Botulinum Toxin

Published by: Global Industry Analysts

Published: Oct. 1, 2011 - 187 Pages


Table of Contents

1. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations

Disclaimers

Data Interpretation & Reporting Level

Quantitative Techniques & Analytics

Product Definitions and Scope of Study

Cosmetic Applications

Therapeutic Applications

2. INDUSTRY OVERVIEW

A Prelude

Current and Future Scenario

By Geographic Region

By Application

Botulinum Toxin: “The Science, The Hopes & the Risks”

Future Opportunities Span Beyond The Developed Markets

3. TRENDS & ISSUES

Acceptance for Cosmetic BTX Treatment Grows

Aging Population: A Weighty Demographic Driver

Unmet Medical Needs Encourage Off-Label Use: A Cause for Concern or Jubilation?

Urgent Need for Physician Education about Off Label Usage

High Voltage Ad Campaigns Boost Patient Awareness

Societal Pressure to Look Young Drives up Demand for Facial Aesthetics

Cosmetic Botulinum Toxin to Feel the Pinch of the Recession

Financing of Non-Reimbursed Healthcare: The Need of the Hour

Combination Therapies: A Double Whammy Success

Short Lived Aesthetic Effects: A Strong Business Case for Revision Treatments

Consolidation Blows in the Aesthetic Healthcare Industry

Undesirable Side Effects: A Challenge to Reckon With

Immunogenicity Undermines Patient Compliance

Antigenicity: One of the Most Problematic Issues in Drug Development

Stringent Regulations Delay Market Approval & Put Reimbursements in Limbo

Non-Injectable Alternatives to Turn On the Heat

Fears of Terrorism & Biological Warfare Thwart International Trade

Competition

Allergan Wields the Scepter

Table 1: European Market for Non-Surgical Cosmetic Procedures (2010): Percentage ShareBreakdown of Revenues by Leading Players -Allergan, Q-Med, Mentor Corporation,Mattioli Engineering, and Others (includescorresponding Graph/Chart)

Table 2: European Market for Non-Surgical Cosmetic Procedures (2010): Percentage Breakdown of Revenuesby Type of Procedure -Cosmetic Botulinum ToxinInjections, Facial Fillers, Microdermabrasion,Chemical Peeling, and Aesthetic Lasers(includes corresponding Graph/Chart)

Reloxin Emerges to Threaten Allergan’s Dominance

Reloxin Vs Botox: A Comparison

Outlook for Allergan’s Botox

Market Share Statistics

Global

Table 3: World Market for Therapeutic Neurotoxins (2010): Percentage Breakdown of Revenues by Company/Brand -Botox (Allergan), Dysport (Ispen),Myobloc (Solstice), and Others (includes corresponding Graph/Chart)

Table 4: World Market for Cosmetic Neurotoxins (2010): Percentage Breakdown of Revenues by Company/Brand -Botox/Vistabel (Allergan) and Dysport/Reloxin (Ipsen/Medicis) (includes corresponding Graph/Chart)

Europe

Table 5: European Market for Cosmetic Neurotoxins (2010): Percentage Breakdown of Revenues by Company/Brand -Botox/Vistabel (Allergan) and Dysport (Ipsen) (includes corresponding Graph/Chart)

Table 6: European Market for Therapeutic Neurotoxins (2010): Percentage Breakdown of Revenues by Company/Brand -Botox (Allergan), Dysport (Ispen),and Others (includes corresponding Graph/Chart)

United States

Table 7: US Market for Therapeutic Neurotoxins (2010): Percentage Breakdown of Revenues by Company/Brand -Botox (Allergan) and Myobloc (Solstice) (includes corresponding Graph/Chart)

Market Share Statistics: Through the Looking Glass: Year


Global

Table 8: World Market for Therapeutic Neurotoxins(2012P): Percentage Breakdown of Revenues byCompany/ Brand -Botox (Allergan), Dysport (Ispen), Myobloc (Solstice), Puretox (Mentor), Xeomin (Merz),and Others (includes corresponding Graph/Chart)

Table 9: World Market for Cosmetic Neurotoxins (2012P): Percentage Breakdown of Revenues by Company/Brand -Botox (Allergan), Dysport/Reloxin (Ipsen/Medicis), Xeomin (Merz), and Puretox(Mentor) (includes corresponding Graph/Chart)

United States

Table 10: US Market for Therapeutic Neurotoxins(2012P): Percentage Breakdown of Revenues by Company/Brand -Botox (Allergan), Myobloc (Solstice),Dysport (Ispen), Puretox (Mentor) and Xeomin (Merz) (includes corresponding Graph/Chart)

Table 11: US Market for Cosmetic Neurotoxins (2008 & 2012P): Percentage Breakdown of Revenuesby Company/ Brand -Botox (Allergan), Reloxin(Medicis), and Puretox (Mentor) (includescorresponding Graph/Chart)

Europe

Table 12: European Market for Therapeutic Neurotoxins (2012P): Percentage Breakdown of Revenues by Company/Brand -Botox (Allergan), Dysport (Ispen),Xeomin (Merz) and Neurobloc (Solstice) (includes corresponding Graph/Chart)

4. PRODUCT OVERVIEW

Botulinum Toxin: A Poison That Cures

Structure & Mechanism of Action

Disadvantages

Classification of Botulinum Toxin

Botulinum Toxin Type A

Historical Timeline of Botulinum Toxin: 1885-2002

Botox®

Key Characteristics of Botox® and Botox® Cosmetic

Approvals and Indications of Botox in Select Regions

Common Adverse Reactions with Botox

Dysport®/ Reloxin®

Key Characteristics of Dysport®

PurTox®

Key Characteristics of PurTox®

Xeomin®/ NT-201


Key Characteristics of Xeomin®/ NT-201


Botulinum Toxin Type B

Myobloc®/NeuroBloc®

Key Characteristics of Myobloc®

Applications of Botulinum Toxin

Cosmetic Applications

Glabellar Lines

Facial Wrinkles

Key Cosmetic Indications for Botulinum Toxin

Therapeutic Applications

Movement Disorders/Pain

Cervical Dystonia

Hemifacial Spasm

Blepharospasm

Strabismus

Chronic Pain

Botox in Migraine Treatment

Hyperhidrosis

Bladder Dysfunctions

Spasticity

Other Applications

5. PRODUCT APPROVALS & INTRODUCTIONS

SMC Approves the Use of Botox® for the Treatment of Focal Spasticity

Merz Launches Xeomin in the US

Ipsen Launches Dysport in US

Ipsen and Medicis Receives FDA Approval for DysportTM

Xeomin Receives Approval From European Health Authorities

Ranbaxy and MedyTox Collaborates to Launch Neuronox

GlaxoSmithKline Receives Approval for Botox Vista

Galderma and Ipsen Obtain Marketing Authorization for Azzalure

Azzalure® Gains Approval from 15 European Countries

Inclusion of New Side Effect in Botox and Botox Cosmetic Labels

Azzalure® Gains Approval for Aesthetic Application in the UK

Ipsen and Medicis File BLA for Reloxin®

Allergan and Clinique Launch New Skin Care Products

FDA Accepts Ipsen's Filing for Reloxin

GlaxoSmithKline Gains Approval for BOTOX® in Japan

Mentor Completes Phase IIIb Trial for Its Botulinum Toxin Type A Product

Allergan Commences Botox Study for Urological Cases in India

FDA Accepts BLA Filing for Dysport® in Cervical Dystonia Cases

Allergan Successfully Completes Analysis of Two Phase III Trials for BOTOX®

Allergan to Launch New Products in India

6. RECENT INDUSTRY ACTIVITY

US WorldMeds Takes Over Solstice Neurosciences

Johnson & Johnson Acquires Mentor Corporation

Ranbaxy Signs an in-Licensing Agreeement with Medy-Tox

Ranbaxy Signs Marketing Agreement with MedyTox

Revance and Medicis Sign Licensing Agreement

GlaxoSmithKline and Wakamoto Pharmaceutical Collaborate to Market Botox

BioForm Medical Acquires Advanced Cosmetic Intervention

Galderma to Acquire CollaGenex

Allergan and Clinique Form Strategic Collaboration

Allergan to Set Up a New Subsidiary in India

Allergan Join Hands with India-Based Kaya

Q-Med and Medy-Tox Cancel the Collaboration Agreement

Galderma to Increase Awareness in Brazil

Galderma Receives License to Market Dysport

7. FOCUS ON SELECT KEY PLAYERS

Allergan, Inc (US)

Ipsen Group (France)

Lanzhou Institute of Biological Products (China)

Metabiologics Inc, (US)

Merz Pharmaceuticals GmbH (Germany)

Mentor Corporation (US)

Medy-Tox Incorporated (South Korea)

Medicis Pharmaceutical Corporation (US)

Solstice Neurosciences, Inc. (US)

8. GLOBAL MARKET PERSPECTIVE

Table 13: World Recent Past, Current & Future Analysisfor Botulinum Toxin by Geographic Region/Country -US, Europe and Rest of World Markets IndependentlyAnalyzed by Annual Sales in US$ Millionfor the Years 2009 through 2017 (includescorresponding Graph/Chart)

Table 14: World Historic Review for Botulinum Toxin byGeographic Region/Country - US, Europe and Rest of WorldMarkets Independently Analyzed by Annual Salesin US$ Million For the Years 2003 through 2008(includes corresponding Graph/Chart)

Table 15: World 15-Year Perspective for Botulinum Toxin by Geographic Region - Percentage Breakdownof Dollar Sales for US, Europe and Rest of World Marketsfor the Years 2003, 2010 & 2017 (includescorresponding Graph/Chart)

Table 16: World Recent Past, Current & Future Analysisfor Botulinum Toxin in Cosmetic Applications by GeographicRegion - US, Europe and Rest of World Markets Independently Analyzed by Annual Sales in US$ Million for the Years 2009through 2017 (includes corresponding Graph/Chart)

Table 17: World Historic Review for Botulinum Toxin in Cosmetic Applications by Geographic Region - US, Europeand Rest of World Markets Independently Analyzed byAnnual Sales in US$ Million for the Years 2003 through2008 (includes corresponding Graph/Chart)

Table 18: World 15-Year Perspective for Botulinum Toxinin Cosmetic Applications by Geographic Region - Percentage Breakdown of Dollar Sales for US, Europe and Rest of World Markets for the Years 2003, 2010 &2017 (includes corresponding Graph/Chart)

Table 19: World Recent Past, Current & Future Analysisfor Botulinum Toxin in Therapeutic Applications byGeographic Region - US, Europe and Rest of WorldMarkets Independently Analyzed by Annual Salesin US$ Million for the Years 2009 through 2017(includes corresponding Graph/Chart)

Table 20: World Historic Review for Botulinum Toxinin Therapeutic Applications by Geographic Region - US,Europe and Rest of World Markets Independently Analyzedby Annual Sales in US$ Million for the Years 2003 through2008 (includes corresponding Graph/Chart)

Table 21: World 15-Year Perspective for Botulinum Toxin in Therapeutic Applications by Geographic Region - Percentage Breakdown of Dollar Sales for US, Europe and Rest of World Markets for the Years 2003, 2010 &2017 (includes corresponding Graph/Chart)

Table 22: World Recent Past, Current & Future Analysisfor Botulinum Toxin in Therapeutic Application by Disease Indication - Movement Disorders/Pain, Headache,Hyperhidrosis, Overactive Bladder and Spasticity-Markets Analyzed with Annual Sales Figuresin US$ Million for Years 2009 through 2017(includes corresponding Graph/Chart)

Table 23: Global Historic Review for Botulinum Toxin in Therapeutic Application by Disease Indication -Movement Disorders/Pain, Headache, Hyperhidrosis,Overactive Bladder and Spasticity- MarketsAnalyzed with Annual Sales Figures in US$ Million for Years 2003 through 2008 (includescorresponding Graph/Chart)

Table 24: World 15-Year Perspective for Botulinum Toxin in Therapeutic Application by Disease Indication - Percentage Breakdown of Dollar Salesfor Movement Disorders/Pain, Headache, Hyperhidrosis, Overactive Bladder and Spasticity - Marketsfor the Years 2003, 2010 & 2017 (includescorresponding Graph/Chart)

9. THE UNITED STATES

A. Market Analysis

Current and Future Scenario

By Application

Cosmetic Procedures: An Overview

Botox Leads the US Botulinum Toxin Market

Botox Approvals and Indications in the US

Major Market Trends

Botulinum Toxin to Drive Growth in the Facial Aesthetics Market

Booming Non-Surgical Treatments

Aging Baby Boomers Drive Aesthetic Business

Expanding Physician Base Extends Impetus to Growth

Demand for Professional Help On the Rise

Direct-to-Consumer Advertising Drive Cosmetic Botulinum Toxin

Botulism Poisoning: A Major Concern

Botox Injection - Popular Non-Invasive Cosmetic Procedure

Product Approvals and Introductions

Strategic Corporate Developments

Key Players

B. Market Analytics

Table 25: US Recent Past, Current & Future Analysis for Botulinum Toxin by Application - CosmeticApplications and Therapeutic Applications Markets Independently Analyzed by Annual Sales Figuresin US$ Million for the Years 2009 through 2017(includes corresponding Graph/Chart)

Table 26: US Historic Review for Botulinum Toxinby Application - Cosmetic Applications andTherapeutic Applications Markets Independently Analyzed by Annual Sales Figures in US$ Millionfor the Years 2003 through 2008 (includescorresponding Graph/Chart)

Table 27: US 15-Year Perspective for Botulinum Toxinby Application - Percentage Breakdown of Dollar Salesfor Cosmetic Applications and Therapeutic Applications Markets for the Years 2003, 2010 & 2017 (includes corresponding Graph/Chart)

Table 28: US Recent Past, Current & Future Analysis for Botulinum Toxin in Therapeutic Applications by Disease Indication - Movement Disorders/Pain, Headache, Hyperhidrosis, Overactive Bladder and Spasticity- Markets Independently Analyzed by Annual SalesFigures in US$ Million for the Years 2009 through2017 (includes corresponding Graph/Chart)

Table 29: US Historic Review for Botulinum Toxin in Therapeutic Application by Disease Indication -Movement Disorders/Pain, Headache, Hyperhidrosis, Overactive Bladder and Spasticity MarketsIndependently Analyzed with Annual Sales Figuresin US$ Million for Years 2003 through 2008(includes corresponding Graph/Chart)

Table 30: US 15-Year Perspective for Botulinum Toxinin Therapeutic Application by Disease Indication - Percentage Breakdown of Dollar Sales for Movement Disorders/Pain, Headache, Hyperhidrosis, Overactive Bladder and Spasticity for the Years 2003, 2010 &2017 (includes corresponding Graph/Chart)

10. EUROPE

A. Market Analysis

Current and Future Scenario

By Application

European BTX Cosmetics Treatments Market - A Primer

Botox Approvals and Indications in Select European Countries

Botox to Support Radiation Treatments

Product Approvals and Introductions

Key Players

B. Market Analytics

Table 31: European Recent Past, Current & FutureAnalysis for Botulinum Toxin by Application -Cosmetic Applications and Therapeutic ApplicationsMarkets Independently Analyzed by Annual SalesFigures in US$ Million for the Years 2009 through2017 (includes corresponding Graph/Chart)

Table 32: European Historic Review for Botulinum Toxinby Application -Cosmetic Applications and Therapeutic Applications Markets Independently Analyzed by Annual Sales Figures in US$ Million for the Years 2003 through 2008 (includes corresponding Graph/Chart)

Table 33: European 15-Year Perspective for BotulinumToxin by Application - Percentage Breakdown of Dollar Sales for Cosmetic Applications and TherapeuticApplications Markets for the Years 2003, 2010 &2017 (includes corresponding Graph/Chart)

Table 34: European Recent Past, Current & FutureAnalysis for Botulinum Toxin in Therapeutic Applicationsby Disease Indication - Movement Disorders/Pain, Headache, Hyperhidrosis, Overactive Bladder andSpasticity- Markets Independently Analyzed byAnnual Sales Figures in US$ Millionfor the Years 2009 through 2017 (includescorresponding Graph/Chart)

Table 35: European Historic Review for Botulinum Toxin in Therapeutic Application by Disease Indication - Movement Disorders/Pain, Headache, Hyperhidrosis, Overactive Bladder and Spasticity - Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2008 (includes corresponding Graph/Chart)

Table 36: European 15-Year Perspective for Botulinum Toxinin Therapeutic Application by Disease Indication - Percentage Breakdown of Dollar Sales for Movement Disorders/Pain, Headache, Hyperhidrosis, Overactive Bladder and Spasticity- Markets for the Years 2003,2010 & 2017 (includes corresponding Graph/Chart)

11. REST OF WORLD

A. Market Analysis

Current and Future Scenario

By Applications

A Peek into Select Markets

India - An Emerging Market for Botox

Competitive Landscape in South Korea

Table 37: Korean Botulinum Toxin Market (2010): Percentage Breakdown of Sales by Leading Players -Medy-Tox, Allergan, Ipsen, and Lanzhou Institute (includes corresponding Graph/Chart)

Australia - A Well Supported Market

Botox Approvals and Indications in Select Asian Countries

Latin America- Cosmetic Surgery Market

Botox Approvals and Indications in Select Latin American Regions

Botox Approvals and Indications in Other Select Global Regions

Product Approvals and Introductions

Strategic Corporate Developments

Key Players

B. Market Analytics

Table 38: Rest of World Recent Past, Current & Future Analysis for Botulinum Toxin by Application - Cosmetic Applications and Therapeutic Applications Markets Independently Analyzed by Annual Sales Figuresin US$ Million for the Years 2009 through 2017) (includes corresponding Graph/Chart)

Table 39: Rest of World Historic Review for Botulinum Toxinby Application - Cosmetic Applications and Therapeutic Applications Markets Independently Analyzed by Annual Sales Figures in US$ Million for the Years 2003 through 2008 (includes corresponding Graph/Chart)

Table 40: Rest of World 15-Year Perspective for Botulinum Toxin by Application - Percentage Breakdown of Dollar Sales for Cosmetic Applications and TherapeuticApplications Markets for the Years 2003, 2010 &2017 (includes corresponding Graph/Chart)

Table 41: Rest of World Recent Past, Current & FutureAnalysis for Botulinum Toxin in Therapeutic Applicationsby Disease Indication - Movement Disorders/Pain, Headache, Hyperhidrosis, Overactive Bladder andSpasticity- Markets Independently Analyzed by AnnualSales Figures in US$ Million for the Years 2009through 2017 (includes corresponding Graph/Chart)

Table 42: Rest of World Historic Review for BotulinumToxin in Therapeutic Application by DiseaseIndication - Movement Disorders/Pain, Headache, Hyperhidrosis, Overactive Bladder and SpasticityMarkets Independently Analyzed with Annual SalesFigures in US$ Million for Years 2003 through2008 (includes corresponding Graph/Chart)

Table 43: Rest of World 15-Year Perspective for Botulinum Toxin in Therapeutic Application byDisease Indication - Percentage Breakdown ofDollar Sales for Movement Disorders/Pain,Headache, Hyperhidrosis, Overactive Bladderand Spasticity for the Years 2003, 2010 & 2017(includes corresponding Graph/Chart)

COMPETITIVE LANDSCAPE

Total Companies Profiled: 19 (including Divisions/Subsidiaries - 22)Region/Country Players

The United States

Japan 2

Europe

France

Germany

The United Kingdom

Rest of Europe 1

Asia-Pacific (Excluding Japan)

Abstract

This report analyzes the worldwide markets for Botulinum Toxin in US$ Million by the following Product Segments: Cosmetic Applications, and Therapeutic Applications (Movement Disorders/Pain, Headache, Hyperhidrosis, Overactive Bladder, & Spasticity). The report provides separate comprehensive analytics for the US, Japan, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2009 through 2017. Also, a six-year historic analysis is provided for these markets.The report profiles 19 companies including many key and niche players such as Allergan, Inc., Ipsen Group, Lanzhou Institute of Biological Products, Metabiologics, Inc., Merz Pharmaceuticals GmbH, Mentor Corporation, Medy-Tox Incorporated, Medicis Pharmaceutical Corporation, and Solstice Neurosciences, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

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