The Global Respiratory Care Devices Market is expected to grow from USD 25.375 billion in 2025 to USD 35.650 billion in 2030, at a CAGR of 7.04%.
The growing popularity of home healthcare is propelling the market demand in the forecast period. This is further supported by the growing geriatric population, which will bolster the market demand over the next five years. The prevalence of chronic obstructive pulmonary disease (COPD) is driving the market demand. Smoking is considered to be an underlying cause of the disease. The rising cases of premature births are further providing an impetus for the market to grow at a significant pace owing to the growing number of neonatal deaths due to respiratory diseases. With the growing demand for ventilators, at present, the market is projected to surge due to the growing number of cases of coronavirus patients at the global level.
The most advanced intelligent ventilation offerings are capable of automatically regulating ventilation and oxygenation in accordance with the goals specified by the doctors and the patient's physiologic inputs. Such inventions provide an opportunity for the market to grow at a significant pace generating high revenues due to their ease of operation.
Additionally, the high health expenditure is further augmenting the market growth in the forecast period. The Asia-Pacific region is said to be the fastest-growing region with a high prevalence of chronic diseases requiring assisted breathing. Also, Japan, in the APAC region, holds the highest number of elderly people in the world; this is further augmenting the market demand in the forecast period.
Neonatal respiratory diseases are common in premature births. These diseases are defined as breathing disorders affecting newborns. Newborns born before 32 weeks of pregnancy are commonly susceptible to respiratory disorders because of the fact that their lungs are not able to make sufficient surfactant, which is a foamy substance that helps in keeping the lungs in full expansion. The most common neonatal respiratory disease includes apnea of prematurity, bronchopulmonary dysplasia, and pneumonia, among others. According to WHO estimates, around 15 million babies are born before 37 weeks of gestation, and the number of preterm births is rising. The mortality rates due to premature birth complications (which include respiratory diseases as well) are also rising. In order to avoid maximum preterm deaths, it is essential to strengthen the medical facilities, create a need for the manufacturing of state-of-the-art respiratory care devices for neonates, and provide a huge market opportunity with high market demand in the forecast period.
Over 60% of premature births take place in the African and South Asian regions. It is noted that the prevalence of premature births is higher in low (12%) and middle-income countries in comparison to high-income countries, which is only 9% (source: WHO, 2018).
Chronic obstructive pulmonary disease (COPD), a group of diseases causing air-flow blockage and breathing problems, is quite prevalent worldwide. Currently, COPD has no cure, but it can be treated. As per WHO estimates, the global burden of disease study reported that COPD was prevalent in around 251 million individuals in 2016 at the global level. Around 3.5 million deaths were caused in 2015. It was also noted that the maximum (more than 90%) prevalence of deaths by COPD took place in low and middle-income countries. The major factors affecting individuals with COPD are active and passive smoking. Hence, with the presence of smoking at the international level, market growth is expected to fuel the growing number of affected individuals. Also, COPD is found to be prevalent among the geriatric population. Hence, with the increasing geriatric population in the world, the market is projected to surge at a rapid pace.
The pace of population ageing is much faster in comparison to the past. This has given rise to increasing healthcare costs required for the treatment of non-communicable age-associated diseases. Japan from the Asia-Pacific region has the maximum geriatric population worldwide, followed by Italy. Population ageing and growth at advanced stages, above 65 years of age, has further risen to concerns such as the pressure on health systems that need to adapt in order to meet the growing demands for care, services, and technologies for the prevention and treatment of age-associated chronic diseases. Thus, propelling the market’s growth during the forecast period. Other risk factors for COPD include indoor and outdoor pollution, as well as occupational dust and chemicals.
As per the procedure-related risks associated, medical devices are categorized into categories or classes of medical devices on the basis of the risks associated. All medical devices are required to pass through certain phases during their life. These steps include conception and development, manufacturing, packaging and labelling, and advertising, among others. These steps involve undergoing certain checkpoints, failing which would lead to the disqualification of the product. Additionally, misleading or fraudulent advertisements may tend to increase sales, but the buyer may experience a loss of money and reputation as it may harm the patient or the user. Therefore, strict regulations provide protection against such fraudulent cases, and this poses a threat to hampering the market’s growth due to the rejection of medical devices resulting in disqualification for further use.
In the case of high-risk devices, medical devices categorized under Class III, FDA has determined that the general and special controls alone are not sufficient to provide assurance that these Class III devices are safe. Hence, these devices are required to fill in a premarket approval application to obtain marketing approval. However, respiratory devices are classified under device class II and require FDA review through premarket notification 510 (k).
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