The global artificial organ and bionics market size was valued at USD 33.78 billion in 2022. It is estimated to reach USD 75.82 billion by 2031, growing at a CAGR of 9.4% during the forecast period (2023–2031).
Artificial organs and bionic implants are externally worn or implantable engineered medical devices manufactured artificially. An artificial organ is a man-made device or tissue implanted or integrated into a person — interacting with living tissue — to substitute a natural organ, to replicate or augment a certain function or function so the patient can get back to their normal life as soon as feasible. The substituted function does not need to be connected to life support, though it sometimes is. For instance, artificial organs could also include replacement bones and joints, as used in hip replacements.
Bionics, often known as biologically inspired engineering, studies and creates engineering systems and contemporary technology using biological principles and natural systems. Implantable devices with mechanical and electrical components are known as bionic implants. They can be bifurcated into two categories: mechanical and electronics. They also use more advanced robotic technology. Biomaterials are man-made substances that interact with biological systems and are employed in artificial organs and bionic implants.
Factors contributing to the surge in the incidence of organ failure are serious trauma, sepsis, loss of blood, poisoning, drug abuse, leukemia, and other acute illnesses. Organ failure is associated with acute illnesses caused due to degradation or damage to the organs. Glomerular disease, diabetes, and hypertensive nephrosclerosis may result in kidney failure. Similarly, cirrhosis results in liver failure; likewise, coronary heart disease may result in heart failure.
Most of the time, unhealthy eating habits, lack of exercise, alcohol and drug abuse, and other activities like smoking contribute to conditions that ultimately result in organ failure. Therefore, the demand for artificial organs, mainly for bone marrow, heart, liver, kidney, and lung, is globally very high. In addition, the increase in the geriatric population and well-established healthcare facilities have also contributed to the high demand for artificial organs. Thus, a rise in acute illnesses and an increase in the geriatric population are factors expected to drive demand for organ transplantation, driving market growth.
Institutions known as tissue banks collect and preserve human cadaver tissues for use in medical research and teaching. There are instances where tissue banks have stored biomedical tissues under cryogenic conditions. With the demand for tissue transplantation, the need for tissue banks providing services like assessing donor suitability, processing, recovery, storage, labeling, and delivery of tissues has considerably increased. In addition, tissue banks primarily use low-temperature storage to maintain and store tissues in ideal conditions. The most commonly stored tissues that are harvested and stored are cornea, skin, bone joints, tendons, cartilage, and dura mater.
Increased burn injuries have resulted in high demand for tissue banks that retrieve skin and store it in aseptic conditions for donation. In addition, advances in technology and instruments, including centrifuge and cryopreservation systems, facilitate efficient tissue preservation. Computerized support systems with advanced hardware and software allow easy maintenance of tissues with high efficiency. The advancements in tissue banks have made it relatively simpler to store and retrieve organs, which is what is fueling the market's expansion.
According to the Living Kidney Donors Network, there were more than 90,000 kidney transplant recipients globally in 2017, and these numbers are estimated to grow in the future. Typically, organs are harvested from deceased patients that have suffered a brain injury or stroke. With an increase in unhealthy practices like smoking, alcohol consumption, and drug abuse, there is a significant decrease in the number of healthy patients suitable for organ donation. In addition, the unavailability of organ donors has resulted in an increased number of patients on transplant waiting lists. Lack of awareness about organ donation has also been a major factor limiting market growth.
Technological advancements in 3D bioprinting are boosting the adoption of artificial organs. The ongoing shortage of organ donors and an increasing number of patients waiting for organ transplants have increased the need for 3D bioprinting. These techniques create customized prosthetics, fabricate tissues, and support transplantation through synthetic models. However, the vascularization of larger tissue structures remains a challenge, and the development of a fully functional 3D-printed organ is anticipated in a few years.
The lack of organ preservation facilities also boosts the demand for artificial organs. Preservation of organs is of paramount importance during transplantation surgery. Change in donor demography directly impacts the outcome of procedures. In addition, organ preservation is a supply line for organ transplantation. The best method to use the preserved organ is based on the suppression of metabolism by hypothermia. Such advancements in organ transplantation create opportunities for market growth.
The global artificial organ and bionics market is segmented by product and technology.
Based on product, the global market is bifurcated into artificial organ and bionics.
The artificial organ segment dominates the global market and is projected to exhibit a CAGR of 8.7% over the forecast period. Rising healthcare expenditure and technological advancements in 3D printing boost demand for artificial organs. The artificial organ segment is divided into the artificial kidney, heart, liver, lungs, and pancreas. The artificial kidney segment dominated the market, which can be attributed to the increasing number of patients on the waiting list and the rising number of kidney transplantations. Patients with kidney illness typically receive renal transplantation as treatment. However, the shortage of kidney donors and the rise in disabling medical conditions drive the need for artificial kidneys.
Additionally, innovative technologies, like AI and ML, are progressively transforming medical procedures and are expected to offer great opportunities for dialysis therapies. The recent trend in developing computer-based artificial neural networks and genetic algorithms also boosts market growth. Biomaterial and micro 3D printing developments support the growth of regenerative medicine and bio-printed kidneys. However, bioprinting of kidneys is still in its infancy stage, and there is a high growth opportunity for 3D-printed kidneys soon.
The bionics segment growth is propelled by favorable reimbursement policies and fast-track FDA approval of implants. For instance, in November 2017, the FDA put the device on its expedited access pathway to facilitate faster entry of Orion's "bionic eye" into the commercial market. The device is a cortical visual prosthesis that uses a camera and a brain implant to bypass the optic nerve in visually impaired people. An increasing number of cochlear implants and exoskeletons, limb and brain replacements, and vision bionics are expected to drive market growth. The aging population and technological advancements in cochlear implants drive segment growth. Moreover, increasing FDA approval and a rising number of product launches are aiding growth. For instance, in June 2019, Cochlear Limited announced the U.S. FDA approval of the Nucleus profile plus implant and Nucleus Profile Plus Series.
Based on technology, the global market is segmented into mechanical and electronic.
The mechanical segment owns the highest market share and is estimated to exhibit a CAGR of 9.1% during the forecast period. The high market size of the mechanical segment can primarily be attributed to the surging prevalence of organ failure and the low price of mechanical instruments. Mechanical, artificial heart valves last much longer than the other options, creating demand for mechanical devices. Other factors contributing to the growth are speedy FDA approval and reimbursement policies. For instance, in March 2018, FDA approved Abbott's world's smallest mechanical heart valve. The device is made to treat infants and young children who require mitral and aortic heart valves.
The electronic segment is also expected to grow significantly over the forecast period. According to Bionics Queensland, approximately 1 billion people have a physical disability, and approximately 190 million adults have major functional difficulties. In many developing countries, the logistical and financial barriers are very high. The only option for disadvantaged people is to obtain prosthetics that can operate myoelectrical. These devices are battery and electronic systems and create nerve movement through sensors that can attach the device using suction technology. This electric sensory technology enables mobility in artificial limbs.
In addition, these devices use personalized computational neuromuscular skeletal models, which use machine learning, smart wearables, and element modeling to achieve mobility. Therefore, the increasing number of road accidents and the rising number of amputees and individuals born without limbs create demand for electronic bionics.
Based on region, the global artificial organ and bionics market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
North America is the most significant global artificial organ and bionics market shareholder and is estimated to exhibit a CAGR of 10.51% during the forecast period. North America accounted for the largest share of the market, owing to an increase in organ transplantation procedures and growth in the need for organ transplants due to the high incidence of organ failures. According to the Organ Procurement and Transplantation Network, 118,020 individuals required organ transplantation in the U.S. in 2017. The incidence of organ failure has also increased with a surging prevalence of chronic diseases like cancer, kidney diseases, and cardiac disorders. This has led to a high demand for artificial organs, further encouraging R&D.
In addition, the number of transplant centers has increased in the U.S. and Canada, creating a greater demand for artificial organs and bionics. According to the Transplant Observatory, 2,490 organ transplant procedures were performed in Canada, including 1,437 kidney transplants and 526 liver transplants. An increase in chronic kidney diseases in the region will likely boost the demand for artificial organs. Therefore, North America's market is expected to grow at a lucrative rate over the forecast period.
Asia-Pacific is estimated to exhibit a CAGR of 11.3% over the forecast period. The Asia-Pacific region comprises several emerging economies, such as Japan, China, and India. These countries have large populations with a high incidence of chronic diseases. An increase in chronic diseases that lead to organ failure is expected to fuel the demand for transplants in this region over the coming years. In addition, the countries are advancing technologically and offer various advanced surgical procedures, with booming medical tourism. The region's low cost of surgical procedures allows many foreign patients to visit for medical reasons. As a result, the expansion of the organ and bionics market in the region has been greatly influenced by the rise in medical tourism and the number of chronic diseases that cause organ failure.
Europe is expected to grow significantly over the forecast period. According to a report published by the NHS Blood and Transplant, 2018-2019, around 3,951 transplant procedures were performed in the U.K. The presence of many organ donors in Europe is boosting the organ support system in the region. In addition, advancements in transplantation technology and highly developed healthcare infrastructure in most European countries have driven the demand for artificial organs. Growing demand for artificial organs can be attributed to increased chronic diseases, including cancers, renal diseases, and COPD, which may lead to organ failures. Increasing healthcare expenditure and the strong local presence of key players further increase the region's demand.
The Latin American region consists of countries such as Brazil and Mexico. The regional market is expected to grow rapidly over the next few years, owing to the presence of emerging economies in the region. The quick expansion of the medical tourism industry has helped patients seek affordable medical care. The region's extensive network of private hospital chains is one of the primary draws for increasing tourists from other countries. According to the International Trade Administration, 70% of 6,400 hospitals were registered as private in 2016. This region is also expected to witness a rise in the incidence of chronic diseases, which can create a greater demand for organ donations, fueling the market.
The Middle East and Africa consist of countries such as South Africa and Saudi Arabia. Many surgical procedures are reported from this region because it is home to economically developed nations. Saudi Arabia's Center for Organ Transplantation has performed many organ transplants and donations. The center facilitates the process of organ donation between donor hospitals and transplant centers by managing the coordination and teams and assuring consent between organ donors and receivers. South Africa faces cultural and religious issues concerning organ donation. This obstructs the growth of the transplantation market in the country. According to the NCBI, most individuals are not willing to donate organs unless they are donating to close relatives. Thus, the market's growth is comparatively slow in the region; however, various nonprofit organizations, such as the Organ Donor Foundation, help raise awareness and facilitate organ donations in the country.
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