B군 연쇄상구균(GBS)은 생후 3개월 이내의 영아에게 패혈증, 폐렴, 수막염 등 치명적인 질병을 유발할 수 있습니다. 임산부 4명 중 1명은 체내에 GBS균을 보유하고 있으며, 출산 시 또는 출산 직전에 태아에게 감염될 수 있습니다.
현재 B군 연쇄상구균(GBS)에 대한 예방 백신은 개발 중이지만 아직 승인되지 않았습니다. 신생아 생후 1주일 동안 의료진이 GBS를 예방하기 위해 할 수 있는 조치가 있습니다.
또한, 의료 전문가, 임산부 및 일반인들은 GBS와 그 잠재적 위험에 대한 이해도가 높아짐에 따라 혜택을 받을 수 있으며, 정부가 의료 서비스 및 질병에 대한 기술 발전을 위해 노력하는 것이 B형 용혈성 연쇄상구균의 시장 규모를 확대하는 원동력이 되고 있습니다.
다이나믹스
B군 연쇄상구균의 유병률 증가 /p>
B군 연쇄상구균(GBS)은 일반적으로 인체에 해를 끼치지 않고 존재하는 박테리아의 일종입니다. 그러나 GBS는 특히 영유아, 임산부, 면역력이 약한 사람에게 감염을 일으킬 수 있으며, 출산 후 산모로부터 아기에게 전염되어 신생아에게 심각한 감염을 일으킬 수 있기 때문에 임신 기간 동안 중요한 관심사입니다. 따라서 B군 연쇄상구균의 유병률 증가는 시장 확대로 이어질 것입니다.
예를 들어, 세계보건기구(WHO)의 발표에 따르면 임산부 5명 중 1명이 B형 용혈성 연쇄상구균(GBS)에 감염된 것으로 추정되며, 전 세계적으로 산모와 신생아 질병의 주요 원인이지만, 예방이 가능하다고 합니다. 또한, 전 세계 100명 이상의 학자들이 참여한 런던대학교 보건열대의학대학원의 11개 연구 논문은 연간 41만 건의 GBS 사례 중 전 세계적으로 최소 14만 7천 건의 사산과 영아 사망이 발생할 것으로 예상했습니다. 아프리카는 전 세계 인구의 13%에 불과하지만 예상 사례의 54%, 사산과 영아 사망의 65%를 차지해 가장 큰 부담을 안게 될 것으로 보입니다.
또한 2020년 5월, 미국 루이빌 대학교와 화이자는 입원 환자에서 침습성 및 비침습성 B군 연쇄상구균(GBS) 감염의 유병률을 보여주는 첫 번째 연구를 진행했습니다. 이 연구의 저자에 따르면, 침습성 및 비침습성 GBS 감염을 모두 고려할 때, 미국 내 18세 이상 GBS 관련 입원 환자 수는 매년 188,570명, 사망자 수는 5,660명에 달합니다. 이러한 모든 요인들이 시장 확대를 촉진하고 있습니다.
B군 연쇄상구균에 대한 임상시험 증가
신약 개발 및 출시를 위한 임상시험이 활발해지면서 시장 성장을 견인하고 있습니다. 예를 들어, 화이자는 2022년 9월 7일 미국 식품의약국(FDA)이 임신부에게 적극적인 예방접종을 통해 신생아 및 유아의 백신 혈청형에 의한 침습성 GBS 질환을 예방하기 위해 자사의 B형 용혈성 연쇄상구균(GBS) 백신 후보물질인 GBS6 또는 PF-06760805에 대해 혁신 치료제 지정을 승인했다고 밝혔습니다.
또한, 2023년 4월, 미네르바크스는 노인 B형 용혈성 연쇄상구균(GBS) 집단에서 새로운 GBS 백신의 안전성과 면역원성을 평가하기 위한 임상 1상 시험을 시작했습니다. 벨기에 겐트에 위치한 백신학 센터(CEVAC)에서 진행되는 이번 임상시험은 기저질환 유무에 관계없이 55세에서 75세 사이의 고령자를 대상으로 GBS 백신을 2회 접종합니다. 면역학적 반응이 불충분한 합병증이 있는 노인은 GBS 백신을 3회 접종하게 됩니다. 따라서 더 나은 치료와 예방을 위한 신약 개발을 위한 임상시험의 증가는 시장 성장을 가져올 것으로 예상됩니다.
치료에 따른 부작용
GBS의 식민지 형성은 일반적으로 증상이나 부작용이 없습니다. 그러나 GBS는 필요한 사람에게 감염되어 많은 건강 문제와 어려움을 초래할 수 있으며, GBS 감염은 폐렴을 유발할 수 있으며, 이는 전신에 영향을 미치는 심각하고 때로는 치명적인 질병으로, 특히 영유아와 면역 체계가 저하된 사람들에게서 흔히 볼 수 있습니다. 또한, 임산부의 GBS 감염은 빈도는 낮지만 분만 후 감염, 융모막 양막염, 요로 감염을 유발할 수 있습니다. 따라서 위의 모든 이유는 시장 성장을 제한합니다.
Group B Streptococcus (GBS) can cause potentially fatal diseases in infants within their first three months of life, including sepsis, pneumonia, and meningitis. One in four pregnant women have GBS bacteria in their bodies, which they could transmit to their unborn child during or just before birth.
There are presently no vaccines approved for prevention against group B streptococcus (GBS), although they are under development. During the first week of a newborn's life, there are measures that medical professionals can take to prevent GBS disease.
Moreover, health care professionals, pregnant women, and people in general can all benefit from a greater understanding of GBS and its potential hazards and the government taking initatives on healthcare services and technological advancements of the diseases are driving the expansion of the Group B Streptococcus market size.
Dynamics
The Rising Prevalence of Group B Streptococcus
Group B Streptococcus (GBS) is a type of bacteria that commonly resides in the human body without causing harm. GBS, however, can cause infections, particularly in infants, pregnant women, and those with weakened immune systems. GBS can pass from mother to baby after birthing and may cause serious infections in the newborn, making it an important concern in this phase of pregnancy. As such, the growth of Group B Streptococcus leads to market expansion.
For instance, according to WHO, stated that, estimated that one in five pregnant women had the bacteria Group B Streptococcus (GBS), which is a major but preventable cause of mother and newborn illness around the world. In addition, the series of 11 research articles from the London School of Hygiene & Tropical Medicine, which involved more than 100 academics from around the world, conservatively predicts that out of the 410,000 GBS cases per year, there will be at least 147,000 stillbirths and infant deaths worldwide. Africa has the biggest burden with 54% of projected cases and 65% of stillbirths and infant deaths, although having only 13% of the world's population.
Additionally, in May 2020, the first study to demonstrate the prevalence of both invasive and non-invasive Group B Streptococcus (GBS) infections among hospitalized individuals in the United States was conducted by the University of Louisville and Pfizer Inc. According to the study's authors, when both invasive and non-invasive GBS infections are taken into account, there are 188,570 GBS-related hospitalizations and 5,660 deaths among U.S. individuals 18 and older every year. Thus, all of these factors boost market expansion.
The Rising the Clinical Trials on Group B Streptococcus
The rising clinical trials for developing and launching several new drugs are drive the market growth. For instance, on September 07, 2022, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) approved the breakthrough therapy designation to its investigational Group B Streptococcus (GBS) vaccine candidate, GBS6 or PF-06760805, for the purpose of preventing invasive GBS disease caused by vaccine serotypes in newborns and young infants through active immunization of their mothers during pregnancy.
Moreover, in April 2023, to evaluate the safety and immunogenicity of its novel GBS vaccine in the older adult population with Group B Streptococcus (GBS), MinervaX has initiated a Phase I clinical trial. In the trial, conducted at the Centre for Vaccinology (CEVAC) in Ghent, Belgium, older persons aged 55 to 75 with and without underlying medical issues would get two doses of the GBS vaccination. Due to an insufficient immunological response, older persons with comorbidities will receive three doses of the GBS vaccination. Therefore, increased rising the clinical trials for developing novel drugs for better treatment and prevention are anticipated to create market growth.
Side Effects Associated with the Treatment
GBS colonization typically has no symptoms or side effects. GBS can, however, infect individuals in need, which can result in a number of health issues and difficulties. GBS infections can cause pneumonia, a serious occasionally fatal disease that affects the entire body, particularly in infants and people with compromised immune systems. Additionally, GBS infections in pregnant women are less frequent but can result in postpartum infections, chorioamnionitis, and urinary tract infections. Thus, all of the above reasons restrict market growth.
The global Group B Streptococcus(GBS) market is segmented based on infection type, treatment, end user and region.
Antibiotics are Only needed for Treat Bacterial Infections
During the delivery process, medical professionals treat patients with intravenous (IV) antibiotics to avoid GBS infection in the baby. Penicillin or ampicillin is the most often used antibiotic to treat group B strep. Antibiotic administration to the patient at this time helps prevent the transmission of GBS from mother to newborn. GBS treatment prior to delivery is effective. It is preferable to take the antibiotics at least four hours before birth. This kind of therapy prevents about 90% of infections. Therefore, the segment's expansion is accelerated by the usage of antibiotics.
Moreover, according to NLM, stated that, the preferred method of treatment for intrapartum antibiotic prophylaxis against Group B Streptococcus is intravenous penicillin G. A loading dose of 5 million units of penicillin G is given intravenously, and then 2.5 to 3 million units are given every four hours throughout delivery process. If penicillin G is not available, ampicillin is a suitable substitute. During labor and up until delivery, ampicillin is given as a 2 gm intravenous loading dose followed by 1 gm intravenous every 4 hours. Thus, all of these factors boost segment expansion.
Geographical Penetration
Expanding the Health Services in the Region
North America was the most significant market for GBS. The market has grown as a consequence of North America's expanding need for healthcare services. In addition, the region's growth is contributed to by factors like rising pregnancy rates, rising health expenditures, and increasing product launches and product approvals.
For instance, in November 2022, a molecular diagnostic test for the qualitative detection of Group B Streptococcus (GBS) using enriched Lim broth cultures of patient samples has been made public by Cepheid. It is called Xpert GBS LB XC (extended coverage). The success of the 2012 release of Xpert GBS LB is built upon by Xpert GBS LB XC. The next-generation test is already available, and US customers will start receiving shipments in November. Preventing newborn GBS infections depends on accurate antepartum GBS testing. To enhance performance and coverage, Xpert GBS LB XC includes new dual targets in highly conserved GBS genomic regions. Thus, all of these factors will be contributing in boosting regional growth.
The effect of COVID-19 on the treatment of GBS may not be directly related, however there may be some potential indirect effects. For instance, many healthcare systems became overloaded with the care of COVID-19 patients at the peak of the COVID-19 pandemic. The management and treatment of other diseases, including GBS infections, may be impacted by this strain on resources and medical staff. In an effort to stop the spread of GBS to newborns following childbirth, pregnant women are frequently checked for colonization.
However, COVID-19-related complications in prenatal care could impact the early detection and treatment of GBS colonization in pregnant women. Moreover, the increased use of antibiotics to treat severe COVID-19 cases may indirectly affect the treatment of GBS infections through supporting the growth of antibiotic-resistant bacteria.
The major global players in the market include Pfizer Inc, MinervaXApS, Wellstat Vaccines LLC, GlaxoSmithKline, LUMINEX CORPORATION, PATH, USAntibiotics, Novartis, HAL, TAJ LIFE SCIENCES PVT. LTD and among others.
The global Group B Streptococcus (GBS) market report would provide approximately 61 tables, 58 figures and 186 Pages.
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