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细胞伤害性医药品和HPAPI的製造市场:各产品类型，各企业规模，各产业规模，各分子类型，各高药理活性最终剂型类型，各主要地区:产业趋势与全球预测，2022年～2035年
市场调查报告书
商品编码
1162463

细胞伤害性医药品和HPAPI的製造市场:各产品类型，各企业规模，各产业规模，各分子类型，各高药理活性最终剂型类型，各主要地区:产业趋势与全球预测，2022年～2035年

Cytotoxic Drugs & HPAPI Manufacturing Market by Type of Product, Company Size, Scale of Operation, Type of Molecule, Type of Highly Potent Finished Dosage Form, & Key Geographies: Industry Trends & Global Forecasts, 2022-2035
出版日期: | 出版商: Roots Analysis | 英文 338 Pages | 商品交期: 最快1-2个工作天内

价格

本报告提供全球细胞伤害性医药品和HPAPI的製造市场相关调查，市场概要，以及各产品类型，各企业规模，各产业规模，各分子类型，各高药理活性最终剂型类型，各主要地区的趋势，及加入此市场的主要企业简介等资讯。

目录

第1章 序文

第2章 摘要整理

第3章 简介

  • 章概要
  • 高活性疗效原料药

第4章 市场形势

  • 章概要
  • HPAPI及细胞伤害性医药品的受託製造商:整体市场形势

第5章 企业的竞争力分析

第6章 企业简介: 北美

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

第7章 企业简介: 欧洲

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

第8章 企业简介: 亚太地区及其他地区

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

第9章 伙伴关係和合作

第10章 最近的扩张

第11章 能力分析

第12章 地区的能力评估分析

第13章 自製、购买选择的决策架构

第14章 市场规模机会分析

  • 章概要
  • 预测调查手法主要的假设
  • 全球HPAPI及细胞伤害性医药品的受託製造市场，2022年～2035年

第15章 SWOT分析

第16章 案例:抗体药物复合体的受託製造

第17章 结论

第18章 执行见解

  • 章概要
  • BSP Pharmaceuticals
  • Catalent
  • CordenPharma
  • ProJect Pharmaceutics
  • Alphora Research
  • Piramal Healthcare
  • Helsinn
  • Cerbios-Pharma
  • Idifarma

第19章 附录1:表格形式的资料

第20章 附录2:公司及组织的清单

Product Code: RA100386

INTRODUCTION

Aided by the ongoing advancements in clinical pharmacology and oncology research, as well as the rising demand for targeted therapies, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have emerged as one of the key areas of interest for researchers and drug developers worldwide. As is well known, HPAPIs are pharmacologically active compounds which are capable of eliciting a biological response even at extremely low concentrations. Specifically, HPAPIs are categorized on the basis of their toxicity, occupational exposure limit (OEL) and pharmacological potency. OEL is defined as the maximum admissible exposure to a physical or chemical hazard, for a specific period of time (usually 8 hours), without endangering the health and safety of workers; typically, highly potent compounds have an OEL less than or equal to 10 µg / m3. It is worth highlighting that HPAPIs offer a range of benefits over conventional APIs, including high target specificity, retention (in their active form) within the body for longer durations, and fewer side effects. As a result, at present, such products are being developed / evaluated for the treatment of a myriad of indications, including asthma, autoimmune disorders, cancer, diabetes and hormone imbalances.

Q1. What are the current opportunities within the HPAPI and cytotoxic drug market?

The HPAPI and cytotoxic drug market is presently considered as one of the most powerful and dynamic sectors of the pharmaceutical industry. At present, more than 40% of the total number of drugs are highly potent in nature. Further, around 60% of the HPAPIs are being developed against oncological indications. Considering the upsurge in demand for novel anti-cancer therapeutics, including antibody-drug conjugates (ADCs), high potency compounds have generated significant interest among several researchers and industry stakeholders.

Q2. What is the need for contract manufacturing organizations (CMOs) in the HPAPI and cytotoxic drug domain?

The manufacturing of highly potent APIs and cytotoxic drugs requires an adequate working environment (to prevent cross contamination within multi-product assets), stringent manufacturing protocols (to comply with the established regulatory standards) and a trained workforce (to satisfactorily handle highly potent materials). In addition, it requires an expensive infrastructure, which is often complex to engineer, install and maintain. As a result, various companies rely on third party service providers to leverage their technologies for manufacturing highly potent and cytotoxic compounds and achieve greater operational flexibility. The inherent expertise of CMOs is believed to be capable of enabling reduction in the time-to-market a product and offer significant cost-benefits.

Q3. What is the current market landscape and recent trends in the HPAPI and cytotoxic drug contract manufacturing domain?

Presently, close to 145 companies have the required capabilities to offer HPAPI and cytotoxic drug manufacturing services across different scales of operation. In addition, several contract service providers are entering into strategic alliances in order to consolidate their presence in this field and enhance their existing capabilities to meet the growing demand for high potency molecules. It is worth mentioning that close to 50% of the expansion activities carried out in this market have been focused on improving the existing manufacturing facilities for highly potent molecules, through the addition of new structures and equipment.

Q4. What are the key challenges faced by HPAPI and cytotoxic drug CMOs?

The primary challenge faced during the manufacturing of HPAPI and cytotoxic drugs is related to limiting / altogether preventing cross-contamination of the highly potent molecule with other molecules being produced at the same site. Further, the lack of information related to safe exposure levels and toxicity of new chemical entities can risk the lives of workers and harm the environment. As a result, comprehensive management systems are required for safe handling and containment of highly potent molecules. In addition, proper cleaning techniques and waste treatment systems are extremely essential while producing such compounds.

Q5. What are the key value drivers in the HPAPI and cytotoxic drug contract manufacturing market?

The increasing demand for cytotoxic drugs has led to a rise in the number of HPAPIs in the overall pharmaceutical development pipeline. In order to cater to the growing demand for the production of such drug candidates, there is a requirement for safe manufacturing and containment technologies. Even though some pharmaceutical companies have made considerable investments to establish in-house capabilities, the capital-intensive nature and specialized containment requirements make the role of contract manufacturers crucial, specifically for small and mid-sized players.

Q6. How is the revenue generation potential associated with HPAPI and cytotoxic drug manufacturing market likely to evolve in the coming years?

The HPAPI and cytotoxic drug manufacturing market is projected to grow at a CAGR of approximately 12% in the coming years. Currently, in terms of type of molecule, the market is likely to be driven by highly potent small molecules. However, this trend is expected to change in the foreseen future, as the demand for highly potent biologics, such as cell and gene therapies, increases further. In addition, in terms of scale of operation, majority share of the contract service revenues is expected to be generated by commercial scale manufacturing operations. Specifically, in terms of geography, the HPAPI and cytotoxic drug manufacturing market in Asia-Pacific is likely to grow at a relatively faster pace (~13%), in the long term.

SCOPE OF THE REPORT

The "HPAPI and Cytotoxic Drugs Manufacturing Market (4th Edition), 2022-2035: Distribution by Type of Product (HPAPIs and Highly Potent Finished Dosage Forms), Company Size (Small, Mid-sized, Large and Very Large), Scale of Operation (Preclinical, Clinical and Commercial), Type of Molecule (Small Molecules and Biologics), Type of Highly Potent Finished Dosage Form (Injectables, Oral Solids, Creams and Others), and 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) and Rest of the World" report features an extensive study of the current market landscape and future potential of the HPAPI and cytotoxic drug manufacturing market, over the next decade. The study also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field. Amongst other elements, the report includes:

  • A general overview of HPAPIs and cytotoxic drugs, along with information on the different types of HPAPIs and challenges associated with the handling of HPAPIs. The chapter also lays emphasis on the growing need for outsourcing the manufacturing of highly potent compounds, and provides details related to the regulatory considerations in this domain.
  • A detailed assessment of the overall landscape of companies offering contract manufacturing services for HPAPI and cytotoxic drugs, along with information on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, location of manufacturing facility, area of manufacturing facility (less than 10,000 sq. ft., 10,000 to 40,000 sq. ft., 40,001 to 80,000 sq. ft. and more than 80,000 sq. ft.), scale of operation (preclinical, clinical and commercial), type of product manufactured (HPAPIs and highly potent finished dosage forms), type of highly potent finished dosage form (capsules, tablets, liquids / injectables, granules and others), Occupational Exposure Limit (less than 0.1 µg/m3, 0.1 µg/m3 to 1 µg/m3 and more than 1 µg/m3), type of molecule manufactured (small molecules and biologics), type of primary packaging system (blisters, vials, prefilled syringes, ampoules, syringes and others), regulatory certifications / accreditations received and type of service(s) offered (analytical testing, process development / pre-formulation, scale-up, packaging, stability studies, formulation development, regulatory support and fill / finish).
  • A detailed competitiveness analysis of HPAPI and cytotoxic drug contract manufacturers, taking into consideration supplier strength (based on company size and their experience in this field) and service strength (based on scale of operation, number of highly potent finished dosage form, number of primary packaging system and number of service(s) offered).
  • Elaborate profiles of prominent players (shortlisted based on a proprietary criterion) offering contract manufacturing services for HPAPI and cytotoxic drugs, across North America, Europe and Asia-Pacific. Each profile features a brief overview of the company, along with details related to its HPAPI and cytotoxic drug-related service portfolio, dedicated facilities, recent developments and an informed future outlook.
  • An insightful analysis of the recent collaborations within the HPAPI and cytotoxic drug manufacturing industry, based on several relevant parameters, such as year of partnership, type of partnership (acquisitions, manufacturing agreements, research and development agreements, product development and commercialization agreements, technology licensing agreements and others), scale of operation (preclinical, clinical and commercial), type of product (HPAPI and high potent FDFs), most active players (in terms of number of deals inked) and regional distribution of partnership activity that have been undertaken in this domain, during the period 2014-2022.
  • A detailed analysis of the recent expansions undertaken by several HPAPI and cytotoxic drug contract manufacturers, based on various relevant parameters, such as year of expansion, type of expansion (capacity expansions, facility expansions and new facility addition), company size (small, mid-sized, large and very large companies), location of headquarters, scale of operation (preclinical, clinical and commercial), type of product (HPAPI and high potent FDFs), location of expanded facility, area of expanded facility, amount invested in expansions, most active players (in terms of number of recent expansions) and geographical distribution.
  • An estimate of the overall installed capacity for the manufacturing of HPAPIs, based on information reported by various industry stakeholders in the public domain. The analysis highlights the distribution of global installed capacity, based on company size (small, mid-sized and large), scale of operation (preclinical, clinical and commercial) and key geographical regions (North America, Europe, Asia-Pacific and Rest of the World).
  • A regional capability assessment framework, which compares the HPAPI and cytotoxic drug manufacturing capabilities across key geographies, based on several parameters, such as the number of HPAPI and cytotoxic drug contract manufacturers, number of HPAPI and cytotoxic drug manufacturing facilities, number of facility expansions and installed HPAPI capacity in that particular geographical region.
  • A detailed discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry's evolution highlighting the relative effect of each SWOT parameter on the overall HPAPI and cytotoxic drug manufacturing market.
  • A case study on companies offering manufacturing services for antibody drug conjugates (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.

One of the key objectives of the report was to evaluate the current opportunity and the future growth potential of the HPAPI and cytotoxic drug manufacturing market over the coming years. We have provided an informed estimate on the likely evolution of the market in the short to mid-term and long term, for the period 2022-2035. The report also features a likely distribution of the current and forecasted opportunity across important parameters, such as [A] type of product (HPAPI and highly potent finished dosage form), [B] type of highly potent finished dosage form (injectables, oral solids, creams and others), [C] type of molecule (small molecules and biologics), [D] scale of operation (preclinical, clinical and commercial), [E] company size (small, mid-sized, large and very large) and [F] key geographies (North America, Europe, Asia-Pacific, and Rest of the World).

In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry's growth.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following individuals:

  • Antonella Mancuso and Maria Elena Guadagno (Vice President and Chief Operating Officer and Business Director, BSP Pharmaceuticals)
  • Stacy McDonald and Jennifer L. Mitcham (Ex-Group Product Manager and Ex-Director-Business Development); Abul Khair (Business Development Associate, Catalent)
  • Roberto Margarita (Business Development Director, CordenPharma)
  • Klaus Hellerbrand (Managing Director, ProJect Pharmaceutics)
  • Kevin Rosenthal (Ex-Business Head, Formulations and Finished Products, Alphora research)
  • Mark Wright (Ex-Site Head, Grangemouth, Piramal Healthcare)
  • Allison Vavala (Ex-Senior Manager, Business Development, Helsinn)
  • Valentino Mandelli (Marketing and Sales Manager, Pharma, Cerbios-Pharma)
  • Javier E. Aznarez Araiz (Ex-Business Development, Idifarma)

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:

  • Annual reports
  • Investor presentations
  • SEC filings
  • Industry databases
  • News releases from company websites
  • Government policy documents
  • Industry analysts' views

While the focus has been on forecasting the market till 2035, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES

Chapter 2 is an executive summary of the insights captured in our report. It offers a high-level view of the current state of HPAPI and cytotoxic drug manufacturing market and its likely evolution in the short term, mid-term and long term.

Chapter 3 provides a general overview of HPAPIs and cytotoxic drugs, featuring information on the different types of HPAPIs and challenges associated with the handling of HPAPIs. The chapter also lays emphasis on the growing need for outsourcing the manufacturing of highly potent compounds, and provides details related to the regulatory considerations in this domain.

Chapter 4 features a detailed review of the overall landscape of HPAPI and cytotoxic drug manufacturing market, along with information on their year of establishment, company size (in terms of employee count), location of headquarters, location of manufacturing facilities, area of manufacturing facility (less than 10,000 sq. ft., 10,000 to 40,000 sq. ft., 40,001 to 80,000 sq. ft. and more than 80,000 sq. ft.), scale of operation (preclinical, clinical and commercial), type of product manufactured (HPAPIs and highly potent finished dosage forms), type of highly potent finished dosage form (capsules, tablets, liquids / injectables, granules and others), Occupational Exposure Limit (less than 0.1 µg/m3, 0.1 µg/m3 to 1 µg/m3 and more than 1 µg/m3), type of molecule manufactured (small molecules and biologics), type of primary packaging system (blisters, vials, prefilled syringes, ampoules, syringes and others), regulatory certifications / accreditations received and type of service(s) offered (analytical testing, process development / pre-formulation, scale-up, packaging, stability studies, formulation development, regulatory support and fill / finish).

Chapter 5 presents an insightful company competitiveness analysis of HPAPI and highly potent finished dosage form manufacturers. The companies are further segmented based on their geography, into three categories, namely North America, Europe and, Asia Pacific and Rest of the World. The analysis compares the contract manufacturers on the basis of various parameters, such as number of manufacturing facilities, scale of operation, number of highly potent finished dosage form, number of primary packaging system and number of service(s) offered.

Chapter 6 features detailed profiles of the prominent companies that offer contract manufacturing services for HPAPI and cytotoxic drugs in North America. Each company profile features a brief overview of the company, details related to HPAPI and cytotoxic drug-related service portfolio, dedicated facilities, recent developments and an informed future outlook.

Chapter 7 features detailed profiles of the prominent companies that offer contract manufacturing services for HPAPI and cytotoxic drugs in Europe. Each company profile features a brief overview of the company, details related to HPAPI and cytotoxic drug-related service portfolio, dedicated facilities, recent developments and an informed future outlook.

Chapter 8 features detailed profiles of the prominent companies that offer contract manufacturing services for HPAPI and cytotoxic drugs in Asia-Pacific. Each company profile features a brief overview of the company, details related to HPAPI and cytotoxic drug-related service portfolio, dedicated facilities, recent developments and an informed future outlook.

Chapter 9 features an elaborate analysis of the several recent collaborations within various HPAPI and cytotoxic drug manufacturers, in the period 2014 - 2022. Further, the partnership activity in this domain has been analyzed based on various parameters, such as year of partnership, type of partnership model (acquisitions, manufacturing agreements, research and development agreements, product development and commercialization agreements, technology licensing agreements and others), scale of operation (preclinical, clinical and commercial), type of product (HPAPI and high potent FDFs), most active player(s) (in terms of number of deals inked) and regional distribution of partnership activity.

Chapter 10 provides a detailed analysis of the various expansion initiatives undertaken by HPAPI and cytotoxic drug manufacturers, during the period 2014-2022, along with information on several relevant parameters, such as year of expansion, type of expansion (capacity expansions, facility expansions and new facility additions), company size (small, mid-sized, large and very large companies), location of headquarters, scale of operation (preclinical, clinical and commercial), type of product (HPAPI and high potent FDFs), location of expanded facility, area of expanded facility, amount invested in expansions, most active players (in terms of number of recent expansions) and geographical distribution.

Chapter 11 features an estimate of the overall installed capacity for manufacturing HPAPIs, based on information reported by various industry stakeholders in the public domain. It also features the distribution of global installed HPAPIs and cytotoxic drugs manufacturing capacity across different type of companies (small, mid-sized, large and very large), scale of operation (preclinical, clinical and commercial), and key geographical regions (North America, Europe, Asia-Pacific, and Rest of the World).

Chapter 12 presents a detailed regional capability assessment framework, which compares the HPAPI and cytotoxic drug manufacturing capabilities across key geographies, based on a number of parameters, such as the number of HPAPI and cytotoxic drugs contract manufacturers, number of HPAPI and cytotoxic drugs manufacturing facilities, number of facility expansions and installed HPAPI capacity in that particular geographical region.

Chapter 13 presents a qualitative analysis highlighting the affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry's evolution highlighting the relative effect of each SWOT parameter on the overall HPAPI and cytotoxic drug manufacturing market.

Chapter 14 features a comprehensive market forecast analysis, highlighting the likely growth of the HPAPI and cytotoxic drug manufacturing market, till 2035. In order to provide details on the future outlook, our projections have been segmented on the basis of [A] type of product (HPAPI and highly potent finished dosage form), [B] type of highly potent finished dosage form (injectables, oral solids, creams and others), [C] type of molecule (small molecules and biologics), [D] scale of operation (preclinical, clinical and commercial), [E] company size (small, mid-sized, large and very large) and [F] key geographies (North America, Europe, Asia-Pacific, and Rest of the World). It is worth mentioning that we have adopted a top-down approach for this analysis, backing our claims with relevant datapoints and credible inputs from primary research.

Chapter 15 presents a discussion on affiliated trends, key drivers and challenges, under a SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall HPAPI and cytotoxic drugs manufacturing market.

Chapter 16 features a case study on companies offering contract manufacturing services for ADCs, highlighting the key components of ADCs, its manufacturing process and, the challenges associated with supply chain and method transfer. Further, the chapter presents a list of players that provide contract manufacturing for ADCs.

Chapter 17 presents the summary of the overall report. The chapter provides the key takeaways from the report and expresses our independent opinion of the HPAPI and cytotoxic drug manufacturing market, based on the research and analysis described in the previous chapters.

Chapter 18 is a collection of interview transcripts of the discussions held with several key stakeholders in this domain. In this chapter, we have presented the details of interview held with Antonella Mancuso and Maria Elena Guadagno (Vice President and Chief Operating Officer and Business Director, BSP Pharmaceuticals), Stacy McDonald and Jennifer L. Mitcham (Ex-Group Product Manager and Ex-Director-Business Development); Abul Khair (Business Development Associate, Catalent), Roberto Margarita (Business Development Director, CordenPharma), Klaus Hellerbrand (Managing Director, ProJect Pharmaceutics), Kevin Rosenthal (Ex-Business Head, Formulations and Finished Products, Alphora research), Mark Wright (Ex-Site Head, Grangemouth, Piramal Healthcare), Allison Vavala (Ex-Senior Manager, Business Development, Helsinn), Valentino Mandelli (Marketing and Sales Manager, Pharma, Cerbios-Pharma) and Javier E. Aznarez Araiz (Ex-Business Development, Idifarma).

Chapter 19 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 20 is an appendix, which contains the list of companies and organizations mentioned in the report.

TABLE OF CONTENTS

1. PREFACE

  • 1.1. Scope of the Report
  • 1.2. Market Segmentation
  • 1.3. Research Methodology
  • 1.4. Key Questions Answered
  • 1.5. 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
    • 8.2.4. 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 Country
      • 10.2.14.2. Analysis by Continent

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, 2022-2035
    • 14.3.1. HPAPI and Cytotoxic Drug Contract Manufacturing Market: Analysis by Type of Product, 2022-2035
    • 14.3.2. HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Analysis by Company Size, 2022-2035
    • 14.3.3. HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Analysis by Scale of Operation, 2022-2035
    • 14.3.4. HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Analysis by Type of Molecule, 2022-2035
    • 14.3.5. HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Analysis by Type of Highly Potent Finished Dosage Forms, 2022-2035
    • 14.3.6 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Analysis by Geography, 2022-2035
    • 14.3.7. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in North America, 2022-2035
      • 14.3.7.1. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the US, 2022-2035
      • 14.3.7.2. HPAPI and Cytotoxic Drug Contract Manufacturing Market in Canada, 2022-2035
      • 14.3.7.3. HPAPI and Cytotoxic Drug Contract Manufacturing Market in Mexico, 2022-2035
    • 14.3.8. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Europe, 2022-2035
      • 14.3.8.1. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the UK, 2022-2035
      • 14.3.8.2. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Italy, 2022-2035
      • 14.3.8.3. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Germany, 2022-2035
      • 14.3.8.4. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in France, 2022-2035
      • 14.3.8.5. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Spain, 2022-2035
      • 14.3.8.6. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Europe, 2022-2035
    • 14.3.9. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Asia-Pacific, 2022-2035
      • 14.3.9.1. HPAPI and Cytotoxic Drug Contract Manufacturing Market in China, 2022-2035
      • 14.3.9.2. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in India, 2022-2035
      • 14.3.9.3. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Asia-Pacific, 2022-2035
    • 14.3.10. HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the Rest of the World, 2022-2035

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. BSP Pharmaceuticals
    • 18.2.1. Company Snapshot
    • 18.2.2. Interview Transcript: Antonella Mancuso and Maria Elena Guadagno, Vice President and Chief Operating Officer and Business Director
  • 18.3. Catalent
    • 18.3.1. Company Snapshot
    • 18.3.2. Interview Transcript: Stacy McDonald and Jennifer L. Mitcham, Group Product Manager and Director-Business Development
    • 18.3.3. Interview Transcript: Abul Khair, Business Development Associate
  • 18.4. CordenPharma
    • 18.4.1. Company Snapshot
    • 18.4.2. Interview Transcript: Roberto Margarita, Business Development Director
  • 18.5. ProJect Pharmaceutics
    • 18.5.1. Company Snapshot
    • 18.5.2. Interview Transcript: Klaus Hellerbrand, Managing Director
  • 18.6. Alphora Research
    • 18.6.1. Company Snapshot
    • 18.6.2. Interview Transcript: Kevin Rosenthal, Business Head, Formulations and Finished Products
  • 18.7. Piramal Healthcare
    • 18.7.1. Company Snapshot
    • 18.7.2. Interview Transcript: Mark Wright, Site Head, Grangemouth
  • 18.8. Helsinn
    • 18.8.1. Company Snapshot
    • 18.8.2. Interview Transcript: Allison Vavala, Senior Manager, Business Development
  • 18.9. Cerbios-Pharma
    • 18.9.1. Company Snapshot
    • 18.9.2. Interview Transcript: Valentino Mandelli, Marketing and Sales Manager, Pharma
  • 18.10. Idifarma
    • 18.10.1. Company Snapshot
    • 18.10.2. Interview Transcript: Javier E. Aznarez Araiz, 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, 2014-2022
  • Table 10.1 HPAPI and Cytotoxic Drugs Contract Manufacturing: List of Recent Expansions, 2014-2022
  • 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, 2014-2022
  • 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 by 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 (Region-Wise)
  • 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: Country-wise Distribution
  • Table 19.43 Recent Expansions: Continent 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, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.52 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Type of Product, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.53 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Company Size, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.54 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Scale of Operation, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.55 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Type of Molecule, 2022-2035: 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, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.57 HPAPI and Cytotoxic Drugs Contract Manufacturing Market: Distribution by Regions, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.58 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in North America, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.59 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the US, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.60 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Canada, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.61 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Mexico, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.62 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Europe, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.63 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the UK, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.64 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Italy, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.65 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Germany, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.66 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in France, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.67 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Spain, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.68 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Europe, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.69 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Asia Pacific, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.70 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in China, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.71 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in India, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.72 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Asia Pacific, 2022-2035: Conservative, Base and Optimistic Scenario (USD Billion)
  • Table 19.73 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of the World, 2022-2035: 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, 2014-2022
  • 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 by 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: Country-wise Distribution
  • Figure 10.15 Recent Expansions: Region 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, 2022-2035 (USD Billion)
  • Figure 14.2 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2022-2035: 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, 2022-2035: Distribution by Scale of Operation (USD Billion)
  • Figure 14.5 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2022-2035: Distribution by Type of Molecule (USD Billion)
  • Figure 14.6 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2022-2035: Distribution by Type of Highly Potent Finished Dosage Forms (USD Billion)
  • Figure 14.7 HPAPI and Cytotoxic Drugs Contract Manufacturing Market, 2022-2035: Distribution by Geography (USD Billion)
  • Figure 14.8 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in North America, 2022-2035 (USD Billion)
  • Figure 14.9 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the US, 2022-2035 (USD Billion)
  • Figure 14.10 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Canada, 2022-2035 (USD Billion)
  • Figure 14.11 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Mexico, 2022-2035 (USD Billion)
  • Figure 14.12 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Europe, 2022-2035 (USD Billion)
  • Figure 14.13 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the UK, 2022-2035 (USD Billion)
  • Figure 14.14 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Italy, 2022-2035 (USD Billion)
  • Figure 14.15 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Germany, 2022-2035 (USD Billion)
  • Figure 14.16 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in France, 2022-2035 (USD Billion)
  • Figure 14.17 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Spain, 2022-2035 (USD Billion)
  • Figure 14.18 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of Europe, 2022-2035 (USD Billion)
  • Figure 14.19 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Asia Pacific, 2022-2035 (USD Billion)
  • Figure 14.20 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in China, 2022-2035 (USD Billion)
  • Figure 14.21 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in India, 2022-2035 (USD Billion)
  • Figure 14.22 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in the Rest of Asia Pacific, 2022-2035 (USD Billion)
  • Figure 14.23 HPAPI and Cytotoxic Drugs Contract Manufacturing Market in Rest of the World, 2022-2035 (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