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Copyright © 2014 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.
Editorial
Are Artificial Organs Still Needed? We live in very exciting times, particularly from a medical-care perspective. Innovation abounds, and technologies are being advanced and perfected. New diagnostics promise to detect diseases early and allow them to be treated before they reach end stage. Health care is becoming more widely available and, in some cases, less costly. Information exchange is widespread, and in many cases, patients are playing a greater role in their own care. This is good. Not a day goes by without the media touting a new technology or advancement in organ treatment. We recognize, however, that new knowledge is usually not directly translated to the bedside. Clinical trials, manufacturing developments, business investments, regulatory approvals, reimbursement considerations, and other factors temper and delay the delivery to the patient. To answer the question: Are artificial organs still needed? YES! Let us take a look at the numbers of patients receiving or on the waiting list for solid organ transplants in the USA (Table 1). Over the years from 2003 to 2013, the total number of all organ transplants has not grown that dramatically (i.e., it has increased by only 12%). A significant number of candidates die while waiting despite the support of artificial organ technologies such as ventricular assist, extracorporeal life support, dialysis, and insulin control. The kidney continues as the dominant organ of transplant, but the need continues to rise and outpaces the number of transplants. Over the past couple of years, the number of kidney transplants has declined despite the higher demand; pancreas transplants, alone or with a kidney, have declined in parallel with the number of candidates listed; and liver and lung transplants have also declined (1). The general shortage of organs continues. While efforts are being made to improve the preservation and quality of available organs, this alone is not sufficient. The discard rate for kidneys is the highest of all organs, at about 18% for the past several years (2). The number of patients on dialysis in the USA is now over 600 000 (3), of whom about 95%
doi:10.1111/aor.12419
receive hemodialysis and about 5% receive peritoneal dialysis. Over 6500 patients have been put on mechanical circulatory support devices (various cardiac support pumps) from June 2006 to June 2012 (4). While the application of cardiac assist devices has grown significantly in the past decade, significant opportunities remain. In another estimate, it was reported that more than 2% of Americans have an artificial joint, and roughly 7 million people in the USA are living with a total hip or knee replacement. More than 600 000 knees and 400 000 hips are replaced each year, at an average cost of about $20 000 each (5). There is growing excitement in the area of tissue engineering. 3-D printing of organs is an active area of development. While the more immediate applications appear to be limited to noncellular constructs, investigators continue to make progress with functioning organs such as the kidney and liver. Still, the development of a functioning organ for clinical implant appears decades away considering the status of the technology, the expense, and regulatory considerations, to mention a few. Tissue engineering technologies and stem cell therapies hold promise, but much effort is still needed, in particular to ensure safety and show efficacy in clinically controlled trials for regulatory clearance. With more of the world’s population living longer, the needs are rising. A New York Times report (6) noted that there has been a sharp decline in deaths from malnutrition and infectious diseases like measles and tuberculosis, which has caused a shift in the global mortality patterns over the past 20 years— far more of the world’s population is now living into old age and dying from diseases more associated with rich countries, like cancer, heart disease, stroke, and diabetes. As the needs rise, so must the development efforts and the quality of the technology, not only for the solid organs noted but also for other cardiac assist devices, orthopedic devices, neuroprostheses and neurological support, urological support, visual support, blood cell and tissue replacements, and therapeutic technologies for treating various autoimmune and metabolic disorders. As artificial organ technologies are relatively expensive, the focus Artificial Organs 2014, 38(10):827–828
828
EDITORIAL TABLE 1. US organ transplants 2003–2013 Transplants performed
All Kidney Liver Pancreas Kidney/pancreas Heart Lung Heart/lung Intestine
Died on the waiting list
2003
2013
Percentage change, 2003–2013
2003
2013
Percentage change, 2003–2013
Current waiting list*
25 473 15 138 5 673 504 871 2 057 1 085 29 112
28 954 16 895 6 455 256 762 2 531 1 923 23 108
12.0 6.9 12.1 −49.2 −12.5 18.7 43.6 −20.7 −3.6
6740 3895 1858 47 210 536 472 16 46
6293 4435 1496 47 135 326 173 7 19
−6.6 12.2 −19.5 0 −35.7 −39.2 −63.4 −56.3 −58.7
123 118 101 076 15 784 1 192 2 058 4 012 1 613 53 266
*Based on Organ Procurement and Transplantation Network data as of July 25, 2014.
should be on their role in enhancing the patient’s quality of life and minimizing the overall costs of health care. They should be considered not only for end-stage diseases but also for supportive and therapeutic purposes. Many analyses of the artificial organ markets have been made; in general, the markets are very large, but typically the analyses are limited to the support or replacement of some solid organs. The market drivers continue to be the lack and limitations of organs for transplantation and the aging population. The overall global medical device market, of which artificial organ technologies form a major component, was noted to be $322 billion in 2011 and is expected to grow to $415 billion in 2016 (7), with the USA as the largest market at $142 billion in sales (56% of the total), and European sales accounting for about 29% of the global market. Another market report (8) notes that the global market for artificial organs and medical bionics is expected to reach $32.3 billion in 2018, but like most market reports on artificial organ technologies, it limits the scope of coverage. A report from PricewaterhouseCoopers places the global medical device market at about $350 billion, with the US market accounting for about 40%. As the markets open further in the developing world, the impact will also grow. In a report from Transparency Market Research (9), the US implantable medical device market is predicted to grow by an annual compounded rate of 8% over the next few years to be worth $73.9 billion by 2018, up from $43.1 billion in 2011. The population is aging, people are living longer, and the markets are large and growing. We encourage the development of cost-effective artificial organ technologies and look forward to following this progress in the pages of Artificial Organs.
Artif Organs, Vol. 38, No. 10, 2014
Paul S. Malchesky, DEng Editor-in-Chief 10 W. Erie St. #200 Painesville, OH 44077, USA E-mail: [email protected] REFERENCES 1. Organ Procurement and Transplantation Network. National Data, 2003–2013. Available at: http://optn.transplant.hrsa.gov. Accessed August 4, 2014. 2. Organ Procurement and Transplantation Network. OPTN/ SRTR 2012 Annual Data Report. Available at: http://optn .transplant.hrsa.gov/data/annualReport.asp. Accessed August 4, 2014. 3. United States Renal Data System. 2013 Annual Report. Available at: http://www.usrds.org/adr.aspx. Accessed August 4, 2014. 4. Kirklin JK, Naftel DC, Kormos RL, et al. Fifth INTERMACS annual report: risk factor analysis from more than 6,000 mechanical circulatory support patients. J Heart Lung Transplant 2013;32:141–56. 5. Marchione M. Two percent of Americans have new hips and knees. Medical Design Technology, March 12, 2014. Available at: http://www.mdtmag.com/print/news/2014/03/two-percent -americans-have-new-hips-knees. Accessed August 4, 2014. 6. Tavernise S. Life expectancy rises around the world, study finds. The New York Times, December 13, 2012. Available at: http://www.nytimes.com/2012/12/14/health/worlds-population -living-longer-new-report-suggests.html. Accessed August 4, 2014. 7. Leonard S. Despite challenges ahead, global medical device market to reach $415 billion in 2016. Med Tech Pulse Blog, May 16, 2012. Available at: http://www.qmed.com/mpmn/ medtechpulse/despite-challenges-ahead-global-medicaldevice-market-reach-415-billion-2016. Accessed August 4, 2014. 8. Research and Markets. Artificial Vital Organs and Medical Bionics Market—Global Industry Analysis, Size, Share, Growth, Trends. Available at: http://www.researchandmarkets .com/research/89jj9c/artificial_vital. Accessed August 4, 2014. 9. Parmar A. U.S. implantable medical devices market will grow 8 percent to $73.9 billion by 2018. Med City News, January 23, 2013. Available at: http://medcitynews.com/2013/01/ u-s-implantable-medical-devices-market-will-grow-8-percent -to-73-9-billion-by-2018/. Accessed August 4, 2014.
Copyright © 2014 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.
Editorial
Are Artificial Organs Still Needed? We live in very exciting times, particularly from a medical-care perspective. Innovation abounds, and technologies are being advanced and perfected. New diagnostics promise to detect diseases early and allow them to be treated before they reach end stage. Health care is becoming more widely available and, in some cases, less costly. Information exchange is widespread, and in many cases, patients are playing a greater role in their own care. This is good. Not a day goes by without the media touting a new technology or advancement in organ treatment. We recognize, however, that new knowledge is usually not directly translated to the bedside. Clinical trials, manufacturing developments, business investments, regulatory approvals, reimbursement considerations, and other factors temper and delay the delivery to the patient. To answer the question: Are artificial organs still needed? YES! Let us take a look at the numbers of patients receiving or on the waiting list for solid organ transplants in the USA (Table 1). Over the years from 2003 to 2013, the total number of all organ transplants has not grown that dramatically (i.e., it has increased by only 12%). A significant number of candidates die while waiting despite the support of artificial organ technologies such as ventricular assist, extracorporeal life support, dialysis, and insulin control. The kidney continues as the dominant organ of transplant, but the need continues to rise and outpaces the number of transplants. Over the past couple of years, the number of kidney transplants has declined despite the higher demand; pancreas transplants, alone or with a kidney, have declined in parallel with the number of candidates listed; and liver and lung transplants have also declined (1). The general shortage of organs continues. While efforts are being made to improve the preservation and quality of available organs, this alone is not sufficient. The discard rate for kidneys is the highest of all organs, at about 18% for the past several years (2). The number of patients on dialysis in the USA is now over 600 000 (3), of whom about 95%
doi:10.1111/aor.12419
receive hemodialysis and about 5% receive peritoneal dialysis. Over 6500 patients have been put on mechanical circulatory support devices (various cardiac support pumps) from June 2006 to June 2012 (4). While the application of cardiac assist devices has grown significantly in the past decade, significant opportunities remain. In another estimate, it was reported that more than 2% of Americans have an artificial joint, and roughly 7 million people in the USA are living with a total hip or knee replacement. More than 600 000 knees and 400 000 hips are replaced each year, at an average cost of about $20 000 each (5). There is growing excitement in the area of tissue engineering. 3-D printing of organs is an active area of development. While the more immediate applications appear to be limited to noncellular constructs, investigators continue to make progress with functioning organs such as the kidney and liver. Still, the development of a functioning organ for clinical implant appears decades away considering the status of the technology, the expense, and regulatory considerations, to mention a few. Tissue engineering technologies and stem cell therapies hold promise, but much effort is still needed, in particular to ensure safety and show efficacy in clinically controlled trials for regulatory clearance. With more of the world’s population living longer, the needs are rising. A New York Times report (6) noted that there has been a sharp decline in deaths from malnutrition and infectious diseases like measles and tuberculosis, which has caused a shift in the global mortality patterns over the past 20 years— far more of the world’s population is now living into old age and dying from diseases more associated with rich countries, like cancer, heart disease, stroke, and diabetes. As the needs rise, so must the development efforts and the quality of the technology, not only for the solid organs noted but also for other cardiac assist devices, orthopedic devices, neuroprostheses and neurological support, urological support, visual support, blood cell and tissue replacements, and therapeutic technologies for treating various autoimmune and metabolic disorders. As artificial organ technologies are relatively expensive, the focus Artificial Organs 2014, 38(10):827–828
828
EDITORIAL TABLE 1. US organ transplants 2003–2013 Transplants performed
All Kidney Liver Pancreas Kidney/pancreas Heart Lung Heart/lung Intestine
Died on the waiting list
2003
2013
Percentage change, 2003–2013
2003
2013
Percentage change, 2003–2013
Current waiting list*
25 473 15 138 5 673 504 871 2 057 1 085 29 112
28 954 16 895 6 455 256 762 2 531 1 923 23 108
12.0 6.9 12.1 −49.2 −12.5 18.7 43.6 −20.7 −3.6
6740 3895 1858 47 210 536 472 16 46
6293 4435 1496 47 135 326 173 7 19
−6.6 12.2 −19.5 0 −35.7 −39.2 −63.4 −56.3 −58.7
123 118 101 076 15 784 1 192 2 058 4 012 1 613 53 266
*Based on Organ Procurement and Transplantation Network data as of July 25, 2014.
should be on their role in enhancing the patient’s quality of life and minimizing the overall costs of health care. They should be considered not only for end-stage diseases but also for supportive and therapeutic purposes. Many analyses of the artificial organ markets have been made; in general, the markets are very large, but typically the analyses are limited to the support or replacement of some solid organs. The market drivers continue to be the lack and limitations of organs for transplantation and the aging population. The overall global medical device market, of which artificial organ technologies form a major component, was noted to be $322 billion in 2011 and is expected to grow to $415 billion in 2016 (7), with the USA as the largest market at $142 billion in sales (56% of the total), and European sales accounting for about 29% of the global market. Another market report (8) notes that the global market for artificial organs and medical bionics is expected to reach $32.3 billion in 2018, but like most market reports on artificial organ technologies, it limits the scope of coverage. A report from PricewaterhouseCoopers places the global medical device market at about $350 billion, with the US market accounting for about 40%. As the markets open further in the developing world, the impact will also grow. In a report from Transparency Market Research (9), the US implantable medical device market is predicted to grow by an annual compounded rate of 8% over the next few years to be worth $73.9 billion by 2018, up from $43.1 billion in 2011. The population is aging, people are living longer, and the markets are large and growing. We encourage the development of cost-effective artificial organ technologies and look forward to following this progress in the pages of Artificial Organs.
Artif Organs, Vol. 38, No. 10, 2014
Paul S. Malchesky, DEng Editor-in-Chief 10 W. Erie St. #200 Painesville, OH 44077, USA E-mail: [email protected] REFERENCES 1. Organ Procurement and Transplantation Network. National Data, 2003–2013. Available at: http://optn.transplant.hrsa.gov. Accessed August 4, 2014. 2. Organ Procurement and Transplantation Network. OPTN/ SRTR 2012 Annual Data Report. Available at: http://optn .transplant.hrsa.gov/data/annualReport.asp. Accessed August 4, 2014. 3. United States Renal Data System. 2013 Annual Report. Available at: http://www.usrds.org/adr.aspx. Accessed August 4, 2014. 4. Kirklin JK, Naftel DC, Kormos RL, et al. Fifth INTERMACS annual report: risk factor analysis from more than 6,000 mechanical circulatory support patients. J Heart Lung Transplant 2013;32:141–56. 5. Marchione M. Two percent of Americans have new hips and knees. Medical Design Technology, March 12, 2014. Available at: http://www.mdtmag.com/print/news/2014/03/two-percent -americans-have-new-hips-knees. Accessed August 4, 2014. 6. Tavernise S. Life expectancy rises around the world, study finds. The New York Times, December 13, 2012. Available at: http://www.nytimes.com/2012/12/14/health/worlds-population -living-longer-new-report-suggests.html. Accessed August 4, 2014. 7. Leonard S. Despite challenges ahead, global medical device market to reach $415 billion in 2016. Med Tech Pulse Blog, May 16, 2012. Available at: http://www.qmed.com/mpmn/ medtechpulse/despite-challenges-ahead-global-medicaldevice-market-reach-415-billion-2016. Accessed August 4, 2014. 8. Research and Markets. Artificial Vital Organs and Medical Bionics Market—Global Industry Analysis, Size, Share, Growth, Trends. Available at: http://www.researchandmarkets .com/research/89jj9c/artificial_vital. Accessed August 4, 2014. 9. Parmar A. U.S. implantable medical devices market will grow 8 percent to $73.9 billion by 2018. Med City News, January 23, 2013. Available at: http://medcitynews.com/2013/01/ u-s-implantable-medical-devices-market-will-grow-8-percent -to-73-9-billion-by-2018/. Accessed August 4, 2014.
