Abstract
Drug Delivery Technology: Assessing its potential
The time when advanced drug delivery was merely a means for profitable product
life extension has gone. Drug delivery is now a major component of the
pharmaceutical industry' s future and critical to bringing novel therapies to
market.
Indeed, without the ability to effectively deliver targeted drugs in
therapeutically significant quantities, many of the gene-based agents in
research would not be viable. Despite the importance of the sector, the
pharmaceutical industry has not always been quick to embrace the full range of
potential technologies and opportunities on offer.
With so many companies pursuing a wide range of research strategies, it is
difficult for industry and commercial executives to get a balanced and
independent overview of the competitive landscape.
That is why this major new 4-volume report, Drug Delivery Technologies:
Players, Products and Prospects to 2018, is essential reading for everyone in
the field, from niche technology specialists through to the investment
community and the pharmaceutical industry itself.
By 2018 sales of products using the novel drug delivery technology assessed in
this report could exceed US$58 billion.
This report provides a detailed insight into the current and future market for drug delivery technology and...
- Provides an overview of the marketplace, outlining current thinking on the
technologies being researched and employed;
- Appraises currently available products which utilise drug delivery
technology and assesses their future;
- Examines new product developments from major specialist drug delivery
companies, critically analysing the prospects at the product level and
forecasting sales;
- Allows ready comparison on different technologies within a company' s
portfolio;
- Provides a unique window on the sector' s product launch timetable;
- Includes detailed appendices which allow at-a-glance reviews of the
competitive landscape for both new and up and coming products.
Use this report to...
- Assess the strengths and weaknesses of competing products/technologies in
the context of specific delivery sectors and development companies;
- Identify and review licencing and collaboration partners;
- Understand the merits and applications of the main approaches being
researched;
- Quantify the commercial prospects for current and future products.
Volume I
Controlled-release Delivery
The controlled-release market was worth nearly US$21 billion globally in 2008.
The sector is dominated by the launch of oral controlled-release formulations
in key therapeutic areas such as the central nervous system, cardiovascular,
metabolic and respiratory diseases. The growth of controlled-release delivery
continues to be fuelled by line extensions helping to offset the impact of
generic erosion. We estimate there are around 60 approved controlled-release
products which will generate global sales of over US$21.5 billion in 2009,
peaking at around US$29.5 billion in 2017 as products mature and face patent
expiration leading to a decline in mature product sales to US$28.9 billion by
2018. In addition, we forecast that controlled-release products in
development from 17 key companies could generate additional sales of over
US$5.1 billion by 2018.
Impact on product lifecycles
Controlled-release technologies, possibly more than any other approved
delivery systems, have been an important tool for pharmaceutical companies to
protect their branded franchises from the ever increasing and competitive
generic market. These formulations play a critical role in establishing a
balanced portfolio of solid dosage products and may lead to enhanced efficacy
and improved patient compliance. This leads to reductions in patient costs
and extending product life-cycle management for both branded and generic
pharmaceuticals.
In the past, pharmaceutical companies have tended to develop
controlled-release formulations as immediate-release counterparts near patent
expiration. This trend is reversing and companies are developing
controlled-release formulations earlier in the product life-cycle and often
launching multiple formulations (immediate release, controlled release/
modified release, and delayed release) in parallel to expand the potential
addressable patient population and gain a significant share of competitive
market places.
This report answers key questions...
- Who will have launched novel products by 2018 and what technologies could
they be using?
- Can market leaders such as ALZA and Elan maintain their status in
controlled release in the face of growing competition?
- What obstacles must companies overcome to achieve full market potential?
- What strategies are proving most productive and for which companies?
- What will the product/company landscape look like in 2018?
Volume II
Nano-enabled Delivery
The true value of nanotechnology lies in its potential to improve the
solubility and enhance the efficiency of product delivery. It has been
successfully applied to the commercialisation of more than 30 drugs.
Regulators have published numerous white papers on the topic and established
Task Forces to monitor the progress and application of this technology
although there are presently no regulations specific to nanomedicine or
nano-enabled medical devices.
As the field of nanotechnology gains momentum and nano-enabled platforms
emerge to address the industry' s need for therapeutic, bioavailable and less
toxic products, this market is expected to grow significantly over the next
decade. Proof of concept data with novel compounds is accumulating and new
formulations of old chemotherapeutic drugs offer the promise to revolutionise
cancer therapies.
The potential of future applications:
- Tissue specific delivery - targeting the delivery of small and macro
molecules across biological membranes such as the blood brain barrier for CNS
drugs;
- Gene and vaccine delivery - non-viral delivery of genetic materials in
nanohydrogels and nanocarriers with a high degree of efficiency and expression;
- Controlled-release devices - design of new nanoporous, bioerodible
membranes;
- Increased biocompatibility - design of artificial surfaces engineering
for medical and dental implants to by-pass unwanted inflammatory response;
- Improved drug bioavailability and solubility - through the engineering of
drugs and reagents by nanostructuring;
- Applied diagnosis, etiology, prognosis and therapy (ADEPT) technology for
the safe targeted delivery of toxic therapeutic drugs.
By 2018, the market could exceed US$13 billion
By 2018 the established nanotechnology product market will be US$10.2 billion.
The market will mature as the number of marketed nano-enabled products
doubles and second generation nanomedicines begin to emerge. These agents
will address areas of high unmet clinical need and result in the formulation
of approved and novel drugs which are safer, less toxic and more efficacious
than first generation products.
By 2018 these second generation nanomedicines could generate sales of nearly
US$2.9 billion and establish nanotechnology as an important tool in the
industry' s delivery armoury. A range of proprietary delivery platforms will
utilise CaP technologies, FluidCrystals, micelles and polymeric nanoparticles
to target a number of therapy areas such as CNS disorders, oncology and
infectious diseases.
Volume III
Nucleic Acid Delivery
The nucleic acid delivery market is maturing with over 1,450 clinical trials
underway worldwide. The majority of these are in early clinical development
(approximately 60%) with just over 3% in Phase III trials. Our analysis
indicates that up to 35 novel nucleic acid products could reach the market
within our forecasting period (2008-2018). However the harsh economic
environment may force companies to place promising drugs on hold as they focus
on lead projects rather than multiple programmes. To date, only a handful of
nucleic acid-based products have been approved for human prescription and
these products rely on delivery technologies in one shape or form. We
estimate the nucleic acid market was worth just over US$80 million globally in
2008.
By 2018 we anticipate the nucleic acid technology market will have matured as
many of the late-stage clinical programmes come to fruition and drug delivery
companies continue to overcome issues surrounding its safety and efficiency.
The development of nucleic acid delivery systems will help to improve
specificity whilst the development of novel polymers and lipopolymer complexes
will help to carry larger DNA payloads in order to target cells and make
multigene targeting a reality. We forecast that nucleic acid products in
development from 11 key companies could generate additional sales of nearly
US$2.3 billion by 2018. These products utilise a range of delivery platforms
including viral to non-viral delivery systems, and cover gene therapies, gene
agents and DNA vaccines for a variety of targets including cancer,
cardiovascular and infectious diseases.
Catalysts for change
- Improvements in our understanding into the underlying genetic causes of
disease as well as the uptake of new mechanisms of modulating DNA such as RNA
interference which will help to fuel market growth.
- The development of a new generation of DNA vaccines that will provoke
strong immunogenic responses and will help to determine whether this has been
a sound investment for the pharma industry.
- Launch of the first siRNA-based therapeutics (although progress has been
dampened following the recent termination of Opko Health' s leading eye
treatment at the Phase III development stage). We anticipate companies will
pursue other conditions such as infectious diseases and cancer where robust
preclinical studies have already been performed and where drug delivery
platforms have been adopted rather than the use of naked siRNAs.
Which companies and products will dominate?
This volume will tell you!
Volume IV
Targeted Delivery
By 2018, over 30 new products will be launched resulting in a global market for advanced targeted delivery products worth over US$8.5 billion.
Despite considerable advances in drug delivery technologies, there continues
to be a high unmet clinical need for safer and better-tolerated drugs.
Sub-optimal compliance and failure to persist with drug treatments are
important determinants of therapeutic non-response and are of significant cost
to healthcare providers. Advanced targeted drug delivery technologies will
help to overcome some of these issues by improving pharmacokinetics,
increasing tolerability and reducing dose-limiting off-target effects.
The need for targeted delivery platforms is increasing as patients and drug
regulators seek to meet these challenges.
Current and future applications
Whilst the majority of targeted delivery systems under evaluation incorporate
passive carrier systems, there will be a shift towards the use of actively
targeted carriers to increase the therapeutic index of existing and new
products. There are significant opportunities for future commercial
developments within the pharmaceutical industry.
These include:
- Cost-effective production of antibodies and antibody fragments for drug
targeting;
- Development of new polymers and biopolymers that may be utilised in the
safe and efficient targeted delivery of drugs and pro-drugs into host cells;
- Development and selective targeting of macromolecules to improve
intracellular uptake and tissue specificity;
- Development of inactive pro-drugs for tissue specific release;
- Extended product life-cycles through the development of targeted
formulations;
- Identification of new targeting ligands to improve the targeted delivery
of small molecules and macromolecules;
- Utilisation of multiple targeting ligands to address the needs of patient
sub-types;
- Combined technology platforms to develop targeted therapeutics and
diagnostics in a single molecule.
A new generation of targeted delivery systems is under development to meet
these needs which should provide greater control over the selective targeting
of tissue, either with active moieties or inactive moieties which may be
activated within the tissue by biological (enzymes), chemical (pH) or physical
means (light, ultrasound) in order to release the active agent. The multitude
of delivery platforms will lend themselves to the delivery of both small
molecules and macromolecules and to a variety of target sites and delivery
routes.
Unique company & technology evaluation
It is vital that management information is reliable, current and insightful.
Today, product and company assessment must be seen in a wider competitive and
market environment.
In this report we present a précis on each of the leading delivery
specialists and potential new delivery platforms and have identified their key
attributes, based on a number of criteria including:
- Proprietary delivery technology
- Applications of the delivery technology within the pharmaceutical industry
- Management/technical expertise of the delivery specialist
- Competition within the delivery technology sector
- Products in development/approved utilising the delivery technology
We have established a competitor ratio analysis based on each of the criteria
mentioned above. Each criterion attracts an award of up to 10 points, with a
maximum score of 50, thus enabling the establishment of an Espicom
“ranking table” in each segment of the market, dependent on their
relative attributes.
Multi-point evaluation and scoring assessment
Pharma drugs that utilise drug delivery systems have been evaluated based on a
number of parameters, including:
The technology
Comparison of delivery platforms within each area including: activated,
degradation or diffusion for controlled-release systems; nano-engineered
(nanocrystals, nanoparticle, nanosuspension) or nanocarriers (carbon/ceramic,
dendrimer, liposome, micelle, polymeric nanoparticles) for nano-enabled
delivery; viral or non-viral platforms for nucleic acid delivery and active or
passive platforms for targeted delivery systems
The application of the technology within a number of therapy areas
Route of delivery (oral, parenteral, transdermal, implantable), delivery of
small molecules/macromolecules and vaccines, additional features such as
bioerodible materials etc
The current status of the technology in clinical development or following
approval
Number of approved and marketed products, clinical or preclinical development
candidates, single or multiple products.
Competition within the technology arena
Alternative drug delivery systems to technologies under evaluation, advantages
and disadvantages over competitors.
The drug delivery specialist' s expertise
Number of drug delivery systems in development, strategic alliances, financial
position, marketing presence.
The product portfolio
Drug delivery systems under evaluation, products in development,
commercialisation/development partnerships.
Potential drug sales
Based on key events such as market, competition, patent expiry, time of entry
into the market.
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