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Intranasal Drug Delivery - Global Business Strategic Report Product Image

Intranasal Drug Delivery - Global Business Strategic Report

  • ID: 516888
  • May 2012
  • Region: Global
  • 441 Pages
  • Global Industry Analysts, Inc

This report analyzes the US market for Intranasal Drug Delivery in US$ Million by the following Therapeutic Areas: Allergic Infections, Analgesics, Osteoporosis, and Vaccinations. Annual estimates and forecasts are provided for the period 2009 through 2017. Also, a six-year historic analysis is provided for this market. The report profiles 71 companies including many key and niche players such as Aegis Therapeutics LLC, Alza Corporation, AptarGroup, Inc., Archimedes Pharma Limited., AstraZeneca Plc., MedImmune, Inc., Bayer Consumer Care, Bespak Plc., GlaxoSmithKline Plc, Ikano Therapeutics Inc., Javelin Pharmaceuticals, Inc., Kurve Technology, Inc., Marina Biotech, Inc., Merck & Co., Inc., Novartis AG, OptiNose AS, Pfizer, Inc., Rexam Plc, Sanofi S.A, and Unigene Laboratories, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

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INTRANASAL DRUG DELIVERY

A US MARKET REPORT

CONTENTS

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

II. A US MARKET REPORT

1. INDUSTRY OVERVIEW II-1
Drug Delivery: A Quick Primer II-1
The Nose: An Attractive Avenue to Cross the Blood Brain Barrier II-1
Self-Administration of Drugs Brings Intranasal Drug Delivery
Into the Spotlight II-2
Research & Technology Opens Up New Therapeutic Areas for
Nasal Drug Delivery II-2
Product Developments in the US Intranasal Drug Delivery Market II-2
R&D: Critical to the Commercialization of Intranasal Drug
Delivery II-3
Tight Junction Biology: A Key Speed Breaker in
Commercialization II-3
RNA Interference (RNAi): A Tool to Manipulate Tight Junctions II-4
Why Is Nasal Drug Delivery the Theme of All Drug Delivery
Research Projects? II-4
Nasal Drug Delivery Devices & Equipment II-4
Preservative Free Systems (PFS) II-4
Traditional Vs. Advanced Intranasal Drug Delivery Devices II-6
Bi-Directional Nasal Drug Delivery: A Technology With a Huge
Potential II-6
Benefits of Bi-Directional Delivery Authenticated Through
Research Studies II-7
Market for Nasal Spray Devices in the US II-7
GSK Looses Share to Merck, Following Patent Expiry of Flonase II-7
Table 1: US Intra-Nasal Steroid Market for Allergic Rhinitis:
Sales of Leading Nasal Formulations for 2008 (includes
corresponding Graph/Chart) II-8

Table 2: The US Nasal Drug Delivery Market for Allergic
Rhinitis: Sales Of Top Four Nasal Steroid Formulations for
The Year 2005 (In US$ Million) (includes corresponding
Graph/Chart) II-8

2. MARKET DYNAMICS II-9
Innovation in Drug Delivery: A Talisman For Success II-9
Controlled Release Technology Is the Buzz Word II-9
Target-Specific Delivery Devices: Of Critical Value II-9
Safety and Cost: Primary Growth Drivers II-9
Preservatives Losing Sheen in Nasal Spray Formulations II-10
Multi-Dose Containers Evolve to Offer Resistance Against
Microbial Contamination II-10
Bioavailability: An Important Facet of Intranasal Drug Delivery II-10
Chemical Modification II-11
Transient Modification & Limited Enzymatic Activity II-11
Bioavailability of Large Molecules II-11
Bio-Adhesive Polymers: Useful in Increasing Drug Absorption II-11
Mixed Opinions on Efficiency of Calcitonin Nasal Spray II-11
Nasal Preparations Gaining Foothold in Cough and Allergic
Categories II-12
Patent Expiries Impact Market Opportunities II-12

3. TECHNOLOGY OVERVIEW II-13
Intranasal Drug Delivery: A Descriptive Exposition II-13
Nasal Physiology II-13
Challenges Involved In Formulating Nasal Drugs II-14
The Importance of Bioadhesion II-15
Overview of the Traditional Drug Administration Routes,
Molecular Weight Capabilities, and Dosage Range II-15
Intranasal Drugs - Prescription (Rx) and Over-the- Counter (OTC) II-16
Differences Between Systemic Delivery and Local Effects II-16
Nasal Powders Vs. Sprays II-16
Nasal Drug Delivery Devices II-17
Types of Drug Delivery Devices II-17
Droppers II-17
Sprays II-17
Aerosol Containers/Inhalers II-18
Pumps II-18
Nasal Aspirator II-18
Intranasal Drug Delivery Vis-à-vis Other Delivery Techniques II-18
Table 3: US Market for Intranasal Drugs: Percentage share of
Topical and Systemic Drugs by value for the Years 2006 and
2015 (includes corresponding Graph/Chart) II-19
Limitations of Intranasal Drug Delivery II-19
Allergy II-19
Definition II-19
Symptoms II-20
Allergic Rhinitis II-20
Nasal Allergies II-20
Table 4: US Market for Nasal Sprays: Top Five Nasal Sprays
for Cough, Cold, Sinus and Allergy Ranked by Dollar Retail
Sales for the Year Ended January 2008 (In US $ Million)
(includes corresponding Graph/Chart) II-21

Table 5: US Market for Nasal Sprays, Drops and Inhalers: Top
10 Brands Ranked by Dollar Sales through Drug Stores for the
Year Ended January 2008 (In US $ Million) (includes
corresponding Graph/Chart) II-21

Table 6: US Market for Nasal Sprays, Drops and Inhalers: Top
10 Brands Ranked by Unit Sales through Drug Stores for the
Year Ended January 2008 (In Thousand Units) (includes
corresponding Graph/Chart) II-22

4. NASAL DRUGS: AN OVERVIEW II-23
Nasal Drugs for Allergies II-23
Corticosteroid Nasal Sprays II-23
Flonase II-23
Patanase II-23
Beconase II-24
Other Nasal Corticosteroid Drugs II-24
Antihistamine Nasal Sprays II-24
Astelin Nasal Spray II-24
Otrivin Nasal Spray II-24
Livostin Nasal Spray II-24
Other Nasal Antihistamine Drugs II-25
Select Brands of Allergy Relievers II-25
Nasal Drugs for Postmenopausal Osteoporosis II-25
Calcitonin-Salmon Nasal Spray II-25
Miacalcin Nasal Spray II-25
Fortical® Nasal Spray II-25
Intranasal Pain Management Drugs II-26
Stadol Nasal Spray II-26
Imitrex II-27
Migranal II-27
Zolmitriptan Nasal Spray II-27
Intranasal Analgesics for Treating Migraine II-27
Intranasal Vaccination II-28
Process of Intranasal Immunization II-29
Market Drivers II-29
“LAIV” Nasal Spray Flu Vaccine II-29
FluMist® Vaccine From MedImmune II-30
Intranasal Drugs for Sexual Dysfunction II-30
Nasal Spray for Treating Vitamin B12 Deficiency II-30
Nasal Spray for Aiding Smoking Cessation II-31
Intranasal Drugs in Pipeline II-31

5. SELECT RESEARCH & DEVELOPMENT INITIATIVES II-33
Nastech Enrolls 551 Patients for Phase 2 Trials of PYY3-36
Nasal Spray II-33
Archimedes Pharma Commences Phase III Trials for NasalFent® II-33
Archimedes Presents New Clinical Data on NasalFent® II-33
LigoCyte Commences Clinical Trials for Intranasal Norovirus
Vaccine II-33
Javelin Pharmaceuticals Reveals Phase 2 Study Results for PMI-
100/150 II-34
Javelin Pharmaceuticals Commences Phase III studies for PMI-150 II-34
Nastech Commences Phase 2 Trials for Insulin Nasal Spray II-34
ACAAI Reveals Results for Trials of Nasacort® AQ Nasal Spray
in Children II-34
TGAR01H from Fabre Kramer II-35
Aegis Therapeutics Completes First Human Clinical Study on
Intravail® II-35
Nastech Pharmaceutical Presents Clinical Test Results on
Parathyroid Hormone II-35
Zolmitriptan Promises Relief for Cluster Headaches II-36
CAIV-T: More Effective than Injectable Influenza Vaccines II-36
Intranasal Therapeutics Conducts Study on Midazolam II-36
Nastech Announces Phase I Results of Insulin Nasal Spray II-37
Archimedes Completes Phase II Trials of NASALFENT II-37
Intranasal Corticosteroid Proven Effective for Treating
Allergic Rhinitis II-37
Aegis Files DMF for Intravail II-38
Nasal Sprays: A New-Generation Treatment for Gynecological
Problems II-38
Aegis Therapeutics Conducts Feasibility Study on Drug Delivery
Technology II-38
GelVac Powder Delivery System Completes Phase I Clinical Trial II-39
OptiNose Develops Intranasal Delivery System for Osteoporosis II-39
Nastech Initiates Dose Ranging Study of PYY(3-36) II-40
Valois Develops New Nasal Dispensing System II-40
Rigel Pharmaceuticals to Initiate R112 Phase II Clinical Trial II-40
MedPointe Pharmaceuticals Demonstrates ACT1 Study Results on
ASTELIN® II-41
Bentley Pharmaceuticals Demonstrates Clinical Trial Results of
its Intra Nasal Insulin Spray II-41

6. RECENT TECHNOLOGICAL DEVELOPMENTS II-42
New-Generation Technologies and Devices II-42
ViaNase from Kurve Technology II-42
A New Product from OptiNose II-42
Nastech’s “Tight Junction Biology” Research Program II-43
ChiSys™ Nasal Delivery Technology from Archimedes II-43

7. PRODUCT INTRODUCTIONS/INNOVATIONS II-44
TheraBiogen to Introduce TheraMax Cold & Flu Nasal Spray II-44
Sinus Dynamics™ Unveils NasaTouch™ Nasal Delivery Device II-44
3M Drug Delivery Systems Introduces Nasal MDI II-44
MeadWestvaco Introduces Preservative-Free Nasal Pumps II-44
GlaxoSmithKline Introduces Avamys Nasal Spray II-45

8. PRODUCT INNOVATIONS/INTRODUCTIONS - A HISTORIC PERSPECTIVE BUILDER II-46
Aegis Therapeutics Develops ProTek™ II-46
Heel Launches Luffeel® in the US II-46
Archimedes to Introduce Intranasal Formulation of Human Growth
Hormone II-46
Sinofresh Launches SinoFresh™ Nasal & Sinus Care II-46
PARI Respiratory Launches Nasal Drug Delivery Program II-46
OptiNose to Develop New Range of Intranasal Products II-47
OptiNose and Cambridge Consultants to Develop Advanced Nasal
Delivery Device II-47
Kurve Technology Develops ViaNase ID™ II-47
Upsher-Smith Introduces Fortical® Nasal Spray II-48
Schering-Plough Launches New Formulation of NASONEX® II-48

9. RECENT INDUSTRY ACTIVITY II-49
Marina Biotech Obtains Patent Rights for Intranasal Insulin
Delivery in China II-49
Takeda Acquires Nycomed II-49
Upsher-Smith Acquires ITI-111 from Ikano Therapeutics II-49
Hospira Acquires Javelin Pharmaceuticals II-49
Archimedes Pharma Receives Approval for PecFent Nasal Spray II-50
Cypress Bioscience Obtains Patent Rights for Carbetocin Therapy II-50
MDRNA, Inc. Announces Change of Name II-51
Prosonix Inks Product Co-Development and Licensing with Trimel
Biopharma II-51
Serenity Pharmaceuticals and Allergan Sign Agreement II-51
Ethicon Acquires Acclarent II-51
Ikano’s Midazolam Obtains Orphan Drug Designation II-52
FDA Issues Not-Approvable Letter for Nastech’s Generic
Calcitonin-Salmon II-52
Trimel BioPharma Acquires Direct Haler II-52
Lupin Takes Over AllerNaze™ Rights from Collegium Pharmaceutical II-52
Nanotherapeutics Purchases DelSite Assets II-53
Schering-Plough Merges with Merck II-53
Valois Pharma and Nycomed Launch Spray Pump for Fentanyl II-53
Phylogica and Aegis Therapeutics Collaborate II-53
Intranasal Therapeutics is Now Ikano Therapeutics II-54

10. CORPORATE ACTIVITY - A HISTORIC PERSPECTIVE BUILDER II-55
FDA Clears Use of New Clone in Calcitonin Production of Unigene II-55
Zelos Therapeutics Collaborates with Aegis Therapeutics II-55
ImmuneRegen BioSciences Partners with LRRI II-55
Avamys™ Nasal Spray Receives Approval in Europe II-55
PMI-150 Receives Canadian Patent II-56
Javelin Releases Phase III Data of Rylomine Intranasal Morphine II-56
FDA Recommends Supplemental Study for Javelin’s PMI-150 II-56
Palatin Re-Acquires Bremelanotide Rights from King Pharma II-56
USFDA Approves FluMist® for Young Children II-57
USFDA Approves Veramyst Nasal Spray for Individuals Aged Two
Years and Above II-57
Kurve Technology Inks Agreement with Schering-Plough II-57
MedImmune Clarifies FDA Observations II-57
FluMist(R) Receives FDA Approval for Refrigerated Formulation II-57
Nastech Regains Rights for PTH1-34 Nasal Spray II-58
NASONEX(R) Receives Ease-of-Use Commendation from Arthritis
Foundation II-58
Aegis Therapeutics Establishes Cedar Therapeutics Inc. II-58
EMEA Provides Encouraging Feedback for Avamys™ Nasal Spray II-58
Kurve Technologies Introduces Blog on Nasal Drug Delivery II-58
Accentia Extends Agreement with Mayo Foundation II-59
Nastech Signs Development and License Agreement with Amylin II-59
MedImmunes FluMist Plant Gets FDA Approval II-59
ShinNippon Subsidiaries Sign Licensing Agreement with Tokai
Pharmaceuticals II-59
MeadWestvaco Acquires Saint-Gobain Calmar II-60
Merck Terminates PYY3-36 Partnership with Nastech II-60
Inspire Signs Licensing Agreement with Boehringer Ingelheim II-60
P&G Partners with Nastech to Develop PTH(1-34) II-61
Unigene Laboratories Signs Distribution Agreement with Tzamal
Bio Pharma II-61
GlaxoSmithKline Seeks Marketing Approval for Fluticasone
Furoate in the US and Europe II-61
Kurve Technology Relocates Corporate Headquarters II-61
Kurve Inks an Agreement with DARA BioSciences II-62
Kurve Enters into a Development Agreement with Schering-Plough II-62
Altana Submits NDS for Approval of Ciclesonide Nasal Spray in
Canada II-62
Altana Pharma AG Receives FDA Approval for Pediatric Use of
Omnaris II-62
Intranasal Therapeutics Inc. Receives Financial Funding II-62
FDA Completes Pre-Approval Inspections at Nastech’s Washington
Facility II-63
Kos Signs Exclusive License Agreement with SkyePharma II-63
Bentley Signs Agreement with Biocon II-63
Intranasal Therapeutics Files Patent Application for Synthetic
THC II-63
Ionix Pharmaceuticals in Collaboration with Reckitt Benckiser
for Drug Development II-64
University of Kentucky Receives Patent for new Intranasal Device II-64
Intranasal Technology Extends Collaboration with Aegis
Therapeutics II-64
Accentia Biopharmaceuticals Signs License Agreement with
Collegium Pharmaceuticals II-64
Aegis Therapeutics Extends License Agreement with Intranasal
Technologies II-65
Bentley Pharmaceuticals Signs Agreement with Dong Sung
Pharmaceuticals II-65
Unigene Gets FDA Approval for Fortical Calcitonin- Salmon
Nasal Spray II-65
OptiNose Signs Collaborative Agreement with MedPharm II-65
West Pharmaceutical Divests Drug Delivery Business to
Archimedes Pharma II-66
Nastech Pharmaceutical Receives FDA Approval for Nascobal
Nasal Spray II-66

11. FOCUS ON SELECT GLOBAL PLAYERS II-67
Aegis Therapeutics LLC (USA) II-67
Alza Corporation (USA) II-67
AptarGroup, Inc. (USA) II-67
Archimedes Pharma Limited. (UK) II-68
AstraZeneca Plc. (UK) II-68
MedImmune, Inc. (USA) II-68
Bayer Consumer Care (USA) II-69
Bespak Plc. (UK) II-69
GlaxoSmithKline Plc. (UK) II-69
Ikano Therapeutics Inc. (USA) II-70
Javelin Pharmaceuticals, Inc. (USA) II-70
Kurve Technology, Inc. (USA) II-70
Marina Biotech, Inc. (USA) II-71
Merck & Co., Inc. (USA) II-71
Novartis AG (Switzerland) II-72
OptiNose AS (Norway) II-72
Pfizer, Inc. (USA) II-72
Rexam Plc. (UK) II-73
Sanofi S.A. (France) II-73
Unigene Laboratories, Inc. (USA) II-73

12. MARKET ANALYTICS II-74
Table 7: The US Recent Past, Current & Future Analysis for
Intranasal Drug Delivery by Therapeutic Area - Allergic
Infections, Analgesics, Osteoporosis, and Vaccinations Markets
Independently Analyzed by Annual Sales Figures in US$ Million
for Years 2009 through 2017 (includes corresponding
Graph/Chart) II-74

Table 8: The US Historic Review for Intranasal Drug Delivery
by Therapeutic Area - Allergic Infections, Analgesics,
Osteoporosis, and Vaccinations Markets Independently Analyzed
by Annual Sales Figures in US$ Million for Years 2003 through
2008 (includes corresponding Graph/Chart) II-75

Table 9: The US 15-Year Perspective for Intranasal Drug
Delivery by Therapeutic Area -Percentage Breakdown of Values
Sales for Allergic Infections, Analgesics, Osteoporosis, and
Vaccinations for Years 2003, 2011 & 2017 (includes
corresponding Graph/Chart) II-76

III. COMPETITIVE LANDSCAPE

Total Companies Profiled: 71 (including Divisions/Subsidiaries - 87)

------------------------------------------
Region/Country Players
------------------------------------------
The United States 54
Canada 2
Japan 2
Europe 24
France 4
Germany 5
The United Kingdom 10
Rest of Europe 5
Asia-Pacific (Excluding Japan) 2
Middle-East 3
------------------------------------------

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