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雙特異性抗體治療合約製造市場 - 全球產業規模、佔有率、趨勢、機會和預測,2018-2028 按適應症、給藥途徑、最終用途、地區、競爭預測和機會細分,2018-2028F

Bispecific Antibody Therapeutics Contract Manufacturing Market-Global Industry Size, Share, Trends, Opportunity, & Forecast, 2018-2028 Segmented By Indication, Route of Administration, End Use, Region, Competition Forecast & Opportunities, 2018-2028F

出版日期: | 出版商: TechSci Research | 英文 190 Pages | 商品交期: 2-3個工作天內

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簡介目錄

2022年,全球雙特異性抗體治療合約製造市場價值為50.2億美元,預計到2028年年複合成長率(CAGR)將達到15.56%。全球雙特異性抗體治療合約製造市場的成長生物製藥產業越來越認知到雙特異性抗體在治療複雜疾病(包括癌症和自體免疫疾病)方面的潛力,推動了這一重大進展。合約製造組織 (CMO) 透過提供專業知識和基礎設施來高效且經濟高效地生產雙特異性抗體,在該市場中發揮關鍵作用。

主要市場促進因素

市場概況
預測期 2024-2028
2022 年市場規模 50.2億美元
2028 年市場規模 119.4億美元
2023-2028 年年複合成長率 15.56%
成長最快的細分市場 癌症
最大的市場 北美洲

雙特異性抗體治療的持續研究活動

雙特異性抗體治療領域正在進行的研究活動有助於推動全球雙特異性抗體治療合約製造市場。這些活動的特點是對創新治療解決方案的不懈追求,導致越來越多的雙特異性抗體候選物正在開發中。研究的激增推動了對雙特異性抗體合約製造服務的需求,具體如下:候選藥物管道的不斷擴大反映了對雙特異性抗體日益成長的興趣。生物製藥公司正在大力投資研究,開發針對從癌症到自體免疫疾病等多種疾病的雙特異性抗體。治療適應症的多樣性推動了對具有生產這些複雜分子專業知識的合約製造合作夥伴的需求。

雙特異性抗體是高度複雜的分子,通常需要先進的製造技術。研究工作旨在最佳化其設計和功能,從而創建新穎的雙特異性格式。合約製造組織 (CMO) 受到追捧,希望利用其技術能力和基礎設施來準確生產這些複雜的治療藥物。正在進行的研究也有助於生物製造過程的進步。不斷完善新的生產方法、純化技術和細胞系開發策略,以提高雙特異性抗體生產的效率和可擴展性。 CMO 處於這些進步的最前沿,為生物製藥公司提供最先進的製造解決方案。研究活動探討雙特異性抗體的新治療方式和作用機轉。這項創新導致了突破性療法的開發,並提高了療效和安全性。合約製造合作夥伴對於擴大這些創新雙特異性抗體的生產規模以進行臨床試驗和商業化是不可或缺的。

學術界、生技新創公司和成熟製藥公司之間的合作研究推動了雙特異性抗體的發現和開發。 CMO 經常與這些實體合作,提供製造支持,使研究能夠從臨床前階段迅速進展到臨床試驗。研究在促進雙特異性抗體監管理解方面發揮關鍵作用。正在進行的研究有助於為這些複雜的治療方法制定強力的監管指南,為生產預期提供明確性和一致性。 CMO 確保遵守這些不斷變化的法規,並促進產品開發的成功。總之,以持續研究和治療創新為特徵的雙特異性抗體療法的動態格局推動了對合約製造服務的需求。 CMO 在支持生物製藥產業尋求新型治療解決方案方面發揮關鍵作用,使其成為推進全球雙特異性抗體治療合約製造市場不可或缺的合作夥伴。

雙特異性抗體療法在癌症和非癌症計畫中迅速取得成功

雙特異性抗體療法在癌症和非癌症計畫中的快速成功是全球雙特異性抗體療法合約製造市場成長的驅動力。雙特異性抗體已成為一種變革性的生物製藥,其在各個治療領域的多功能應用正在促進研究和開發活動的激增。以下是這些療法的成功如何推動合約製造市場。雙特異性抗體在癌症免疫治療中取得了顯著的成功,特別是在重定向免疫細胞攻擊腫瘤細胞方面。 blinatumomab 和 emicizumab 等核准的雙特異性抗體為新癌症治療的開發奠定了基礎。隨著越來越多的生物製藥公司投資腫瘤項目,合約製造組織 (CMO) 在滿足日益成長的產能需求方面發揮著至關重要的作用。

雙特異性抗體在早期臨床試驗中的成功促使不同治療領域的項目激增。除了癌症之外,這些療法也正在探索用於治療自體免疫疾病、傳染病等。 CMO 是透過提供必要的專業知識和製造基礎設施來支持這些試驗的關鍵合作夥伴。隨著幾種雙特異性抗體候選物進入後期臨床試驗,商業化的潛力是巨大的。雙特異性抗體產品的成功上市促使生物製藥公司尋找可靠的製造合作夥伴。 CMO 提供大規模生產所需的可擴展性和法規遵循。某些雙特異性抗體療法取得的令人印象深刻的臨床成果吸引了製藥公司和創投家的更多投資。這種資本的湧入加速了雙特異性抗體管道的開發,進一步推動了對合約製造服務的需求。

雙特異性抗體通常具有複雜的結構和獨特的製造挑戰。成功開發和製造這些療法需要專業知識。憑藉著在雙特異性抗體生產方面的經驗,CMO 成為應對這些複雜問題的寶貴合作夥伴。隨著雙特異性抗體的成功超越國界,這些療法的全球市場不斷擴大。業務遍及全球的 CMO 具有策略定位,可為不同地區營運的生物製藥公司提供製造解決方案,從而促進市場成長。總之,雙特異性抗體治療在癌症和非癌症計畫中的快速成功是全球雙特異性抗體治療合約製造市場的強大催化劑。這一成功推動了研究、臨床試驗、投資和對專業製造專業知識的需求的增加。合約製造組織在支持生物製藥公司充分發揮雙特異性抗體的潛力方面發揮關鍵作用,確保及時有效地生產雙特異性抗體,造福全球患者。

生物製造的進步

生物製造的進步透過提高雙特異性抗體生產的效率、可擴展性和成本效益,在推動全球雙特異性抗體治療合約製造市場方面發揮關鍵作用。這些進步正在改變生物製藥製造的格局,其對合約製造業的影響尤其顯著。首先,拋棄式生物反應器技術的創新徹底改變了雙特異性抗體的生產。拋棄式系統無需進行大量清潔和驗證,從而減少了生產運作之間的停機時間。這增強了生產敏捷性,使合約製造組織 (CMO) 能夠快速回應不斷變化的客戶需求並加快專案時間表。

其次,製程強化技術最佳化了生物製造程序,進而提高產量並降低生產成本。這些進步對於雙特異性抗體的生產至關重要,因為它們有助於滿足對這些複雜分子不斷成長的需求,同時控制製造成本。處於流程強化最前沿的首席行銷長可以為其客戶提供有競爭力的價格,進一步提高他們的吸引力。自動化和數位化也在改變生物製造。機器人系統、資料分析和人工智慧擴大整合到製造過程中,從而增強製程控制、資料準確性和品質保證。採用這些技術的 CMO 可確保穩定且高品質的雙特異性抗體生產,並滿足嚴格的監管要求。此外,細胞系開發和最佳化的進步有助於提高表達水平和提高產品品質。擁有細胞系工程專業知識的合約製造商可以提供卓越的產量和產品屬性,使其成為生物製藥公司的首選合作夥伴。

此外,連續製造方法在生物製造領域也越來越受到關注。連續生物加工最大限度地減少批次之間的差異並縮短生產週期時間。採用這些方法的 CMO 可以為雙特異性抗體提供更有效率、更永續的製造解決方案。採用靈活和模組化的製造設施是生物製造的另一項進步,有利於合約製造市場。這些設施可以輕鬆重新配置,以適應不同的生產需求,使 CMO 能夠有效地生產不同規格的雙特異性抗體。總之,生物製造的進步,包括拋棄式系統、製程強化、自動化、數位化、細胞系開發、連續製造和靈活設施,正在推動全球雙特異性抗體治療合約製造市場。這些創新提高了雙特異性抗體生產的速度、成本效益和質量,使合約製造成為尋求將創新療法推向市場的生物製藥公司不可或缺的合作夥伴。

不斷變化的醫療保健格局

不斷發展的醫療保健格局是全球雙特異性抗體治療合約製造市場成長的重要驅動力。隨著醫療保健產業經歷變革,對雙特異性抗體等創新和個人化療法的需求不斷增加,而合約製造組織 (CMO) 在滿足這些不斷變化的需求方面發揮著至關重要的作用。

推動該市場的關鍵因素之一是以患者為中心的護理的轉變。在當今的醫療保健領域,人們越來越重視根據患者個別情況制定治療方案,以期獲得更好的結果並減少副作用。雙特異性抗體能夠同時針對多種疾病途徑或抗原,與這種以患者為中心的方法完美契合。專門從事雙特異性抗體製造的 CMO 提供了生產滿足個別患者需求的客製化療法所需的靈活性,確保醫療保健變得更加以患者為中心。此外,世界各地的醫療保健系統正在應對管理慢性和複雜疾病的挑戰。雙特異性抗體具有解決腫瘤學、自體免疫疾病和傳染病等各種治療領域的潛力,提供了多功能的解決方案。擁有製造這些複雜分子專業知識的 CMO 能夠很好地支持生物製藥公司開發有效應對這些醫療保健挑戰的療法。

此外,不斷發展的醫療保健格局的特點是從傳統治療方式轉變為新型標靶生物製劑的轉變。雙特異性抗體代表了疾病管理的前沿方法,吸引了製藥公司和研究人員的極大關注。 CMO 在將這些創新療法從研發轉化為商業生產方面發揮著重要作用,確保患者能夠獲得醫療保健領域的最新進展。此外,對包括雙特異性抗體在內的生物製劑的需求是由對副作用較少的有效治療的需求所驅動的。不斷發展的醫療保健格局的特點是人們對某些藥物相關的安全性和有效性問題的認知不斷增強。雙特異性抗體以其精確靶向而聞名,提供了更安全的替代方案,CMO 確保其可靠且合規的生產,並符合不斷發展的醫療品質標準。總之,不斷發展的醫療保健格局,以患者為中心的護理、慢性疾病的管理、向靶向生物製劑的轉變以及對安全性和有效性的關注,是全球雙特異性抗體治療契約製造市場的主要驅動力。專門從事雙特異性抗體生產的 CMO 將在滿足不斷變化的醫療保健環境的需求方面發揮關鍵作用,確保為世界各地的患者提供創新和個人化的療法。

主要市場挑戰

與雙特異性抗體治療藥物的製造相關的挑戰 雙特異性抗體治療藥物的製造提出了一些複雜的挑戰,需要細緻的關注和創新的解決方案。這些挑戰源自於雙特異性抗體的獨特性質和設計複雜性,使得其生產比傳統的單株抗體更複雜。主要挑戰之一是雙特異性抗體結構本身的複雜性。這些分子通常將兩種不同的抗原結合特異性結合成一個實體,產生複雜的分子設計。這種複雜性需要對製造過程進行精確控制,以確保一致的品質和功效。此外,由於各種翻譯後修飾,例如糖基化和氧化,雙特異性抗體通常表現出異質性。這些變化會影響產品的穩定性和功效,要求製造商採用先進的分析技術來監控和控制產品品質。放大和製程開發代表了另一組挑戰。隨著雙特異性抗體從研究和開發轉向商業生產,製造商必須建立能夠滿足市場需求同時保持產品一致性的可擴展流程。鑑於雙特異性抗體製造的複雜性,要實現這種平衡尤其具有挑戰性。

純化和分離是雙特異性抗體生產的關鍵步驟。由於每種雙特異性抗體設計的獨特性,將雙特異性抗體與其他雜質(包括聚集體和宿主細胞蛋白)分離在技術上可能具有挑戰性。製造商必須為每個分子製定客製化的純化策略,從而增加了製造過程的複雜性。此外,生產雙特異性抗體需要專門的設備和設施來滿足其獨特的生產需求。這包括專為雙特異性抗體生產量身定做的生物反應器和層析系統,其實施和維護成本高。監管合規性是生物製藥製造持續面臨的挑戰,雙特異性抗體也不例外。製造商必須遵守嚴格的品質和安全標準,同時遵循針對這些創新療法不斷發展的監管指南。

供應鏈物流也面臨自身的挑戰。雙特異性抗體的保存期限通常較短,必須仔細管理其分佈以維持產品完整性。這需要製造商、分銷商和醫療保健提供者之間的精確協調。總之,雙特異性抗體療法的製造提出了一些複雜的挑戰,這些挑戰涉及這些分子的獨特結構、製程可擴展性、純化複雜性、專用設備和設施、監管合規性和供應鏈物流。克服這些挑戰需要持續創新、先進的分析方法,並致力於確保持續生產高品質的雙特異性抗體,以滿足患者和生物製藥行業不斷變化的需求。

擴大規模的挑戰

擴大規模的挑戰是全球雙特異性抗體治療合約製造市場的一個重大障礙。從實驗室規模生產到商業規模製造的轉變是一個複雜的過程,需要仔細的規劃、技術專長和細緻的執行。擴大雙特異性抗體生產規模的主要問題之一是需要更大的生物反應器和生產設施。實驗室規模的生產通常涉及小型生物反應器,不足以滿足商業生產的需求。大型生物反應器的選擇、安裝和驗證是關鍵步驟,任何錯誤都可能擾亂製造過程。此外,製程最佳化對於在放大過程中維持產品品質和產量至關重要。必須仔細控制攪拌、氧轉移和營養供應等因素,以確保產生雙特異性抗體的細胞在更大的規模下一致地發揮作用。這不僅涉及調整參數,還涉及驗證整個過程的可擴展性。

另一個挑戰是原料和消耗品的物流。更大規模的生產需要更多的材料,例如細胞培養基、緩衝液和純化樹脂。確保這些關鍵部件的連續供應鏈對於防止生產中斷至關重要。由於其結構複雜性和潛在的異質性,雙特異性抗體的純化本質上具有挑戰性。在不影響產品純度和產量的情況下擴大純化製程是一項艱鉅的任務。製造商必須開發和驗證在更大規模上有效的純化策略,同時保持最終產品的品質。監管方面的考慮為擴大規模的努力增加了另一層複雜性。確保放大過程符合監管標準和要求對於雙特異性抗體療法獲得批准和商業化至關重要。這包括驗證品質控制方法並確保產品屬性的一致性。

此外,擴大規模通常涉及不同製造基地或合約製造組織 (CMO) 之間的技術轉移。此過程需要密切協作、知識轉移和全面的文件記錄,以確保產品保持一致並滿足監管期望。總之,全球雙特異性抗體治療合約製造市場的擴大規模挑戰是多方面的,需要仔細注意。成功的擴大規模需要整合先進技術、流程最佳化、物流規劃、法規遵循和無縫技術轉移。克服這些挑戰對於滿足雙特異性抗體療法日益成長的需求,同時確保商業規模的產品品質、安全性和監管遵守至關重要。生物製藥公司和擁有雙特異性抗體製造專業知識的 CMO 之間的合作對於有效應對這些挑戰至關重要。

主要市場趨勢

對雙特異性抗體的需求不斷增加

對雙特異性抗體的需求不斷成長已成為推動全球雙特異性抗體治療合約製造市場的突出且持久的趨勢。需求激增是由多個因素支撐的,這些因素共同凸顯了雙特異性抗體在解決一系列疾病中未滿足的醫療需求方面的變革潛力。首先,雙特異性抗體同時針對兩種不同抗原或途徑的獨特能力激發了生物製藥產業的熱情。這種熱情導致雙特異性抗體管道的顯著擴展,眾多生物製藥公司積極開發這些分子並將其推進臨床試驗和商業化。在腫瘤學中,雙特異性抗體,例如雙特異性 T 細胞接合劑 (BiTE),透過利用免疫系統對抗癌細胞,已展現出令人印象深刻的臨床效果。這項成功推動了針對各種癌症的雙特異性抗體的開發,對合約製造服務產生了很高的需求。除了腫瘤學之外,雙特異性抗體在解決自體免疫疾病、傳染病和其他治療領域方面也顯示出前景,從而擴大了其適用性。隨著研究人員探索新的疾病標靶和適應症,對生產這些多樣化雙特異性抗體形式的合約製造支援的需求持續成長。

此外,個人化醫療的趨勢正在推動雙特異性抗體的客製化,以適應特定的患者群體或疾病亞型。這一趨勢要求合約製造合作夥伴能夠生產客製化療法,從而滿足對專業製造專業知識的整體需求。總之,對雙特異性抗體的需求不斷成長是推動全球雙特異性抗體治療合約製造市場向前發展的普遍趨勢。隨著生物製藥公司認知到這些創新療法的潛力,支持其開發和生產的合約製造服務的需求預計將保持強勁,從而使雙特異性抗體成為生物製藥行業尋求變革療法的焦點。

技術進步

技術進步處於全球雙特異性抗體治療合約製造市場發展趨勢的最前線。這些進步在重塑和增強雙特異性抗體的製造模式方面發揮關鍵作用,使雙特異性抗體的生產更容易獲得、更具成本效益且更有效率。這一趨勢的一個關鍵方面是生物製造技術的不斷創新。新的和改進的生物反應器設計,例如拋棄式系統,透過提供靈活性和可擴展性,正在徹底改變雙特異性抗體的生產。這些系統減少了設備準備和驗證所需的時間,使合約製造組織 (CMO) 能夠快速回應不斷變化的客戶需求。過程強化是另一個關鍵面向。先進技術正在最佳化生物加工,從而提高產量並降低生產成本。製程強化不僅提高了生產率,還有助於滿足對雙特異性抗體不斷成長的需求,同時又不影響品質。自動化和數位化也在推動這一趨勢。機器人技術、人工智慧和資料分析擴大整合到製造過程中,從而增強了控制、資料準確性和品質保證。這些技術有助於維持雙特異性抗體生產的一致性和可靠性。此外,細胞系開發和最佳化的進步有助於提高表達水平和提高產品品質。擁有細胞系工程專業知識的 CMO 能夠提供卓越的產量和產品屬性。

連續製造方法的採用正在獲得動力。連續生物加工最大限度地減少批次之間的差異並縮短生產週期時間。探索這些方法的 CMO 可以為雙特異性抗體提供更有效率、更永續的製造解決方案。總之,技術進步是全球雙特異性抗體治療合約製造市場趨勢背後的驅動力。這些創新,包括生物反應器的進步、製程強化、自動化、數位化、細胞系開發和連續製造,共同提高了雙特異性抗體生產的速度、成本效益和品質。採用這些技術的合約製造組織已準備好滿足對具有最先進製造能力的雙特異性抗體不斷成長的需求。

細分市場洞察

適應症見解

2022年,癌症細分市場佔據主導地位,佔據了可觀的市場。癌症仍然是全球健康挑戰,也是死亡的主要原因,推動了重大研究工作。在癌症免疫治療領域,雙特異性抗體(bsAB)因其對癌症患者顯著的臨床療效而受到關注。這促使人們大力努力將 bsAB 轉化為有效的療法。例如,2022年6月,羅氏獲得了歐盟委員會對Lunsumio(mosunetuzumab)的有條件行銷授權,這是一種CD20xCD3 T細胞結合bsAB,用於治療先前接受過兩次全身治療的複發或難治性濾泡性淋巴瘤患者。

相反,專注於自體發炎和自體免疫疾病的細分市場預計將在整個預測期內保持穩定的成長速度。這是由新型 bsAB 療法的廣泛採用所推動的,該療法有可能顯著提高治療效果。自體免疫疾病的盛行率很高,估計美國有 1,400 萬受影響者,涵蓋 80 至 100 種公認的自體免疫相關疾病。值得注意的是,大約 80% 的確診患者是女性,這凸顯了 bsAB 在應對這些健康挑戰方面的重要性。

最終用途見解

2022 年,靜脈注射 (IV) 細分市場佔據全球收入的最大市場。靜脈注射療法在支持免疫系統有效對抗癌細胞方面發揮著至關重要的作用,代表著某些癌症類型治療的一個有希望的突破。此外,抗體藥物已成為患有特定癌症患者的一個充滿希望的途徑。據美國血液學會(ASH) 稱,在2018 年1 月至2021 年11 月期間進行的一項I 期臨床試驗中,bsAB 療法在患者中取得了73% 的成功率,該試驗涉及來自全球各個癌症中心的232 名參與者。

同時,皮下注射領域預計在預測期內實現 36.8% 的最快年複合成長率 (CAGR)。皮下注射 bsAB 在治療復發性或難治性多發性骨髓瘤的患者中顯示出顯著的陽性反應。對皮下注射途徑的日益偏好預計將在可預見的未來為市場擴張做出重大貢獻。這些因素共同推動了該領域的成長。

區域洞察

2022年,北美地區成為市場的主導力量,佔據最大的收入佔有率。該地區的成長可歸因於其成熟的市場、癌症和傳染病的日益流行,這些都需要先進的解決方案。此外,不斷升級的研究工作、越來越多的臨床試驗和大量投資對該地區的擴張做出了重大貢獻。在北美國家中,美國脫穎而出,成為 bsAB 療法合約製造的最大市場,這主要是由臨床試驗、研發活動激增以及公司投資增加所推動的。

相反,亞太地區將在預測期內見證最快的年複合成長率(CAGR)。該地區的成長受到多種因素的支撐,包括巨大的癌症負擔和對新藥的迫切需求,特別是在日本和中國等國家。此外,市場需求的增加和公司之間合作夥伴關係數量的增加預計將推動整個預測期內的成長。

目錄

第 1 章:產品概述

第 2 章:研究方法

第 3 章:執行摘要

第 4 章:客戶之聲

第 5 章:全球雙特異性抗體治療合約製造市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按適應症(癌症、傳染病、自體發炎和自體免疫疾病、中樞神經系統疾病、其他)
    • 依給藥途徑(靜脈、皮下、其他)
    • 依最終用途(製藥公司、生物製藥公司、其他)
    • 按公司分類 (2022)
    • 按地區
  • 市場地圖

第 6 章:北美雙特異性抗體治療合約製造市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按適應症
    • 依給藥途徑
    • 按最終用途
    • 按國家/地區
  • 北美:國家分析
    • 美國
    • 墨西哥
    • 加拿大

第 7 章:歐洲雙特異性抗體治療合約製造市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按適應症
    • 依給藥途徑
    • 按最終用途
    • 按國家/地區
  • 歐洲:國家分析
    • 法國
    • 德國
    • 英國
    • 義大利
    • 西班牙

第 8 章:亞太地區雙特異性抗體治療合約製造市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按適應症
    • 依給藥途徑
    • 按最終用途
    • 按國家/地區
  • 亞太地區:國家分析
    • 中國
    • 印度
    • 韓國
    • 日本
    • 澳洲

第 9 章:南美洲雙特異性抗體治療合約製造市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按適應症
    • 依給藥途徑
    • 按最終用途
    • 按國家/地區
  • 南美洲:國家分析
    • 巴西
    • 阿根廷
    • 哥倫比亞

第 10 章:中東和非洲雙特異性抗體治療合約製造市場展望

  • 市場規模及預測
    • 按價值
  • 市佔率及預測
    • 按適應症
    • 依給藥途徑
    • 按最終用途
    • 按國家/地區
  • MEA:國家分析
    • 南非雙特異性抗體療法合約製造
    • 沙烏地阿拉伯雙特異性抗體療法合約製造
    • 阿拉伯聯合大公國雙特異性抗體療法合約製造

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:大環境分析

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:競爭格局

  • 商業概覽
  • 公司概況
  • 產品與服務
  • 財務(上市公司)
  • 最近的發展
  • SWOT分析
    • Lonza Group AG
    • Creative Biolabs Inc
    • Amgen Inc
    • Johnson & Johnson
    • Wuxi Biologics Cayman Inc
    • Roche Holding AG
    • Sino Biological Inc
    • IQVIA Inc
    • Janssen Pharmaceuticals Inc
    • AbbVie Inc

第 16 章:策略建議

簡介目錄
Product Code: 16116

In 2022, the Global Bispecific Antibody Therapeutics Contract Manufacturing Market was valued at USD 5.02 billion, and it is expected grow with a Compound Annual Growth Rate (CAGR) of 15.56% through 2028. The growth of the Global Bispecific Antibody Therapeutics Contract Manufacturing Market is substantial, driven by the increasing recognition within the biopharmaceutical industry of the potential of bispecific antibodies in treating complex diseases, including cancer and autoimmune disorders. Contract manufacturing organizations (CMOs) play a pivotal role in this market by offering their expertise and infrastructure for the efficient and cost-effective production of bispecific antibodies.

Several factors are propelling the market's growth, including the expanding pipeline of bispecific antibody candidates, the demand for specialized manufacturing capabilities, and the inclination to outsource production to focus on core competencies. As biopharmaceutical companies strive to advance novel therapeutic solutions, the Bispecific Antibody Therapeutics Contract Manufacturing Market is poised to expand further, providing a wide range of services to support the development and production of these innovative therapies.

Key Market Drivers

Market Overview
Forecast Period2024-2028
Market Size 2022USD 5.02 Billion
Market Size 2028USD 11.94 Billion
CAGR 2023-202815.56%
Fastest Growing SegmentCancer
Largest MarketNorth America

Ongoing Research Activities in Bispecific Antibody Therapeutics

Ongoing research activities in Bispecific Antibody Therapeutics are instrumental in driving the Global Bispecific Antibody Therapeutics Contract Manufacturing Market. These activities are characterized by a relentless pursuit of innovative therapeutic solutions, resulting in an increasing number of bispecific antibody candidates in development. This surge in research fuels the demand for contract manufacturing services for bispecific antibodies, and here's how: The growing interest in bispecific antibodies is reflected in the expanding pipeline of drug candidates. Biopharmaceutical companies are investing heavily in research to develop bispecific antibodies targeting a wide range of diseases, from cancer to autoimmune disorders. The diversity of therapeutic indications drives the need for contract manufacturing partners with specialized expertise in producing these complex molecules.

Bispecific antibodies are highly complex molecules that often require advanced manufacturing technologies. Research efforts aim to optimize their design and functionality, resulting in the creation of novel bispecific formats. Contract manufacturing organizations (CMOs) are sought after to leverage their technical capabilities and infrastructure to produce these sophisticated therapeutics accurately. Ongoing research also contributes to advancements in biomanufacturing processes. Novel production methods, purification techniques, and cell line development strategies are continually refined to enhance the efficiency and scalability of bispecific antibody production. CMOs, at the forefront of these advancements, offer state-of-the-art manufacturing solutions to biopharmaceutical companies. Research activities explore novel therapeutic modalities and mechanisms of action for bispecific antibodies. This innovation leads to the development of groundbreaking therapies with improved efficacy and safety profiles. Contract manufacturing partners are indispensable for scaling up the production of these innovative bispecific antibodies for clinical trials and commercialization.

Collaborative research efforts between academia, biotech startups, and established pharmaceutical companies drive the discovery and development of bispecific antibodies. CMOs often collaborate with these entities, offering manufacturing support that enables research to progress swiftly from preclinical stages to clinical trials. Research plays a pivotal role in advancing regulatory understanding of bispecific antibodies. Ongoing studies contribute to the development of robust regulatory guidelines for these complex therapeutics, providing clarity and consistency in manufacturing expectations. CMOs ensure compliance with these evolving regulations, facilitating successful product development. In conclusion, the dynamic landscape of bispecific antibody therapeutics, characterized by ongoing research and therapeutic innovation, propels the demand for contract manufacturing services. CMOs play a critical role in supporting the biopharmaceutical industry's quest for novel therapeutic solutions, making them integral partners in advancing the Global Bispecific Antibody Therapeutics Contract Manufacturing Market.

Rapid success of bispecific antibody therapeutics in cancer and non-cancer programs

The rapid success of bispecific antibody therapeutics in both cancer and non-cancer programs is a driving force behind the growth of the Global Bispecific Antibody Therapeutics Contract Manufacturing Market. Bispecific antibodies have emerged as a transformative class of biopharmaceuticals, and their versatile applications across various therapeutic areas are fostering a surge in research and development activities. Here's how the success of these therapeutics is fueling the contract manufacturing market. Bispecific antibodies have demonstrated remarkable success in cancer immunotherapy, particularly in redirecting immune cells to attack tumor cells. Approved bispecific antibodies like blinatumomab and emicizumab have set the stage for the development of new cancer treatments. As more biopharmaceutical companies invest in oncology programs, contract manufacturing organizations (CMOs) play a vital role in meeting the increasing demand for production capacity.

The success of bispecific antibodies in early-phase clinical trials has prompted a proliferation of programs across diverse therapeutic areas. Beyond cancer, these therapeutics are being explored for autoimmune diseases, infectious diseases, and more. CMOs are key partners in supporting these trials by providing the necessary expertise and infrastructure for manufacturing. With several bispecific antibody candidates advancing through late-stage clinical trials, the potential for commercialization is substantial. The successful launch of bispecific antibody products in the market drives biopharmaceutical companies to secure reliable manufacturing partners. CMOs offer the scalability and regulatory compliance required for large-scale production. The impressive clinical outcomes achieved by certain bispecific antibody therapeutics have attracted increased investment from both pharmaceutical companies and venture capitalists. This influx of capital accelerates the development of bispecific antibody pipelines, further driving the need for contract manufacturing services.

Bispecific antibodies often feature complex structures and unique manufacturing challenges. Success in developing and manufacturing these therapeutics requires specialized expertise. CMOs, with their experience in bispecific antibody production, become invaluable partners in navigating these complexities. As the success of bispecific antibodies transcends borders, the global market for these therapeutics expands. CMOs with a global presence are strategically positioned to offer manufacturing solutions to biopharmaceutical companies operating in different regions, promoting market growth. In conclusion, the rapid success of bispecific antibody therapeutics across cancer and non-cancer programs is a powerful catalyst for the Global Bispecific Antibody Therapeutics Contract Manufacturing Market. This success is driving increased research, clinical trials, investment, and demand for specialized manufacturing expertise. Contract manufacturing organizations are playing a pivotal role in supporting biopharmaceutical companies in realizing the full potential of bispecific antibodies, ensuring their timely and efficient production for the benefit of patients worldwide.

Biomanufacturing Advancements

Biomanufacturing advancements play a pivotal role in driving the Global Bispecific Antibody Therapeutics Contract Manufacturing Market by enhancing the efficiency, scalability, and cost-effectiveness of producing bispecific antibodies. These advancements are transforming the landscape of biopharmaceutical manufacturing, and their impact on the contract manufacturing sector is particularly significant. Firstly, innovations in single-use bioreactor technology have revolutionized the production of bispecific antibodies. Single-use systems eliminate the need for extensive cleaning and validation, reducing downtime between manufacturing runs. This enhances production agility, allowing contract manufacturing organizations (CMOs) to respond rapidly to changing client demands and expedite project timelines.

Secondly, process intensification techniques optimize biomanufacturing processes, resulting in higher yields and reduced production costs. These advancements are crucial for bispecific antibody production, as they help meet the growing demand for these complex molecules while keeping manufacturing expenses in check. CMOs at the forefront of process intensification can offer competitive pricing to their clients, further boosting their appeal. Automation and digitalization are also transforming biomanufacturing. Robotic systems, data analytics, and artificial intelligence are increasingly integrated into manufacturing processes, enhancing process control, data accuracy, and quality assurance. CMOs embracing these technologies ensure consistent and high-quality bispecific antibody production, meeting stringent regulatory requirements. Furthermore, advances in cell line development and optimization contribute to higher expression levels and improved product quality. Contract manufacturers with expertise in cell line engineering can deliver superior yields and product attributes, making them preferred partners for biopharmaceutical companies.

Additionally, continuous manufacturing approaches are gaining traction in biomanufacturing. Continuous bioprocessing minimizes batch-to-batch variability and reduces production cycle times. CMOs adopting these methods can offer more efficient and sustainable manufacturing solutions for bispecific antibodies. The adoption of flexible and modular manufacturing facilities is another biomanufacturing advancement that benefits the contract manufacturing market. These facilities can be easily reconfigured to accommodate different production needs, enabling CMOs to efficiently produce bispecific antibodies with varying specifications. In conclusion, biomanufacturing advancements, including single-use systems, process intensification, automation, digitalization, cell line development, continuous manufacturing, and flexible facilities, are driving the Global Bispecific Antibody Therapeutics Contract Manufacturing Market. These innovations enhance the speed, cost-efficiency, and quality of bispecific antibody production, making contract manufacturing an indispensable partner for biopharmaceutical companies seeking to bring innovative therapies to market.

Evolving Healthcare Landscape

The evolving healthcare landscape is a significant driver behind the growth of the Global Bispecific Antibody Therapeutics Contract Manufacturing Market. As the healthcare industry undergoes transformative changes, the demand for innovative and personalized therapies, such as bispecific antibodies, is on the rise, and contract manufacturing organizations (CMOs) are playing a crucial role in meeting these evolving needs.

One of the key factors driving this market is the shift towards patient-centric care. In today's healthcare landscape, there is a growing emphasis on tailoring treatments to individual patient profiles, aiming for better outcomes and reduced side effects. Bispecific antibodies, with their ability to target multiple disease pathways or antigens simultaneously, align perfectly with this patient-centric approach. CMOs specializing in bispecific antibody manufacturing offer the flexibility needed to produce customized therapies that cater to individual patient requirements, ensuring that healthcare becomes more patient-focused. Additionally, healthcare systems worldwide are grappling with the challenge of managing chronic and complex diseases. Bispecific antibodies, with their potential to address various therapeutic areas, including oncology, autoimmune diseases, and infectious diseases, provide a versatile solution. CMOs with expertise in manufacturing these complex molecules are well-positioned to support biopharmaceutical companies in developing therapies that tackle these healthcare challenges effectively.

Moreover, the evolving healthcare landscape is marked by a shift from traditional treatment modalities to novel, targeted biologics. Bispecific antibodies represent a cutting-edge approach to disease management, attracting significant attention from pharmaceutical companies and researchers. CMOs are instrumental in translating these innovative therapies from research and development into commercial production, ensuring that patients can access the latest advancements in healthcare. Furthermore, the demand for biologics, including bispecific antibodies, is driven by the need for effective treatments with fewer side effects. The evolving healthcare landscape is characterized by a growing awareness of safety and efficacy concerns associated with certain pharmaceuticals. Bispecific antibodies, known for their precise targeting, offer a safer alternative, and CMOs ensure their reliable and compliant production, aligning with the evolving healthcare quality standards. In conclusion, the evolving healthcare landscape, characterized by patient-centric care, the management of chronic diseases, the shift to targeted biologics, and a focus on safety and efficacy, is a major driver of the Global Bispecific Antibody Therapeutics Contract Manufacturing Market. CMOs that specialize in bispecific antibody production are poised to play a pivotal role in meeting the demands of this changing healthcare environment, ensuring that innovative and personalized therapies reach patients around the world.

Key Market Challenges

Challenges associated with manufacturing of bispecific antibody therapeutics The manufacturing of bispecific antibody therapeutics presents several complex challenges that require meticulous attention and innovative solutions. These challenges stem from the unique properties and design complexities of bispecific antibodies, making their production more intricate compared to traditional monoclonal antibodies. One of the primary challenges is the complexity of the bispecific antibody structure itself. These molecules typically combine two different antigen-binding specificities into a single entity, resulting in intricate molecular designs. This complexity demands precise control over the manufacturing process to ensure consistent quality and potency. Furthermore, bispecific antibodies often exhibit heterogeneity due to various post-translational modifications, such as glycosylation and oxidation. These variations can impact product stability and efficacy, requiring manufacturers to employ advanced analytical techniques to monitor and control product quality. Scale-up and process development represent another set of challenges. As bispecific antibodies move from research and development to commercial production, manufacturers must establish scalable processes capable of meeting market demand while maintaining product consistency. Achieving this balance is particularly challenging given the complexities of bispecific antibody manufacturing.

Purification and separation are critical steps in bispecific antibody production. Separating bispecific antibodies from other impurities, including aggregates and host cell proteins, can be technically challenging due to the uniqueness of each bispecific antibody design. Manufacturers must develop customized purification strategies for each molecule, increasing the complexity of the manufacturing process. Additionally, manufacturing bispecific antibodies requires specialized equipment and facilities to accommodate their unique production needs. This includes bioreactors and chromatography systems tailored to bispecific antibody manufacturing, which can be cost-intensive to implement and maintain. Regulatory compliance is a constant challenge in biopharmaceutical manufacturing, and bispecific antibodies are no exception. Manufacturers must adhere to stringent quality and safety standards while navigating evolving regulatory guidelines specific to these innovative therapeutics.

Supply chain logistics present their own challenges. Bispecific antibodies often have short shelf lives, and their distribution must be carefully managed to maintain product integrity. This requires precise coordination between manufacturers, distributors, and healthcare providers. In conclusion, the manufacturing of bispecific antibody therapeutics poses several intricate challenges related to the unique structure of these molecules, process scalability, purification complexity, specialized equipment and facilities, regulatory compliance, and supply chain logistics. Overcoming these challenges requires ongoing innovation, advanced analytical methods, and a commitment to ensuring the consistent production of high-quality bispecific antibodies that meet the evolving needs of patients and the biopharmaceutical industry.

Scale-Up Challenges

Scale-up challenges represent a significant hurdle for the Global Bispecific Antibody Therapeutics Contract Manufacturing Market. The transition from laboratory-scale production to commercial-scale manufacturing is a complex process that demands careful planning, technical expertise, and meticulous execution. One of the primary issues in scaling up bispecific antibody manufacturing is the need for larger bioreactors and production facilities. Laboratory-scale production often involves small bioreactors, which are insufficient to meet the demands of commercial production. The selection, installation, and validation of larger bioreactors are critical steps, and any errors can disrupt the manufacturing process. Moreover, process optimization is essential for maintaining product quality and yield during scale-up. Factors such as agitation, oxygen transfer, and nutrient supply must be carefully controlled to ensure that the cells producing bispecific antibodies perform consistently at larger scales. This involves not only adjusting parameters but also validating the scalability of the entire process.

Another challenge is the logistics of raw materials and consumables. Larger-scale production requires greater quantities of materials such as cell culture media, buffers, and purification resins. Ensuring a continuous supply chain for these critical components is essential to prevent disruptions in production. Purification of bispecific antibodies is inherently challenging due to their structural complexity and potential heterogeneity. Scaling up purification processes without compromising product purity and yield is a delicate task. Manufacturers must develop and validate purification strategies that are effective at larger scales while maintaining the quality of the final product. Regulatory considerations add another layer of complexity to scale-up efforts. Ensuring that the scaled-up process complies with regulatory standards and requirements is essential for obtaining approvals and commercializing bispecific antibody therapeutics. This includes validating the quality control methods and ensuring consistency in product attributes.

Furthermore, scale-up often involves technology transfer between different manufacturing sites or contract manufacturing organizations (CMOs). This process requires close collaboration, knowledge transfer, and comprehensive documentation to ensure that the product remains consistent and meets regulatory expectations. In conclusion, scale-up challenges in the Global Bispecific Antibody Therapeutics Contract Manufacturing Market are multifaceted and demand meticulous attention. Successful scale-up requires the integration of advanced technologies, process optimization, logistical planning, regulatory compliance, and seamless technology transfer. Overcoming these challenges is essential to meet the increasing demand for bispecific antibody therapeutics while ensuring product quality, safety, and regulatory adherence on a commercial scale. Collaborative efforts between biopharmaceutical companies and CMOs with expertise in bispecific antibody manufacturing are crucial to addressing these challenges effectively.

Key Market Trends

Increasing Demand for Bispecific Antibodies

The increasing demand for bispecific antibodies has emerged as a prominent and enduring trend driving the Global Bispecific Antibody Therapeutics Contract Manufacturing Market. This surge in demand is underpinned by several factors that collectively highlight the transformative potential of bispecific antibodies in addressing unmet medical needs across a spectrum of diseases. First and foremost, the unique capabilities of bispecific antibodies to simultaneously target two different antigens or pathways have sparked enthusiasm within the biopharmaceutical industry. This enthusiasm has led to a significant expansion of bispecific antibody pipelines, with numerous biopharmaceutical companies actively developing and advancing these molecules into clinical trials and commercialization. In oncology, bispecific antibodies, such as bispecific T-cell engagers (BiTEs), have demonstrated impressive clinical outcomes by harnessing the immune system to combat cancer cells. This success has fueled the development of bispecific antibodies for various cancers, creating a high demand for contract manufacturing services. Beyond oncology, bispecific antibodies show promise in addressing autoimmune disorders, infectious diseases, and other therapeutic areas, broadening their applicability. As researchers explore new disease targets and indications, the demand for contract manufacturing support in producing these diverse bispecific antibody formats continues to grow.

Furthermore, the trend towards personalized medicine is driving the customization of bispecific antibodies to suit specific patient populations or disease subtypes. This trend necessitates contract manufacturing partners capable of producing tailored therapies, contributing to the overall demand for specialized manufacturing expertise. In conclusion, the increasing demand for bispecific antibodies is a prevailing trend that propels the Global Bispecific Antibody Therapeutics Contract Manufacturing Market forward. As biopharmaceutical companies recognize the potential of these innovative therapeutics, the need for contract manufacturing services to support their development and production is expected to remain robust, making bispecific antibodies a focal point in the biopharmaceutical industry's quest for transformative therapies.

Technological Advancements

Technological advancements are at the forefront of the evolving trend within the Global Bispecific Antibody Therapeutics Contract Manufacturing Market. These advancements play a pivotal role in reshaping and enhancing the manufacturing landscape for bispecific antibodies, making them more accessible, cost-effective, and efficient to produce. One key facet of this trend is the continuous innovation in biomanufacturing technologies. New and improved bioreactor designs, such as single-use systems, are revolutionizing the production of bispecific antibodies by offering flexibility and scalability. These systems reduce the time required for equipment preparation and validation, enabling contract manufacturing organizations (CMOs) to respond swiftly to changing client demands. Process intensification is another crucial aspect. Advanced techniques are optimizing bioprocessing, resulting in higher yields and reduced production costs. Process intensification not only enhances productivity but also helps meet the growing demand for bispecific antibodies without compromising quality. Automation and digitalization are also driving this trend. Robotics, artificial intelligence, and data analytics are increasingly integrated into manufacturing processes, enhancing control, data accuracy, and quality assurance. These technologies are instrumental in maintaining the consistency and reliability of bispecific antibody production. Furthermore, advancements in cell line development and optimization are contributing to higher expression levels and improved product quality. CMOs equipped with expertise in cell line engineering are well-positioned to deliver superior yields and product attributes.

The adoption of continuous manufacturing approaches is gaining momentum. Continuous bioprocessing minimizes batch-to-batch variability and reduces production cycle times. CMOs exploring these methods can offer more efficient and sustainable manufacturing solutions for bispecific antibodies. In summary, technological advancements are a driving force behind the trend in the Global Bispecific Antibody Therapeutics Contract Manufacturing Market. These innovations, including bioreactor advancements, process intensification, automation, digitalization, cell line development, and continuous manufacturing, are collectively enhancing the speed, cost-efficiency, and quality of bispecific antibody production. Contract manufacturing organizations that embrace these technologies are poised to meet the growing demand for bispecific antibodies with state-of-the-art manufacturing capabilities.

Segmental Insights

Indication Insights

In 2022, the cancer segment dominated the market, capturing a substantial market share. Cancer remains a global health challenge as the leading cause of death, driving significant research efforts. Within the realm of cancer immunotherapy, bispecific antibodies (bsABs) have gained prominence due to their remarkable clinical efficacy in cancer patients. This has spurred intensive efforts to translate bsABs into effective therapies. For example, in June 2022, Roche received conditional marketing authorization from the European Commission for Lunsumio (mosunetuzumab), a CD20xCD3 T-cell binding bsAB used to treat relapsed or refractory follicular lymphoma patients who have undergone two prior systemic therapies.

Conversely, the segment focused on autoinflammatory, and autoimmune diseases is expected to maintain a steady growth rate throughout the forecast period. This is driven by the widespread adoption of novel bsAB therapeutics, which offer the potential to significantly enhance treatment efficacy. The prevalence of autoimmune diseases is substantial, with an estimated 14 million affected individuals in the U.S., encompassing 80 to 100 recognized autoimmune-related conditions. Notably, around 80% of those diagnosed are women, underscoring the importance of bsABs in addressing these health challenges.

End Use Insights

In 2022, the intravenous (IV) segment claimed the largest market share for global revenue. IV therapies play a crucial role in supporting the immune system to effectively combat cancer cells, representing a promising breakthrough in the treatment of certain cancer types. Moreover, antibody drugs have emerged as a hopeful avenue for patients with specific cancer conditions. According to the American Society of Hematology (ASH), bsAB therapy achieved a success rate of 73% among patients in a Phase I clinical trial involving 232 participants from various cancer centers worldwide, conducted between January 2018 and November 2021.

Concurrently, the subcutaneous segment is poised to experience the swiftest Compound Annual Growth Rate (CAGR) of 36.8% during the forecast period. Subcutaneous administration of bsABs demonstrated a significant positive response among patients dealing with relapsed or refractory multiple myeloma. The growing preference for subcutaneous delivery routes is expected to contribute significantly to market expansion in the foreseeable future. These factors collectively drive the segment's growth.

Regional Insights

In 2022, North America emerged as the dominant force in the market, commanding the largest share of revenue. The region's growth can be attributed to its well-established market, the increasing prevalence of cancer and infectious diseases, which necessitate advanced solutions. Additionally, the escalating research endeavors, a growing number of clinical trials, and substantial investments contribute significantly to the region's expansion. Among North American countries, the United States stands out as the largest market for bsAB therapeutics contract manufacturing, primarily driven by the surge in clinical trials, research and development activities, and increased investments by companies.

Conversely, the Asia Pacific region is poised to witness the most rapid Compound Annual Growth Rate (CAGR) during the forecast period. The region's growth is underpinned by various factors, including the substantial burden of cancer and the pressing need for novel drugs, particularly in countries like Japan and China. Furthermore, increased market demand and a rising number of collaborative partnerships among companies are expected to fuel growth throughout the forecast period.

Key Market Players

  • Lonza Group AG
  • Creative Biolabs Inc
  • Amgen Inc
  • Johnson & Johnson
  • Wuxi Biologics Cayman Inc
  • Roche Holding AG
  • Sino Biological Inc
  • IQVIA Inc
  • Janssen Pharmaceuticals Inc
  • AbbVie Inc

Report Scope:

In this report, the Global Bispecific Antibody Therapeutics Contract Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Bispecific Antibody Therapeutics Contract Manufacturing Market, By Indication:

  • Cancer
  • Infectious Diseases
  • Autoinflammatory and Autoimmune Diseases
  • CNS Conditions
  • Others

Bispecific Antibody Therapeutics Contract Manufacturing Market, By Route of Administration:

  • Intravenous
  • Subcutaneous
  • Others

Bispecific Antibody Therapeutics Contract Manufacturing Market, By Route of Administration:

  • Pharmaceutical Companies
  • Biopharmaceutical Companies
  • Others

Bispecific Antibody Therapeutics Contract Manufacturing Market, By Region:

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

Competitive Landscape

  • Company Profiles: Detailed analysis of the major companies present in the Global Bispecific Antibody Therapeutics Contract Manufacturing Market.

Available Customizations:

  • Global Bispecific Antibody Therapeutics Contract Manufacturing 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

2. Research Methodology

3. Executive Summary

4. Voice of Customers

5. Global Bispecific Antibody Therapeutics Contract Manufacturing Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Indication (Cancer, Infectious Diseases, Autoinflammatory and Autoimmune Diseases, CNS Conditions, Others)
    • 5.2.2. By Route of Administration (Intravenous, Subcutaneous, Others)
    • 5.2.3. By End Use (Pharmaceutical Companies, Biopharmaceutical Companies, Others)
    • 5.2.4. By Company (2022)
    • 5.2.5. By Region
  • 5.3. Market Map

6. North America Bispecific Antibody Therapeutics Contract Manufacturing Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Indications
    • 6.2.2. By Route of Administration
    • 6.2.3. By End Use
    • 6.2.4. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
        • 6.3.1.2.2. By Route of Administration
        • 6.3.1.2.3. By End Use
    • 6.3.2. Mexico Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
        • 6.3.2.2.2. By Route of Administration
        • 6.3.2.2.3. By End Use
    • 6.3.3. Canada Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
        • 6.3.3.2.2. By Route of Administration
        • 6.3.3.2.3. By End Use

7. Europe Bispecific Antibody Therapeutics Contract Manufacturing Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Indications
    • 7.2.2. By Route of Administration
    • 7.2.3. By End Use
    • 7.2.4. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. France Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
        • 7.3.1.2.2. By Route of Administration
        • 7.3.1.2.3. By End Use
    • 7.3.2. Germany Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
        • 7.3.2.2.2. By Route of Administration
        • 7.3.2.2.3. By End Use
    • 7.3.3. United Kingdom Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
        • 7.3.3.2.2. By Route of Administration
        • 7.3.3.2.3. By End Use
    • 7.3.4. Italy Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
        • 7.3.4.2.2. By Route of Administration
        • 7.3.4.2.3. By End Use
    • 7.3.5. Spain Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
        • 7.3.5.2.2. By Route of Administration
        • 7.3.5.2.3. By End Use

8. Asia-Pacific Bispecific Antibody Therapeutics Contract Manufacturing Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Indications
    • 8.2.2. By Route of Administration
    • 8.2.3. By End Use
    • 8.2.4. By Country
  • 8.3. Asia-Pacific: Country Analysis
    • 8.3.1. China Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
        • 8.3.1.2.2. By Route of Administration
        • 8.3.1.2.3. By End Use
    • 8.3.2. India Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
        • 8.3.2.2.2. By Route of Administration
        • 8.3.2.2.3. By End Use
    • 8.3.3. South Korea Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
        • 8.3.3.2.2. By Route of Administration
        • 8.3.3.2.3. By End Use
    • 8.3.4. Japan Bispecific Antibody Therapeutics Contract Manufacturing Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Indications
        • 8.3.4.2.2. By Route of Administration
        • 8.3.4.2.3. By End Use
    • 8.3.5. Australia Bispecific Antibody Therapeutics Contract Manufacturing Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Indications
        • 8.3.5.2.2. By Route of Administration
        • 8.3.5.2.3. By End Use

9. South America Bispecific Antibody Therapeutics Contract Manufacturing Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Indications
    • 9.2.2. By Route of Administration
    • 9.2.3. By End Use
    • 9.2.4. By Country
  • 9.3. South America: Country Analysis
    • 9.3.1. Brazil Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
        • 9.3.1.2.2. By Route of Administration
        • 9.3.1.2.3. By End Use
    • 9.3.2. Argentina Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
        • 9.3.2.2.2. By Route of Administration
        • 9.3.2.2.3. By End Use
    • 9.3.3. Colombia Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
        • 9.3.3.2.2. By Route of Administration
        • 9.3.3.2.3. By End Use

10. Middle East and Africa Bispecific Antibody Therapeutics Contract Manufacturing Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Indications
    • 10.2.2. By Route of Administration
    • 10.2.3. By End Use
    • 10.2.4. By Country
  • 10.3. MEA: Country Analysis
    • 10.3.1. South Africa Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
        • 10.3.1.2.2. By Route of Administration
        • 10.3.1.2.3. By End Use
    • 10.3.2. Saudi Arabia Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
        • 10.3.2.2.2. By Route of Administration
        • 10.3.2.2.3. By End Use
    • 10.3.3. UAE Bispecific Antibody Therapeutics Contract Manufacturing 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 Indications
        • 10.3.3.2.2. By Route of Administration
        • 10.3.3.2.3. By End Use

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. PESTLE 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. Competitive Landscape

  • 15.1. Business Overview
  • 15.2. Company Snapshot
  • 15.3. Product & Services
  • 15.4. Financials (In case of listed companies)
  • 15.5. Recent Developments
  • 15.6. SWOT Analysis
    • 15.6.1. Lonza Group AG
    • 15.6.2. Creative Biolabs Inc
    • 15.6.3. Amgen Inc
    • 15.6.4. Johnson & Johnson
    • 15.6.5. Wuxi Biologics Cayman Inc
    • 15.6.6. Roche Holding AG
    • 15.6.7. Sino Biological Inc
    • 15.6.8. IQVIA Inc
    • 15.6.9. Janssen Pharmaceuticals Inc
    • 15.6.10. AbbVie Inc

16. Strategic Recommendations