To investigate the diagnostic efficiency of Raman spectroscopy for the diagnosis of breast cancer, we searched PubMed, Web of Science, Cochrane Library, and Embase for articles published from the database establishment to May 20, 2022. Pooled sensitivity, specificity, diagnostic odds ratio, and area under the receiver pooled operating characteristic curve were derived for the included studies as outcome measures. The methodological quality was assessed according to the questionnaires and criteria suggested by the Diagnostic Accuracy Research Quality Assessment-2 tool. Sixteen studies were included in this meta-analysis. The pooled sensitivity and specificity of Raman spectroscopy for breast cancer diagnosis were 0.97 (95% CI, [0.92–0.99]) and 0.96 (95% CI, [0.91–0.98]). The diagnostic odds ratio was 720.89 (95% CI, [135.73–3828.88]) and the area under the curve of summary receiver operating characteristic curves was 0.99 (95% CI, [0.98–1]). Subgroup analysis revealed that all subgroup types in our analysis, including different races, sample types, diagnostic algorithms, number of spectra, instrument types, and laser wavelengths, turned out to have a sensitivity and specificity greater than 0.9. Significant heterogeneity was found between studies. Deeks’ funnel plot demonstrated that publication bias was acceptable. This meta-analysis suggests that Raman spectroscopy may be an effective and accurate tool to differentiate breast cancer from normal breast tissue, which will help us diagnose and treat breast cancer.