Research and Development (R&D) in the Pharmaceutical Sector
advances, limitations, selectivity, and neglect
DOI:
https://doi.org/10.5216/teri.v14i1.79594Palavras-chave:
Pharmaceutical Sector, Research and Development (R&D), Investments, Growth, LimitationsResumo
In order to contribute to the studies and debates on the Research and Development (R&D) process in the pharmaceutical sector, this paper conducted an extensive collection, organization, and analysis of data on the topic, exploring the advances, limitations, selectivity, and neglect in this area. It was revealed that the pharmaceutical sector is the second largest investor in R&D, with global expenditures of $238 billion in 2021. The pursuit of profits from successful drugs has driven significant growth in the number of pharmaceutical companies focused on R&D, resulting in 5,416 corporations testing over 20,000 drugs in various phases of research and development. However, this study also points to the limitations of products derived from pharmaceutical R&D, noting that many newly approved drugs do not present significant advantages over existing ones and tend to prioritize maintaining profitable franchises or market competition over population well-being. Furthermore, the selectivity and neglect in R&D investments are highlighted, with certain diseases receiving more attention due to a variety of interests, including socioeconomic aspects.
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ABBVIE - Annual Reports (2010 2022). North Chicago, Illinois, EUA: AbbVie, 2023. Available: https://investors.abbvie.com/annual-report-proxy. Accessed on: 23 dec. 2023.
ANGELL, Marcia. The Truth about the Drug Companies: how they deceive us and what to do about it. illustrated edition (2005). New York City, NY, United States: Random House Trade, 2005. 319 p.
ARONSON, Jeffrey K.; GREEN, A. Richard. Me‐too pharmaceutical products: history, definitions, examples, and relevance to drug shortages and essential medicines lists. British Journal of Clinical Pharmacology, [S.L.], v. 86, n. 11, p. 2114-2122, 13 may 2020. http://dx.doi.org/10.1111/bcp.14327.
BRANCH, Sarah K.; AGRANAT, Israel. “New Drug” Designations for New Therapeutic Entities: new active substance, new chemical entity, new biological entity, new molecular entity. Journal of Medicinal Chemistry, [S.L.], v. 57, n. 21, p. 8729-8765, 4 sep. 2014. http://dx.doi.org/10.1021/jm402001w.
CAMARGO JR., Kenneth Rochel de. O grande investimento da indústria farmacêutica nos últimos anos foi para disfunção erétil, não para malária. [Entrevista concedida a Raquel Júnia]. EPSJV/Fiocruz (Escola Politécnica de Saúde Joaquim Venâncio), [Online], nov. 2016. Available: https://www.epsjv.fiocruz.br/noticias/entrevista/o-grande-investimento-da-industria-farmaceutica-nos-ultimos-anos-foi-para. Accessed on: 25 mar. 2024.
CITELINE. Pharma Intelligence. Pharma R&D: annual review 2022. London (England): Pharma Intelligence, 2022. 55 p. Available: https://pharmaintelligence.informa.com/. Accessed on: 22 oct. 2023.
COHEN, Deborah. Cancer drugs: high price, uncertain value. Bmj, [S.L.], p. 1-4, 4 oct. 2017. http://dx.doi.org/10.1136/bmj.j4543.
DAVIS, Courtney et al. Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13. Bmj, [S.L.], p. 1-13, 4 oct. 2017. http://dx.doi.org/10.1136/bmj.j4530.
DIMASI, Joseph A. et al. Innovation in the pharmaceutical industry: new estimates of R&D costs. Journal of Health Economics, [S.L.], v. 47, p. 20-33, may. 2016. Elsevier BV. http://dx.doi.org/10.1016/j.jhealeco.2016.01.012.
EFPIA - The European Federation of Pharmaceutical Industries and Associations. The Pharmaceutical Industry in Figures. Belgium (Europe): EFPIA, 2022. 28 p. Available: https://www.efpia.eu/. Accessed on: 10 out. 2023.
FDA - Food and Drug Administration (FDA). The Drug Development Process. Federal agency of the Department of Health and Human Services (USA). Silver Spring, Maryland, U.S. 2018. Available: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process. Accessed on: 16 oct. 2023.
GLOY, Viktoria et al. The evidence base of US Food and Drug Administration approvals of novel cancer therapies from 2000 to 2020. International Journal of Cancer, [S.L.], v. 152, n. 12, p. 2474-2484, 24 feb. 2023. http://dx.doi.org/10.1002/ijc.34473.
GYAWALI, Bishal et al. Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval. Jama Internal Medicine, [S.L.], v. 179, n. 7, p. 906, 1 jul. 2019. http://dx.doi.org/10.1001/jamainternmed.2019.0462.
HILAL, Talal et al. Limitations in Clinical Trials Leading to Anticancer Drug Approvals by the US Food and Drug Administration. Jama Internal Medicine, [S.L.], v. 180, n. 8, p. 1108, 1 aug. 2020. http://dx.doi.org/10.1001/jamainternmed.2020.2250.
HOTEZ, Peter J et al. Rescuing the bottom billion through control of neglected tropical diseases. The Lancet, [S.L.], v. 373, n. 9674, p. 1570-1575, may. 2009. http://dx.doi.org/10.1016/s0140-6736(09)60233-6.
KESSELHEIM, Aaron S. et al. Determinants of Market Exclusivity for Prescription Drugs in the United States. Jama Internal Medicine, [S.L.], v. 177, n. 11, p. 1658, 1 nov. 2017. http://dx.doi.org/10.1001/jamainternmed.2017.4329.
KIM, Chul; PRASAD, Vinay. Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival. Jama Internal Medicine, [S.L.], v. 175, n. 12, p. 1992, 1 dec. 2015. http://dx.doi.org/10.1001/jamainternmed.2015.5868.
LIGHT, Donald. W.; LEXCHIN, Joel. R. Pharmaceutical research and development: what do we get for all that money?. Bmj, [S.L.], v. 345, n. 071, p. 1-5, 7 aug. 2012. http://dx.doi.org/10.1136/bmj.e4348.
MALERBA, Franco; ORSENIGO, Luigi. The evolution of the pharmaceutical industry. Business History, [S.L.], v. 57, n. 5, p. 664-687, 3 jun. 2015. http://dx.doi.org/10.1080/00076791.2014.975119.
MORGAN, Steven G et al. “Breakthrough” drugs and growth in expenditure on prescription drugs in Canada. Bmj, [S.L.], v. 331, n. 7520, p. 815-816, 2 sep. 2005. http://dx.doi.org/10.1136/bmj.38582.703866.ae.
NACI, Huseyin et al. Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis. Bmj, [S.L.], p. 1-17, 18 sep. 2019. http://dx.doi.org/10.1136/bmj.l5221.
PEDRIQUE, Belen et al. The drug and vaccine landscape for neglected diseases (2000–11): a systematic assessment. The Lancet Global Health, [S.L.], v. 1, n. 6, p. 371-379, dec. 2013. http://dx.doi.org/10.1016/s2214-109x(13)70078-0.
PRASAD, Vinay et al. The high price of anticancer drugs: origins, implications, barriers, solutions. Nature Reviews Clinical Oncology, [S.L.], v. 14, n. 6, p. 381-390, 14 mar. 2017. http://dx.doi.org/10.1038/nrclinonc.2017.31.
RAJKUMAR, S. Vincent. The high cost of prescription drugs: causes and solutions. Blood Cancer Journal, [S.L.], v. 10, n. 6, p. 1-5, 23 jun. 2020. http://dx.doi.org/10.1038/s41408-020-0338-x.
SOMO - investigates multinationals. Public health over pharmaceutical profit. 2024. Available: https://www.somo.nl/our-work/sectors/pharmaceutical-industry/. Accessed on: 25 mar. 2024.
STACCIARINI, João Henrique Santana. Drug advertising in Brazil. Sociedade & Natureza, [S.L.], v. 36, n.1, p. e72114, 2024b. http://dx.doi.org/10.14393/sn-v36-2024-72114x.
STACCIARINI, João Henrique Santana. (article in press). O Setor Farmacêutico Global: Números e Dinâmicas. Caminhos de Geografia, [S.L.], 2024a. PPUFU - Portal de Periódicos da Universidade Federal de Uberlândia.
STACCIARINI, João Henrique Santana. The Consolidation of the Pharmaceutical Sector in the Global Economy: growth, influence, deviations, and marketing. 2023. 145 p. PhD Thesis - Geography, Universidade Federal de Goiás, Goiânia (Brazil), 2023. https://doi.org/10.5281/zenodo.10377840.
STATISTA - Insights and facts across 170 industries and 150 countries. Research and development worldwide: Statistics & Facts. Hamburg, Germany. 2022a. Available: https://www.statista.com/topics/6737/research-and-development-worldwide/. Accessed on: 28 oct. 2023.
STATISTA - Insights and facts across 170 industries and 150 countries. Total global spending on pharmaceutical research and development from 2014 to 2028. Hamburg, Germany. 2022b. Available: https://www.statista.com/statistics/309466/global-r-and-d-expenditure-for-pharmaceuticals/. Accessed on: 29 out. 2023.
STATISTA - Insights and facts across 170 industries and 150 countries. Percentage of global research and development spending in 2021, by industry. Hamburg, Germany. 2023. Disponível em: https://www.statista.com/statistics/270233/percentage-of-global-rundd-spending-by-industry/. Acesso em: 29 out. 2023.
TROUILLER, Patrice et al. Drug development for neglected diseases: a deficient market and a public-health policy failure. The Lancet, [S.L.], v. 359, n. 9324, p. 2188-2194, jun. 2002. http://dx.doi.org/10.1016/s0140-6736(02)09096-7.
VAN LUIJN, Johan C. F. et al. Superior efficacy of new medicines? European Journal Of Clinical Pharmacology, [S.L.], v. 66, n. 5, p. 445-448, 12 mar. 2010. http://dx.doi.org/10.1007/s00228-010-0808-3.
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