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US Transdermal Patch Market, Dosage, Price & Clinical Trials Insight 2029

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    Report

  • 230 Pages
  • September 2023
  • Region: United States
  • Kuick Research
  • ID: 5308213

US Transdermal Patch Market, Dosage, Price & Clinical Trials Insight 2029 Report Highlights:

  • US Transdermal Patch Market Opportunity: > US$ 5 Billion By 2029
  • Commercially available Patches In US Market: > 25 Patches
  • Clinical Insight On All approved transdermal Patches In US Market
  • Ongoing Clinical Trials Of Transdermal Patches in US: > 40 Patches
  • US Transdermal Patch Clinical Trials Insight By Company, Indication & Phase
  • Dosage & Price Insight Of Approved Patches By Indications

Competitive Landscape

Transdermal patches are an innovative means of delivering medications to the body and keeping medicine doses at the ideal levels required to treat an illness. The majority of transdermal patches on the market are reformulated versions of existing medications that are delivered orally or subcutaneously, and were produced after the patents on these drugs expired. In the US, the landscape of transdermal patch development is highly active, with contributions from both pharmaceutical corporations and researchers, who are now looking for creative ways to improve the features of these patches compared to conventional transdermal.

It is anticipated that over 100 clinical studies are being done globally to evaluate investigational transdermal patches, with approximately 50 of them taking place in the US. Neurological illnesses are currently dominating clinical trials in terms of indications. The most prospects are being developed for Parkinson’s and Alzheimer’s diseases. The number of people in the US suffering from neurological diseases has grown in recent years, as contributing environmental variables have increased in this age of modernization. With increased awareness of transdermal patches and their patient-friendliness, they are quickly becoming one of the most popular therapeutic interventions for these disorders. Transdermal patches are attracting interest in the US market for a variety of indications, particularly those that require long term treatment, such as cardiovascular disorders and chronic pain. The US is emerging as a hotspot for transdermal patch development, with many big and small companies executing clinical trials for transdermal patches created for various indications in the region. 

Transdermal patches for pain relief are also an important field of study and development in the US. Aside from pain produced by joint difficulties, muscle strains, and nerve damage, among other things, researchers are focusing on pain caused by various health diseases such as cancer or its treatment, as well as pain experienced after specific surgeries. Transdermal patches release the drug at a steady rate over several hours, giving pain relief and serving as the most convenient alternative for pain reduction. Furthermore, unlike oral pain relievers, which can produce unpleasant events such as gastritis, transdermal patches have no substantial side effects.

Several medical universities and health centers in the US are also involved in the research and development of transdermal patches at present, and several of their products are now undergoing late phase clinical trials in the region. For instance, the Washington University School of Medicine is conducting a phase III trial for its buprenorphine transdermal matrix patch in pregnant patients with opioid use disorder. The aim of the trial is to see if the patch can induce opioid withdrawal in these subjects, which will determine the feasibly of the protocol of using patches as a bridge towards using sublingual buprenorphine films. Some others are the University of California, Davis and the Brown University that are conducting trials for oxybutynin and nicotine-based transdermal patches, respectively. 

With the rapid approvals of transdermal patches lately, the FDA has also marked itself as an important player in the US market of transdermal patches. The FDA provides a detailed communication on the requirements of an ideal transdermal patch, and patches that meet these are allowed entry in the regional market. In September 2023, the FDA approved Zydus Lifesciences’ transdermal patch to prevent pregnancy. The patch is a generic version of a marketed hormonal patch and contains norelgestromin and ethinyl estradiol as its active ingredients. 

The US transdermal patch market offers a plethora of opportunities encouraged by patient convenience, therapeutic versatility and the potential to address healthcare challenges such as pain management and vaccine administration. As technology continues to advance, and as patient preferences shift towards non-invasive and user-friendly drug delivery methods, the market for transdermal patches is expected to experience significant growth. Pharmaceutical companies and researchers are continuously exploring and investing in this field, which will continue in the coming years as well. In addition, as patent protection of some commonly used patches are coming to end, generic competition is expected to drive innovation in the market.  

 

 

Table of Contents


1. Research Methodology
2. US Transdermal Patch Market Outlook
2.1 Approved Transdermal Patches Insight
2.2 Current Market Scenario
2.3 Favorable Market Growth Inhibitors
2.4 Clinical & Commercialization Challenges
2.5 Future Marketing Opportunities

3. Branded vs Generic Transdermal Patches Comparison
4. Transdermal Patch Clinical & Market Trends By Indication
4.1 Brain, Neurological & Psychotic Disorders
4.2 Hormone Modulators
4.2.1 Hormone Replacement Therapies (HRT)
4.2.2 Contraception
4.3 Diabetes
4.4 Vaccine
4.5 Substance Use Disorders
4.6 Cardiovascular Diseases

5. US Transdermal Patch Clinical Pipeline Overview
5.1 By Company
5.2 By Drug Class
5.3 By Indication
5.4 By Phase
5.5 By Priority Status

6. Cardiovascular Diseases Transdermal Patch - US Market Availability, Dosage & Price Analysis
6.1 Clonidine Transdermal Patch
6.2 Nitroglycerin Transdermal Patch

7. Opioid Drug Containing Transdermal Patches - US Market Availability, Dosage & Price Analysis
7.1 Fentanyl Transdermal Patch
7.2 Buprenorphine Transdermal Patch

8. Neurological Disorders Transdermal Patch - US Market Availability, Dosage & Price Analysis
8.1 Selegiline Transdermal Patch
8.2 Rivastigmine Transdermal Patch
8.3 Methylphenidate Transdermal Patch
8.4 Asenapine Transdermal Patch
8.5 Rotigotine Transdermal Patch (Neupro) sales
8.6 Donepezil Transdermal Patch
8.7 Dextroamphetamine Transdermal Patch

9. Hormonal Therapy Transdermal Patch - US Market Availability, Dosage & Price Analysis
9.1 Estradiol Transdermal Patch
9.2 Testosterone Transdermal Patch (Androderm)

10. Transdermal Patches for Other Conditions - US Market Availability, Dosage & Price Analysis
10.1 Nicotine Transdermal Patch
10.2 Oxybutynin Transdermal Patch
10.3 Granisetron Transdermal Patch (Sancuso)

11. US Transdermal Patch Clinical Trials Insight By Company, Indication & Phase
11.1 Research
11.2 Preclinical
11.3 Phase-I
11.4 Phase-II
11.5 Phase-III
11.6 Preregistration
11.7 Registered

12. US Commercially Available Transdermal Patches Clinical Insight by Indication
13. Competitive Landscape
13.1 AbbVie
13.2 AFYX Therapeutics
13.3 Agile Therapeutics
13.4 Bayer HealthCare Pharmaceuticals
13.5 Corsair Pharma
13.6 DBV Technologies
13.7 Hisamitsu Pharmaceutical
13.8 IBSA
13.9 Privo Technologies
13.10 Psilera
13.11 Starton Therapeutics
13.12 Teikoku Pharma USA
13.13 Teikoku Seiyaku
13.14 UCB
13.15 Vaxess Technologiess
13.16 Verndari

List of Figures
Figure 2.1: Advantages of Transdermal Patches
Figure 2.2: Disadvantages of Transdermal Patches
Figure 2.3: US - Transdermal Patch Market (US$ Billion), 2021-2029
Figure 2.4: Transdermal Patch Market Favorable Factors
Figure 2.5: Transdermal Patch Market Commercialization Challenges
Figure 3.1: Nitroglycerin - Branded v/s Generic Version Costs for Different Doses (US$), September 2023
Figure 3.2: Nitroglycerin - Branded v/s Generic Version Percentage Decrease in Cost, September 2023
Figure 3.3: Implications of Branded vs Generic Competition
Figure 4.1: Potential Market Segments of Transdermal Drug Delivery Systems
Figure 4.2: NCT03740204 Phase 2 Study - Initiation & Completion Years
Figure 4.3: DepMIND3 Phase 2 Study - Initiation & Completion Years
Figure 4.4: NCT05704036 Phase 2 Study - Initiation & Completion Years
Figure 4.5: NCT03875378 Phase 2 Study - Initiation & Completion Years
Figure 4.6: Requirements of Female Contraceptive Transdermal Patches
Figure 4.7: Benefits of Female Contraceptive Transdermal Drug Delivery System
Figure 4.8: Benefits of Insulin Transdermal Patch
Figure 4.9: Drawbacks of Insulin Transdermal Patch
Figure 4.10: Benefits of Vaccine Transdermal Patch
Figure 4.11: Drawbacks of Vaccine Transdermal Patch
Figure 4.12: Factors Responsible for Increased Consumption of Nicotine Patches
Figure 4.13: NCT05886582 Phase 2 Study - Initiation & Completion Years
Figure 5.1: US - Transdermal Patch Pipeline by Company (Numbers), 2023 till 2029
Figure 5.2: US Transdermal Patch Pipeline by Drug Class (Numbers), 2023 till 2029
Figure 5.3: US Transdermal Patch Pipeline by Indication (Numbers), 2023 till 2029
Figure 5.4: US Transdermal Patch Pipeline by Phase (Numbers), 2023 till 2029
Figure 5.5: US Transdermal Patch Pipeline by Priority Status (Numbers), 2023 till 2029
Figure 6.1: Catapres - FDA Approval, First Generic Approval & Branded Drug Discontinuation Years
Figure 6.2: Generic Clonidine Patch - Price per Unit & Supply of Different Doses (US$), September 2023
Figure 6.3: Clonidine Transdermal Patch - Recommended Initial, Incremented & Maximum Doses (mg/week)
Figure 6.4: Clonidine Transdermal Patch - Monthly & Annual Treatment Costs (US$), September 2023
Figure 6.5: Nitro-Dur - Price per Unit & Supply of Different Doses (US$), September 2023
Figure 6.6: Generic Nitroglycerin Transdermal Patch - Price per Unit & Supply of Different Doses (US$), September 2023
Figure 7.1: Duragesic - FDA Approval, First Generic Approval & Branded Drug Discontinuation Years
Figure 7.2: Generic Fentanyl Transdermal Patch - Price per Unit & Supply of Different Doses (US$), September 2023
Figure 7.3: Butrans - Price per Unit & Supply of Different Doses (US$), September 2023
Figure 7.4: Generic Buprenorphine Transdermal Patch - Price per Unit & Supply of Different Doses (US$), September 2023
Figure 8.1: Emsam - Price per Unit & Supply (US$), September 2023
Figure 8.2: Emsam - Monthly & Annual Treatment Costs (US$), September 2023
Figure 8.3: Exelon - Price per Unit & Supply (US$), September 2023
Figure 8.4: Generic Rivastigmine Transdermal Patch - Price per Unit & Supply (US$), September 2023
Figure 8.5: Exelon - Initial & Maintenance Dose for Treatment of Parkinson’s disease
Figure 8.6: Exelon - Monthly & Annual Treatment Costs for Parkinson’s disease (US$), September 2023
Figure 8.7: US - Daytrana Patent Issue & Expiration Year
Figure 8.8: Daytrana - Price per Unit & Supply of All Doses (US$), September 2023
Figure 8.9: US - Secuado Patent Issue & Expiration Years
Figure 8.10: Secuado - Price per Unit & Supply of All Doses (US$), September 2023
Figure 8.11: Secuado - Recommended Initial & Incremented Dose (mg/Day)
Figure 8.12: US - Neupro Patent Issue & Expiration Years
Figure 8.13: Neupro - Price per Unit & Supply (US$), September 2023
Figure 8.14: Neupro - Initial & Maximum Recommended Doses for Early-Stage & Advanced Parkinson’s disease (mg/day)
Figure 8.15: Neupro - Initial & Maximum Recommended Dose for Restless Leg Syndrome (mg/day)
Figure 8.16: US - Neupro Annual Sales (US$ Million), 2019-2022
Figure 8.17: Global - Neupro Annual Sales (US$ Million), 2019-2023*
Figure 8.18: US - Adlarity Patent Issue & Expiration Years
Figure 8.19: Adlarity - Price per Unit & Supply for All Doses (US$), September 2023
Figure 8.20: Adlarity - Recommended Initial & Incremented Dose (mg/day)
Figure 8.21: Adlarity - Monthly & Yearly Treatment Costs (US$), September 2023
Figure 8.22: US - Xelstrym Patent Issue & Expiration Years
Figure 8.23: Xelstrym - Price per Unit & Supply for All Doses (US$), September 2023
Figure 8.24: Xelstrym - Recommended Initial & Maximum Doses for Pediatric & Adult Patients (mg/day)
Figure 9.1: Vivelle-Dot - FDA Branded & First Generic Approval Years
Figure 9.2: Vivelle-Dot - Price per Unit & Supply of Different Doses (US$), September 2023
Figure 9.3: Recommended Doses for Treatment of Vaginal Atrophy, Vasomotor Symptoms, & Postmenopausal Osteoporosis (mg/Day)
Figure 9.4: Minivelle - FDA Branded & First Generic Approval Years
Figure 9.5: US - Minivelle Patent Issue & Expiration YearS
Figure 9.6: Minivelle - Price per Unit & Supply of All Doses (US$), September 2023
Figure 9.7: Minivelle - Recommended Dose by Indication (mg/Day)
Figure 9.8: Climara - FDA Branded & First Generic Approval Years
Figure 9.9: Climara - Price per Unit & Supply of Various Doses (US$), September 2023
Figure 9.10: Menostar - FDA Branded & First Generic Approval Years
Figure 9.11: Menostar - Price per Unit & Supply (US$), September 2023
Figure 9.12: Climara Pro - Price per Unit & Supply (US$), September 2023
Figure 9.13: CombiPatch - Price per Unit & Supply of Both Doses (US$), September 2023
Figure 9.14: Xulane - Price per Unit & Supply (US$), September 2023
Figure 9.15: Xulane - Recommended Schedule for Achieving Birth Control Effect (Days)
Figure 9.16: Zafemy - Price per Unit & Supply (US$), September 2023
Figure 9.17: US - Twirla Patent Issue & Expiration Year
Figure 9.18: Twirla - Price per Unit & Supply (US$), September 2023
Figure 9.19: Twirla - Recommended Schedule for Achieving Birth Control Effect (Days)
Figure 9.20: Generic Estradiol Transdermal Patch - Price per unit & Supply (US$),  September 2023
Figure 9.21: Androderm - Price per Unit & Supply (US$), September 2023
Figure 9.22: Androderm - Recommended Initial & Maintainence Dose for Treatment of  Hypogonadism (mg/day)
Figure 10.1: Nicoderm CQ - Price per Unit & Supply of 7mg & 14mg Transdermal Patches (US$), September 2023
Figure 10.2: Nicoderm CQ - Price per Unit & Supply of 21mg Transdermal Patches  (US$), September 2023
Figure 10.3: Nicoderm CQ - Recommended Dose & Treatment Schedule for Patients  with Consumption of >10 Cigarette/Day (mg/day)
Figure 10.4: Nicoderm CQ - Recommended Dose & Treatment Schedule for Patients  with Consumption of <10 Cigarette/Day (mg/day)
Figure 10.5: Nicoderm CQ - Full Treatment Cost for Patients with Daily Consumption  of <10 Cigarettes & >10 Cigarettes (US$), September 2023
Figure 10.6: Habitrol - Price per Unit & Supply (US$), September 2023
Figure 10.7: Habitrol - Recommended Dose & Treatment Schedule for Patients with  Consumption of >10 Cigarettes/Day (mg/day)
Figure 10.8: Habitrol - Recommended Dose & Treatment Schedule for Patients with  Consumption of <10 Cigarettes/Day (mg/day)
Figure 10.9: Habitrol - Full Treatment Cost for Patients with Daily Consumption of <10  Cigarettes & >10 Cigarettes (US$), September 2023
Figure 10.10: Generic Nicotine Transdermal Patch - Price per Unit & Supply of Dose  7mg (US$), September 2023
Figure 10.11: Generic Nicotine Transdermal Patch - Price per Unit & Supply of Dose  14mg (US$), September 2023
Figure 10.12: Generic Nicotine Transdermal Patch - Price per Unit & Supply of Dose  21mg (US$), September 2023
Figure 10.13: Oxytrol - Price per Unit & Supply (US$), September 2023
Figure 10.14: Oxytrol for Women - Price per Unit & Supply (US$), September 2023
Figure 10.15: Sancuso - Patent Issue & Expiration Year

List of Tables
Table 2.1: US - Currently Available Branded Transdermal Patches
Table 2.2: Features Required in Transdermal Patches
Table 3.1: Comparison of Features of Branded & Generic Patches
Table 7.1: Butrans - Initial Dose Calculation using Previous Opioid (Morphine) Dosage
Table 8.1: Daytrana - Recommended Titration Schedule for ADHD Treatment

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • AbbVie 
  • AFYX Therapeutics 
  • Agile Therapeutics 
  • Bayer HealthCare Pharmaceuticals 
  • Corsair Pharma 
  • DBV Technologies 
  • Hisamitsu Pharmaceutical 
  • IBSA 
  • Privo Technologies 
  • Psilera 
  • Starton Therapeutics 
  • Teikoku Pharma USA 
  • Teikoku Seiyaku 
  • UCB 
  • Vaxess Technologiess 
  • Verndari