Keywords : botulinum toxine
This report analyzes the worldwide markets for Botulinum Toxin in US$ Million by the following Product Segments: Cosmetic Applications, and Therapeutic Applications. The report provides separate comprehensive analytics for the US, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2010 through 2018. Also, a six-year historic analysis is provided for these markets.The report profiles 22 companies including many...
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This report analyzes the worldwide markets for Botulinum Toxin in US$ Million by the following Product Segments: Cosmetic Applications, and Therapeutic Applications. The report provides separate comprehensive analytics for the US, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2010 through 2018. Also, a six-year historic analysis is provided for these markets.The report profiles 22 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, Revance Therapeutics, Inc., and US WorldMeds. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.
Global Medical Devices Industry
I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-2
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
Cosmetic Applications I-3
Therapeutic Applications I-3
II. EXECUTIVE SUMMARY
1. INDUSTRY OVERVIEW II-1
A Prelude II-1
Current and Future Scenario II-1
By Geographic Region II-1
Botulinum Toxin: “The Science, The Hopes & the Risks” II-2
Developed Regions Continue to Hold Sway Over Global Botulinum
Toxin Market II-2
Developing Markets Not Far Behind, But Not Yet There II-3
Pharma Companies Keenly Eye Lucrative BT Market II-3
2. TRENDS & ISSUES II-5
Acceptance for Cosmetic BTX Treatment Grows II-5
Aging Population: A Weighty Demographic Driver II-5
Unmet Medical Needs Encourage Off-Label Use: A Cause for
Concern or Jubilation? II-5
Urgent Need for Physician Education about Off Label Usage II-6
High Voltage Ad Campaigns Boost Patient Awareness II-6
Societal Pressure to Look Young, Drives up Demand for Facial
Aesthetics II-6
Financing of Non-Reimbursed Healthcare: The Need of the Hour II-7
Combination Therapies: A Double Whammy Success II-7
Short Lived Aesthetic Effects: A Strong Business Case for
Revision Treatments II-8
Consolidation Blows in the Aesthetic Healthcare Industry II-8
Undesirable Side Effects: A Challenge to Reckon With II-8
Immunogenicity Undermines Patient Compliance II-9
Protein Free BTX Products - The Probable Answer for
Immunogenicity II-9
Antigenicity: One of the Most Problematic Issues in Drug
Development II-10
Stringent Regulations Delay Market Approval & Put
Reimbursements in Limbo II-10
Non-Injectable Alternatives to Turn On the Heat II-10
Alternative Methods of Botulinum Application under
Development - A Review II-11
Fears of Terrorism & Biological Warfare Thwart International
Trade II-11
3. PRODUCT/INDUSTRY DYNAMICS II-12
Comparison of Botox®, Dysport® and Xeomin® by Indications and
Year of Approval II-12
Scarce Differentiation Between the Four Approved BTX Products II-13
Comparison of Leading Neurotoxins - Botox, Dysport and Xeomin
by Safety and Efficacy II-13
Botox® - An Overview II-14
Key Characteristics of Botox® and Botox® Cosmetic II-14
Common Adverse Reactions with Botox II-15
Approvals and Indications of Botox in Select Regions II-15
Global Botox Sales Shoot Up, Competition Begins to Hurt
Prospects II-15
Migraine Indication to Bolster Allergan’s Botox Sales II-16
Allergan Commences Advertising for Botox in Migraine
Settings in the US II-16
Therapeutics to Offer Higher Prospects for Botox II-17
Botox Therapeutic Approvals in the US by Indication II-17
Dysport® II-17
Key Characteristics of Dysport® II-18
Ipsen Counts on New Indications for Future Growth of Dysport II-18
Dysport Therapeutic Development Pipeline by Region II-18
Dysport Cosmetic Development Pipeline by Region II-19
Next Generation Dysport - A Breakthrough in BTX Market on the
Cards II-19
Xeomin® II-19
Key Characteristics of Xeomin® II-19
Xeomin Development Pipeline: Approved and Investigational
Indications as of 2011 II-20
Global Expansion Helps Merz Gain in the BTX Market II-20
Myobloc®/NeuroBloc® II-20
Key Characteristics of Myobloc® II-21
Myobloc - Still Long Way to Go II-21
Meditoxin® II-21
Meditoxin® Expanding Its Wings across the Globe II-21
PurTox® II-22
Key Characteristics of PurTox® II-22
PurTox Beckons Success in Clinical Trial Stage, Launch Still
Years Away II-22
RT001 II-22
Revance’s RT001 -Potential Revolution in BTX Market under
Development II-22
How Does RT001 Work? II-23
RT001 - A Potential Convenient Treatment Option for
Hyperhydrosis Patients II-23
4. COMPETITION II-24
Allergan Wields the Scepter II-24
Allergan’s Botox Faces the Heat of Competition II-24
Market Share Statistics II-24
Global II-24
Table 1: Leading Products in the Global Botulinum Toxin
Market (2011E): Percentage Breakdown of Revenue for Botox,
Dysport, Xeomin and Others (includes corresponding
Graph/Chart) II-24
Table 2: World Market for Therapeutic Neurotoxins (2011E):
Percentage Breakdown of Revenues by Brand -Botox, Dysport,
Xeomin and Others (includes corresponding Graph/Chart) II-25
Table 3: World Market for Cosmetic Neurotoxins (2011E):
Percentage Breakdown of Revenues by Brand - Botox, Dysport,
Xeomin and Others (includes corresponding Graph/Chart) II-25
5. PRODUCT OVERVIEW II-26
Botulinum Toxin: A Poison That Cures II-26
Structure & Mechanism of Action II-26
Disadvantages II-27
Classification of Botulinum Toxin II-27
Botulinum Toxin Type A II-27
Historical Timeline of Botulinum Toxin: 1885-2002 II-28
Botulinum Toxin Type B II-28
Applications of Botulinum Toxin II-29
Cosmetic Applications II-29
Glabellar Lines II-29
Facial Wrinkles II-29
Key Cosmetic Indications for Botulinum Toxin II-29
Therapeutic Applications II-30
Movement Disorders/Pain II-30
Cervical Dystonia II-30
Hemifacial Spasm II-30
Blepharospasm II-31
Strabismus II-31
Chronic Pain II-31
Botox in Migraine Treatment II-31
Hyperhidrosis II-32
Bladder Dysfunctions II-32
Spasticity II-32
Other Applications II-33
Side Effects II-34
An Overview of Side Effects of BTX Treatment II-34
Table 4: Side-Effects of BOTOX Treatment for Urinary
Incontinence Associated with Neuromuscular Disorders:
Percentage Breakdown of Major Conditions Reported Within 12
weeks of Injections during Phase III Clinical Trials
(includes corresponding Graph/Chart) II-34
Table 5: Side-Effects of BOTOX Treatment for Urinary
Incontinence Associated with Neuromuscular Disorders:
Percentage Breakdown of Major Conditions Reported Within 44
weeks of Injections during Phase III Clinical Trials
(includes corresponding Graph/Chart) II-35
6. PRODUCT INTRODUCTIONS/APPROVALS II-36
Botox Receives Health Canada Approval for Treating Neurogenic
Bladder Condition II-36
Allergan Obtains FDA Approval for New In -Vitro Cell-Based
Assay for BOTOX II-36
Merz Aesthetics Obtains FDA Approval for XEOMIN® for Treating
Glabellar Lines II-36
IMB Recommends Botox for Urinary Incontinence Management in
Neurognenic OAB in EU II-37
FDA Approves Botox for Treating Urinary Incontinence in
Neurogenic OAB Patients II-37
Allergan Receives Health Canada Approval for Botox for
Treating Chronic Migraine II-38
BOTOX® Receives Approval for Treating Chronic Headaches II-38
Eisai’s NerBloc Intramuscular Injection Approved for Sale in
Japan. II-38
SMC Approves the Use of Botox® for the Treatment of Focal
Spasticity II-38
FDA Grants Approval for Botox for Treating Migraine II-39
MHRA Grants Approval for Botox for Treating Chronic Migraine II-39
Allergan Receives FDA Approval for Botox for Treating Upper
Limb Spasticity II-39
Russian Authorities Approve Xeomin for Cosmetic Applications II-39
Merz Launches Xeomin in the US II-39
Ipsen Launches Dysport in US II-40
Ipsen and Medicis Receives FDA Approval for Dysport™ II-40
Xeomin Receives Approval From European Health Authorities II-41
Ranbaxy and MedyTox Collaborates to Launch Neuronox II-41
GlaxoSmithKline Receives Approval for Botox Vista II-41
Galderma and Ipsen Obtain Marketing Authorization for Azzalure II-41
Azzalure® Gains Approval from 15 European Countries II-41
Inclusion of New Side Effect in Botox and Botox Cosmetic Labels II-42
Azzalure® Gains Approval for Aesthetic Application in the UK II-42
Allergan and Clinique Launch New Skin Care Products II-43
FDA Accepts Ipsen's Filing for Reloxin II-43
GlaxoSmithKline Gains Approval for BOTOX® in Japan II-43
Mentor Completes Phase IIIb Trial for Its Botulinum Toxin Type
A Product II-43
Allergan Commences Botox Study for Urological Cases in India II-43
FDA Accepts BLA Filing for Dysport® in Cervical Dystonia Cases II-44
Allergan Successfully Completes Analysis of Two Phase III
Trials for BOTOX® II-44
Allergan to Launch New Products in India II-44
7. RECENT INDUSTRY ACTIVITY II-45
Amgen Inc Acquires Brazilian Company Bergamo II-45
Ipsen and Syntaxin Forge Agreement to Formulate Novel
Botulinum Toxin Product II-45
Xoma Bags Federal Contract to Develop Broad-Spectrum Antitoxins II-45
US WorldMeds Takes Over Solstice Neurosciences II-45
Merz Pharma Acquires BioForm Medical II-46
Johnson & Johnson Acquires Mentor Corporation II-46
Merz Pharmaceuticals and Biolab Set Up Joint Venture II-47
Ranbaxy Signs an in-Licensing Agreement with Medy-Tox II-47
Ranbaxy Signs Marketing Agreement with MedyTox II-47
Revance and Medicis Sign Licensing Agreement II-47
GlaxoSmithKline and Wakamoto Pharmaceutical Collaborate to
Market Botox II-48
BioForm Medical Acquires Advanced Cosmetic Intervention II-48
Galderma to Acquire CollaGenex II-48
Allergan and Clinique Form Strategic Collaboration II-48
Allergan to Set Up a New Subsidiary in India II-49
Allergan Join Hands with India-Based Kaya II-49
Q-Med and Medy-Tox Cancel the Collaboration Agreement II-49
Galderma to Increase Awareness in Brazil II-49
Galderma Receives License to Market Dysport II-49
8. FOCUS ON SELECT GLOBAL PLAYERS II-50
Allergan, Inc. (US) II-50
Ipsen Group (France) II-50
Lanzhou Institute of Biological Products (China) II-51
Metabiologics, Inc. (US) II-51
Merz Pharma GmbH & Co. KGaA (Germany) II-51
Mentor Corporation (US) II-52
Medy-Tox Incorporated (South Korea) II-52
Medicis Pharmaceutical Corporation (US) II-52
Revance Therapeutics, Inc. (US) II-53
US WorldMeds (US) II-53
9. GLOBAL MARKET PERSPECTIVE II-55
Table 6: World Recent Past, Current & Future Analysis for
Botulinum Toxin by Geographic Region/Country - US, Europe and
Rest of World Markets Independently Analyzed by Annual Sales
in US$ Million for the Years 2010 through 2018 (includes
corresponding Graph/Chart) II-55
Table 7: World Historic Review for Botulinum Toxin by
Geographic Region/Country - US, Europe and Rest of World
Markets Independently Analyzed by Annual Sales in US$ Million
For the Years 2004 through 2009 (includes corresponding
Graph/Chart) II-56
Table 8: World 15-Year Perspective for Botulinum Toxin by
Geographic Region - Percentage Breakdown of Dollar Sales for
US, Europe and Rest of World Markets for the Years 2004, 2011
& 2018 (includes corresponding Graph/Chart) II-57
Table 9: World Recent Past, Current & Future Analysis for
Botulinum Toxin in Cosmetic Applications by Geographic Region-
US, Europe and Rest of World Markets Independently Analyzed
by Annual Sales in US$ Million for the Years 2010 through 2018
(includes corresponding Graph/Chart) II-58
Table 10: World Historic Review for Botulinum Toxin in
Cosmetic Applications by Geographic Region - US, Europe and
Rest of World Markets Independently Analyzed by Annual Sales
in US$ Million for the Years 2004 through 2009 (includes
corresponding Graph/Chart) II-59
Table 11: World 15-Year Perspective for Botulinum Toxin in
Cosmetic Applications by Geographic Region - Percentage
Breakdown of Dollar Sales for US, Europe and Rest of World
Markets for the Years 2004, 2011 & 2018 (includes
corresponding Graph/Chart) II-60
Table 12: World Recent Past, Current & Future Analysis for
Botulinum Toxin in Therapeutic Applications by Geographic
Region - US, Europe and Rest of World Markets Independently
Analyzed by Annual Sales in US$ Million for the Years 2010
through 2018 (includes corresponding Graph/Chart) II-61
Table 13: World Historic Review for Botulinum Toxin in
Therapeutic Applications by Geographic Region - US, Europe and
Rest of World Markets Independently Analyzed by Annual Sales
in US$ Million for the Years 2004 through 2009 (includes
corresponding Graph/Chart) II-62
Table 14: 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 2004, 2011 & 2018 (includes
corresponding Graph/Chart) II-63
III. MARKET
1. THE UNITED STATES III-1
A.Market Analysis III-1
Current and Future Scenario III-1
Cosmetic Procedures: An Overview III-1
Major Market Trends III-2
Botulinum Toxin to Drive Growth in the Facial Aesthetics
Market III-2
Competition Heats Up in the US BTX Market III-2
Booming Non-Surgical Treatments III-2
Aging Baby Boomers Drive Aesthetic Business III-3
Expanding Physician Base Extends Impetus to Growth III-3
Demand for Professional Help On the Rise III-3
Direct-to-Consumer Advertising Drive Cosmetic Botulinum Toxin III-3
Botulism Poisoning: A Major Concern III-4
Botox Injection - Popular Non-Invasive Cosmetic Procedure III-4
Recession Dents Cosmetic BTX Procedural Volume, Albeit
Slightly III-4
Table 15: US Cosmetic BTX Procedure Volume: 2007-2011
(includes corresponding Graph/Chart) III-4
Botox Therapeutic to Drive Growth in Botox Franchise III-5
Dysport Takes on Botox in the Therapeutic Space III-5
Pricing and Promotions to Help Dysport Gain Market Share in
Cosmetic Arena III-5
Tremendous Prospects in Therapeutics Space for Dysport in
the Long Run III-6
Therapeutic BTX Market - New Entrants Slow in Gaining
Market Share III-6
Botox’s Therapeutic Indications (Approved and
Investigational) in the US by Year of Approval/Stage III-6
Cosmetic BTX Market - Competition Threatens Botox Long-Term
Dominance III-7
Key BTX Products and Associated Fillers and Implants in
the Cosmetic Botulinum Toxin Market III-7
Market Opportunities for Botox in Migraine Beckons a Slow Star III-7
Neurogenic OAB - A Relatively Smaller Market Opportunity III-7
Idiopathic OAB Bodes Superior Prospects for Botox III-8
Issues Persist in the Idiopathic OAB Space Dampening Prospects III-8
Xeomin - Will the “Pure” Factor Finds Many Takers? III-9
Xeomin Takes Big Leap in the US III-9
Xeomin’s Potential in the US Cosmetic Market III-9
Merz Fortifies Position in the US Facial Injectables Market
with BioForm Acquisition III-10
PurTox Touted to Emerge as a Direct Competitor to Botox in
the US III-10
Competitive Landscape III-11
Botox Leads the US Botulinum Toxin Market III-11
Market Share Statistics III-11
Table 16: US Market for Therapeutic Neurotoxins (2011E):
Percentage Breakdown of Revenues by Brand - Botox, Myobloc,
Dysport and Xeomin (includes corresponding Graph/Chart) III-11
Table 17: US Market for Aesthetic Neurotoxins (2011E):
Percentage Breakdown of Revenues by Brand - Botox and
Dysport (includes corresponding Graph/Chart) III-11
Product Approvals/Launches III-12
Strategic Corporate Developments III-15
Key Players III-18
B.Market Analytics III-21
Table 18: US Recent Past, Current & Future Analysis for
Botulinum Toxin by Application - Cosmetic Applications and
Therapeutic Applications Markets Independently Analyzed by
Annual Sales Figures in US$ Million for the Years 2010
through 2018 (includes corresponding Graph/Chart) III-21
Table 19: US Historic Review for Botulinum Toxin by
Application - Cosmetic Applications and Therapeutic
Applications Markets Independently Analyzed by Annual Sales
Figures in US$ Million for the Years 2004 through 2009
(includes corresponding Graph/Chart) III-22
Table 20: US 15-Year Perspective for Botulinum Toxin by
Application - Percentage Breakdown of Dollar Sales for
Cosmetic Applications and Therapeutic Applications Markets
for the Years 2004, 2011 & 2018 (includes corresponding
Graph/Chart) III-23
2. EUROPE III-24
A.Market Analysis III-24
Current and Future Scenario III-24
European BTX Cosmetics Treatments Market - A Primer III-24
Botox Approvals and Indications in Select European Countries III-24
Botox to Support Radiation Treatments III-24
Botox Loses Market to New Entrants in Europe III-25
Galderma’s Azzalure Makes Market Entry in Europe, Gains
Share from Botox III-25
Russia Mandates Registration of BTX Drugs III-25
Market Share Statistics III-25
Table 21: European Market for Therapeutic Neurotoxins
(2011E): Percentage Breakdown of Revenues by Brand -Botox,
Dysport, Xeomin, and Neurobloc (includes corresponding
Graph/Chart) III-25
Table 22: European Market for Cosmetic Neurotoxins (2011E):
Percentage Breakdown of Revenues by Brand - Botox
(Vistabel/Vistabex), Dysport and Xeomin (includes
corresponding Graph/Chart) III-26
Product Approvals and Launches III-26
Strategic Corporate Development III-28
Key Players III-29
B.Market Analytics III-30
Table 23: European Recent Past, Current & Future Analysis
for Botulinum Toxin by Application - Cosmetic Applications
and Therapeutic Applications Markets Independently Analyzed
by Annual Sales Figures in US$ Million for the Years 2010
through 2018 (includes corresponding Graph/Chart) III-30
Table 24: European Historic Review for Botulinum Toxin by
Application -Cosmetic and Therapeutic Markets Independently
Analyzed by Annual Sales Figures in US$ Million for the
Years 2004 through 2009 (includes corresponding Graph/Chart) III-31
Table 25: European 15-Year Perspective for Botulinum Toxin
by Application - Percentage Breakdown of Dollar Sales for
Cosmetic Applications and Therapeutic Applications Markets
for the Years 2004, 2011 & 2018 (includes corresponding
Graph/Chart) III-32
3. REST OF WORLD III-33
A.Market Analysis III-33
Current and Future Scenario III-33
A Peek into Select Markets III-33
India - An Emerging Market for Botox III-33
South Korean BTX Market - An Overview III-33
Table 26: Botulinum Toxin Demand in South Korea: 2007-
2011E List of Botulinum Toxin Products Sold in South Korea
by Year of Launch (includes corresponding Graph/Chart) III-34
List of Botulinum Toxin Products Sold in South Korea by
Year of Launch III-34
Meditoxin Dominates Domestic BTX Market III-34
Table 27: Korean Botulinum Toxin Market (2010): Percentage
Breakdown of Sales by Leading Players -Medy-Tox, Allergan,
Ipsen, and Lanzhou Institute (includes corresponding
Graph/Chart) III-34
Australia - A Well Supported Market III-35
Botox Approvals and Indications in Select Asian Countries III-35
Latin America- Cosmetic Surgery Market III-35
Botox Approvals and Indications in Select Latin American
Regions III-36
Botox Approvals and Indications in Other Select Global
Regions III-36
Product Approvals and Launches III-37
Strategic Corporate Developments III-38
Key Players III-41
B.Market Analytics III-42
Table 28: Rest of World Recent Past, Current & Future
Analysis for Botulinum Toxin by Application - Cosmetic and
Therapeutic Markets Independently Analyzed by Annual Sales
Figures in US$ Million for the Years 2010 through 2018
(includes corresponding Graph/Chart) III-42
Table 29: Rest of World Historic Review for Botulinum Toxin
by Application - Cosmetic and Therapeutic Markets
Independently Analyzed by Annual Sales Figures in US$
Million for the Years 2004 through 2009 (includes
corresponding Graph/Chart) III-43
Table 30: Rest of World 15-Year Perspective for Botulinum
Toxin by Application - Percentage Breakdown of Dollar Sales
for Cosmetic Applications and Therapeutic Applications
Markets for the Years 2004, 2011 & 2018 (includes
corresponding Graph/Chart) III-44
IV. COMPETITIVE LANDSCAPE
Total Companies Profiled: 22 (including Divisions/Subsidiaries - 26)
------------------------------------------
Region/Country Players
------------------------------------------
The United States 9
Japan 3
Europe 7
France 1
Germany 2
The United Kingdom 3
Rest of Europe 1
Asia-Pacific (Excluding Japan) 7
------------------------------------------
