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수술 부위 감염 : 시장 인사이트, 역학 및 예측(2036년)

Surgical Site Infections - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 200 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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수술 부위 감염(SSI)에 대한 인사이트 및 동향

  • SSI는 의료 관련 감염증 중에서도 가장 흔한 유형 중 하나로, 수술 후 30일 이내에 발생하며 수술 부위의 미생물 오염으로 인해 유발됩니다.
  • 수술 기술과 감염 관리 기법의 발전에도 불구하고, 수술 부위 감염(SSI)으로 인한 부담은 여전히 막대합니다. 그 발생률은 수술의 유형나 환자의 위험 요인에 따라 다르며, 많은 선진 의료 시스템에서 의료 관련 감염 전체의 약 20%를 차지하고 있어, 수술 부위 감염(SSI)의 예방은 공중보건상 중요한 우선 과제입니다.
  • ASEPSIS 점수는 수술 부위 감염의 중증도를 평가하기 위해 사용되는 검증된 객관적인 임상 점수 체계입니다. 이 점수는 상처 부위의 외관, 항생제 사용, 고름 배출, 병원균 분리, 입원 기간 등의 지표를 종합하여 산출된 것입니다.
  • 적절한 수술 전후 항생제 예방 투여, 수술 부위 소독 및 적절한 수술 후 상처 관리를 병행함으로써, 수술 부위 감염(SSI)의 최대 55%를 예방할 수 있는 것으로 나타났습니다.
  • 현재의 표준 치료는 주로 예방적 성격이 강하며, 수술 전후 항생제의 예방적 투여, 피부 소독, 무균 수술법, 그리고 수술 후 상처 관리에 의존하고 있습니다. 일반적으로 사용되는 항균제에는 세파졸린, 반코마이신, 클린다마이신 및 기타 수술 유형에 따른 예방약이 포함됩니다.
  • SSI에 대해 승인된 유일한 약물은 오츠카 제약이 제조하는 오라넥시딘 글루코네이트(OLANEDINE)이지만, 그 승인 범위는 일본 국내로 한정되어 있습니다. 미국, 유럽 및 기타 주요 시장에서는 SSI에 특화된 치료법이 승인되지 않았으며, 전 세계적으로 수술 후 감염 및 이와 관련된 의료 부담을 줄이기 위한 효과적인 예방적 개입에 대한 막대한 미충족 수요가 부각되고 있습니다.
  • SSI는 선진국에서도 여전히 심각한 의료비 부담으로 남아 있습니다. 미국에서는 SSI로 인해 매년 40만 일 이상의 추가 입원 일수가 발생하고 있으며, 그 결과 연간 약 9억 달러의 초과 비용이 발생하고 있는 것으로 추정됩니다.
  • 신흥 SSI 파이프라인에 참여하고 있는 제약 및 바이오기술 기업으로는 PolyPid(D-PLEX100)와 AMR Bio(XF-73) 등이 있으며, 이는 기존의 전신 항생제를 뛰어넘는 차별화된 감염 예방 기술에 대한 업계의 관심이 높아지고 있음을 반영하고 있습니다.
  • 새로운 치료법 중에서도 D-PLEX100은 수술 부위에서 독시사이클린을 지속적으로 국소 방출함으로써, 수술 후 수술 부위 감염(SSI) 발생률을 낮추는 데 유망한 효능을 보이고 있습니다.
  • 지속적인 혁신이 이루어지고 있음에도 불구하고, 항생제 내성, 수술 기법별 수술 후 감염(SSI) 위험의 편차, SSI에 특화된 승인된 제품의 부족 등 여전히 큰 과제가 남아 있습니다. 이러한 상황이 SSI 시장에서 혁신과 신약 승인 기회를 창출하고 있습니다.

본 SSI 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 상황에 대한 종합적인 분석을 제공합니다. SSI 환자의 부담 동향, 수익 및 시장 점유율 동향, 피크 시 환자 점유율 및 치료법 보급 현황에 대한 분석을 평가함과 동시에, 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 전망(과거 데이터 및 2022-2036년 전망)을 제시하고 있습니다. 본 보고서에서는 SSI 분야의 주요 미충족 수요 사항을 부각시키고, 경쟁 구도 및 임상 현황을 분석하여 고부가가치의 성장 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

수술 부위 감염 시장을 주도하는 주요 요인

수술 건수 증가

고령화, 만성 질환 유병률의 상승, 그리고 의료 서비스에 대한 접근성 확대에 힘입어 전 세계적으로 수술 건수가 증가하고 있는 만큼, 수술 후 감염(SSI) 위험에 노출된 인구는 계속해서 늘어나고 있습니다.

항생제 내성에 대한 우려 고조

메티실린 내성 황색포도상구균(MRSA) 및 다제내성균을 포함한 항생제 내성 병원체의 출현으로 인해, 기존 항생제에 대한 의존도를 낮추는 혁신적인 수술부위 감염(SSI) 예방 기술에 대한 관심이 높아지고 있습니다.

규제 및 품질 관리 노력 강화

정부 기관, 의료 기관 및 인증 기관은 더욱 엄격한 감염 관리 지침과 품질 평가 기준을 도입하고 있으며, 의료 종사자들에게 선진적인 수술 관련 감염(SSI) 예방 대책의 도입을 장려하고 있습니다.

수술 부위 감염(SSI)에 대한 이해와 치료 알고리즘

수술 부위 감염(SSI)의 개요와 진단

SSI란 수술 후 30일 이내, 또는 임플란트가 식립된 경우에는 1년 이내에 수술 부위나 그 주변에서 발생하는 감염증을 말합니다. SSI는 의료 관련 감염증 중 가장 흔한 유형 중 하나이며, 피부, 피하 조직, 심부 연부 조직, 장기 또는 수술 부위까지 확산될 가능성이 있습니다. 일반적인 원인균으로는 황색포도상구균, 코아글라제 음성 포도상구균, 엔테로코커스속 및 그람 음성균이 포함됩니다. SSI는 입원 기간의 장기화, 의료비 증가, 재수술, 그리고 발병률 및 사망률의 상승으로 이어질 가능성이 있습니다.

SSI 진단은 주로 임상 평가를 바탕으로 이루어집니다. 일반적인 징후 및 증상으로는 수술 부위의 발적, 부종, 열감, 통증 및 압통, 고름 배출, 상처 열개, 발열 등이 있습니다. 상처 삼출액이나 조직 검체에서 채취한 미생물 배양 검사는 원인 병원체를 규명하고 항균제 치료의 지침을 마련하는 데 도움이 됩니다. 심부 절개부 감염이나 장기·공간 감염이 의심되는 경우, 초음파 검사, 컴퓨터 단층촬영(CT) 또는 자기공명영상(MRI) 등의 영상 진단법이 사용될 수 있습니다.

현재 수술 부위 감염(SSI)의 치료 현황

SSI의 치료는 감염의 중증도와 범위에 따라 달라집니다. 경미한 표재성 감염은 상처 부위 관리와 표적 항균제 요법으로 조절할 수 있는 경우도 있지만, 심부 감염이나 장기·공간 감염의 경우 대부분 외과적 배농, 데브리드먼트 또는 추가적인 수술적 개입이 필요합니다. 경험적 항생제 요법은 일반적으로 추정되는 병원체를 바탕으로 시작되며, 이후 배양 결과에 따라 조정됩니다. 수술 전후 항생제 예방 투여, 비강 살균, 적절한 피부 소독, 그리고 국소 항생제 전달 및 광소독 요법 등의 신기술을 포함한 예방 전략은 수술 부위 감염(SSI) 발생률을 낮추고 수술 예후를 개선하는 데 매우 중요한 역할을 하고 있습니다.

수술 부위 감염(SSI)의 역학

SSI에 대한 역학 분석 및 예측을 통해 도출된 주요 결과

  • 세계보건기구(WHO)가 중대한 세계 보건 문제로 인식하고 있는 수술 후 감염(SSI)은 환자의 예후를 극적으로 악화시킵니다. SSI가 발생한 환자는 SSI가 발생하지 않은 환자에 비해 사망할 확률이 2배, 중환자실 치료가 필요할 확률이 60% 더 높으며, 재입원할 확률은 5배 더 높습니다.
  • 유럽에서는 수술의 약 5%에서 수술 부위 감염(SSI)이 발생하고 있으나, 그 발생률은 수술 유형에 따라 크게 다릅니다.
  • 수술을 받은 환자에서 수술 부위 감염(SSI)의 발생률은 1-3%로 추정됩니다.
  • SSI는 높은 사망률 및 유병률과 관련이 있으며, 의료 자원에 막대한 부담을 주기 때문에 여전히 중대한 임상적 문제로 남아 있습니다. SSI 발생률은 수술의 유형, 적용되는 감시 기준, 그리고 데이터 수집의 질에 따라 20%에 달할 수도 있습니다.
  • SSI의 발생률은 수술 유형을 포함한 여러 요인에 따라 2-15% 범위 내에서 변동합니다.

수술 부위 감염 시장 전망

SSI 치료 방식은 기존의 전신 항생제 예방 투여에 의존하던 방식에서 유효성을 높이는 동시에 항생제 내성과 의료비를 절감하도록 설계된 혁신적인 감염 예방 기술로 점차 전환되고 있습니다.

현재의 SSI 관리에는 확립된 감염 관리 대책 외에도 세파졸린, 세폭시틴, 반코마이신 등의 수술 전후 항균제에 여전히 크게 의존하고 있습니다. 일본에서는 SSI 위험을 줄이기 위한 수술 전 피부 소독제로 승인된 오라넥시딘 글루코네이트가 현재 SSI 전용으로 승인된 유일한 제품입니다. 그러나 특히 고위험 수술의 경우, 여전히 돌파 감염이 계속 발생하고 있습니다. 그 결과, 감염 위험을 근본적으로 해결하는 표적 중심의 접근법에 대한 관심이 높아지고 있습니다.

새로운 치료법 중에서도 D-PLEX100은 개발이 가장 진전된 파이프라인 자산 중 하나로, 수술 부위에서 최대 30일 동안 독시사이클린을 지속적으로 국소 방출하는 능력이 입증되어, 전신에 대한 항생제 노출을 제한하면서도 수술 후 감염을 줄일 가능성이 있습니다. STERIWAVE는 비강 내 광소독 기술을 활용하여 수술 전에 비강 내 병원체를 근절함으로써, 세균의 정착으로 인한 수술 후 감염 위험을 줄여주는 차별화된 비항생제 치료법입니다. XF-73은 수술 전에 MRSA(수술 부위 감염의 주요 원인)를 포함한 황색포도상구균을 신속하게 제거하도록 설계된, 동종 최초의 비강 내 항균제입니다.

SSI 시장은 기존의 예방적 항생제 사용을 보완하고, 환자의 예후를 개선하며, 재입원을 줄이고, 항생제 적정 사용 노력을 지원하는 기술에 의해 주도될 것으로 예측됩니다. 이러한 신제품들이 후기 임상시험에서 양호한 결과를 보여주고 규제 당국의 승인을 받을 수 있다면, 고위험 수술 환경에서 새로운 치료 기준을 확립함으로써 수술 부위 감염(SSI) 예방 현황을 크게 바꿀 가능성이 있습니다.

  • 비구아나이드계 항균제 : 오라넥시딘 글루코네이트는 수술 후 감염(SSI)을 예방하기 위한 수술 전 피부 소독용으로 개발된 새로운 비구아나이드계 소독제입니다. 세균의 세포막을 파괴함으로써 신속하고 광범위한 살균 작용을 발휘하며, 다양한 병원체에 대해 효과적입니다.
  • 국소 항균제 전달 시스템 : D-PLEX100은 국소 항균제 전달 시스템으로 분류됩니다. 이 회사의 독자적인 PLEX 기술을 활용하여, D-PLEX100은 수술 부위에서 최대 30일 동안 독시사이클린을 지속적이고 제어된 방식으로 방출합니다.
  • 비강 살균용 항균제 : XF-73은 수술 전에 비강 내에 투여되는 최초의 합성 포르피린계 항균제로, MRSA를 포함한 황색포도상구균을 신속하게 박멸합니다.

수술 부위 감염(SSI) 대책의 혁신은 국소적 항생제 전달, 비항생제 기반 감염 관리 기술, 그리고 표적화된 살균 전략의 결합을 통해 점점 더 가속화되고 있습니다. 이러한 다양화로 인해 수술 성과 향상, 의료 관련 감염 부담 경감, 항생제 적정 사용 노력에 대한 지원이 기대되며, 예측 기간 동안 SSI 예방 시장의 성장을 견인할 것으로 전망됩니다.

자주 묻는 질문

  • 수술 부위 감염(SSI)의 발생 원인은 무엇인가요?
  • 수술 부위 감염(SSI)의 예방을 위해 어떤 조치가 필요한가요?
  • 수술 부위 감염(SSI) 치료에 사용되는 주요 약물은 무엇인가요?
  • 수술 부위 감염(SSI)의 발생률은 어떻게 되나요?
  • 수술 부위 감염(SSI) 시장의 주요 성장 요인은 무엇인가요?
  • 수술 부위 감염(SSI) 예방을 위한 혁신적인 기술은 무엇인가요?
  • 수술 부위 감염(SSI) 치료의 현재 상황은 어떤가요?

목차

제1장 주요 인사이트

제2장 서론

제3장 수술 부위 감염 : 주요 요약

제4장 주요 이벤트

제5장 수술 부위 감염 : 역학 및 시장 조사 방법

제6장 수술 부위 감염 : 시장 개요

제7장 수술 부위 감염 : 질환 배경 및 개요

제8장 수술 부위 감염 : 역학 및 환자 인구

제9장 수술 부위 감염 : 환자 경과

제10장 시판 치료제

제11장 신흥 치료법

제12장 수술 부위 감염 : 주요 7개국 분석

제13장 수술 부위 감염 : 미충족 수요

제14장 수술 부위 감염 : SWOT 분석

제15장 수술 부위 감염 : KOL(Key Opinion Leader)의 견해

제16장 시장 참여 및 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight에 대해

KTH

Surgical Site Infections (SSI) Insights and Trends

  • SSIs are among the most common healthcare-associated infections, occurring within 30 days of surgery and resulting from microbial contamination of the surgical wound.
  • The burden of SSI remains substantial despite advances in surgical techniques and infection-control practices. The incidence varies by procedure type and patient risk factors, accounting for approximately 20% of all healthcare-associated infections in many developed healthcare systems, making SSI prevention a major public health priority.
  • The ASEPSIS score is a validated, objective clinical scoring system used to assess the severity of surgical wound infections. It integrates parameters such as wound appearance, antibiotic use, drainage of pus, isolation of pathogenic bacteria, and length of hospital stay.
  • Incorporation of appropriate perioperative antibiotic prophylaxis, antiseptic surgical site preparation, and proper postoperative wound care has been shown to prevent up to 55% of SSI.
  • Current standard of care is primarily preventive and relies on perioperative antibiotic prophylaxis, antiseptic skin preparation, sterile surgical techniques, and postoperative wound management. Commonly used antibiotics include cefazolin, vancomycin, clindamycin, and other procedure-specific prophylactic agents.
  • The only approved drug for SSI is olanexidine gluconate (OLANEDINE), made by Otsuka Pharmaceutical, with regulatory approval limited in Japan. No SSI-specific therapies have been approved in the United States, Europe, or other major markets, highlighting a substantial unmet need for effective preventive interventions to reduce postoperative infections and associated healthcare burden worldwide.
  • SSIs remain a significant healthcare burden even in developed countries. In the United States, SSIs contribute to over 400,000 additional hospitalization days each year, resulting in an estimated annual excess cost of USD 900 million.
  • The pharmaceutical and biotechnology companies involved in the emerging SSI pipeline include PolyPid (D-PLEX100), AMR Bio (XF-73), among others, reflecting growing industry interest in differentiated infection-prevention technologies beyond conventional systemic antibiotics.
  • Among emerging therapies, D-PLEX100 has demonstrated promising efficacy in reducing postoperative SSI rates through prolonged local doxycycline release at the surgical site.
  • Despite ongoing innovation, significant challenges remain, including antimicrobial resistance, variability in SSI risk across surgical procedures, lack of dedicated SSI-specific approved products which is creating opportunitites in the SSI market for innovation & new drug approvals.

DelveInsight's 'Surgical Site Infections (SSI) - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the SSI, historical and forecasted epidemiology, as well as the SSI market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The SSI market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates SSI patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in SSI and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Surgical Site Infections (SSI) Market

Growing Surgical Procedure Volume

The increasing number of surgical procedures worldwide, driven by aging populations, rising prevalence of chronic diseases, and expanding access to healthcare services, continues to increase the population at risk for SSIs.

Growing Concerns About Antimicrobial Resistance

The emergence of antibiotic-resistant pathogens, including methicillin-resistant staphylococcus aureus (MRSA) and multidrug-resistant organisms, is driving interest in innovative SSI prevention technologies that reduce reliance on conventional antibiotics.

Increasing Regulatory and Quality Initiatives

Government agencies, healthcare organizations, and accreditation bodies are implementing stricter infection-control guidelines and quality metrics, encouraging healthcare providers to adopt advanced SSI prevention measures.

Surgical Site Infections (SSI) Understanding and Treatment Algorithm

Surgical Site Infections (SSI) Overview and Diagnosis

SSI are infections that occur at or near a surgical incision within 30 days of a procedure, or within one year if an implant is placed. SSI is among the most common healthcare-associated infections and can involve the skin, subcutaneous tissue, deep soft tissues, organs, or surgical spaces. Common causative pathogens include staphylococcus aureus, coagulase-negative staphylococci, enterococcus species, and gram-negative bacteria. SSI can lead to prolonged hospitalization, increased healthcare costs, reoperations, and higher morbidity and mortality.

The diagnosis of SSI is primarily based on clinical evaluation. Common signs and symptoms include redness, swelling, warmth, pain or tenderness at the surgical site, purulent drainage, wound dehiscence, and fever. Microbiological cultures obtained from wound exudates or tissue samples help identify the causative pathogen and guide antimicrobial therapy. Imaging modalities such as ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI) may be utilized when deep incisional or organ/space infections are suspected.

Current Surgical Site Infections (SSI) Treatment Landscape

Treatment of SSI depends on the severity and extent of infection. Mild superficial infections may be managed with wound care and targeted antibiotic therapy, whereas deep or organ/space infections often require surgical drainage, debridement, or additional operative intervention. Empiric antibiotic therapy is typically initiated based on the likely pathogens and later adjusted according to culture results. Preventive strategies, including perioperative antibiotic prophylaxis, nasal decolonization, proper skin antisepsis, and emerging technologies such as localized antimicrobial delivery and photodisinfection therapies, play a critical role in reducing SSI incidence and improving surgical outcomes.

Surgical Site Infections (SSI) Unmet Needs

The section "unmet needs of SSI" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Persistent SSI burden despite standard prophylaxis

2. Antimicrobial resistance concerns

3. Lack of targeted therapies specifically approved for SSI prevention

4. Challenges in high-risk patient populations, and others.....

Surgical Site Infections (SSI) Epidemiology

Key Findings from SSI Epidemiological Analysis and Forecast

  • Recognized by the World Health Organization (WHO) as a significant global health issue, SSIs dramatically worsen patient outcomes, individuals who develop an SSI are twice as likely to die, 60% more likely to require intensive care, and five times more likely to be readmitted to the hospital than patients without an SSI.
  • In Europe, SSI occur in roughly 5% of operations, although incidence varies significantly by procedure.
  • The incidence of SSIs among surgical patients is estimated to range from 1-3%.
  • SSIs remain a significant clinical problem as they are associated with substantial mortality and morbidity and impose severe demands on healthcare resources. The incidence of SSIs may be as high as 20%, depending on the surgical procedure, the surveillance criteria used, and the quality of data collection.
  • The incidence rate of SSIs vary from 2-15% depending on multiple factors, including the type of operation.

Surgical Site Infections (SSI) Drug Analysis & Competitive Landscape

The SSI drug chapter provides a detailed, market-focused review of the emerging pipeline across Phase III/II-III clinical trials and preclinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the SSI treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the SSI therapeutics market.

Approved Therapies for Surgical Site Infections (SSI)

Olanexidine gluconate (OLANEDINE): Otsuka Pharmaceutical

Olanexidine gluconate is a topical antiseptic agent approved in Japan for skin disinfection prior to surgery and invasive medical procedures, with the goal of reducing the risk of SSI. It exhibits broad-spectrum bactericidal activity against gram-positive and gram-negative pathogens. Since its approval in Japan in 2015, olanexidine gluconate has been incorporated into routine surgical antisepsis practices and is regarded as an important alternative to conventional skin disinfectants.

Surgical Site Infections (SSI) Pipeline Analysis

D-PLEX100: Polypid

D-PLEX100 is built on the company's proprietary Kynatrix technology. In the SHIELD II study, D-PLEX100 demonstrated a statistically significant 60% reduction in incisional SSIs compared with standard of care alone. The therapy works against both gram-positive and gram-negative bacteria. D-PLEX100 was granted FDA Fast Track Designation (FTD), Breakthrough Therapy Designation (BTD), and Qualified Infectious Disease Product (QIDP) designations. The company anticipates a potential FDA decision in the Q1 of 2027 under the Prescription Drug User Fee Act ("PDUFA") review timeline.

XF-73: AMR Bio

XF-73 is a first-in-class topical antimicrobial nasal gel designed for the prevention of SSIs, particularly those caused by staphylococcus aureus, including MRSA. AMR Bio is advancing XF-73 toward Phase III development as a pre-surgical decolonization therapy. The candidate has received both QIDP designation and FTD from the US FDA, recognizing its potential to address a serious unmet need in the prevention of post-surgical bacterial infections and antimicrobial resistance.

Surgical Site Infections (SSI) Key Players, Market Leaders and Emerging Companies

  • Otsuka Pharmaceutical
  • Polypid
  • AMR Bio, and others

Surgical Site Infections (SSI) Drug Updates

  • In June 2026, PolyPid announced the successful completion of its NDA submission on a rolling review basis to the US FDA for D-PLEX100 for the prevention of SSIs in patients undergoing colorectal surgery.
  • In May 2026, PolyPid announced that it presented at the 45th Annual Meeting of the Surgical Infection Society. The presentation focused on a detailed analysis of the ASEPSIS (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and prolonged Stay as inpatient) score data from the company's Phase III SHIELD II trial of D-PLEX100.
  • In May 2026, AMR Bio announced that they are advancing XF-73 towards Phase III development.
  • In April 2026, PolyPid announced that the company presented new pharmacokinetic data from the Phase III SHIELD II trial evaluating D-PLEX100 at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global 2026.
  • In March 2026, Ondine has announced the North American phase III study has reached more than 93% enrolment, bringing the company closer to FDA submission.

Surgical Site Infections (SSI) Market Outlook

The treatment landscape for SSI is undergoing a gradual shift from reliance on conventional systemic antibiotic prophylaxis toward innovative infection-prevention technologies designed to improve efficacy while reducing antimicrobial resistance and healthcare costs.

Current SSI management remains largely dependent on perioperative antibiotics such as cefazolin, cefoxitin, and vancomycin, along with established infection-control practices. Olanexidine gluconate approved in Japan for preoperative skin antisepsis to reduce SSI risk, is currently the sole SSI-specific approved product. However, breakthrough infections continue to occur, particularly in high-risk surgical procedures. As a result, there is growing interest in targeted approaches that address infection risk at its source.

Among emerging therapies, D-PLEX100 is one of the most advanced pipeline assets and has demonstrated the ability to provide sustained local doxycycline release at the surgical site for up to 30 days, potentially reducing postoperative infections while limiting systemic antibiotic exposure. STERIWAVE represents a differentiated non-antibiotic approach that utilizes nasal photodisinfection technology to eradicate pathogens in the nasal cavity before surgery, thereby reducing the risk of postoperative infections associated with bacterial colonization. XF-73, is a first-in-class intranasal antimicrobial designed to rapidly decolonize staphylococcus aureus, including MRSA (a leading cause of SSIs) prior to surgery.

The SSI market is expected to be driven by technologies that complement existing prophylactic antibiotics, improve patient outcomes, reduce hospital readmissions, and support antimicrobial stewardship initiatives. Successful late-stage clinical outcomes and regulatory approvals for these emerging products could significantly reshape the SSI prevention landscape by establishing new standards of care in high-risk surgical settings.

Drug Class/Insights into Leading Emerging and Marketed Therapies in SSI (2022-2036 Forecast)

The SSI market (2022-2036 forecast) is evolving from a landscape dominated by conventional perioperative antibiotic prophylaxis toward innovative infection-prevention technologies.

  • Biguanide-based Antimicrobial Agent: Olanexidine gluconate is a novel biguanide antiseptic developed for preoperative skin disinfection to prevent SSIs. It exerts rapid and broad-spectrum bactericidal activity by disrupting bacterial cell membranes and is active against a wide range of pathogens.
  • Localized Antibiotic Delivery Systems: D-PLEX100 belongs to the localized antibiotic delivery class. Utilizing the company's proprietary PLEX technology, D-PLEX100 provides sustained, controlled release of doxycycline directly at the surgical site for up to 30 days.
  • Nasal Decolonization Antimicrobials: XF-73 is a first-in-class synthetic porphyrin-based antimicrobial administered intranasally before surgery to rapidly eradicate Staphylococcus aureus, including MRSA.

SSI innovation is increasingly being driven by a combination of localized antimicrobial delivery, non-antibiotic infection-control technologies, and targeted decolonization strategies. This diversification is expected to enhance surgical outcomes, reduce healthcare-associated infection burdens, support antimicrobial stewardship initiatives, and drive growth in the SSI prevention market throughout the forecast period.

Surgical Site Infections (SSI) Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the SSI drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.

Among emerging SSI therapies, D-PLEX100 is expected to achieve strong uptake in high-risk surgical settings, supported by positive Phase III SHIELD II results that demonstrated a 60% relative risk reduction in SSI compared with standard of care. Its ability to provide sustained local doxycycline release at the surgical site for up to 30 days offers a differentiated approach that addresses limitations of conventional perioperative antibiotics. XF-73 is expected to compete in the nasal decolonization segment due to its rapid activity against staphylococcus aureus. If ongoing clinical development confirms meaningful reductions in SSI incidence, XF-73 could emerge as a valuable preoperative intervention for patients at elevated risk of postoperative infections.

The uptake of emerging SSI therapies will be largely determined by their ability to demonstrate clinically meaningful reductions in postoperative infection rates while integrating seamlessly into existing surgical workflows.

Detailed insights of emerging therapies' drug uptake is included in the report

Market Access and Reimbursement of Approved therapies in Surgical Site Infections (SSI)

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

NOTE: Further Details are provided in the final report....

Surgical Site Infections (SSI) Therapies Price Scenario & Trends

Pricing and analogue assessment of SSI therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.

Industry Experts and Physician Views for Surgical Site Infections (SSI)

To keep up with SSI market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the SSI emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in SSI, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 15+ KOLs to gather insights at the country level. Centers such as Duke University Medical Center, University Hospital Cologne, and University Hospital of Bordeaux etc. were contacted. Their opinion helps understand and validate current and emerging SSI therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in SSI.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of SSI, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of SSI, explaining their causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the SSI market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM SSI market.

Report Insights

  • Surgical Site Infections (SSI) Patient Population Forecast
  • Surgical Site Infections (SSI) Therapeutics Market Size
  • Surgical Site Infections (SSI) Pipeline Analysis
  • Surgical Site Infections (SSI) Market Size and Trends
  • Surgical Site Infections (SSI) Market Opportunity (Current and Forecasted)

Report Key Strengths

  • Epidemiology-based (Epi-based) Bottom-up Forecasting
  • Artificial Intelligence (AI)-Enabled Market Research Report
  • 11-Year Forecast
  • Surgical Site Infections (SSI) Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (By Geography)
  • Surgical Site Infections (SSI) Treatment Addressable Market (TAM)
  • Surgical Site Infections (SSI) Competitive Landscape
  • Surgical Site Infections (SSI) Major Companies Insights
  • Surgical Site Infections (SSI) Price Trends and Analogue Assessment
  • Surgical Site Infections (SSI) Therapies Drug Adoption/Uptake
  • Surgical Site Infections (SSI) Therapies Peak Patient Share Analysis

Report Assessment

  • Surgical Site Infections (SSI) Current Treatment Practices
  • Surgical Site Infections (SSI) Unmet Needs
  • Surgical Site Infections (SSI) Clinical Development Analysis
  • Surgical Site Infections (SSI) Emerging Drugs Product Profiles
  • Surgical Site Infections (SSI) Market attractiveness
  • Surgical Site Infections (SSI) Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

  • What was the SSI market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of SSI?
  • What are the disease risks, burdens, and unmet needs of SSI? What will be the growth opportunities across the 7MM concerning the patient population with SSI?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of SSI? What are the current guidelines for treating SSI in the US, Europe, and Japan?

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the SSI market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
  • This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets with in the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Surgical Site Infections (SSI)

4. Key Events

  • 4.1. Upcoming Key Catalyst
  • 4.2. Key Conferences And Meetings
  • 4.3. Key Transactions And Collaborations
  • 4.4. News Flow

5. Epidemiology and Market Methodology of Surgical Site Infections (SSI)

6. Surgical Site Infections (SSI) Market Overview at a Glance

  • 6.1. Clinical Landscape Analysis (By Molecule Type, Phase, and Route of Administration [ROA])
  • 6.2. Market Share of Surgical Site Infections (SSI) By Therapies (%) in the 7MM in 2025
  • 6.3. Market Share of Surgical Site Infections (SSI) By Therapies (%) in the 7MM in 2036

7. Disease Background And Overview of Surgical Site Infections (SSI)

  • 7.1. Introduction
  • 7.2. Causes
  • 7.3. Signs And Symptoms
  • 7.4. Diagnosis
    • 7.4.1. Differential Diagnosis
    • 7.4.2. Diagnostic Algorithm
  • 7.5. Treatment and Management
    • 7.5.1. Treatment Algorithm

8. Epidemiology and Patient Population of Surgical Site Infections (SSI)

  • 8.1. Key Findings
  • 8.2. Assumption and Rationale
  • 8.3. Total Incident Cases of Surgical Site Infections (SSI) in the 7MM
  • 8.4. The United States
    • 8.4.1. Total Incident Cases of Surgical Site Infections (SSI) in the United States
    • 8.4.2. Type-specific Incident Cases of Surgical Site Infections (SSI) in the United States
    • 8.4.3. Organ-specific Incident Cases of Surgical Site Infections (SSI) in the United States
    • 8.4.4. Treatable Cases of Surgical Site Infections (SSI) in the United States
  • 8.5. EU4 and the UK
    • 8.5.1. Total Incident Cases of Surgical Site Infections (SSI) in EU4 and the UK
    • 8.5.2. Type-specific Incident Cases of Surgical Site Infections (SSI) in EU4 and the UK
    • 8.5.3. Organ-specific Incident Cases of Surgical Site Infections (SSI) in EU4 and the UK
    • 8.5.4. Treatable Cases of Surgical Site Infections (SSI) in EU4 and the UK
  • 8.6. Japan
    • 8.6.1. Total Incident Cases of Surgical Site Infections (SSI) in Japan
    • 8.6.2. Type-specific Incident Cases of Surgical Site Infections (SSI) in Japan
    • 8.6.3. Organ-specific Incident Cases of Surgical Site Infections (SSI) in Japan
    • 8.6.4. Treatable Cases of Surgical Site Infections (SSI) in Japan

9. Patient Journey of Surgical Site Infections (SSI)

10. Marketed Therapies

  • 10.1. Marketed Competitive Landscape of Surgical Site Infections (SSI)
  • 10.2. Olanexidine gluconate (OLANEDINE): Otsuka Pharmaceutical
    • 10.2.1. Product Description
    • 10.2.2. Regulatory Milestones
    • 10.2.3. Other Developmental Activities
    • 10.2.4. Summary of Pivotal Trials
    • 10.2.5. Analyst Views

11. Emerging Therapies

  • 11.1. Emerging Competitive Landscape of Surgical Site Infections (SSI)
  • 11.2. D-PLEX100: Polypid
    • 11.2.1. Product Description
    • 11.2.2. Other Developmental Activities
    • 11.2.3. Clinical Development
      • 11.2.3.1. Clinical Trial Information
    • 11.2.4. Safety and Efficacy
    • 11.2.5. Analyst Views
  • 11.3. XF-73: AMR Bio
    • 11.3.1. Product Description
    • 11.3.2. Other Developmental Activities
    • 11.3.3. Clinical Development
      • 11.3.3.1. Clinical Trial Information
    • 11.3.4. Safety and Efficacy
    • 11.3.5. Analyst Views

12. Surgical Site Infections (SSI): Seven Major Market Analysis

  • 12.1. Key Findings
  • 12.2. Market Outlook of Surgical Site Infections (SSI)
  • 12.3. Conjoint Analysis of Surgical Site Infections (SSI)
  • 12.4. Key Market Forecast Assumptions
    • 12.4.1. Cost Assumptions
    • 12.4.2. Pricing Trends
    • 12.4.3. Analogue Assessment
    • 12.4.4. Launch Year and Therapy Uptakes
  • 12.5. Total Market Size of Surgical Site Infections (SSI) in the 7MM
  • 12.6. The United States
    • 12.6.1. Total Market Size of Surgical Site Infections (SSI) in the United States
    • 12.6.2. Market Size of Surgical Site Infections (SSI) by Therapies in the United States
  • 12.7. EU4 and the UK
    • 12.7.1. Total Market Size of Surgical Site Infections (SSI) in EU4 and the UK
    • 12.7.2. Market Size of Surgical Site Infections (SSI) by Therapies in EU4 and the UK
  • 12.8. Japan
    • 12.8.1. Total Market Size of Surgical Site Infections (SSI) in Japan
    • 12.8.2. Market Size of Surgical Site Infections (SSI) by Therapies in Japan

13. Unmet Needs of Surgical Site Infections (SSI)

14. SWOT Analysis of Surgical Site Infections (SSI)

15. KOL Views of Surgical Site Infections (SSI)

  • 15.1. Expert/KOL Interview Highlights

16. Market Access and Reimbursement

  • 16.1. The US
  • 16.2. In EU4 and the UK
    • 16.2.1. Germany
    • 16.2.2. France
    • 16.2.3. Italy
    • 16.2.4. Spain
    • 16.2.5. United Kingdom
  • 16.3. Japan
  • 16.4. Summary and Comparison of Market Access and Pricing Policy Developments in 2025
  • 16.5. Market Access and Reimbursement of Surgical Site Infections (SSI) Therapies

17. Appendix

  • 17.1. Bibliography
  • 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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