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침습성 폐렴구균 질환 : 시장 인사이트, 역학 및 예측(2036년)

Invasive Pneumococcal Disease - 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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침습성 폐렴구균 질환(IPD)에 대한 인사이트 및 동향

  • 이번 조사 기간 동안, 침습성 폐렴구균 질환 시장은 미국, EU4(독일, 프랑스, 이탈리아, 스페인), 영국, 일본 등 주요 시장에서 강력한 성장세를 보이고 있습니다. 이는 폐렴구균 질환의 부담 증가, 백신 접종률 확대, 그리고 고가의 다중형 폐렴구균 백신의 보급이 주된 원동력이 되고 있습니다.
  • IPD의 상당 부분은 고령자, 영유아, 만성 질환자 및 면역 결핍 상태에 있는 사람들에게서 발생하고 있으며, 중증화, 합병증 및 사망률을 낮추기 위해서는 백신 접종률을 더욱 광범위하게 높이고, 대상군을 선별한 예방 전략이 필요하다는 점이 부각되고 있습니다.
  • IPD 예방은 주로 폐렴구균 백신 접종 전략에 의존하며, 여기에는 PCV20이나 PCV21과 같은 다가 결합형 백신뿐만 아니라 PCV13이나 PCV15와 같은 검증된 백신도 포함됩니다. 이 백신들은 더 광범위한 혈청형을 포괄하며, 특히 고령자 및 기타 고위험군에서 침습성 감염증, 질병 부담 및 관련 합병증을 줄이는 데 기여하고 있습니다.
  • G7 국가의 침습성 폐렴구균 질환 시장에서는 PCV20(PREVNAR 20/APEXXNAR)이 사용 가능한 폐렴구균 백신 중 가장 큰 시장 점유율을 차지하고 있습니다. 이는 광범위한 혈청형 커버리지, 의사들의 높은 채택률, 그리고 성인 예방접종 프로그램에 대한 광범위한 도입이 요인으로 작용하고 있습니다.
  • IPD와 관련된 다양한 감시 시스템 및 혈청형 모니터링 프로그램(미국의 Active Bacterial Core surveillance(ABCs), 유럽질병예방통제센터(ECDC)의 감시 네트워크(유럽), 그리고 일본의 전국 폐렴구균 감시 프로그램 등)은 질병의 발생률, 혈청형 분포, 백신의 유효성, 그리고 항생제 내성 양상의 추적을 지원하고 있습니다. 이러한 시스템은 예방접종 정책 지침 수립, 공중보건에 미치는 영향 평가, 그리고 지역별 예방 전략 수립에 기여하고 있습니다.
  • 개발 중인 IPD 백신 후보는 비교적 제한적이며, 주로 혈청형 커버율을 확대하고 남아 있는 질병 부담을 해결하는 것을 목표로 하는 차세대 고가 백신에 초점이 맞추어져 있습니다. 주요 후보로는 사노피와 SK바이오사이언스가 개발한 SP0202, 화이자가 개발한 PF-07872412(25vPnC), GSK가 개발한 GSK5459248 등이 있으며, 이들 모두 폐렴구균 질환 예방 전략을 한층 더 강화하기 위해 평가가 진행되고 있습니다.

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 시장을 주도하는 주요 요인

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 이해와 치료 알고리즘

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 역학

침습성 폐렴구균 질환(IPD)의 역학적 분석 및 예측에 관한 주요 조사 결과

  • DelveInsight사의 추산에 따르면, 인구 고령화, 항생제 내성 증가, 세균 균주의 변이, 그리고 백신 접종률의 잠재적 격차와 같은 요인으로 인해 예측 기간 동안 IPD 신규 환자 수는 증가할 것으로 전망됩니다.
  • IPD의 연령별 발생률은 65세 이상 성인에서 가장 높은데, 이는 노화에 따른 면역 기능 저하 및 동반 질환이 원인인 것으로 보입니다.
  • IPD의 사례 수는 여성에 비해 남성에서 약간 더 많이 나타났습니다. 이러한 차이는 흡연, 음주, 직업적 노출과 같은 위험 요인에 대한 노출이 남성에게서 더 높다는 점과, 폐렴구균 감염에 대한 감수성을 높일 가능성이 있는 만성 기저질환의 유병률이 남성에게서 더 높다는 점에 기인한 것으로 보입니다.
  • 새로운 치료법과 신흥 치료법의 도입으로 인해, 미국에서는 치료 가능한 IPD 환자 수가 증가할 것으로 예측됩니다.

침습성 폐렴구균 질환 시장 전망

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.

  • 추산에 따르면, 조사 기간 동안 주요 시장 중 미국이 침습성 폐렴구균 질환 시장에서 가장 큰 점유율을 차지했습니다.
  • 침습성 폐렴구균 질환 시장은 예방 전략이 기존의 폐렴구균 백신에서 더 광범위한 혈청형을 포괄하는 차세대 결합형 백신으로 전환됨에 따라 변화하고 있으며, 고가 다중 PCV나 단백질 기반 백신과 같은 새로운 후보들이 유행 혈청형 및 백신 미포함 혈청형에 대한 방어력을 향상시키고, 침습성 질환의 부담 경감을 위한 노력을 주도하고 있습니다.
  • 지역별 시장 동향을 살펴보면, 미국은 백신 접종률, 감시 체계, 임상 연구 분야에서 주도적인 입지를 차지하고 있는 반면, 유럽과 일본에서는 침습성 질환의 부담에 대한 인식이 높아지고, 인구 고령화가 진행되며, 공중보건 대책이 강화됨에 따라 예방접종 프로그램 및 폐렴구균 백신의 보급 확대에 점점 더 주력하고 있습니다.

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.

자주 묻는 질문

  • 침습성 폐렴구균 질환(IPD) 시장의 주요 성장 요인은 무엇인가요?
  • 침습성 폐렴구균 질환(IPD)의 주요 예방 전략은 무엇인가요?
  • 침습성 폐렴구균 질환(IPD)의 발생률은 어떤 경향을 보이고 있나요?
  • 침습성 폐렴구균 질환(IPD) 시장의 향후 전망은 어떻게 되나요?
  • 침습성 폐렴구균 질환(IPD) 치료의 주요 목표는 무엇인가요?
  • 침습성 폐렴구균 질환(IPD) 시장에서 주요 백신은 무엇인가요?
  • 침습성 폐렴구균 질환(IPD) 관련 감시 시스템은 어떤 역할을 하나요?

목차

제1장 주요 인사이트

제2장 서론

제3장 주요 요약

제4장 주요 이벤트

제5장 역학 및 예측 조사 방법

제6장 침습성 폐렴구균 질환 : 시장 개요

제7장 침습성 폐렴구균 질환 : 질환 배경 및 개요

제8장 치료

제9장 침습성 폐렴구균 질환 : 역학 및 환자 인구

제10장 침습성 폐렴구균 질환 : 환자 경과

제11장 시판 치료제

제12장 신흥 치료제

제13장 침습성 폐렴구균 질환 : 주요 7개국 분석

제14장 침습성 폐렴구균 질환 : 미충족 수요

제15장 침습성 폐렴구균 질환 : SWOT 분석

제16장 침습성 폐렴구균 질환 : KOL(Key Opinion Leader)의 견해

제17장 침습성 폐렴구균 질환 : 시장 참여 및 상환

제18장 부록

제19장 DelveInsight의 서비스 내용

제20장 면책사항

제21장 DelveInsight에 대해

KTH

Invasive Pneumococcal Disease (IPD) Insights and Trends

  • The invasive pneumococcal disease market is witnessing strong growth across the leading markets, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, during the study period, driven by the increasing burden of pneumococcal infections, expanding vaccination coverage, and the uptake of higher-valent pneumococcal vaccines.
  • A significant proportion of the IPD burden is associated with older adults, young children, and individuals with chronic or immunocompromising conditions, highlighting the need for broader vaccination coverage and targeted preventive strategies to reduce severe disease, complications, and mortality.
  • The prevention of IPD primarily relies on pneumococcal vaccination strategies, including higher-valent conjugate vaccines such as PCV20 and PCV21, as well as established vaccines like PCV13 and PCV15, which provide broader serotype coverage and help reduce invasive infections, disease burden, and related complications, particularly among older adults and other high-risk populations.
  • In the IPD market across the 7MM, PCV20 (PREVNAR 20/APEXXNAR) has the largest share among available pneumococcal vaccines, driven by its broad serotype coverage, strong physician adoption, and widespread implementation in adult immunization programs.
  • Various surveillance systems and serotype-monitoring programs for IPD, including the Active Bacterial Core surveillance (ABCs) (US), European Centre for Disease Prevention and Control (ECDC) surveillance networks (Europe), and national pneumococcal surveillance programs in Japan, support the tracking of disease incidence, serotype distribution, vaccine effectiveness, and antimicrobial resistance patterns. These systems help guide vaccination policies, assess public health impact, and inform region-specific prevention strategies.
  • The emerging IPD pipeline is relatively limited and primarily focused on next-generation higher-valent vaccines designed to expand serotype coverage and address residual disease burden. Key candidates include SP0202, developed by Sanofi and SK Bioscience; PF-07872412 (25vPnC), developed by Pfizer; and GSK5459248, developed by GSK, all of which are being evaluated to strengthen pneumococcal disease prevention strategies further.

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) Understanding and Treatment Algorithm

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.

1. Delayed diagnosis and rapid disease progression lead to high morbidity and mortality

2. Increasing antimicrobial resistance limiting treatment effectiveness

3. Incomplete protection against emerging pneumococcal serotypes

4. Low vaccination coverage in high-risk and elderly populations, and others.....

Invasive Pneumococcal Disease (IPD) Epidemiology

Key Findings from Invasive Pneumococcal Disease (IPD) Epidemiological Analysis and Forecast

  • According to DelveInsight's estimates, the incident cases of IPD are expected to increase during the forecast period due to factors such as population aging, increased antibiotic resistance, evolving bacterial strains, and potential gaps in vaccination coverage.
  • Age-specific rates for IPD were highest among adults aged 65 years or older, likely due to age-related decline in immune function and comorbidities.
  • IPD cases were slightly more common in males compared with females. This difference may be attributed to higher exposure to risk factors such as smoking, alcohol use, occupational exposure, and a greater prevalence of chronic underlying conditions in males, which can increase susceptibility to pneumococcal infection.
  • The treatable cases of IPD are expected to increase in the US, owing to the introduction of new and emerging therapies.

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

  • Pfizer
  • Merck
  • Sanofi
  • SK Bioscience
  • GSK, and others

Invasive Pneumococcal Disease (IPD) Drug Updates

  • In May 2026, Pfizer reported positive Phase II results for its 25-valent pneumococcal conjugate vaccine candidate, PF-07872412 (25vPnC) in infants. The study evaluated a four-dose regimen against PREVNAR 20 and demonstrated favorable safety, tolerability, and immunogenicity. Notably, 25vPnC generated 8.8-fold higher geometric mean antibody titers against serotype 3 compared with PREVNAR 20 one month after the third dose.
  • In September 2025, Sanofi initiated a study evaluating the safety and immunogenicity of its investigational pneumococcal conjugate vaccine, SP0202, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers, with PREVNAR 13 as the comparator.
  • In March 2025, Merck announced that the European Commission approved PCV21 (CAPVAXIVE) for the prevention of IPD and pneumonia caused by 21 Streptococcus pneumoniae serotypes in adults aged 18 years and older. The approval was supported by safety and immunogenicity data from the Phase III STRIDE clinical program, with CAPVAXIVE specifically designed to target the serotypes responsible for most adult IPD cases.

Drug Class Insights

Invasive Pneumococcal Disease (IPD) Market Outlook

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.

  • According to the estimates, the United States accounted for the largest share of the Invasive Pneumococcal Disease (IPD) market among the major markets during the study period.
  • The IPD market is evolving as prevention strategies shift from traditional pneumococcal vaccines toward broader serotype coverage and next-generation conjugate vaccines, with emerging candidates such as higher-valent PCVs and protein-based vaccines driving efforts to improve protection against circulating and non-vaccine serotypes and reduce invasive disease burden.
  • Regional market dynamics show the United States leading in vaccine uptake, surveillance, and clinical research, while Europe and Japan are increasingly focused on immunization programs and expanding adoption of pneumococcal vaccination, driven by rising awareness of the invasive disease burden, ageing populations, and strengthened public health initiatives.

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.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of IPD, explaining its 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 IPD 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 IPD market.

Report Insights

  • Invasive Pneumococcal Disease (IPD)Patient Population Forecast
  • Invasive Pneumococcal Disease (IPD)Therapeutics Market Size
  • Invasive Pneumococcal Disease (IPD)Pipeline Analysis
  • Invasive Pneumococcal Disease (IPD)Market Size and Trends
  • Invasive Pneumococcal Disease (IPD)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
  • Invasive Pneumococcal Disease (IPD)Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (by geography)
  • Invasive Pneumococcal Disease (IPD)Treatment Addressable Market (TAM)
  • Invasive Pneumococcal Disease (IPD)Competitive Landscape
  • Invasive Pneumococcal Disease (IPD)Major Companies Insights
  • Invasive Pneumococcal Disease (IPD)Price Trends and Analogue Assessment
  • Invasive Pneumococcal Disease (IPD)Therapies Drug Adoption/Uptake
  • Invasive Pneumococcal Disease (IPD)Therapies Peak Patient Share analysis

Report Assessment

  • Invasive Pneumococcal Disease (IPD)Current Treatment Practices
  • Invasive Pneumococcal Disease (IPD)Unmet Needs
  • Invasive Pneumococcal Disease (IPD)Clinical Development Analysis
  • Invasive Pneumococcal Disease (IPD)Emerging Drugs Product Profiles
  • Invasive Pneumococcal Disease (IPD)Market Attractiveness
  • Invasive Pneumococcal Disease (IPD)Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

  • What was the Invasive Pneumococcal Disease (IPD) 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 Invasive Pneumococcal Disease (IPD)?
  • What are the disease risks, burdens, and unmet needs of Invasive Pneumococcal Disease (IPD)? What will be the growth opportunities across the 7MM concerning the patient population with Invasive Pneumococcal Disease (IPD)?
  • 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 Invasive Pneumococcal Disease (IPD)? What are the current guidelines for treating Invasive Pneumococcal Disease (IPD) 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 Invasive Pneumococcal Disease (IPD) 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 current and 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 within 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

4. Key Events

  • 4.1. Upcoming Key Catalysts
  • 4.2. Key Transactions And Collaborations
  • 4.3. News Flow

5. Epidemiology and Market Forecast Methodology

6. Invasive Pneumococcal Disease (IPD) Market Overview at a Glance

  • 6.1. Emerging Landscape Analysis (By Phase, Molecule Type, and RoA)
  • 6.2. Market Share (%) Distribution of IPD By Therapies in the 7MM, in 2025
  • 6.3. Market Share (%) Distribution of IPD By Therapies in the 7MM, in 2036

7. Disease Background and Overview of Invasive Pneumococcal Disease (IPD)

  • 7.1. Introduction
  • 7.2. Signs and Symptoms
  • 7.3. Causes
  • 7.4. Risk factors
  • 7.5. Pathophysiology
  • 7.6. Diagnosis
    • 7.6.1. Differential Diagnosis
    • 7.6.2. Diagnostic Algorithm

8. Treatment

  • 8.1. Algorithm for the Treatment
  • 8.2. Guidelines for the Treatment

9. Epidemiology and Patient Population of Invasive Pneumococcal Disease (IPD)

  • 9.1. Key Findings
  • 9.2. Assumptions and Rationale
  • 9.3. Total Diagnosed Prevalent Cases of IPD in the 7MM
  • 9.4. The United States
    • 9.4.1. Total Incident Cases of Invasive Pneumococcal Disease (IPD) in United States
    • 9.4.2. Age-specific Incident Cases of Invasive Pneumococcal Disease (IPD) in United States
    • 9.4.3. Gender-specific Incident Cases of Invasive Pneumococcal Disease (IPD) in United States
    • 9.4.4. Treatable Cases of Invasive Pneumococcal Disease (IPD) in United States
  • 9.5. EU4 and the UK
    • 9.5.1. Total Incident Cases of Invasive Pneumococcal Disease (IPD) in EU4 and the UK
    • 9.5.2. Age-specific Incident Cases of Invasive Pneumococcal Disease (IPD) in EU4 and the UK
    • 9.5.3. Gender-specific Incident Cases of Invasive Pneumococcal Disease (IPD) in EU4 and the UK
    • 9.5.4. Treatable Cases of Invasive Pneumococcal Disease (IPD) in EU4 and the UK
  • 9.6. Japan
    • 9.6.1. Total Incident Cases of Invasive Pneumococcal Disease (IPD) in Japan
    • 9.6.2. Age-specific Incident Cases of Invasive Pneumococcal Disease (IPD) in Japan
    • 9.6.3. Gender-specific Incident Cases of Invasive Pneumococcal Disease (IPD) in Japan
    • 9.6.5. Treatable Cases of Invasive Pneumococcal Disease (IPD) in Japan

10. Patient Journey of Invasive Pneumococcal Disease (IPD)

11. Marketed Drugs

  • 11.1. Marketed Competitive Landscape of Invasive Pneumococcal Disease (IPD)
  • 11.2. PCV20 (PREVNAR/APEXXNAR): Pfizer
    • 11.2.1. Drug Description
    • 11.2.2. Regulatory Milestones
    • 11.2.3. Other Developmental Activities
    • 11.2.4. Summary of Pivotal Trials
    • 11.2.5. Clinical Development
      • 11.2.5.1. Clinical Trial Information
    • 11.2.6. Analyst's Views
  • 11.3. PCV21 (CAPVAXIVE): Merck
    • 11.3.1. Drug Description
    • 11.3.2. Regulatory Milestones
    • 11.3.3. Other Developmental Activities
    • 11.3.4. Summary of Pivotal Trials
    • 11.3.5. Clinical Development
      • 11.3.5.1. Clinical Trial Information
    • 11.3.6. Analyst's Views

. Note: List to be continued in the report

12. Emerging Drugs

  • 12.1. Emerging Competitive Landscape of Invasive Pneumococcal Disease (IPD)
  • 12.2. SP0202: Sanofi/ SK Bioscience
    • 12.2.1. Drug Description
    • 12.2.2. Other Developmental Activities
    • 12.2.3. Clinical Development
      • 12.2.3.1. Clinical Trials Information
    • 12.2.4. Analyst's Views
  • 12.3. PF-07872412 (25vPnC): Pfizer
    • 12.3.1. Drug Description
    • 12.3.2. Other Developmental Activities
    • 12.3.3. Clinical Development
      • 12.3.3.1. Clinical Trials Information
    • 12.3.4. Analyst's Views

. Note: List to be continued in the report

13. Invasive Pneumococcal Disease (IPD): 7MM Analysis

  • 13.1. Key Findings
  • 13.2. Market Outlook of Invasive Pneumococcal Disease (IPD)
  • 13.3. Conjoint Analysis of Invasive Pneumococcal Disease (IPD)
  • 13.4. Key Market Forecast Assumptions
    • 13.4.1. Cost Assumptions
    • 13.4.2. Pricing Trends
    • 13.4.3. Analogue Assessment
    • 13.4.4. Launch Year and Therapy Uptakes
  • 13.5. Total Market Size of Invasive Pneumococcal Disease (IPD) in the 7MM
  • 13.6. Total Market Size of Invasive Pneumococcal Disease (IPD) by Therapies in the 7MM
  • 13.7. The United States
    • 13.7.1. Total Market Size of Invasive Pneumococcal Disease (IPD) in the United States
    • 13.7.2. Total Market Size of Invasive Pneumococcal Disease (IPD) by Therapies in the United States
  • 13.8. EU4 and the UK
    • 13.8.1. Total Market Size of Invasive Pneumococcal Disease (IPD) in EU4 and the UK
    • 13.8.2. Total Market Size of Invasive Pneumococcal Disease (IPD) by Therapies in EU4 and the UK
  • 13.9. Japan
    • 13.9.1. Total Market Size of Invasive Pneumococcal Disease (IPD) in Japan
    • 13.9.2. Total Market Size of Invasive Pneumococcal Disease (IPD) by Therapies in Japan

14. Unmet Needs of Invasive Pneumococcal Disease (IPD)

15. SWOT Analysis of Invasive Pneumococcal Disease (IPD)

16. KOL Views of Invasive Pneumococcal Disease (IPD)

17. Market Access and Reimbursement of Invasive Pneumococcal Disease (IPD)

  • 17.1. The United States
  • 17.2. EU4 and the UK
    • 17.2.1. Germany
    • 17.2.2. France
    • 17.2.3. Italy
    • 17.2.4. Spain
    • 17.2.5. United Kingdom
  • 17.3. Japan
  • 17.4. Summary and comparison of Market Access and Pricing Policy Developments in 2025
  • 17.5. Market Access and Reimbursement of Invasive Pneumococcal Disease (IPD) Therapies

18. Appendix

  • 18.1. Bibliography
  • 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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