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Transcript of toptech in health and wetllness-2012_ti.pdf
Top Technology Trends in Health and
Wellness (Technical Insights)
June 2012
D4A9-TI
Technologies for the betterment of the healthcare system
D4A9-TI 2
Contents
Section Slide Numbers
Executive Summary 3
3D Cell Culture Systems--Mimic In vivo Conditions 6
Nanoparticle-based Therapies--Cancer Therapeutics 11
Recombinant Expression Systems—Plant-based Transgenics for Protein Therapeutics 16
Biosensing--Nanobiomedicine Approach 21
Next Generation Prebiotics--Targeted and Second-degree Prebiotics 26
Genetically Engineered Foods--The 2nd Agricultural Revolution 31
Nutrient Encapsulation--Ensuring Nutrient Delivery 36
Nanofluidics and BioNEMs--Intelligent Miniaturized Systems 41
Next Gen Sequencing--Thousand Dollar Genome 46
Adult Stem Cell Therapies--The Commercial Cell of Origin 52
The Frost & Sullivan Story 59
4 D4A9-TI
Research Scope and Index
Technical Insights division of Frost & Sullivan
evaluated technology trends in the Health and
Wellness sector and has identified 10 technology
trends that are likely to have an impact in the year
2012.
The slides provide information on the following
lines on a best effort basis, as applicable to the
technology under consideration. They are as
follows:
• Brief Snapshot of the Technology
• Recent Developments
• Key Stakeholders and their Solutions
• Future Scenario
To
p T
ec
hn
olo
gy T
ren
ds
3D Cell Culture System
Nanoparticle-based Therapies
Recombinant Expression Systems
Biosensing
Next-Generation Prebiotics
Genetically Engineered Foods
Nutrient Encapsulation
Nanofluidics and BioNEMS
Next-Gen Sequencing
Adult Stem Cell Therapies
5 D4A9-TI
Executive Summary--Research Process and Methodology
• Technology Journals • Periodicals • Market Research Studies • Technology Policy Information Sites • Internal Databases • Thought Leader Briefings
Secondary Research
Primary Research
• Engineers • CTOs/CEOs/CIOs • Technical Architects • Research Heads • Strategic Decision Makers • Technology Policy Heads
2. Interview Participants
Stakeholder Insights,
Perspectives and Strategies
Innovators and Innovations
1. Patent Review
3. Assess Innovations
Technology Capabilities and Stakeholder Initiatives
Technology/Business Challenges
Application Market Potential and Needs
Technology/Business Drivers
OUTCOME--Forecast Future of Technology,
Market Adoption, and Potential Application Sectors
Research Methodology Research Process
7 D4A9-TI
3D Cell Culture systems are ex-vivo cellular arrangements, generated in a scaffolds that intend to
simulate the extracellular matrix (ECM) microenvironment to control culture conditions that propel
cell proliferation. One of the main goals of these systems is the replication of in vivo conditions of
organotypic cultured systems to perform in vitro diagnostic or in vitro metabolic studies. In
particular, the spatial and temporal distribution of these signals is tightly controlled and unique to
each organ.
• In the human body, all cells exist in a complex
three-dimensional (3D) network mesh and this has
motivated scientists to replicate the structure and
composition of natural cellular environments.
• The architecture of such a culture system enables
close interaction between cells, growth factors and
extra-cellular matrix.
• Products from 3D Biotek, Invitrogen, Millipore are already in
the market. Increasing awareness should enhance adoption
rates and newer application areas like 3D microspheres
which would impact the market by 2013.
• 3D cell culture systems can reduce animal testing, improve
efficiency and reduce cost and time of testing procedures.
Technology Snapshot
Importance Year of Impact
Overview
8 D4A9-TI
Global Footprint
USA/ Canada
Extensive research in the areas of 3D
microplates, coverglass, scaffolds,
matrices, assay wells, organotypic
microtissue models,. Greater adoption
has been noted in the area of cell culture
and by 2015 there would be transition
from 2D to 3D cell culture.
Japan
Research and adoption in the areas of
cell culture applied to stem cells and
various other kinds of cells or models
to develop drugs and therapeutics
Europe
The main application areas include cell-
cell and cell-matrix interactions. Adoption
is noted in the areas of 3D cell culture.
Australia/New Zealand
3D cell cultures
3D scaffolds
3D organotyping
India
3D bioreactors, 3D scaffolds are
available through distributors of
top firms like Invitrogen, Sigma-
Aldrich . Basic research in the
area of 3Dscaffolds and matrices
is observed.
Source: Frost & Sullivan.
Intensity of Technology
Development
Very High
High
Medium
Low
Very Low
9 D4A9-TI
Stakeholders and Developments
Key Challenge: Petri dishes, tissue culture flasks, and micro-well plates are commonly used systems for cell
culture owing to simplicity, convenience, and high-cell viability. These conventional flat systems or two-
dimensional (2D) mechanisms to culture cells played a vital role in understanding cell biology, but are
insufficient for the new challenges of cellular biology or pharmaceutical assays.
Company Product /
Technology Details
Life
Technologies
Corporation
Gibco Products
Invitrogen (renamed as Life Technologies) provides extracellular matrices,
scaffolds and proteins under the Gibco umbrella to support stem cell and other cell
cultures.
Hamilton and
Global Cell
Solutions,
Inc.
BioLevitator
BioLevitator a benchtop incubator and bioreactor that uses GEM (Global
Eukaryotic Microcarrier) technology that allows GEMs to be kept in suspension
with the ability to automatically culture them, and minimizes the need for manual
handling.
Sigma-Aldrich
Co. LLC 3D Matrices
The 3D matrices include HydroMatrix synthetic peptide, MaxGel human ECM, and
Mouse ECM. These products provide three-dimensional environments in which
cells are better able to mimic their in vivo counterparts.
3D Biotek,
LLC 3D Insert
3D Biotek is developing 3-D cell culture devices for stem cell/tissue engineering
and drug discovery applications. Product 3D Insert--PCL has been chosen by the
NIST as the reference 3D tissue engineering scaffold.
Synthecon
Inc.
BIOFELT, Rotary Cell
Culture Systems,
Biomerix
Synthecon allows users to grow dynamic cultures in which the matrix, suspended
in a fluid bath, and promotes 3-D cell growth
10 D4A9-TI
Impact on Application Areas
• Organ Engineering
• Target validation
• Secondary screening/
Lead optimization
• Safety assessment/
Toxicology
• DMPK
• Primary screening
• Stem cell culture
• Cell biology model systems
• Developmental biology
• Cell supply and
cryopreservation
• 3D matrices and scaffolds
• Culturing tumor cells
• Drug testing
• Cell culture methodology
2012 2014
Tissue
Engineering
Drug Discovery
Basic Research
12 D4A9-TI
• Nanoparticles are used for a wide variety of biomedical applications to aid in laboratory
diagnostics and in medical drug targeting. In targeted cancer therapies they are used as
conjugates with cancer biotherapeutics such as peptides, proteins or antibodies.
• Among the next generation of nanoparticles that are being used for this purpose are
superparamagnetic nanoparticles, gold nanoparticles, interactive nanoparticles composed of
conjoined gold nanorods and iron oxide nanocrystals.
• Conventional cancer therapies such as
chemotherapy using small molecules or even
targeted therapy using antibodies do not target
cancer cells with a high degree of precision.
Nanoparticles can identify, target and kill specific
cancer cells while leaving healthy cells
undamaged.
• Nanoparticle conjugates of targeted cancer drugs
show superior therapeutic efficacy, specificity and
selectivity compared to conventional targeted
therapies.
• Several nanoparticle-based conjugates are the products of
research labs. Examples include the interactive nanoparticles
and the RNA nanospheres (RNA encapsulated in lipid-based
cationic nanoparticles), both from the Massachusetts Institute
of Technology.
• Companies such as Cytimmune and NanoSpectra
Biotherapies have already demonstrated heat-based
nanoparticle treatment. The year of impact can be expected
to be 2016 as several such conjugates have completed
Phase I clinical trials.
Technology Snapshot
Importance Year of Impact
Overview
13 D4A9-TI
Global Footprint
North America
• USA has been active in this sector in both basic and
applied research. Dr. Sangeetha Bhatia’s group at the
Massachusetts Institute of Technology and the
California Institute of Technology have pioneered the
use of several types of nanoparticles from lipid-based
cationic particles to gold nanorods.
• Companies such as CytImmune, Tempo
Pharmaceuticals and Carigent Therapeutics are
already developing nanoscale systems for the delivery
of cancer drugs. Ortho Biotech, a subsidiary of
Johnson and Johnson has already launched such a
system using liposome nanoparticles (Doxil).
Europe
• The Turku Center for Biotechnology , the University of
London and the Karolinska Institut have been leading
research efforts for the use of gold, porous silica and
carbon-based nanoparticles in cancer therapy for
prostate, pancreatic and non-small cell lung tumors.
• Nanobiotix and Ensemble Therapeutics based out of
France and Magnamedics based out of Germany are
notable companies developing nanaoparticle-based
therapies for cancer.
• The European Commission has formulated a roadmap
till 2020 to incorporate milestone-based developments
for nanoparticle-based drug delivery.
Japan, Taiwan and Korea
• Japan has been exploring the use of platinum and
silica nanoparticles for targeted cancer therapeutics
through the Tokyo Institute of Medicine and the Riken
Institute.
• Korea Institute of Science and Technology has
pioneered the development of chitosan-based
nanoparticles fro targeting tumors.
• The National Health Research Institute in Taiwan has
optimized the use of nanoparticles in cancer by
combining a diagnostic contrast agent with an
anticancer drug.
Source: Frost & Sullivan.
Intensity of Technology
Development
Very High
High
Medium
Low
Very Low
Australia
• Work in this sector is limited to basic
research. The Cancer Council SA has
funded researchers from both the Hanson
Institute at the Royal Adelaide Hospital and
the Wark Institute at the University of South
Australia to develop such nanoparticles.
14 D4A9-TI
Funding Trends
• Nanomedicine has been stated as a key developmental area on the innovation agenda for a number of
countries including the United States, South Korea, Taiwan and Japan. The European Commission has
been maintaining nanomedicine as a key research focus since the 6th Framework Plan and has so far
already committed $367 million USD to the field since 2004.
• Among the applications of nanomedicine, drug delivery which includes targeted cancer therapy is
indicated to have the highest precedence with 59% funding being allocated to it in Europe and USA.
• NIH includes nanomedicine as a part of its Common Fund Program that is aimed at providing targeted
funding and training programs for ten key research areas. Nanomedicine has been on the Common
Fund since 2006.
Source: NIH, EC, KIST, ITRI Source: Journal of Nanomedicine, IEEE EMBS
15 D4A9-TI
Impact of Technologies
Lipid-
based/Liposomal
nanoparticles
Carbon
nanotube-based
particles
Composite
nanoparticles
Silica-based
porous
nanoparticles
Gold
Nanoparticles
Co-development and licensing
projects with both government and
pharma companies such as Merck,
AstraZeneca and Novartis.
Applied research will be conducted
in these fields with funding from
NIAID, DARPA and the Medical
Research Council.
These nanoparticles will be exploited
to carry and dispense drug payloads
to breast and lung tumors in
preclinical studies.
These nanoparticles will be tested in
preclinical studies by UCLA, NIST
and NIH. Photoluminescent particles
particularly useful for dermal drugs
The efficacy of these particles is
being tested with different
biotherapeutics in vitro. Start-ups
like Pilot Therapeutics are also
involved.
Companies like Tekmira
Pharmaceuticals and Encapsula
NanoSciences are already
developing lipid nanoparticles for
pharmaceutical use.
McGill, University of Lancashire,
University of South Florida and
Stanford University have
identified carbon nanotubes as
conducive for drug delivery.
MIT has demonstrated the use of
interactive nanoparticles—
composites using gold nanorods
and iron oxide particles.
Silica-based porous nanoparticles
have been proposed for
photodynamic therapy by Nancy
University. Cornell University is
also a major participant.
Gold nanoparticles have been
used in conjugation with anti-
cancer drugs by researchers at
MIT—nanorods and colloidal
particles.
Pictures
2012 2015
17 D4A9-TI
• Plant-based transgenics involve the use of plant-based material such as cash crops,
vegetables or moss for the extraction of recombinant proteins for therapeutics and research.
Human protein forms from antibodies to enzymes can all be isolated from plants.
• The most commonly used materials for such transgenics are tobacco, carrots and moss and
the process sometimes involves genetic engineering or cross-transfections.
• Plant-based transgenics do not have standardized regulatory protocols.
• Conventional recombinant expression systems
such as yeast and bacterial systems require
expensive infrastructure and production equipment
in the form of fermenters.
• The yield percentage using yeast or bacterial
system is usually around 35%-50%, much lower
than the required rate for therapeutics dosage.
• Plant-based transgenics are cost-effective in terms
of culture and production, can be used to derive
naturally glycosylated proteins and require
inexpensive raw materials.
• Plant-based transgenics are in demand as glycosylated
proteins can be naturally derived from them. In addition,
isolation and purification is cost-effective making it a
conducive choice for the manufacture of biosimilars and bio-
betters.
• These products not only comply with the required safety
standards but are also more humane and environment-
friendly as they do not use any animal-based raw materials.
• The year of impact for these systems is, therefore, likely to
be 2015-16.
Technology Snapshot
Importance Year of Impact
Overview
18 D4A9-TI
Global Footprint
North America
• USA does not have a very strong presence in plant-based
transgenic systems in terms of commercialization. This can
be due to the lack of standardized FDA protocols for
approving them.
• Basic and applied research are done extensively at a
number of institutes including the Roswell Park Cancer
Clinic, Arizona State University, School of Medicine and
Cornell University.
• Companies such as Medicago and GreenVax have gone
into Phase I clinical trials with their vaccines from Proficia
and tobacco plants respectively. However, advancement to
later phases has been a hurdle.
Europe
• The most active countries in Europe pursuing plant-based
transgenics for recombinant protein therapeutics are
Israel and Germany. The former houses two major
companies, Collplant and Protalix Biotherapeutics. The
former develops recombinant virgin collagen while the
latter is developing taliglucerase alfa for Gaucher, Fabry
and autoimmune diseases
• Germany is home to Greenovation, the only company
commercializing a moss-based recombinant expression
platform. Icon Genetics is also a leading company there.
• The adoption footprint is Europe is considerably higher
due to the provision of a risk analysis procedure from the
European Commission.
Australia and Africa
• AzarGen is an early stage recombinant
expression platform developer in South
Africa. Their technology is still in the design
phase.
• CSL in Australia has a plant for the
manufacture of recombinant proteins from
plant-based products but acquires
technology platforms for the same through
in-licensing deals. Source: Frost & Sullivan analysis
Intensity of Technology
Development
Very High
High
Medium
Low
Very Low
19 D4A9-TI
Funding Trends
• Plant-based protein has recently come into focus due to its applicability in producing recombinant human
vaccines. Major government institutions such DARPA and NIAID have extended investments to aid the
development of plant-based systems for recombinant proteins.
• The most ambitious project for plant-based recombinant systems in USA is GreenVax, a Texas-based
initiative that is aimed at producing vaccines for infectious diseases using tobacco plants.
• Europe is already active in this space with the majority of funding being allocated to Italy and Germany.
The latter is home to 2 major companies in this sector, Icon Genetics and Greenovation.
Source: NIH, EC
20 D4A9-TI
Research Area Stakeholders Technology Developments & Trends
Recombinant
collagen from
tobacco
• Development of virgin homogeneous human collagen from
recombinant expression in tobacco plants.
• Two flagship products—Vergenix for wound repair and the same as a
flowable gel. They are also branching into orthopaedics applications
with Pfizer (bone void filler).
Taliglucerase alfa
from carrot and
tobacco
• ProCellex platform for optimized genetic engineering and plant-based
recombinant expression.
• Taliglucerase alfa for Fabry, Gaucher, biodefense and other
autoimmune diseases.
• Ready for USA market—was granted PDUFA status after successful
Phase II trial, by FDA.
Multi-stage drug
delivery chips using
nanoporous silicon
particles
• Formerly subsidiary of Bayer with Nomad Biosciences, currently
independent. Plant-based recombinant expression tools—work for
any plant.
• Two major recombinant expression tools—nuclear transformation
and plastid transformation suite.
• Highest soluble protein percentage and conversion quotient in
industry. They are working on therapeutic products in collaboration
with Pfizer.
Stakeholders and Technology Developments
22 D4A9-TI
Carbon Nanotubes (CNTs) and other nanostructures, including Peptide Nanotubes (PNTs) exhibit
ideal properties for use as a sensing material: high surface area, chemical and mechanical
stability, which has resulted in the increasing design of a variety of sensors including biosensors,
electrochemical sensors and gas sensors, to be applied in life sciences and biomedicine fields.
The ability to incorporate any antibody without destroying the recognition function allows the
development of new highly specific targeted therapies for a broad spectrum of diseases.
CNTs/PNTs are excellent platforms for developing sensors due to the high effective area, together
with excellent electrical, mechanical, thermal properties and chemical stability.
• PNTs are useful nanomaterial building blocks that
have been used to construct a variety of device
geometries, as their self-assembly is robust, and
locations for their immobilization on substrates can
be targeted by biomolecular recognition.
• The biological functionalization of CNTs, attaching
proteins and/or DNA or RNA, has received a great
deal of interest due to the potential biomedical
applications of the nanotubes in both diagnostics
and therapeutics.
• This technology is expected to be increasingly adopted by
2013.
• Assembling PNT sensors with a simple chip geometry
enables the electrical detection of viruses and other
pathogenic organisms with an extremely low detection limit.
Technology Snapshot
Importance Year of Impact
Overview
23 D4A9-TI
Global Footprint
USA/Canada
Nanoimmunology
Microarrays and molecular diagnosis
Implantable biosensing devices
Implantable nano-tagreting devices
Drug discovery and development based
on nanobiosensing platforms
Japan
Microarrays and molecular diagnostics
Nanoimmunology
New biomarkers discovery and
development strategy
Drug discovery and development
based on nanobiosensing platforms
Europe
Microarrays and molecular diagnostics
Point-of-care systems
New biomarkers discovery and
development strategy
Drug discovery and development based on
nanobiosensing platforms
Australia/New Zealand
Microarrays and molecular diagnostics
Drug discovery and development
based on nanobiosensing platforms Argentina/Brasil
Molecular diagnosis
Point-of-care systems
Source: Frost & Sullivan.
Intensity of Technology
Development
Very High
High
Medium
Low
Very Low
India
Microarrays
Molecular diagnostics
New biomarkers discovery and
development strategy
24 D4A9-TI
Research Area Company Technology Developments
Pathogen detection
systems through nano-
scale biosensing devices
BioForce
Nanosciences
, Inc
BioForce Nanosciences developed a platform for fast, sensitive and non-destructive virus detection, the
ViriChip virus detection platform. The platform consists of a silicon chip functionalized with an ultramicro
array of antibodies using the Nano eNabler, and a detection system based on Atomic Force Microscopy.
Metal nanoparticle
sensors for hydrogen
detection
Applied
Nanotech
Holdings
Applied Nanotech has developed a nanotechnology based Metal Nanoparticle Sensor (MNPS) Platform,
whose first product is a palladium nanoparticle-based hydrogen sensor. Nanoparticles of palladium
provide high surface to bulk ratio compared to macro scale palladium thin films used for hydrogen sensing
in biotech.
Protein interaction
studies for quantitative
assays on a single
platform
Axela Inc
The dotLab® System uses dot technology to significantly shorten the transition from protein discovery to
application in both research and diagnostics. New panelPlus™ Sensors simplify multiplexing, and allow
the freedom to combine established markers with novel content.
Interventional cardiology
and critical care
procedures
Biosensors
International
Biosensors International offers abluminal drug-eluting stents with a biodegradable coated, limus-eluting
technology on its proven stent platforms, the S-Stent™ and Juno™. The company’s key R&D initiative in
the interventional cardiology field is a family of "polymer-free" drug-eluting stent systems coated with
proprietary BA9™ anti-restenosis drug.
Point-of-care systems
NeuroSearch
(Atonomics
A/S)
The PoC system, Atolyzer® , aims to address a wide range of important clinical markets including
cardiology, maternal tests and prostate cancer.
Label free biomolecular
interaction measurement
for bioprocess
applications
SAW
Instruments
GmbH
The biosensor sam®5 enables the label free measurement of biomolecular interactions and their kinetics
in real time. Binding processes can be detected selectively and with highest sensitivity, and can further be
analyzed.
Stakeholders and Developments
25 D4A9-TI
Impact on Application Areas
Short term
2012-2013
Monitoring
Thera
peutics
Dia
gnostics
Medium term
2013-2015
Long term
2015-2017
Clinical monitoring
Point-of-care assessment
Implantable post-
surgical biosensing monitors
Nanotechnology has made it possible for a single chip to possess more than million features with supra-sensitive detection abilities than
that of conventional methods. Because of the nature of this industry, breakthroughs in applications and solutions can be expected in the
near future in the areas of sustainability, nanotechnology and biocybernetics.
With recent advances in micro, nano-
fabrication techniques and
multidisciplinary research studies
focusing on bridging sensing platforms
for medical applications, new applications
in clinical monitoring are arising.
High resolution and high throughput
screening capabilities, which enable a
wide variety of biological assays can be
significantly enhanced by using novel
biosensing platforms.
The use of nanoscale biosensors is
applied to therapeutic areas by
evaluating cellular systems response in
drug discovery process.
Drug discovery and development
Nano-therapeutics,
nano-immunology assessment
Implantable targeting devices
Microarrays technology
Nano-beads for genetic diagnostics
Implantable biomarkers
27 D4A9-TI
• Prebiotics are slightly fermented or non-fermented, non-digestible ingredient that promote the
growth of beneficial microorganisms in the human intestine.
• Targeted prebiotics are unique ingredients from various carbohydrate and cellulose sources
that promote the growth of specific bacteria for a particular function.
• Second-degree prebiotics prevent the growth of a particular species of pathogenic bacteria
promoting immunity.
• Prebiotics help in growth of bacteria in the intestine
directly. Compared to probiotics, the survival rate of
prebiotics is higher as the action of prebiotics starts
inside the small intestine; whereas probiotic
bacteria are affected by acidic pH of the stomach.
Targeted and second degree prebiotics promote
the functionality of prebiotics.
• Prebiotics are easy to be integrated into solid foods
such as cereals. They can also be incorporated
into beverages and powders.
• The year of impact of targeted beyond 2015 as it is in applied
research stage.
• The year of impact of second-degree prebiotics is beyond
2013 as it is in clinical trials stage.
• Prebiotics’ ultimate aim is to be available as drug
replacements over the counter. This is expected to impact
beyond 2020
Technology Snapshot
Importance Year of Impact
Overview
28 D4A9-TI
Global Footprint
Latin America
Native fruits and other
ingredients are exported to the
US and Europe to produce
prebiotic ingredients.
Japan
Japanese companies
are researching and
manufacturing prebiotic
ingredients. They are
focusing on prebiotics
as drug replacers.
Switzerland and
Netherlands
Leading companies such
as Nestle and Danone are
researching to add
second-degree prebiotic
ingredients in their food
products .
Australasia
Unique vegetation helps in providing
sources for next generation prebiotics.
United States of
America
Prebiotic companies are
researching the
possibility of utilizing
inulin as a targeted
prebiotic ingredient
since this has the
highest market share in
the world in the US.
Source: Frost & Sullivan.
Intensity of Technology
Development
Very High
High
Medium
Low
Very Low
France
Leading cosmetic
companies such as Loreal
and Dedeor use prebiotics
in their cosmetics.
UK
Utilization of
prebiotics for feeds
of animals to
prevent specific
diseases.
29 D4A9-TI
Funding Trends
• The highest amount of funding is provided to dairy foods integrated with prebiotic ingredients. Prebiotics are sometimes
mixed with probiotics to improve digestion. Hence the research is backed by both functional foods and dairy food
companies.
• To reduce recalls of meat due to bacterial outbreaks, second degree prebiotics are being researched. This aspect is being
aided by governments of various countries.
• Prebiotics in cosmetics is relatively new and is still in basic research stage. Leading cosmetic companies are funding the
same.
Funding sources
Dairy
Confectionery and processed foods
Animal Feed
Dairy products
40%
confectionery and processed
foods 30%
animal feed 15%
beverages 10%
cosmetics 5%
Beverages
Cosmetics Source: NIH, FDA
30 D4A9-TI
Impact of Technologies
Prebiotic
blends
Prebiotics in
cosmeceuticals
Second
generation
prebiotics
Synbiotics
Encapsulated
prebiotics
Prebiotics as
drug
replacement
Prebiotic blend combinations of inulin and fructooligosaccharides (FOS) are likely to be launched and globally marketed.
Loreal and Dedeor are likely to introduce skin products containing prebiotics based on their patented technologies
Applied research is estimated to increase in the field of utilizing prebiotics to prevent cardiovascular diseases.
Synbiotic yoghurt technologies are likely to be patented. Products are expected to start launching by the end of the year.
There is an estimated increase in the amount of research for encapsulated prebiotics to prevent specific diseases that are not intestine related.
Along with Japan, the US and Europe, middle east and other Southeast Asian countries are likely to research in this area.
Prebiotic blends are combination of two or more prebiotic ingredients. Combinations of inulin were tested and launched.
Glasgow university researched the possibility of prebiotic ingredient glucomannan hydrolsylates to prevent acne
Researchers across the world are developing prebiotic ingredients that can prevent gastrointestinal diseases.
Blends of prebiotics and probiotics known as synbiotics are being clinically trialed by dairy companies to sample yoghurts.
Encapsulated prebiotics are being trialed for cosmeceuticals. They help in drug delivery apart from functioning as bacteria promoters.
Possibility of combining targeted, second-degree and encapsulated prebiotic technologies could lead to drug replacement prebiotics.
Pictures
2012 2015
32 D4A9-TI
Ever since advances in biological sciences have paved way to manipulate
organisms at the DNA level, modern biology has made huge strides in improving
life forms to suit humankind. This has extended to plants and animal food too.
Genetically engineered food also known as biotech food are a class of agricultural
(both animal and plant based) products that have been modified at the genetic
level. These types of food are specially modified with enhanced properties that
enable the food to either grow in a more sustained manner or to provide additional
nutritive value to the final product
The importance of genetically engineered food cannot
be understated. Many times, such food helps
overcome issues of poor consumption, in other
instances such food aids in providing additional
nutritional benefits to people who do no have easy
access nutritional supplements. It is even possible to
incorporate vaccines into genetically modified plants
so that when consumed the food will provide the
necessary immunity against dangerous diseases
• Products that are meant for agricultural users are already
available in the market with new technology incorporating
multi-stacked traits.
• New, state-of –the-art technology includes test tube food.
Such kind of foods are excepted to be commercialized in the
near future with the year of impact being 2014
Technology Snapshot
Importance Year of Impact
Overview
33 D4A9-TI
Global Footprint
Source: Frost & Sullivan.
Adherence to CODEX
Standards
Very High
High
Medium
Low
Very Low
USA/Canada
GM food need not be labelled.
Does not follow CODEX
standards Europe
Very strict labeling laws.
Follows CODEX standards
India
Moderate laws regarding
GM crops. Strict when
implied in food.
Follows CODEX
standards
China
Pro GMOs especially
in case of GM Rice.
Not too strict in
following CODEX
standards
Australia & New Zealand
Strict Laws. Labelling laws
similar to E.U. Follows
CODEX standards.
Latin America
Pro certain GM crops such as biofuels
generating crops. Moderately strict in
terms of GM food Crops.
Follows CODEX standards in parts.
The Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) established the CODEX Alimentarius, sets
standards and guidelines to protect the health of consumers and ensure fair practices in the international food trade. In addition to standards for specific
foods, the Codex Alimentarius contains general standards covering matters such as food labeling, food hygiene, food additives, pesticides and safety.
34 D4A9-TI
Stakeholders and Developments
Key Challenge: Difficulty in obtaining biological sequences; long R&D timelines and nature overcoming target
mutations are the most significant technology related challenges. While high R&D costs, ill-perception of BT
products, patent infringement and enforcement and lack of uniform laws for international trade are some of the
most significant business challenges facing genetically engineered food as of today.
Company Product /
Technology Details
Okanagan
Specialty
Fruits Inc
Modified Apples
The Canadian based company has applied for permission to grow and market its ‘arctic
granny’ and ‘arctic golden’ apples. The genetically engineered fruit, was originally
developed in Australia and has the ability to keep their white flesh even when exposed
for several hours. The browning of cut apples usually leads to the perception that the
food has spoilt and increased wastage of good quality fruit. This innovation allows for
the fruit to be wasted less easily
AquaBounty
Technologies Modified Salmon
The US based company has produced its in-house developed AquAdvantage Salmon.
This is a genetically enhanced breed of salmon that grows faster than regular salmon.
The company is currently seeking federal approval for the salmon. If approved, the
salmon would be the first genetically engineered animal in the human food supply.
Considering the fact that salmon (and hence even caviar) are a rare commodity, this
should reduce strain on naturally occurring salmon population and preserve its diversity.
Agrargen Modified Camelina
The company plans to introduce its in-house developed modified Camelina that
contains increased oil content. This is said to enhance biofuel production by making the
process more economical.
35 D4A9-TI
Impact on Application Areas
2014 2016 2020
Crop protection and production are the most important traits
being imparted to crops currently. This trend will decrease in the
long term once all popular crops have been suitably genetically
modified.
Currently, there are very few commercial animal products that
have been genetically modified. With food security predicted to
be a major issue in the long term, such foods will be more
commonplace.
Currently, functional foods have little bearing in the mainstream
global market as they’re resigned for countries with poor
nutritional access. This trend is expected to be continued in the
long term.
Pharmaceuticals are probably the biggest impact in the long
term. This is due to long timelines of research and
commercialization.
Legend: Low High
Crop Production
Protection
Animal Husbandry
Functional Foods
Pharmaceuticals
Renewable Chemicals
Renewable chemicals will benefit from genetically engineered
plants. Varieties that allow for greater productions and easier
extraction of renewable chemical content will show greatest
promise.
37 D4A9-TI
Nutrient Encapsulation involves the incorporation (entrapping or enveloping) of core materials that
include food ingredients, enzymes, cells or other materials such as additives, nutrients, flavors,
colors, micro organisms, essential oils, vitamins, minerals, in an enclosing material (carrier, shell,
wall, capsule, or membrane).
The enclosing materials are designed to protect the core material from the damage and to prevent
unwanted reactions with the environment, moisture and heat. The coating materials are typically
made from sugars, proteins, gums, natural and modified polysaccharides, synthetic polymers, and
even fats.
• Nutrient Encapsulation helps in extended shelf life
of the product and improved performance
characteristics.
• It increases the bioavailability of the encapsulated
ingredient and helps in controlling their reactions
within a specific environment.
• It prevents loss of nutrients and prevents their
interactions with atmosphere and other
constituents during storage.
• While encapsulated probiotics, nutrients (amino acids,
vitamins and minerals) are available in market, controlled
release and multi-functional products are expected to be
widely adopted within early 2015.
• While early adoption of nanotechnology and
microencapsulation for increasing product performance is
perceived, they are expected to gain prominence by 2014.
Technology Snapshot
Importance Year of Impact
Overview
38 D4A9-TI
Global Footprint
USA/ Canada:
Extensive research to ensure stability
during processing and packaging,
reduction of capsule size and enhancing
bioavailability.
UK:
Research efforts are more focused on
novel encapsulation materials, controlled
release and increasing bioavailability
Australia/New Zealand
Research efforts mimicking global
trends. Current focus on novel
encapsulation technologies and multi
component encapsulation.
Source: Frost & Sullivan.
Intensity of Technology
Development
Very High
High
Medium
Low
Very Low
Rest of Europe:
Focus on nanoencapsulation and
microencapsulation techniques, especially
in countries like Germany, The
Netherlands, Israel and Sweden..
39 D4A9-TI
Stakeholders and Developments
Key Challenge: While many nutrients are encapsulated, product stability and release of active ingredient at
targeted site are the major challenges that need to be addressed for sustained growth of the industry.
Company Product /
Technology Details
Technion Israel
Institute of
Technology
Nano capsules to
protect hydrophobic
nutraceuticals
Nano capsules (conjugates) made of casein and maltodextrin are developed to
protect hydrophobic nutraceuticals such as vitamin D. The conjugates were used
for the enrichment of clear beverages . The development of nano capsules have
the additional benefit of masking off-flavors and off-odors.
Nanologica
Mesoporous Silica as
encapsulating
material
Mesoporous silica particles are developed as an encapsulation material using
nanotechnology. The material is perceived to be safe, stable, cost effective and is
capable of addressing the challenges such as off-taste masking, controlled release
and increasing nutrient bioavailability
Tropicana
Products
Fatty acid enriched
fruit juices
Fortified fruit juices with omega 3 essential fatty acids using double encapsulation
techniques to ensure nutrient bioavailability and to ensure increased performance
characteristics.
Biogaia AB ProTectis and
ProDentis
Encapsulated probiotic strain, Lactobacillus reuteri in chewable tablets, capsules
and other carriers to promote oral health, combat infant colic and digestive
aliments.
Lipofoods Lipophytol
Micorencapsulation techniques used for coating the microparticles of phytosterols,
thereby, providing a water-dispersible form to supplement phytosterols into the
daily diet.
40 D4A9-TI
Technology Roadmap
2010 2013 2015 2017 2019
Source: Frost & Sullivan.
Self
assembled
Nutrients
Microencapsul
ation
Powdered
Technology
Controlled
release
Mechanism
Targeted
Delivery
Droplet
technologies
Hybrid
Technologies
Nano capsules
Nutrient Encapsulation aid in incorporating reactive additives and other ingredients into stable ingredients to add value to the final product. The development of
encapsulation technologies has the ability to transform health and wellness industry and helps in expansion of application areas such as nutraceuticals, fortified
and other functional foods apart from conventional applications that include taste-, color- and odor- masking and flavor stabilization,
42 D4A9-TI
Nanofluidics refers to the control and manipulation of excessively small fluids of dimension less
than 1nm. Fluids in the nano-scale range exhibit behavior normally not observed in the macro
scale. This industry is experiencing considerable growth in recent years. A benefit of nanofluidics
is that it offers the possibility of exploring fluid behaviour using controlled regular nanostructures.
This technology has had a great impact on drug delivery devices as the systems have the ability
to completely control drug release rate depending on the on-demand requirements for extended
periods of time.
The use of NEMS based technology in medical
applications is an area with immense potential.
Demand for improved healthcare at reduced cost,
along with point-of-care applications for the elderly
population, has made nano-scale biomedical
technologies an attractive opportunity for investors
and manufacturers..
Nanofluidic technology has been successfully implemented in
technologies involving analytical separations and the
manipulation of proteins, RNA and DNA. However most of the
applications are in combination with bioMEMS technology. The
number of application areas is emerging enabled by innovative
fabrication methods. An important advantage of nano-scaled
systems is the small amount of sample or reagent used for
analysis. This reduces the time required for sample processing
and further speeds up the processes thereby increasing
throughput of the analysis.
Technology Snapshot
Importance Strength
Overview
43 D4A9-TI
Global Footprint
• Nanofluidics is a converging technology and OEMs are manufacturing NEMS based devices in combination with MEMS
based systems.
• BioMEMS technology has revolutionised drug discovery and molecular based diagnostics. It is expected that these two
applications will boost the nanofludics and bioNEMS technology in a similar fashion.
• In the western countries such as North America (NA) and European Union (EU), nanofludics technology is currently driven by
the government initiatives and funding undertaken for promoting nano-based technologies.
• The Chinese market is slowly catching up with the western and European countries in terms of the bioMEMS industry.
Chinese medical companies have traditionally distributed North American and European products on their home market. That
is starting to change slowly and China is emerging as a key participant in the bioMEMS field. Given the current technology
development trends taking place in China, it can be expected that China will soon emerge as a key global player in this field.
44 D4A9-TI
Company Product Description
BioNano Genomics NanoAnalyzer System
Minute samples are utilised by the nanoAnalyzer System to analyze several
gigabases per hour. Valuable information is obtained about the genome structure
as the sample is analysed without breaking up the molecules. The technology
enables high-throughput processing. The proprietary nanoAnalyzer technology is
capable of delivering precise genetic data in a fraction of the time and at a cost
which is a fraction of existing technologies.
RainDance Technologies RDT 1000
RainDance Technologies’ (RDT) is a company which develops a proprietary
microdroplet-based technology with special emphasis in the prediction and
prevention of human disease. Some of the proven application of this technology
are for assays such as PCR and cell sorting. The technology proposed by
RainDance produces picoliter-volume droplets at a rate of 10 million per hour,
avoiding complex automation solutions.
Vyteris Inc LidoSite Topical System
Topical local anesthetic delivery system indicated for use on normal intact skin to
provide local analgesia for superficial dermatological procedures such as
venipuncture, intravenous cannulation, and laser ablation of superficial skin lesions.
Boston Scientific TAXUS Express
The TAXUS stent uses Translute™ Polymer which is a proprietary polymer carrier
technology, to control drug release. The Translute Polymer protects the drug and
maintains coating integrity during preparation, delivery, and stent expansion.
Cytosurge
FluidFM
FluidFM technology utilises hollow connecting cantilevers with a microfluidic
system for fluid application. The technology is used for dispensing and stimulating
single cells under a physiological condition. Nanofluidic channels allow soluble
molecules to get dispensed through submicrometer aperture in the AFM tip.
Stakeholders and Developments
The regulatory barrier is a huge challenge for companies in this field. Companies might have the expertise to manufacture
bioNEMS but they have modest experience in the rigorous regulatory process. Apart from the regulations that medical devices
must comply with, there are additional standards for bioMEMS devices, applicable for NEMS based devices as well which
manufacturers must comply with.
45 D4A9-TI
2010 2015
Application Roadmap
2020 2025 Beyond--
Source: Frost & Sullivan.
Lab Automation
µTAS
LOC
• Injectable BioMEMS
• Implantable LOC
Nanodrugs, Drug
Delivery, Diagnostics,
cancer Treatment
Nano Robotics, Nano
sensors
In Vitro Analysis Nano-In Vivo Analysis
BioNEMS
Benchtop
Devices
Portable
Devices
Wearable
Devices
Implantable
Devices
Nanomaterials and
Implants
Digestable sensors
47 D4A9-TI
• The large scale adoption of sequencing can be useful for
clinical diagnostics and drug discovery in addition to basic
biomedical research and genetics studies.
• Regular genetic testing can improve clinical management
of diseases based on patient stratification and personalized
therapy design.
• Regular use of sequencing can reduce healthcare costs,
bring down drug development costs and timelines and
improve therapeutic outcomes for many diseases.
• Predictive disease models can be developed with use of
valuable sequencing data.
• Several next gen sequencers are already in the market and these
include Pacific Biosciences’ SMRT sequencer, Ion Torrent’s Ion
Proton and Oxford Nanopore’s GridION and MinION. Solid state
nanopore based sequencers. should enter the market by 2013
• Regular application in clinical diagnostics and genetic screening
tests by 2013 or 2014.
• Microbiome research and research on human pathogen interactions
should find increased applications by 2015.
• Whole genome sequencing lower than $1000 combined with low
instrumentation costs is likely to be achieved by 2013.
Technology Snapshot
Importance Year of Impact
Overview
Next Gen Sequencing involves technologies that can significantly decrease the cost and time of
sequencing while improving accuracy and length of reads. Technologies, such as real-time single molecule
detection, nanopore sequencing, high-density semiconductors allow multiplexing, label-free detection,
increased read-lengths, and reduced overall costs and time. Use of novel materials and the integration of
biology, chemistry, electronics, and micro/ nanofluidics is playing a significant role in development of follow
on next gen sequencing technologies. Portable sequencers, (PoC) which are cost effective and can be
used for small size runs will find increased applications in diagnostics and regular point-of-care clinical
studies.
48 D4A9-TI
Global Footprint
USA/ Canada
Highest amount of research and funding for next gen sequencing
projects. Most of the Tier 1 companies as well as mid and small sized
innovation driven companies are based in USA and research on DNA
methylation , RNA profiling, epigenetics and so on.
Adoption of next gen sequencing in drug discovery, genetic tests is the
highest in US and several partnerships between sequencing
developers and research labs, allied tech developers is helping to
increase adoption and shorten time to market.
The government initiatives are the maximum in US and these include
$1000 genome project, Human Microbiome Project(HMP), 1000
genomes project- supported by NHGRI. China
BGI (Beijing Institute of Genomics), the
largest global genomics center is the pioneer
in sequencing research and has
partnerships with US companies and
institutions around the globe. However, the
developments in terms of next gen
sequencing technologies has been slow in
China and increased private and federal
investments combined with increased
collaborations will help develop better
analytical systems .
Europe
More than 220 high throughput next gen sequencing facilities in
focusing on different applications. The adoption of gene
screening tests for genetic diseases is relatively low in EU.
EU Epigenomics Consortium , E-Rare are some of the initiatives
focused of NGS technologies and applications. The
developments of NGS technologies is moderate except a few
countries such as UK and Germany that have developed
innovative sample preparation methods and sequencers,
Australia/New Zealand
The research is slow paced and the
number of sequencing providers are
also few in number.
India
Research is relatively low - mainly in the area of
bioinformatics for next gen sequencing. Adoption of
next gen sequencing is witnessed mainly in basic
research (plant genomics, cancer genomics) and
so on. Tier 1 company Life Technologies(Ion
Torrent) recently launched its Ion Proton to
increase adoption for drug discovery and
diagnostics applications. Currently there are about
15 sequencing centers in the country.
Source: Frost & Sullivan.
Intensity of Technology
Development
Very High
High
Medium
Low
Very Low
49 D4A9-TI
Stakeholders and Technology Segments
Technology Segments Stakeholders Trends/ Developments
Sequencing by
Synthesis
Sequencing by
Ligation
Nanopore
Sequencing
Direct Imaging
by Advanced
Microscopy
• The development of single molecule analysis SBS methods such as Life
Technologies- Ion Torrent’s products has led to drastic improvements in
accuracy and read lengths while bringing down the costs of sequencing.
• Non optical detection techniques that detect based on changes in pH or
current will help reduce reagent costs. Use of non labeled nucleotides are
simplifying the sequencing process.
• Development of high density chips such as Ion Torrent’s Ion Proton that can
improve throughput and generate large amounts of data per run.
• Generally read lengths are short with SBL methods; new platforms are
aimed at improving the read lengths.
• Hairpin DNA system using magnetic beads being developed by the startup
Picoseq can be used for high throughput sequencing using hybridization.
• Highly scalable technology area that can revolutionize sequencing in terms
of costs, speed and throughput. This single molecule, label free method of
sequencing area is being actively explored by companies and academia,
which are working on different types of nanopores and different detection
methods.
• Oxford Nanopore has launched its first nanopore based sequencer recently-
both portable and desktop versions have been introduced. A few of the
nanopore sequencers are expected to enter the market in the next 2-3 years (
eg. Noblegen Biosciences, Stratos Genomics, Genia).
• Only a handful of companies are working on direct microscopy based
sequencing methods- still in research phase and far from commercialization
• The instrument is prohibitively expensive but the sequencing costs would drop
drastically.
• TEM(Transmission electron microscopy), SEM( Scanning electron microscopy)
and AFM (atomic force microscopy) are some of the microscopy based
sequencing platforms under development.
50 D4A9-TI
Recent Developments
Company Product /
Technology Details
Stratos
Genomics
Sequencing by
Expansion™ (SBX™)
The company is developing a nanopore sequencer based on DNA expansion
technology. The DNA is encoded into constructs called Xpandomers (reporters) .
These reporters have a high signal to noise ratio and are best adapted for
nanopore detection and Stratos is developing a sequencing instrument based on
this.
GnuBIO Inc Integrated GnuBIO
system
The desktop microfluidic sequencer to be launched later in 2012 is based on SBH
chemistry. The integrated sequencing platform is centered around picoinjector
technology that the company licensed exclusively from Harvard University. Sample
preparation, target enrichment, sequencing, and data analysis can be done in
microfluidic channels in a much simpler and rapid fashion when compared to
competing methods.
Oxford
Nanopore
Technologies
GridION and MinION
MinION ( disposable chip for PoC settings) and GridION (high throughput desktop
sequencer) launched in 2012 utilize biological nanopores for low cost, rapid and
high throughput sequencing. Illumina has made investments in ONT and the
company has a number of other collaborations with academia, working on
advanced technologies.
Noblegen
Biosciences Optipore
Optipore is an enzyme free, optical method that uses nanopores. It allows
analysis at single molecule and it is a highly multiplexed, rapid method of
sequencing in a highly cost effective manners. The system converts DNA into a
synthetic coded version that is then captured by a beacon as it passes through the
nanopores and the color codes correspond to the bases. The second prototype of
the sequencer is under development and the company expects to go commercial
in the next 1-2 years.
51 D4A9-TI
Industry Landscape--2015
Technology
Developments
Academic and
Corporate Research
Government
Initiatives
• Efficient massive parallelisation and automation of sample preparation, combined with improved sensitivities
will enable reduced sample preparation time, costs and IT burden.
• Portable sequencers that will be capable of sequencing entire genomes of bacteria, viruses and larger
genomes.
• Solid state nanopores and the use of semiconductors more regularly in sequencing applications
• Sequencing research is expected to reach significant height by the year 2015. With increase in federal and
venture funding for core and allied technologies, technology developers are poised to deliver a number of
products in the next couple of years. Many consortia and research groups are working on bioinformatics tools
and cloud based data management systems that can be effectively used for data analysis.
• Current initiatives such as the $1000 Genome, 1000 genome project, Human Microbiome Project in the USA
and few EU initiatives will eventually allow next gen sequencing to find increased utility in drug discovery ,
companion diagnostics and regular genetic screening and SNP testing. Regulatory policies that favor the
rational use of next gen sequencing for healthcare applications is likely to become more standardized.
53 D4A9-TI
• Adult stem cell therapies are more feasible lines of
treatment compared to embryonic stem cells as their use
is not impeded by ethical issues and the policies are
globally uniform.
• Adult stem cell therapies are also less time-consuming in
terms of developmental cycle and therefore, more
attractive for technology investors. In addition, as the cells
are extracted from the patients own marrow, they preclude
the possibilities of immunogenic reactions, making the
therapy viable with respect to regulatory standards.
• Adult stem cell therapeutics are still in their infancy in the United
States and Europe as no stem cell therapies have been approved
to date.
• The most advanced therapies such as those from Cytori
Therapeutics, Osiris Therapeutics and Aastrom are in early or late
Phase 3. These therapies are for autoimmune or cardiovascular
diseases. Other therapies for oncology, neurology and
dermatology are being developed and are in Phase I or II. The
year of impact is therefore, 2017-20.
Technology Snapshot
Importance Year of Impact
Overview
• Adult stem cells are undifferentiated cells found among differentiated cells in tissue/organ. They can
differentiate themselves to yield some or all of the major specialized cell types of that tissue/organ for
replacement of damaged or injured tissue. Adult stem cells can be derived from marrow (stromal cells) or
from placental cord blood. Therapies are being developed for a range of diseases from myocardial
infarction to liver disease and diabetes. Stromal cells are extracted from the patient and differentiated in
vitro.
• Globally, more than 200 companies are involved in developing stem cell products and the therapies are
likely to be disruptive treatments for medical sectors (For instance knee implants, bone marrow
transplant, heart muscle repair).
54 D4A9-TI
Global Footprint
North America
• USA has five states most active in the development
of adult stem cell therapeutics—New York, New
Jersey, Maryland, California and Massachusetts.
• Osiris Therapeutics and Aastrom have stem cell
therapies for cardiovascular diseases and
autoimmune diseases. In Phase III trials.
• All the above-mentioned states have state-centric
funding as well as regulatory guidance institutions to
accelerate the development process.
Europe
• UK, Sweden and Denmark are the countries in
Europe that have more permissible policies and
are concentrating on adult stem cell therapies,
particularly for autoimmune diseases and
oncology.
• ReNeuron, Capsant, NsGene A/S and the
Karolinska and Lund research centers are the
centers of development.
• Stem cell therapies are mostly in Phase I or II
and commercialization is slower.
Rest of APAC
• The biggest participants in the stem cell industry
are Singapore, Australia and Israel.
• Pluristem Therapeutics and Gamida Cell already
have products for autoimmune diseases and cell
expansion (inflammatory diseases) in Phase II/III.
• Mesoblast in Australia is both developing and
promoting APSCs for cardiovascular, diabetes,
oncology, eye disease, and orthopedic therapies.
All products are in Phase I/II.
•
China
• The Ministry of Science and Technology has
made available up to $293 million for stem cell
research/spinoffs from 2006-2010.
• The Chinese Academy of Science provides an
additional $20 million as well as set-up
assistance for new start-ups in this field.
• There is also a clear focus of resources on the
applications of stem cell research, such as
therapeutic uses and drug testing.
Source: Frost & Sullivan.
Intensity of Technology
Development
Very High
High
Medium
Low
Very Low
55 D4A9-TI
Funding Trends
• NIH is the primary institute for stem cell funding, particularly for start-ups engaged in the development of
adult stem cell therapies. It has shown a steadily increasing trend and the investment was close to $350
million in 2010, excluding ARRA funding.
• The Small Business Innovation Research grant has also been a good source of funding for early-stage
startups but has shown a decline since 2010. It has however, increased till 2011, with the allocated
budget for 2012 being $3.1 million.
0
50
100
150
200
250
300
350
400
2002 2003 2004 2005 2006 2007 2008 2009 2010
Fu
nd
s (
$ m
illio
n)
Year
NIH Stem Cell Funding 2002-2010
Embryonic
Non-embryonic
ARRA 0
1
2
3
2006 2007 2008 2009 2010
Fu
nd
ing
($ m
illio
n)
Year
SBIR Funding 2006-2010
Source: NIH, EC, MRC
56 D4A9-TI
Technology Benchmarking
Therapeutic Efficacy Development (Stage and
Progress) Disease Market
ReNeuron Low High 1 5 2 3 4
Low High 1 5 2 3 4
Low High 11.9
Osiris
Therapeutics Low High
1 5 2 3 4
Low High
1 5 2 3 4
Low High 13.4
Aastrom Low High
1 5 2 3 4
Low High
1 5 2 3 4
Low High 12.9
Gamida Cell Low High 1 5 2 3 4
Low High 1 5 2 3 4
Low High 13.1
Mesoblast Low High 1 5 2 3 4
Low High
1 5 2 3 4
Low High 13.5
Pluristem
Therapeutics Low High
1 5 2 3 4 Low High
1 5 2 3 4 Low High
13.0
Total
15 Points
1 5 2 3 4
1 5 2 3 4
1 5 2 3 4
1 5 2 3 4
1 5 2 3 4
1 5 2 3 4
Dashboard
Summary
• The companies have been rated on the basis of the stage and progress of development of the therapy, the market for
the diseases at which the therapies are targeted and the therapeutic efficacy of the treatment (as indicated by results of
clinical trials).
• Aastrom and Osiris Therapeutics have both scored the highest with respect to the development stage and progress of
their therapies. They are both US companies, implying that easy access to the streamlined regulatory process provided
by the FDA for APSC therapies.
• Mesoblast has a leading position in terms of disease market as it is currently running clinical trials for the top 3 diseases
identified by WHO and NIH for highest healthcare burden and mortality rates, i.e., diabetes, cardiovascular diseases and
oncology. The only other company that has a disease portfolio close to that of Mesoblast is Pluristem Therapeutics.
• ReNeuron and Gamida Cell have scored the highest in terms of therapeutic efficacy of their treatments. Both companies
have reported successful Phase IIa trials with over 70% efficacy quotients. Although the other companies have also
advanced to Phase III trials, the efficacy quotient has been less and the pharmaco-toxicity profile is not at the same level
as the treatments from these two companies.
57 D4A9-TI
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We also certify that no part of our analyst compensation was, is or will be, directly or
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58 D4A9-TI
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60 D4A9-TI
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