Drug
Device Combination Products : Market Review and Future
Trends
What Are
Combination Products?
The
therapeutic and diagnostic products that combine drugs,
devices, and/or biological products are called combination
products and can include following types: drug-device,
biologicdevice, drug-biologic and drug-device-biologic.
These products have emerged as innovative medical products
due to their contribution in advancing medical care and
are thus expected to have major impact on the overall
medical devices market.
For
example, smart implants may provide a means of remotely
monitoring and managing therapeutic dosing; in turn,
wireless communication with implants may allow health care
services for chronic disease to shift from the hospital to
the home setting.
Market
Review
The global
drug device combination products market has been
differentiated into eight segments based on the product
types. The major product types include drug eluting stents,
prefilled syringes, antimicrobial-coated catheters,
co-packaged products that are required to be delivered
sequentially for therapeutic effect, and infusion pumps,
photo sensitizers, orthopedic combination products, wound
care combination products, inhalers, transdermal patches
and others which include intraocular implants and drug
eluting beads. The global drug device combination products
market was valued at USD 66 billion in 2012 and is
expected to grow at a CAGR of 7.9% from 2013 to 2019, to
reach an estimated value of USD 115billion in 2019
according to the Transparency Market Research report.
Geographically, North America dominated the global drug
device combination products market and is expected to
continue to lead in terms of revenue generation throughout
the forecast period. The market in North American region
was valued at USD 28.5 billion in the year 2012.
Asia-Pacific is considered as the most lucrative market
for drug device combination products owing to the increase
in incidences of cardiovascular diseases, diabetes related
disorders and obesity through 2019.
The leading
players in the market for drug device combination products
are Abbott Laboratories, Inc., Medtronic, Inc., Boston
Scientific Corporation, CareFusion Corporation, Allergen,
Inc. and others.
Major
Growth Drivers
Various
emerging technologies such as implants with drugs to
permit faster healing, relief from pain and decreased
morbidity currently form the major driver for the growth
of this market. High incidence rates of chronic pain
causing diseases, prostate cancer, diabetic retinopathy,
cardiovascular diseases, colorectal cancer, asthma,
obesity along with rapidly aging global population also
form the key drivers for the global drug device
combination products market.
The
following scenarios regarding drug/device combinations
approval may take place:
• The
device and drug are approved and on the market
individually.
- When the
drug and the device are both approved, the
biocompatibility of the device and the toxicology of the
pharmaceutical are known. It must be shown that the
stability and bioavailability of the drug have not been
compromised by the new drug-device combination.
• The
device is approved, but the drug is not approved.
- When the
device is approved and the drug is not, the drug will need
to go through the extensive evaluations typically done for
a new drug product, plus those studies indicated in the
first scenario above.
• The
device is not approved, but the drug is approved.
- Most of
these devices today fall into a category where a known
drug is available but the delivery system needs
enhancement to achieve improved therapy.
• Neither
the device nor the drug is approved.
- In this
scenario, when neither drug nor device is approved,
significant device evaluations (IDE, PMA) and drug
evaluations (IND, NDA) will be required.
Depending
upon the exact nature of the device, a range of biological
effects may need evaluation per ISO 10993. First
consideration should be given to vertical standards (an
FDA guideline or ISO standard in use for a specific
device). In the absence of such guidance, ISO 10993-1
should be consulted to determine areas of concern for
these devices.
Future
Trends
The
anticipated developments in the device combination product
category between now and 2020 will lead to new clinical
products.
Three types
of developments are expected.
1 First,
additional products designed for implanted delivery of
insulin and other drugs.
2 Second,
new developments in drug impregnated devices are expected.
3 Finally
under development are new developments in drug delivery
systems to simplify reliable use by unsophisticated
patients in home settings, including the increasing
elderly population.
It is
expected that in the future large numbers of combination
products will be filed as technological advances continue
to ‘unite’ different product types and thereby effectively
‘blur’ the historical lines of separation between FDA’s
medical product centers, i.e., the Center for Biologics
Evaluation and Research (CBER), the Center for Drug
Evaluation and Research (CDER), and the Center for Devices
and Radiological Health (CDRH). Furthermore, statistics
vary on the potential of the combination product market,
with estimates ranging from 10%-14%8 annual growth..
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