Regenerative medicine is the interdisciplinary field comprising tissue engineering, cell therapy, and gene therapy. These biopharmaceutical modalities, also referred to as advanced therapies, are growing rapidly, characterized by groundbreaking therapeutic advances that have the potential to change how healthcare providers deliver care. Cell and gene therapies have gained traction over the past decade, as evidenced by large increases in investment and the number of marketed products. By contrast, tissue engineering investment and product commercialization has lagged.
Based on our analysis, we believe that the delayed maturation of tissue-engineered drug products is caused primarily by the greater relative complexity of tissue-engineered medical products (TEMPs) compared with cell and gene therapies. In BioProcess International, we explore how that elevated complexity has manifested itself in three interrelated difficulties for the tissue-engineering field: complex manufacturing, ambiguous regulation, and insufficient reimbursement.