Nanotechnology in Drug Delivery - Technological
Improvements and Novel Approaches to Fulfill High Potential
Reference Code: GBIHC043MR Publication Date: December 2010
The nano-enabled drug delivery market has seen high growth in the market and is expected to
grow at a faster rate in the near future. The market will witness increased competition, high
High unmet need in the investment from venture capitalists and government. The M&A and licensing landscape will see
nano-enabled drug significant changes in the future. This is because the market is expected to become more lucrative.
delivery market offers
tremendous scope for new The Nano-Enabled Market Represents Significant Opportunities and High Level of Unmet
entrants and existing Needs
players
Nanotechnology in Drug Delivery Market, Opportunity and Unmet Needs, 2010
Opportunities Unmet Needs
Opportunities for
Nanotoxicity of
New Dug Delivery
Nanomaterials
Companies
Need of
Market Growth Opportunity and Understanding
Unmet Needs Biological behavior
Need of
Understanding
Licensing Distribution Pattern
Opportunity of Nanomaterials
Source: GBI Research
The nano-enabled drug delivery market has plenty of opportunities and a high level of unmet need.
Opportunities for creating a new drug delivery company are tremendous. Many small companies
have launched the technology to develop novel methods for exploiting nanotechnologies in drug
delivery. In the past, companies have been dedicated to the nano-enabled drug delivery that has
been popping up all over the world.
The creation of new companies will not only increase the investment and market growth, but also
increase the competition in the market place. In addition, the emergence of new companies will
provide licensing and merger and acquisition (M&A) opportunities for larger pharmaceutical
markets.
The market is also characterized by high levels of unmet need. This is primarily because
development in this area is in its initial stages and has a significant number of unaddressed issues
such as nanotoxicity, biological behavior and distribution pattern of nanoparticles. These unmet
needs represent a significant opportunity for companies to explore.
Nanotechnology in Drug Delivery - Technological Improvements GBIHC043MR / Published DEC 2010
and Novel Approaches to Fulfill High Potential
Page 1
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In summary, high growth in the nano-enabled drug delivery markets will provide significant
opportunities for companies.
Increased Investment and Emerging Business Models Will Support the Market Growth
The increasing investment in the nano-enabled drug delivery market has significantly driven the
market. Funding for nanotechnology programs increased during the administration of George Bush.
The nanotechnology funding is expected to increase significantly in the future. Among all the major
geographies, the European government is investing more in nanotechnology R&D. This suggests
that there will be increased governmental support for nanotechnology R&D. In addition, increase in
early stage venture capital will also affect the market positively.
Careful Approach of Regulator towards Nanotechnology is Negatively Affecting the Market
Challenges Facing Regulators Regarding Nanotechnology
Address Promote Growth
Concerns in
Related Nanotechnology
to Health and
Environment
Assess whether
Finding Criteria New Regulations
for Segregating Regulatory Challenges are Required or
Nanoparticles in Nanotechnology Not
Regulations Co-operation
across the Globe between
should be Domestic
in-sync Regulators
Source: GBI Research
The toxicity increases due to increased surface area for the particle when the size is reduced. This
gives rise to concerns about the possible negative impact on public health and environment due to
increased use of nanotechnology enabled products. Nanotechnology is increasingly being
employed in industries such as medicine, cosmetics, food, semiconductor devices, energy and
telecommunications due to the advantages it provides over the conventional technology. As the
use of nanotechnology progresses, the risk of exposure to the population also rises. This has led a
cautious approach of regulators toward nanotechnology.
Nanotechnology in Drug Delivery - Technological Improvements GBIHC043MR / Published DEC 2010
and Novel Approaches to Fulfill High Potential
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1 Table of Contents
1 Table of Contents ........................................................................................................................ 3
1.1 List of Tables..................................................................................................................... 6
1.2 List of Figures ................................................................................................................... 6
2 Nanotechnology in Drug Delivery – Introduction.......................................................................... 7
2.1 Introduction ....................................................................................................................... 7
2.2 GBI Research Report Guidance ....................................................................................... 8
3 Application of Nanotechnology in Drug Delivery .......................................................................... 9
3.1 Current Applications of Nano-enabled Drug Delivery........................................................ 9
3.1.1 Nano-engineered drugs ............................................................................................. 9
3.1.2 Nano-carriers ........................................................................................................... 10
3.2 Future Applications of Nano-enabled Drug Delivery ....................................................... 11
3.2.1 Gene and Vaccine Delivery ..................................................................................... 11
3.2.2 Controlled-Release Devices .................................................................................... 12
3.2.3 Increased Biocompatibility ....................................................................................... 12
3.2.4 Improved Drug Bioavailability and Solubility ............................................................ 12
3.2.5 Applied Diagnosis, Etiology, Prognosis and Therapy (ADEPT) ............................... 12
3.2.6 Tissue Specific Delivery .......................................................................................... 12
4 Nanotechnology in Drug Delivery – Case Studies ..................................................................... 13
4.1 Abraxis Bioscience, Inc. – Paclitaxel-Albumin Nanoparticles (Abraxane) ....................... 13
4.2 Nanospectra Biosciences– AuroShell Particles .............................................................. 13
4.3 Calando Pharmaceuticals, Inc. – RONDEL Technology ................................................. 13
4.4 Starpharma Holdings, Ltd. – Dendrimer-Based VivaGel ................................................. 14
4.5 Mersana Therapeutics: Fleximer – Camptothecin Conjugate ......................................... 14
4.6 Elan Corporation – NanoCrystal Technology .................................................................. 14
5 Nanotechnology in Drug Delivery – Market Characterization .................................................... 16
5.1 Introduction ..................................................................................................................... 16
5.2 Nano-enabled Drug Delivery Market Drivers................................................................... 16
5.2.1 Clinical Benefits of Nano-enabled Drug delivery...................................................... 16
5.2.2 Value Addition to Existing Pharmaceutical Products through Reformulation ........... 16
5.2.3 Strong Pipeline Portfolio .......................................................................................... 16
5.3 Nano-Enabled Drug Delivery Market Barriers ................................................................. 17
5.3.1 Poor R&D Facilities and Time Gap between Research and Commercialization ...... 17
5.3.2 Lack of Consistent Policy on Technology Transfer and Lack of Capacity to Produce
Products .................................................................................................................. 17
5.3.3 Regulatory Hindrance .............................................................................................. 17
5.4 Opportunity and Unmet Need – Drug Delivery ................................................................ 18
5.4.1 Opportunities ........................................................................................................... 18
5.4.2 Unmet Need ............................................................................................................ 18
5.5 Selected Nano-Enabled Therapeutics Approved by the FDA ......................................... 20
5.5.1 Doxil (Caelyx) .......................................................................................................... 20
5.5.2 Abraxane ................................................................................................................. 21
5.5.3 AmBisome ............................................................................................................... 22
5.5.4 Diprivan ................................................................................................................... 23
5.5.5 Triglide ..................................................................................................................... 24
5.5.6 Myocet ..................................................................................................................... 25
5.5.7 DepoCyt .................................................................................................................. 26
5.5.8 DaunoXome............................................................................................................. 27
5.5.9 Estrasorb ................................................................................................................. 27
5.5.10 Macugen .................................................................................................................. 28
5.5.11 Abelcet .................................................................................................................... 29
5.5.12 Adagen .................................................................................................................... 30
5.5.13 Pegasys ................................................................................................................... 30
5.5.14 Somavert ................................................................................................................. 32
Nanotechnology in Drug Delivery - Technological Improvements GBIHC043MR / Published DEC 2010
and Novel Approaches to Fulfill High Potential
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5.5.15 Neulasta .................................................................................................................. 33
5.5.16 Copaxone ................................................................................................................ 34
5.5.17 Amphotec ................................................................................................................ 35
5.5.18 PegIntron ................................................................................................................. 35
5.5.19 Oncaspar ................................................................................................................. 37
5.5.20 Epaxal ..................................................................................................................... 38
5.5.21 Elestrin .................................................................................................................... 38
6 Nanotechnology in Drug Delivery – Trend Analysis................................................................... 40
6.1 Increasing Government Funding for Nanotechnology R&D ............................................ 40
6.2 Increasing Seed and Early-Stage Venture Capital .......................................................... 40
6.3 Creation of a New Registration Category for Nanotechnology Products within the USPTO
........................................................................................................................................ 40
6.4 Genericization and Emerging Business Models Driving a Need for Novel Drug Delivery
Methods .......................................................................................................................... 41
7 Nanotechnology in Drug Delivery – Regulatory Landscape ...................................................... 42
7.1 Introduction ..................................................................................................................... 42
7.2 Europe ............................................................................................................................ 44
7.2.1 REACH Regulation .................................................................................................. 44
7.2.2 European Medicines Agency ................................................................................... 46
7.3 The US ............................................................................................................................ 46
7.3.1 Environment Protection Agency .............................................................................. 46
7.3.2 Food and Drug Administration ................................................................................. 47
7.3.3 National Institute of Occupational Safety and Health............................................... 47
7.4 Japan .............................................................................................................................. 48
8 Nanotechnology in Drug Delivery – Pipeline Analysis ............................................................... 49
8.1 Overview ......................................................................................................................... 49
8.1.1 Pipeline Analysis by Phase ..................................................................................... 50
9 Nanotechnology in Drug Delivery – Strategic Consolidations .................................................... 55
9.1 Overview ......................................................................................................................... 55
9.2 Mergers and Acquisitions ................................................................................................ 55
9.2.1 Mergers and Acquisitions by Geography ................................................................. 55
9.2.2 Mergers and Acquisitions by Deal value.................................................................. 56
9.2.3 Mergers and Acquisition Analysis by Deal Type ...................................................... 57
9.3 Summary of Major M&A Deals ........................................................................................ 58
9.3.1 AstraZeneca Acquires MedImmune ........................................................................ 58
9.3.2 Pfizer Completes Acquisition of Wyeth .................................................................... 58
9.3.3 Celgene Announces To Acquire Abraxis BioScience .............................................. 58
9.3.4 Amgen Acquires Abgenix ........................................................................................ 59
9.3.5 Teva Pharmaceutical Acquires Ivax ........................................................................ 59
9.4 Licensing Agreement ...................................................................................................... 60
9.4.1 Deals by Year of Consolidations.............................................................................. 60
9.4.2 Deals by Geography ................................................................................................ 61
9.4.3 Deals by Deal value................................................................................................. 62
9.5 Summary of Major M&A Deals ........................................................................................ 62
9.5.1 AstraZeneca Enters Into Collaboration and Licensing Agreement with Targacept .. 62
9.5.2 AstraZeneca Enters into Licensing Agreement with Rigel Pharmaceuticals............ 63
9.5.3 Isis Pharmaceuticals Enters Into Licensing Agreement with Genzyme ................... 63
9.5.4 Nektar Therapeutics Enters Into Licensing Agreement with AstraZeneca ............... 63
9.5.5 Abraxis Enters Into License Agreement With ProMetic Life Sciences ..................... 64
10 Nanotechnology in Drug Delivery – Future Players ................................................................... 65
10.1 Overview ......................................................................................................................... 65
10.2 Abraxis Bioscience (Abraxis) .......................................................................................... 66
10.2.1 Overview ................................................................................................................. 66
10.2.2 Business Description ............................................................................................... 66
10.2.3 Product Portfolio ...................................................................................................... 67
Nanotechnology in Drug Delivery - Technological Improvements GBIHC043MR / Published DEC 2010
and Novel Approaches to Fulfill High Potential
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10.3 AlphaRx Corporation....................................................................................................... 68
10.3.1 Overview ................................................................................................................. 68
10.3.2 Business Description ............................................................................................... 68
10.3.3 Product Portfolio ...................................................................................................... 69
10.4 Camurus AB.................................................................................................................... 69
10.4.1 Overview ................................................................................................................. 69
10.4.2 Product Portfolio ...................................................................................................... 70
10.5 Eurand ............................................................................................................................ 70
10.5.1 Overview ................................................................................................................. 70
10.5.2 Business Description ............................................................................................... 70
10.5.3 Product Portfolio ...................................................................................................... 71
10.6 NanoBio Corporation ...................................................................................................... 71
10.6.1 Overview ................................................................................................................. 71
10.6.2 Product Portfolio ...................................................................................................... 72
10.7 NanoCarrier .................................................................................................................... 72
10.7.1 Overview ................................................................................................................. 72
10.7.2 Product Portfolio ...................................................................................................... 73
11 Nanaotechnology in Drug Delivery – Appendix ......................................................................... 74
11.1 Market Definitions ........................................................................................................... 74
11.2 Abbreviations .................................................................................................................. 74
11.3 Research Methodology ................................................................................................... 75
11.3.1 Coverage ................................................................................................................. 76
11.3.2 Secondary Research ............................................................................................... 76
11.3.3 Primary Research .................................................................................................... 76
11.3.4 Expert Panel Validation ........................................................................................... 77
11.4 Contact Us ...................................................................................................................... 77
11.5 Disclaimer ....................................................................................................................... 77
11.6 Sources ........................................................................................................................... 77
Nanotechnology in Drug Delivery - Technological Improvements GBIHC043MR / Published DEC 2010
and Novel Approaches to Fulfill High Potential
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1.1 List of Tables
Table 1: Elan Pharmaceutical, Drugs Based on NanoCrystal Technology, 2010 ............................ 15
Table 2: Nanotechnology in Drug Delivery, Global, Regulatory Filing Clinical Pipeline, 2010 ........ 50
Table 3: Nanotechnology in Drug Delivery, Global, Phase III Clinical Pipeline, 2010 .................... 51
Table 4: Nanotechnology in Drug Delivery, Global, Phase II Clinical Pipeline, 2010 ..................... 51
Table 5: Nanotechnology in Drug Delivery, Global, Phase I Clinical Pipeline, 2010 ...................... 52
Table 6: Nanotechnology in Drug Delivery, Global, Preclinical Pipeline, 2010 ............................... 53
Table 7: Nanotechnology in Drug Delivery, Global, Discovery Pipeline, 2010 ............................... 54
Table 8: Abraxis BioScience, Inc., Nano-Enabled Drug Delivery Pipeline Products, 2010.............. 67
Table 9: AlphaRx Corporation, Inc., Nano-enabled Drug Delivery Pipeline Products, 2010.......... 69
Table 10: Camurus AB, Inc., Nano-enabled Drug Delivery Pipeline Products, 2010 ..................... 70
Table 11: Eurand, Inc., Nano-enabled Drug Delivery Pipeline Products, 2010 .............................. 71
Table 12: NanoBio Corporation, Inc., Nano-enabled Drug Delivery Pipeline Products, 2010 ........ 72
Table 13: NanoCarrier, Inc., Nano-enabled Drug Delivery Pipeline Products, 2010 ...................... 73
1.2 List of Figures
Figure 1: Nanotechnology in Drug Delivery, Comparison of General and Nano-enabled Drugs,
2010 ................................................................................................................................. 7
Figure 2: Nanotechnology in Drug Delivery, Current Application of Nanotechnology in the
Pharmaceutical Industry, 2010 ......................................................................................... 9
Figure 3: Nanotechnology in Drug Delivery, Future Application of Nanotechnology in Drug
Pharmaceutical Industry, 2010 ....................................................................................... 11
Figure 4: Nanotechnology in Drug Delivery, Global, Driver and Restraints, 2010 ........................... 17
Figure 5: Nanotechnology in Drug Delivery, Opportunity and Unmet Needs, 2010......................... 19
Figure 6: Nanotechnology in Drug Delivery, Trend Analysis, 2010 ................................................. 40
Figure 7: Nanotechnology in Drug Delivery, Challenges Facing Regulators Regarding
Nanotechnology ............................................................................................................. 43
Figure 8: Nanotechnology in Drug Delivery, Global, Pipeline by Therapy Area (%), 2010 .............. 49
Figure 9: Nanotechnology in Drug Delivery, Global, Pipeline by Phase (%), 2010 ......................... 50
Figure 10: Nanotechnology in Drug Delivery, Global, M&A Deals by Geography (%), (2006-2010)
....................................................................................................................................... 55
Figure 11: Nanotechnology in Drug Delivery, Global, M&A Deals by Deals Value (%), 2006-201056
Figure 12: Nanotechnology in Drug Delivery, Global, M&A Deals by Deals Type (%), 2006-2010 57
Figure 13: Nanotechnology in Drug Delivery, Global, Licensing Agreements by Years of
Consolidation (%), 2006-2010 ........................................................................................ 60
Figure 14: Nanotechnology in Drug Delivery, Global, Licensing Agreements by Geography (%),
2006-2010 ...................................................................................................................... 61
Figure 15: Nanotechnology in Drug Delivery, Global, Licensing Agreements by Deals Value (%),
2006-2010 ...................................................................................................................... 62
Figure 16: Nanotechnology in Drug Delivery, Global, Clinical Pipeline by Company, 2010 ............ 65
Nanotechnology in Drug Delivery - Technological Improvements GBIHC043MR / Published DEC 2010
and Novel Approaches to Fulfill High Potential
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2 Nanotechnology in Drug Delivery – Introduction
2.1 Introduction
Nanotechnology witnesses a lot of attention with the never-seen-before interest because of its
future growth potential. This is because it can revolutionize the areas in which it is being exploited.
In the pharmaceutical market, nanotechnology is just starting to make an impact. The application of
nanotechnology in drug delivery systems has the ability to manipulate molecules for manufacturing
devices with programmed functions. The current pharmaceutical market has many drugs, which
use nanotechnology in their drug delivery approaches. These nano-enabled systems include
liposomes, polymeric micelles, nanoparticles, dendrimers, and nanocrystals.
Liposomes and polymer micelles were first prepared in 1960’s. Following this, nanoparticles and
dendrimers were prepared in the 1970’s. The conjugation of colloidal gold particles with antibody to
target specific staining during 1980’s, is considered as a precursor of recent widespread use of
gold particles in nanotechnology.
GBI research analysis suggests that the nano-enabled drug delivery market will witness a high
growth in the future. The high growth in the nano-enabled drug delivery market is primarily because
of increasing acceptance of nano-enabled drugs, promising nano-enabled drugs in the pipeline
portfolio and increased governmental funding in the nanotechnology research. In addition to these,
rapidly increasing interest in nanotech R&D, and increased availability of seed and early-stage
venture capital will drive the market during the forecast period.
GBI Research analysis shows that significant opportunities exist at the intersection of
nanotechnology and traditional pharmaceutical R&D, though much uncertainty remains on how this
will affect the industry. GBI Research suggests the dosing benefits of nano-enabled drug delivery
systems have a great potential in treating both infectious disease and cancer.
Figure 1: Nanotechnology in Drug Delivery, Comparison of General and Nano-enabled
Drugs, 2010
Parameters General Drug Nano-Enabled Drug
Bioavailability Low High
Specificity
Low High
Solubility Low Improved
Efficacy Low High
Safety Low High
Liver and Renal Toxicity Low High
Pharmacokinetics Low Improved
Patients Compliance Low High
Source: GBI Research
Nanotechnology in Drug Delivery - Technological Improvements GBIHC043MR / Published DEC 2010
and Novel Approaches to Fulfill High Potential
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2.2 GBI Research Report Guidance
· The report starts with an executive summary of the key points influencing the global nano-
enabled drug delivery market.
· The chapter titled Nanotechnology in Drug Delivery details the current and future potential
application of nanotechnology in drug delivery systems.
· The next chapter analyzes the major nano-enabled drug delivery technology case studies.
· The chapter titled Nanotechnology in Drug Delivery- Market Characterization analyzes the
market drivers and restrains. This chapter also analyzes opportunities and unmet needs in the
nano-enabled drug delivery market, and product profiles of major marketed products.
· The chapter titled Nanotechnology in Drug Delivery- Trend Analysis analyzes prevailing and
upcoming trends and its effects on the market.
· The chapter titled Nanotechnology in Drug Delivery- Regulatory landscape analyzes regulatory
acceptance and guidelines in different geographical regions. This section also analyzes the
regulatory challenges in nano-enabled drug delivery system market.
· The chapter titled Nanotechnology in Drug Delivery- Pipeline Analysis provides pipeline
analysis for nano-enabled drug delivery. This section includes detailed analysis of the top
companies operating in the market.
· The chapter titled Nanotechnology in Drug Delivery: Strategic Consolidations talks in detail
about the strategic consolidations that have taken place within the nano-enabled drug delivery
market. An analysis of the key licensing agreements is also given with an increasing focus on
geographies.
· The chapter titled Nanotechnology in Drug Delivery: Future Players talks in detail about the
companies, which have strong pipeline candidates.
Nanotechnology in Drug Delivery - Technological Improvements GBIHC043MR / Published DEC 2010
and Novel Approaches to Fulfill High Potential
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3 Application of Nanotechnology in Drug Delivery
Nano-carriers and nano-
engineered drugs are 3.1 Current Applications of Nano-enabled Drug Delivery
widely used in drug
delivery systems 3.1.1 Nano-engineered drugs
3.1.1.1 Nano Crystals
These are single crystalline nano materials which has at least one dimension on the order of
100nm. Nano crystals have a wide range of proven and potential applications in different fields.
Elan Pharma International Ltd. has FDA approval on a NanoCrystal technology in 2000. The
technology improves the bioavailability of Wyeth’s drug sirolimus. The new formulation Rapamune
overcame the drug’s relative insolubility by reducing the particle size to less than 200nm.
3.1.1.2 Nano Suspensions
The poor water solubility of drugs is a major problem for drug formulation which leads to low
bioavailability and erratic absorption. There are a number of formulation approaches to resolve the
problems of low solubility and low bioavailability. The reduction of drug particles into the sub-micron
range leads to a significant increase in the dissolution rate and therefore enhances bioavailability.
Nano suspensions are candidates that can be used to increase the dissolution of drugs that are
poorly soluble in water. Nano suspensions contain submicron colloidal dispersion of
pharmaceutical active ingredient particles in a liquid phase stabilized by surfactants.
Figure 2: Nanotechnology in Drug Delivery, Current Application of Nanotechnology in the
Pharmaceutical Industry, 2010
Nanocrystals- •Carbon & Ceramic
Increased surface Nanostructures
area
•Dendrimers-
Increased drug load
Current
Applications of
Nanotechnology
•Liposomes- Targeted
Nanosuspensions- drug delivery
Increased
bioavailability •Mycelles and
polymeric
Nanoparticles
Source: GBI Research
Nanotechnology in Drug Delivery - Technological Improvements GBIHC043MR / Published DEC 2010
and Novel Approaches to Fulfill High Potential
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3.1.2 Nano-carriers
3.1.2.1 Carbon and Ceramic Nanostructures
The carbon-based nanostructures include carbon nanotubes, carbon nano particles, and porous
carbons, activated carbon fibers and carbon aerogels. Among these carbon nanotubes are
presently the most attractive carbon nanostructured material being researched in the
pharmaceutical market. The carbon nanotubes are allotropes of carbon with a cylindrical
nanostructure. Ceramic nanostructures are used in biomedical implants.
3.1.2.2 Dendrimers
Dendrimers are monodisperse macromolecules, which fall under a new class of polymeric
materials. These are repeatedly branched and roughly spherical large molecules with very high
symmetry. These unique behaviors make dendrimers a suitable candidate for a wide range of
biomedical and industrial applications. Applications mainly involve conjugation of other chemical
species to the dendrimer surface that can function as detecting agents, imaging agents, and
pharmaceutically active compounds. Dendrimers provide a multivalent system that is exploited in a
number of drug delivery systems.
3.1.2.3 Liposomes
Liposomes are concentric bilayered structures made of amphipathic phospholipids. The Liposomes
are classified as multilamellar (MLV), small unilamellar (SUVs), and large unilamellar (LUV