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

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  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 HPAPI / 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 HPAPI and finished cytotoxic drugs. Examples include AbbVie, AMRI, Baxter BioPharma Solutions, CordenPharma and Fareva.
  5. North America and Europe are the predominant regions where HPAPI 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 HPAPI 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.

Overview

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.

Contents

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.

Table of Contents

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 Farmacéutico
16.3. Klaus Hellerbrand, Managing Director, ProJect Pharmaceutics
16.4 Antonella Mancuso, Vice President & 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 & 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 & 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 & 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 & 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

Listed Companies

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 & 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 & Johnson
  114. Johnson Matthey Pharma Services
  115. Kemwell
  116. KKR & 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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