NexoBrid and its Awaiting US Approval

A Burn takes place when the skin comes into contact with a heat source. Burns can occur from many different sources. The most common sources that cause Burns are fire/flame, scalds, hot objects, electrical, and chemical agents, respectively. Burns is a common injury seen in emergency departments around the world. Even as emergency management improves, Burns continues to have significant morbidity and mortality. Burns treatment is based upon the classification of the burn and thus it becomes essential to accurately classify burns to optimize treatment and provide an accurate prognosis. In the current Burns market scenario, the standard treatment for skin burn involves medications, wound dressings, therapy, and surgery. The treatment goals are to control pain, remove dead tissue, prevent infection, reduce scarring risk, and regain function. The treatment depends on the severity of the burn. The Burn market is expected to be driven by the factors such as increasing number of surgery procedures, availability of wide range of treatment option and favorable reimbursement policies. The stringent regulatory guidelines for the approval of new treatment or medicine, high cost for the treatment may hamper the Burns market.

Encountering fire leads to severe burns, contributing to approximately 40% of all cases. Fire/Flame is one of the leading causes of burns; however, other etiologies include contact (nearly 9%), scald (nearly 31%), electrical (nearly 4%), and chemical (nearly 3%), as well as radiation, frostbite, and unknown/unspecified causes.

DelveInsight’s analysis indicates that the majority of Burns injury cases taking treatment are males due to most Burn cases occurring at the workplace making males more vulnerable to Burns. There were 411,066 male and 251,944 female cases of treated burn injuries in 2020 in the United States. In the same year, the Burns severity-specific estimated cases were observed to be 144,536; 387,198; 19,890; and 111,386 for first-degree, second-degree, third-degree, and unspecified, respectively in the United States. The Burns Market Report proffers epidemiological analysis in the 7MM segmented into Incident Cases of Burns Patient Requiring Treatment, Gender-specific Incident Cases of Treated Burn Injuries, Etiology-specific Incident Cases of Treated Burn Injuries, Severity-specific Incident Cases of Treated Burn Injuries, and Incident Cases of Hospitalized Burns Patients.

Burns Market

Burns are segregated based on severity as first-degree (superficial), second-degree (deep partial-thickness), third-degree (full-thickness), and finally, a fourth-degree burn which involves injury to deeper tissues. According to DelveInsight’s analysts, it is estimated that in the US, in 2021, there were around 2.4 million burn cases reported, of which 27% of cases required treatment. The Burns market is expected to be driven by factors such as the increasing incidence, availability of a wide range of treatment options, and advancements in burn care treatments and products. Compared with first- and second-degree burns, third-degree burns carry the most risk for complications, such as infections, blood loss, and shock. Moreover, morbidity and mortality tend to increase as the surface area of the burn increases. Approximately 6.5% of all burn victims are treated in specialized burn centers.

The Burns market size was USD 830 million in 2020 in the United States. DelveInsight estimates suggest that the United States had the highest incident population of burn injuries that required medical treatment. The market size of Burns is expected to grow at a CAGR of 1.96%  in the 7MM. The Burns pipeline therapies include DenovoSkin, NexoBrid, CellMist System, MW-III, and others, which may improve the treatment dynamics in the upcoming future.

Major pharma giants working proactively in the Burns therapeutic market include CUTISS AG, Skingenix, Polynovo, Mallinckrodt Pharmaceuticals, Kerecis, MediWound, Kaken Pharmaceutical Co., Avita Medical, Vericel Corporation, KeraNetics, Integra Life Sciences Corporation, Medline Industries, Anika Therapeutics, ACell, Amryt Pharma, Skingenix, RenovaCare, and many more.

MediWound’s Lead Burns Product – NexoBrid

In the Burns market, MediWound is anticipated to be a rising star with its lead product – NexoBrid in the Burns pipeline. MediWound is an Israel-based pharmaceutical company which almost a decade ago, in 2012, entered the pharmaceutical market of burns with the biological product NexoBrid. It received marketing approval in Europe as well as other international countries for the treatment of adults with deep partial- and full-thickness burns or severe burns. Despite not attaining a strong foothold in the market, NexoBrid reported encouraging pediatric data. The currently available marketed treatment of burn injuries includes general and advanced treatment care, which involves using various hemostatic adjuncts, skin grafting, medications, and other wound dressings, depending on the severity of the injury. The overall Burns market in the 7MM is a golden billion-dollar market. 

Since NexoBrid failed to achieve any golden number in the market in Europe, it becomes vital to gain US approval for MediWound to accomplish a reputed position in the market and cover the financial gaps.       

In 2020, MediWound submitted Biological Licensing Agreement (BLA) to US FDA. But, in 2021, FDA rejected the BLA, stating some Chemistry, Manufacturing, and Controls “CMC” issues in the BLA and the inability to inspect the manufacturing facilities due to COVID-19 travel restrictions. In addition to this, the FDA had an observation on safety-related data as well. After this response letter, MediWound and its US commercial partner, Vericel, suffered a major setback. 

Nevertheless, a few months back, as a glimpse of hopes, the company received clarity from the US FDA regarding resubmitting the NexoBrid BLA, which is now scheduled for mid-2022. But, the success in grabbing the approval is uncertain, along with its success in the US market even after its approval.

Hence with a 50–50 situation, MediWound is targeting to launch NexoBrid in the US in 2023 and has entered into an exclusive license agreement with Vericel to commercialize the product there. Vericel will now draw the market sculpture for NexoBrid in the US and, hopefully, cover up its scars in the market.

Until then, procurement of NexoBrid by the US Biomedical Advanced Research and Development Authority (BARDA) for emergency stockpile as part of the country’s Health and Human Services (HHS) mission will remain a source of earnings in the US.

Based on DelveInsight’s analysis, if NexoBrid receives the green flag for the US in 2023, it could cross the USD 50 million milestones by 2032.

Expected Burns Market Roadblocks vs. Growth Factors

The unreported and undiagnosed Burns cases and the absence of effective treatment are some of the major blockades in the Burns market growth. Apart from that, stringent regulatory guidelines are also applied for the approval of new treatments with the high cost for the treatment of Burns which may act as an obstruction in the  Burns market.

The rise in the number of incident Burn cases can be considered a prominent factor for Burns market surge in the coming years. The Burns market is expected to show positive growth, mainly attributed to factors like an increase in research and development activities, a rise in the number of clinical studies, an increasing number of surgical procedures, the launch of upcoming therapies, and the availability of a wider range of treatment options.

Way Ahead

Burns continues to present a significant public health problem, resulting in scores of preventable deaths and disability every year. The burden of burns disproportionately falls to the world’s poor residing in low and middle-income countries (LMICs). Those who are burnt require timely access to acute burns management, including definitive surgical care. The current lack of access to safe and affordable surgical care with anaesthesia worldwide means that some 5 billion people do not have access to acute burns management, including definitive surgical care for burns, when needed most. Major limitations to access to burn care at healthcare facilities in LMICs include a lack of appropriately trained staff (including surgeons), appropriate equipment and resources. Burn prevention measures have been successful in reducing the incidence of burns and deaths in many developed countries, however there is currently a paucity of robust understanding of what works in LMICs to prevent burns. A combined effort to implement proven burn prevention strategies and address the unmet need for access to safe and affordable surgical care with anesthesia is required to reduce the global burden of burns that still exists.

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