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Market

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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