Addressing the unmet need in respiratory viruses: an interdisciplinary analysis of product development pipeline in Asia

Jelle J. Feddema, Eric Claassen


Background: Respiratory tract infections (RTIs) pose a significant burden on health systems worldwide. Progress has been booked in reducing RTI disease burden through development of diagnostics, therapeutics and vaccines, though most efforts often fail to address the contribution of non-influenza viruses. Increasing awareness and the prevailing unmet need has resulted in the establishment of initiatives that aim to explore ways in which to extend innovation efforts for influenza to the broad range of respiratory viruses. This study will provide a detailed description of the state of the RTI market in Asia.

Methods: By developing a dataset containing data from patent documents and clinical trials (CTs) we aimed to provide a detailed description of the RTI market in Asia.

Results: We found a downward patent filing trend in respiratory diagnostics but a high number of phase 3 studies. A strong preference for the development of therapeutics and vaccines targeting bacterial pneumonia and influenza became apparent, whereas less attention is given towards product development targeting non-influenza viruses.

Conclusions: The findings indicate a mature respiratory diagnostics market with minor industrial interest but at the same time an evolving RTI CT market with a strong late-stage pipeline. Asia represents only a handful of studies related to non-influenza viruses, mostly conducted by non-profit organisations. The business segment appears to focus upon product development for more profitable respiratory infections thereby suggesting that involvement and engagement of the industry within global initiatives and efforts to increase innovation for non-influenza viruses is not optimal.


Respiratory tract infections, Non-influenza respiratory viruses, Respiratory diagnostics, Patents, Clinical trials

Full Text:



Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2095-128.

WHO. Ending Preventable Child Deaths from Pneumonia and Diarrhoea by 2025: The integrated Global Action PLan for PNeumonia and Diarrhoea. WHO and UNICEF; 2013.

Legand A, Briand S, Shindo N, Brooks WA, de Jong MD, Farrar J, et al. Addressing the public health burden of respiratory viruses: the Battle against Respiratory Viruses (BRaVe) Initiative. Future Virology. 2013;8(10):953-68.

Ruuskanen O, Lahti E, Jennings LC, Murdoch DR. Viral pneumonia. Lancet. 2011;377(9773):1264-75.

Cashat-Cruz M, Morales-Aguirre JJ, Mendoza-Azpiri M. Respiratory tract infections in children in developing countries. Semin Pediatr Infect Dis. 2005;16(2):84-92.

Tang JW, Lam TT, Zaraket H, Lipkin WI, Drews SJ, Hatchette TF, et al. Global epidemiology of non-influenza RNA respiratory viruses: data gaps and a growing need for surveillance. Lancet Infect Dis. 2017;17(10):e320-e6.

Yamada T, Yamada T, Morikawa M, Cho K, Endo T, Sato SS, et al. Pandemic (H1N1) 2009 in pregnant Japanese women in Hokkaido. J Obstet Gynaecol Res. 2012;38(1):130-6.

Sugaya N, Kohno S, Ishibashi T, Wajima T, Takahashi T. Efficacy, safety, and pharmacokinetics of intravenous peramivir in children with 2009 pandemic H1N1 influenza A virus infection. Antimicrob Agents Chemother. 2012;56(1):369-77.

Cottingham MD, Kalbaugh CA, Fisher JA. Tracking the pharmaceutical pipeline: clinical trials and global disease burden. Clin Transl Sci. 2014;7(4):297-9.

Dorsey ER, Thompson JP, Carrasco M, de Roulet J, Vitticore P, Nicholson S, et al. Financing of U.S. biomedical research and new drug approvals across therapeutic areas. PLoS One. 2009;4(9):e7015.

Perel P, Miranda JJ, Ortiz Z, Casas JP. Relation between the global burden of disease and randomized clinical trials conducted in Latin America published in the five leading medical journals. PLoS One. 2008;3(2):e1696.

Peeling RW, Mabey D. Point-of-care tests for diagnosing infections in the developing world. Clin Microbiol Infect. 2010;16(8):1062-9.

WHO. Battle against Respiratory Viruses (BRaVe) initiative: WHO; 2012.

Blaschke AJ, Hersh AL, Beekmann SE, Ince D, Polgreen PM, Hanson KE. Unmet diagnostic needs in infectious disease. Diagn Microbiol Infect Dis. 2015;81(1):57-9.

Ernst H. The Use of Patent Data for Technological Forecasting: The Diffusion of CNC-Technology in the Machine Tool Industry. Small Business Economics. 1997;9(4):361-81.

WHO. International Clinical Trials Registry Platform (ICTRP) 2018 Available at: http://apps. Accessed on 3 June 2018.

NIH. U.S. National Library of Medicine; 2018 Available at: https://www.clinical Accessed on 3 June 2018.

Weenen TCFK, Pronker ES, Commandeur H, Claassen E. Bridging a Pharma-Like Innovation Gap in Medical Nutrition. Pharma-Nutrition. 2013: 29-52.

McNamee LM, Ledley FD. Patterns of technological innovation in biotech. Nat Biotechnol. 2012;30(10):937-43.

Pronker ES, Weenen TC, Commandeur H, Claassen EH, Osterhaus AD. Risk in vaccine research and development quantified. PLoS One. 2013;8(3):e57755.

Suntharalingam G, Perry MR, Ward S, Brett SJ, Castello-Cortes A, Brunner MD, et al. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412. N Engl J Med. 2006;355(10):1018-28.

Louisa M, Takeuchi M, Setiabudy R, Nafrialdi, Takeuchi M. Current status of phase I clinical trials in Asia: an academic perspectives. Acta Med Indones. 2012;44(1):71-7.

Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360(8):816-23.

Zwierzyna M, Davies M, Hingorani AD, Hunter J. Clinical trial design and dissemination: comprehensive analysis of and PubMed data since 2005. BMJ. 2018;361:k2130.

Kresse H, Rovini H. Influenza vaccine market dynamics. Nat Rev Drug Discov. 2009;8(11):841-2.

Hamad B. The antibiotics market. Nat Rev Drug Discov. 2010;9(9):675-6.

Wang Y, Ji W, Chen Z, Yan YD, Shao X, Xu J. Comparison of severe pneumonia caused by Human metapneumovirus and respiratory syncytial virus in hospitalized children. Indian J Pathol Microbiol. 2014;57(3):413-7.

Garcia-Garcia ML, Calvo C, Casas I, Bracamonte T, Rellan A, Gozalo F, et al. Human metapneumovirus bronchiolitis in infancy is an important risk factor for asthma at age 5. Pediatric pulmonology. 2007;42(5):458-64.

IPRI. The International Property Rights Index 2017: IPRI; 2017 Available at: Accessed on 3 June 2018.

Hepeng J. IP litigation in China could drive innovation. Nature Biotechnol. 2004;22:368.

Xinjian L, Martin P. Strategy implications of business culture differences between Japan and China. Business Strategy Series. 2007;8(2):148-54.

Lee JK, Yathindranath S, Kureishi A, Singh S, Yeow S, Grace G, et al. Evolution of the clinical trial landscape in Asia Pacific. 2014: 75.

ASPE. Medidata Grants Manager, Cost Comparisons 2016: U.S. Department of Health & Human Services; 2016 Available AT: https://aspe. Accessed on 7 June 2018.

Sullivan F. Report: Asia: preferred destination for clinical trials. 2016.

Shih WJ. Clinical trials for drug registrations in Asian-Pacific countries: Proposal for a new paradigm from a statistical perspective. Control Clin Trials. 2001;22(4):357-66.

Saito K, Kodama Y, Ono S, Mutoh M, Kawashima S, Fujimura A. Current status of quality in Japanese clinical trials. Contemp Clin Trials. 2005;26(4):503-9.