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The Current State of the Chronic Wound Industry in the US


Chronic wounds are wounds that fail to heal in a timely and orderly manner, usually due to underlying conditions such as diabetes, obesity, infection, or poor blood circulation. They can affect any part of the body, but are most common on the lower extremities, especially the feet and legs. Chronic wounds impact the quality of life (QoL) of nearly 2.5% of the total population in the US and impose a significant economic burden on patients and healthcare systems.[1]


Chronic Wound Care Costs in the U.S.


Data regarding the incidence and costs associated with chronic wounds in the US varies. Nevertheless, the numbers available reveal a staggering number of cases and significant costs, even given the wide range of estimates. Over a 5-year period, from 2014-2019, wound prevalence increased from 14.5% to 16.4%. The number of Medicare beneficiaries with a chronic wound increased from 8.2 million to 10.5 million.[2] In the same analysis, wound care expenditure for chronic wounds ranged from $22.5–67.0 billion for 2019. Worthy of note, the most expensive wounds were surgical wounds and pressure injuries, while cost expenditures for venous leg ulcers increased by 1.5x.[2] To further highlight this subset, over 30 million Americans lived with diabetes in 2015 with a 13% prevalence of foot ulcers in this population.[3] The number of diabetics in the US alone has ballooned to 37.3 million in 2022, a 3.2% annual growth rate.[10]

The growth potential of the advanced wound care market

Given the aging population, the continued threat of diabetes and obesity, and the persistent problem of infection, it is expected that chronic wounds will continue to be a substantial challenge in the US. The advanced wound care market for surgical and chronic wound products is expected to top $22 billion by 2024.[3]


The five-year mortality rate of patients who develop diabetic ulders

The large and growing number of chronic wounds is also associated with the increase in morbidity, mortality, and reduced QoL for patients.[3] For example, the five-year mortality rate after developing a diabetic ulcer is approximately 42% and up to 56.6% when lower extremity amputations are considered[4,5,6], while the five-year mortality rate for breast cancer is 10% and just 4% for prostate cancer.[7,8] In other words, the five-year mortality rate for patients with chronic wounds is 4-5.5x that of patients with breast cancer and 10-13x the mortality rate of patients with prostate cancer. These dramatic differences in mortality rates are even more jarring when one considers cancer research dollars outpace wound care research dollars by a ratio of 150:1.[9] The frustration of this imbalance is further amplified given the racial and social inequities that exist among wound care patients. African-American patients suffer amputation as a result of chronic wounds at two times the rate of their white counterparts.[10] Justifiably, chronic wounds are often considered the silent epidemic. For these reasons, NOxy is developing a new technology to change the wound care mindset from one of management to one of healing.

A change in the wound care industry's mindset from  wound treating to wound healing is needed.

To date, the market response to chronic wounds has been to produce advanced wound management products such as dressings, devices, active therapies, and biologics.[11] However, these treatments tend to only address one facet of the chronic wound problem, leading to incomplete wound management regimes. A change in mindset from wound management to wound healing—therapies targeting the molecular and cellular activity of the wound bed—is needed in the field. Thus, there is a need for more research and innovation in wound care to strike at the core etiologies of chronic wounds and produce healing.



Prevalence and Incidence of Chronic Wounds in US


Although estimates may be outdated or vary depending on the source, the table below reveals the magnitude of the chronic wound epidemic, representing the top etiologies of chronic wound incidences in 2019.[2]

​Type of Chronic Wound

​Annual Incidence in the US

​Skin Disorders

​3.4 million

Diabetic foot ulcers

2.91 million*

​Venous leg ulcers

1.52 million*

Pressure injuries

1.27 million

Arterial leg ulcers

0.51 million

*with and without infection

By comparison, the number of new breast cancer and prostate cancer cases each year are approximately 300,000 and 290,000, respectively. In total, roughly 1.9 million new cases of cancer are diagnosed annually.[13]


Segmentation and Analysis of Chronic Wound Care Products in the US


The chronic wound care market can be segmented based on product type, into conventional wound dressings, advanced wound dressings, surgical wound dressings, and wound therapy devices.[14] Conventional wound dressings include gauze, bandages, tapes, and cotton wool that provide protection and absorb exudate from the wound surface. Advanced wound dressings include cell or tissue-based therapies, hydrogels, hydrocolloids, alginates, foams, films, and silver dressings that provide moisture balance, infection control, debridement, and healing promotion to the wound bed. Surgical wound dressings include sutures, staples, adhesives, and meshes that close and secure surgical incisions or traumatic wounds. Wound therapy devices include negative pressure wound therapy (NPWT), electrical stimulation therapy (EST), ultrasound therapy (UST), hyperbaric oxygen therapy (HBOT), and bioprinting that provide mechanical or biological stimulation to enhance wound healing.


According to a report by Verified Market Research, the advanced wound dressings segment accounted for one of the largest shares of the US chronic wound care market in 2022, followed by the wound therapy devices segment. The advanced wound dressings segment is expected to grow at a CAGR of 3.4% from 2023 to 2030.[15]


Foam dressings are expected to see the highest growth rate in the wound care industry

The growth of the advanced wound dressings segment can be attributed to the increasing demand for innovative products that offer faster healing, reduced infection risk, and improved patient comfort. Among the advanced wound care dressings, occlusive or moisture-retentive dressing dominated the market with a share of 59.83% in 2021.[16] Such moist dressings are further subdivided into foams, collagen, hydrocolloids, hydrogels, and alginates. Of these, foam dressings are expected to witness the highest growth rate during the forecast period due to their versatility, ease of use, and ability to be used with other treatments.[16]


The growth of the wound therapy devices segment can be attributed to the rising adoption of NPWT devices that provide controlled suction to remove fluid and debris from the wound bed and promote granulation tissue formation. According to a report by Allied Market Research, NPWT devices accounted for 57.1% of the US wound therapy devices market in 2020 and are expected to grow at a CAGR of 4.4% from 2021 to 2027.[17] Other emerging technologies in this segment include EST devices that deliver electrical currents to stimulate cellular activity and blood flow in the wound area; UST devices that use low-frequency ultrasound waves to enhance tissue regeneration and reduce inflammation; HBOT devices that deliver pressurized oxygen to increase oxygen supply and tissue oxygenation in hypoxic wounds; and bioprinting devices that use bioinks containing living cells and biomaterials to create three-dimensional structures of skin tissue.


NOxy believes the root cause in healing chronic wounds is the deficiency of nitric oxide

Nitric oxide offers antimicrobial, anti-inflammatory and natural vasodilation benefits and promotes cellular growth

However, none of the products in these segments target the root cause of chronic wounds, leaving practitioners with a piecemeal solution of multiple products, each addressing a different aspect of healing, often compromising the quality or consistency of care. A better approach would be a sole active drug that could address the root cause of non-healing wounds in a single treatment, or in combination with standard of care. NOxy believes this root cause is the deficiency of nitric oxide—the key molecule that regulates the molecular and cellular processes involved in each stage of wound healing.[18] Nitric oxide plays a role in the wound healing sequence as a natural vasodilator, antimicrobial, anti-inflammatory, and immunomodulator that also stimulates cell proliferation, collagen synthesis, and angiogenesis. Therefore, novel technologies based on nitric oxide have the potential to disrupt the advanced wound care market by providing a product capable of complementing or replacing several existing products, challenging the current projections for the growth of products in these segments. The market is ready for disruption given the lack of drug products that heal wounds rather than manage their symptoms.


Key Players in the Chronic Wound Care Market in the US


The chronic wound care market in the U.S. is highly competitive and fragmented, with many players offering a variety of products and services. According to a report by Grand View Research, some of the main players in the U.S. chronic wound care market are Smith & Nephew plc, Mölnlycke Health Care AB, ConvaTec Group plc, Coloplast A/S, 3M Company, Integra LifeSciences Holdings Corporation, Johnson & Johnson, B. Braun Melsungen AG, Medtronic plc, and Cardinal Health Inc.


Companies that can develop nitric-oxide based treatments stand to garner market share and growth in the wound care industry

The main players in the industry account for nearly 50% of the market’s revenues and are expected to retain their collective market share through 2030.[19] For these large companies to keep their highly competitive positions, a strong appetite exists to innovate or acquire technologies which address the core factors impacting wound healing. These companies recognize an abundance of “me too” products which are only marginally beneficial for wound healing, making them vulnerable to competition from new active products with multiple modes of action designed to address the fundamental challenges of non- or slow-healing wounds. Companies that can effectively develop and utilize NO-based treatments stand to garner market share and growth amid the array of both inert and active advanced wound care products.


With Medicare and Medicaid, the lack of standardized definitions in diagnosis and classification drastically affect reimbursement

Cost and Reimbursement of Chronic Wound Care in the US


In the US, Medicare and Medicaid are the major payers for wound care services, covering about 60% of the total cost. However, the lack of standardized definitions in diagnosis and classification drastically affects the reimbursement policies and rates applied to each patient. Consequently, coverage dramatically varies depending on the type of wound, the setting of care, the product used, and the patient's eligibility. Even with clearly defined wounds, care settings, and products, the cost and reimbursement of chronic wound care also depends on the severity and complexity of the wound, the duration and frequency of treatment, and the outcomes and complications of care. For instance, chronic wounds that are infected or have comorbidities such as diabetes or vascular disease require more intensive and costly interventions than those that are not. Without clear standardization, it is difficult for patients or practitioners to consider the many nuances when applying for reimbursement.


These many variables all lead to reimbursement policies that are difficult to navigate. For example, Medicare covers 80% of the cost of NPWT devices for home use, but only if the patient meets certain criteria such as having a chronic wound that has not improved with standard therapy for at least 30 days. Similarly, Medicaid covers wound care products and services for eligible beneficiaries, but the coverage and payment rates differ by state and program.


Many patients pay out-of-pocket for their wound care or receive suboptimal care

Because of these concerns, cost and reimbursement asymmetries were addressed by a public workshop on wound healing held by FDA.


According to speakers from academies, industry, government, and patient advocacy groups at the workshop, patients face difficulties in obtaining coverage and reimbursement for their wound care products and services, due to factors such as:

  • Lack of clear and consistent criteria for defining and documenting chronic wounds and their severity[20,21]

  • Lack of alignment between FDA approval pathways and CMS coverage determinations[21]

  • Lack of adequate coding systems and payment models that account for the complexity and diversity of wound care products and services[20,21,22]

  • Lack of financial incentives for providers to adopt innovative and evidence-based wound care practices.[20,21,22]


As a result of the unclear asymmetries, many patients end up paying out-of-pocket for their wound care, or receiving suboptimal or inappropriate care that may lead to worse outcomes and higher costs.[20,21,22] Some examples of these issues that were mentioned at the workshop include:

  • Patients with diabetic foot ulcers being misdiagnosed or underdiagnosed, leading to delayed or denied access to advanced therapies such as cellular and tissue-based products (CTPs)[20,21]

  • Patients with venous leg ulcers being prescribed compression therapy without proper assessment of their vascular status, resulting in potential harm or non-compliance[20,21]

  • Patients with pressure injuries being denied coverage for CTPs or negative pressure wound therapy (NPWT), due to lack of documentation or evidence of medical necessity[20,21]

  • Patients with complex wounds requiring multidisciplinary care being referred to multiple providers or facilities, increasing their out-of-pocket expenses and reducing their continuity of care.[20,21,22]


To address these cost and reimbursement asymmetries, some of the suggestions that were made at the workshop include:

  • Developing standardized definitions, diagnosis, and classification systems for chronic wounds that are aligned across regulatory, clinical, and payer domains[20,21,22]

  • Enhancing collaboration and communication between FDA and CMS to facilitate faster and more consistent approval and coverage decisions for wound care products[20,21]

  • Updating coding systems and payment models to reflect the value and quality of wound care products and services, rather than the volume or type[20,21,22]

  • Creating incentives for providers to adopt best practices and evidence-based guidelines for wound care management[20,21,22]

  • Engaging patients and caregivers in shared decision making and education about their wound care options and costs.[20,21,22]


In an effort to make wound care solutions more accessible, the FDA hopes to address these asymmetries to improve access and affordability of wound care products for patients with chronic wounds, as well as stimulate innovation and research in this field.


These asymmetries point to the vulnerability of the market to disruption. Many of the difficulties patients face in receiving proper wound care exist because care is currently too expensive, as noted above, particularly given that the forum also revealed that many patients pay for care out of pocket. If an affordable and effective product could be introduced that treats chronic wounds, these inefficiencies would be resolved.


Recent innovations in manufacturing have solved the prior limitations for delivering NO to the wound bed

Nitric oxide may prove to be a solution. Because of its ability to modulate various aspects of wound healing such as inflammation, angiogenesis, infection control, and tissue regeneration, it presents a possible solution to the maze of alternatives attempting to treat chronic wounds. Furthermore, with recent innovations to more effectively deliver NO to the wound bed, past limitations regarding manufacture and effective dosing no longer pose a challenge. Thus, NO can be produced in a cost-effective way to change a continuous wound management regime into a wound healing plan.


Conclusion

Despite all the products, resources, and research dedicated to the wound care space, wound care remains unsatisfactory and the number of chronic wounds continues to expand. Innovation is needed. Nitric oxide (NO) presents a hopeful solution. For more information on how NO can transform wound care in the US, please visit noxyhp.com.


References

[1] Sen CK. Human Wound and Its Burden: Updated 2020 Compendium of Estimates. Adv Wound Care (New Rochelle). 2021 May;10(5):281-292. doi: 10.1089/wound.2021.0026. PMID: 33733885; PMCID: PMC8024242.

[2] Marissa J. Carter, Joan DaVanzo, Randall Haught, Marcia Nusgart, Donna

Cartwright & Caroline E. Fife (2023) Chronic wound prevalence and the associated cost of

treatment in Medicare beneficiaries: changes between 2014 and 2019, Journal of Medical

Economics, 26:1, 894-901, DOI: 10.1080/13696998.2023.2232256.

[3] Sen CK. Human Wounds and Its Burden: An Updated Compendium of Estimates. Adv Wound Care (New Rochelle). 2019 Feb 1;8(2):39-48. doi: 10.1089/wound.2019.0946. Epub 2019 Feb 13. PMID: 30809421; PMCID: PMC6389759.

[4] Everett, Estelle, and Nestoras Mathioudakis. “Update on management of diabetic foot ulcers.” Annals of the New York Academy of Sciences vol. 1411,1 (2018): 153-165. doi:10.1111/nyas.13569

[5] Armstrong, David G et al. “Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer.” Journal of foot and ankle research vol. 13,1 16. 24 Mar. 2020, doi:10.1186/s13047-020-00383-2

[6] Eaglstein, William H et al. “Food and Drug Administration (FDA) drug approval end points for chronic cutaneous ulcer studies.” Wound repair and regeneration: official publication of the Wound Healing Society [and] the EuropeanTissue Repair Society vol. 20,6 (2012): 793-6. doi:10.1111/j.1524-475X.2012.00849.x

[7] Centers for Disease Control and Prevention. U.S. Cancer Statistics Prostate Cancer Stat Bite: 2020. Accessed on https://www.cdc.gov/cancer/uscs/about/stat-bites/stat-bite-prostate.htm

[8] Centers for Disease Control and Prevention. U.S. Cancer Statistics Breast Cancer Stat Bite: 2020. Accessed on https://www.cdc.gov/cancer/uscs/about/stat-bites/stat-bite-breast.htm

[9] Tang, Xin et al. “Wound Healing Driver Gene and Therapeutic Development: Political and Scientific Hurdles.” Advances in wound care vol. 10,8 (2021): 415-435. doi:10.1089/wound.2019.1143

[10] McDermott, Katherine et al. “Etiology, Epidemiology, and Disparities in the Burden of Diabetic Foot Ulcers.” Diabetes care vol. 46,1 (2023): 209-221. doi:10.2337/dci22-0043

[11] Advanced Wound Care Market Size | Industry Report, 2020-2027 | Grand View Research. Available from: https://www.grandviewresearch.com/industry-analysis/advanced-wound-care-market

[12] Diabetes Research Institute. Diabetes Statistics: 2022. Accessed on https://diabetesresearch.org/diabetes-statistics/

[13] Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA: A Cancer Journal for Clinicians 2023; 73(1):17-48. Last accessed February 21, 2023

[14] Wound Care Market Size & Share Report - Grand View Research; Available from: https://www.grandviewresearch.com/industry-analysis/wound-care-market

[15] U.S Chronic Wound Care Market Size | Industry Report - Verified Market Research; Available from: https://www.verifiedmarketresearch.com/product/us-chronic-wound-care-market/

[16] U.S. Advanced Wound Care Market Size & Share Report - Grand View Research; Available from: https://www.grandviewresearch.com/industry-analysis/us-advanced-wound-care-market

[17] U.S. Advanced Wound Care Market Size & Share Report - Allied Market Research; Available from: https://www.alliedmarketresearch.com/us-advanced-wound-care-market-A06638

[18] Kandhwal, Mimansa et al. “Understanding the Potential Role and Delivery Approaches of Nitric Oxide in Chronic Wound Healing Management.” Current pharmaceutical design vol. 27,17 (2021): 1999-2014. doi:10.2174/1381612826666201026152209

[19] U.S. Wound Care Centers Market Size & Share Report, 2030. https://www.grandviewresearch.com/industry-analysis/us-wound-care-centers-market

[20] Public Workshop: FDA Wound Healing Scientific Workshop - 04/28/2022 | FDA https://www.fda.gov/drugs/news-events-human-drugs/public-workshop-fda-wound-healing-scientific-workshop-04282022

[21] Federal Register: Wound Healing Scientific Workshop; Public Workshop; Request for Comments https://www.federalregister.gov/documents/2021/12/20/2021-27459/wound-healing-scientific-workshop-public-workshop-request-for-comments

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