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Cited by 7Sex and Gender in HealthcareTissue Engineering and Regenerative MedicineBone Tissue Engineering Materials

Toward Sex-Specific Biomaterials Innovation: A Perspective

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Koons, Gerry L.·2025·ACS Biomaterials Science & Engineering
DOI 10.1021/acsbiomaterials.5c00342PMC PMC12421524
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Abstract

Sex-related differences influence key biological processes relevant to biomaterials research, including tissue regeneration, immune response, drug metabolism, and relevant diseases. Despite increasing recognition of sex as a critical biological variable, biomaterials research has historically relied on generalized study designs that fail to account for sex-specific physiological variability. This oversight has contributed to inconsistencies in biomaterial performance, reduced predictive accuracy in preclinical studies, and increased the risk of suboptimal clinical outcomes. A transition toward sex-specific biomaterials research is necessary to advance precision medicine and ensure that biomaterials are designed to perform optimally across different patient populations. This perspective examines the motivations and barriers to integrating sex-related differences in biomaterials, including current approaches to (pre)clinical study design, data generation and sharing, funding realities, and regulatory frameworks. This work also highlights biomaterials applications for female-specific conditions, from pelvic floor disorders and uterine wound healing to endometriosis. Furthermore, biomaterials applications for diseases such as osteoporosis, diabetes, and cancer are discussed in terms of sex-related differences in immune response, drug metabolism, and tissue regeneration and the subsequent impact on biomaterial performance. To address these challenges, this perspective proposes strategies for improving biomaterials research, including the adoption of standardized experimental frameworks, integration and aggregation of sex-specific analyses in data sets, and application of artificial intelligence-driven biomaterial evaluation. Priorities for collaborative partners, funding bodies, and regulatory agencies in facilitating these solutions are outlined to improve scientific practice and clinical applicability. By implementing these strategies, biomaterial designs can move beyond a one-size-fits-all paradigm and improve alignment with the principles of precision medicine.

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  • The female immune system tends to higher acute reactions and therefore cases of immune hypersensitivity and fibrosis.

    “The immune system also presents notorious differences between sexes, where the female immune system tends to higher acute reactions and therefore cases of immune hypersensitivity and fibrosis [173].”

    From Immune Response to Extracellular Matrix Bioscaffolds: A Comprehensive Review (2025) · cites this paper as [173]

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200 of 209 shown

Cited by

Sorted by citations

Authors
Koons, G. L.
Affiliations
Radboud University Medical Center (NL)
Corresponding author
Koons, Gerry L.
ORCID
Koons, Gerry L.
Venue
ACS Biomaterials Science & Engineering
Publisher
American Chemical Society (ACS)
Published
2025-08-20
Volume
11
Issue
9
Pages
5131-5144
ISSN
2373-9878 (ISSN-L)
DOI
10.1021/acsbiomaterials.5c00342
PMC
PMC12421524
OpenAlex
W4413355711
Cited by
7
References
11
Citations by year
2026: 6 · 2025: 1
FWCI
1.34
Type
journal article
Language
en
Open access
Licence
Locations
  • ACS Biomaterials Science & Engineering (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • PubMed Central (publishedVersion, cc-by)
  • Radboud Repository (Radboud University) (submittedVersion, other-oa)
Funders
  • Radboud Universiteit (Radboud Excellence Initiative)
  • HORIZON EUROPE Marie Sklodowska-Curie Actions (101154946)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Sex and Gender in Healthcare
  • Health Sciences › Medicine › Surgery › Tissue Engineering and Regenerative Medicine
  • Physical Sciences › Engineering › Biomedical Engineering › Bone Tissue Engineering Materials
Keywords
sex differences, sex as a biological variable, tissue regeneration, immune response, drug metabolism, preclinical study design, precision medicine, pelvic floor dysfunction, endometriosis, osteoporosis, diabetes mellitus, cancer, artificial intelligence, regulatory framework, data sharing
MeSH terms
Animals, Biocompatible Materials, Female, Humans, Male, Sex Characteristics, Precision Medicine

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