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시장보고서
상품코드
2082984
수술 부위 감염 : 시장 인사이트, 역학 및 예측(2036년)Surgical Site Infections - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
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 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)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.
SSI에 대한 역학 분석 및 예측을 통해 도출된 주요 결과
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.
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.
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) 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.
Key Findings from SSI Epidemiological Analysis and Forecast
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
Surgical Site Infections (SSI) Drug Updates
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.
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.
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