23 Jul, 2026
According to Straits Research the global cell and gene therapy manufacturing QC market size was valued at $2.82 billion in 2025 and is projected to grow from $3.54 billion in 2026 to $22.06 billion by 2034, at a CAGR of 25.7% during the forecast period 2026–2034.
Cell therapy refers to the process of administering live cells to patients with the purpose of treating various diseases. Both autologous and allogeneic cells, which can be produced from stem cells found in places like bone marrow, can serve as the source of the cell. The treatment of bone marrow transplant patients often involves stem cell therapy. In the context of medical practise, "gene therapy" refers to any procedure that modifies, deletes, or otherwise alters a patient's genetic code. In addition, it can change the way a person's genes are expressed or fix genes that aren't functioning properly. In this treatment, the nucleic acid (DNA or RNA) is given to the patient together with carriers that are referred to as vectors.
The quality control in manufacturing for cell and gene therapy is expected to be one of the markets with the highest rate of change. A persistent driving force behind the rise of overall acceptance of novel medicines is manufacturing, which is a hallmark of enabling advanced therapies to be spread across the patient community. Quality Control is an essential component of the manufacturing process, particularly when it comes to developing cutting-edge treatments like cell and gene therapies.
Cell therapy targets various diseases at the cellular level, such as by restoring a certain cell population or by using cells as carriers of therapeutic carrier, whereas gene therapy aims to influence the course of various genetic and acquired disorders at the genetic level. Gene therapies also aims to treat inherited disorders as well as acquired ones.
The majority of pharmaceutical companies continue to make significant investments in the development of new medications and equipment. The pharmaceutical business, in particular, is heavily invested in research and development. Pharmaceutical firms spend in research and development in order to bring high-quality, innovative goods to market. The trend implies that major pharma companies are enhancing their R&D efficiency by investing heavily in R&D in order to obtain long-term returns on their investment, as well as through collaborating on R&D.
Clinical tests are an essential component of medical research, and they provide assistance to the pharmaceutical and biopharmaceutical industries in their efforts to develop and bring innovative cell and gene treatments to market. As a consequence of the increased need for innovative medications to satisfy unmet medical requirements, there has been a worldwide increase in the number of clinical trials that have been conducted during the past several years. In 2018, there were 289 cell and gene treatments that were in the clinical development stage at biopharmaceutical firms, as stated in a study that was published by PhRMA on the cell and gene therapy pipeline in 2020. In the year 2020, there were 362 cell and gene treatments that were in the clinical development stage.
Because of a large number of ongoing cell and gene therapy clinical trials, massive amounts of government funding, expansion activities by major companies, and an overall high adoption rate for developing therapies, the North American region holds the largest share of the cell and gene therapy manufacturing quality control market. In addition to this, it is predicted that growth in the Asia-Pacific region would occur at the highest CAGR over the projection period of 2020-2030.
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