Over the last decade, demand for allograft tissues has grown dramatically, making tissue sterilization a top priority for both surgeons and the patients who rely on them. While traditional sterilization methods have long served the tissue banking industry, innovation is accelerating, and with it, the potential to improve tissue quality, operational efficiency, and patient outcomes.
One technology gaining traction as an alternative sterilization modality that can help preserve the delicate structure of allograft materials is supercritical carbon dioxide (scCO₂). Supercritical CO₂ technology isn’t new, having been researched and commercially used for decades. Its adoption in tissue sterilization has grown on a global scale, both highlighting its benefits and creating exciting possibilities for tissue banks to increase performance and provide surgeons with a superior product.
For tissue banks looking to enhance their current processes and product offerings while preparing for what comes next, the time to evaluate the emerging uses of scCO₂ is now.
Market Readiness: Why Change Is Coming
According to the report “Allografts Market by Type, Application, End-Users – Global Forecast 2025-2030,” the global allograft market is projected to grow at a compound annual growth rate of 8.67% through 2030, “driven by an increasing prevalence of musculoskeletal disorders, advancements in surgical techniques, and a growing geriatric population demanding effective treatment options for bone and tissue-related ailments.” The U.S. market is expected to jump from $2.4 billion in 2024 to $3.99 billion by 2030. With more tissue banks competing in a value-based care environment, those who deliver biologically effective, structurally sound grafts will be best positioned to succeed.
Modern donor screening, precision freeze-drying (lyophilization), and tissue customization have increased the clinical value of each donated graft. As processing becomes more advanced, post-processing sterilization methods must keep pace, and technologies like supercritical CO₂ that preserve these gains are becoming more essential.
Why Supercritical CO₂ is Gaining Ground in Tissue Sterilization
Supercritical CO₂ applications in tissue banking are evolving rapidly. What makes it so compelling?
Supercritical CO₂ sterilization is a gentle and versatile approach that achieves sterilization while preserving the structure and properties of biologics. When heat and pressure are applied to CO₂, it reaches a supercritical state. In this state, CO₂ exhibits the properties of both a gas and a liquid, which allows it to penetrate materials at a molecular level. Read on to explore some of the features and benefits of scCO₂ for tissue banks.
- Low Temperature: Operating at mild temperatures (typically 35°C), supercritical CO₂ avoids high heat that can denature proteins.
- Non-ionizing: Prevents damage to collagen and key structural components of the extracellular matrix (ECM).
- Low inflammatory potential: The strong natural solvent properties of scCO₂ help remove trapped blood, lipids, and other immunogenic contaminants.
- Short cycle times: Enables lean workflows by reducing tissue sterilization time and simplifying post-processing steps.
- Scalable systems: Systems range from 20-L up to >1,000-L to accommodate a wide variety of manufacturing flows.
“Supercritical CO₂ combines the most effective qualities of gaseous and liquid sterilants while offering unique advantages of its own,” said Eric Eisenhut, Executive Vice President of NovaSterilis. “It sterilizes within the physiological temperature range, so sensitive tissue structures remain intact.”
These benefits are not theoretical. A growing body of scientific literature supports the safety, efficacy, and scalability of scCO₂ sterilization – qualities that can help tissue banks differentiate themselves in a competitive market.
Data and Global Adoption: Supercritical CO₂ Use in Tissue Sterilization
There is a large (and growing) body of evidence that supports the safety, efficacy, and scalability of supercritical CO₂.
The report “Outcomes of ACL Reconstruction Utilizing Supercritical CO₂-Sterilized Allografts” reviewed the clinical outcomes of anterior cruciate ligament reconstruction using allograft tendons sterilized with supercritical carbon dioxide supplied by Australian Biotechnologies. The study found that, at 24 months, 95% of patients had successful anterior cruciate ligament reconstruction and “a high rate of return to sports … suggesting that terminal supercritical CO₂ sterilization results in a suitable graft choice for primary ACLR.”
A 2020 study in the International Journal of Molecular Sciences evaluated whether supercritical CO₂ could offer a better way to both sterilize and decellularize tendon allografts in a single step. The results found that tendons treated with supercritical CO₂ retained “significantly higher” mechanical strength compared to those treated with traditional methods.
Those studies represent just a few of the successes achieved by early adopters of supercritical CO₂ sterilization. As these early successes accumulate, the U.S. tissue banking market may soon find itself at a crossroads: stay the course with legacy sterilization protocols or evaluate how choosing a different path might enhance current processes and offerings.
Growing Pains and Opportunities of a New Sterilization Method
As with any innovation, the shift to scCO₂ sterilization comes with questions—and some hesitation. For many tissue banks, there’s a natural resistance to changing long-established protocols that maintain the status quo. The prevailing sentiment in the industry is: if it isn’t broken, don’t fix it.
While legacy sterilization methods, such as gamma, e-beam, and antibiotic washes, are well understood, widely used, and deeply embedded in current workflows, they also come with certain limitations. Meanwhile, the demands placed on tissue banks are intensifying. Hospitals and surgeons want grafts that perform better, last longer, and meet the latest sterilization guidance of regulatory bodies.
Considered together, these forces signal that continuing with “business as usual” may not be viable long-term. Tissue banks that wait too long to adapt may find themselves on the wrong side of the innovation curve – scrambling to catch up as competitors raise the bar.
Conversion Concerns: From Barrier to Opportunity
Switching to new sterilization methods presents challenges that are increasingly solvable.
| Traditional Concern | Challenge | Solution |
|---|---|---|
| Capital Cost | Acquiring new equipment | In-house sterilization allows for a semi-continuous manufacturing flow and removes the added costs of shipping product to a contract sterilizer. |
| Validation Complexity | There is currently no scCO₂-specific ISO standard for carrying out a sterilization validation study. | NovaSterilis has experience completing scCO₂ sterilization validation studies using ISO 14937. |
| Impact on Market Share | Surgeon adoption of scCO₂-sterilized allografts | There is a multitude of data including clinical and animal studies showing the benefits of scCO₂-sterilized products compared to traditional sterilization methods. |
Early adopters report increased surgeon confidence and stronger positioning with premium distributors. This is more than operational improvement—it’s a differentiator in a tightening market.
Those who wait will risk falling behind competitors, losing market share, and failing to meet the evolving expectations of surgeons, hospitals, and regulatory bodies. Every tissue bank has a different risk tolerance, but all can take steps now to explore, test, and prepare.
Adoption Does Not Have to Be “All or Nothing”
Adopting new technology is a spectrum, not a binary choice. You do not have to overhaul your operation overnight to benefit from scCO₂ sterilization. In fact, the most successful transitions happen gradually.
The market is shifting. Early movers are shaping the industry; however, fast followers can benefit by staying informed and prepared.
Tissue Sterilization is Evolving: Prepare Now to Stay Ahead of the Curve
The question isn’t whether more of the tissue banking industry will shift to scCO₂ but rather when. How will your organization be positioned when it does?
Supercritical CO₂ is here and ready to enhance what’s working and open the door to new capabilities. NovaSterilis can help tissue banks understand, evaluate, and adopt supercritical CO₂ technology in a way that works for their operations.
Whether you’re ready to lead the charge or prefer to move once others have paved the way, staying informed is essential. To explore how supercritical CO₂ can fit into your tissue processing strategy or to learn more about this technology, contact NovaSterilis today.