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HPAPIs and Cytotoxic Drugs Manufacturing Market (2nd Edition), 2016 - 2026

  • March 2016
  • -
  • Roots Analysis Private Ltd.
  • -
  • 345 pages

INTRODUCTION
With the rising demand for targeted therapies, high potency compounds such as high potency active pharmaceutical ingredients (HPAPIs) and cytotoxic drugs have become the key focus of researchers and manufacturers worldwide. HPAPIs, which include cytotoxic APIs, are drug substances that are formulated to manufacture high potency drug products. Cytotoxic drugs are a category of highly potent drug products and, due to their increased utility in the treatment of cancer indications, have gained wide attention in recent years.

Some of the key benefits of these compounds include low dosage requirement and lower side effects. With over 25% of the total drugs worldwide being classified as highly potent, the HPAPI market is currently cited as one of the most important segments of pharmaceutical industry. The market is currently dominated by contract manufacturers. Though some pharmaceutical companies have invested in building in-house capabilities, the capital intensive nature and specialized containment requirements make the role of contract manufacturers crucial. SAFC, Lonza and Evonik are amongst the pioneers in the field of manufacturing highly potent compounds. In addition, new entrants such as Labochim, Medichem, OPKO Health, Project Pharmaceutics, Regis Technologies, ScinoPharm and Wuxi Pharma have also recently sprung up.

The growing number of investments and partnerships in this field are evident of the current market intensity. Majority of the investments in recent years have been expansion programs highlighting that manufacturers are keen to expand their existing production facilities to meet the growing demand. Looking at the ongoing focus, we certainly believe that stakeholders will continue to invest in this area. The current market landscape will gradually evolve as manufacturers look to gain competitive advantage in the near future.

SCOPE OF THE REPORT
The ‘HPAPIs and Cytotoxic Drugs Manufacturing Market, 2016-2026 (2nd edition)’ report provides an extensive study of the rapidly growing manufacturing market of HPAPIs and cytotoxic drugs. Due to their numerous advantages and widespread application in treatment of cancer and other disorders, HPAPIs and cytotoxics have emerged as one of the key focus areas of researchers across the globe. When compared to conventional therapeutic products, these compounds offer multiple advantages including low dosage requirements, low cost and high target specificity. The focus of this report is primarily to understand the current competitive landscape and the likely future evolution of both the HPAPIs and cytotoxic drugs market over the next decade. Amongst other elements, the report covers the following aspects:
- Review of the manufacturing sites of various CMOs involved in HPAPIs / cytotoxic drugs manufacturing.
- Overview of the pharmaceutical companies with in-house manufacturing capabilities.
- Investments in the expansion or for setting up of new facilities as well as collaborations that have taken place in the recent past.
- A detailed case study on the manufacturing of antibody drug conjugates (ADCs), one of the well-known emerging classes of cytotoxic drugs.

Though some pharmaceutical companies have in-house capabilities, the development of HPAPIs / cytotoxic drugs is primarily outsourced to contract manufacturers. The future growth of this market is likely to be driven by the increasing demand for oncology drugs, as majority of high potency and cytotoxic drugs are being developed for the treatment of cancer. As this segment continues to evolve, the use of HPAPIs and cytotoxic drugs in other therapeutic areas such as glaucoma, hormonal imbalances and respiratory disorders are also being investigated.

Despite their benefits and the scope of a promising future, the study also highlights that there are considerable challenges associated with the production of these compounds. Due to their highly toxic nature, they pose significant occupational hazards, if not handled carefully. In addition, cross-contamination with other products can be highly detrimental for the patients. Therefore, adequate containment strategies and a proper classification of hazards is essential for the uptake of this market.

The base year for this report is 2015; actual sales data of respective companies has been presented for up to last five years. The report provides market forecasts for the period 2016 – 2026. The research, analysis and insights presented in this report is backed by a deep understanding of key insights gathered both from secondary and primary research.

RESEARCH METHODOLOGY
Most of the data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews 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 is likely to evolve across different geographical regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The various secondary sources of information that we use 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 over the coming ten years, 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.

1.1. CHAPTER OUTLINES
Chapter 2 provides an executive summary of the key insights captured in our research. The summary offers a high-level view on the likely evolution of the contract manufacturing market for HPAPIs and cytotoxic drugs.

Chapter 3 provides a general introduction to HPAPIs and cytotoxic drugs. In this chapter, we have also explained, in detail, specific containment requirements for handling HPAPIs and cytotoxic drugs.

Chapter 4 identifies the contract manufacturers actively involved in the HPAPIs / cytotoxic drugs market. The chapter also provides details on various aspects related to these CMOs including their production capabilities, scale of operation, occupational exposure limits (OELs) and the geographic location of their facilities. It also highlights the leading pharmaceutical companies that have in-house capabilities for developing HPAPIs / cytotoxic drugs. In addition, the chapter provides a comprehensive overview of the current regulatory landscape governing this segment of the industry.

Chapter 5 provides a detailed analysis of the various CMOs involved in the manufacturing of HPAPIs. The chapter presents an in-depth comparative analysis of the major players in this segment based on regional distribution, scale of operation and OELs. The chapter also highlights the production specifications of the leading manufacturers in the market.

Chapter 6 provides a detailed analysis of the CMOs involved in the manufacturing of cytotoxic drugs. In addition to regional distribution of these organizations, the chapter presents a comprehensive review of various other parameters related to their capabilities such as scale of operation, OELs and fill / finish.

Chapter 7 introduces the one-stop-shop model with respect to HPAPIs / cytotoxic drugs manufacturing. The chapter includes case studies of five leading companies: AMRI, Baxter BioPharma Solutions, CordenPharma, Fareva and Pierre Fabre Laboratories that are operating as one-stop-shops.
Chapter 8 presents our forecast for both HPAPIs and cytotoxic drugs contract manufacturing market. All our predictions related to this market’s future have been backed up by robust analysis of data procured from both secondary and primary sources. Due to the uncertain nature of the market, we have presented three different growth tracks outlined as the conservative, base and optimistic scenarios. The chapter also presents a region-wise market forecast for both HPAPIs and cytotoxic drugs contract manufacturing.

Chapter 9 contains detailed profiles of key CMOs, located in the US, that are involved in the manufacturing of HPAPIs and cytotoxic drugs. Each profile includes information such as the company’s geographical presence, its financial performance, manufacturing capabilities, investments and partnerships.

Chapter 10 provides detailed profiles of key CMOs, located in Europe, that are involved in the manufacturing of HPAPIs and cytotoxic drugs. Similar to chapter 9, each profile includes information on the company’s geographical presence, its financial performance, manufacturing capabilities, investments and partnerships.

Chapter 11 provides detailed profiles of key CMOs that provide manufacturing services for HPAPIs and cytotoxic drugs in the Asia Pacific region. Similar to the earlier two chapters, each company profile includes information on the company’s geographical presence, its financial performance, manufacturing capabilities, investments and partnerships.

Chapter 12 provides profiles of several emerging CMOs in the HPAPIs and cytotoxic drugs manufacturing market. As in the earlier chapters, each profile contains information on the company’s geographical presence, financial performance (where available), manufacturing capabilities, investments and partnerships.

Chapter 13 analyzes the recent developments in the HPAPIs / cytotoxic drugs manufacturing market. This chapter contains information on the investments that have been made and the various partnerships that have been established in the past few years. It also presents an analysis of how the market has evolved over the years. In addition, the chapter contains a brief section on how recent technological advancements have led to the market’s evolution.

Chapter 14 provides a SWOT analysis capturing the key elements that are likely to influence future growth in this market.
Chapter 15 presents a case study on antibody drug conjugates (ADCs) manufacturing market; ADCs represent one of the rapidly expanding segments of biopharmaceutical industry and are expected to emerge as a significant opportunity for the CMOs in near future. The case study contains detailed information on both in-house and contract manufacturing in the ADC market.

Chapter 16 is a collection of transcripts of interviews conducted during the course of this study. The senior people interviewed for this study were Antonella Mancuso, Vice President & Chief Operating Officer and Maria Elena Guadagno, Business Director (BSP Pharmaceuticals), Stacy McDonald, Group Product Manager & Jennifer L. Mitcham, Director - Business Development (Catalent Pharma Solutions), Roberto Margarita, Business Development Director (CordenPharma), Allison Vavala, Senior Manager, Business Development (Helsinn), Javier E. Aznárez Araiz, Business Development (Idifarma), Mark Wright, Site Head, Grangemouth (Piramal Healthcare) and Klaus Hellerbrand, Managing Director (ProJect Pharmaceutics). In addition to detailed interviews, we had also conducted a comprehensive survey to learn more about the manufacturing capabilities / capacities of various stakeholders in the industry.

Chapter 17 summarizes the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in the previous chapters.

Chapter 18 is an appendix that provides tabulated data for all the figures provided in the report.

Chapter 19 is an appendix that provides a list of companies and organizations mentioned in the report.

EXAMPLE HIGHLIGHTS
1. Oncology is the key driver behind the growth of HPAPIs and cytotoxic drugs. Around 60% of the HPAPIs are being developed for the treatment of cancer. The trend is likely to continue and the anti-cancer market will sustain the growth of HPAPIs and cytotoxics in the future.
2. CMOs are the key stakeholders in the market as a good proportion of HPAPIs / cytotoxics manufacturing is currently outsourced due to stringent manufacturing protocols and safety requirements. During our research, we identified 96 CMOs (with over 130 production facilities worldwide) that are focused in this area; approximately 40% of these facilities are dedicated to manufacturing of both HPAPIs and cytotoxic drugs.
3. The market is highly fragmented; companies such as Capsugel, Idifarma, Labochim, Medichem, OPKO Health, ScinoPharm, WuXi PharmaTech are some of the new entrants in this market that have recently expanded their service portfolio. Having said this, established pharma companies such as Roche, Merck, GSK, BMS and Boehringer Ingelheim have also established in-house capabilities.
4. Over 15% CMOs have established one-stop-shop model to provide manufacturing services for both HPAPIs and finished cytotoxic drugs. Examples include AbbVie, AMRI, Baxter BioPharma Solutions, CordenPharma and Fareva.
5. North America and Europe are the predominant regions where HPAPIs and cytotoxic drugs production facilities are located. The US accounts for around 23% of the total HPAPI production facilities followed by Italy (13%) and Switzerland (11%). In the case of cytotoxic drugs, 30% of production facilities are located in the US; this is followed by Germany (14%) and the UK (10%). Companies have also moved their focus to developing countries such as China and India in order to take advantage of relatively lower costs.
6. Several collaborations have been recently inked between stakeholders with an aim to combine their manufacturing expertise. Of the 50 partnerships we studied during our research, an overwhelming proportion were acquisitions (55%) and manufacturing collaborations (38%).
7. Catering to the wider demand, several CMOs have regularly engaged in investment programs to expand their production set ups. Since 2006, there have been more than 100 investments to add new facilities and / or to expand existing capacities; SAFC has led this activity followed by Novasep, Aesica Pharmaceuticals, CARBOGEN AMCIS, Lonza, Piramal, Helsinn and Baxter BioPharma Solutions.
8. Overall, the HPAPIs and cytotoxic drugs market holds enormous potential for the contract manufacturers. We anticipate this opportunity for the CMOs to grow at an annualized rate of ~10% over the next ten years. North American and Western European CMOs will continue to dominate with a share of over 70% in the overall market. Developing countries, such as India and China, are likely to emerge with a share of around 13% by 2026.

Table Of Contents

HPAPIs and Cytotoxic Drugs Manufacturing Market (2nd Edition), 2016 - 2026
1. Preface
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2. Executive Summary

3. Introduction
3.1. Context and Background
3.2. HPAPIs: Definition
3.2.1. Containment Measures
3.2.2. Classification of HPAPIs
3.3. Cytotoxic Drugs: Definition
3.3.1. Containment Measures
3.4. Role of CMOs in the Pharmaceutical Industry
3.4.1. Contract Manufacturing in HPAPIs and Cytotoxic Drugs

4. Market Overview
4.1. Chapter Overview
4.2. HPAPIs / Cytotoxic Drugs Manufacturers
4.3. In-house Capabilities
4.4. Regulatory Landscape

5. HPAPI Manufacturing Market
5.1. Chapter Overview
5.2. HPAPI Capability Analysis
5.2.1. Analysis by Scale of Operation
5.2.2. Regional Analysis
5.2.2.1. Laboratory Scale
5.2.2.2. Development Scale
5.2.2.3. Commercial/Industrial Scale
5.2.2.4. Regional Distribution
5.2.3. Analysis by Occupational Exposure Limit (OEL)
5.3. CMOs: Production Capabilities
5.3.1. Aesica Pharmaceuticals
5.3.2. Ajinomoto Omnichem
5.3.3. Ampac Fine Chemicals (AFC)
5.3.4. Aptuit
5.3.5. Asymchem Laboratories
5.3.6. AVANTHERA
5.3.7. Cambrex
5.3.8. Cerbios
5.3.9. CordenPharma
5.3.10. Farmabios
5.3.11. Helsinn Advanced Synthesis
5.3.12. IRIX Pharmaceuticals
5.3.13. FineTech Pharmaceuticals
5.3.14. Pfanstiehl
5.3.15. Syntagon

6. Cytotoxic Drugs Manufacturing Market
6.1. Chapter Overview
6.2. Cytotoxics Capability Analysis
6.2.1. Analysis by Scale of Operation
6.2.2. Regional Analysis
6.2.2.1. Laboratory Scale
6.2.2.2. Development Scale
6.2.2.3. Commercial / Industrial Scale
6.2.2.4. Regional Distribution
6.2.3. Analysis by Operational Exposure Limits (OEL)
6.2.4. Fill / Finish Capability Analysis

7. Case In Point: The ‘One-Stop-Shops'
7.1. Introduction
7.2. Case Studies
7.3. Albany Molecular Research (AMRI Global)
7.3.1. Introduction
7.3.2. Financial Performance
7.3.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
7.3.4. Manufacturing Experience
7.3.5. Recent Developments

7.4. Baxter BioPharma Solutions (Business Unit of Baxter International)
7.4.1. Introduction
7.4.2. Financial Performance
7.4.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
7.4.4. Recent Developments

7.5. CordenPharma
7.5.1. Introduction
7.5.2. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
7.5.3. Recent Developments

7.6. Fareva
7.6.1. Introduction
7.6.2. Financial Performance
7.6.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
7.6.4. Manufacturing Experience
7.6.5. Recent Developments

7.7. Pierre Fabre Laboratories
7.7.1. Introduction
7.7.2. Financial Performance
7.7.3. Pierre Fabre Medicament Production (PFMP) / Aquitaine Pharm International
7.7.4. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
7.7.5. Manufacturing Experience
7.7.6. Recent Developments

8. Market Size and Forecast
8.1. Chapter Overview
8.2. Forecast Methodology
8.3. Cytotoxic Drugs Manufacturing Market, 2016- 2026
8.3.1. Overall Market Forecast
8.3.2. Regional Market Forecast
8.4. HPAPIs Manufacturing Market, 2016- 2026
8.4.1. Overall Market Forecast
8.4.2. Regional Market Forecast

9. Leading CMOs in the US
9.1. Chapter Overview
9.2. AbbVie (Abbott Contract Manufacturing)
9.2.1. Introduction
9.2.2. Financial Performance
9.2.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
9.2.4. Manufacturing Experience
9.2.5. Recent Developments

9.3. Catalent Pharma Solutions
9.3.1. Introduction
9.3.2. Financial Performance
9.3.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
9.3.4. Recent Developments

9.4. Evonik
9.4.1. Introduction
9.4.2. Financial Performance
9.4.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
9.4.4. Recent Developments

9.5. Pfanstiehl
9.5.1. Introduction
9.5.2. Financial Performance
9.5.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
9.5.4. Recent Developments

9.6. Sigma-Aldrich Fine Chemicals (SAFC)
9.6.1. Introduction
9.6.2. Financial Performance
9.6.3. SAFC Commercial: The Contract Manufacturer
9.6.4. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
9.6.5. Manufacturing Experience
9.6.6. Recent Developments

10. Leading CMOs in the EU
10.1. Chapter Overview
10.2. BSP Pharmaceuticals
10.2.1. Introduction
10.2.2. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
10.2.3. Manufacturing Experience
10.2.4. Recent Developments

10.3. CARBOGEN AMCIS
10.3.1. Introduction
10.3.2. Financial Performance
10.3.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
10.3.4. Recent Developments

10.4. Helsinn Advanced Synthesis (Division of Helsinn Group)
10.4.1. Introduction
10.4.2. Financial Performance
10.4.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
10.4.4. Manufacturing Experience
10.4.5. Recent Developments

10.5. Lonza
10.5.1. Introduction
10.5.2. Financial Performance
10.5.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
10.5.4. Classification System by Lonza
10.5.5. Manufacturing Experience
10.5.6. Recent Developments

10.6. Novasep
10.6.1. Introduction
10.6.2. Financial Performance
10.6.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
10.6.4. Manufacturing Experience
10.6.5. Recent Developments

10.7. Pfizer CentreSource
10.7.1. Introduction
10.7.2. Financial Performance
10.7.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities

10.8. Piramal Healthcare Pharma Solutions
10.8.1. Introduction
10.8.2. Financial Performance
10.8.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
10.8.4. Manufacturing Experience
10.8.5. Recent Developments

10.9. TAPI (Teva Active Pharmaceutical Ingredients)
10.9.1. Introduction
10.9.2. Financial Performance
10.9.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities


11. Leading CMOs in Asia Pacific
11.1. Chapter Overview
11.2. Dr. Reddy's Laboratories (Custom Pharmaceutical Services)
11.2.1. Introduction
11.2.2. Financial Performance
11.2.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
11.2.4. Recent Developments

11.3. IDT Australia
11.3.1. Introduction
11.3.2. Financial Performance
11.3.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
11.3.4. Recent Developments

11.4. Intas Pharmaceuticals
11.4.1. Introduction
11.4.2. Financial Performance
11.4.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
11.4.4. Recent Developments

12. Emerging CMOs
12.1. Chapter Overview
12.2. Capsugel
12.2.1. Introduction
12.2.2. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
12.2.3. Recent Developments

12.3. Formosa Laboratories
12.3.1. Introduction
12.3.2. Financial Performance
12.3.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
12.3.4. Recent Developments

12.4. Icrom
12.4.1. Introduction
12.4.2. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities

12.5. Idifarma
12.5.1. Introduction
12.5.2. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
12.5.3. Recent Developments

12.6. Infa Group
12.6.1. Introduction
12.6.2. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
12.6.3. Recent Developments

12.7. Medichem
12.7.1. Introduction
12.7.2. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
12.7.3. Recent Developments

12.8. NerPharMa
12.8.1. Introduction
12.8.2. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
12.8.3. Recent Developments

12.9. OPKO Health
12.9.1. Introduction
12.9.2. Financial Performance
12.9.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
12.9.4. Recent Developments

12.10. ProJect Pharmaceutics
12.10.1. Introduction
12.10.2. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities

12.11. Regis Technologies
12.11.1. Introduction
12.11.2. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities

12.12. ScinoPharm
12.12.1. Introduction
12.12.2. Financial Performance
12.12.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities
12.12.4. Recent Developments

12.13. SynTheAll Pharmaceutical Co. (Manufacturing Subsidiary of WuXi AppTec)
12.13.1. Introduction
12.13.2. Financial Performance
12.13.3. HPAPIs and / or Cytotoxic Drugs Manufacturing Facilities

13. Recent Developments
13.1. Chapter Overview
13.2. Investments by CMOs: Establishment of New Facilities and Facility Expansions
13.2.1. Growing Number of Investments over the Years
13.2.2. Sigma Aldrich Fine Chemicals Leads the Investments Activity
13.3. Deals and Partnerships
13.3.1. Analysis by Type of Partnership
13.3.2. Analysis by Year of Partnership

14. SWOT Analysis
14.1. Chapter Overview
14.2. Strengths
14.2.1. Advantages of HPAPIs and Cytotoxics
14.2.2. Ongoing Focus from Leading Pharmaceutical Companies
14.3. Weaknesses
14.3.1. Lack of a Universal System of Classification
14.3.2. Occupational Hazards
14.3.3. Cross-contamination Risks
14.3.4. High Cost Involved in Production
14.4. Opportunities
14.4.1. Technological Advancements
14.4.1.1. Prospects for Single-use Systems in High potency/ Cytotoxics manufacturing
14.4.1.2. Continuous Flow Processing
14.4.2. Growing Opportunities for CMOs
14.5. Threats
14.5.1. Regional Reforms in Drug Pricing and Reimbursement Policies
14.5.2. In-House Manufacturing

15. Case in Point: Contract Manufacturing in ADCs
15.1. Background
15.2. ADC Drugs: Limited Technology Providers
15.3. ADC Manufacturing: Key Steps
15.4. ADC Manufacturing: Key Challenges
15.5. In-House Manufacturing of ADCs
15.6. Global Presence of Contract Manufacturers
15.7. A Promising Scope for Investment
15.8. Emergence of Start-Ups
15.9. Contract Manufacturers Collaborating to Provide ADC Capabilities
15.10. CMOs Manufacturing Linkers
15.11. CMOs with HPAPI / Cytotoxic Manufacturing Capabilities
15.12. Growing Conjugation Capability
15.13. Full Service Providers for ADCs: An Unmet Need

16. Interview Transcripts
16.1. Chapter Overview
16.2. Javier E. Aznárez Araiz, Business Development, Idifarma Desarrollo Farmaceutico
16.3. Klaus Hellerbrand, Managing Director, ProJect Pharmaceutics
16.4 Antonella Mancuso, Vice President and Chief Operating Officer; Maria Elena Guadagno, Business Director, BSP Pharmaceuticals
16.5. Mark Wright, Site Head, Grangemouth, Piramal Healthcare
16.6. Roberto Margarita, Business Development Director, CordenPharma
16.7. Allison Vavala, Senior Manager, Business Development, Helsinn
16.8. Stacy McDonald, Group Product Manager and Jennifer L. Mitcham, Director - Business Development, Catalent Pharma Solutions

17. Conclusion
17.1. Oncological Indications are Likely to Continue to Generate the Maximum Demand for HPAPIs and Cytotoxic Drugs
17.2. Multiple Drivers to Result in a Healthy Growth Rate
17.3. CMOs Likely to Play a Pivotal Role in the Market's Evolution
17.4. US and Europe to Remain as the Key Manufacturing Hubs
17.5. A Multi-billion Dollar Rapidly Expanding Market
17.6. Concluding Remarks

18 Appendix 1: Tabulated Data

19. Appendix 2: List of Companies and Organizations

List of Figures
Figure 3.1 OEB System: International Safety Systems
Figure 3.2 HPAPIs: Different Forms
Figure 5.1 HPAPI Production Facilities: Distribution by Scale of Operation
Figure 5.2 HPAPI CMOs: Regional Presence (Laboratory Scale)
Figure 5.3 HPAPI CMOs: Regional Presence (Development Scale)
Figure 5.4 HPAPI CMOs: Regional Presence (Commercial / Industrial Scale)
Figure 5.5 HPAPI Production Facilities: Regional Distribution
Figure 6.1 Cytotoxic Drugs Production Facilities: Distribution by Scale of Operation
Figure 6.2 Cytotoxic Drugs CMOs: Regional Presence (Laboratory Scale)
Figure 6.3 Cytotoxic Drugs CMOs: Regional Presence (Development Scale)
Figure 6.4 Cytotoxic Drugs CMOs: Regional Presence (Commercial / Industrial Scale)
Figure 6.5 Cytotoxic Drugs Production Facilities: Regional Distribution
Figure 7.1 AMRI Global: Contract Revenues (USD Million), FY 2010 - H1 2015
Figure 7.2 AMRI Global: Segment Revenues (USD Million), FY 2014
Figure 7.3 AMRI Global: Segment Contract Revenues (USD Million), H1 2014 and H1 2015
Figure 7.4 Baxter BioPharma Solutions: Service Portfolio
Figure 7.5 Baxter BioPharma Solutions: Revenues (USD Million), FY 2011 - FY 2014
Figure 7.6 Pierre Fabre Laboratories: Revenues (EUR Million), FY 2014
Figure 8.1 Cytotoxic Drugs Sales Forecast, 2016 - 2026: Base Scenario (USD Billion)
Figure 8.2 Cytotoxic Drugs Contract Manufacturing Market, 2016 - 2026: Base Scenario (USD Billion)
Figure 8.3 Cytotoxic Drugs Contract Manufacturing Market: Regional Distribution, 2016, 2021 and 2026
Figure 8.4 HPAPIs Contract Manufacturing Market, 2016 - 2026: Base Scenario (USD Billion)
Figure 8.5 HPAPI Contract Manufacturing Market: Regional Distribution, 2016, 2021 and 2026
Figure 9.1 AbbVie: Revenues (USD Billion), FY 2010 - H1 2015
Figure 9.2 Catalent Pharma Solutions: Revenues (USD Billion), FY 2010 - H1 2016
Figure 9.3 Catalent Pharma Solutions: Segment Revenues (USD Million), FY 2015
Figure 9.4 Evonik: Revenues (EUR Billion), FY 2010 - H1 2015
Figure 9.5 Evonik: Segment Revenues (EUR Billion), FY 2014
Figure 9.6 Sigma-Aldrich: Revenues (USD Billion), FY 2010 - H1 2015
Figure 9.7 Sigma-Aldrich: Segment Revenues (USD Million), FY 2014
Figure 9.8 Sigma-Aldrich: Segment Revenues (USD Million), Q1 - Q3 2015
Figure 9.9 SAFC Commercial: Revenues (USD Million)
Figure 10.1 Dishman Group: Turnover (INR Billion), FY 2010 - H1 2016
Figure 10.2 Dishman Group: Segment Revenues (INR Billion), FY 2015
Figure 10.3 CARBOGEN AMCIS: Revenues (INR Billion), FY 2011 - FY 2015
Figure 10.4 Lonza: Revenues (CHF Billion), FY 2010 - H1 2015
Figure 10.5 Lonza: Segment Revenues (CHF Billion), FY 2014
Figure 10.6 Lonza: Potency Classification System
Figure 10.7 Novasep: Segment Revenues (EUR Million)
Figure 10.8 Pfizer CentreSource: Revenues, (USD Million), FY 2010 - FY 2014
Figure 10.9 Piramal Healthcare: Revenues (INR Billion), FY 2011 - H1 2016
Figure 10.10 Piramal Healthcare: Segment Revenues (INR Billion), FY 2015
Figure 11.1 Dr. Reddy Laboratories: Revenues (INR Billion), FY 2011 - H1 2016
Figure 11.2 Dr. Reddy's Laboratories: Segment Revenues (INR Billion), FY 2015
Figure 11.3 IDT Australia: Revenues (USD Million), FY 2010 - FY 2015
Figure 11.4 Intas Pharmaceuticals: Revenues (INR Billion), FY 2011 - FY 2015
Figure 12.1 Formosa Laboratories: Revenues (NTD Billion), FY 2012 - Q1 2015
Figure 12.2 OPKO Health: Revenues (USD Million), FY 2010 - H1 2015
Figure 12.3 ScinoPharm: Revenues (NTD Billion), FY 2010 - H1 2015
Figure 12.4 WuXi PharmaTech: Net Revenues (USD Million), FY 2010 - H1 2015
Figure 13.1 CMO Investments, 2006-2015: Distribution by Type of Investment
Figure 13.2 HPAPIs and Cytotoxic Drugs: Leading Players by Investments
Figure 13.3 HPAPIs and Cytotoxic Drugs: Distribution by Type of Partnership
Figure 13.4 HPAPIs and Cytotoxic Drugs: Deals and Partnerships, 2006 - 2015
Figure 17.1 HPAPIs and Cytotoxic Drugs Contract Manufacturing Market Forecast: 2016, 2021 and 2026 (USD Billion)

List of Tables
Table 3.1 APIs and HPAPIs: OEL
Table 3.2 Categorization of APIs: International Safety Systems
Table 3.3 SafeBridge: Categorization System
Table 3.4 Merck Categorization System
Table 3.5 Lonza Categorization System
Table 4.1 CMOs with HPAPI and Cytotoxic Drugs Production Facilities
Table 4.2 New Entrants in HPAPI and Cytotoxic Market
Table 4.3 Pharma Companies with In-house HPAPI and Cytotoxics Production Facilities
Table 4.4 US Guidelines for Handling Hazardous / Cytotoxic Drugs
Table 5.1 HPAPI: CMO Capability Analysis
Table 5.2 HPAPI CMOs: Analysis by OELs
Table 5.3 Aesica: Production Capacity
Table 5.4 Ajinomoto Omnichem: Production Capacity
Table 5.5 Helsinn: HPAPI Production Capacity
Table 5.6 Helsinn: Cytotoxic API Production Capacity
Table 6.1 Cytotoxic Drugs: CMOs Capability Analysis
Table 6.2 Cytotoxic Drugs CMOs: Analysis by Occupational Exposure Limits (OELs)
Table 6.3 Cytotoxic Drugs CMOs: Fill / Finish Capability Analysis
Table 6.4 Cytotoxic Drugs CMOs: Distribution by Packaging Form
Table 7.1 HPAPIs and Cytotoxic Drugs: Companies Providing One-Stop-Shop Services
Table 7.2 Baxter BioPharma Solutions: Facility Sites and Manufacturing Services
Table 7.3 CordenPharma: Production Facilities
Table 7.4 CordenPharma, Latina: Cytotoxic Drugs Production Capacity
Table 7.5 Excella: Highly Potent Drug Manufacturing Services' Capacity
Table 8.1 ADCs: Level of Outsourcing
Table 9.1 SAFC Commercial: Highly Potent Compound Facilities
Table 10.1 Helsinn: Cytotoxic Plant, Production Area Capabilities
Table 11.1 Intas Pharmaceuticals: Facility Sites and Functions
Table 12.1 Formosa Laboratories: High Potency Compounds Production Capability
Table 12.2 NerPharma DS: Manufacturing Suites Production Capability
Table 13.1 CMO Investments, 2006-2015
Table 13.2 HPAPIs and Cytotoxic Drugs: Deals and Partnerships, 2003-2015
Table 14.1 HPAPIs and Cytotoxic Drugs: SWOT Analysis
Table 15.1 List of Contract Manufacturers and Their Capabilities in ADC Manufacturing
Table 15.2 CMOs Offering ADC Conjugation Services
Table 15.3 Full Service Contract Manufacturers for ADCs
Table 18.1 HPAPI Production Facilities: Distribution by Scale of Operation
Table 18.2 HPAPI Production Facilities: Regional Distribution
Table 18.3 Cytotoxic Drugs Production Facilities: Distribution by Scale of Operation
Table 18.4 Cytotoxic Drugs Production Facilities: Regional Distribution
Table 18.5 AMRI Global: Contract Revenues (USD Million), FY 2010 - H1 2015
Table 18.6 AMRI Global: Segment Revenues (USD Million), FY 2014
Table 18.7 AMRI Global: Segment Contract Revenues (USD Million), H1 2014 and H1 2015
Table 18.8 Baxter BioPharma Solutions: Revenues (USD Million), FY 2011 - FY 2014
Table 18.9 Pierre Fabre Laboratories: Revenues (EUR Million), FY 2014
Table 18.10 Cytotoxic Drugs Sales Forecast, 2016 - 2026: Base Scenario (USD Billion)
Table 18.11 Cytotoxic Drugs Sales Forecast, 2016 - 2026: Conservative Scenario (USD Billion)
Table 18.12 Cytotoxic Drugs Sales Forecast, 2016 - 2026: Optimistic Scenario (USD Billion)
Table 18.13 Cytotoxic Drugs Contract Manufacturing Market, 2016 - 2026: Base Scenario (USD Billion)
Table 18.14 Cytotoxic Drugs Contract Manufacturing Market, 2016 - 2026: Conservative Scenario (USD Billion)
Table 18.15 Cytotoxic Drugs Contract Manufacturing Market, 2016 - 2026: Optimistic Scenario (USD Billion)
Table 18.16 Cytotoxic Drugs Contract Manufacturing Market: Regional Distribution, 2016, 2021 and 2026
Table 18.17 HPAPIs Contract Manufacturing Market, 2016 - 2026: Base Scenario (USD Billion)
Table 18.18 HPAPIs Contract Manufacturing Market, 2016 - 2026: Conservative Scenario (USD Billion)
Table 18.19 HPAPIs Contract Manufacturing Market, 2016 - 2026: Optimistic Scenario (USD Billion)
Table 18.20 HPAPIs Contract Manufacturing Market: Regional Distribution, 2016, 2021 and 2026
Table 18.21 AbbVie: Revenues (USD Billion), FY 2010 - H1 2015
Table 18.22 Catalent Pharma Solutions: Revenues (USD Billion), FY 2010 - Q1 2016
Table 18.23 Catalent Pharma Solutions: Segment Revenues (USD Million), FY 2015
Table 18.24 Evonik: Revenues (EUR Billion), FY 2010 - H1 2015
Table 18.25 Evonik: Segment Revenues (EUR Million), FY 2014
Table 18.26 Sigma-Aldrich: Revenues (USD Billion), FY 2010 - H1 2015
Table 18.27 Sigma-Aldrich: Segment Revenues (USD Million), FY 2014
Table 18.28 Sigma-Aldrich: Segment Revenues (USD Million), Q1 - Q3 2015
Table 18.29 SAFC Commercial: Revenues (USD Million)
Table 18.30 Dishman Group: Turnover (INR Billion), FY 2010 - H1 2016
Table 18.31 Dishman Group: Segment Revenues (INR Billion), FY 2015
Table 18.32 CARBOGEN AMCIS: Revenues (INR Billion), FY 2011 - FY 2015
Table 18.33 Lonza: Revenues, (CHF Billion), FY 2010 - H1 2015
Table 18.34 Lonza: Segment Revenues (CHF Million), FY 2014
Table 18.35 Novasep: Segment Revenues (EUR Million), FY 2013
Table 18.36 Pfizer CentreSource: Revenues, (USD Million) FY 2010 - H1 2015
Table 18.37 Piramal Healthcare: Revenues (INR Billion), FY 2011 - H1 2016
Table 18.38 Piramal Healthcare: Segment Revenues (INR Billion), FY 2015
Table 18.39 Dr. Reddy's Laboratories: Revenues (INR Billion), FY 2011 - H1 2016
Table 18.40 Dr. Reddy's Laboratories: Segment Revenues (INR Billion), FY 2015
Table 18.41 IDT Australia: Revenues (USD Million), FY 2010 - FY 2015
Table 18.42 Intas Pharmaceuticals: Revenues (INR Billion), FY 2011 - FY 2015
Table 18.43 Formosa Laboratories: Revenues (NTD Billion), FY 2012 - Q1 2015
Table 18.44 OPKO Health: Revenues (USD Million), FY 2010 - H1 2015
Table 18.45 ScinoPharm: Revenues (NTD Billion), FY 2010 - H1 2015
Table 18.46 WuXi PharmaTech: Net Revenues (USD Million), FY 2010 - H1 2015
Table 18.47 CMO Investments, 2006-2015: Distribution by Type of Investment
Table 18.48 HPAPIs and Cytotoxic Drugs: Leading Players by Investments
Table 18.49 HPAPIs and Cytotoxic Drugs: Distribution by Type of Partnership
Table 18.50 HPAPIs and Cytotoxic Drugs: Deals and Partnerships, 2006 - 2015
Table 18.51 HPAPI Contract Manufacturing Market (USD Billion) Forecast: 2016, 2021 and 2026
Table 18.52 Cytotoxic Drugs Contract Manufacturing Market (USD Billion) Forecast: 2016, 2021 and 2026

Companies Mentioned
The following companies and organizations have been mentioned in this report.
1. AAIPharma Services Corp.
2. AB SCIEX
3. AbbVie
4. ACES Pharma
5. ADC Biotechnology
6. Aenova Group
7. Aesica Pharmaceuticals
8. Affinity Lifesciences
9. Agno Pharma
10. Ajinomoto Omnichem
11. Alkermes Contract Pharma Services
12. ALMAC Group
13. Alphora Research
14. Amatsigroup
15. AMPAC Fine Chemicals
16. AMRI
17. Aptuit
18. Arch Pharmalabs
19. Ash Stevens
20. Aspen Holdings
21. Asymchem Laboratories
22. AVANTHERA
23. Avecia
24. AzayaTherapeutics
25. Bachem
26. Banner Pharmacaps
27. Baxter BioPharma Solutions
28. Bayer
29. Bend Research
30. BioAgilytix Labs
31. BioOutsource
32. Biopharma Technology
33. Biotechnique
34. Biotest
35. BioVectra
36. Boehringer Ingelheim
37. Bristol Myers Squibb
38. Bryllan
39. BSP Pharmaceuticals
40. Cadila Healthcare
41. Cambrex
42. Cambridge Major Laboratories
43. Capsugel
44. CARBOGEN AMCIS
45. Catalent
46. Cedarburg Pharmaceuticals
47. Celldex Therapeutics
48. Celon Labs
49. Cerbios
50. ChemCon
51. ChemPartner
52. ChemSun Pharmaceutical
53. CMC Biologics
54. Coland Holdings
55. Coldstream Laboratories
56. Concortis Biosystems
57. CordenPharma
58. Creapharm Parenterals
59. Creative Biolabs
60. Cytovance Biologics
61. Dalton Pharma Services
62. Dishman Group
63. Dorizoe LifeSciences
64. Dottikon Exclusive Synthesis
65. Dr. Reddy's Laboratories
66. DSM Pharmaceuticals
67. EaglePicher Pharmaceutical Services
68. EirGen Pharma
69. EirGenix
70. Eisai
71. Eli Lilly
72. EMD Serono
73. Encap Drug Delivery
74. Eucodis Bioscience
75. Evonik
76. Excella GmbH
77. Fareva
78. Farmabios
79. Ferro Pfanstiehl
80. FineTech Pharmaceuticals
81. Foresee Pharmaceuticals
82. Formex
83. Formosa Laboratories
84. Fresenius Kabi
85. FUJIFILM Diosynth Biotechnologies
86. Gadea Pharmaceutical Group
87. Genentech
88. GlaxoSmithKline
89. Goodwin Biotechnology
90. GP Pharm
91. Granules
92. Haupt Pharma
93. Helsinn
94. Heraeus Deutschland GmbH and Co. KG (Chemicals Division of Heraeus Group)
95. Heraeus Precious Metals
96. Hikal
97. Hikma Pharmaceutical
98. Hospira
99. Holodiag
100. Hovione
101. iBIOSOURCE
102. Icrom
103. Idifarma
104. IDT Australia
105. ImmunoGen
106. Immunomedics
107. Indena
108. Infa Group
109. InSphero
110. Intas Pharmaceuticals
111. Intellect Neurosciences
112. IRIX Pharmaceuticals (acquired by Patheon)
113. Johnson and Johnson
114. Johnson Matthey Pharma Services
115. Kemwell
116. KKR and Co.
117. Kyongbo Pharmaceutical Co. Ltd
118. Labochim SpA
119. Lipocine
120. Lonza
121. Matrix Laboratories
122. Mayne Pharmaceuticals
123. Medichem
124. MedImmune
125. Merck Serono
126. Mersana Therapeutics
127. Metrics
128. Micron Technologies
129. Millennium Pharmaceuticals
130. MI-mAbs
131. Minafen
132. Natco Pharma
133. NerPharMa
134. Nerviano Medical Sciences
135. Neuland Laboratories
136. NextPharma Technologies
137. Nicholas Laboratories
138. Normon
139. Novartis
140. Novasep
141. Nycomed Amersham
142. Oasmia Pharmaceutical
143. Olon S.p.A.
144. Omni Chem
145. One2One (Hospira)
146. OPKO Health
147. Organichem
148. OsoBio
149. Pacific GMP
150. Patheon
151. Penn Pharma
152. Pfanstiehl
153. Pfizer CentreSource
154. Pharmascience
155. Pharmatek
156. Pierre Fabre Medicament Production
157. Piramal
158. Polymun Scientific
159. Polytherics
160. Powder Systems Limited
161. Prasfarma
162. Priaxon
163. Procos
164. Progenics Pharmaceuticals
165. ProJect Pharmaceutics
166. QPS Holdings
167. QS Pharma
168. Quanta BioDesign
169. Ranbaxy Laboratories
170. Redwood Biosciences
171. Regis Technologies
172. Roche
173. Rottendorf Pharma GmbH
174. Sigma Aldrich Fine Chemicals
175. Sandoz
176. Sanofi Aventis
177. ScinoPharm
178. SCM Pharma
179. Seattle Genetics
180. Serina Therapeutics
181. Siegfried
182. Spirogen
183. Stason Pharmaceuticals
184. Sumitra Pharmaceuticals
185. Sun European Partners
186. Sundia Meditech
187. Symbiosis Pharmaceutical Services
188. Syntagon
189. Syn-the-All Pharmaceutical Co. Ltd. (STA)
190. Synthon Biopharmaceuticals
191. TAPI
192. Tetrionics
193. The Chemistry Research Solution
194. Transporin
195. TUBE Pharma
196. Uman Pharma
197. UPM Pharmaceuticals
198. Vianex S.A.
199. Vion Pharmaceuticals
200. VUAB Pharma (acquired Brno plant in 2010)
201. VxP Pharmaceuticals
202. Waters
203. Wuxi Pharma

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