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市場調查報告書
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1379948

治療性卡介苗疫苗市場 - 2018-2028 年全球產業規模、佔有率、趨勢、機會和預測,按類型(免疫卡介苗、治療卡介苗)、人口統計(成人、兒科)、最終用戶(診所、醫院)細分地區、競爭

Therapeutic BCG Vaccine Market - Global Industry Size, Share, Trends, Opportunity, & Forecast, 2018-2028 Segmented by Type (Immune BCG, Therapy BCG), by Demographics (Adults, Pediatrics), by End User (Clinics, Hospitals), by region, & Competition

出版日期: | 出版商: TechSci Research | 英文 188 Pages | 商品交期: 2-3個工作天內

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簡介目錄

2022 年,全球治療性卡介苗疫苗市場價值為 1.2854 億美元,預計到 2028 年,複合CAGR將達到 6.37%,預測期內將出現令人印象深刻的成長。卡介苗 (BCG) 疫苗簡稱為 BCG 疫苗。它是市面上唯一有助於預防結核病的疫苗。在結核病流行的國家,新生兒在分娩後不久會服用單劑。在結核病罕見的國家,結核病只針對高危險新生兒進行。卡介苗疫苗用於治療結核病。雖然它主要影響肺部,但這種被稱為結核病的嚴重疾病也可以擴散到身體的其他部位。出生後,應接種疫苗的健康嬰兒會接種一劑,因為他們的風險較高,並建議接種年齡。卡介苗疫苗是目前最受歡迎的疫苗之一。國家兒童免疫規劃包括它。目前正在研究卡介苗疫苗對膀胱癌以外的各種疾病(如結核病、自體免疫疾病和某些癌症)的潛在治療用途,擴大了市場的潛力。

主要市場促進因素

市場概況
預測期 2024-2028
2022 年市場規模 1.2854億美元
2028 年市場規模 1.8503億美元
2023-2028 年CAGR 6.37%
成長最快的細分市場 醫院
最大的市場 北美洲

生物技術進步

生物技術進步是指生物技術領域的進步和創新,即應用生物學原理和技術開發產品和技術,改善和增強人類生活的各個方面,包括醫療保健、農業、工業和環境永續性。生物技術涵蓋廣泛的科學學科和技術,該領域的進步具有深遠的影響。基因工程的進步使得能夠操縱和修改生物體的遺傳物質。 CRISPR-Cas9 等技術徹底改變了基因編輯,可以對多種生物體(包括人類、動物和植物)進行精確且有針對性的基因修飾。生物技術促進了生物製藥的發展,生物製藥是利用生物技術製程生產的治療藥物。這包括單株抗體、疫苗、基因療法和其他針對各種疾病的先進療法。人類基因組定序和基因組學的進步為個人化醫療鋪平了道路。現在可以根據個人的基因組成來客製化醫療保健,從而實現更有效和客製化的治療。幹細胞研究的進展為再生醫學、組織工程和退化性疾病的治療帶來了希望。幹細胞可以分化成各種細胞類型,為組織和器官修復提供潛在的解決方案。合成生物學涉及出於有用目的而設計和建造生物部件、裝置和系統。它可用於製造生物燃料、設計生物感測器以及為各種工業製程設計微生物。

生物技術的進步使得基因改造(GM)作物具有抗病蟲害、耐除草劑和改善營養成分等特性。這些創新旨在提高作物產量和糧食安全。生物技術用於環境目的,例如生物修復,利用微生物來清除土壤和水中的污染物和污染物。生物技術在疫苗開發中發揮著至關重要的作用,包括創建 mRNA 疫苗,例如針對 COVID-19 開發的疫苗。免疫療法利用免疫系統來對抗癌症等疾病,也是一項重大的生物技術進步。發酵等生物加工技術用於生產多種產品,包括藥品、生物燃料和工業酵素。生物加工的進步提高了生產效率和產品品質。生物資訊學領域將生物學與電腦科學結合來分析和解釋生物資料,例如基因組序列。這對於基因組學研究、藥物發現和個人化醫療至關重要。奈米技術和生物技術的融合導致了奈米生物技術的發展,其中涉及在奈米尺度上操縱生物分子。它在藥物傳輸、診斷和成像方面有應用。生物技術被用來應對環境挑戰,包括開發可生物分解塑膠、廢水處理技術以及永續生物燃料的生產。這項因素將有助於全球治療性卡介苗疫苗市場的發展。

結核病控制力道不斷加大

卡介苗疫苗最初是為了預防結核病而開發的。在結核病負擔較高的國家,卡介苗疫苗接種通常是常規兒童免疫計畫的一部分。隨著結核病控制工作的繼續,對預防性卡介苗疫苗的需求持續存在,從而推動了需求。結核病高發生率地區,如亞洲部分地區、非洲和部分東歐國家,對治療性卡介苗疫苗有大量需求。這項需求源自於治療結核病感染和防止疾病在社區內傳播的需要。世界衛生組織 (WHO) 等組織制定了消滅和控制結核病的雄心勃勃的目標。這些目標包括提高結核病病例的發現率和治療率。治療性卡介苗疫苗可用作結核病患者的輔助治療,其給藥符合這些目標。多重抗藥性結核病 (MDR-TB) 和廣泛抗藥性結核病 (XDR-TB) 等抗藥性結核菌株的出現,產生了對替代治療的需求。人們正在探索治療性卡介苗疫苗作為潛在的輔助療法,以改善抗藥性結核病的治療效果。

卡介苗疫苗具有免疫調節特性,這意味著它們可以增強人體的免疫反應。這項特性使它們在結核病控制方面很有價值,因為它們可以增強免疫系統對抗結核病感染的能力。正在進行的研究和臨床試驗正在調查卡介苗疫苗在結核病預防之外的潛在治療應用。這些研究探討了疫苗在治療其他疾病(例如某些癌症和自體免疫疾病)方面的功效,如果表現出正面的結果,可能會增加需求。與其他一些結核病治療方法相比,卡介苗疫苗相對便宜,這使其成為結核病流行的資源有限地區的可行選擇。這種負擔能力支持它們在結核病控制工作中的使用。許多結核病控制規劃和措施已涵蓋更廣泛的社區健康規劃。卡介苗疫苗接種和治療使用通常是對抗結核病和改善公共衛生的綜合努力的一部分。國際組織、政府和非政府組織在結核病控制措施上合作,並分享資源,以確保最需要的地區獲得結核病治療,包括卡介苗疫苗。這項因素將加速全球治療性卡介苗疫苗市場的需求。

不斷加強對新適應症的研究

研究工作已將卡介苗疫苗的潛在應用擴展到結核病預防之外。人們正在研究它們作為各種疾病的治療方法,包括某些癌症、自體免疫疾病和傳染病。這種多樣化拓寬了治療性卡介苗疫苗的市場。當研究顯示出積極的臨床結果和治療特定病症的功效時,就會引起醫療保健專業人員和患者的興趣。正面的結果可能會導致更多地採用卡介苗免疫療法來治療這些適應症。在傳統治療可能有限制或副作用的情況下,治療性卡介苗疫苗可以提供替代或補充治療選擇。患者和醫療保健提供者尋求替代療法,這可以推動需求。臨床試驗對於評估治療性卡介苗疫苗在新適應症的安全性和有效性至關重要。患者參與這些試驗可以創造需求,因為個人尋求獲得有希望的實驗療法。當監管機構根據可靠的臨床資料批准將卡介苗用於特定治療適應症時,就使其使用合法化,並可能導致臨床實踐中對這些疫苗的需求增加。隨著患者越來越了解治療性卡介苗疫苗對其特定情況的潛在益處,他們可能會向醫療保健提供者請求這些治療。患者需求可以推動卡介苗疫苗的處方和使用增加。

當醫學協會和組織更新治療指南以涵蓋針對某些疾病的治療性卡介苗疫苗時,會鼓勵醫療保健專業人員將這些疫苗視為護理標準的一部分,從而導致需求增加。世界各地的機構和醫療保健組織之間的研究合作促進了使用卡介苗疫苗治療新適應症的知識和最佳實踐的共享,從而促進了全球需求。分配給治療性卡介苗新適應症研究的資金和資源有助於實證療法的開發,並可以鼓勵其採用。用於治療用途的卡介苗疫苗的生產、配方和輸送方法的創新可能會導致專利或專有產品的開發,從而可能推動需求。針對特定疾病的宣傳活動和倡導團體可以提高人們對治療性卡介苗疫苗作為潛在治療方法的認知,從而增加受影響患者群體的需求。向醫療保健提供者介紹治療性卡介苗疫苗的最新研究成果和臨床應用可以帶來更明智的治療決策並提高利用率。這項因素將加速全球治療性卡介苗疫苗市場的需求。

主要市場挑戰

疫苗短缺

卡介苗疫苗的生產是一個複雜的過程,涉及在受控條件下培養活細菌。生產過程中的任何中斷,例如污染或品質控制問題,都可能導致短缺。 BCG 疫苗的生產僅限於全球相對少數的製造商。如果任何一家製造商面臨生產挑戰,供應鏈缺乏多樣性可能會使市場容易出現短缺。確保卡介苗疫苗的品質和安全至關重要。嚴格的品質控制措施可能會導致生產延誤或不符合品質標準的批次被丟棄。滿足疫苗生產的監管要求至關重要。監管指南的變更或批准的延遲可能會影響卡介苗疫苗的生產和分銷。治療性 BCG 疫苗的需求可能會根據疾病流行情況、臨床試驗需求和新興治療應用而波動。製造商在準確預測和滿足需求方面可能面臨挑戰。需求和分配的地區差異可能會加劇疫苗短缺。一些對治療性卡介苗需求量大的地區可能會因分配不均而面臨短缺。如果需求突然增加,例如在疾病爆發或臨床試驗招募期間,現有疫苗庫存可能會迅速耗盡,導致短缺。

競爭日益激烈

全球生產用於治療目的的卡介苗疫苗的製造商數量相對較少。有限數量的參與者可能會導致激烈的競爭,因為他們爭奪市場佔有率。一些製造商可能因其聲譽、歷史或產品品質而確立了市場主導地位。對於新進業者或規模較小的公司來說,與主導企業競爭可能具有挑戰性。卡介苗疫苗市場的價格競爭可能非常激烈,特別是在醫療保健預算有限的地區。製造商可能會採取使競爭對手難以進入市場或維持獲利能力的定價策略。開發和測試針對新適應症的治療性 BCG 疫苗可能既昂貴又耗時。公司需要大量資源來資助研究和管理監管流程,這可以阻止潛在的競爭對手。對新適應症的治療性卡介苗疫苗的監管批准通常是一個複雜而漫長的過程。滿足監管機構的嚴格要求可能會成為一些公司的進入障礙。確保卡介苗疫苗的安全和品質至關重要。競爭製造商必須投資強大的品質控制和保證流程,以滿足監管標準並贏得醫療保健專業人員和患者的信任。競爭製造商必須進行廣泛的臨床試驗並產生強力的科學證據來支持其用於治療用途的卡介苗疫苗的功效和安全性。建立這個證據庫可能非常耗時且成本高昂。

主要市場趨勢

結核病 (TB) 治療與預防

傳統用途:卡介苗疫苗用於預防結核病有著悠久的歷史,特別是在結核病負擔較高的地區。它們通常在兒童時期對個體進行給藥,以降低結核病感染和嚴重疾病的風險。膀胱癌的治療:BCG 免疫療法是一種成熟的非肌肉浸潤性膀胱癌 (NMIBC) 治療方法。它直接注入膀胱,可以刺激免疫系統攻擊癌細胞。卡介苗的這種應用被認為是癌症治療的一種輔助療法。正在進行的研究正在探索卡介苗疫苗對結核病和膀胱癌以外的各種疾病和病症的治療潛力。這包括對自體免疫疾病、傳染病和膀胱癌以外的癌症類型的研究。抗藥性菌株:抗藥性結核菌株的出現,例如多重抗藥性結核病(MDR-TB)和廣泛抗藥性結核病(XDR-TB),對全球健康構成威脅。治療性卡介苗疫苗正在被研究作為潛在的輔助療法,以改善抗藥性結核病的治療結果。

細分市場洞察

類型洞察

2022 年,全球治療性 BCG 疫苗市場最大佔有率由免疫 BCG 細分市場佔據,預計未來幾年將繼續擴大。卡介苗免疫療法已廣泛用於治療膀胱癌,特別是非肌肉層浸潤性膀胱癌(NMIBC)。它在預防這一特定適應症的腫瘤復發和進展方面具有悠久的有效性。這種既定用途可能對免疫卡介苗領域的主導地位做出了重大貢獻。卡介苗疫苗刺激免疫系統針對癌細胞的反應的治療功效已得到臨床試驗和研究的支持。這些研究證明了卡介苗能夠活化免疫系統並誘導抗腫瘤反應。在某些膀胱癌病例中,卡介苗治療一直是標準治療方法,並且可能有有限的替代療法來提供類似的效果。缺乏可行的替代品可能會推動對免疫卡介苗的需求。卡介苗治療膀胱癌已獲得許多國家監管部門的批准,進一步鞏固了其市場地位。

最終使用者見解

2022年,全球治療性卡介苗疫苗市場最大佔有率由醫院部門在預測期內佔據,預計未來幾年將繼續擴大。當用於治療目的時,卡介苗疫苗通常在臨床或醫院環境中施用。這是因為卡介苗疫苗的接種需要醫學專業知識,以確保適當的劑量並最大限度地減少不良反應的風險。將卡介苗疫苗用於治療應用(例如膀胱癌治療)涉及複雜的治療方案。通常需要多次給藥並仔細監測患者的病情。醫院設備齊全,可以處理如此複雜的治療方案。醫院擁有專門的醫務人員,包括泌尿科醫生和腫瘤科醫生,他們接受過針對膀胱癌等疾病進行卡介苗免疫治療的培訓。這些專家在確定治療方法和確保患者安全方面發揮關鍵作用。接受 BCG 免疫治療的患者通常需要密切監測,以評估治療反應並管理潛在的副作用。醫院有能力提供這種程度的病患照護和監測。

區域洞察

2022年,北美地區將主導全球治療性卡介苗疫苗市場。北美地區,特別是美國和加拿大,膀胱癌的發生率相對較高。膀胱癌是卡介苗疫苗的主要治療適應症之一。該地區膀胱癌患者的盛行率較高,增加了對卡介苗免疫治療的需求。北美擁有先進的醫療保健基礎設施,包括設備齊全的醫院、專門的癌症治療中心以及在卡介苗免疫治療方面經驗豐富的醫療保健專業人員網路。此基礎設施支持有效提供用於治療目的的卡介苗疫苗。北美是醫學研究和臨床試驗的中心。關於卡介苗疫苗用於膀胱癌以外的各種治療應用的研究正在進行中。該地區強大的研究生態系統促進了該領域的進步以及使用卡介苗疫苗開發新治療方法。北美擁有多家製藥公司和生物技術公司,專門生產和分銷用於治療目的的卡介苗疫苗。這些公司在向醫療機構和患者供應疫苗方面發揮著至關重要的作用。

目錄

第 1 章:產品概述

  • 市場定義
  • 市場範圍
    • 涵蓋的市場
    • 研究年份
    • 主要市場區隔

第 2 章:研究方法

  • 研究目的
  • 基線方法
  • 主要產業夥伴
  • 主要協會和二手資料來源
  • 預測方法
  • 數據三角測量與驗證
  • 假設和限制

第 3 章:執行摘要

  • 市場概況
  • 主要市場細分概述
  • 主要市場參與者概述
  • 重點地區/國家概況
  • 市場促進因素、挑戰、趨勢概述

第 4 章:客戶之聲

第 5 章:全球治療性卡介苗疫苗市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按類型(免疫卡介苗、治療卡介苗)
    • 按最終用戶(診所、醫院)
    • 按公司分類 (2022)
  • 市場地圖

第 6 章:亞太地區治療性卡介苗疫苗市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按類型
    • 按最終用戶
    • 按國家/地區
  • 亞太地區:國家分析
    • 中國治療性卡介苗
    • 印度治療性卡介苗疫苗
    • 澳洲治療性卡介苗疫苗
    • 日本治療性卡介苗疫苗
    • 韓國治療性卡介苗疫苗

第 7 章:歐洲治療性卡介苗疫苗市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按類型
    • 按最終用戶
    • 按國家/地區
  • 歐洲:國家分析
    • 法國
    • 德國
    • 西班牙
    • 義大利
    • 英國

第 8 章:北美治療性卡介苗疫苗市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按類型
    • 按最終用戶
    • 按國家/地區
  • 北美:國家分析
    • 美國
    • 墨西哥
    • 加拿大

第 9 章:南美洲治療性卡介苗疫苗市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按類型
    • 按最終用戶
    • 按國家/地區
  • 南美洲:國家分析
    • 巴西
    • 阿根廷
    • 哥倫比亞

第 10 章:中東和非洲治療性卡介苗疫苗市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按類型
    • 按最終用戶
    • 按國家/地區
  • MEA:國家分析
    • 南非治療性卡介苗疫苗
    • 沙烏地阿拉伯治療性卡介苗疫苗
    • 阿拉伯聯合大公國治療性卡介苗疫苗

第 11 章:市場動態

  • 促進要素
  • 挑戰

第 12 章:市場趨勢與發展

  • 最近的發展
  • 產品發布
  • 併購

第 13 章:全球治療性 BCG 疫苗市場:SWOT 分析

第 14 章:波特的五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的力量
  • 客戶的力量
  • 替代產品的威脅

第 15 章:大環境分析

第16章:競爭格局

  • 默克公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 賽諾菲巴斯德公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 日本BCG實驗室
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 中國生物技術集團
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 印度血清研究所列兵。有限公司,
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 英特瓦克斯有限公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 綠訊號生物製藥有限公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 史坦頓血清研究所
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • PowderJect 製藥有限公司
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis
  • 盧布林生物醫學中心
    • Business Overview
    • Company Snapshot
    • Products & Services
    • Financials (In case of listed companies)
    • Recent Developments
    • SWOT Analysis

第 17 章:策略建議

第 18 章:關於我們與免責聲明

簡介目錄
Product Code: 16984

Global Therapeutic BCG Vaccine Market has valued at USD 128.54 million in 2022 and is anticipated to witness an impressive growth in the forecast period with a CAGR of 6.37% through 2028. Bacillus Calmette-Gurin (BCG) vaccine is referred to by the acronym BCG vaccine. It is the only vaccination on the market that can aid in TB prevention. A single dosage is administered to a newborn in nations where TB is common shortly after delivery. In nations where it is rare, TB is only administered to high-risk newborns. The BCG vaccination is used to treat tuberculosis. Although it mostly affects the lungs, the serious illness known as tuberculosis can also spread to other regions of the body. After birth, healthy infants who should receive a vaccination dose are given one because of their high risk and recommended age for immunization. The Bacille Calmette-Guerin vaccination is one of the most popular ones currently available. The national childhood immunization program includes it. Ongoing research into the potential therapeutic uses of BCG vaccines for various diseases beyond bladder cancer, such as tuberculosis, autoimmune diseases, and certain cancers, has expanded the market's potential.

Clinical trials exploring the efficacy of BCG vaccines for different therapeutic applications have generated promising results. Positive clinical outcomes have driven interest and investment in BCG vaccine development. BCG vaccines continue to be an essential tool in the global effort to control tuberculosis (TB). Initiatives and programs aimed at TB prevention and treatment drive the production and distribution of BCG vaccines. Advances in biotechnology have improved the manufacturing and quality control processes for BCG vaccines, making them more reliable and accessible. Healthcare professionals' awareness of the therapeutic potential of BCG vaccines and patient education about treatment options have driven the adoption of BCG immunotherapy.

Key Market Drivers

Market Overview
Forecast Period2024-2028
Market Size 2022USD 128.54 Million
Market Size 2028USD 185.03 Million
CAGR 2023-20286.37%
Fastest Growing SegmentHospitals
Largest MarketNorth America

Biotechnology Advancements

Biotechnology advancements refer to the progress and innovations in the field of biotechnology, which is the application of biological principles and techniques to develop products and technologies that improve and enhance various aspects of human life, including healthcare, agriculture, industry, and environmental sustainability. Biotechnology encompasses a wide range of scientific disciplines and technologies, and advancements in this field have far-reaching implications. Advances in genetic engineering have enabled the manipulation and modification of the genetic material of organisms. Techniques such as CRISPR-Cas9 have revolutionized gene editing, allowing for precise and targeted genetic modifications in a variety of organisms, including humans, animals, and plants. Biotechnology has led to the development of biopharmaceuticals, which are therapeutic drugs produced using biotechnological processes. This includes monoclonal antibodies, vaccines, gene therapies, and other advanced treatments for various diseases. The sequencing of the human genome and advancements in genomics have paved the way for personalized medicine. Healthcare can now be tailored to an individual's genetic makeup, allowing for more effective and customized treatments. Progress in stem cell research holds promise for regenerative medicine, tissue engineering, and the treatment of degenerative diseases. Stem cells can differentiate into various cell types, offering potential solutions for tissue and organ repair. Synthetic biology involves the design and construction of biological parts, devices, and systems for useful purposes. It has applications in creating biofuels, designing biosensors, and engineering microorganisms for various industrial processes.

Advancements in biotechnology have led to genetically modified (GM) crops with traits such as resistance to pests and diseases, tolerance to herbicides, and improved nutritional content. These innovations aim to enhance crop yields and food security. Biotechnology is used for environmental purposes, such as bioremediation, where microorganisms are employed to clean up pollutants and contaminants in soil and water. Biotechnology plays a crucial role in vaccine development, including the creation of mRNA vaccines like those developed for COVID-19. Immunotherapies, which harness the immune system to combat diseases like cancer, are also a significant biotechnological advancement. Bioprocessing techniques, such as fermentation, are used to produce a wide range of products, including pharmaceuticals, biofuels, and industrial enzymes. Advances in bioprocessing have improved production efficiency and product quality. The field of bioinformatics combines biology with computer science to analyze and interpret biological data, such as genomic sequences. This is essential for genomics research, drug discovery, and personalized medicine. The convergence of nanotechnology and biotechnology has led to the development of nanobiotechnology, which involves the manipulation of biological molecules at the nanoscale. It has applications in drug delivery, diagnostics, and imaging. Biotechnology is being used to address environmental challenges, including the development of biodegradable plastics, wastewater treatment technologies, and the production of sustainable biofuels. This factor will help in the development of the Global Therapeutic BCG Vaccine Market.

Rising Tuberculosis Control Efforts

BCG vaccines were originally developed for the prevention of tuberculosis. In countries with a high burden of TB, BCG vaccination is often part of routine childhood immunization programs. As TB control efforts continue, the need for preventive BCG vaccines persists, driving demand. Regions with a high incidence of TB, such as parts of Asia, Africa, and some Eastern European countries, have a substantial demand for therapeutic BCG vaccines. This demand arises from the need to treat TB infections and prevent disease from spreading within communities. Organizations like the World Health Organization (WHO) have set ambitious goals for TB eradication and control. These goals include increasing TB case detection and treatment rates. Therapeutic BCG vaccines can be used as an adjunct therapy for TB patients, and their administration aligns with these goals. The emergence of drug-resistant TB strains, such as multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB), has created a need for alternative treatments. Therapeutic BCG vaccines are being explored as potential adjunct therapies to improve the outcomes of drug-resistant TB treatment.

BCG vaccines have immunomodulatory properties, meaning they can enhance the body's immune response. This property makes them valuable in the context of TB control, as they can boost the immune system's ability to combat TB infections. Ongoing research and clinical trials are investigating the potential therapeutic applications of BCG vaccines beyond TB prevention. These studies explore the vaccine's efficacy in treating other diseases, such as certain cancers and autoimmune conditions, which can increase demand if positive outcomes are demonstrated. BCG vaccines are relatively affordable compared to some other TB treatments, making them a viable option for resource-constrained regions where TB is prevalent. This affordability supports their use in TB control efforts. Many TB control programs and initiatives are integrated into broader community health programs. BCG vaccination and therapeutic use are often part of these comprehensive efforts to combat TB and improve public health. International organizations, governments, and NGOs collaborate on TB control initiatives and share resources to ensure access to TB treatments, including BCG vaccines, in regions where they are needed most. This factor will pace up the demand of the Global Therapeutic BCG Vaccine Market.

Growing Research into New Indications

Research efforts have expanded the potential applications of BCG vaccines beyond TB prevention. They are being investigated as treatments for various diseases, including certain cancers, autoimmune disorders, and infectious diseases. This diversification broadens the market for therapeutic BCG vaccines. When research studies demonstrate positive clinical outcomes and efficacy in treating specific conditions, it generates interest from healthcare professionals and patients. Positive results can lead to increased adoption of BCG immunotherapy for those indications. In cases where conventional treatments may have limitations or side effects, therapeutic BCG vaccines may offer an alternative or complementary therapeutic option. Patients and healthcare providers seek alternative treatments, which can drive demand. Clinical trials are essential for assessing the safety and efficacy of therapeutic BCG vaccines in new indications. The participation of patients in these trials can create demand as individuals seek access to experimental therapies that show promise. When regulatory agencies approve the use of BCG vaccines for specific therapeutic indications based on robust clinical data, it legitimizes their use and can lead to increased demand for these vaccines in clinical practice. As patients become more informed about the potential benefits of therapeutic BCG vaccines for their specific conditions, they may request these treatments from their healthcare providers. Patient demand can drive increased prescription and use of BCG vaccines.

When medical associations and organizations update treatment guidelines to include therapeutic BCG vaccines for certain diseases, it encourages healthcare professionals to consider these vaccines as part of the standard of care, contributing to increased demand. Research collaborations between institutions and healthcare organizations worldwide promote the sharing of knowledge and best practices in using BCG vaccines for new indications, fostering global demand. Funding and resources allocated to research on new indications for therapeutic BCG vaccines contribute to the development of evidence-based therapies and can encourage their adoption. Innovations in the production, formulation, and delivery methods of BCG vaccines for therapeutic use can lead to the development of patented or proprietary products, which may drive demand. Disease-specific awareness campaigns and advocacy groups can raise awareness about therapeutic BCG vaccines as potential treatments, increasing demand from affected patient populations. Educating healthcare providers about the latest research findings and clinical applications of therapeutic BCG vaccines can lead to more informed treatment decisions and increased utilization. This factor will accelerate the demand of the Global Therapeutic BCG Vaccine Market.

Key Market Challenges

Vaccine Shortages

BCG vaccine production is a complex process that involves growing live bacteria cultures under controlled conditions. Any disruptions in the production process, such as contamination or quality control issues, can lead to shortages. The production of BCG vaccines is limited to a relatively small number of manufacturers worldwide. A lack of diversity in the supply chain can make the market vulnerable to shortages if any single manufacturer faces production challenges. Ensuring the quality and safety of BCG vaccines is paramount. Stringent quality control measures may lead to delays in production or batches being discarded if they do not meet quality standards. Meeting regulatory requirements for vaccine production is essential. Changes in regulatory guidelines or delays in approvals can impact the production and distribution of BCG vaccines. Demand for therapeutic BCG vaccines can fluctuate based on disease prevalence, clinical trial needs, and emerging therapeutic applications. Manufacturers may face challenges in accurately predicting and meeting demand. Vaccine shortages can be exacerbated by regional disparities in demand and distribution. Some regions with a high demand for therapeutic BCG vaccines may face shortages due to uneven distribution. In the event of a sudden increase in demand, such as during a disease outbreak or clinical trial enrollment, existing vaccine stockpiles may be quickly depleted, leading to shortages.

Growing Competition

There are a relatively small number of manufacturers worldwide that produce BCG vaccines for therapeutic purposes. This limited number of players can lead to intense competition as they vie for market share. Some manufacturers may have established market dominance due to their reputation, history, or the quality of their products. Competing against dominant players can be challenging for newer entrants or smaller companies. Price competition can be fierce in the BCG vaccine market, particularly in regions where healthcare budgets are constrained. Manufacturers may engage in pricing strategies that can make it difficult for competitors to enter the market or maintain profitability. Developing and testing therapeutic BCG vaccines for new indications can be costly and time-consuming. Companies need substantial resources to fund research and navigate regulatory processes, which can deter potential competitors. Regulatory approval for therapeutic BCG vaccines in new indications is often a complex and lengthy process. Meeting the stringent requirements of regulatory agencies can be a barrier to entry for some companies. Ensuring the safety and quality of BCG vaccines is of utmost importance. Competing manufacturers must invest in robust quality control and assurance processes to meet regulatory standards and gain the trust of healthcare professionals and patients. Competing manufacturers must conduct extensive clinical trials and generate strong scientific evidence to support the efficacy and safety of their BCG vaccines for therapeutic use. Building this evidence base can be time-consuming and costly.

Key Market Trends

Tuberculosis (TB) Treatment and Prevention

Traditional Use: BCG vaccines have a long history of use for the prevention of TB, particularly in regions with a high TB burden. They are administered to individuals, typically in childhood, to reduce the risk of TB infection and severe forms of the disease. Treatment of Bladder Cancer: BCG immunotherapy is a well-established treatment for non-muscle-invasive bladder cancer (NMIBC). It is administered directly into the bladder and can stimulate the immune system to attack cancer cells. This application of BCG is considered a form of adjunct therapy for cancer treatment. Ongoing research is exploring the therapeutic potential of BCG vaccines for various diseases and conditions beyond TB and bladder cancer. This includes research into autoimmune diseases, infectious diseases, and cancer types other than bladder cancer. Drug-Resistant Strains: The emergence of drug-resistant TB strains, such as multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB), poses a global health threat. Therapeutic BCG vaccines are being investigated as potential adjunct therapies to improve the outcomes of drug-resistant TB treatment.

Segmental Insights

Type Insights

In 2022, the Global Therapeutic BCG Vaccine Market largest share was held by Immune BCG segment and is predicted to continue expanding over the coming years. BCG immunotherapy has been widely used for the treatment of bladder cancer, particularly non-muscle-invasive bladder cancer (NMIBC). It has a long history of effectiveness in preventing tumour recurrence and progression in this specific indication. This established use may have contributed significantly to the dominance of the Immune BCG segment. The therapeutic efficacy of BCG vaccines in stimulating the immune system's response against cancer cells has been supported by clinical trials and research. These studies have demonstrated BCG's ability to activate the immune system and induce an anti-tumour response. In certain cases of bladder cancer, BCG therapy has been the standard of care, and there may be limited alternative treatments that offer comparable effectiveness. This lack of viable alternatives can drive the demand for Immune BCG. BCG therapy for bladder cancer has received regulatory approval in many countries, further solidifying its position in the market.

End User Insights

In 2022, the Global Therapeutic BCG Vaccine Market largest share was held by Hospitals segment in the forecast period and is predicted to continue expanding over the coming years. BCG vaccines, when used for therapeutic purposes, are typically administered in a clinical or hospital setting. This is because the administration of BCG vaccines requires medical expertise to ensure proper dosage and minimize the risk of adverse reactions. The use of BCG vaccines for therapeutic applications, such as bladder cancer treatment, involves a complex treatment regimen. It often requires multiple doses and careful monitoring of the patient's condition. Hospitals are well-equipped to handle such complex treatment protocols. Hospitals have specialized medical personnel, including urologists and oncologists, who are trained to administer and manage BCG immunotherapy for conditions like bladder cancer. These specialists play a critical role in determining the treatment approach and ensuring patient safety. Patients receiving BCG immunotherapy often require close monitoring to assess treatment response and manage potential side effects. Hospitals are equipped to provide this level of patient care and monitoring.

Regional Insights

The North America region dominates the Global Therapeutic BCG Vaccine Market in 2022. North America, particularly the United States and Canada, has a relatively high incidence of bladder cancer. Bladder cancer is one of the primary therapeutic indications for BCG vaccines. The higher prevalence of bladder cancer patients in this region increases the demand for BCG immunotherapy. North America boasts advanced healthcare infrastructure with well-equipped hospitals, specialized cancer treatment centers, and a network of healthcare professionals who are experienced in administering BCG immunotherapy. This infrastructure supports the effective delivery of BCG vaccines for therapeutic purposes. North America is a hub for medical research and clinical trials. There has been ongoing research into the use of BCG vaccines for various therapeutic applications beyond bladder cancer. The region's robust research ecosystem has contributed to advancements in the field and the development of new therapeutic approaches using BCG vaccines. North America is home to several pharmaceutical companies and biotechnology firms that specialize in the production and distribution of BCG vaccines for therapeutic purposes. These companies play a crucial role in supplying the vaccines to healthcare facilities and patients.

Key Market Players

  • Merck & Co.
  • Sanofi Pasteur Inc.
  • Japan BCG Laboratory
  • China National Biotec Group
  • Serum Institute of India Pvt. Ltd,
  • InterVax Ltd
  • GreenSignal Bio Pharma Limited
  • Statens Serum Institute
  • PowderJect Pharmaceuticals
  • Biomed Lublin

Report Scope:

In this report, the Global Therapeutic BCG Vaccine Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Therapeutic BCG Vaccine Market, By Type:

  • Immune BCG
  • Therapy BCG

Therapeutic BCG Vaccine Market, By End User:

  • Clinics
  • Hospitals

Global Therapeutic BCG Vaccine Market, By region:

  • North America
  • United States
  • Canada
  • Mexico
  • Asia-Pacific
  • China
  • India
  • South Korea
  • Australia
  • Japan
  • Europe
  • Germany
  • France
  • United Kingdom
  • Spain
  • Italy
  • South America
  • Brazil
  • Argentina
  • Colombia
  • Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

  • Company Profiles: Detailed analysis of the major companies present in the Global Therapeutic BCG Vaccine Market.

Available Customizations:

  • Global Therapeutic BCG Vaccine Market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Therapeutic BCG Vaccine Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Type (Immune BCG, Therapy BCG)
    • 5.2.2. By End User (Clinics, Hospitals)
    • 5.2.3. By Company (2022)
  • 5.3. Market Map

6. Asia Pacific Therapeutic BCG Vaccine Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Type
    • 6.2.2. By End User
    • 6.2.3. By Country
  • 6.3. Asia Pacific: Country Analysis
    • 6.3.1. China Therapeutic BCG Vaccine Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Type
        • 6.3.1.2.2. By End User
    • 6.3.2. India Therapeutic BCG Vaccine Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Type
        • 6.3.2.2.2. By End User
    • 6.3.3. Australia Therapeutic BCG Vaccine Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Type
        • 6.3.3.2.2. By End User
    • 6.3.4. Japan Therapeutic BCG Vaccine Market Outlook
      • 6.3.4.1. Market Size & Forecast
        • 6.3.4.1.1. By Value
      • 6.3.4.2. Market Share & Forecast
        • 6.3.4.2.1. By Type
        • 6.3.4.2.2. By End User
    • 6.3.5. South Korea Therapeutic BCG Vaccine Market Outlook
      • 6.3.5.1. Market Size & Forecast
        • 6.3.5.1.1. By Value
      • 6.3.5.2. Market Share & Forecast
        • 6.3.5.2.1. By Type
        • 6.3.5.2.2. By End User

7. Europe Therapeutic BCG Vaccine Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Type
    • 7.2.2. By End User
    • 7.2.3. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. France Therapeutic BCG Vaccine Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Type
        • 7.3.1.2.2. By End User
    • 7.3.2. Germany Therapeutic BCG Vaccine Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Type
        • 7.3.2.2.2. By End User
    • 7.3.3. Spain Therapeutic BCG Vaccine Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Type
        • 7.3.3.2.2. By End User
    • 7.3.4. Italy Therapeutic BCG Vaccine Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Type
        • 7.3.4.2.2. By End User
    • 7.3.5. United Kingdom Therapeutic BCG Vaccine Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Type
        • 7.3.5.2.2. By End User

8. North America Therapeutic BCG Vaccine Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Type
    • 8.2.2. By End User
    • 8.2.3. By Country
  • 8.3. North America: Country Analysis
    • 8.3.1. United States Therapeutic BCG Vaccine Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Type
        • 8.3.1.2.2. By End User
    • 8.3.2. Mexico Therapeutic BCG Vaccine Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Type
        • 8.3.2.2.2. By End User
    • 8.3.3. Canada Therapeutic BCG Vaccine Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Type
        • 8.3.3.2.2. By End User

9. South America Therapeutic BCG Vaccine Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Type
    • 9.2.2. By End User
    • 9.2.3. By Country
  • 9.3. South America: Country Analysis
    • 9.3.1. Brazil Therapeutic BCG Vaccine Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Type
        • 9.3.1.2.2. By End User
    • 9.3.2. Argentina Therapeutic BCG Vaccine Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Type
        • 9.3.2.2.2. By End User
    • 9.3.3. Colombia Therapeutic BCG Vaccine Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Type
        • 9.3.3.2.2. By End User

10. Middle East and Africa Therapeutic BCG Vaccine Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Type
    • 10.2.2. By End User
    • 10.2.3. By Country
  • 10.3. MEA: Country Analysis
    • 10.3.1. South Africa Therapeutic BCG Vaccine Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Type
        • 10.3.1.2.2. By End User
    • 10.3.2. Saudi Arabia Therapeutic BCG Vaccine Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Type
        • 10.3.2.2.2. By End User
    • 10.3.3. UAE Therapeutic BCG Vaccine Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Type
        • 10.3.3.2.2. By End User

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Recent Developments
  • 12.2. Product Launches
  • 12.3. Mergers & Acquisitions

13. Global Therapeutic BCG Vaccine Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Product

15. PESTLE Analysis

16. Competitive Landscape

  • 16.1. Merck & Co., Inc
    • 16.1.1. Business Overview
    • 16.1.2. Company Snapshot
    • 16.1.3. Products & Services
    • 16.1.4. Financials (In case of listed companies)
    • 16.1.5. Recent Developments
    • 16.1.6. SWOT Analysis
  • 16.2. Sanofi Pasteur Inc.
    • 16.2.1. Business Overview
    • 16.2.2. Company Snapshot
    • 16.2.3. Products & Services
    • 16.2.4. Financials (In case of listed companies)
    • 16.2.5. Recent Developments
    • 16.2.6. SWOT Analysis
  • 16.3. Japan BCG Laboratory
    • 16.3.1. Business Overview
    • 16.3.2. Company Snapshot
    • 16.3.3. Products & Services
    • 16.3.4. Financials (In case of listed companies)
    • 16.3.5. Recent Developments
    • 16.3.6. SWOT Analysis
  • 16.4. China National Biotec Group
    • 16.4.1. Business Overview
    • 16.4.2. Company Snapshot
    • 16.4.3. Products & Services
    • 16.4.4. Financials (In case of listed companies)
    • 16.4.5. Recent Developments
    • 16.4.6. SWOT Analysis
  • 16.5. Serum Institute of India Pvt. Ltd,
    • 16.5.1. Business Overview
    • 16.5.2. Company Snapshot
    • 16.5.3. Products & Services
    • 16.5.4. Financials (In case of listed companies)
    • 16.5.5. Recent Developments
    • 16.5.6. SWOT Analysis
  • 16.6. InterVax Ltd
    • 16.6.1. Business Overview
    • 16.6.2. Company Snapshot
    • 16.6.3. Products & Services
    • 16.6.4. Financials (In case of listed companies)
    • 16.6.5. Recent Developments
    • 16.6.6. SWOT Analysis
  • 16.7. GreenSignal Bio Pharma Limited
    • 16.7.1. Business Overview
    • 16.7.2. Company Snapshot
    • 16.7.3. Products & Services
    • 16.7.4. Financials (In case of listed companies)
    • 16.7.5. Recent Developments
    • 16.7.6. SWOT Analysis
  • 16.8. Statens Serum Institute
    • 16.8.1. Business Overview
    • 16.8.2. Company Snapshot
    • 16.8.3. Products & Services
    • 16.8.4. Financials (In case of listed companies)
    • 16.8.5. Recent Developments
    • 16.8.6. SWOT Analysis
  • 16.9. PowderJect Pharmaceuticals Ltd.
    • 16.9.1. Business Overview
    • 16.9.2. Company Snapshot
    • 16.9.3. Products & Services
    • 16.9.4. Financials (In case of listed companies)
    • 16.9.5. Recent Developments
    • 16.9.6. SWOT Analysis
  • 16.10. Biomed Lublin
    • 16.10.1. Business Overview
    • 16.10.2. Company Snapshot
    • 16.10.3. Products & Services
    • 16.10.4. Financials (In case of listed companies)
    • 16.10.5. Recent Developments
    • 16.10.6. SWOT Analysis

17. Strategic Recommendations

18. About Us & Disclaimer