the field of nanomedicine research, the US accounts for one-third of all
publications and half of patent filings. A comparison between Europe as a whole
and the US shows that while Europe is at the forefront of research, the US
leads in the number of patent filings. The strong patenting activity of US
scientists and companies indicates a more advanced commercialization status.
to BCC Research (www.bccresearch.com), the global market for nanoparticles in
the life sciences is estimated at over $29.6 billion for 2014. This market is
forecast to grow to more than $79.8 billion by 2019, to register a healthy
compound annual growth rate (CAGR) of 22%. The biggest increase will come in
the area of drug delivery systems.
products complete clinical trials and gain US FDA market approval, the revenues
from these products will grow at 23%. Basic biotechnology research revenues
will increase due to the quest to find more nanoparticle applications, as more
drugs become successfully delivered by these carrier systems. Drug development
and formulation will show steady sustained growth at 20.7%. Nanoparticles for
use in diagnostic imaging will continue to show healthy growth at 20.1%. This
will result from the need to develop more definitive nanoparticle markets for
APPLICATIONS IN MEDICINE
several distinct application
areas, including drug delivery, drugs and therapies, in vivo imaging, in vitro
and active implants. In these fields, nanomedicine has seen increased research activity during
the past decade. Currently, nanomedicine accounts for about 5% of nanotechnology
The dominant research
is drug delivery, contributing 76% of the scientific publications, followed by
with a contribution of 11%. The countries of the European Union account for 36% of all
worldwide, compared to the US with a contribution of 32% and Asia with 18%. Research efforts
in nanomedicine are driven by significant governmental nanotechnology funding programs.
Three countries - the US, Germany, and Japan - have given clear commitments to
nanomedicine by establishing focused nanomedicine research programs.
However, when one looks at
the commercialization of this field, the US emerges as having about half of the
world market for nanomedicine products. US companies manufacture 45% to 50% of marketed
nanomedicine products, while European companies have a 35% share. Product pipelines
suggest that this gap will widen, reflecting mainly the weak position of European
nanomedicine companies in the drug delivery sector, where they represent less
than one quarter of all the companies in this field, compared to 60% for US
Of the approximately 200
companies identified as active in nanomedicine worldwide, some three-quarters
are startups and SMEs focusing on the development of nanotechnology-enhanced pharmaceuticals
and medical devices. Another 40-plus major pharmaceutical and medical device
corporations have nanomedicine products. Individual nanomedicine application
areas are defined below.
Drug Delivery: Nanoscale particles/molecules
are developed to improve the bioavailability and pharmacokinetics of therapeutics.
Examples are liposomes (and virosomes), polymer nanoparticles, nanosuspensions,
and polymer therapeutics. Drugs in which a protein is combined with a polymer
nanoparticle or chemical nanostructure to improve its pharmacokinetic properties
would qualify as nano-enhanced drug delivery.
Drugs and Therapy: Nanoscale particles/molecules
used in the treatment of diseases that according to their structure have unique
medical effects and as such differ from traditional small-molecule drugs;
examples include drugs based on fullerenes or dendrimers.
In Vivo Imaging: Nanoparticle contrast agents,
particularly for MRI and ultrasound, provide improved contrast and favorable biodistribution;
oxide nanoparticles for use as MRI contrast agents.
In Vitro Diagnostics: Novel sensor concepts are
based on nanotubes, nanowires, cantilevers, or atomic force microscopy applied
to diagnostic devices/sensors. The aim of these sensors is to improve
sensitivity, reduce production costs, or measure novel analytes (eg, Alzheimer
plaques) that could not otherwise be detected reliably.
Biomaterials: These include
self-assembling particles or other types of nanomaterial that improve the
mechanical properties and biocompatibility of biomaterials for medical implants;
examples include nanocomposite materials used as dental fillers and nanohydroxyapatite
used for implant coatings and bone substitutes.
Active Implants: Particles/materials
improve electrode surfaces and biocompatibility of device housings. Examples
include magnetic nanoparticle-based coatings that make medical implants safe
for use with MRI imaging.
products began appearing on the market over a decade ago and some have become
best-sellers in their therapeutic categories. The main areas in which nanomedical products
have made an
are cancer, CNS diseases, cardiovascular disease, and infection control.
At present, cancer is one
of the largest therapeutic areas in which nano-enabled products have made major
contributions; these include Abraxane, Depocyt, Oncospar, Doxil, and Neulasta. Cancer is a
prime focus for nanopharmaceutical R&D, and companies with clinical-stage
developments in this field include Celgene, Access, Camurus, and Cytimmune.
Treatments for CNS
disorders including Alzheimer’s disease and stroke also feature prominently in
nanotherapeutic research, seeking to build on achievements already posted by products such as
Tysabri, Copazone, and Diprivan. According to BCC Research, this is a field hungry for
advances and annual growth from existing and advanced pipeline products is expected to reach 16% over
the next 5 years.
has an increasingly high profile, and nanotechnology has contributed to the success of products such as
Remicade and Humira. Enzon is among companies vigorously pursuing new product development
in this field, and new products
are expected to add to the continuing market penetration of existing therapies, contributing to
annual growth rates around 15%.
nanotechnology has contributed to a wide variety of anti-infective products, from PEGylated
interferons used in viral disease to nanocrystalline silver used topically in wound
infections. Biosanté and NanoBio are among companies actively involved in this field.
The US market is by far
the largest in the global nanomedicine market, and is set to continue to dominate
the world marketplace, but other national markets are expected to increase their
shares over the next 5 years.
COMMERCIALIZED & FUTURE MARKETS
Apart from targeted cancer
chemotherapy, nanotechnology is being used more widely in creating a new
generation of drug delivery systems. A key factor in its
adoption is that nanoscale
particles have a greater surface-to-volume ratio than macroparticles. Thus, a
drug-bearing nanoparticle can release a drug more quickly and more abundantly
than larger particles. This is helpful when the drug poses problems with
solubility and absorption, as is the case with a considerable proportion of new
Already on the market in
the US and elsewhere are wound dressings that exploit the antimicrobial
properties of nanocrystalline silver. Ionic silver is a powerful antibacterial,
effective even against problem organisms like MRSA, and nanotechnology offers a
way to optimize its effect when incorporated in a wound dressing.
While current medical
nanotech applications focus on single nanoparticles and simple structures,
future possibilities will involve combing such single elements into structures
that can carry out more complex tasks than, for example, releasing drug payloads.
Thus, nanostructures may be developed that can insert probes into elected cells
and inject DNA or protein to correct genetic abnormalities.
Another possibility is to
design nanostructures that can foster and direct the regeneration of nerve
cells; these would be used in the treatment of stroke and trauma victims, and possibly
for the restoration of lost function in Alzheimer’s disease. However, a sober
estimate of timing would warn us not to expect these developments to become reality
until 10 to 20 years from now.
The nanomedicine market is
in early growth. While nano-enhanced drug delivery products are already a
commercial reality, more advanced nanotech-based medical devices are still in
development, although some are at the clinical testing stage.
Most of the money being
spent on the wider field of nanotechnology R&D comes from government and
established corporations. In the nanomedicine field, pharmaceutical and
specialist companies are at the forefront of research into the medical
applications of nanotechnology.
To date, drug delivery has
been the main near-term opportunity for medical nanotechnology. This market has
an estimated value of $15.8 billion for 2014 and is forecast to grow to $44.5
billion by 2019, to register a significant CAGR of 23%. The drug development
category, the second fastest-growing opportunity, was projected at nearly $12.6
billion for 2014 and is expected to increase to $32.2 billion by 2019 at a
This article is based on
the following market analysis reports published by BCC Research: Nanoparticles
in Biotechnology, Drug Development & Drug Delivery (BIO113B) by
Jackson Highsmith, and Nanotechnology in Medical Applications: The
Global Market (HLC069B) by Paul Evers. For more information, visit www.bccresearch.com.
To view this issue and all
back issues online, please visit www.drug-dev.com.
Kevin James is a New York City-based healthcare
and medical communications professional with more than 15 years of experience
in the private and public health sectors.
Jackson Highsmith is a life sciences research
consultant with more than 16 years of research experience. Mr. Highsmith has
been consulting with specialty pharmaceuticals and large pharmaceutical
industry players since 2007. Prior to that, he worked at a large research
consultancy, where he focused on in-depth
research; he has also
worked at a large pharmaceutical company dealing with a wide range of medical
therapeutics in early- and mid-stage drug development.
Paul Evers has been involved in
analyzing pharmaceutical and medical markets for 20 years. His expertise
includes nanotechnology in medical applications, generic drugs, pharmaceutical
regulatory issues, and trends in major therapeutic categories.