Omisirge Market Report 2026: Epidemiology, Pipeline Analysis, Market Insights & Forecasts

The growth in the historic period can be attributed to increasing incidence of hematologic malignancies, limitations of conventional cord blood transplantation, early clinical success of cell expansion technologies, growing use of allogeneic stem cell transplants, regulatory approvals for advanced cell therapies.

The growth in the forecast period can be attributed to expansion of personalized cell therapy pipelines, rising investments in regenerative medicine, increasing adoption of advanced transplantation protocols, growing focus on reducing post-transplant complications, expansion of cell therapy manufacturing infrastructure. Major trends in the forecast period include increasing adoption of expanded cord blood therapies, rising use of ex vivo cell expansion techniques, growing focus on faster neutrophil engraftment, expansion of allogeneic hsct applications, enhanced manufacturing scalability for cell therapies.

The growing demand for personalized treatments is expected to drive the expansion of the Omisirge market in the future. Personalized treatments refer to medical interventions tailored to an individual's unique genetic, environmental, and lifestyle factors to optimize effectiveness and minimize side effects. The increasing demand for such treatments is fueled by advancements in genetic research, greater awareness of individualized healthcare, and the rising recognition that tailored therapies offer better efficacy and fewer side effects than traditional one-size-fits-all approaches. Omisirge enhances personalized treatments by adapting to individual patient needs, targeting specific immune responses, and optimizing therapeutic outcomes based on the distinct characteristics of each patient's cancer profile. For example, in February 2024, the Personalized Medicine Coalition, a U.S.-based non-profit organization, noted that in 2023, the FDA approved 16 new personalized treatments for rare diseases, a significant rise from the six approvals in 2022. Consequently, the growing demand for personalized treatments is expected to propel the growth of the Omisirge market.

Key players in the Omisirge market are focusing on technological advancements, such as omidubicel-onlv, to improve transplant efficiency and patient recovery outcomes. Omidubicel-onlv is an allogeneic, stem-cell-based therapy derived from umbilical cord blood and engineered to enhance cell expansion for faster engraftment. For instance, in May 2023, the U.S. Food and Drug Administration (FDA) approved Gamida Cell's product Omisirge, which aims to improve stem cell engraftment and reduce infection risks in transplant patients. The FDA approval introduced an enhanced, expanded cord-blood-derived cell therapy designed to speed up neutrophil recovery and reduce infection risk in patients with hematologic malignancies. It provides a more reliable engraftment profile compared to traditional cord blood, making transplants faster and safer clinically.

In March 2025, Ayrmid Pharma Ltd., a U.S.-based cell therapy company specializing in nicotinamide-enhanced allogeneic progenitor cell therapies, entered into a partnership with RoslinCT to enhance its manufacturing capabilities and support the scalable production of its cell therapy programs. Through this collaboration, Ayrmid ensures a dual sourcing strategy to maintain a stable, commercial-scale supply of Omisirge (omidubicel-only) by transferring the technology and enabling RoslinCT's Hopkinton, Massachusetts facility to manufacture the product. This partnership aims to boost the manufacturing capacity and supply reliability. RoslinCT, a Scotland-based contract development and manufacturing organization (CDMO), offers process development, analytical services, and GMP manufacturing for advanced cell and gene therapies.

Major companies operating in the omisirge market are Gamida Cell Ltd.

North America was the largest region in the omisirge market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the omisirge market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the omisirge market report are Australia, India, China, South Korea, Japan, UK, France, Germany, USA, Canada.

Tariffs are impacting the omisirge market by increasing costs associated with imported bioprocessing equipment, cell culture media, single-use consumables, and cold-chain logistics required for advanced cell therapy manufacturing. North America and Europe are most affected due to dependence on specialized imported laboratory equipment and reagents, while Asia-Pacific faces higher costs for technology transfer and scale-up facilities. These tariffs are contributing to higher production and commercialization expenses. However, they are also encouraging domestic biomanufacturing investments, regional supply chain localization, and innovation in cost-efficient cell processing technologies.

The omisirge market research report is one of a series of new reports that provides omisirge market statistics, including omisirge industry global market size, regional shares, competitors with a omisirge market share, detailed omisirge market segments, market trends and opportunities, and any further data you may need to thrive in the omisirge industry. This omisirge market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Omisirge is an advanced cell therapy used in allogeneic hematopoietic stem cell transplantation (HSCT) for patients with blood cancers or disorders. It is derived from umbilical cord blood and is specifically designed to speed up neutrophil recovery, thereby reducing the risk of infection and other complications after transplantation. Omisirge contains expanded hematopoietic progenitor cells (CD34+ cells) that are cultured to increase their quantity and functionality, enabling faster engraftment compared to conventional cord blood transplantation.

Omisirge is primarily indicated for conditions such as leukemia, lymphoma, myeloma, and other related disorders. Leukemia, a cancer affecting the blood and bone marrow, leads to the production of abnormal white blood cells. The therapy is distributed through both direct sales and distributors and is predominantly used in hospitals, clinics, and ambulatory surgical centers.

The omisirge market consists of sales of cell therapy products, gene therapy products, cord blood-derived products, and tissue engineering products. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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