NEW YORK, May 19, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Medical Aesthetic Devices: Technologies and Global Markets
http://www.reportlinker.com/p0490900/Medical-Aesthetic-Devices-Technologies-and-Global-Markets.html?utm_source=prnewswire&utm_medium=pr&utm_campaign=Medical_Devices
Descriptions of various medical devices used in aesthetic medicine, including light-based systems, sound-based systems, and mechanical technologies. A focus on the end-user market, including physician's offices and medical spas. Analysis of global market trends, with data from 2009, estimates for 2010, and projections of compound annual growth rates (CAGRs) through 2015. Coverage of various technologies, including silicone gel, cohesive, and saline breast implants; ultrasound-, laser-, and water-jet-assisted liposuction devices; laser devices for skin resurfacing, hair removal, and varicose vein removal; soft-tissue fillers (hyaluronic acid, collagen, PMMA, poly-L-lactic acid); botulinum toxins; tattoo removal devices; and microdermabrasion devices. An overview of the emerging home-use device market. Discussion of guidelines issued by professional groups and insurers.
INTRODUCTION
STUDY GOALS AND OBJECTIVES
This report examines the global market for materials and devices used in the delivery of aesthetic treatments.
The key objective is to present a comprehensive analysis of the medical aesthetic devices market for its five largest sectors and to forecast the direction of the global market through 2015.
REASONS FOR DOING THE STUDY
Recent U.S. Food and Drug Administration (FDA) approvals have expanded the number of medical aesthetic devices available in the U.S. These items have been available elsewhere in the world for many years, social stigmas or the absence of a middle class that can afford them has inhibited their adoption until now.
The expansion of the middle classes in developing economies, shifts in cultural outlooks for developed economies, and regulatory actions in the U.S. have led to a rapidly changing global market for medical aesthetic devices.
SCOPE OF REPORT
This report details the principles of operation, method of manufacture, regulatory restrictions, and current status of the global market for the following medical aesthetic devices:
Botulinum neuromodulators for aesthetic applications Breast augmentation devices, including implants and injectable materials Injectable dermal fillers Devices for assisted liposuction using ultrasound, light, or water Externally-applied energy-emitting devices for:
Permanent hair removal Ablative skin resurfacing Non-ablative skin resurfacing Treatment of vascular skin lesions Skin tightening Tattoo removal Acne treatment Treatment of pigmented skin lesions Cellulite reducti The global market is also segmented geographically into the following regions:
U.S Brazil China India Mexico Japan Europe Rest of the World Trends in the markets are identified and used in conjunction with past market behavior to forecast future revenues and compounded annual growth rates (CAGRs) in current U.S. dollars from 2010 to 2015.
The regulatory environment for medical devices and drugs in the U.S. and Europe is described in detail, as it exerts a strong effect on the availability of the devices considered in this report. The properties and characteristics of human skin, hair, and breasts are discussed insofar as they affect device demand.
CHAPTER ONE: INTRODUCTION
STUDY GOALS AND OBJECTIVES
REASONS FOR DOING THE STUDY
SCOPE OF REPORT
INTENDED AUDIENCE
METHODOLOGY AND INFORMATION SOURCES
ANALYST CREDENTIALS
RELATED BCC REPORTS
BCC ONLINE SERVICES
DISCLAIMER
CHAPTER TWO: SUMMARY
SUMMARY
SUMMARY TABLE 1 GLOBAL DEMAND FOR MEDICAL AESTHETIC DEVICES BY REGION, THROUGH 2015 ($ MILLIONS)
SUMMARY FIGURE GLOBAL DEMAND FOR MEDICAL AESTHEIC DEVICES BY REGION, 2009-2015 ($ MILLIONS)
SUMMARY TABLE 2 GLOBAL DEMAND FOR MEDICAL AESTHETIC DEVICES BY TECHNOLOGY, 2009-2015 ($ MILLIONS)
CHAPTER THREE: INDUSTRY OVERVIEW
PRACTITIONERS
TABLE 1 U.S. PHYSICIANS BY SPECIALTY, 2009
MEDICAL SOCIETIES
PATIENTS
SEX DISTRIBUTION
AGE DISTRIBUTION
INCOME DISTRIBUTION
TABLE 2 MIDDLE- AND UPPER-INCOME WOMEN BY REGION, 2009-2015 (MILLIONS)
SURGERY VERSUS MINIMAL INVASIVENESS
MEDICAL TOURISM
INDUSTRY INTEGRATION
TABLE 3 HORIZONTAL INTEGRATION OF INJECTABLES MANUFACTURERS
TABLE 4 HORIZONTAL INTEGRATION OF LASER DEVICE MANUFACTURERS
COMBINATION TREATMENTS
PATIENT COMFORT
HAND REJUVENATION
CHAPTER FOUR: PROPERTIES OF HUMAN SKIN
SKIN LAYERS
HYPODERMIS
DERMIS
EPIDERMIS
COMPONENTS OF SKIN TISSUE
COLLAGEN
ELASTIN
HYALURONIC ACID
FITZPATRICK SCALE
TABLE 5 FITZPATRICK SKIN PHOTOTYPES
FACIAL ANATOMY
MUSCLES
WRINKLES
CHAPTER FIVE: REGULATORY ASPECTS
UNITED STATES
MEDICAL DEVICES
Premarket Approval
Pre-Market Notification
Investigational Device Exemption
Post-Market Surveillance
Quality System Regulation
Device Modifications
Adverse Events Reporting
BIOLOGICAL LICENSE APPLICATION
LASER SAFETY
OFF-LABEL USE
INTERNATIONAL STANDARDS
EUROPEAN UNION
DRUGS
JAPAN
CHINA
OTHER COUNTRIES
CHAPTER SIX: BOTULINUM NEUROMODULATORS
DESCRIPTION
HISTORY
MARKET OVERVIEW
TABLE 6 BOTULINUM MODULATORS ON THE GLOBAL MARKET
MANUFACTURING
TABLE 7 MATERIAL CHARACTERISTICS OF BOTULINUM PRODUCTS
DISTRIBUTION AND PACKAGING
APPLICATION
TABLE 8 TYPICAL DOSES USED IN BOTOX TREATMENTS
EFFECTS
FACTORS DRIVING GROWTH
GEOGRAPHIC DISTRIBUTION
TABLE 9 FEMALE POPULATION AGE 35 TO 65, 2010 AND 2015 (MILLIONS)
TABLE 10 GLOBAL MARKET FORECAST FOR BOTULINUM TOXIN BY REGION, THROUGH 2015 (THOUSANDS)
TABLE 11 GLOBAL MARKET FORECAST FOR BOTULINUM TOXIN SALES BY REGION, THROUGH 2015 ($ MILLIONS)
SKIN TYPE PREVALENCE
NEW APPLICATIONS
PRICE
FACTORS INHIBITING GROWTH
SAFETY
FAKE BOTOX
REGULATORY
PRODUCTION CAPACITY
TERRORIST ACTIVITY
PRODUCT PIPELINE
NEW FORMULATIONS
PurTox
Neuronox
RT001 and RT002
NEW PRODUCTS
CRYO-TOUCH
NEW DRUGS
TABLE 12 PATENTS RELATED TO BTX PRODUCTION AND FORMULATION METHODS
TABLE 13 PATENTS RELATED TO NEW USES AND DELIVERY
MODES OF BTX PRODUCTS
TABLE 14 PATENTS RELATED TO REPLACEMENTS FOR BTX
TABLE 15 OTHER BOTULINUM PATENTS
CHAPTER SEVEN: DERMAL FILLERS
POLY-L-LACTIC ACID
HISTORY
DESCRIPTION
APPLICATION
COST
DEMOGRAPHICS
CALCIUM HYDROXYLAPATITE
HISTORY
DESCRIPTION
APPLICATION
COST
DEMOGRAPHICS
COLLAGEN
HISTORY
DESCRIPTION
TABLE 16 COLLAGEN-BASED DERMAL FILLERS
APPLICATION
COST
HYALURONIC ACID
HISTORY
TABLE 17 HYALURONIC ACID MANUFACTURERS
DESCRIPTION
PRODUCT OVERVIEW
APPLICATION
COST
DEMOGRAPHICS
PERMANENT FILLERS
TABLE 18 PROPERTIES OF AN IDEAL NON-ABSORBABLE FILLER
Polyacrylamide
Polyalkylimide
Bioplastique (Uroplasty)
Silicone
Polymethylmethacrylate
Gore-Tex
Laresse
PRODUCT PIPELINE
EPLICA
KYTHERA
LAVIV
NOVABEL
EMERVEL
FACTORS AFFECTING GROWTH
REGULATORY
U.S.
Europe
COST
DURATION
TABLE 19 COMPARATIVE COSTS OF DERMAL FILLERS ($)
QUALITY
SAFETY
TABLE 20 DERMAL FILLER INJURIES REPORTED TO THE FDA, 2009 AND 2010
AGE PROGRESSION
FORECAST BY REGION
TABLE 21 DERMAL FILLER REVENUES BY TECHNOLOGY, THROUGH 2015 ($ MILLIONS)
TABLE 22 DERMAL FILLER REVENUES BY REGION, THROUGH 2015 ($ MILLIONS)
TABLE 23 U.S. DERMAL FILLER REVENUES, THROUGH 2015 ($ MILLIONS)
TABLE 24 BRAZIL DERMAL FILLER REVENUES, THROUGH 2015 ($ MILLIONS)
TABLE 25 CHINA DERMAL FILLER REVENUES, THROUGH 2015 ($ MILLIONS)
TABLE 26 INDIA DERMAL FILLER REVENUES, THROUGH 2015 ($ MILLIONS)
TABLE 27 MEXICO DERMAL FILLER REVENUES, THROUGH 2015 ($ MILLIONS)
TABLE 28 JAPAN DERMAL FILLER REVENUES, THROUGH 2015 ($ MILLIONS)
TABLE 29 EUROPE DERMAL FILLER REVENUES, THROUGH 2015 ($ MILLIONS)
TABLE 30 REST OF WORLD DERMAL FILLER REVENUES, THROUGH 2015 ($ MILLIONS)
FORECAST BY MATERIAL
TABLE 31 POLY-L-LACTIC ACID DERMAL FILLER REVENUES BY REGION, THROUGH 2015 ($ MILLIONS)
TABLE 32 COLLAGEN DERMAL FILLER REVENUES BY REGION, THROUGH 2015 ($ MILLIONS)
TABLE 33 CALCIUM HYDROXYLAPATITE DERMAL FILLER REVENUES BY REGION, THROUGH 2015 ($ MILLIONS)
TABLE 34 HYALURONIC ACID DERMAL FILLER REVENUES BY REGION, THROUGH 2015 ($ MILLIONS)
TABLE 35 PERMANENT DERMAL FILLER REVENUES BY REGION, THROUGH 2015 ($ MILLIONS)
PATENTS
TABLE 36 PATENTS FOR CALCIUM HYDROXLYAPATITE
TABLE 37 PATENTS FOR HYALURONIC ACID
TABLE 38 PATENTS FOR PERMANENT DERMAL FILLERS
TABLE 39 PATENTS FOR OTHER DERMAL FILLERS
CHAPTER EIGHT: BREAST AUGMENTATION
STRUCTURE OF THE BREAST
EARLY ATTEMPTS
SILICON AND SILICONE
IMPLANT STRUCTURE
IMPLANT SHAPES
SILICONE LITIGATION
TABLE 40 MEDICAL ORGANIZATIONS' COMMENTS REGARDING THE SAFETY OF SILICONE IMPLANTS
PLATINUM
IMPLANT PROCEDURE
PHYSICIAN/FACILITY
ANESTHESIA
INCISION
IMPLANT PLACEMENT
DOWNTIME
COMPLICATIONS
Capsular Contracture
Synmastia
Bottoming Out
Infection
Rippling
Silent Rupture
Mammography
Breastfeeding
LONGEVITY OF RESULTS
TABLE 41 COMPARISON OF SALINE-FILLED AND SILICONE GELFILLED IMPLANTS (%)
GUMMY BEAR IMPLANTS
TABLE 42 MANUFACTURERS OF HIGH-COHESIVE SILICONE GEL IMPLANTS
MACROLANE
BREFORM
OTHER BODY IMPLANTS
EPLICA
MARKET OVERVIEW
TABLE 43 PRODUCERS OF SALINE BREAST IMPLANTS
TABLE 44 PRODUCERS OF SILICONE BREAST IMPLANTS
COST
INSURANCE COVERAGE
WARRANTY
MATERIAL
REGULATORY
U.S.
ANAPLASTIC LARGE CELL LYMPHOMA
Globally
DEMOGRAPHICS
CULTURE
PATIENT INPUT
FORECAST BY REGION
TABLE 45 GLOBAL DEMAND FOR BREAST AUGMENTATION DEVICES, THROUGH 2015 ($ MILLIONS)
FORECAST BY TECHNOLOGY
TABLE 46 SALINE-FILLED BREAST IMPLANTS AMONG ALL BREAST IMPLANTS, 2009-2015 (%)
TABLE 47 GLOBAL DEMAND FOR SALINE-FILLED BREAST IMPLANTS, THROUGH 2015 ($ MILLIONS)
TABLE 48 GLOBAL DEMAND FOR SILICONE GEL-FILLED BREAST IMPLANTS, THROUGH 2015 ($ MILLIONS)
TABLE 49 GLOBAL DEMAND FOR GUMMY BEAR BREAST IMPLANTS, THROUGH 2015 ($ MILLIONS)
TABLE 50 GLOBAL DEMAND FOR MACROLANE BREAST INJECTIONS, THROUGH 2015 ($ MILLIONS)
PATENTS
TABLE 51 PATENTS FOR COHESIVE-GEL IMPLANTS
TABLE 52 PATENTS FOR TEXTURED SURFACES
TABLE 53 OTHER BREAST IMPLANT PATENTS
CHAPTER NINE: EXTERNAL ENERGY-EMITTING DEVICES
APPLICATIONS OF DEVICES
TABLE 54 EEED PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
TABLE 55 EEED PROCEDURES BY REGION, THROUGH 2015 (THOUSANDS)
TABLE 56 U.S. EEED PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
TABLE 57 BRAZIL EEED PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
TABLE 58 CHINA EEED PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
TABLE 59 INDIA EEED PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
TABLE 60 MEXICO EEED PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
TABLE 61 JAPAN EEED PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
TABLE 62 EUROPE EEED LASER PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
TABLE 63 REST OF WORLD EEED PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
HAIR REMOVAL
Hair Structure and Growth
Principle of Operation
TABLE 64 DEVICES FOR HAIR REMOVAL
History
Treatment
ABLATIVE SKIN RESURFACING
Principle of Operation
Treatment
TABLE 65 DEVICES FOR ABLATIVE SKIN RESURFACING
NON-ABLATIVE SKIN RESURFACING
TABLE 66 DEVICES FOR NON-ABLATIVE SKIN RESURFACING
VASCULAR LESIONS
Varicose Veins
Principle of Operation
Procedure
TABLE 67 DEVICES FOR VASCULAR LESIONS
Demographics
SKIN TIGHTENING
TABLE 68 DEVICES FOR SKIN TIGHTENING
TATTOO REMOVAL
TABLE 69 DEVICES FOR TATTOO REMOVAL
ACNE
TABLE 70 DEVICES FOR ACNE TREATMENT
PIGMENTED LESIONS
TABLE 71 DEVICES FOR THE TREATMENT OF PIGMENTED LESIONS
CELLULITE
TABLE 72 DEVICES FOR THE TREATMENT OF CELLULITE
TYPES OF DEVICES
LASERS
Properties of Laser Light
Principle of Operation
Application
TABLE 73 EEED LIGHT SOURCES (NM)
Q-Switching
Thulium Lasers
Neodymium-Yttrium Aluminum Garnet Lasers
Erbium Lasers
Yttrium-Scandium-Gallium Garnet Lasers
Diode Lasers
Potassium Titanyl Phosphate
Carbon Dioxide Lasers
Ruby Lasers
Dye Lasers
Alexandrite Lasers
LIGHT-EMITTING DIODES
FLASHLAMPS
RADIOFREQUENCY
ELĂ?S
SPOT SIZE
FRACTIONAL DEVICES
EPIDERMAL COOLING
MARKET OVERVIEW
MODULARITY
CONSUMABLES
TABLE 74 EEED PRINCIPAL CONSUMABLES, 2010 ($ MILLIONS)
OVER-THE-COUNTER DEVICES
TABLE 75 FDA-CLEARED OVER-THE-COUNTER EEEDS
MARKETING
TABLE 76 EEED MANUFACTURERS, 2009-2010 ($ MILLIONS)
ALMA LASERS
TABLE 77 ALMA LASERS EEED PRODUCTS
CUTERA
TABLE 78 CUTERA EEED PRODUCTS
CYNOSURE
TABLE 79 CYNOSURE EEED PRODUCTS
IRIDEX
TABLE 80 IRIDEX EEED PRODUCTS
LUMENIS
TABLE 81 LUMENIS EEED PRODUCTS
PALOMAR MEDICAL
TABLE 82 PALOMAR MEDICAL EEED PRODUCTS
SOLTA MEDICAL
TABLE 83 SOLTA MEDICAL EEED PRODUCTS
SYNERON
TABLE 84 SYNERON EEED PRODUCTS
REGULATORY ISSUES
SAFETY
FORECAST BY CATEGORY AND TECHNOLOGY
CORE MARKET
NON-CORE MARKETS
NEW UNIT SALES
UPGRADE SALES
SYSTEM LEASING
CONSUMABLE SALES
TABLE 85 EEED MARKET BY TECHNOLOGY, THROUGH 2015 ($ MILLIONS)
TABLE 86 EEED MARKET BY CATEGORY, THROUGH 2015 ($ MILLIONS)
FORECAST BY GEOGRAPHY
TABLE 87 EEED MARKET, THROUGH 2015 ($ MILLIONS)
TABLE 88 EEED NEW UNITS MARKET BY REGION, THROUGH 2015 ($ MILLIONS)
TABLE 89 EEED MARKET UPGRADES BY REGION, THROUGH 2015 ($ MILLIONS)
TABLE 90 EEED CONSUMABLES MARKET BY REGION, THROUGH 2015 ($ MILLIONS)
PRODUCT PIPELINE
NEW TECHNOLOGY
PATENTS
FRACTIONAL TECHNOLOGY OPEN PATENT PROGRAM
TABLE 91 PATENTS AND PATENT APPLICATIONS FOR FRACTIONAL METHODS
TABLE 92 PATENTS FOR HAIR REMOVAL
TABLE 93 PATENTS FOR EPIDERMAL COOLING
TABLE 94 PATENTS FOR WRINKLE REDUCTION
TABLE 95 PATENTS INVOLVING ACNE, SKIN LESIONS, AND TATTOOS
TABLE 96 PATENTS FOR RADIOFREQUENCY METHODS
TABLE 97 OTHER EEED PATENTS
CHAPTER TEN: DEVICES FOR ASSISTED LIPOSUCTION
TABLE 98 GLOBAL OVERWEIGHT ADULT FEMALE POPULATION, 2010-2015 (MILLIONS)
STRUCTURE OF FAT
EARLY ATTEMPTS
SUITABILITY FOR LIPOSUCTION
TRADITIONAL PROCEDURE (SAL/PAL)
COMPLICATIONS AND SIDE EFFECTS
ULTRASOUND-ASSISTED LIPOSUCTION
LASER-ASSSTED LIPOSUCTION
WATER-ASSISTED LIPOSUCTION
TABLE 99 MANUFACTURERS OF LIPOSUCTION DEVICES
DEMOGRAPHICS
COMPARISON OF METHODS
COST
RESULTS
FORECAST BY REGION
TABLE 100 GLOBAL LIPOSUCTION PROCEDURES BY REGION, THROUGH 2015 (THOUSANDS)
TABLE 101 GLOBAL DEMAND FOR ASSISTIVE LIPOSUCTION DEVICES BY REGION, THROUGH 2015 ($ MILLIONS)
FORECAST BY TECHNOLOGY
TABLE 102 GLOBAL LIPOSUCTION PROCEDURES BY TECHNOLOGY, THROUGH 2015 (THOUSANDS)
TABLE 103 GLOBAL DEMAND FOR ASSISTIVE LIPOSUCTION DEVICES BY TECHNOLOGY, THROUGH 2015 ($ MILLIONS)
PRODUCT PIPELINE
FAT TRANSFER
HIGH-INTENSITY FOCUSED ULTRASOUND
INJECTION LIPOLYSIS
PATENTS
TABLE 104 PATENTS FOR LASER-ASSISTED LIPOSUCTION
TABLE 105 PATENTS FOR ULTRASOUND-ASSISTED LIPOSUCTION
TABLE 106 PATENTS FOR WATER-ASSISTED LIPOSUCTION
TABLE 107 OTHER ASSISTED-LIPOSUCTION PATENTS
CHAPTER ELEVEN: COMPANY PROFILES
ALCON, INC.
ALLERGAN, INC.
ALMA LASERS, LTD.
ANIKA THERAPEUTICS, INC
ANTEIS SA
BIOCOMPATIBLES INTERNATIONAL
BIOFORM MEDICAL, INC.
BIOSIL, LTD.
BREFORM LIMITED
CONTURA INTERNATIONAL A/S
CRISALIX S.A.
CUTERA
CYNOSURE, INC.
DEKA LASER
EL.EN. GROUP
ETHICON
EUROSILICONE S.A.S.
FIBROCELL SCIENCE, INC.
FOCUS MEDICAL
FZIOMED, INC.
GALDERMA PHARMA SA/GALDERMA SA
GENZYME CORPORATION
GLOBAL CONSOLIDATED AESTHETICS, LTD.
HOYA CONBIO
HUMAN MED AG
IPSEN PHARMA
IRIDEX CORP.
JOHNSON & JOHNSON
LANZHOU INSTITUTE OF BIOLOGICAL PRODUCTS
LASERING
LCA PHARMACEUTICAL
LUMENIS, LTD.
LUTRONIC, INC.
MEDICIS PHARMACEUTICAL CORP.
MEDICIS TECHNOLOGIES CORPORATION
MEDY-TOX, INC.
MENTOR WORLDWIDE LLC
MERZ GMBH & CO. KGAA
MISONIX, INC.
MYOSCIENCE INC.
NAGOR, LTD.
OSYRIS MEDICAL
PALOMAR MEDICAL TECHNOLOGIES, INC.
PHAROS LIFE CORPORATION
POLYMEKON S.R.L.
PROLLENIUM MEDICAL TECHNOLOGIES, INC.
Q-MED AB
REVANCE THERAPEUTICS, INC.
SANOFI-AVENTIS U.S., LLC
SCITON, INC.
SEBBIN (LABORATOIRES SEBBIN)
SIENTRA, INC.
SILIMED LTDA.
SOLSTICE NEUROSCIENCES, LLC
SOLTA MEDICAL, INC.
SOERING GMBH MEDIZINTECHNIK
SOUND SURGICAL TECHNOLOGIES, LLC
STIEFEL LABORATORIES, INC.
SUNEVA MEDICAL, INC.
SYNERON MEDICAL, LTD.
SYNOPTICS (NORTHROP GRUMMAN SYNOPTICS)
TEOXANE (LABORATOIRES TEOXANE)
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Nicolas BombourgReportlinkerEmail: [email protected]US: (805)652-2626Intl: +1 805-652-2626
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Descriptions of various medical devices used in aesthetic medicine, including light-based systems, sound-based systems, and mechanical technologies. A focus on the end-user market, including physician's offices and medical spas. Analysis of global market trends, with data from 2009, estimates for 2010, and projections of compound annual growth rates (CAGRs) through 2015. Coverage of various technologies, including silicone gel, cohesive, and saline breast implants; ultrasound-, laser-, and water-jet-assisted liposuction devices; laser devices for skin resurfacing, hair removal, and varicose vein removal; soft-tissue fillers (hyaluronic acid, collagen, PMMA, poly-L-lactic acid); botulinum toxins; tattoo removal devices; and microdermabrasion devices. An overview of the emerging home-use device market. Discussion of guidelines issued by professional groups and insurers.
INTRODUCTION
STUDY GOALS AND OBJECTIVES
This report examines the global market for materials and devices used in the delivery of aesthetic treatments.
The key objective is to present a comprehensive analysis of the medical aesthetic devices market for its five largest sectors and to forecast the direction of the global market through 2015.
REASONS FOR DOING THE STUDY
Recent U.S. Food and Drug Administration (FDA) approvals have expanded the number of medical aesthetic devices available in the U.S. These items have been available elsewhere in the world for many years, social stigmas or the absence of a middle class that can afford them has inhibited their adoption until now.
The expansion of the middle classes in developing economies, shifts in cultural outlooks for developed economies, and regulatory actions in the U.S. have led to a rapidly changing global market for medical aesthetic devices.
SCOPE OF REPORT
This report details the principles of operation, method of manufacture, regulatory restrictions, and current status of the global market for the following medical aesthetic devices:
Botulinum neuromodulators for aesthetic applications Breast augmentation devices, including implants and injectable materials Injectable dermal fillers Devices for assisted liposuction using ultrasound, light, or water Externally-applied energy-emitting devices for:
Permanent hair removal Ablative skin resurfacing Non-ablative skin resurfacing Treatment of vascular skin lesions Skin tightening Tattoo removal Acne treatment Treatment of pigmented skin lesions Cellulite reducti The global market is also segmented geographically into the following regions:
U.S Brazil China India Mexico Japan Europe Rest of the World Trends in the markets are identified and used in conjunction with past market behavior to forecast future revenues and compounded annual growth rates (CAGRs) in current U.S. dollars from 2010 to 2015.
The regulatory environment for medical devices and drugs in the U.S. and Europe is described in detail, as it exerts a strong effect on the availability of the devices considered in this report. The properties and characteristics of human skin, hair, and breasts are discussed insofar as they affect device demand.
CHAPTER ONE: INTRODUCTION
STUDY GOALS AND OBJECTIVES
REASONS FOR DOING THE STUDY
SCOPE OF REPORT
INTENDED AUDIENCE
METHODOLOGY AND INFORMATION SOURCES
ANALYST CREDENTIALS
RELATED BCC REPORTS
BCC ONLINE SERVICES
DISCLAIMER
CHAPTER TWO: SUMMARY
SUMMARY
SUMMARY TABLE 1 GLOBAL DEMAND FOR MEDICAL AESTHETIC DEVICES BY REGION, THROUGH 2015 ($ MILLIONS)
SUMMARY FIGURE GLOBAL DEMAND FOR MEDICAL AESTHEIC DEVICES BY REGION, 2009-2015 ($ MILLIONS)
SUMMARY TABLE 2 GLOBAL DEMAND FOR MEDICAL AESTHETIC DEVICES BY TECHNOLOGY, 2009-2015 ($ MILLIONS)
CHAPTER THREE: INDUSTRY OVERVIEW
PRACTITIONERS
TABLE 1 U.S. PHYSICIANS BY SPECIALTY, 2009
MEDICAL SOCIETIES
PATIENTS
SEX DISTRIBUTION
AGE DISTRIBUTION
INCOME DISTRIBUTION
TABLE 2 MIDDLE- AND UPPER-INCOME WOMEN BY REGION, 2009-2015 (MILLIONS)
SURGERY VERSUS MINIMAL INVASIVENESS
MEDICAL TOURISM
INDUSTRY INTEGRATION
TABLE 3 HORIZONTAL INTEGRATION OF INJECTABLES MANUFACTURERS
TABLE 4 HORIZONTAL INTEGRATION OF LASER DEVICE MANUFACTURERS
COMBINATION TREATMENTS
PATIENT COMFORT
HAND REJUVENATION
CHAPTER FOUR: PROPERTIES OF HUMAN SKIN
SKIN LAYERS
HYPODERMIS
DERMIS
EPIDERMIS
COMPONENTS OF SKIN TISSUE
COLLAGEN
ELASTIN
HYALURONIC ACID
FITZPATRICK SCALE
TABLE 5 FITZPATRICK SKIN PHOTOTYPES
FACIAL ANATOMY
MUSCLES
WRINKLES
CHAPTER FIVE: REGULATORY ASPECTS
UNITED STATES
MEDICAL DEVICES
Premarket Approval
Pre-Market Notification
Investigational Device Exemption
Post-Market Surveillance
Quality System Regulation
Device Modifications
Adverse Events Reporting
BIOLOGICAL LICENSE APPLICATION
LASER SAFETY
OFF-LABEL USE
INTERNATIONAL STANDARDS
EUROPEAN UNION
DRUGS
JAPAN
CHINA
OTHER COUNTRIES
CHAPTER SIX: BOTULINUM NEUROMODULATORS
DESCRIPTION
HISTORY
MARKET OVERVIEW
TABLE 6 BOTULINUM MODULATORS ON THE GLOBAL MARKET
MANUFACTURING
TABLE 7 MATERIAL CHARACTERISTICS OF BOTULINUM PRODUCTS
DISTRIBUTION AND PACKAGING
APPLICATION
TABLE 8 TYPICAL DOSES USED IN BOTOX TREATMENTS
EFFECTS
FACTORS DRIVING GROWTH
GEOGRAPHIC DISTRIBUTION
TABLE 9 FEMALE POPULATION AGE 35 TO 65, 2010 AND 2015 (MILLIONS)
TABLE 10 GLOBAL MARKET FORECAST FOR BOTULINUM TOXIN BY REGION, THROUGH 2015 (THOUSANDS)
TABLE 11 GLOBAL MARKET FORECAST FOR BOTULINUM TOXIN SALES BY REGION, THROUGH 2015 ($ MILLIONS)
SKIN TYPE PREVALENCE
NEW APPLICATIONS
PRICE
FACTORS INHIBITING GROWTH
SAFETY
FAKE BOTOX
REGULATORY
PRODUCTION CAPACITY
TERRORIST ACTIVITY
PRODUCT PIPELINE
NEW FORMULATIONS
PurTox
Neuronox
RT001 and RT002
NEW PRODUCTS
CRYO-TOUCH
NEW DRUGS
TABLE 12 PATENTS RELATED TO BTX PRODUCTION AND FORMULATION METHODS
TABLE 13 PATENTS RELATED TO NEW USES AND DELIVERY
MODES OF BTX PRODUCTS
TABLE 14 PATENTS RELATED TO REPLACEMENTS FOR BTX
TABLE 15 OTHER BOTULINUM PATENTS
CHAPTER SEVEN: DERMAL FILLERS
POLY-L-LACTIC ACID
HISTORY
DESCRIPTION
APPLICATION
COST
DEMOGRAPHICS
CALCIUM HYDROXYLAPATITE
HISTORY
DESCRIPTION
APPLICATION
COST
DEMOGRAPHICS
COLLAGEN
HISTORY
DESCRIPTION
TABLE 16 COLLAGEN-BASED DERMAL FILLERS
APPLICATION
COST
HYALURONIC ACID
HISTORY
TABLE 17 HYALURONIC ACID MANUFACTURERS
DESCRIPTION
PRODUCT OVERVIEW
APPLICATION
COST
DEMOGRAPHICS
PERMANENT FILLERS
TABLE 18 PROPERTIES OF AN IDEAL NON-ABSORBABLE FILLER
Polyacrylamide
Polyalkylimide
Bioplastique (Uroplasty)
Silicone
Polymethylmethacrylate
Gore-Tex
Laresse
PRODUCT PIPELINE
EPLICA
KYTHERA
LAVIV
NOVABEL
EMERVEL
FACTORS AFFECTING GROWTH
REGULATORY
U.S.
Europe
COST
DURATION
TABLE 19 COMPARATIVE COSTS OF DERMAL FILLERS ($)
QUALITY
SAFETY
TABLE 20 DERMAL FILLER INJURIES REPORTED TO THE FDA, 2009 AND 2010
AGE PROGRESSION
FORECAST BY REGION
TABLE 21 DERMAL FILLER REVENUES BY TECHNOLOGY, THROUGH 2015 ($ MILLIONS)
TABLE 22 DERMAL FILLER REVENUES BY REGION, THROUGH 2015 ($ MILLIONS)
TABLE 23 U.S. DERMAL FILLER REVENUES, THROUGH 2015 ($ MILLIONS)
TABLE 24 BRAZIL DERMAL FILLER REVENUES, THROUGH 2015 ($ MILLIONS)
TABLE 25 CHINA DERMAL FILLER REVENUES, THROUGH 2015 ($ MILLIONS)
TABLE 26 INDIA DERMAL FILLER REVENUES, THROUGH 2015 ($ MILLIONS)
TABLE 27 MEXICO DERMAL FILLER REVENUES, THROUGH 2015 ($ MILLIONS)
TABLE 28 JAPAN DERMAL FILLER REVENUES, THROUGH 2015 ($ MILLIONS)
TABLE 29 EUROPE DERMAL FILLER REVENUES, THROUGH 2015 ($ MILLIONS)
TABLE 30 REST OF WORLD DERMAL FILLER REVENUES, THROUGH 2015 ($ MILLIONS)
FORECAST BY MATERIAL
TABLE 31 POLY-L-LACTIC ACID DERMAL FILLER REVENUES BY REGION, THROUGH 2015 ($ MILLIONS)
TABLE 32 COLLAGEN DERMAL FILLER REVENUES BY REGION, THROUGH 2015 ($ MILLIONS)
TABLE 33 CALCIUM HYDROXYLAPATITE DERMAL FILLER REVENUES BY REGION, THROUGH 2015 ($ MILLIONS)
TABLE 34 HYALURONIC ACID DERMAL FILLER REVENUES BY REGION, THROUGH 2015 ($ MILLIONS)
TABLE 35 PERMANENT DERMAL FILLER REVENUES BY REGION, THROUGH 2015 ($ MILLIONS)
PATENTS
TABLE 36 PATENTS FOR CALCIUM HYDROXLYAPATITE
TABLE 37 PATENTS FOR HYALURONIC ACID
TABLE 38 PATENTS FOR PERMANENT DERMAL FILLERS
TABLE 39 PATENTS FOR OTHER DERMAL FILLERS
CHAPTER EIGHT: BREAST AUGMENTATION
STRUCTURE OF THE BREAST
EARLY ATTEMPTS
SILICON AND SILICONE
IMPLANT STRUCTURE
IMPLANT SHAPES
SILICONE LITIGATION
TABLE 40 MEDICAL ORGANIZATIONS' COMMENTS REGARDING THE SAFETY OF SILICONE IMPLANTS
PLATINUM
IMPLANT PROCEDURE
PHYSICIAN/FACILITY
ANESTHESIA
INCISION
IMPLANT PLACEMENT
DOWNTIME
COMPLICATIONS
Capsular Contracture
Synmastia
Bottoming Out
Infection
Rippling
Silent Rupture
Mammography
Breastfeeding
LONGEVITY OF RESULTS
TABLE 41 COMPARISON OF SALINE-FILLED AND SILICONE GELFILLED IMPLANTS (%)
GUMMY BEAR IMPLANTS
TABLE 42 MANUFACTURERS OF HIGH-COHESIVE SILICONE GEL IMPLANTS
MACROLANE
BREFORM
OTHER BODY IMPLANTS
EPLICA
MARKET OVERVIEW
TABLE 43 PRODUCERS OF SALINE BREAST IMPLANTS
TABLE 44 PRODUCERS OF SILICONE BREAST IMPLANTS
COST
INSURANCE COVERAGE
WARRANTY
MATERIAL
REGULATORY
U.S.
ANAPLASTIC LARGE CELL LYMPHOMA
Globally
DEMOGRAPHICS
CULTURE
PATIENT INPUT
FORECAST BY REGION
TABLE 45 GLOBAL DEMAND FOR BREAST AUGMENTATION DEVICES, THROUGH 2015 ($ MILLIONS)
FORECAST BY TECHNOLOGY
TABLE 46 SALINE-FILLED BREAST IMPLANTS AMONG ALL BREAST IMPLANTS, 2009-2015 (%)
TABLE 47 GLOBAL DEMAND FOR SALINE-FILLED BREAST IMPLANTS, THROUGH 2015 ($ MILLIONS)
TABLE 48 GLOBAL DEMAND FOR SILICONE GEL-FILLED BREAST IMPLANTS, THROUGH 2015 ($ MILLIONS)
TABLE 49 GLOBAL DEMAND FOR GUMMY BEAR BREAST IMPLANTS, THROUGH 2015 ($ MILLIONS)
TABLE 50 GLOBAL DEMAND FOR MACROLANE BREAST INJECTIONS, THROUGH 2015 ($ MILLIONS)
PATENTS
TABLE 51 PATENTS FOR COHESIVE-GEL IMPLANTS
TABLE 52 PATENTS FOR TEXTURED SURFACES
TABLE 53 OTHER BREAST IMPLANT PATENTS
CHAPTER NINE: EXTERNAL ENERGY-EMITTING DEVICES
APPLICATIONS OF DEVICES
TABLE 54 EEED PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
TABLE 55 EEED PROCEDURES BY REGION, THROUGH 2015 (THOUSANDS)
TABLE 56 U.S. EEED PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
TABLE 57 BRAZIL EEED PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
TABLE 58 CHINA EEED PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
TABLE 59 INDIA EEED PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
TABLE 60 MEXICO EEED PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
TABLE 61 JAPAN EEED PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
TABLE 62 EUROPE EEED LASER PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
TABLE 63 REST OF WORLD EEED PROCEDURES BY APPLICATION, THROUGH 2015 (THOUSANDS)
HAIR REMOVAL
Hair Structure and Growth
Principle of Operation
TABLE 64 DEVICES FOR HAIR REMOVAL
History
Treatment
ABLATIVE SKIN RESURFACING
Principle of Operation
Treatment
TABLE 65 DEVICES FOR ABLATIVE SKIN RESURFACING
NON-ABLATIVE SKIN RESURFACING
TABLE 66 DEVICES FOR NON-ABLATIVE SKIN RESURFACING
VASCULAR LESIONS
Varicose Veins
Principle of Operation
Procedure
TABLE 67 DEVICES FOR VASCULAR LESIONS
Demographics
SKIN TIGHTENING
TABLE 68 DEVICES FOR SKIN TIGHTENING
TATTOO REMOVAL
TABLE 69 DEVICES FOR TATTOO REMOVAL
ACNE
TABLE 70 DEVICES FOR ACNE TREATMENT
PIGMENTED LESIONS
TABLE 71 DEVICES FOR THE TREATMENT OF PIGMENTED LESIONS
CELLULITE
TABLE 72 DEVICES FOR THE TREATMENT OF CELLULITE
TYPES OF DEVICES
LASERS
Properties of Laser Light
Principle of Operation
Application
TABLE 73 EEED LIGHT SOURCES (NM)
Q-Switching
Thulium Lasers
Neodymium-Yttrium Aluminum Garnet Lasers
Erbium Lasers
Yttrium-Scandium-Gallium Garnet Lasers
Diode Lasers
Potassium Titanyl Phosphate
Carbon Dioxide Lasers
Ruby Lasers
Dye Lasers
Alexandrite Lasers
LIGHT-EMITTING DIODES
FLASHLAMPS
RADIOFREQUENCY
ELĂ?S
SPOT SIZE
FRACTIONAL DEVICES
EPIDERMAL COOLING
MARKET OVERVIEW
MODULARITY
CONSUMABLES
TABLE 74 EEED PRINCIPAL CONSUMABLES, 2010 ($ MILLIONS)
OVER-THE-COUNTER DEVICES
TABLE 75 FDA-CLEARED OVER-THE-COUNTER EEEDS
MARKETING
TABLE 76 EEED MANUFACTURERS, 2009-2010 ($ MILLIONS)
ALMA LASERS
TABLE 77 ALMA LASERS EEED PRODUCTS
CUTERA
TABLE 78 CUTERA EEED PRODUCTS
CYNOSURE
TABLE 79 CYNOSURE EEED PRODUCTS
IRIDEX
TABLE 80 IRIDEX EEED PRODUCTS
LUMENIS
TABLE 81 LUMENIS EEED PRODUCTS
PALOMAR MEDICAL
TABLE 82 PALOMAR MEDICAL EEED PRODUCTS
SOLTA MEDICAL
TABLE 83 SOLTA MEDICAL EEED PRODUCTS
SYNERON
TABLE 84 SYNERON EEED PRODUCTS
REGULATORY ISSUES
SAFETY
FORECAST BY CATEGORY AND TECHNOLOGY
CORE MARKET
NON-CORE MARKETS
NEW UNIT SALES
UPGRADE SALES
SYSTEM LEASING
CONSUMABLE SALES
TABLE 85 EEED MARKET BY TECHNOLOGY, THROUGH 2015 ($ MILLIONS)
TABLE 86 EEED MARKET BY CATEGORY, THROUGH 2015 ($ MILLIONS)
FORECAST BY GEOGRAPHY
TABLE 87 EEED MARKET, THROUGH 2015 ($ MILLIONS)
TABLE 88 EEED NEW UNITS MARKET BY REGION, THROUGH 2015 ($ MILLIONS)
TABLE 89 EEED MARKET UPGRADES BY REGION, THROUGH 2015 ($ MILLIONS)
TABLE 90 EEED CONSUMABLES MARKET BY REGION, THROUGH 2015 ($ MILLIONS)
PRODUCT PIPELINE
NEW TECHNOLOGY
PATENTS
FRACTIONAL TECHNOLOGY OPEN PATENT PROGRAM
TABLE 91 PATENTS AND PATENT APPLICATIONS FOR FRACTIONAL METHODS
TABLE 92 PATENTS FOR HAIR REMOVAL
TABLE 93 PATENTS FOR EPIDERMAL COOLING
TABLE 94 PATENTS FOR WRINKLE REDUCTION
TABLE 95 PATENTS INVOLVING ACNE, SKIN LESIONS, AND TATTOOS
TABLE 96 PATENTS FOR RADIOFREQUENCY METHODS
TABLE 97 OTHER EEED PATENTS
CHAPTER TEN: DEVICES FOR ASSISTED LIPOSUCTION
TABLE 98 GLOBAL OVERWEIGHT ADULT FEMALE POPULATION, 2010-2015 (MILLIONS)
STRUCTURE OF FAT
EARLY ATTEMPTS
SUITABILITY FOR LIPOSUCTION
TRADITIONAL PROCEDURE (SAL/PAL)
COMPLICATIONS AND SIDE EFFECTS
ULTRASOUND-ASSISTED LIPOSUCTION
LASER-ASSSTED LIPOSUCTION
WATER-ASSISTED LIPOSUCTION
TABLE 99 MANUFACTURERS OF LIPOSUCTION DEVICES
DEMOGRAPHICS
COMPARISON OF METHODS
COST
RESULTS
FORECAST BY REGION
TABLE 100 GLOBAL LIPOSUCTION PROCEDURES BY REGION, THROUGH 2015 (THOUSANDS)
TABLE 101 GLOBAL DEMAND FOR ASSISTIVE LIPOSUCTION DEVICES BY REGION, THROUGH 2015 ($ MILLIONS)
FORECAST BY TECHNOLOGY
TABLE 102 GLOBAL LIPOSUCTION PROCEDURES BY TECHNOLOGY, THROUGH 2015 (THOUSANDS)
TABLE 103 GLOBAL DEMAND FOR ASSISTIVE LIPOSUCTION DEVICES BY TECHNOLOGY, THROUGH 2015 ($ MILLIONS)
PRODUCT PIPELINE
FAT TRANSFER
HIGH-INTENSITY FOCUSED ULTRASOUND
INJECTION LIPOLYSIS
PATENTS
TABLE 104 PATENTS FOR LASER-ASSISTED LIPOSUCTION
TABLE 105 PATENTS FOR ULTRASOUND-ASSISTED LIPOSUCTION
TABLE 106 PATENTS FOR WATER-ASSISTED LIPOSUCTION
TABLE 107 OTHER ASSISTED-LIPOSUCTION PATENTS
CHAPTER ELEVEN: COMPANY PROFILES
ALCON, INC.
ALLERGAN, INC.
ALMA LASERS, LTD.
ANIKA THERAPEUTICS, INC
ANTEIS SA
BIOCOMPATIBLES INTERNATIONAL
BIOFORM MEDICAL, INC.
BIOSIL, LTD.
BREFORM LIMITED
CONTURA INTERNATIONAL A/S
CRISALIX S.A.
CUTERA
CYNOSURE, INC.
DEKA LASER
EL.EN. GROUP
ETHICON
EUROSILICONE S.A.S.
FIBROCELL SCIENCE, INC.
FOCUS MEDICAL
FZIOMED, INC.
GALDERMA PHARMA SA/GALDERMA SA
GENZYME CORPORATION
GLOBAL CONSOLIDATED AESTHETICS, LTD.
HOYA CONBIO
HUMAN MED AG
IPSEN PHARMA
IRIDEX CORP.
JOHNSON & JOHNSON
LANZHOU INSTITUTE OF BIOLOGICAL PRODUCTS
LASERING
LCA PHARMACEUTICAL
LUMENIS, LTD.
LUTRONIC, INC.
MEDICIS PHARMACEUTICAL CORP.
MEDICIS TECHNOLOGIES CORPORATION
MEDY-TOX, INC.
MENTOR WORLDWIDE LLC
MERZ GMBH & CO. KGAA
MISONIX, INC.
MYOSCIENCE INC.
NAGOR, LTD.
OSYRIS MEDICAL
PALOMAR MEDICAL TECHNOLOGIES, INC.
PHAROS LIFE CORPORATION
POLYMEKON S.R.L.
PROLLENIUM MEDICAL TECHNOLOGIES, INC.
Q-MED AB
REVANCE THERAPEUTICS, INC.
SANOFI-AVENTIS U.S., LLC
SCITON, INC.
SEBBIN (LABORATOIRES SEBBIN)
SIENTRA, INC.
SILIMED LTDA.
SOLSTICE NEUROSCIENCES, LLC
SOLTA MEDICAL, INC.
SOERING GMBH MEDIZINTECHNIK
SOUND SURGICAL TECHNOLOGIES, LLC
STIEFEL LABORATORIES, INC.
SUNEVA MEDICAL, INC.
SYNERON MEDICAL, LTD.
SYNOPTICS (NORTHROP GRUMMAN SYNOPTICS)
TEOXANE (LABORATOIRES TEOXANE)
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Nicolas BombourgReportlinkerEmail: [email protected]US: (805)652-2626Intl: +1 805-652-2626
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