Drug-Device Combination Products Market Analysis

Drug-device combination products are therapeutic and diagnostic products including a drug and a medical device. Prefilled syringes, drug coated devices, and co-packages are some of the examples of traditional drug/device combination products.

Global Drug-device Combination Products Market – Impact of Coronavirus (COVID – 19) Pandemic

The COVID-19 pandemic is expected to hamper the global drug-device combination products market growth during the forecast period. The COVID-19 pandemic and resulting lockdowns in various countries across the globe have impacted the financial status of businesses in all sectors. The private healthcare sector has been impacted majorly due to the COVID-19 pandemic. Many clinical trials have been suspended during the pandemic. In order to restart the clinical trials, the U.S. Food and Drug Administration (FDA) released guidelines during the COVID-19 public health emergency in March 2020. The guidelines were further updated on July 02, 2020. The guidelines include general considerations to assist sponsors and researchers, which ensure the safety of trial participants, and compliance with good clinical practice (GCP) for the duration of the COVID-19 public health emergency. The appendix of the guidelines also provide answers to some general questions, which the U.S. Food and Drug Administration (FDA) received from various sponsors and researchers about conducting clinical trials during the COVID-19 public health emergency.

Furthermore, players operating in the global drug-device combination products market are facing major challenges on various fronts due to the COVID-19 pandemic. The major challenges include supply of raw materials for manufacturing drug formulations due to irregularities in transportation facility. Moreover, distributors of products are experiencing irregular demand for products from the retailers due to increasing patient population suffering from COVID-19 and other life threatening disorders.

The global drug-device combination products market is estimated to be valued at US$ 123.5 billion in 2020 and is expected to exhibit a CAGR of 8.2% during the forecast period (2020-2027).

Figure 1: Global Drug-device Combination Products Market Share (%) Analysis, By Product Type, 2020

Increasing prevalence of chronic diseases is expected to drive growth of the global drug-device combination products market during the forecast period

The rising incidence of chronic diseases such as chronic diseases and disorders including cancer, cardiac conditions, multiple sclerosis, and diab etes, among others is a major factor which is expected to drive the market growth. According to the National Center for Biotechnology Information (NCBI), 2020, in 2017, globally, around 126 million people suffered from ischemic heart disease (1,655 per 100,000), which constituted to 1.72% of the total world population.

Moreover, increasing geriatric population is also expected to aid in growth of the market. For instance, according to the U.S. Census Bureau, the U.S. geriatric population is expected to reach 77 million by 2034. 

Drug-device Combination Products Market Report Coverage

Report Coverage	Details
Base Year:	2019	Market Size in 2020:	Over US$ 123.5 Bn
Historical Data for:	2016 to 2019	Forecast Period:	2020 to 2027
Forecast Period 2020 to 2027 CAGR:	8.2%	2027 Value Projection:	Over US$ 214.0 Bn
Geographies covered:	North America: U.S. and Canada Latin America: Brazil, Argentina, Mexico, and Rest of Latin America Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific Middle East: GCC, Israel, and Rest of Middle East Africa: South Africa, North Africa, and Central Africa
Segments covered:	By Product Type: Drug Eluting Stents: Coronary Stent, Peripheral Vascular Stents. Infusion Pumps: Implantable, Ambulatory. Photosensitizers Orthopedic Combination Products Wound care Combination Products Inhalers: Dry Powder Inhaler, Nebulizers, Metered Dose Inhaler. Transdermal Patches Others By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies.
Companies covered:	Teva Pharmaceutical Industries Ltd., AbbVie Inc., Abbott Laboratories, Medtronic Plc., Kaleo, Inc., SINOMED, Becton, Dickinson and Company, Alcon Inc., Boston Scientific Corporation, Integer Holdings Corporation, Teleflex Incorporated, Bausch Health Companies Inc., Haselmeier GmbH, and Flowonix Medical, Inc.
Growth Drivers:	Increasing prevalence of chronic diseases Launch and approval of novel drug-device combination products
Restraints & Challenges:	Product recalls

Global Drug-device Combination Products Market – Restraints

Drug-device combination products increase the risk of infections, which is expected to hinder growth of the market. Although stent infection is rare, it is associated with high morbidity and mortality. Drug eluting stents (DES) are associated with higher infection risk than bare metal stent (BMS), owing to their antiproliferative effects.

Rising products recalls is expected to restrain the global drug-device combination products market growth during the forecast period. For instance, in September 2020, Perrigo Company plc, a developer of self-care products, recalled albuterol sulfate inhalers, manufactured by Catalent Pharma Solutions for Perrigo Pharmaceutical Company. Albuterol sulfate inhalation aerosol is indicated for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm. But, to date, Perrigo has received complaints that clogging of the inhaler is resulting in patients not receiving enough or any medicine.

Moreover, presence of stringent and non-specific regulatory pathway for approval of drug-device combination products is also expected to limit the market growth. There are separate regulatory approval pathways for pharmaceutical products and medical devices in the U.S. Investigational new drug (IND) application process is suited for pharmaceutical products, whereas medical devices fall under the investigational device exemption (IDE) pathway.

Global Drug-device Combination Products Market: Opportunities

Adoption of cloud-based data management software in combination products is expected to offer lucrative growth opportunities for players in the global drug-device combination products market. For instance, in January 2020, Medtronic plc launched Efficio, a cloud-based data management software for use with the SynchroMed II intrathecal drug delivery system, for effective management of targeted drug delivery pump.

Moreover, launch of generic combination products is also expected to aid in growth of the market. For instance, in August 2019, Teva Pharmaceutical Industries Ltd. launched generic version of Mylan’s EpiPen for young children.

Global Drug-device Combination Products Market – Regional Analysis

On the basis of region, the global drug-device combination products market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.

North America is expected to hold dominant position in the global drug-device combination products market during the forecast period, owing to rising approval and launch of new products in the region. For instance, in February 2020, Flowonix Medical, Inc. received the U.S. Food and Drug Administration approval for Prometra II Programmable Pump System for use with intrathecal baclofen. Prometra II Pump utilizes a pressure-driven, valve-gated delivery mechanism to deliver boluses of medication into the intrathecal space.

Europe is an emerging drug-device combination products market, owing to the rising prevalence of chronic diseases such as cardiovascular diseases and others. For instance, according to the British Heart Foundation (BHF), in 2018, around 7 million people were suffering from cardiovascular disease in the U.K., which was a total of 3.5 million men and 3.5 million women. BHF also stated that heart and circulatory disease account for 26% of all deaths in the U.K., which is over 150,000 deaths each year.

Figure 2: Global Drug-device Combination Products Market Value (US$ Bn), by Region, 2020

Global Drug-Device Combination Products Market: Key Developments

Major players in the market are focused on approval and launch of new products to expand their product portfolio. For instance, in February 2020, Flowonix Medical, Inc. received the U.S. Food and Drug Administration approval for its Prometra II Programmable Pump System for use with intrathecal baclofen. Prometra II Pump utilizes a pressure-driven, valve-gated delivery mechanism to deliver boluses of medication into the intrathecal space.

Major players in the market are focused on adopting partnership strategies to expand their product portfolio. For instance, in October 2019, Haselmeier, a manufacturer of self-injection devices, partnered with Stevanato Group, a producer of glass primary packaging based in Italy, for development, manufacturing, and supply of the axis-D pen-injector in the therapeutic area of diabetes care.

Global Drug-device Combination Products Market - Competitive Landscape

Some of the key players operating in the global drug-device combination products market include Teva Pharmaceutical Industries Ltd., AbbVie Inc., Abbott Laboratories, Medtronic Plc., Kaleo, Inc., SINOMED, Becton, Dickinson and Company, Alcon Inc., Boston Scientific Corporation, Integer Holdings Corporation, Teleflex Incorporated, Bausch Health Companies Inc., Haselmeier GmbH, and Flowonix Medical, Inc.