세포독성 약물 및 HPAPI 제조 시장 : 제품 유형별, 기업 규모별, 사업 규모별, 분자 유형별, 고활성 완성제형 유형별, 주요 지역별 - 업계 동향과 세계 예측(- 2035년)

Cytotoxic Drugs & HPAPI Manufacturing Market by Type of Product, Company Size, Scale of Operation, Type of Molecule, Type of Highly Potent Finished Dosage Form, and Key Geographies: Industry Trends and Global Forecasts, Till 2035

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한글목차

세계 세포독성 약물 및 HPAPI 제조 시장 규모는 2035년까지 예측 기간 동안 11.6%의 연평균 복합 성장률(CAGR)로 확대되어 현재 117억 달러에서 2035년까지 399억 달러로 성장할 것으로 예상됩니다.

임상약리학 및 종양학 연구의 발전과 표적치료에 대한 수요 증가로 인해 고약리활성 성분(HPAPI)과 세포독성 약물은 전 세계 연구자들과 제약회사들의 중요한 관심사가 되고 있습니다. 전 세계 의약품의 45%가 고약물 활성 성분이라는 사실은 주목할 만합니다. 그러나 HPAPI의 제조는 복잡한 과정이기 때문에 그 과정에는 여러 가지 문제가 있습니다. 가장 큰 과제는 제조 과정에서 교차 오염을 방지하는 것이며, 그 다음으로는 환경, 근로자 및 전체 공급망에 걸친 모든 사람을 보호하는 것입니다. 격리 장비, 절차, PPE 등 올바른 격리 및 보호 전략을 선택하는 것도 마찬가지로 중요하며, HPAPI 취급은 일반적으로 안전한 취급 영역에 대한 지속적인 투자가 필요하며, 세계 지침과 고도의 기술 전문 지식이 필요하기 때문에 이 영역의 도전에 박차를 가하고 있습니다. 이 분야의 도전에 박차를 가하고 있습니다. 이에 따라 제약회사들은 적극적으로 제조 업무를 아웃소싱하고 있습니다.

위탁생산 시장의 큰 잠재력과 긍정적인 성장 전망을 이해하고 있는 대부분의 대형 제약사들은 현재 제조 시설을 확장 및 업그레이드하기 위한 투자를 고려하고 있습니다. 많은 CMO들이 일본, 중국, 인도, 브라질 등 신흥국의 낮은 제조 비용, 저렴한 인건비, 숙련된 노동력, 규제 환경 등의 이점을 누리기 위해 새로운 시설에 투자하고 있습니다. 항암제 산업 전반의 성장, 최근 기술 발전, 아웃소싱 증가 추세에 힘입어 향후 10년간 시장은 안정적인 성장을 이룰 것으로 예상됩니다.

현재 140개 이상의 기업이 다양한 규모의 고활성 화합물 수탁 제조 서비스를 제공하는 데 필요한 전문 지식을 보유하고 있다고 주장하고 있습니다. 현재 시장 상황은 매우 세분화되어 있으며, 주요 지역에 걸쳐 신규 진출기업과 기존 기업이 모두 존재합니다. 이해관계자들은 전문 지식을 활용하여 수많은 고활성 화합물의 수탁 제조 서비스를 제공합니다. 약 70%의 서비스 제공업체가 HPAPI 분석 테스트 역량을 보유하고 있습니다. 이 분야에 대한 관심이 증가하고 있는 것은 제휴 활동의 활성화에서 알 수 있습니다. 실제로 HPAPI와 세포독성 약물 제조와 관련된 제휴가 최근 가장 많이 이루어지고 있습니다. 고활성 화합물에 대한 수요 증가에 대응하기 위해 CMO들은 시설과 역량을 확대하기 위한 투자를 아끼지 않고 있습니다. 이러한 추세는 미국, 스위스, 영국에서 두드러지게 나타나고 있습니다.

HPAPI의 세계 위탁생산 능력은 다양한 지역에 분산되어 있으며, 현재 능력의 80%는 초대형 기업이 소유한 시설에 설치되어 있습니다. 항체 의약품 접합체는 고활성 화합물의 가장 인기 있는 클래스 중 하나이며, 현재 30개 이상의 기업이 이러한 바이오 의약품의 수탁 제조 및 접합 서비스를 제공한다고 주장하고 있습니다. 고활성 의약품 개발 기업들은 제조 업무를 아웃소싱할 가능성이 높으며, 서비스 기반 수익은 연간 11.6%의 성장률을 보일 것으로 예상됩니다.

세계의 세포독성 약물 및 HPAPI 제조 시장에 대해 조사했으며, 시장 개요와 함께 제품 유형별/기업 규모별/사업 규모별/분자 유형별/고활성 완제의약품 유형별/주요 지역별 동향, 시장 진출 기업 프로파일 등의 정보를 전해드립니다.

목차

제1장 서문

제2장 주요 요약

제3장 서론

제4장 시장 구도

제5장 기업 경쟁력 분석

제6장 기업 개요 : 북미의 세포독성 약물 및 HPAPI 제조업체

• 본 장의 개요
• AbbVie
• Cambrex
• Catalent
• Pfizer CentreOne
• Piramal Pharma Solutions

제7장 기업 개요 : 유럽의 세포독성 약물 및 HPAPI 제조업체

• 본 장의 개요
• Abzena
• Aenova
• CARBOGEN AMCIS
• Hovione
• Lonza

제8장 기업 개요 : 아시아태평양 및 기타 지역의 세포독성 약물 및 HPAPI 제조업체

• 본 장의 개요
• Intas Pharmaceuticals
• Scinopharm
• STA Pharmaceutical(a WuXi AppTec company)
• Syngene
• Teva API

제9장 파트너십 및 협업

제10장 최근 확장

제11장 용량 분석

제12장 지역 능력 평가 분석

제13장 제조 vs. 구입 의사 의사결정 프레임워크

제14장 시장 규모 평가와 기회 분석

제15장 SWOT 분석

제16장 사례 : 항체 약물 결합체 수탁제조

제17장 결론

제18장 주요 인사이트

제19장 부록 1 : 표 형식 데이터

제20장 부록 2 : 기업 및 단체 리스트

LSH

영문 목차

영문목차

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 11.7 billion in the current year to USD 39.9 billion by 2035, at a CAGR of 11.6% during the forecast period, till 2035.

The market opportunity for cell and gene therapy supply chain software 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 Geographical Regions

• 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

With advances in clinical pharmacology and oncology research, and the increasing demand for targeted therapies, high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become the key focus of researchers and drug manufacturers across the world. It is worth highlighting that 45% of the drugs globally are highly potent leading to specialized HPAPI production. However, manufacturing HPAPIs is a complex process and therefore, there are various challenges associated with the process. The biggest challenge is to inhibit cross-contamination during manufacturing followed by the protection of the environment, workers and everyone across the supply chain. It is equally important to choose the correct containment and protective strategy, inclusive of containment equipment, procedures and PPE. HPAPIs handling generally requires continued investment in the area of safe handling, the need for global guidance and advance technical expertise adding to the challenges in the domain. Therefore, drug developers are actively outsourcing their manufacturing operations.

Understanding the vast potential and positive growth outlook of the contract manufacturing market, the majority of big pharma players are looking to make investments to expand and / or upgrade their current manufacturing facilities. A number of CMOs are investing in new facilities in developing countries such as Japan, China, India and Brazil to avail the benefits of lower manufacturing costs, cheap and skilled labor and supportive regulatory landscapes in these areas. Driven by the overall growth of the anti-cancer therapeutics industry, recent technological advancements and the growing trend of outsourcing, the market is anticipated to witness steady growth in the coming 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.
• 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 11.6%.

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 scale. 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, HPAPI Project Service
• Vice President and Chief Operating Officer and Business Director, BSP Pharmaceuticals
• ILC Dover, Vice President, Pharma/Bio Technical Support
• Ex-Group Product Manager and Ex-Director-Business Development, Catalent
• Business Development Director, CordenPharma
• Managing Director, ProJect Pharmaceutics
• Ex-Business Head, Formulations and Finished Products, Alphora Research
• Ex-Site Head, Piramal Healthcare
• Ex-Senior Manager, Business Development, Helsinn
• Marketing and Sales Manager, Pharma, Cerbios-Pharma
• Ex-Business Development Technician, Idifarma

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. 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
  • 8.3.4. 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
  • 13.2.1. Scenario 1
  • 13.2.2. Scenario 2
  • 13.2.3. Scenario 3
  • 13.2.4. 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. BSP Pharmaceuticals
  • 18.2.1. Company Snapshot
  • 18.2.2. Interview Transcript: Vice President and Chief Operating Officer and Business Director
• 18.3. Catalent
  • 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. CordenPharma
  • 18.4.1. Company Snapshot
  • 18.4.2. Interview Transcript: Business Development Director
• 18.5. ProJect Pharmaceutics
  • 18.5.1. Company Snapshot
  • 18.5.2. Interview Transcript: Managing Director
• 18.6. Alphora Research
  • 18.6.1. Company Snapshot
  • 18.6.2. Interview Transcript: Ex-Business Head, Formulations and Finished Products
• 18.7. Piramal Healthcare
  • 18.7.1. Company Snapshot
  • 18.7.2. Interview Transcript: Ex-Site Head, Grangemouth
• 18.8. Helsinn
  • 18.8.1. Company Snapshot
  • 18.8.2. Interview Transcript: Ex-Senior Manager, Business Development
• 18.9. Cerbios-Pharma
  • 18.9.1. Company Snapshot
  • 18.9.2. Interview Transcript: Marketing and Sales Manager, Pharma
• 18.10. Idifarma
  • 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

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