

Spinal and Epidural Anesthesia....................................................................................... 50


Intrathecal Block ..................................................................................................................... 50
Epidural, Peridural Block ........................................................................................................ 51

Description of Products ..................................................................................................... 52


Amides ............................................................................................................................ 52
Carbocaine/Isocaine/Polocaine ............................................................................................... 53
Citanest ................................................................................................................................... 53
Exparel .................................................................................................................................... 53
Marcaine/Sensorcaine ............................................................................................................. 53
Naropin ................................................................................................................................... 54
Septocaine ............................................................................................................................... 54
Xylocaine/LidoSite/Lidoderm................................................................................................. 54

Esters ............................................................................................................................... 55
Cocaine Hydrochloride ........................................................................................................... 55
Nesacaine ................................................................................................................................ 55
Novocaine ............................................................................................................................... 55
Pontocaine ............................................................................................................................... 56

Combinations .................................................................................................................. 56
EMLA ..................................................................................................................................... 56
Pliaglis .................................................................................................................................... 56
Synera ..................................................................................................................................... 56
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Table of Contents
iii
Generic Drug Impact and Availability ............................................................................ 58
Research and Development .............................................................................................. 60
Market Size and Growth................................................................................................... 63
Total Market .................................................................................................................... 63
Market by Delivery Method ............................................................................................ 66
Market by Geographical Region ..................................................................................... 67
Competitive Analysis ......................................................................................................... 68
FIVE: ADJUNCTIVE THERAPIES IN ANESTHESIA .................................................................. 71

Overview............................................................................................................................. 71
Description of Products ..................................................................................................... 72
Neuromuscular Blocking Agents ............................................................................................ 72
Preanesthetic Sedation and Anesthesia Maintenance .............................................................. 75
Precedex/dexdor ...................................................................................................................... 77
Anesthesia Reversal Agents .................................................................................................... 78

Generic Drug Impact and Availability ............................................................................ 81


Research and Development .............................................................................................. 85
Bridion (sugammadex) ............................................................................................................ 86
Gantacurium ............................................................................................................................ 86
Remimazolam (CNS 7056) ..................................................................................................... 86

Market Size and Growth................................................................................................... 87


Total Market .................................................................................................................... 87
Market by Geographical Region ..................................................................................... 90
Competitive Analysis ......................................................................................................... 92
SIX: ANESTHESIA DRUGS: TOTAL MARKET SIZE AND FORECAST ................................. 95

Total Market Size and Forecast ....................................................................................... 95


Anesthesia Market by Product Type ............................................................................... 98
Anesthesia Market by Geographical Region................................................................. 102
Competitor Analysis ........................................................................................................ 104
SEVEN: ISSUES AND TRENDS AFFECTING THE ANESTHESIA DRUG MARKET .......... 107

Introduction ..................................................................................................................... 107


Regulation of Anesthesia Drugs ..................................................................................... 108
Dentistry and Anesthesia ................................................................................................ 109
Anesthesia and Complications in Pediatric Applications ............................................ 110
Allergic Reactions in Anesthesia .................................................................................... 110
Propofol Recall ......................................................................................................................111

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Table of Contents
iv
Anesthesia and the Benefits to Depression Patients ..................................................... 111
Pediatric Studies in Bipolar Disorders ...................................................................................112

Anesthesia and Sleep ....................................................................................................... 113


Gender Differences in Anesthesia Reaction .................................................................. 113
Manufacturing and Supply Issues ................................................................................. 114
Drug Shortages.......................................................................................................................114
Propofol .................................................................................................................................115

Recreational Use of Anesthetics ..................................................................................... 115


Trends in Conscious Sedation ........................................................................................ 116
Long-term Effects of Anesthesia .................................................................................... 118
Anesthesia and Numbing Technologies ......................................................................... 119
Sedasys .......................................................................................................................... 119
EIGHT: CORPORATE PROFILES ................................................................................................ 121

Introduction ..................................................................................................................... 121


Acquisitions, Alliances and Agreements ........................................................................ 122
Hospira and DURECT Corporation .............................................................................. 122
Hospira and Javelin Pharmaceuticals, Inc. .................................................................... 122
ZARS Pharma and Nuvo Research, Inc. ....................................................................... 122
Abbott Laboratories ........................................................................................................ 123
AstraZeneca ..................................................................................................................... 125
Baxter International ........................................................................................................ 127
Eisai Co., Ltd. .................................................................................................................. 129
Endo Pharmaceuticals, Inc. ............................................................................................ 131
Hospira, Inc. ..................................................................................................................... 133
Merck/Schering-Plough .................................................................................................. 135
Roche ................................................................................................................................ 137
APPENDIX: LIST OF COMPANIES .............................................................................................. 139

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Table of Contents
v
L

ONE: EXECUTIVE SUMMARY

Table 1-1 ............................................................................................................................... 4


The Total World Market for Anesthesia Drugs 2007-2016 .............................................. 4
Figure 1-1 ............................................................................................................................. 5
The Total Market for Anesthesia Drugs 2007-2016 ......................................................... 5
TWO: INTRODUCTION THE WORLD ANESTHESIA DRUG MARKET

Table 2-1 ............................................................................................................................. 19


World Population by Selected Geographical Region, 2010 - 2050................................. 19
Figure 2-1 ........................................................................................................................... 20
World Population by Selected Geographical Region, 20102050 .................................. 20
Table 2-2 ............................................................................................................................. 22
Procedures by Type, Average Annually 2007-2011 ....................................................... 22
Figure 2-2 ........................................................................................................................... 23
Procedures by Type Worldwide, Average Annually 2007-2011 .................................... 23
Figure 2-3 ........................................................................................................................... 24
Procedures by Type U.S., Average Annually 2007-2011 ............................................... 24
Table 2-3 ............................................................................................................................. 26
Worldwide Anesthesia Complications ............................................................................ 26
Table 2-4 ............................................................................................................................. 26
U.S. Physician Work Force (including Anesthesiologists) by Year ............................... 26
Figure 2-4 ........................................................................................................................... 27
U.S. Physician Work Force (including Anesthesiologists) by Year ............................... 27
THREE: GENERAL ANESTHESIA

Table 3-1 ............................................................................................................................. 34


Marketed Brands for General Anesthesia Drugs
(Brand Name, Generic Name, and Supplier) .................................................................. 34
Table 3-2 ............................................................................................................................. 35
Selected Generic Drug Manufacturers and Products for General Anesthesia ................. 35
Table 3-3 ............................................................................................................................. 36
Brand vs. Generic General Anesthetic Market 2007-2011 ............................................. 36
Table 3-4 ............................................................................................................................. 38
The Market for General Anesthesia Drugs 2007-2016 ................................................... 38
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Table of Contents
vi
Figure 3-1
The Market for General Anesthesia Drugs 2007-2016 ................................................... 39
Figure 3-2
The Market for General Anesthesia Drugs Market Share by Delivery Method, 2011 .... 40
Table 3-5
The Market for General Anesthesia Drugs Estimated Products Sales by Geographic
Region, 2011 ................................................................................................................... 41
Figure 3-3
The Market for General Anesthesia Drugs Market Share by Geographic Region, 2011...... 41
Table 3-6
The Market for General Anesthesia Drugs Estimated Revenues and Market Share of
Leading Suppliers 2009-2011 ......................................................................................... 43
Figure 3-4
The Market for General Anesthesia Drugs Estimated Market Share by Leading
Suppliers 2011 ................................................................................................................. 43
LOCAL ANESTHESIA

Table 4-1
Selected Marketed Local Anesthesia Drugs (Brand Name, Generic Name and Supplier) .. 57
Table 4-2
Selected Generic Drug Manufacturers and Products for Local Anesthesia .................... 59
Figure 4-1
Brand vs. Generic Local Anesthetic Market 2007-2011 ................................................. 60
Table 4-3
Local Anesthesia Drugs in Development ........................................................................ 62
Table 4-4
The Market for Local Anesthesia Drugs 2007-2016 ....................................................... 64
Figure 4-2
The Total Market for Local Anesthesia Drugs 2007-2016 ............................................. 65
Figure 4-3
The Market for Local Anesthesia Drugs Market Share by Delivery Method, 2011 ....... 66
Table 4-5
The Market for Local Anesthesia Drugs Estimated Products Sales by Geographic
Region, 2011 ................................................................................................................... 67
Figure 4-4
The Market for Local Anesthesia Drugs Market Share by Geographic Region, 2011 ......... 68
Table 4-6
The Market for Local Anesthesia Drugs Estimated Revenues and Market Share of
Leading Suppliers 2009-2011 ......................................................................................... 69

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Figure 4-5
The Market for Local Anesthesia Drugs Estimated Market Share by
Leading Suppliers 2011................................................................................................... 70
FIVE: ADJUNCTIVE THERAPIES IN ANESTHESIA

Table 5-1
Selected Marketed Adjunctive Therapies in Anesthesia (Type, Brand Name, Generic
Name, and Supplier)........................................................................................................ 82
Table 5-2
Selected Generic Drug Manufacturers and Products for Adjunctive Therapies in
Anesthesia ....................................................................................................................... 82
Figure 5-1
Brand vs. Generic Adjunctive Therapies in Anesthesia Market 2007-2011 ................... 85
Table 5-3
Adjunctive Therapies in Anesthesia in Development ..................................................... 87
Table 5-4
The Market for Adjunctive Therapies in Anesthesia 2007-2016 .................................... 89
Figure 5-2
The Market for Adjunctive Therapies in Anesthesia 2007-2016 .................................... 90
Table 5-5
The Market for Adjunctive Therapies in Anesthesia Estimated Products Sales by
Geographic Region, 2011................................................................................................ 91
Figure 5-3
The Market for Adjunctive Therapies in Anesthesia Market Share by Geographic
Region, 2011 ................................................................................................................... 91
Table 5-6
The Market for Adjunctive Therapies in Anesthesia Estimated Revenues and Market
Share of Leading Suppliers 2009-2011 ........................................................................... 93
Figure 5-4
The Market for Adjunctive Therapies in Anesthesia Estimated Market Share by Leading
Suppliers 2011 ................................................................................................................. 93
SIX: ANESTHESIA DRUGS: TOTAL MARKET SIZE AND FORECAST

Table 6-1
The Total World Market for Anesthesia Drugs 2007-2016 ............................................ 96
Figure 6-1
The Total Market for Anesthesia Drugs 2007-2016 ....................................................... 97
Table 6-2
Anesthesia Drug Market by Type 2007-2016 ................................................................ 99
Figure 6-2
Anesthesia Drug Market by Type 2007-2016 .............................................................. 100
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Figure 6-3
Anesthesia Drug Market by Type 2011 ....................................................................... 101
Figure 6-4
Anesthesia Drug Market by Type 2016 ....................................................................... 101
Table 6-3
Anesthesia Drug Market Estimated Products Sales by Geographic Region, 2011 ....... 103
Figure 6-5
Anesthesia Drug Market Market Share by Geographic Region, 2011 .......................... 103
Table 6-4
Leading Suppliers Anesthesia Revenues and Significant Segments of Participation,
2011 ............................................................................................................................... 105
Figure 6-6
Leading SuppliersAnesthesia Revenues, 2011 .......................................................... 105

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Two: Introduction
16

corrects depression, but respiration must be controlled to keep oxygen


hypoventilation and cardiac depression.
While the respiratory system is employed for distribution of anesthetic, it also
must carry on its normal function of ventilation. The amount of anesthetic vapor
inspired is influenced by the volume and rate of respirations. Gas or vapor
concentration and rate of delivery are also significant. Pulmonary circulation is the
vehicle for oxygen and anesthetic transport to general circulation. The large
absorptive surface of the lungs, and their extensive microcirculation provide a large
gas exchange surface. In optimum gas exchange all alveoli share inspired gas and
cardiac output equally. Because respiratory and anesthetic gases interact with
pulmonary circulation, alveolar anesthetic concentrations are rapidly reflected in
circulating blood.
Alveolar concentration results from a balance between two forces: ventilation
that delivers anesthetic to the alveoli and uptake that removes anesthetic from alveoli.
Certain factors influence uptake of the anesthetic and therefore induction and
recovery.
Synthesis of potent nonflammable, halogenated, volatile liquids has replaced
cyclopropane and ether, which are highly flammable agents. All inhalation agents are
administered with oxygen. Volatile liquids are vaporized for inhalation by oxygen,
which acts as a vaporizer on the anesthesia machine. The oxygen picks up XX% to
XX% concentration of the halogenated agent.
Intravenous
IV anesthesia became popular with the introduction in the 1930s of rapidly
acting barbiturates. A drug that produces hypnosis, sedation, amnesia, and analgesia
is injected directly into the circulation, usually by a peripheral vein in the arm.
Diluted by blood in the heart and the lungs, the drug passes in high concentration to
the brain, heart, liver and kidneys, the organs of highest blood flow. Concentration in
the brain is rapid. With recirculation, redistribution occurs in the body, decreasing
cerebral concentration. Dissipation of effects depends on redistribution and
biotransformation. Because removal of the drug from circulation is impossible, safety
in use is related to metabolism. Oxygen is always given during IV anesthesia.
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Three: General Anesthesia


38

for Eisais Lusedra (fospropofol). By 2016, the general anesthesia market is expected
to display an increase in sales of XX% due to factors mentioned above. Revenues in
2016 are expected to increase to $XX xxxx.
Table 3-4
The Market for General Anesthesia Drugs
2007-2016
Year

Segment
Alkyphenols

Other Products

Total Revenues
(in millions)

2007
2008
2009
2010
2011
2012
2013
2014
2015
2016

Compound Annual Growth Rate


Period

Segment
Alkyphenols
Other Products

Total

2007-2011
2012-2016
2007-2016
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Percent Change

Five: Adjunctive Therapies in Anesthesia


73

Nondepolarizing

Depolarizing

Both effectively induce paralysis, but produce this effect through different
mechanisms of action.
Neuromuscular blocking agents work by interrupting or preventing the
electrochemical transfer of information at the point at which the axon of a neuron
meets a muscle fiber, that is, at the neuromuscular junction. At this junction, the axon
of the motor neuron divides to form branching terminals that are enfolded in muscle
fibers. These axon terminals are separated from the fibers by the synaptic cleft or
synapse. Impulses do not jump across these synapses. Instead, the electrical
conduction of a signal down the axon occurs as an action potential. As the action
potential invades the nerve ending, a chemical presynaptic neurotransmitting
substance, acetylcholine, is released into the synapse. The acetylcholine diffuses
across the synapse to act on the post synaptic membrane to produce a new action
potential or modulate a preexisting action. Neuromuscular blocking agents act at the
neuromuscular junction by competing with acetylcholine for the receptor sites or by
blocking depolarization.
Because neuromuscular blocking agents cannot readily cross membranes, they
must always be administered parenterally. And, because of their inability to cross the
blood brain barrier, they have no effect on the central nervous system. Thus,
neuromuscular blocking agents do not diminish consciousness or the perception of
pain.
These drugs must be accompanied by adequate anesthesia during surgery to
prevent patient distress. Neuromuscular blocking agents are administered after
unconsciousness is induced.
Neuromuscular blocking agents are used to induce sufficient muscle
relaxation to assist with various surgical procedures. As an adjunct to anesthesia,
neuromuscular blockers can decrease the dosage of the general anesthetic, providing a
greater margin of safety for the patient. There is less risk of respiratory depression,
and recovery from anesthesia occurs more quickly. Neuromuscular blockers also help

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