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細胞毒性藥物和高效能原料藥 (HPAPI) 製造市場：產業趨勢及 2035 年全球預測 - 按產品類型、公司規模、業務規模、分子類型、高活性最終劑型類型和主要地區劃分

Cytotoxic Drugs & HPAPI Manufacturing Market: Industry Trends and Global Forecasts, Till 2035 - Distribution by Type of Product, Company Size, Scale of Operation, Type of Molecule, Type of Highly Potent Finished Dosage Form, and Key Geographies
出版日期: | 出版商: Roots Analysis | 英文 442 Pages | 商品交期: 最快1-2個工作天內

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細胞毒性藥物和高效能原料藥 (HPAPI) 製造市場：概覽

預計到 2035 年，全球細胞毒性藥物和高效原料藥 (HPAPI) 製造市場規模將從目前的 139.8 億美元增長至 464.1 億美元，預測期內複合年增長率為 12.75%。

細胞毒性藥物和高效能原料藥 (HPAPI) 製造市場的市場機會分佈在以下細分領域：

產品類型

  • HPAPI
  • 高活性最終劑型

事業規模

  • 前臨床
  • 臨床試驗
  • 商業

分子類型

  • 低分子
  • 生技藥品

高活性最終劑型類型

  • 注射劑
  • 口服固態劑
  • 乳膏
  • 其他

主要地區

  • 北美(美國，加拿大，墨西哥)
  • 歐洲(英國，義大利，德國，法國，西班牙，其他)
  • 亞太地區(中國，印度，其他)
  • 其他地區

細胞毒性藥物與高效能原料藥製造市場：成長與趨勢

由於臨床藥理學和腫瘤學的進步，以及人們對標靶治療的興趣日益濃厚，全球研究人員和製藥商越來越關注高效藥物高效原料藥 (HPAPI) 和細胞毒性藥物。值得注意的是，全球 45% 的藥品都屬於高效藥物，因此需要專門生產 HPAPI。然而，HPAPI 的生產過程複雜，面臨許多課題。首要課題是防止生產過程中的交叉污染，其次是確保供應鏈中環境和工人的安全。此外，選擇合適的控制和保護措施，包括設施、流程和個人防護裝備 (PPE) 也至關重要。處理 HPAPI 通常需要持續投資於安全處理方法和先進的技術專長，這進一步增加了該領域的複雜性。因此，藥物開發商越來越多地選擇外包其生產流程。

合約製造業的巨大潛力和良好的成長前景促使大多數大型公司投資擴建或升級其現有的生產設施。一些合約製造組織 (CMO) 正在日本、中國、印度和巴西等新興市場建立新工廠，以受益於這些地區不斷下降的製造成本、熟練的勞動力和有利的監管環境。在整體市場擴張、近期技術創新和日益增長的外包趨勢的推動下，預計該行業將在未來十年持續成長。

細胞毒性藥物和高效能原料藥 (HPAPI) 製造市場：關鍵洞察

本報告深入探討了細胞毒性藥物和高效原料藥 (HPAPI) 製造市場的現狀，並識別了行業內的潛在成長機會。主要發現包括：

  • 目前，超過 140 家公司聲稱擁有必要的專業知識，能夠為不同規模的高效能化合物提供合約製造服務。
  • 目前的市場格局高度分散，主要地區既有新進者，也有老牌企業。
細胞毒性藥物和高效原料藥 (HPAPI) 製造市場-IMG1
  • 利害關係人正在利用其專業知識，為各種高效能化合物提供合約製造服務。約 70% 的服務提供者俱備高效原料藥 (HPAPI) 的分析測試能力。
  • 合作活動的增加證明了人們對這一領域的興趣日益濃厚。事實上，高效原料藥和細胞毒性藥物製造的合作夥伴數量已在近期達到高峰。
  • 為了滿足對高效能化合物日益增長的需求，CMO 正在謹慎投資，以擴大其設施和產能。這一趨勢在美國、瑞士和英國尤為明顯。
  • 全球高效能原料藥 (HPAPI) 的合約生產能力分散在各個地區，目前 80% 的產能位於大型公司旗下的工廠。
  • 抗體藥物偶聯物是最受歡迎的高效化合物之一，目前有 30 多家公司聲稱提供此類生物製藥的合約生產和偶聯服務。
  • 高效藥物開發商可能會將其生產業務外包，預計基於服務的銷售額將以每年 12.75% 的速度成長。
細胞毒性藥物和高效原料藥製造市場-IMG2

細胞毒性藥物和高效能原料藥製造市場：主要細分市場

高效原料藥 (HPAPI) 細分市場在細胞毒性藥物和高效能原料藥製造市場中佔最大佔有率

依產品類型，市場細分為高效能原料藥 (HPAPI) 和高效能成品劑型。目前，高效原料藥 (HPAPI) 細分市場在細胞毒性藥物和高效能原料藥製造市場中佔最大佔有率。這一趨勢在短期內不太可能改變。

在預測期內，大型公司很可能主導細胞毒性藥物和高效原料藥 (HPAPI) 製造市場。

依公司規模劃分，市場分為中小型企業、中型企業、大型企業及超大型企業。目前，細胞毒性藥物和高效能原料藥 (HPAPI) 製造市場由大型公司主導。預計這一趨勢將在未來十年持續下去。

按業務規模劃分，商業規模很可能主導細胞毒性藥物和高效原料藥 (HPAPI) 製造市場。

依業務規模，市場分為臨床前、臨床及商業規模。目前，商業規模在細胞毒性藥物和高效能原料藥 (HPAPI) 製造市場中佔有很大佔有率。預計這一趨勢將在未來幾年持續下去。

在預測期內，生物製劑將成為細胞毒性藥物和高效原料藥 (HPAPI) 製造市場中成長最快的細分市場。

依分子類型劃分，市場分為小分子和生物製劑。目前，小分子在細胞毒性藥物和高效能原料藥 (HPAPI) 製造市場中佔主導地位。這主要得益於CMO對高效能小分子的投資和產能擴張。由於對高效藥物的需求不斷增長，預計未來十年生物製劑市場將以更快的速度成長。

在預測期內，口服FDF（藥物開發配方）很可能在細胞毒性藥物和高效原料藥 (HPAPI) 製造市場中佔主導地位。

依高活性最終劑型劃分，市場分為注射劑、口服固體製劑、乳膏劑和其他FDF。值得注意的是，口服FDF目前在細胞毒性藥物和高效能原料藥 (HPAPI) 製造市場中佔最大佔有率。由於口服製劑的優勢，例如製造商的成本效益以及患者使用的舒適性和易用性，預計未來十年趨勢將保持不變。

歐洲將佔最大的市場佔有率。

依地區劃分，市場分為北美、歐洲、亞太地區及亞太其他地區。歐洲公司佔了大部分市場佔有率。這是因為該地區擁有成熟的公司，擁有強大的產能和生產能力。值得注意的是，預計未來幾年亞太市場將以更高的複合年增長率成長。

細胞毒性藥物和高效原料藥 (HPAPI) 製造市場參與者

  • AbbVie
  • Cambrex
  • Catalent
  • Pfizer CentreOne
  • Piramal Pharma Solutions
  • Abzena
  • Aenova
  • CARBOGEN AMCIS
  • Hovione
  • Lonza
  • Intas Pharmaceuticals
  • Scinopharm
  • STA Pharmaceutical(a WuXi AppTec company)
  • Syngene
  • Teva API

初步研究概述

本研究中提出的觀點和見解受到與多位利害關係人討論的影響。本研究報告包含與以下產業利害關係人的詳細訪談記錄：

  • A公司所有者兼董事
  • B公司副總裁、營運長兼總經理
  • C公司ILC Dover副總裁
  • D公司前集團產品經理及前業務發展總監
  • E公司業務發展總監
  • F公司董事總經理
  • G公司製劑及成品部門前總經理
  • H公司前現場負責人
  • I公司前高級業務發展經理
  • J公司醫藥行銷與銷售經理
  • K公司前業務發展工程師

細胞毒性藥物與高效能原料藥製造市場：研究主題

  • 市場規模與機會分析：本研究報告對細胞毒性藥物和高效原料藥製造市場進行了深入分析，重點關注以下關鍵細分市場： [A] 產品類型，[B] 公司規模，[C] 企業規模，[D] 分子類型，[E] 高效成品劑型類型，[F] 主要地區。
  • 市場格局：本報告對從事高效原料藥 (HPAPI) 和細胞毒性藥物合約生產的公司進行了全面評估，考慮了以下各種參數：A) 成立年份，[B] 公司規模（員工人數），[C] 總部所在地，[D] 生產設施所在地，[E] 生產設施面積，[F] 企業規模，[G] 生產的產品生產的分子類型，[H] 初級包裝系統類型，[i] 獲得的監管認證/認可，以及 [J] 提供的服務類型。
  • 競爭分析：本報告對高效原料藥 (HPAPI) 和細胞毒性藥物的合約製造商進行了全面的競爭分析，考慮的因素包括：A) 供應商優勢、[B] 服務優勢等。
  • 公司簡介：本報告詳細介紹了提供高效原料藥 (HPAPI) 和細胞毒性藥物合約製造服務的主要公司，重點關注：A) 公司概況、[B] 高效原料藥 (HPAPI) 和細胞毒性藥物相關服務組合、[C] 專用設施、[D] 最新發展和 [E] 明智的未來展望。
  • 合作夥伴關係與協作：本分析基於相關參數分析了該領域建立的合作夥伴關係，例如：[A] 合作年份、[B] 合作類型、[C] 業務規模、[D] 產品類型、[E] 最活躍的參與者（簽署的協議數量）和 [F] 細胞毒性藥物和高效原料藥 (HPAPI) 製造市場合作活動的區域分佈。
  • 近期擴張：本分析檢視了該領域高效原料藥 (HPAPI) 和細胞毒性藥物合約製造商為提升生產能力而開展的各種擴張措施。本分析涵蓋：[A] 擴張年份，[B] 擴張類型，[C] 公司規模，[D] 總部位置，[E] 企業規模，[F] 產品類型，[G] 擴張設施位置，[H]我們考慮了各種因素，例如：[i] 擴建設施的面積；[ii] 擴建投資金額；[J] 最活躍的參與者（近期擴建數量）；以及 [K] 區域分佈。
  • 產能分析：我們根據各利害關係人發布的數據估算全球高效能原料藥 (HPAPI) 的生產能力。此分析重點在於以下因素的可用產能分佈：[A] 公司規模（小型、中型、大型）；[B] 業務規模（臨床前、臨床、商業化）；以及 [C] 主要地區（北美、歐洲、亞太地區）。
  • 區域產能評估分析：一個區域產能評估框架，該框架基於多個參數比較主要地區的高效原料藥 (HPAPI) 和細胞毒性藥物的生產能力，例如：[A] 高效原料藥 (HPAPI) 和細胞毒性藥物的合約製造商數量；[B] 高效原料藥 (HPAPI) 和細胞毒性藥物的生產設施數量；[C] 儲存設施數量；
  • SWOT 分析：SWOT 分析重點突顯可能影響產業發展的關鍵推動因素和課題。
  • 案例研究：提供抗體藥物偶聯物 (ADC) 製造服務的公司的案例研究。本章也重點介紹了 ADC 的關鍵組成部分以及製造這些產品面臨的主要課題。此外，本章還提供了提供 ADC 合約製造服務的公司清單。

目錄

第1章 序文

第2章 摘要整理

第3章 簡介

  • 章概要
  • 高活性API

第4章 市場形勢

  • 章概要
  • HPAPI及細胞傷害性醫藥品的受託製造廠商:市場形勢

第5章 企業競爭力分析

  • 章節概要
  • 假設和關鍵參數
  • 研究方法
  • 高效率原料藥 (HPAPI) 合約生產組織：競爭分析
  • 高效能原料藥 (FDF) 合約製造商：競爭分析
  • 高效原料藥 (HPAPI) 與高效效力FDF合約生產組織：競爭分析

第6章 企業簡介:北美的HPAPI及細胞傷害性醫藥品廠商

  • 章概要
  • AbbVie
  • Cambrex
  • Catalent
  • Pfizer CentreOne
  • Piramal Pharma Solutions

第7章 企業簡介:歐洲的HPAPI及細胞傷害性醫藥品廠商

  • 章概要
  • Abzena
  • Aenova
  • CARBOGEN AMCIS
  • Hovione
  • Lonza

第8章 企業簡介:亞太地區及其他地區的HPAPI及細胞傷害性醫藥品廠商

  • 章概要
  • Intas Pharmaceuticals
  • Scinopharm
  • STA Pharmaceutical(WuXi AppTec旗下)
  • Syngene
  • Teva API

第9章 夥伴關係和合作

  • 章概要
  • 夥伴關係模式
  • HPAPI和細胞毒性藥:夥伴關係和合作清單

第10章 最近的擴張

  • 章概要
  • HPAPI及細胞毒性藥:最近的擴大一覽

第11章 容量分析

第12章 地區能力評估分析

第13章 是製造還是購買意思決策架構

  • 章概要
  • 前提主要的參數
  • 結論

第14章 與市場規模的評估機會分析

  • 章概要
  • 預測調查手法主要的前提條件
  • 到2035年前的全球高活性API及細胞毒性藥的契約製造市場

第15章 SWOT分析

第16章 案例:抗體藥物複合體的受託製造

  • 章概要
  • 抗體藥物複合體的主要成分
  • ADC製造概要
  • 供應鏈與手法遷移伴隨的課題
  • CMO合作夥伴選擇時應該考慮的重點
  • ADC契約製造服務供應商:市場形勢
  • 結論

第17章 結論

第18章 執行洞察

第19章 附錄1:表格形式資料

第20章 附錄2:企業·團體一覽

Product Code: RA100386

Cytotoxic Drugs and HPAPI Manufacturing Market: Overview

As per Roots Analysis, the global cytotoxic drugs and HPAPI manufacturing market is estimated to grow from USD 13.98 billion in the current year to USD 46.41 billion by 2035, at a CAGR of 12.75% during the forecast period, till 2035.

The market opportunity for cytotoxic drugs and HPAPI manufacturing market has been distributed across the following segments:

Type of Product

  • HPAPIs
  • Highly Potent Finished Dosage Forms

Scale of Operation

  • Preclinical
  • Clinical
  • Commercial

Type of Molecule

  • Small Molecules
  • Biologics

Type of Highly Potent Finished Dosage Form

  • Injectables
  • Oral Solids
  • Creams
  • Others

Key Geographies

  • North America (US, Canada and Mexico)
  • Europe (UK, Italy, Germany, France, Spain, and Rest of Europe)
  • Asia-Pacific (China, India, and Rest of Asia-Pacific)
  • Rest of the World

Cytotoxic Drugs and HPAPI Manufacturing Market: Growth and Trends

Due to the progress in clinical pharmacology and oncology, along with rising interest of players in targeted therapies, researchers and drug manufacturers worldwide are increasingly focusing on high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs. It is important to note that 45% of drugs worldwide are highly potent, necessitating the need for specialized production of HPAPIs. However, the manufacturing of HPAPIs involves a complicated process, leading to various challenges. The primary challenge is preventing cross-contamination during production, followed by ensuring the safety of the environment and workers involved in the supply chain. Additionally, selecting the appropriate containment and protective measures, including equipment, procedures, and personal protective equipment (PPE), is crucial. Handling HPAPIs typically requires ongoing investment in safe handling practices, and advanced technical expertise, which further complicates the field. As a result, drug developers are increasingly turning to outsourcing their manufacturing processes.

Owing to the significant potential and favorable growth prospects of the contract manufacturing sector, most of the leading pharmaceutical companies are seeking to invest in the expansion or enhancement of their existing manufacturing facilities. Several contract manufacturing organizations (CMOs) are establishing new facilities in emerging markets such as Japan, China, India, and Brazil to benefit from lower production costs, skilled labor, and favorable regulatory environments in these regions. Driven by the overall expansion of the market, recent technological innovations, and a rising trend towards outsourcing, the sector is expected to experience consistent growth in the next decade.

Cytotoxic Drugs and HPAPI Manufacturing Market: Key Insights

The report delves into the current state of the cytotoxic drugs & HPAPI manufacturing market and identifies potential growth opportunities within the industry. Some key findings from the report include:

  • Presently, more than 140 players claim to have the required expertise to offer contract manufacturing services for highly potent compounds, across different scales of operation.
  • The current market landscape is highly fragmented, featuring the presence of both new entrants and established players across key geographical regions.
Cytotoxic Drugs & HPAPI Manufacturing Market - IMG1
  • Leveraging their expertise, stakeholders are offering contract manufacturing services for a myriad of highly potent compounds; around 70% of the service providers possess analytical testing capability for HPAPIs.
  • The growing interest in this domain is evident from the rise in partnership activity; in fact, the maximum number of collaborations related to HPAPI and cytotoxic drug manufacturing were inked in the recent past.
  • In order to meet the rising demand for high potency compounds, CMOs have made elaborate investments to expand their facilities and capacities; this trend is most pronounced in the US, Switzerland and the UK.
  • The installed global contract manufacturing capacity for HPAPIs is well distributed across different geographies; 80% of the present capacity is installed in facilities owned by very large players.
  • Antibody Drug Conjugates are one of the most popular classes of highly potent compounds; more than 30 players currently claim to offer contract manufacturing / conjugation services for such biopharmaceuticals.
  • It is anticipated that the highly potent drug developers are likely to outsource their manufacturing operations, enabling the service based revenues to grow at an annualized rate of 12.75%.
Cytotoxic Drugs & HPAPI Manufacturing Market - IMG2

Cytotoxic Drugs & HPAPI Manufacturing Market: Key Segments

HPAPI Segment Occupies the Largest Share of the Cytotoxic Drugs and HPAPI Manufacturing Market

Based on the type of product, the market is segmented into HPAPI and highly potent finished dosage forms. At present, HPAPI segment holds the maximum share of the cytotoxic drugs & HPAPI manufacturing market. This trend is unlikely to change in the near future.

Very Large Players are Likely to Dominate the Cytotoxic Drugs & HPAPI Manufacturing Market During the Forecast Period

Based on the company size, the market is segmented into small, mid-sized, large and very large companies. At present, very large companies hold the maximum share of the cytotoxic drugs & HPAPI manufacturing market. This trend is likely to remain the same in the coming decade.

By Scale of Operation, Commercial Scale is Likely to Dominate the Cytotoxic Drugs and HPAPI Manufacturing Market

Based on scales of operation, the market is segmented into preclinical, clinical and commercial scales. It is worth highlighting that, at present, commercial scale holds a larger share of the cytotoxic drugs and HPAPI manufacturing market. This trend is likely to remain the same in the forthcoming years.

Biologics is the Fastest Growing Segment of the Cytotoxic Drugs and HPAPI Manufacturing Market During the Forecast Period

Based on the type of molecule, the market is segmented into small molecules and biologics. It is worth highlighting that, at present, small molecules dominate the cytotoxic drugs and HPAPI manufacturing market. This is primarily due to the fact the CMOs have invested and expanded their capabilities for highly potent small molecules. It is important to note the demand for highly potent drugs is on the rise, therefore the market for biologics is expected to grow at a faster pace in the coming decade.

Oral FDFs are Likely to Dominate the Cytotoxic Drugs and HPAPI Manufacturing Market During the Forecast Period

Based on the type of highly potent finished dosage forms, the market is segmented into injectables, oral solids, creams and other FDFs. It is worth highlighting that, at present, oral FDFs capture the highest share of the cytotoxic drugs and HPAPI manufacturing market. This trend is likely to remain the same in the coming decade owing to the benefits offered by oral formulations, such as cost-efficiency for manufacturers, comfort and ease of use for patients.

Europe Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the world. The majority of the share is expected to be captured by players based in Europe. This is due to the fact that there are well-established players in this region with considerable installed capacities and capabilities. It is worth highlighting that, over the years, the market in Asia-Pacific is expected to grow at a higher CAGR.

Example Players in the Cytotoxic Drugs & HPAPI Manufacturing Market

  • AbbVie
  • Cambrex
  • Catalent
  • Pfizer CentreOne
  • Piramal Pharma Solutions
  • Abzena
  • Aenova
  • CARBOGEN AMCIS
  • Hovione
  • Lonza
  • Intas Pharmaceuticals
  • Scinopharm
  • STA Pharmaceutical (a WuXi AppTec company)
  • Syngene
  • Teva API

Primary Research Overview

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:

  • Owner and Director, Company A
  • Vice President and Chief Operating Officer and Business Director, Company B
  • ILC Dover, Vice President, Company C
  • Ex-Group Product Manager and Ex-Director-Business Development, Company D
  • Business Development Director, Company E
  • Managing Director, Company F
  • Ex-Business Head, Formulations and Finished Products, Company G
  • Ex-Site Head, Company H
  • Ex-Senior Manager, Business Development, Company I
  • Marketing and Sales Manager, Pharma, Company J
  • Ex-Business Development Technician, Company K

Cytotoxic Drugs and HPAPI Manufacturing Market: Research Coverage

  • Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the cytotoxic drugs and HPAPI manufacturing market, focusing on key market segments, including [A] type of product, [B] company size, [C] scale of operation, [D] type of molecule, [E] type of highly potent finished dosage form and [F] key geographical regions.
  • Market Landscape: A comprehensive evaluation of companies involved in the contract manufacturing of HPAPI and cytotoxic drugs, considering various parameters, such as [A] year of establishment, [B] company size (in terms of number of employees), [C] location of headquarters, [D] location of manufacturing facility, [E] area of manufacturing facility, [F] scale of operation, [G] type of product manufactured, [H] type of highly potent finished dosage form, [G] Occupational Exposure Limit, [H] type of molecule manufactured, [H] type of primary packaging system, [I] regulatory certifications / accreditations received and [J] type of service(s) offered.
  • Company Competitiveness Analysis: A comprehensive competitive analysis of HPAPI and cytotoxic drug contract manufacturers, examining factors, such as [A] supplier strength and [B] service strength.
  • Company Profiles: In-depth profiles of key industry players offering contract manufacturing services for HPAPI and cytotoxic drugs, focusing on [A] company overviews, [B] HPAPI and cytotoxic drug-related service portfolio, [C] dedicated facilities, [D] recent developments and [E] an informed future outlook.
  • Partnerships and Collaborations: An analysis of partnerships established in this sector based on relevant parameters, such as [A] year of partnership, [B] type of partnership, [C] scale of operation, [D] type of product, [E] most active players (in terms of number of deals inked) and [F] regional distribution of partnership activity that have been undertaken in cytotoxic drugs and HPAPI manufacturing market.
  • Recent Expansions: An examination of the different expansion efforts made by the HPAPI and cytotoxic drug contract manufacturers in this field to enhance their manufacturing capabilities. This analysis considers various factors, including the [A] year of expansion, [B] type of expansion, [C] company size, [D] location of headquarters, [E] scale of operation, [F] type of product, [G] location of expanded facility, [H] area of expanded facility, [I] amount invested in expansions, [J] most active players (in terms of number of recent expansions) and [K] geographical distribution.
  • Capacity Analysis: Estimation of global HPAPI manufacturing capacity, derived from data provided by various stakeholders in the public domain. This analysis emphasizes the distribution of the available capacity on the basis of [A] company size (small, mid-sized and large), [B] scale of operation (preclinical, clinical and commercial) and [C] key geographical regions (North America, Europe and Asia-Pacific).
  • Regional Capability Assessment Analysis: A regional capability assessment framework that compares the HPAPI and cytotoxic drug manufacturing capabilities across key geographies, based on several parameters, such as [A] the number of HPAPI and cytotoxic drug contract manufacturers, [B] number of HPAPI and cytotoxic drug manufacturing facilities, [C] number of facility expansions and [D] installed HPAPI capacity in that particular geographical region.
  • SWOT Analysis: A SWOT analysis, focusing on key drivers and challenges that are likely to impact the industry's evolution.
  • Case Study: A case study on companies offering manufacturing services for antibody drug conjugate (ADCs). The chapter also highlights the key components of ADCs and the key challenges associated with the manufacturing of these products. Further, the chapter presents a list of players that provide contract manufacturing services for ADCs.

Key Questions Answered in this Report

  • How many companies are currently engaged in this market?
  • Which are the leading companies in this market?
  • What kind of partnership models are commonly adopted by industry stakeholders?
  • What are the factors that are likely to influence the evolution of this market?
  • What is the current and future market size?
  • What is the CAGR of this market?
  • How is the current and future market opportunity likely to be distributed across key market segments?

Reasons to Buy this Report

  • The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
  • Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
  • The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

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TABLE OF CONTENTS

1. PREFACE

  • 1.1. Introduction
  • 1.2. Key Market Insights
  • 1.3. Scope of the Report
  • 1.4. Research Methodology
  • 1.5. Frequently Asked Questions
  • 1.6. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

  • 3.1. Chapter Overview
  • 3.2. High Potency Active Pharmaceutical Ingredients
    • 3.2.1. Classification by Potency
      • 3.2.1.1. Classification of HPAPIs
    • 3.2.2. Different Types of HPAPIs
      • 3.2.2.1. Antibody Drug Conjugates
      • 3.2.2.2. Cytotoxic Drugs
      • 3.2.2.3. Peptides
      • 3.2.2.4. Hormones
      • 3.2.2.5. Beta-Lactam Compounds
      • 3.2.2.6. Prostaglandins
      • 3.2.2.7. Cytostatics
      • 3.2.2.8. Steroids
    • 3.2.3. Considerations for Handling HPAPIs
    • 3.2.4. Contract Manufacturing of HPAPIs and Cytotoxic Drugs
      • 3.2.4.1. Key Considerations While Selecting a Contract Manufacturing Partner
    • 3.2.5. Regulatory Considerations for Manufacturing HPAPIs
    • 3.2.6. Concluding Remarks

4. MARKET LANDSCAPE

  • 4.1. Chapter Overview
  • 4.2. HPAPI and Cytotoxic Drug Contract Manufacturers: Overall Market Landscape
    • 4.2.1. Analysis by Year of Establishment
    • 4.2.2. Analysis by Company Size
    • 4.2.3. Analysis by Location of Headquarters
    • 4.2.4. Analysis by Company Size and Location of Headquarters
    • 4.2.5. Analysis by Location of Manufacturing Facility
    • 4.2.6. Analysis by Area of Manufacturing Facility
    • 4.2.7. Analysis by Scale of Operation
    • 4.2.8. Analysis by Type of Product Manufactured
    • 4.2.9. Analysis by Location of Manufacturing Facility and Type of Product Manufactured
    • 4.2.10. Analysis by Type of Finished Dosage Form
    • 4.2.11. Analysis by Occupational Exposure Limit (OEL)
    • 4.2.12. Analysis by Type of Molecule Manufactured
    • 4.2.13. Analysis by Type of Primary Packaging System
    • 4.2.14. Analysis by Regulatory Certification / Accreditation Received
    • 4.2.15. Analysis by Type of Service(s) Offered

5. COMPANY COMPETITIVENESS ANALYSIS

  • 5.1. Chapter Overview
  • 5.2. Assumptions and Key Parameters
  • 5.3. Methodology
  • 5.4. HPAPI Contract Manufacturers: Company Competitiveness Analysis
    • 5.4.1. HPAPI Contract Manufacturers based in North America
    • 5.4.2. HPAPI Contract Manufacturers based in Europe
    • 5.4.3. HPAPI Contract Manufacturers based in Asia-Pacific and Rest of the World
  • 5.5. Highly Potent FDF Contract Manufacturers: Company Competitiveness Analysis
    • 5.5.1. Highly Potent FDF Contract Manufacturers based in North America
    • 5.5.2. Highly Potent FDF Contract Manufacturers based in Europe
    • 5.5.3. Highly Potent FDF Contract Manufacturers based in Asia-Pacific and Rest of the World
  • 5.6. HPAPI and Highly Potent FDF Contract Manufacturers: Company Competitiveness Analysis
    • 5.6.1. HPAPI and Highly Potent FDF Contract Manufacturers based in North America
    • 5.6.2. HPAPI and Highly Potent FDF Contract Manufacturers based in Europe
    • 5.6.3. HPAPI and Highly Potent FDF Contract Manufacturers based in Asia-Pacific and Rest of the World

6. COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN NORTH AMERICA

  • 6.1. Chapter Overview
  • 6.2. AbbVie
    • 6.2.1. Company Overview
    • 6.2.2. HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings
    • 6.2.3. Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
    • 6.2.4. Recent Developments and Future Outlook
  • 6.3. Cambrex
    • 6.3.1. Company Overview
    • 6.3.2. HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings
    • 6.3.3. Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
    • 6.3.4. Recent Developments and Future Outlook
  • 6.4. Catalent
    • 6.4.1. Company Overview
    • 6.4.2. HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings
    • 6.4.3. Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
    • 6.4.4. Recent Developments and Future Outlook
  • 6.5. Pfizer CentreOne
    • 6.5.1. Company Overview
    • 6.5.2. HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings
    • 6.5.3. Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
    • 6.5.4. Recent Developments and Future Outlook
  • 6.6. Piramal Pharma Solutions
    • 6.6.1. Company Overview
    • 6.6.2. HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
    • 6.6.3. Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
    • 6.6.4. Recent Developments and Future Outlook

7. COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN EUROPE

  • 7.1. Chapter Overview
  • 7.2. Abzena
    • 7.2.1. Company Overview
    • 7.2.2. HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings
    • 7.2.3. Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
    • 7.2.4. Recent Developments and Future Outlook
  • 7.3. Aenova
    • 7.3.1. Company Overview
    • 7.3.2. HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings
    • 7.3.3. Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
    • 7.3.4. Recent Developments and Future Outlook
  • 7.4. CARBOGEN AMCIS
    • 7.4.1. Company Overview
    • 7.4.2. HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings
    • 7.4.3. Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
    • 7.4.4. Recent Developments and Future Outlook
  • 7.5. Hovione
    • 7.5.1. Company Overview
    • 7.5.2. HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings
    • 7.5.3. Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
    • 7.5.4. Recent Developments and Future Outlook
  • 7.6. Lonza
    • 7.6.1. Company Overview
    • 7.6.2. HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
    • 7.6.3. Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
    • 7.6.4. Recent Developments and Future Outlook

8. COMPANY PROFILES: HPAPI AND CYTOTOXIC DRUG MANUFACTURERS IN ASIA-PACIFIC AND REST OF

THE WORLD

  • 8.1. Chapter Overview
  • 8.2. Intas Pharmaceuticals
    • 8.2.1. Company Overview
    • 8.2.2. HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings
    • 8.2.3. Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
    • 8.2.4. Recent Developments and Future Outlook
  • 8.3. Scinopharm
    • 8.3.1. Company Overview
    • 8.3.2. HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
    • 8.3.3. Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
    • 8.3.4. Recent Developments and Future Outlook
  • 8.4. STA Pharmaceutical (a WuXi AppTec company)
    • 8.4.1. Company Overview
    • 8.4.2. HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings
    • 8.4.3. Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
    • 8.4.4. Recent Developments and Future Outlook
  • 8.5. Syngene
    • 8.5.1. Company Overview
    • 8.5.2. HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings
    • 8.5.3. Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
    • 8.5.4. Recent Developments and Future Outlook
  • 8.6. Teva API
    • 8.6.1. Company Overview
    • 8.6.2. HPAPI and Cytotoxic Drug Manufacturing Focused Service Offerings
    • 8.6.3. Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
    • 8.6.4. Recent Developments and Future Outlook

9. PARTNERSHIPS AND COLLABORATIONS

  • 9.1. Chapter Overview
  • 9.2. Partnership Models
  • 9.3. HPAPI and Cytotoxic Drugs: List of Partnerships and Collaborations
    • 9.3.1. Analysis by Year of Partnership
    • 9.3.2. Analysis by Type of Partnership
    • 9.3.3. Analysis by Year and Type of Partnership
    • 9.3.4. Analysis by Scale of Operation
    • 9.3.5. Analysis by Type of Product
    • 9.3.6. Analysis by Type of Partnership and Type of Product
    • 9.3.7. Analysis of Amount Invested Via Acquisitions
    • 9.3.8. Analysis by Type of Partner
    • 9.3.9. Most Active Players: Analysis by Number of Partnerships
    • 9.3.10. Analysis by Geography
      • 9.3.10.1. Intracontinental and Intercontinental Deals
      • 9.3.10.2. International and Local Deals

10. RECENT EXPANSIONS

  • 10.1. Chapter Overview
  • 10.2. HPAPI and Cytotoxic Drugs: List of Recent Expansions
    • 10.2.1. Analysis by Year of Expansion
    • 10.2.2. Analysis by Type of Expansion
    • 10.2.3. Analysis by Year and Type of Expansion
    • 10.2.4. Analysis by Company Size and Location of Headquarters
    • 10.2.5. Analysis by Scale of Operation
    • 10.2.6. Analysis by Type of Expansion and Scale of Operation
    • 10.2.7. Analysis by Type of Product
    • 10.2.8. Analysis by Type of Expansion and Type of Product
    • 10.2.9. Analysis by Location of Expanded Facility
    • 10.2.10. Analysis by Type of Expansion and Location of Expanded Facility
    • 10.2.11. Analysis by Expanded Facility Area
    • 10.2.12. Analysis by Amount Invested on Expansions
    • 10.2.13. Most Active Players: Analysis by Number of Recent Expansions
    • 10.2.14. Geographical Analysis
      • 10.2.14.1. Analysis by Continent
      • 10.2.14.2. Analysis by Country

11. CAPACITY ANALYSIS

  • 11.1. Chapter Overview
  • 11.2. Key Assumptions and Methodology
  • 11.3. HPAPI Contract Manufacturers: Global Installed Capacity
    • 11.3.1. Analysis by Range of Installed Capacity
    • 11.3.2. Analysis by Company Size
    • 11.3.3. Analysis by Scale of Operation
    • 11.3.4. Analysis by Location of Manufacturing Facility
      • 11.3.4.1. Analysis of HPAPI Contract Manufacturing Capacity Installed in North America
      • 11.3.4.2. Analysis of HPAPI Contract Manufacturing Capacity Installed in Europe
      • 11.3.4.3. Analysis of HPAPI Contract Manufacturing Capacity Installed in Asia-Pacific and Rest of the World
    • 11.3.5. Concluding Remarks

12. REGIONAL CAPABILITY ASSESSMENT ANALYSIS

  • 12.1. Chapter Overview
  • 12.2. Assumptions and Key Parameters
  • 12.3. HPAPI and Cytotoxic Drug Manufacturing Capabilities in North America
  • 12.4. HPAPI and Cytotoxic Drug Manufacturing Capabilities in Europe
  • 12.5. HPAPI and Cytotoxic Drug Manufacturing Capabilities in Asia-Pacific
  • 12.6. HPAPI and Cytotoxic Drug Manufacturing Capabilities in Rest of the World
  • 12.7. Concluding Remarks

13. MAKE VERSUS BUY DECISION MAKING FRAMEWORK

  • 13.1. Chapter Overview
  • 13.2. Assumptions and Key Parameters
    • 12.2.1. Scenario 1
    • 12.2.1. Scenario 2
    • 12.2.1. Scenario 3
    • 12.2.1. Scenario 4
  • 13.3. Concluding Remarks

14. MARKET SIZING AND OPPORTUNITY ANALYSIS

  • 14.1. Chapter Overview
  • 14.2. Forecast Methodology and Key Assumptions
  • 14.3. Global HPAPI and Cytotoxic Drug Contract Manufacturing Market, till 2035
    • 14.3.1. HPAPI and Cytotoxic Drug Contract Manufacturing Market: Analysis by Type of Product, till 2035
    • 14.3.2. HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Analysis by Company Size, till 2035
    • 14.3.3. HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Analysis by Scale of Operation, till 2035
    • 14.3.4. HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Analysis by Type of Molecule, till 2035
    • 14.3.5. HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Analysis by Type of Highly Potent Finished Dosage Forms, till 2035
    • 14.3.6 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Analysis by Geography, till 2035
    • 14.3.7. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in North America, till 2035
      • 14.3.7.1. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the US, till 2035
      • 14.3.7.2. HPAPI and Cytotoxic Drug Contract Manufacturing Market in Canada, till 2035
      • 14.3.7.3. HPAPI and Cytotoxic Drug Contract Manufacturing Market in Mexico, till 2035
    • 14.3.8. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Europe, till 2035
      • 14.3.8.1. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the UK, till 2035
      • 14.3.8.2. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Italy, till 2035
      • 14.3.8.3. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Germany, till 2035
      • 14.3.8.4. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in France, till 2035
      • 14.3.8.5. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Spain, till 2035
      • 14.3.8.6. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Europe, till 2035
    • 14.3.9. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Asia-Pacific, till 2035
      • 14.3.9.1. HPAPI and Cytotoxic Drug Contract Manufacturing Market in China, till 2035
      • 14.3.9.2. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in India, till 2035
      • 14.3.9.3. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Asia-Pacific, till 2035
    • 14.3.10. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the Rest of the World, till 2035

15. SWOT ANALYSIS

  • 15.1. Chapter Overview
  • 15.2. Strengths
  • 15.3. Weaknesses
  • 15.4. Opportunities
  • 15.5. Threats
  • 15.6. Concluding Remarks

16. CASE-IN-POINT: CONTRACT MANUFACTURING OF ANTIBODY DRUG CONJUGATES

  • 16.1. Chapter Overview
  • 16.2. Key Components of Antibody Drug Conjugates
    • 16.2.1. Antibody
    • 16.2.2. Cytotoxin
    • 16.2.3. Linker
  • 16.3. Overview of ADC Manufacturing
    • 16.3.1. Key Process Steps
    • 16.3.2. Challenges Associated with ADC Manufacturing
    • 16.3.3. Growing Trend of Outsourcing in ADC Manufacturing
  • 16.4. Challenges Associated with Supply Chain and Method Transfer
    • 16.4.1. Growing Demand for One-Stop-Shops and Integrated Service Providers
  • 16.5. Key Considerations for Selecting a CMO Partner
  • 16.6. ADC Contract Manufacturing Service Providers: Overall Market Landscape
    • 16.6.1. Analysis by Year of Establishment
    • 16.6.2. Analysis by Company Size
    • 16.6.3. Analysis by Location of Headquarters
    • 16.6.4. Analysis by Service(s) Offered
  • 16.7. Concluding Remarks

17. CONCLUDING REMARKS

18. EXECUTIVE INSIGHTS

  • 18.1. Chapter Overview
  • 18.2. Company A
    • 18.2.1. Company Snapshot
    • 18.2.2. Interview Transcript: Vice President and Chief Operating Officer and Business Director
  • 18.3. Company B
    • 18.3.1. Company Snapshot
    • 18.3.2. Interview Transcript: Ex-Group Product Manager and Ex-Director-Business Development
    • 18.3.3. Interview Transcript: Business Development Associate
  • 18.4. Company C
    • 18.4.1. Company Snapshot
    • 18.4.2. Interview Transcript: Business Development Director
  • 18.5. Company D
    • 18.5.1. Company Snapshot
    • 18.5.2. Interview Transcript: Managing Director
  • 18.6. Company E
    • 18.6.1. Company Snapshot
    • 18.6.2. Interview Transcript: Ex-Business Head, Formulations and Finished Products
  • 18.7. Company F
    • 18.7.1. Company Snapshot
    • 18.7.2. Interview Transcript: Ex-Site Head, Grangemouth
  • 18.8. Company G
    • 18.8.1. Company Snapshot
    • 18.8.2. Interview Transcript: Ex-Senior Manager, Business Development
  • 18.9. Company H
    • 18.9.1. Company Snapshot
    • 18.9.2. Interview Transcript: Marketing and Sales Manager, Pharma
  • 18.10. Company I
    • 18.10.1. Company Snapshot
    • 18.10.2. Interview Transcript: Ex-Business Development Technician

19. APPENDIX 1: TABULATED DATA

20. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

List of Tables

  • Table 3.1 APIs and HPAPIs: Occupational Exposure Limit
  • Table 3.2 Occupational Exposure Limit and Occupational Exposure Band System: International Safety Systems
  • Table 3.3 SafeBridge: Categorization System
  • Table 3.4 Merck: Categorization System
  • Table 3.5 Lonza: Categorization System
  • Table 3.6 Ampac Fine Chemicals: Categorization System
  • Table 3.7 Helsinn: Categorization System
  • Table 3.8 Alkermes: Categorization System
  • Table 4.1 HPAPI and Cytotoxic Drugs Contract Manufacturers: List of Service Providers
  • Table 4.2 HPAPI and Cytotoxic Drugs Contract Manufacturers: Information on Scale of Operation, Type of Product Manufactured and Type of Highly Potent Finished Dosage Forms (FDFs)
  • Table 4.3 HPAPI and Cytotoxic Drugs Contract Manufacturers: Information on Occupational Exposure Limit, and Type of Molecule Manufactured
  • Table 4.4 HPAPI and Cytotoxic Drugs Contract Manufacturers: Information on Type of Primary Packaging and Type of Regulatory Certification / Accreditation
  • Table 4.5 HPAPI and Cytotoxic Drugs Contract Manufacturers: Information on Type of Services Offered
  • Table 6.1 Leading HPAPI and Cytotoxic Drug Manufacturers in North America
  • Table 6.2 AbbVie: Company Snapshot
  • Table 6.3 AbbVie: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
  • Table 6.4 AbbVie: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
  • Table 6.5 AbbVie: Recent Developments and Future Outlook
  • Table 6.6 Cambrex: Company Snapshot
  • Table 6.7 Cambrex: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
  • Table 6.8 Cambrex: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
  • Table 6.9 Cambrex: Recent Developments and Future Outlook
  • Table 6.10 Catalent: Company Snapshot
  • Table 6.11 Catalent: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
  • Table 6.12 Catalent: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
  • Table 6.13 Catalent: Recent Developments and Future Outlook
  • Table 6.14 Pfizer CentreOne: Company Snapshot
  • Table 6.15 Pfizer CentreOne: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
  • Table 6.16 Pfizer CentreOne: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
  • Table 6.17 Pfizer CentreOne: Recent Developments and Future Outlook
  • Table 6.18 Piramal Pharma Solutions: Company Snapshot
  • Table 6.19 Piramal Pharma Solutions: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
  • Table 6.20 Piramal Pharma Solutions: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
  • Table 6.21 Piramal Pharma Solutions: Recent Developments and Future Outlook
  • Table 7.1 Leading HPAPIs and Cytotoxic Drug Manufacturers in Europe
  • Table 7.2 Abzena: Company Snapshot
  • Table 7.3 Abzena: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
  • Table 7.4 Abzena: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
  • Table 7.5 Abzena: Recent Developments and Future Outlook
  • Table 7.6 Aenova: Company Snapshot
  • Table 7.7 Aenova: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
  • Table 7.8 Aenova: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
  • Table 7.9 Aenova: Recent Developments and Future Outlook
  • Table 7.10 CARBOGEN AMCIS: Company Snapshot
  • Table 7.11 CARBOGEN AMCIS: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
  • Table 7.12 CARBOGEN AMCIS: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
  • Table 7.13 CARBOGEN AMCIS: Recent Developments and Future Outlook
  • Table 7.14 Hovione: Company Snapshot
  • Table 7.15 Hovione: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
  • Table 7.16 Hovione: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
  • Table 7.17 Hovione: Recent Developments and Future Outlook
  • Table 7.18 Lonza: Company Snapshot
  • Table 7.19 Lonza: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
  • Table 7.20 Lonza: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
  • Table 7.21 Lonza: Recent Developments and Future Outlook
  • Table 8.1 Leading HPAPI and Cytotoxic Drug Manufacturers in Asia-Pacific
  • Table 8.2 Intas Pharmaceuticals: Company Snapshot
  • Table 8.3 Intas Pharmaceuticals: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
  • Table 8.4 Intas Pharmaceuticals: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
  • Table 8.5 Intas Pharmaceuticals: Recent Developments and Future Outlook
  • Table 8.6 Scinopharm: Company Snapshot
  • Table 8.7 Scinopharm: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
  • Table 8.8 Scinopharm: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
  • Table 8.9 Scinopharm: Recent Developments and Future Outlook
  • Table 8.10 STA Pharmaceutical (a WuXi AppTec company): Company Snapshot
  • Table 8.11 STA Pharmaceutical (a WuXi AppTec company): HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
  • Table 8.12 STA Pharmaceutical (a WuXi AppTec company): Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
  • Table 8.13 STA Pharmaceutical (a WuXi AppTec company): Recent Developments and Future Outlook
  • Table 8.14 Syngene: Company Snapshot
  • Table 8.15 Syngene: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
  • Table 8.16 Syngene: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
  • Table 8.17 Syngene: Recent Developments and Future Outlook
  • Table 8.18 Teva API: Company Snapshot
  • Table 8.19 Teva API: HPAPI and Cytotoxic Drugs Manufacturing Focused Service Offerings
  • Table 8.20 Teva API: Dedicated HPAPI and Cytotoxic Drug Manufacturing Facilities
  • Table 8.21 Teva API: Recent Developments and Future Outlook
  • Table 9.1 HPAPI and Cytotoxic Drugs Contract Manufacturing: List of Partnerships and Collaborations, since 2014
  • Table 10.1 HPAPI and Cytotoxic Drugs Contract Manufacturing: List of Recent Expansions, since 2014
  • Table 11.1 Capacity Analysis: Company Size of CMO
  • Table 11.2 Capacity Analysis: Average Capacity by Company Size of CMO
  • Table 11.3 HPAPI Manufacturing Global Installed Capacity: Total Capacity by Company Size (Liters)
  • Table 16.1 Commonly Used Cytotoxins for ADCs
  • Table 16.2 ADC Contract Manufacturing Service Providers: List of Companies
  • Table 16.3 ADC Contract Manufacturing Service Providers: Information on Type of Service(s) Offered
  • Table 18.1 BSP Pharmaceuticals: Company Snapshot
  • Table 18.2 Catalent: Company Snapshot
  • Table 18.3 CordenPharma: Company Snapshot
  • Table 18.4 ProJect Pharmaceutics: Company Snapshot
  • Table 18.5 Alphora Research: Company Snapshot
  • Table 18.6 Piramal Healthcare: Company Snapshot
  • Table 18.7 Helsinn: Company Snapshot
  • Table 18.8 Cerbios-Pharma: Company Snapshot
  • Table 18.9 Idifarma: Company Snapshot
  • Table 19.1 HPAPIs and Cytotoxic Drugs Contract Manufacturers: Distribution by Year of Establishment
  • Table 19.2 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Company Size
  • Table 19.3 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Headquarters (Region-wise)
  • Table 19.4 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Headquarters (Country-wise)
  • Table 19.5 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Company Size and Location of Headquarters
  • Table 19.6 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Manufacturing Facility (Region-wise)
  • Table 19.7 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Manufacturing Facility (Country-wise)
  • Table 19.8 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Area of Manufacturing Facility (sq. ft.)
  • Table 19.9 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Scale of Operation
  • Table 19.10 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Product Manufactured
  • Table 19.11 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Manufacturing Facility and Type of Product Manufactured
  • Table 19.12 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Finished Dosage Form
  • Table 19.13 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Occupational Exposure Limit (OEL)
  • Table 19.14 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Molecule Manufactured
  • Table 19.15 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Primary Packaging System
  • Table 19.16 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Regulatory Certification / Accreditation Received
  • Table 19.17 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Service(s) Offered
  • Table 19.18 Partnerships and Collaborations: Cumulative Year-wise Trend, since 2014
  • Table 19.19 Partnerships and Collaborations: Distribution by Type of Partnership
  • Table 19.20 Partnerships and Collaborations: Distribution by Year and Type of Partnership
  • Table 19.21 Partnerships and Collaborations: Distribution by Scale of Operation
  • Table 19.22 Partnerships and Collaborations: Distribution by Type of Product
  • Table 19.23 Partnerships and Collaborations: Distribution by Type of Partnership and Type of Product
  • Table 19.24 Partnerships and Collaborations: Distribution of Amount Invested Via Acquisitions (USD Million)
  • Table 19.25 Partnerships and Collaborations: Distribution of Type of Partner
  • Table 19.26 Most Active Players: Distribution by Number of Partnerships
  • Table 19.27 Partnerships and Collaborations: Intracontinental and Intercontinental Deals
  • Table 19.28 Partnerships and Collaborations: International and Local Deals
  • Table 19.29 Recent Expansions: Distribution by Year of Expansion
  • Table 19.30 Recent Expansions: Distribution by Type of Expansion
  • Table 19.31 Recent Expansions: Distribution by Year and Type of Expansion
  • Table 19.32 Recent Expansions: Distribution by Company Size and Location of Headquarters
  • Table 19.33 Recent Expansions: Distribution by Scale of Operation
  • Table 19.34 Recent Expansions: Distribution by Type of Expansion and Scale of Operation
  • Table 19.35 Recent Expansions: Distribution by Type of Product
  • Table 19.36 Recent Expansions: Distribution by Type of Expansion and Type of Product
  • Table 19.37 Recent Expansions: Distribution by Location of Expanded Facility
  • Table 19.38 Recent Expansions: Distribution by Type of Expansion and Location of Expanded Facility
  • Table 19.39 Recent Expansions: Distribution by Expanded Facility Area (sq. ft.)
  • Table 19.40 Recent Expansions: Distribution by Amount Invested (USD Million)
  • Table 19.41 Most Active Players: Distribution by Number of Recent Expansions
  • Table 19.42 Recent Expansions: Continent-wise Distribution
  • Table 19.43 Recent Expansions: Country-wise Distribution
  • Table 19.44 HPAPI Manufacturing Global Installed Capacity: Distribution by Range of Installed Capacity (Liters)
  • Table 19.45 HPAPI Contract Manufacturing Installed Capacity: Distribution by Company Size
  • Table 19.46 HPAPI Contract Manufacturing Installed Capacity: Distribution by Scale of Operation
  • Table 19.47 HPAPI Contract Manufacturing Installed Capacity: Distribution by Location of Manufacturing Facility
  • Table 19.48 HPAPI Contract Manufacturing Capacity Installed in North America
  • Table 19.49 HPAPI Contract Manufacturing Capacity Installed in Europe
  • Table 19.50 HPAPI Contract Manufacturing Capacity Installed in Asia-Pacific and Rest of the World
  • Table 19.51 Global HPAPI and Cytotoxic Drugs Contract Manufacturing Market, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.52 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Type of Product, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.53 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Company Size, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.54 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Scale of Operation, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.55 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Type of Molecule, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.56 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Type of Highly Potent Finished Dosage Forms, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.57 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Regions, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.58 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in North America, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.59 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the US, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.60 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Canada, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.61 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Mexico, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.62 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Europe, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.63 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the UK, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.64 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Italy, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.65 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Germany, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.66 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in France, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.67 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Spain, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.68 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Europe, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.69 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Asia-Pacific, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.70 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in China, till 2035: Conservative, Base and Optimistic Scenario(USD Billion)
  • Table 19.71 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in India, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.72 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Asia-Pacific, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.73 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of the World, till 2035: Conservative, Base and Optimistic Scenario (USD Billion)

List of Figures

  • Figure 2.1. Executive Summary: Overall Market Landscape
  • Figure 2.2. Executive Summary: Partnerships and Collaborations
  • Figure 2.3. Executive Summary: Recent Expansions
  • Figure 2.4. Executive Summary: Capacity Analysis
  • Figure 2.5. Executive Summary: Market Sizing and Opportunity Analysis
  • Figure 3.1 Characteristics of HPAPIs
  • Figure 3.2 Categorization of HPAPIs
  • Figure 3.3 Different Types of HPAPIs
  • Figure 4.1 HPAPIs and Cytotoxic Drugs Contract Manufacturers: Distribution by Year of Establishment
  • Figure 4.2 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Company Size
  • Figure 4.3 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Headquarters (Region-wise)
  • Figure 4.4 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Headquarters (Country-wise)
  • Figure 4.5 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Company Size and Location of Headquarters
  • Figure 4.6 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Manufacturing Facility (Region-wise)
  • Figure 4.7 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Manufacturing Facility (Country-wise)
  • Figure 4.8 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Area of Manufacturing Facility
  • Figure 4.9 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Scale of Operation
  • Figure 4.10 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Product Manufactured
  • Figure 4.11 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Location of Manufacturing Facility and Type of Product Manufactured
  • Figure 4.12 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Finished Dosage Form
  • Figure 4.13 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Occupational Exposure Limit (OEL)
  • Figure 4.14 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Molecule Manufactured
  • Figure 4.15 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Primary Packaging System
  • Figure 4.16 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Regulatory Certification / Accreditation Received
  • Figure 4.17 HPAPI and Cytotoxic Drugs Contract Manufacturers: Distribution by Type of Service(s) Offered
  • Figure 5.1 HPAPI Contract Manufacturers based in North America
  • Figure 5.2 HPAPI Contract Manufacturers based in Europe
  • Figure 5.3 HPAPI Contract Manufacturers based in Asia-Pacific and Rest of the World
  • Figure 5.4 Highly Potent FDF Contract Manufacturers based in North America
  • Figure 5.5 Highly Potent FDF Contract Manufacturers based in Europe
  • Figure 5.6 Potent FDF Contract Manufacturers based in Asia-Pacific and Rest of the World
  • Figure 5.7 HPAPI and Highly Potent FDF Contract Manufacturers based in North America
  • Figure 5.8 HPAPI and Highly Potent FDF Contract Manufacturers based in Europe
  • Figure 5.9 HPAPI and Highly Potent FDF Contract Manufacturers based in Asia-Pacific and Rest of the World
  • Figure 9.1 Partnerships and Collaborations: Cumulative Year-wise Trend, since 2014
  • Figure 9.2 Partnerships and Collaborations: Distribution by Type of Partnership
  • Figure 9.3 Partnerships and Collaborations: Distribution by Year and Type of Partnership
  • Figure 9.4 Partnerships and Collaborations: Distribution by Scale of Operation
  • Figure 9.5 Partnerships and Collaborations: Distribution by Type of Product
  • Figure 9.6 Partnerships and Collaborations: Distribution by Type of Partnership and Type of Product
  • Figure 9.7 Partnerships and Collaborations: Distribution of Amount Invested Via Acquisitions (USD Million)
  • Figure 9.8 Partnerships and Collaborations: Distribution of Type of Partner
  • Figure 9.9 Most Active Players: Distribution by Number of Partnerships
  • Figure 9.10 Partnerships and Collaborations: Intracontinental and Intercontinental Deals
  • Figure 9.11 Partnerships and Collaborations: International and Local Deals
  • Figure 10.1 Recent Expansions: Distribution by Year of Expansion
  • Figure 10.2 Recent Expansions: Distribution by Type of Expansion
  • Figure 10.3 Recent Expansions: Distribution by Year and Type of Expansion
  • Figure 10.4 Recent Expansions: Distribution by Company Size and Location of Headquarters
  • Figure 10.5 Recent Expansions: Distribution by Scale of Operation
  • Figure 10.6 Recent Expansions: Distribution by Type of Expansion and Scale of Operation
  • Figure 10.7 Recent Expansions: Distribution by Type of Product
  • Figure 10.8 Recent Expansions: Distribution by Type of Expansion and Type of Product
  • Figure 10.9 Recent Expansions: Distribution by Location of Expanded Facility (Region-Wise)
  • Figure 10.10 Recent Expansions: Distribution by Type of Expansion and Location of Expanded Facility
  • Figure 10.11 Recent Expansions: Distribution by Expanded Facility Area (sq. ft.)
  • Figure 10.12 Recent Expansions: Distribution by Amount Invested on Expansions (USD Million)
  • Figure 10.13 Most Active Players: Distribution by Number of Expansions
  • Figure 10.14 Recent Expansions: Continent-wise Distribution
  • Figure 10.15 Recent Expansions: Country-wise Distribution
  • Figure 11.1 HPAPI Manufacturing Global Installed Capacity: Distribution by Range of Installed Capacity (Liters)
  • Figure 11.2 HPAPI Contract Manufacturing Installed Capacity: Distribution by Company Size
  • Figure 11.3 HPAPI Contract Manufacturing Installed Capacity: Distribution by Scale of Operation
  • Figure 11.4 HPAPI Contract Manufacturing Installed Capacity: Distribution by Location of Manufacturing Facility
  • Figure 11.5 HPAPI Contract Manufacturing Capacity Installed in North America
  • Figure 11.6 HPAPI Contract Manufacturing Capacity Installed in Europe
  • Figure 11.7 HPAPI Contract Manufacturing Capacity Installed in Asia-Pacific and Rest of the World
  • Figure 12.1. Regional Capability Analysis: HPAPI and Cytotoxic Drug Manufacturing in North America
  • Figure 12.2. Regional Capability Analysis: HPAPI and Cytotoxic Drug Manufacturing in Europe
  • Figure 12.3. Regional Capability Analysis: HPAPI and Cytotoxic Drug Manufacturing in Asia-Pacific
  • Figure 12.4. Regional Capability Analysis: HPAPI and Cytotoxic Drug Manufacturing in Rest of the World
  • Figure 12.5. Regional Capability Analysis: Comparison of HPAPI and Cytotoxic Drug Manufacturing Capabilities across Different Regions
  • Figure 13.1 Make versus Buy Decision Making: Framework
  • Figure 13.2 Make versus Buy Decision Making: Possible Scenario Descriptions
  • Figure 14.1 Global HPAPI and Cytotoxic Drugs Contract Manufacturing Market, till 2035 (USD Billion)
  • Figure 14.2 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, till 2035: Distribution by Type of Product (USD Billion)
  • Figure 14.3 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Company Size (USD Billion)
  • Figure 14.4 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, till 2035: Distribution by Scale of Operation (USD Billion)
  • Figure 14.5 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, till 2035: Distribution by Type of Molecule (USD Billion)
  • Figure 14.6 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, till 2035: Distribution by Type of Highly Potent Finished

Dosage Forms (USD Billion)

  • Figure 14.7 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, till 2035: Distribution by Geography (USD Billion)
  • Figure 14.8 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in North America, till 2035 (USD Billion)
  • Figure 14.9 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the US, till 2035 (USD Billion)
  • Figure 14.10 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Canada, till 2035 (USD Billion)
  • Figure 14.11 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Mexico, till 2035 (USD Billion)
  • Figure 14.12 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Europe, till 2035 (USD Billion)
  • Figure 14.13 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the UK, till 2035 (USD Billion)
  • Figure 14.14 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Italy, till 2035 (USD Billion)
  • Figure 14.15 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Germany, till 2035 (USD Billion)
  • Figure 14.16 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in France, till 2035 (USD Billion)
  • Figure 14.17 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Spain, till 2035 (USD Billion)
  • Figure 14.18 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Europe, till 2035 (USD Billion)
  • Figure 14.19 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Asia-Pacific, till 2035 (USD Billion)
  • Figure 14.20 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in China, till 2035 (USD Billion)
  • Figure 14.21 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in India, till 2035 (USD Billion)
  • Figure 14.22 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the Rest of Asia-Pacific, till 2035 (USD Billion)
  • Figure 14.23 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of the World, till 2035 (USD Billion)
  • Figure 15.1 HPAPIs and Cytotoxic Drugs Contract Manufacturing: SWOT Analysis
  • Figure 15.2 Comparison of SWOT Factors: Harvey Ball Analysis
  • Figure 16.1 Key Components of an ADCs
  • Figure 16.2 ADC Manufacturing: Key Process Steps
  • Figure 16.3 Key Parameters while Selecting a CMO Partner
  • Figure 16.4 ADC Contract Manufacturing Service Providers: Distribution by Year of Establishment
  • Figure 16.5 ADC Contract Manufacturing Service Providers: Distribution by Company Size
  • Figure 16.6 ADC Contract Manufacturing Service Providers: Distribution by Location of Headquarters
  • Figure 16.7 ADC Contract Manufacturing Service Providers: Distribution by Type of Service(s) Offered
  • Figure 16.8 ADC Contract Manufacturing Service Providers: Distribution by Location of Headquarters and Type of Service(s) Offered