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시장보고서
상품코드
2082974
침습성 폐렴구균 질환 : 시장 인사이트, 역학 및 예측(2036년)Invasive Pneumococcal Disease - Market Insight, Epidemiology, and Market Forecast -2036 |
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DelveInsight
본 침습성 폐렴구균 질환 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 현황에 대한 종합적인 분석을 제공합니다. 또한, IPD 환자의 부담 동향, 매출액 및 시장 점유율 동향, 피크 시기의 환자 점유율 및 치료 도입률 분석을 평가함과 동시에, 전 세계 각 지역 시장 규모에 대한 상세한 평가와 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제시하고 있습니다. 본 보고서에서는 IPD 분야의 주요 미충족 수요 사항을 부각시키고, 경쟁 구도 및 임상 현황을 정리하여 고부가가치의 성장 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.
침습성 폐렴구균 질환(IPD)의 발생률 증가
특히 남성의 IPD 유병률 증가는 침습성 폐렴구균 질환 시장 확대를 이끄는 주요 요인입니다. 이는 고령자, 면역결핍자 및 만성 합병증을 가진 환자들 사이에서 폐렴구균 질환의 부담이 증가하고 있는 데 기인하며, 효과적인 백신 접종 및 예방 전략에 대한 수요가 계속해서 높아지고 있습니다.
선진적인 폐렴구균 백신 개발 분야의 기회 확대
IPD의 부담 증가와 폐렴구균 혈청형의 출현으로 인해, 질병 예방을 강화하고 고위험군의 감염률을 낮추기 위한, 더 광범위한 범위를 커버하는 백신의 개발 기회가 생겨나고 있습니다.
침습성 폐렴구균 질환(IPD)의 개요 및 진단
IPD는 폐렴구균(Streptococcus pneumoniae)에 의해 유발되는 중증 세균성 감염증으로, 세균이 혈액, 뇌척수액, 폐 등 일반적으로 무균 상태를 유지해야 하는 부위로 침입함으로써 심각한 합병증과 높은 발병률 및 사망률을 초래합니다. 일반적인 증상으로는 균혈증, 수막염, 균혈증성 폐렴 등이 있으며, 대부분의 경우 영유아, 고령자, 면역결핍자에게서 발병합니다. 위험 요인으로는 만성 질환, 면역력 저하, 흡연, 낮은 백신 접종률 등이 있습니다.
IPD의 진단은 임상 평가, 미생물학적 검사, 그리고 혈액이나 뇌척수액 등 일반적으로 무균 상태인 부위에서 폐렴구균을 확인하는 과정을 통해 이루어집니다. 진단을 위한 검사에는 혈액 배양, 뇌척수액 검사, PCR 검사, 소변 항원 검사, 전혈구 계수(CBC), 염증 마커, 그리고 감염의 중증도 및 합병증을 평가하기 위한 영상 검사가 포함됩니다. 한편, 질환의 진행 상황과 환자의 위험도는 임상 증상 및 기저 질환을 바탕으로 평가됩니다.
침습성 폐렴구균 질환(IPD)의 치료
IPD 치료의 주요 목표는 폐렴구균의 신속한 박멸, 전신성 감염의 통제, 그리고 패혈증이나 수막염 등의 합병증 예방입니다. 치료는 신속한 경험적 항생제 투여(예 : 세프트리아손, 세프타자임, 중증 환자의 경우 반코마이신)를 실시한 후, 배양 결과를 바탕으로 한 표적 치료로 전환합니다. 수막염의 경우, 염증성 손상을 완화하기 위해 보조적으로 코르티코스테로이드를 투여하기도 하지만, 중증 환자의 경우 중환자실(ICU)에서의 지지 요법(산소 공급, 수액 요법, 혈압 상승제 투여)이 필수적입니다. 고위험군에서 IPD 발생률을 낮추기 위한 주요 예방 전략은 여전히 백신 접종입니다.
침습성 폐렴구균 질환(IPD)의 역학적 분석 및 예측에 관한 주요 조사 결과
침습성 폐렴구균 질환 시장은 주로 PCV의 적용 범위가 지속적으로 발전하고 확대됨에 따라, 더 광범위한 혈청형에 대한 보호와 성인 및 소아의 질병 부담 예방 및 개선에 중점을 두는 가운데, 꾸준한 전환기를 맞이하고 있습니다. 현재 이 시장은 PCV13(PREVNAR13), PCV15(VAXNEUVANCE), PCV20(PREVNAR/APEXXNAR), PCV21(CAPVAXIVE) 등의 기존 및 차세대 백신이 주도하고 있으며, 이들은 혈청형 커버 범위를 확대하고 백신 미포함 혈청형에 의한 잔존 질환에 대처함으로써 예방접종 전략을 재구축하고 있습니다. 또한, SP0202, PF-07872412(25vPnC), GSK5459248 등 개발 중인 후보 약물은 예방 범위의 확대와 폐렴구균 질환의 장기적인 관리 향상을 위한 지속적인 노력을 더욱 부각시키고 있습니다.
고가의 백신과 더 광범위한 집단에 대한 접종률에 대한 관심이 높아지는 가운데, 침습성 폐렴구균 질환(IPD)의 현황은 특히 고위험군인 소아, 고령자 및 면역결핍 환자에서 잔존하는 침습성 질환을 줄이기 위한 차세대 예방 전략으로 전환되고 있습니다. 가수(valency)가 확대된 폐렴구균 백신(PCV)의 도입과 보급은 특히 질병 부담이 크고 혈청형 분포가 변화하고 있는 지역에서 예방접종 정책, 경쟁적 위치, 그리고 전 세계 예방접종 프로그램에 큰 영향을 미칠 것으로 예측됩니다.
전반적으로, 고가 폐렴구균 백신의 지속적인 발전과 더불어, 개발 중인 파이프라인의 혁신 및 세균성 감염증 예방에 대한 전 세계적인 관심 증대가 맞물려 침습성 폐렴구균 질환 시장의 지속적인 성장을 견인할 것으로 예측됩니다. 이처럼 끊임없이 변화하는 상황은 기존 백신 제조업체와 차세대 폐렴구균 예방 전략에 주력하는 신흥 개발 기업 모두에게 큰 상업적 기회를 제공합니다.
백신(PCV 및 PPSV) : 폐렴구균 결합형 백신(예 : PCV13, PCV15, PCV20 및 고가수 후보 백신)과 다당류 백신(PPSV23)은 폐렴구균 캡슐 다당류에 대한 혈청형 특이적 항체 반응을 유도함으로써, 옵소노파고시토시스를 통한 살균 작용을 강화하고, 정착 및 침습성 질환을 예방합니다.
전반적으로, 현재 IPD의 관리 및 예방 분야에서는 백신과 항생제가 주류를 이루고 있지만, 한편으로는 더 광범위한 새로운 예방접종 전략과 신규 생물학적 제제가 등장하고 있으며, 이들은 예방접종률 향상, 약물 내성의 영향 완화, 침습성 질환의 부담 경감을 목표로 하는 미래의 혁신을 주도하고 있습니다.
DelveInsight's 'Invasive Pneumococcal Disease (IPD)- Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the IPD, historical and forecasted epidemiology, as well as the IPD market trends in the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.
The IPD market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates IPD 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 IPD 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 Invasive Pneumococcal Disease (IPD) Market
Rising Invasive Pneumococcal Disease (IPD) Incidence
The increasing incidence of IPD, particularly among males, is a primary driver of IPD market expansion, supported by the rising burden of pneumococcal infections among older adults, immunocompromised individuals, and patients with chronic comorbidities, which continues to increase demand for effective vaccination and preventive strategies.
Rising Opportunities in Advanced Pneumococcal Vaccine Development
The growing burden of IPD and the emergence of pneumococcal serotypes are creating opportunities to develop broader-coverage vaccines to enhance disease prevention and reduce infection rates in high-risk populations.
Emerging Invasive Pneumococcal Disease (IPD) Competitive Landscape
The IPD landscape is advancing with the development of next-generation pneumococcal vaccines. Key emerging therapies include SP0202 (Sanofi/SK Bioscience), PF-07872412 (25vPnC) (Pfizer), and GSK5459248 (GSK), which aim to expand serotype coverage and improve protection against invasive pneumococcal disease.
Invasive Pneumococcal Disease (IPD) Overview and Diagnosis
IPD is a severe bacterial infection caused by Streptococcus pneumoniae in which the bacteria invade normally sterile body sites such as the blood, cerebrospinal fluid, or lungs, leading to serious complications and high morbidity and mortality. Common manifestations include bacteremia, meningitis, and bacteremic pneumonia, often occurring in young children, older adults, and immunocompromised individuals, with risk factors including chronic diseases, weakened immunity, smoking, and inadequate vaccination coverage.
IPD is diagnosed through clinical evaluation, microbiological testing, and identification of Streptococcus pneumoniae from normally sterile body sites such as blood or cerebrospinal fluid. Diagnostic workup includes blood cultures, cerebrospinal fluid analysis, PCR assays, urinary antigen tests, CBC, inflammatory markers, and imaging studies to assess infection severity and complications, while disease progression and patient risk are evaluated based on clinical presentation and underlying comorbidities.
Invasive Pneumococcal Disease (IPD) Treatment
The primary goals of IPD treatment are rapid eradication of Streptococcus pneumoniae, control of systemic infection, and prevention of complications such as sepsis and meningitis. Management relies on prompt empiric antibiotics (e.g., ceftriaxone, cefotaxime, vancomycin in severe cases), followed by targeted therapy based on culture results. Adjunctive corticosteroids may be used in meningitis to reduce inflammatory injury, while supportive ICU care (oxygen, fluids, vasopressors) is essential in severe disease. Vaccination remains the key preventive strategy to reduce IPD incidence in high-risk populations.
Invasive Pneumococcal Disease (IPD) Unmet Needs
The section "unmet needs of Invasive Pneumococcal Disease (IPD)" 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 Invasive Pneumococcal Disease (IPD) Epidemiological Analysis and Forecast
Invasive Pneumococcal Disease (IPD) Drug Chapters & Competitive Analysis
The IPD drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical 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 IPD treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the IPD therapeutics market.
Approved Therapies for Invasive Pneumococcal Disease (IPD)
PCV20 (PREVNAR/APEXXNAR): Pfizer
PCV20 by Pfizer is a 20-valent pneumococcal conjugate vaccine administered by intramuscular injection to prevent IPD and pneumococcal pneumonia. The vaccine induces serotype-specific opsonising antibodies against 20 Streptococcus pneumoniae serotypes by conjugation to the CRM197 carrier protein. PCV20 first received FDA approval in 2021 and was later approved in 2023 for the prevention of IPD in infants and children aged six weeks through 17 years, as well as otitis media in younger children. The FDA also granted PREVNAR 20 Breakthrough Therapy Designation in August 2020 for the pediatric IPD indication. In February 2022, the EMA approved PCV20 for use in the European Union under the brand name APEXXNAR. The vaccine expands on PREVNAR 13 by including seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) associated with antibiotic resistance, increased disease severity, and invasive potential, which collectively accounted for an estimated 37% of IPD cases in US children under five years of age. PCV20 is primarily used as a preventive vaccination strategy in pediatric and adult populations at risk of pneumococcal infections.
PCV21 (CAPVAXIVE): Merck
PCV21, developed by Merck, is a 21-valent pneumococcal conjugate vaccine approved for active immunization against IPD and pneumococcal pneumonia in adults aged 18 years and older. Administered as a single intramuscular dose, CAPVAXIVE works by inducing serotype-specific opsonophagocytic antibody responses against 21 Streptococcus pneumoniae serotypes (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B), including eight unique serotypes (15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B) not covered by other approved pneumococcal vaccines. The vaccine is specifically designed to target serotypes predominantly responsible for adult IPD and has demonstrated broader serotype coverage compared to PCV20, covering approximately 84-85% of IPD cases in adults aged 50 years and older based on CDC epidemiological data. CAPVAXIVE received its first FDA approval in 2024 and is positioned as a preventive first-line vaccination strategy for adults at risk of pneumococcal disease.
Invasive Pneumococcal Disease (IPD) Pipeline Analysis
SP0202: Sanofi/SK Bioscience
SP0202, developed by Sanofi and SK Bioscience, is an investigational PCV designed to prevent pneumococcal diseases, including IPD, caused by multiple Streptococcus pneumoniae serotypes. The vaccine works by inducing serotype-specific immune responses through conjugation technology, generating functional antibodies that protect against pneumococcal infection and invasive disease. SP0202 is being evaluated in pediatric populations, including infants and toddlers, to offer broad serotype coverage, durable immune protection, and a favorable safety profile.
PF-07872412 (25vPnC): Pfizer
PF-07872412 (25vPnC), developed by Pfizer, is an investigational 25-valent pneumococcal conjugate vaccine designed to provide broad protection against IPD and other pneumococcal infections. The vaccine works by inducing serotype-specific immune responses against 25 Streptococcus pneumoniae serotypes, including those associated with significant residual disease burden. By expanding serotype coverage beyond currently available pneumococcal conjugate vaccines, PF-07872412 aims to enhance protection against pneumococcal disease while maintaining a favorable safety and immunogenicity profile.
Invasive Pneumococcal Disease (IPD) Key Players, Market Leaders and Emerging Companies
Invasive Pneumococcal Disease (IPD) Drug Updates
Drug Class Insights
The IPD market is witnessing a steady transition driven primarily by the continued evolution and expansion of PCV coverage, with a strong emphasis on broader serotype protection and improved prevention of adult and pediatric disease burden. The market is currently dominated by established and next-generation vaccines, including PCV13 (PREVNAR13), PCV15 (VAXNEUVANCE), PCV20 (PREVNAR/APEXXNAR), and PCV21 (CAPVAXIVE), which are reshaping immunization strategies by expanding serotype coverage and addressing residual disease caused by non-vaccine serotypes. In addition, emerging pipeline candidates such as SP0202, PF-07872412 (25vPnC), and GSK5459248 further highlight ongoing efforts to enhance breadth of protection and improve long-term control of pneumococcal infections.
With increased focus on higher-valency vaccines and broader population coverage, the IPD landscape is shifting toward next-generation preventive strategies to reduce residual invasive disease, particularly in high-risk pediatric, elderly, and immunocompromised populations. The introduction and adoption of expanded-valency PCVs are expected to significantly influence immunization policies, competitive positioning, and global vaccination programs, particularly in regions with high disease burden and evolving serotype distribution.
Overall, the continued advancement of higher-valency pneumococcal vaccines, coupled with ongoing pipeline innovation and the growing global emphasis on preventing bacterial infections, is expected to drive sustained growth in the IPD market. This evolving landscape presents significant commercial opportunities for both established vaccine manufacturers and emerging developers focused on next-generation pneumococcal prevention strategies.
Drug Class/Insights into Leading Emerging and Marketed Therapies in Invasive Pneumococcal Disease (IPD) (2022-2036 Forecast)
The IPD treatment and prevention landscape comprises vaccines (PCVs and PPSVs), antibiotic therapy, adjunctive anti-inflammatory therapy, supportive care therapies and emerging and preventive biologics, each targeting different stages of Streptococcus pneumoniae infection, disease progression, and host immune response.
Vaccines (PCVs and PPSVs): Pneumococcal conjugate vaccines (e.g., PCV13, PCV15, PCV20, and higher-valent candidates) and polysaccharide vaccines (PPSV23) work by inducing serotype-specific antibody responses against pneumococcal capsular polysaccharides, enhancing opsonophagocytic killing and preventing colonisation and invasive disease.
Overall, vaccines and antibiotics currently dominate the IPD management and prevention landscape, while emerging, broader-spectrum immunization strategies and novel biologics are shaping future innovation aimed at improving coverage, reducing the impact of resistance, and lowering the burden of invasive disease.
Invasive Pneumococcal Disease (IPD) 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 IPD market's uptake by drugs, patient uptake by therapy, and sales of each drug.
Established pneumococcal conjugate vaccines, such as PCV13 (PREVNAR 13) and PCV15 (VAXNEUVANCE), have demonstrated clinical efficacy, broad guideline inclusion, and widespread use in pediatric and adult immunization programs. Newer higher-valent vaccines, including PCV20 (PREVNAR/APEXXNAR) and PCV21 (CAPVAXIVE), are anticipated to witness significant market share owing to their expanded serotype coverage and potential to address residual IPD burden. Their adoption is expected to be driven by evolving vaccination recommendations, growing awareness of serotype replacement, and the need for broader protection across at-risk populations.
Market Access and Reimbursement of Invasive Pneumococcal Disease (IPD)
The report further provides detailed insights on country-wise accessibility and reimbursement scenarios, the cost-effectiveness of approved therapies, programs that make accessibility easier and out-of-pocket costs more affordable, patients insured under federal or state government prescription drug programs, etc.
Reimbursement is a crucial factor that affects a drug's market access. Often, the decision to reimburse comes down to the drug's price relative to the benefit it provides to treated patients. To reduce the healthcare burden of high-cost therapies, many payers and other industry stakeholders are considering payment models.
Invasive Pneumococcal Disease (IPD) Therapies Price Scenario & Trends
Pricing and analogue assessment of IPD 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 Invasive Pneumococcal Disease (IPD)
To keep up with IPD 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 IPD 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 IPD, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.
DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the University of Mississippi Medical Center, University of Bologna, and Teikyo University School of Medicine, etc. were contacted. Their opinion helps understand and validate current and emerging IPD therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in IPD.
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 Invasive Pneumococcal Disease (IPD), 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.
Market Insights
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. Note: List to be continued in the report