Transdermal Drug Delivery September 2012

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CHAPTER ONE: EXECUTIVE SUMMARY ..........................................................1

Market Drivers .................................................................................................................... 2
Market Size and Growth..................................................................................................... 3
Total Transdermal/Transmucosal Drug Delivery Market .......................................... 3
Transdermal/Transmucosal Drug Delivery Only Market........................................... 4
Competitive and Market Analysis ..................................................................................... 4

CHAPTER TWO: INTRODUCTION AND OVERVIEW......................................7

Scope and Methodology ...................................................................................................... 7
Reasons for Transdermal/Transmucosal Drug Delivery Systems .................................. 8
Phases of Drug Action ......................................................................................................... 9
Transdermal drug Delivery ............................................................................................. 10
History of Transdermal Drug Delivery ..................................................................... 10
Advantages of Transdermal Drug Delivery ................................................................ 14
Disadvantages of Transdermal Drug Delivery ........................................................... 15
Transdermal Patch (Passive) Drug Delivery ............................................................. 15
Transfersomes ............................................................................................................... 21
Medicated Tattoos ......................................................................................................... 21
Crystal Reservoir Technology ...................................................................................... 22
Active Transdermal Drug Applications .......................................................................... 22
Electrotransport Drug Delivery ................................................................................... 24
Iontophoresis ................................................................................................................. 25
Reverse Iontophoresis ................................................................................................... 26
Sonophoresis .................................................................................................................. 27
Photomechanical Waves ............................................................................................... 27
Transmucosal Drug Delivery............................................................................................ 27
Buccal Drug Delivery .................................................................................................... 32
Vaginal Drug Delivery .................................................................................................. 35

CHAPTER THREE: TRENDS AND DEVELOPMENTS ....................................37

Novel Transdermal Approvals ........................................................................................ 37
Innovations in Transdermal Drug Delivery .................................................................... 38
Adhesive Technology and Issues ...................................................................................... 39
Adhesive Market Issues .................................................................................................... 40
Generic Transdermal Study Design Guidelines ............................................................. 42
Biotechnological Issues ...................................................................................................... 42
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iv

The Market for Transdermal/Transmucosal Delivery Systems

Developments in Insulin Delivery .................................................................................... 45
New Developments in Hormone Drug Delivery ............................................................. 46
New Mucosal/Buccal Delivery Systems ........................................................................... 48
Other New Drug Delivery Systems .................................................................................. 49
Microneedle-Assisted Transdermal Drug Delivery ....................................................... 53
Controlled Thermal Energy Technology ........................................................................ 54
New Ultrasound Technology ............................................................................................ 54
Transdermal Products in Development ...................................................................... 55

CHAPTER FOUR: MARKET SIZE AND GROWTH..........................................59

The Total Transdermal/Transmucosal Drug Delivery Market .................................... 59
Transdermal/Transmucosal Delivery Technology Only Market.................................. 68

CHAPTER FIVE: COMPETITIVE ANALYSIS ...................................................73

Competitive Landscape .................................................................................................... 73
Emerging Participants.................................................................................................. 75
Market Analysis ................................................................................................................ 77

CHAPTER SIX: COMPANY PROFILES ..............................................................79

3M Pharmaceuticals ......................................................................................................... 80
Access Pharmaceuticals, Inc. ........................................................................................... 82
Acrux Limited ................................................................................................................... 83
ALZA Corporation ........................................................................................................... 85
Antares Pharma, Inc. ........................................................................................................ 88
Apricus BioSciences .......................................................................................................... 90
Aveva Drug Delivery Systems .......................................................................................... 92
Generex Biotechnology Corporation ............................................................................... 93
Inovio Pharmaceuticals, Inc. ........................................................................................... 95
Labtec GmbH .................................................................................................................... 96
Lohmann Therapy-Systems Corp (LTS Lohmann Therapie Systeme AG) ................ 98
NITTO DENKO CORPORATION .......................................................................................... 99
Noven Pharmaceuticals, Inc. .......................................................................................... 102
Pantec Biosolutions AG .................................................................................................. 103
Tapemark......................................................................................................................... 104
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Table of Contents

TEVA Pharmaceutical Industries Ltd. .......................................................................... 106

Zosano Pharma ................................................................................................................ 108


CHAPTER TWO: INTRODUCTION AND OVERVIEW 

Table 2-1: Select Leading Transdermal Delivery-Based Products ............................... 13

CHAPTER THREE: TRENDS AND DEVELOPMENTS 

Table 3-1: Selected Transdermal Products in Development ......................................... 56

CHAPTER FOUR: MARKET SIZE AND GROWTH 

Table 4-1: The Worldwide Market for Transdermal/Transmucosal Drug
Delivery Technology and Pharmaceuticals 2010-2017 .................................................. 60
Figure 4-1: The Worldwide Market for Transdermal/Transmucosal Drug
Delivery Technology and Pharmaceuticals 2010-2017 .................................................. 61
Table 4-2: The Worldwide Market for Pharmaceuticals Utilizing
Transdermal/Transmucosal Drug Delivery Systems by Type 20102017.................... 63
Figure 4-2: The Worldwide Market for Pharmaceuticals Utilizing\Transdermal/
Transmucosal Drug Delivery Systems Revenues by Type 20102017 .......................... 64
Table 4-3: The Worldwide Market for Pharmaceuticals Utilizing
Transdermal/Transmucosal Drug Delivery Technologies Market
Share by Type 2010-2017 .................................................................................................. 65
Figure 4-3: Transdermal Drug Delivery Market by Disease Treated
(Cardiovascular, Hormones, Pain Management, Smoking Cessation) ........................ 66
Table 4-4: The Worldwide Market for Transdermal/Transmucosal Drug
Delivery Systems by Region (United States, Europe, Japan, ROW) 20102017 ........ 67
Table 4-5: The Worldwide Market for Transdermal/Transmucosal Drug
Delivery Systems by Pharmaceutical and Drug Delivery
Component 2010-2017 ...................................................................................................... 69
Table 4-5: The Worldwide Market for Transdermal/Transmucosal Drug
Delivery Systems Distribution of Revenue by Pharmaceutical and Drug
Delivery Component 2010-2017 ...................................................................................... 69

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Reproduction without prior written permission, in any media now in existence or hereafter developed,
in whole or in any part, is strictly prohibited.

vi

The Market for Transdermal/Transmucosal Delivery Systems

Figure 4-4: The Worldwide Market for Transdermal/Transmucosal Drug
Delivery Systems Distribution of Revenue by Pharmaceutical and Drug
Delivery Component 2010-2017 ...................................................................................... 70
Figure 4-5: The Worldwide Market for Transdermal/Transmucosal Drug
Delivery Systems Distribution of Revenue by Pharmaceutical and
Drug Delivery Component 2012 ..................................................................................... 71
Figure 4-6: The Worldwide Market for Transdermal/Transmucosal Drug
Delivery Systems Distribution of Revenue by Pharmaceutical and Drug
Delivery Component 2017 ............................................................................................... 72

CHAPTER FIVE: COMPETITIVE ANALYSIS ...................................................73

Table 5-1: Leading Suppliers of Transdermal/Transmucosal Drug Delivery
Technology ......................................................................................................................... 77

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Chapter Two: Introduction

17

enters the body. This ensures that any variations in skin permeability between patients
have a minimal effect on plasma levels of the drug.
Patches generally consist of a porous membrane, a drug, an adhesive, and a
release-liner. The pressure-sensitive adhesives are based on natural or synthetic
rubbers, polyacrylates, or silicone. Many manufacturers prefer silicone adhesives
because they are kind to the skin. They are also chemically stable, biologically inert,
transparent, retain adhesive properties in the presence of moisture, and have high
permeability. The release liner, or peel-away strip, consists of paper, polystyrene,
polyethylene, polyester, or other polymeric films with a light coating of compounds
such as silicones.
There are four basic systems for transdermal patch drug delivery:
x

Membrane-controlled system

Adhesive dispersion-type system

Matrix diffusioncontrolled system

Microreservoir dissolutioncontrolled system

Membrane-Controlled System
In the membrane-controlled transdermal drug delivery system, the membrane
of the patch is what determines how much of the drug is dispersed. Several products
utilize the membrane-controlled system including Transderm-Scop, Transderm-Nitro,
Clonidine-TTS, TestoDerm, and Estraderm.
ALZAs D-Trans Transdermal technology provides drug delivery through
intact skin for as long as one week with a single application. The system routinely
provides improved drug absorption and improved delivery of constant amounts of
drug into the bloodstream. The D-Trans Transdermal system is valuable for drugs
with a narrow therapeutic index, short half-life or inconvenient dosing regimens,
invasive parenteral administration, poor oral bioavailability, suboptimal efficacy in
current dosage forms, and undesirable side effects due to spikes in serum drug levels.
The D-Trans system incorporates a series of thin, flexible films: a backing layer, a
drug reservoir, a rate controlling film, and an adhesive. ALZA developed a scrotal
testosterone patch, TestoDerm, which was launched in the United States in 1994.

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Chapter Three: Trends and Developments

45

technology provides cost-effective self-administration of antibodies and vaccines. The

company has ongoing Phase II clinical trials for ZP-PTH, a once daily patch of Lillys
Forteo for osteoporosis treatment.
This novel approach enabled the use of off-the-shelf electronic piezo transducers
in a revolutionary, programmable way that controls the delivery accurately and
reproducibly. And unlike systems using iontophoresis or electroporation, the MicroDose
system will be able to deliver large molecule therapeutics.
MicroDose Therapeutics has developed a novel needle-free transdermal system.
The system can be designed as a standard pen injector for use by patients who are skilled
at self-injection, but can also be designed to be worn as a patch, and programmed for
intermittent or continuous delivery, allowing medication to be given at a predetermined
time. The patch design would be most helpful for children and patients who are unable or
unwilling to dose themselves, and for those patient groups that are poorly compliant.

DEVELOPMENTS IN INSULIN DELIVERY

Insulin, unlike most other drugs, cannot be delivered orally. It is degraded in the
gastrointestinal tract prior to its absorption into the bloodstream. Therefore, the most
common way to administer insulin to a patient is by injection. However, this approach is
invasive, painful, inaccurate, and inconvenient. Alternative approaches to administer
insulin through the skin surface aim to improve the ease of administration and accuracy
of dosage. Delivery methods that may hold promise in the future for insulin patch
administration include iontophoresis, electroporation, and ultrasound delivery.
Iontophoresis makes use of a small electric current to increase the permeability of
the skin. Due to a change in electric potential across the epidermal layer, charged insulin
molecules are pushed across the stratum corneum. Small battery operated devices have
been designed with reservoirs containing insulin. Electroporation makes use of high
voltage, short duration pulses to generate aqueous pores in the stratum corneum. A
transmembrane potential is applied to the skin. These devices have been demonstrated to
be successful, however the toxicity to the skin is being examined.
Another area of research investigates using ultrasound to increase skin
permeability. These devices deliver low frequency sound waves to induce thermal,
chemical and mechanical alterations in the skin tissue. Studies in rats and rabbits have

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63

Chapter Four: Market Size and Growth

Table 4-2

The Worldwide Market for Pharmaceuticals Utilizing

Transdermal/Transmucosal Drug Delivery
Systems by Type
20102017

Year
2010
2011
2012
2013
2014
2015

Manufacturer Revenue (in billions)

Transdermal
Transmucosal

Growth
Total
Rate

2016
2017
1

Years
20102012
20122017
20102017

Compound Annual Growth Rate

Transdermal Transmucosal
Total

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Copyright 2012 Kalorama Information

Reproduction without prior written permission, in any media now in existence or hereafter developed,
in whole or in any part, is strictly prohibited.