The global drug-device combination products market size was valued at USD 114.1 billion in 2021. It is projected to reach USD 213.32 billion by 2030, growing at a CAGR of 7.2% during the forecast period (2022-2030). Therapeutic and diagnostic products that combine drugs, gadgets, and biological products are known as combination products. Due to careful and precise drug targeting, local administration, and individualized therapy, combination products result in safer and more effective treatments. Patients with severe illnesses and conditions like cancer, heart disease, multiple sclerosis, and diabetes can significantly benefit from these technologies. Drug-device combinations have changed how medical product development, regulatory approval, and corporate engagement are completed. These innovations can be learned as new generations of combination products are created. The prevalence of chronic diseases and the burden of the global aging population are the main drivers propelling growth in the market.
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Rising Chronic Disease Rates and the Need for New Drug Delivery Systems
Due to their improved efficacy and reduced adverse effects, novel drug delivery systems (NDDS), such as controlled drug delivery systems, are used for various treatments. Therapeutic agents that are safer and more effective, with better drug delivery mechanisms, represent advancements in treating diseases and attractive marketing prospects for pharmaceutical businesses. These NDDS are considered the best drug delivery process since they administer a specific amount of medication to a particular region at the right time and pace, depending on the etiology and physiological requirements of the body. In order to treat and control several chronic conditions, including asthma, cardiovascular disease, diabetes, kidney problems, neurological disorders, etc., these delivery methods are the most often utilized drug delivery system.
Globally, the prevalence of many chronic diseases is increasing, which raises the demand for effective treatment dosage forms for these persistent illnesses. Conventional pharmaceutical dosage forms are typically not preferred in all of the aforementioned chronic conditions when therapy is long-term and drug doses are typically modest to avoid any side effects because they cannot control the pace of drug delivery to the target location. The medicine must be administered in traditional dosage forms at therapeutic levels that may be significantly higher than those needed in target cells due to the drug's dispersion in body fluids and non-target tissue.
Stringent Government Policies
One of the primary issues likely to limit market growth for medicine device combinations is the strict regulatory restrictions. The studied items take a while to reach the regulated market, which presents a significant challenge for small-scale competitors. Additionally, these are subject to strict regulatory oversight, which has increased the cost of compliance for manufacturers that want to conduct business in the relevant nations. A demand for R&D expenditure and an excess of capital are other factors that tiny market players cannot afford. For instance, the US Food and Drug Administration created the Office of Combination Products (OCP) on December 24, 2002, by Section 204 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
The agency component in charge of the biological product's premarket evaluation would have primary jurisdiction over the device-biological combination product if its PMOA were attributable to it. The OCP should receive an investigational application for the drug-device combination product, which should include information on the medication and device that is generally included in an IND application and an IDE application, respectively. These factors are expected to hinder market growth over the forecast period.
Rising Geriatric Population
The senior population is increasingly susceptible to numerous chronic diseases, necessitating effective and secure treatment choices for better health outcomes, which is the primary driver for the growth of the drug-device combination products market. Over several decades, many chronic diseases among the elderly have steadily risen. The population of adults above the age of 65 is steadily increasing. One in six persons worldwide will be over 65 by 2050, up from one in eleven in 2019, according to data from World Population Prospects.
According to statistics, life expectancy at birth has increased to 72.3 years globally, with women typically living five more years than men (74.7 years versus 69.9 years, respectively). Since the majority of the elderly population shows higher reliability with non-invasive treatments, the growing burden of the senior population is expected to increase the demand for targeted drug-delivery devices to treat chronic diseases effectively.
The global drug-device combination products market is segmented by products, applications, and end-user.
Based on products, the global drug device combination products market is bifurcated into drug-eluting stents, infusion pumps, inhalers, and others.
The inhalers segment is the highest contributor to the market and is expected to grow at a CAGR of 6.75% during the forecast period. In this inhaler drug delivery system, the patient inhales a mist or spray formulation of the medication. Inhalers are a convenient and accurate method for administering medication directly to the lungs. The two types are metered dose inhalers, commonly referred to as puffers, and dry powder inhalers. The prevalence of chronic respiratory disorders, including COPD and asthma, among others, is one of the main contributors to the growth of the inhaler market. Additionally, market participants are focused on introducing cutting-edge items into the market while implementing various growth tactics. A high-tech add-on is a pMDI inhaler that can be attached to asthma and COPD rescue medications. It records information about each drug use and the conditions surrounding it.
The drug-eluting stent is a metal, semi-rigid tube-shaped device coated in medication that is slowly released or eluted and aids in preventing cell multiplication. The development of the drug-eluting stent (DES) has led to the establishment of a new care standard. There are various drug-eluting stents, including first, second, and third-generation DESs (drug-eluting stents). One of the leading causes of the increased demand for drug-eluting stents is the rising incidence of cardiovascular disease. Key market participants concentrate on frequent product developments and approvals, significantly boosting market growth throughout the predicted period.
Transdermal patches are medicated adhesive patches used to apply a precise dosage of medication or drug to the skin. In order to deliver the drug dosage via the skin and into circulation over a longer time, these patches employ a diffusion method. The fundamental advantage of the patch is that it allows for a controlled release of the medication into the patient, usually through a porous membrane that covers a reservoir of medication or by body heat dissolving thin layers of the drug embedded in the adhesive. Due to their accessibility, affordability, and ease of use, transdermal patches are chosen. There are numerous uses for transdermal patches, including neurological and pain relief.
Based on application, the global drug device combination products market is bifurcated into cardiovascular, diabetes, cancer treatment, respiratory diseases, and other applications.
The respiratory diseases segment owns the highest market share and is expected to grow at a CAGR of 6.95% during the forecast period. According to the National Center for Health Statistics, 2020, in the United States, physician ambulatory-care visits for respiratory disorders were highest in people over 85. It was 57% lower in people between the ages of 75 and 84 and 85% lower in those between the ages of 65 and 74. This market is anticipated to expand considerably more throughout the projection periods as a result of the introduction of the novel coronavirus and the rapid spread of the disease. For instance, Purchase, a new portable and ready-to-use delivery solution created for upper respiratory care in 2018 was introduced by Aptar Pharma in the United States. It is used in conjunction with saline or other natural ingredient formulations to help relieve the symptoms of upper respiratory system conditions.
The most common type of disease proven to exist worldwide is cardiovascular disease, which is also one of the leading causes of death. In India, drug-eluting stents are used in roughly 95% of percutaneous coronary intervention (PCI) cases, according to Diagnostic and Interventional Cardiology, 2020. The demand for these stents increased in 2018 after the Indian National Pharmaceutical Pricing Authority (NPPA) lowered the cost of drug-eluting stents by roughly USD 33. The number of new products being released in the field is anticipated to increase along with the disease's increasing incidence on a global scale.
Based on end-user, the global drug device combination products market is bifurcated into hospitals, ambulatory surgical centers, and others.
The hospital segment is the highest contributor to the market and is expected to grow at a CAGR of 7.15% during the forecast period. Modern technical equipment is well-equipped in hospitals to provide better treatments. Due to the rising number of patients with chronic conditions, the hospital category is expanding quickly. Combination therapy, also known as medication device combination, is used in most medical fields where treatment is complex, such as chemotherapy, because of its benefits, low costs, and straightforward formats. Growing healthcare infrastructure in emerging economies and assistance from government agencies are also assisting in developing this market sector.
ASCs, or ambulatory surgery centers, are cutting-edge medical establishments that provide same-day surgical care, including diagnostic and preventive procedures. The Healthcare Advisory Board estimates that the volume of ASC procedures will likely increase by 27.6% by 2027. Predictions indicate that by the middle of the 2020s, almost 50% of all cardiovascular systems will be conducted in an ASC. Compared to hospital stays, ASC operations often have lower co-pays. In addition to making scheduling and facility access easier, ASC reduces patient wait times. A more reasonable price and a caring clinical staff combine to create an excellent patient-centric experience. Together with the rising use of combination therapies in ambulatory surgery centers, these elements accelerate the segment's rise.
The global drug device combination products industry is divided into four regions, namely North America, Europe, Asia-Pacific, and LAMEA.
North America Dominates the Global Market
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North America is the most significant shareholder in the global drug-device combination products market and is anticipated to grow at a CAGR of 6.75% over the forecast period. The market for medication device combination products is expected to be dominated by the United States over the forecast period due to the rising prevalence of chronic diseases and the growing elderly population. In 2020, there were anticipated to be 612,390 cancer-related fatalities in the United States and 2,281,658 newly diagnosed cases of the disease. Breast cancer, lung cancer, prostate cancer, colorectal cancer, bladder cancer, and skin cancer are the most prevalent malignancies in the US. The prevalence of other chronic diseases is also rising in the US and leading to heart disease, which places a heavy burden on individuals, communities, healthcare providers, and systems.
Europe is expected to grow at a CAGR of 6.80%, generating USD 50.65 billion during the forecast period. The nation also boasts a sizable number of businesses engaged in the healthcare industry. The number of TIA and stroke cases treated in German hospitals increased between 2011 and 2017, according to a 2019 study titled "Inpatient transient ischemic attack (TIA) and stroke care in adult patients in Germany -a retrospective analysis of countrywide administrative data sets of 2011 to 2017." It is anticipated that the extremely high rate of cancer-related deaths will increase demand for innovative drug and device combination products over the forecast period.
Asia-Pacific is expected to grow significantly over the forecast period. The increasing elderly population and the incidence of chronic diseases, together with the expanding research on cutting-edge technologies in the pharmaceutical sector, are the primary drivers of market expansion for medication device combination products in China. Metabolic disorders are also growing increasingly common in China due to increased rates of obesity and sedentary lifestyles. Metabolic disorders are among the most important contributors to obesity, diabetes, cardiovascular disease, and total mortality. Thus, the development of drug-device combination products has received considerable interest due to the increased prevalence of metabolic illnesses.
Saudi Arabia, Kuwait, Bahrain, Qatar, the United Arab Emirates, and Oman are the six nations that make up the GCC. The main drivers of the market examined in the GCC have been the rising elderly population and the rising prevalence of chronic disorders. In the United Arab Emirates, the elderly population is growing. For instance, according to information from the 2018 Dubai Health Investment Guide, it is predicted that by 2030, there will be 3% more people over 65 in the United Arab Emirates than there are today. Among other nations, the rest of the Middle East and Africa includes Israel, Egypt, Iran, Syria, Jordan, Lebanon, and Nigeria. The region's healthcare systems are stressed due to the increased prevalence of chronic diseases.
The global drug device combination products market's major key players are Abbott Laboratories, Medtronic Plc, Boston Scientific Corp., Becton, Dickinson and Company, Novartis AG, GlaxoSmithKline plc, AbbVie Inc. (Allergan), W. L. Gore & Associates Inc., Stryker Corporation, and Terumo Corporation.