B群溶血性レンサ球菌（GBS）の世界市場-2023年～2030年

概要

B群溶血性レンサ球菌（GBS）は、生後3ヵ月以内の乳児に敗血症、肺炎、髄膜炎などの致命的な疾患を引き起こす可能性があります。妊婦の4人に1人は体内にGBS菌を保有しており、出産時または出産直前に胎児に感染する可能性があります。

現在、B群溶血性レンサ球菌（GBS）に対する予防ワクチンは開発中ですが、承認されていません。新生児の生後1週間は、医療従事者がGBS症を予防するためにできる対策があります。

さらに、医療専門家、妊娠中の女性、そして一般的な人々は、GBSとその潜在的な危険性についての理解を深めることで恩恵を受けることができ、政府が医療サービスや疾患の技術進歩に取り組んでいることが、B群溶血性レンサ球菌の市場規模拡大の原動力となっています。

ダイナミクス

B群溶血性レンサ球菌の有病率の上昇

B群溶血性レンサ球菌（GBS）は、一般的に人体に害を与えることなく存在する細菌の一種です。しかしGBSは、特に乳幼児や妊婦、免疫系が弱っている人に感染症を引き起こす可能性があります。GBSは出産後に母親から赤ちゃんに感染し、新生児に重篤な感染症を引き起こす可能性があるため、妊娠のこの時期には重要な関心事となります。そのため、B群溶血性レンサ球菌の有病率の上昇は市場の拡大につながります。

例えば、WHOの発表によると、妊婦の5人に1人がB群溶血性レンサ球菌（GBS）に感染していると推定され、世界中で母体や新生児の病気の主な原因となっていますが、予防可能です。さらに、世界中の100人以上の学者が参加したロンドン大学衛生熱帯医学大学院の一連の11の調査論文では、年間41万件のGBS症例のうち、世界中で少なくとも14万7000件の死産と乳児死亡が発生すると控えめに予測しています。アフリカは、世界人口の13％に過ぎないにもかかわらず、予測される症例の54％、死産と乳児死亡の65％を占め、最大の負担となります。

さらに2020年5月、米国ルイビル大学とファイザー社により、入院患者における侵襲性・非侵襲性B群溶血性レンサ球菌（GBS）感染の有病率を示す初の研究が行われました。この研究の著者によると、侵襲性・非侵襲性GBS感染症の両方を考慮すると、米国の18歳以上のGBS関連入院患者数は毎年188,570人、死亡者数は5,660人です。このように、これらすべての要因が市場拡大を後押ししています。

B群溶血性レンサ球菌に関する臨床試験の増加

新薬の開発・上市に向けた臨床試験の活発化が、市場の成長を後押ししています。例えば、2022年9月7日、ファイザー社は、米国食品医薬品局（FDA）が、妊娠中の母親への積極的な予防接種を通じて、新生児や幼児におけるワクチン血清型による侵襲性GBS疾患を予防する目的で、同社の治験中のB群溶血性レンサ球菌（GBS）ワクチン候補であるGBS6またはPF-06760805に画期的治療薬指定を承認したと発表しました。

さらに、2023年4月には、高齢者のB群溶血性レンサ球菌（GBS）集団における新規GBSワクチンの安全性と免疫原性を評価するため、ミネルバックスが第I相臨床試験を開始しました。ベルギーのゲントにあるワクチン学センター（CEVAC）で実施されるこの試験では、基礎疾患の有無にかかわらず、55歳から75歳の高齢者にGBSワクチンを2回接種します。免疫学的反応が不十分なため、合併症のある高齢者はGBSワクチン接種を3回受けることになります。したがって、より良い治療と予防のための新薬開発のための臨床試験の増加が、市場の成長をもたらすと予想されます。

治療に伴う副作用

GBSのコロニー形成には通常、症状や副作用はありません。しかし、GBSは必要な人に感染し、多くの健康問題や困難をもたらす可能性があります。GBS感染症は肺炎を引き起こすことがあり、これは全身に影響を及ぼす重篤な、時には致命的な疾患で、特に乳幼児や免疫系が低下している人に多くみられます。さらに、妊婦のGBS感染症は頻度は低いもの、分娩後感染症、絨毛膜羊膜炎、尿路感染症を引き起こす可能性があります。したがって、上記の理由はすべて市場の成長を制限します。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • B群溶血性レンサ球菌の有病率の上昇
    • B群溶血性レンサ球菌に関する臨床試験の増加
• 抑制要因
  • 治療に伴う副作用
  • 機会
    • GBSワクチン開発の大きな可能性
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 規制分析
• ロシア・ウクライナ戦争の影響分析
• DMIの見解

第6章 COVID-19分析

第7章 感染タイプ別

• 菌血症
• 髄膜炎
• 敗血症
• 肺炎
• 骨・関節感染症
• 皮膚・軟部組織感染症
• 尿路感染症

第8章 治療法別

• 抗生物質
• 手術

第9章 エンドユーザー別

• 病院
• 在宅医療
• 専門クリニック
• その他

第10章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋
  • 中国
  • インド
  • 日本
  • オーストラリア
  • その他アジア太平洋
• 中東・アフリカ

第11章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A分析

第12章 企業プロファイル

• Pfizer Inc
  • 企業概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な動向
• MinervaXApS
• Wellstat Vaccines LLC
• GlaxoSmithKline
• LUMINEX CORPORATION
• PATH
• USAntibiotics
• Novartis
• HAL
• TAJ LIFE SCIENCES PVT. LTD

第13章 付録

Overview

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.

Segment Analysis

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.

COVID-19 Impact Analysis

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.

By Infection Type

• Bacteremia
• Meningitis
• Sepsis
• Pneumonia
• Bone and joint infections
• Skin and soft tissue infections
• Urinary tract infections

By Treatment

• Antibiotics
• Surgery

By End User

• Hospitals
• Homecare
• Specialty Clinics
• Others

By Region

• North America
  • U.S.
  • Canada
  • Mexico

• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe

• South America
  • Brazil
  • Argentina
  • Rest of South America

• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific

• Middle East and Africa

Key Developments

• In December 2022, according to a Hong Kong study, prenatal screening significantly lowers baby infections and mortality from common bacterial infections. Around 20% of expecting moms carry the Group B Streptococcus bacteria, which is mostly harmless but can have negative effects on babies. After universal screening was implemented, the number of babies with the infection decreased from one in 1,000 to 0.2 in 1,000.
• On September 28, 2022, the development and accessibility of maternal vaccines against Group B Streptococcus (GBS) and Respiratory Syncytial Virus (RSV), two of the leading causes of infant and newborn mortality in low-income countries, will be supported by grants from the Bill & Melinda Gates Foundation totaling nearly $128 million.
• In December 2022, A 72 million EUR financing round for MinervaXApS, a privately held Danish biotechnology company researching a new vaccine against Group B Streptococcus (GBS), has been successfully completed. In addition to existing investors REPAIR Impact Fund (Novo Holdings), Sunstone Life Science Ventures, LF Investment, Wellington Partners, Sanofi Ventures, Adjuvant Capital, and Industrifonden, the 22-million-euro equity financing was co-led by new investors Trill Impact Ventures and PureosBioventures.

Competitive Landscape

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.

Why Purchase the Report?

• To visualize the global Group B Streptococcus (GBS) market segmentation based on infection type, treatment, end user and region as well as understandkey commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of Group B Streptococcus (GBS) market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global Group B Streptococcus (GBS) market report would provide approximately 61 tables, 58 figures and 186 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Infection Type
• 3.2. Snippet by Treatment
• 3.3. Snippet by End User
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. The rising prevalence of Group B Streptococcus
    • 4.1.1.2. The rising the clinical trials on Group B Streptococcus
• 4.2. Restraints
  • 4.2.1.1. Side effects associated with the treatment
  • 4.2.2. Opportunity
    • 4.2.2.1. A significant chance exists for developing a GBS vaccination
  • 4.2.3. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. Russia-Ukraine War Impact Analysis
• 5.6. DMI Opinion

6. COVID-19 Analysis

• 6.1. Analysis of COVID-19
  • 6.1.1. Scenario Before COVID
  • 6.1.2. Scenario During COVID
  • 6.1.3. Scenario Post COVID
• 6.2. Pricing Dynamics Amid COVID-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During Pandemic
• 6.5. Manufacturers Strategic Initiatives
• 6.6. Conclusion

7. By Infection Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Infection Type
  • 7.1.2. Market Attractiveness Index, By Infection Type
• 7.2. Bacteremia *
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Meningitis
• 7.4. Sepsis
• 7.5. Pneumonia
• 7.6. Bone and joint infections
• 7.7. Skin and soft tissue infections
• 7.8. Urinary tract infections

8. By Treatment

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 8.1.2. Market Attractiveness Index, By Treatment
• 8.2. Antibiotics *
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Surgery

9. By End User

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 9.1.2. Market Attractiveness Index, By End User
• 9.2. Hospitals*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Homecare
• 9.4. Specialty Clinics
• 9.5. Others

10. By Region

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 10.1.2. Market Attractiveness Index, By Region
• 10.2. North America
  • 10.2.1. Introduction
  • 10.2.2. Key Region-Specific Dynamics
  • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Infection Type
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 10.2.5.1. U.S.
    • 10.2.5.2. Canada
    • 10.2.5.3. Mexico
• 10.3. Europe
  • 10.3.1. Introduction
  • 10.3.2. Key Region-Specific Dynamics
  • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Infection Type
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.3.7.1. Germany
    • 10.3.7.2. UK
    • 10.3.7.3. France
    • 10.3.7.4. Italy
    • 10.3.7.5. Spain
    • 10.3.7.6. Rest of Europe
• 10.4. South America
  • 10.4.1. Introduction
  • 10.4.2. Key Region-Specific Dynamics
  • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Infection Type
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.4.6.1. Brazil
    • 10.4.6.2. Argentina
    • 10.4.6.3. Rest of South America
• 10.5. Asia-Pacific
  • 10.5.1. Introduction
  • 10.5.2. Key Region-Specific Dynamics
  • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Infection Type
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.5.6.1. China
    • 10.5.6.2. India
    • 10.5.6.3. Japan
    • 10.5.6.4. Australia
    • 10.5.6.5. Rest of Asia-Pacific
• 10.6. Middle East and Africa
  • 10.6.1. Introduction
  • 10.6.2. Key Region-Specific Dynamics
  • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Infection Type
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

11. Competitive Landscape

• 11.1. Competitive Scenario
• 11.2. Market Positioning/Share Analysis
• 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

• 12.1. Pfizer Inc*
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. MinervaXApS
• 12.3. Wellstat Vaccines LLC
• 12.4. GlaxoSmithKline
• 12.5. LUMINEX CORPORATION
• 12.6. PATH
• 12.7. USAntibiotics
• 12.8. Novartis
• 12.9. HAL
• 12.10. TAJ LIFE SCIENCES PVT. LTD

LIST NOT EXHAUSTIVE

13. Appendix

• 13.1. About Us and Services
• 13.2. Contact Us