Biomarkers are quantifiable components in the body or its byproducts that can be used to evaluate human health or pathogen development. This review aimed to explore and evaluate the utilization, challenges, and prospects of biomarkers in enhancing drug development in Africa. We searched for relevant articles in online databases, such as PubMed, Science Direct, and Google Scholar, covering the period from 2013 to 2024. The use of biomarkers can be traced back to the 1800s when they were initially referred to as surrogate markers and later as surrogate endpoints. Biomarkers are specific molecules or cells in the body that serve as indicators of underlying biological processes, aiding in disease diagnosis or measuring pharmacological responses to therapy. Diagnostic biomarkers are biomolecules that indicate the presence of diseases or help identify specific disease subtypes in individuals. Examples of biomarkers for common diseases, such as malaria, include Plasmodium falciparum lactate dehydrogenase, histidine-rich protein 2, and hemozoins; for colorectal cancer, biomarkers include Rat Sarcoma, microsatellite instability, human epidermal growth factor receptor 2, consensus molecular subtypes, and Circulating tumor DNA/Circulating tumor cells. These biomarkers guide targeted therapy and adjuvant chemotherapy approaches by allowing for patient stratification and determining which patients would benefit from adjuvant treatment. Overcoming challenges such as cost-effectiveness and regulatory approval is crucial. Despite initial financial and logistical constraints, these efforts will ultimately result in significant improvements in efficiency.

1. Aryutova K, Stoyanov DS, Kandilarova S, Todeva-Radneva A, Kostianev SS. Clinical use of neurophysiological biomarkers and self-assessment scales to predict and monitor treatment response for psychotic and affective disorders. Curr Pharm Des. 2021;27(39):4039-4048. doi: 10.2174/1381612827666210406151447

2. Ahmad A, Imran M, Ahsan H. Biomarkers as biomedical bioindicators: Approaches and techniques for the detection, analysis, and validation of novel biomarkers of diseases. Pharmaceutics. 2023;15(6):1630.doi: 10.3390/pharmaceutics15061630

3. Azizi M, Kokabi H, Dianat-Moghadam H, Mehrmohammadi M. Challenges and future directions. In: Targeted Cancer Imaging. Netherlands: Elsevier; 2022. p. 139-201. doi: 10.1016/B978-0-12-824513-2.00006-1

4. Agarwal S, Fang L, McGowen K, et al. Tumor-derived biomarkers beyond antigen expression enhance efficacy of CD276/B7H3 antibody-drug conjugate in metastatic prostate cancer. Cancer Biol. 2022. doi: 10.1101/2022.04.19.488784

5. Nagakura Y, Tozaki-Saitoh H, Takeda H. Drug discovery and development for fibromyalgia using practical biomarkers throughout the process from relevant animal models to patients. Expert Opin Drug Discov. 2023;18(5):539-549. doi: 10.1080/17460441.2023.2202908

6. Kumar RR, Kumar A, Chuang CH, Shaikh MO. Recent advances and emerging trends in cancer biomarker detection technologies. Ind Eng Chem Res. 2023;62(14):5691-5713. doi: 10.1021/acs.iecr.2c04097

7. Sahin TK, Rizzo A, Aksoy S, Guven DC. Prognostic significance of the royal marsden hospital (RMH) score in patients with cancer: A systematic review and meta-analysis. Cancers (Basel). 2024;16(10):1835. doi: 10.3390/cancers16101835

8. Moore DC, Guinigundo AS. Revolutionizing cancer treatment: Harnessing the power of biomarkers to improve patient outcomes. J Adv Pract Oncol. 2023;14(Suppl 1):4-8. doi: 10.6004/jadpro.2023.14.3.15

9. Al-Dewik NI, Younes SN, Essa MM, Pathak S, Qoronfleh MW. Making biomarkers relevant to healthcare innovation and precision medicine. Processes. 2022;10(6):1107. doi: 10.3390/pr10061107

10. Waeni JM, Chege T, Gicheru ET, et al. Discovery and validation of plasma-based protein biomarkers for the aetiological distinction of bacterial and non-bacterial febrile infections in African children. medRxiv. 2024:2024-01. doi: 10.1101/2024.01.10.24300882

11. Guven DC, Erul E, Kaygusuz Y, et al. Immune checkpoint inhibitor-related hearing loss: A systematic review and analysis of individual patient data. Support Care Cancer. 2023;31(11):624. doi: 10.1007/s00520-023-08083-w

12. Califf RM. Biomarker definitions and their applications. Exp Biol Med (Maywood). 2018;243(3):213-221. doi: 10.1177/1535370217750088

13. Dhingra R, Vasan RS. Biomarkers in cardiovascular disease: Statistical assessment and section on key novel heart failure biomarkers. Trends Cardiovasc Med. 2017;27(2):123-133. doi: 10.1016/j.tcm.2016.07.005

14. Yang J, Nie J, Ma X, Wei Y, Peng Y, Wei X. Targeting PI3K in cancer: Mechanisms and advances in clinical trials. Mol Cancer. 2019;18(1):26. doi: 10.1186/s12943-019-0954-x

15. FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource. Silver Spring (MD): Food and Drug Administration (US); 2016. Available from: https://www.ncbi.nlm.nih.gov/books/NBK326791 [Last accessed on 2024 Nov 05].

16. Chiu FY, Yen Y. Imaging biomarkers for clinical applications in neuro-oncology: Current status and future perspectives. Biomark Res. 2023;11(1):35. doi: 10.1186/s40364-023-00476-7

17. Bodaghi A, Fattahi N, Ramazani A. Biomarkers: Promising and valuable tools towards diagnosis, prognosis and treatment of Covid-19 and other diseases. Heliyon. 2023;9(2):e13323. doi: 10.1016/j.heliyon.2023.e13323

18. Badianyama M, Mpanya D, Adamu U, Sigauke F, Nel S, Tsabedze N. New biomarkers and their potential role in heart failure treatment optimisation-an African perspective. J Cardiovasc Dev Dis. 2022;9(10):335. doi: 10.3390/jcdd9100335

19. Drugan T, Leucuța D. Evaluating novel biomarkers for personalized medicine. Diagnostics (Basel). 2024;14(6):587. doi: 10.3390/diagnostics14060587

20. Islam SU, Ahmed MB, Ahsan H, Lee YS. Role of biomarkers in personalized medicine. In: Shehzad A, editors. Cancer Biomarkers in Diagnosis and Therapeutics. Berlin: Springer, Singapore; 2022. doi: 10.1007/978-981-16-5759-7_10

21. Francesqui J, Marrades P, Sellares J. Personalized medicine in sarcoidosis: Unravelling biomarkers for targeted care. Curr Opin Pulm Med. 2023;29(5):478-484. doi: 10.1097/MCP.0000000000000985

22. Olichney J, Xia J, Church KJ, Moebius HJ. Predictive power of cognitive biomarkers in neurodegenerative disease drug development: Utility of the P300 event-related potential. Neural Plast. 2022;2022:2104880. doi: 10.1155/2022/2104880

23. Sancandi M, Uysal-Onganer P, Kraev I, Mercer A, Lange S. Protein deimination signatures in plasma and plasma- EVs and protein deimination in the brain vasculature in a rat model of pre-motor Parkinson’s disease. Int J Mol Sci. 2020;21(8):2743. doi: 10.3390/ijms21082743

24. Landeck L, Kneip C, Reischl J, Asadullah K. Biomarkers and personalized medicine: Current status and further perspectives with special focus on dermatology. Exp Dermatol. 2016;25(5):333-339. doi: 10.1111/exd.12948

25. Liquid Biomarkers in Melanoma: Detection and Discovery - Scientific Figure on ResearchGate. Available from: https://www.researchgate.net/figure/advantages-and-disadvantages-of-current-technologies-in-biomarker-discovery_tbl3_322565124 [Last accessed on 25 Jun 2024].

26. Kim SH, Weiß C, Hoffmann U, Borggrefe M, Akin I, Behnes M. Advantages and limitations of current biomarker research: From experimental research to clinical application. Curr Pharm Biotechnol. 2017;18(6):445-455. doi: 10.2174/1389201018666170601091205

27. Mayeux R. Biomarkers: Potential uses and limitations. NeuroRx. 2004;1(2):182-188. doi: 10.1602/neurorx.1.2.182

28. Aronson JK. When I use a word. Too much healthcare- Biomarkers. BMJ. 2022;379:o2533. doi: 10.1136/bmj.o2533

29. Goodsaid F. Challenges of biomarkers in drug discovery and development. Expert Opin Drug Discov. 2012;7(6):457-461. doi: 10.1517/17460441.2012.679615

30. Kim B, Kang SY, Kim KM. DNA-protein biomarkers for immunotherapy in the era of precision oncology. J Pathol Transl Med. 2021;55(1):26-32. doi: 10.4132/jptm.2020.09.23

31. Ke X, Xiong X, Lin Y, Zhang H. Chimeric RNA and exosomes-based liquid biopsy. Methods Mol Biol. 2020;2079:211-218. doi: 10.1007/978-1-4939-9904-0_16

32. Hosseini K, Ranjbar M, Pirpour Tazehkand A, et al. Evaluation of exosomal non-coding RNAs in cancer using high-throughput sequencing. J Transl Med. 2022;20(1):30. doi: 10.1186/s12967-022-03231-y

33. Yu J, Ostowari A, Gonda A, et al. Exosomes as a source of biomarkers for gastrointestinal cancers. Cancers (Basel). 2023;15(4):1263. doi: 10.3390/cancers15041263

34. Aronson JK. Biomarkers and surrogate endpoints. Br J Clin Pharmacol. 2005;59(5):491-494. doi: 10.1111/j.1365-2125.2005.02435.x

35. Sewpersad S, Pillay TS. Historical perspectives in clinical pathology: Bence Jones protein-early urine chemistry and the impact on modern-day diagnostics. J Clin Pathol. 2021;74(4):212-215. doi: 10.1136/jclinpath-2020-206675

36. García-Gutiérrez MS, Navarrete F, Sala F, Gasparyan A, Austrich-Olivares A, Manzanares J. Biomarkers in psychiatry: Concept, definition, types and relevance to the clinical reality. Front Psychiatry. 2020;11:432. doi: 10.3389/fpsyt.2020.00432

37. Condrat CE, Thompson DC, Barbu MG, et al. miRNAs as biomarkers in disease: Latest findings regarding their role in diagnosis and prognosis. Cells. 2020;9(2):276. doi: 10.3390/cells9020276

38. Gouda HN, Charlson F, Sorsdahl K, et al. Burden of non-communicable diseases in sub-Saharan Africa, 1990-2017: Results from the Global Burden of Disease Study 2017. Lancet Glob Health. 2019;7(10):e1375-e1387. doi: 10.1016/S2214-109X(19)30374-2

39. Mathema VB, Na-Bangchang K. A brief review on biomarkers and proteomic approach for malaria research. Asian Pac J Trop Med. 2015;8(4):253-262. doi: 10.1016/S1995-7645(14)60327-8

40. Walzl G, McNerney R, du Plessis N, et al. Tuberculosis: Advances and challenges in the development of new diagnostics and biomarkers. Lancet Infect Dis. 2018;18(7):e199-e210. doi: 10.1016/S1473-3099(18)30111-7

41. Liu Y, Guan S, Xu H, Zhang N, Huang M, Liu Z. Inflammation biomarkers are associated with the incidence of cardiovascular disease: A meta-analysis. Front Cardiovasc Med. 2023;10:1175174. doi: 10.3389/fcvm.2023.1175174

42. Bravo À, Cases M, Queralt-Rosinach N, Sanz F, Furlong LI. A knowledge-driven approach to extract disease-related biomarkers from the literature. Biomed Res Int. 2014;2014:253128. doi: 10.1155/2014/253128

43. Crutcher M, Waldman S. Biomarkers in the development of individualized treatment regimens for colorectal cancer. Front Med. 2022;9:1062423. doi: 10.3389/fmed.2022.1062423

44. Hassan S, Hamideh N, Poulos C, Cheema S, Rangwani S, Lio PA. Atopic dermatitis biomarkers and the movement toward personalized treatment. Dermatitis. 2021;32(1S):S8-S14. doi: 10.1097/DER.0000000000000711

45. Conti V, Corbi G, Costantino M, et al. Biomarkers to personalize the treatment of rheumatoid arthritis: Focus on autoantibodies and pharmacogenetics. Biomolecules. 2020;10(12):1672. doi: 10.3390/biom10121672

46. Refaat MM, Abdel‐Rehim AS, Elmahdi AR, Mohamed NA, Ghonaim SS. Diamine oxidase enzyme: A novel biomarker in respiratory allergy. Int Forum Allergy Rhinol. 2019;9(12):1478-1484. doi: 10.1002/alr.22426

47. Lauková L, Konečná B, Janovičová Ľ, Vlková B, Celec P. Deoxyribonucleases and their applications in biomedicine. Biomolecules. 2020;10(7):1036. doi: 10.3390/biom10071036

48. Ntekim A, Olopade OI. Innovative strategies for developing biomarker-informed cancer clinical trials to accelerate progress in precision oncology in Sub-Saharan Africa. Am Soc Clin Oncol Educ Book. 2022;42:1-9. doi: 10.1200/EDBK_349955

49. Fathi E, Mesbah-Namin SA, Farahzadi R. Biomarkers in medicine: An overview. J Adv Med Med Res. 2013;4:1701-1718.

50. Kotta PA, Nambi V, Bozkurt B. Biomarkers for heart failure prediction and prevention. J Cardiovasc Dev Dis. 2023;10(12):488. doi: 10.3390/jcdd10120488

51. Pillay K, Lewis L, Rambaran S, et al. Plasma biomarkers of risk of tuberculosis recurrence in HIV Co-infected patients from South Africa. Front Immunol. 2021;12:631094. doi: 10.3389/fimmu.2021.631094

52. Cummings J, Lee G, Mortsdorf T, Ritter A, Zhong K. Alzheimer’s disease drug development pipeline: 2017. Alzheimers Dement (N Y). 2017;3(3):367-384. doi: 10.1016/j.trci.2017.05.002

53. Jain P, Chakma B, Patra S, Goswami P. Potential biomarkers and their applications for rapid and reliable detection of malaria. Biomed Res Int. 2014;2014:852645. doi: 10.1155/2014/852645

54. Tribolet L, Kerr E, Cowled C, et al. MicroRNA biomarkers for infectious diseases: From basic research to biosensing. Front Microbiol. 2020;11:1197. doi: 10.3389/fmicb.2020.01197

55. Seijo LM, Peled N, Ajona D, et al. Biomarkers in lung cancer screening: Achievements, promises, and challenges. J Thorac Oncol. 2019;14(3):343-357. doi: 10.1016/j.jtho.2018.11.023