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菌血症の世界市場-2023年~2030年Global Bacteremia Market - 2023-2030 |
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菌血症の世界市場-2023年~2030年 |
出版日: 2023年09月27日
発行: DataM Intelligence
ページ情報: 英文 186 Pages
納期: 約2営業日
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菌血症とは、血液中に細菌が存在する場合に用いられる診断名です。菌血症は臨床的に重要な意味を持つことがあり、必ずしも症状や重篤な疾患をもたらすとは限りませんが、健康上の大きな問題とみなされています。抗生物質に耐性を持つ細菌に対抗するため、新しい抗生物質や抗菌剤が開発されています。しかし、最近は新しい抗生物質のパイプラインはあまり開発されていません。
抗生物質を最大限に使用し、耐性菌の発生を防ぐことを目的とした抗生物質管理プログラムへの注目は、原因菌とその抗生物質感受性をより迅速かつ正確に特定する方法の開発につながった診断学の進歩の結果として高まっています。
さらに、患者の転帰を改善するためには、菌血症の早期発見と適切な治療の開始が不可欠であり、早期発見と介入はPoC(ポイントオブケア)診断ツールによって容易になり、検査室と臨床チーム間のコミュニケーションの増加が菌血症市場規模を押し上げる要因となっています。
ダイナミクス
治療薬の承認数の増加
菌血症を含む細菌感染症は、特に感染が急速に広がる可能性のある医療施設において、公衆衛生上の問題を引き起こす可能性があります。規制機関は、これらの疾患の蔓延を抑える治療法を提供する可能性があります。細菌疾患と抗生物質耐性のプロセスは、微生物学、遺伝学、分子生物学の発展により明らかになってきました。そのため、製品承認の増加が市場の成長を後押ししています。
例えば、2023年5月、アシネトバクター・バウマニ・カルコアセティックス複合体の感受性分離株によって院内細菌性肺炎、菌血症、人工呼吸器関連細菌性肺炎を発症した18歳以上の患者の治療薬として、食品医薬品局(FDA)はザクドゥーロ(注射用スルバクタム;注射用デュロバクタム)を承認しました。βラクタム系抗生物質でありβラクタマーゼ阻害剤であるスルバクタムとβラクタマーゼ阻害剤であるデュロバクタムは、いずれも共同包装薬Xacduroの成分です。そのため、製品承認の増加が市場拡大の加速に寄与しています。
菌血症に関する治験の増加
抗生物質耐性菌の増加により、新規でより効果的な治療法の開発が急務となっています。特に薬剤耐性菌による菌血症の治療は困難であり、そのため新規薬剤の開発が重要となっています。
例えば、2023年5月、合併症を有する黄色ブドウ球菌菌血症の治療薬として開発中のAP-SA02の第1b/2a相治験(「diSArm」)において、最初の患者が投与されました。Armata Pharmaceuticals, Inc.は、抗生物質耐性菌や治療困難な細菌感染症に対する病原体特異的バクテリオファージ治療薬に特化したバイオテクノロジー企業です。
さらに2022年3月には、急性腎盂腎炎を含む複雑性尿路感染症(cUTI)の成人患者に対する潜在的治療薬として、Venatorx Pharmaceuticals社が最近、治験中の新規薬剤セフェピム・タニボルバクタムを試験する主要な第3相研究の良好な結果を発表しました。第4世代セファロスポリンであるセフェピムは、よく使用されるベータラクタム(BL)抗生物質です。セフェピムは20年以上にわたって、感受性の高いグラム陰性菌やグラム陽性菌に対して臨床的に有効です。このように、これらすべての要因が市場の成長に寄与しています。
高齢者人口の増加
免疫老化とは、加齢とともに免疫系が低下する傾向を指す言葉です。これは、細菌感染を含む病気を発見し、それに対抗する身体の能力が低下することを意味します。高齢者は、侵入してくる細菌に対する強固な免疫学的防御を確立できない可能性があります。加齢に伴い、創傷治癒には通常時間がかかります。この治癒遅延の結果、開放創や治療が困難な感染症が発生する可能性があり、菌血症のリスクは高まります。
例えば、ユーロスタットによると、2022年1月のEU人口は4億4,670万人と推計され、そのうち65歳以上の高齢者は21.1%で、前年比0.3ポイント(pp)増、10年前と比べると3.1ポイント(pp)増となっています。
さらに、国連(UN)の新しい報告書によると、世界全体で65歳以上の高齢者の数は、今後30年間で2倍に増加すると予想されています。高齢者人口は2050年には16億人に達し、世界人口の16%以上を占めると予想されています。
治療に伴う副作用
使用する抗生物質や治療計画、患者の状態、その他の要因によって、菌血症の治療に伴う副作用は異なります。例えば、抗生物質は人によってはアレルギー反応を引き起こすことがあり、軽度の皮膚の発疹から、腫れや呼吸障害、アナフィラキシー(命にかかわる重篤なアレルギー反応)などの重篤な徴候や症状が現れることもあります。まれに、特定の抗生物質が、見当識障害、幻覚、痙攣など、中枢神経系に影響を及ぼす副作用を引き起こすことがあります。このように、これらすべての困難が市場拡大の妨げになる可能性があります。
Bacteremia is the diagnosis used for the presence of bacteria in the blood. Bacteremia can have significant clinical implications and is regarded as a major health problem even though it may not always result in symptoms or serious disease. In order to combat germs that are resistant to antibiotics, new antibiotics and antimicrobial agents have been developed. However, there has not been much of a pipeline for new antibiotics recently.
The focus on antibiotic management programmes aimed at maximising the use of antibiotics and preventing the development of antibiotic resistance has increased as a result of advances in diagnostics, which have led to the development of faster and more accurate methods for identifying the causing bacteria and their antibiotic susceptibility.
Moreover, to improve patient outcomes, early detection of bacteremia and the start of the proper therapy are essential, early detection and intervention are made easier by point-of-care diagnostic tools and increased communication between laboratory and clinical teams are some factors helps boost the bacteremia market size.
Dynamics
The Increasing Number of Product Approvals for the Treatment
Public health issues can arise from bacterial infections, including bacteremia, especially in healthcare facilities where infections can spread rapidly. The regulatory bodies could provide therapies that may reduce the spread of these diseases importance in their approval. The processes of bacterial disease and antibiotic resistance have been clarified due to developments in microbiology, genetics, and molecular biology. Thus the rise of product approvals drives the market growth.
For instance, in May 2023, for the treatment of patients 18 years of age and older who have developed hospital-acquired bacterial pneumonia, bacteremia and ventilator-associated bacterial pneumonia caused on by susceptible isolates of the Acinetobacter baumannii-calcoaceticus complex, the Food and Drug Administration (FDA) has approved Xacduro (sulbactam for injection; durlobactam for injection). Sulbactam, a beta-lactam antibiotic and beta lactamase inhibitor, and durlobactam, a beta lactamase inhibitor, are both ingredients in the co-packaged drug Xacduro. Thus, a rise in product approvals contributes in accelerating market expansion.
Rising number of Clinical Trials on Bacteremia
There is an urgent need for novel and more effective treatments due to the rise in antibiotic-resistant bacteria. It can be particularly difficult to treat bacteremia caused on by organisms that are drug-resistant, which is why it is important to develop novel medications.
For instance, in May 2023, the first patient has been dosed in the company's phase 1b/2a clinical trial ('diSArm') of AP-SA02, which is being developed for the treatment of complicated staphylococcus aureus bacteremia. Armata Pharmaceuticals, Inc. is a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections.
Moreover, in March 2022, as a potential treatment for adult patients with complex urinary tract infections (cUTI), including acute pyelonephritis, Venatorx Pharmaceuticals recently released positive results from its pivotal Phase 3 research testing the investigational novel medication cefepime-taniborbactam. Fourth-generation cephalosporin cefepime is a beta-lactam (BL) antibiotic that is often used. It has been clinically effective against susceptible gram-negative and gram-positive bacteria for more than 20 years. Thus, all of these factors contribute to the market'sgrowth.
Increasing Geriatric Population
Immunosenescence is the term for the immune system's tendency to decline with age. This implies that the body's capacity to detect and combat diseases, including bacterial infections, is reduced. Elderly people might be less able to establish a robust immunological defense against invasive germs. With age, wound healing typically takes longer. The risk of bacteremia is increased by the possibility of open wounds or infections that are harder to treat as a result of this delayed healing.
Thus, the aging population is growing, which also contributes to the market's rapid expansion.For instance, according to Eurostat, the EU population in January 2022, was estimated to be 446.7 million, out of which 21.1% were older individuals aged 65 or over indicating an increase of 0.3 percentage points (pp) to the previous year and an increase of 3.1 pp compared with a decade earlier.
In addition, according to a new report by the United Nations (UN), the number of individuals aged 65 years or above globally is anticipated to increase two folds in the next 30 years. The geriatric population is expected to attain 1.6 billion in 2050, making up over 16% of the world population.
Side Effects Associated with the Treatment
Depending on the specific antibiotic or treatment plan being used, the patient's condition, and other factors, the side effects of treating bacteremia may differ. For instance, antibiotics can cause allergic responses in some people, ranging from minor skin rashes to more serious signs and symptoms like swelling, breathing problems, or anaphylaxis, a severe allergic reaction that can be fatal. Rarely, certain antibiotics might cause side effects that affect the central nervous system, like disorientation, hallucinations, or seizures. Thus, all of these difficulties may hinder market expansion.
The global bacteremia market is segmented based on type, infection type, antibiotics, end user and region.
Beta-lactams used to Treat Bacterial Infections
Penicillins and cephalosporins are both examples of beta-lactams that have a rather broad spectrum of activity against a variety of bacteria. They are suitable for actual treatment when the precise bacterium causing the infection has not yet been identified because they are effective against various Gram-positive and Gram-negative bacteria. The bacterial cell wall, which is essential for bacteria to preserve their structural integrity, is the target of beta-lactams.
They prevent the development of the cell wall, which eventually causes the bacteria to be lysed. They are efficient against bacteria that are actively developing due to this method of action. Additionally, the strategies followed by the companies helps to elevate the segment growth. For instance, on November 07, 2022, in order to support enhanced European production capacity for finished dosage form (FDF) penicillins, the most popular class of antibiotics globally, Sandoz announced an additional investment of EUR 50 million.
The latest commitment follows plans to invest more than EUR 100 million in new manufacturing technologies for the production of oral amoxicillin active pharmaceutical ingredient (API) at Kundl, Austria, that were previously announced last year. The manufacturing capacity for FDFs of amoxicillin and other important penicillin products will expand as a result of this investment. Thus above factors helps to srive the segment growth.
Geographical Penetration
Prevalence of the Diseases in the Region
The North American region is anticipated to have significant market expansion, which can mostly be attributed to a developed healthcare system and quicker access to diagnostics, technological developments, awareness of early diagnosis, increased bacteremia prevalence, and the treatment of infectious disorders are anticipated to drive market expansion.
For instance, in the United States alone, according to the CDC, up to 1.7 million people could have bacteremia each year. The most frequent pathogenic agent found inside and outside of hospitals is staphylococcus aureus bacteremia. Staphylococcus aureus bacteremia mortality is higher than that from AIDS, tuberculosis, or viral hepatitis and similar to that from breast or prostate cancer, according to age-adjusted mortality evaluations. Therefore, the prevalence of disease and other factors contribute to the growth of the region.
The COVID-19 pandemic has had a significant impact on healthcare facilities. Infections with respiratory viruses, such as influenza and SARS-CoV-2, put a lot of strain on healthcare systems, leading to an increase in hospitalizations and admissions to hospitals with critical care units.
Blood cultures (BC) are typically taken because these patients may exhibit signs and symptoms of bloodstream infections (BSI). As a result, clinical laboratories process more blood culture vials in the colder months, and automated blood culture equipment may get overloaded. Regarding the COVID-19 pandemic, an increase in blood culture substances during the pandemic's first wave compared to the pre-epidemic period was observed.
The major global players in the market include Pfizer, Pherecydes Pharma, Baxter, Novartis AG, Venatorx Pharmaceuticals, HAL, GSK plc, Sandoz, Basilea Pharmaceutica Ltd, Fresenius SE & Co. KGaA and among others.
The global bacteremia market report would provide approximately 61 tables, 58 figures and 186 Pages.
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