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Extractables and Leachables Testing Services Market, 2018-2028

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    September 2018

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Example Insights

 

Overview

Harmful chemicals / contaminants from primary packaging have often been shown to migrate into pharmaceutical products, threatening the safety of several patients who use these products. For instance, in 2010, McNeil Consumer Healthcare was compelled to recall more than 500 lots of Tylenol, Motrin, Benadryl and Zyrtec upon being made aware of the presence of an antifungal chemical, called 2, 4, 6-tribromoanisole (which is used to chemically treat shipping pallets), in the aforementioned product formulations. In this particular case, the chemical, which is a potential carcinogen, had leached from the pallet, through the outer packaging into the drug containers. It is worth highlighting that this incident caused the manufacturer to suffer a loss of approximately USD 900 million. In fact, in 2014, data by the FDA demonstrated that in the previous two years, there have been over 2,000 drug and device recalls. In the year 2014 alone, FDA has recalled over 800 drugs. In addition, in 2015, Allergan voluntarily recalled certain batches of its eye ointment due to contamination reported by customers.

Considering the aforementioned cases, it can be inferred that, during drug product manufacturing and fill / finish, it is important to consider not only the impurity profiles of the drugs, but also identify potential sources of contamination in the containers / packaging material used. Extractables is the term used to refer to compounds that are extracted from the material used to fabricate closed container systems, in the presence of a particular solvent. On the other hand, leachables are substances that passively migrate into drug formulations from the container closure system used, upon direct contact with the product. Further, due to high variability in the type of impurities (organic (volatile, non-volatile or semi- volatile compounds) or inorganic (metals or salts) elements) that are usually extracted / leached out of various manufacturing components and container closures, it is not possible to identify, characterize and quantify all extractables, using a single analytical technique. Nowadays, a variety of testing solutions / assays are available to assess the risk associated with the migration of mobile chemical species from either the components used during manufacturing, or storage containers. Moreover, regulatory bodies have implemented stringent guidelines, making it mandatory for drug developers and packaging service providers to closely monitor the levels of extractables and leachables in pharmaceutical products, drug delivery systems and biomedical devices. Presently, a number of companies offer services for extractables and leachables testing, and such offerings have grown to become an important segment of the overall pharmaceutical industry.

 

Scope of the Report

The Extractables and Leachables Testing Services Market, 2018-2028’ report provides an extensive study on the current market landscape and future outlook of the players offering such services. The study features an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in this domain. Amongst various elements, the report includes:

  •  A detailed assessment of the current market landscape of companies offering extractables and leachables testing services, including information on their respective geographical location, company size, types of pharmaceutical products tested (parenteral, ophthalmic, topical, nasal and others), types of container closures and devices tested (container closure components, single use systems, medical devices and combination products, electronic nicotine delivery systems and others), types of techniques used (spectroscopic techniques, chromatographic techniques and others) and different regulatory guidelines that they comply with.
  • A competitiveness analysis of contemporary service providers, presented in the form of a 2X2 matrix, highlighting the most important companies within North America, Europe and Asia Pacific, based on the number of products tested, number of techniques used, extent of regulatory compliance and the company’s experience.
  • Comprehensive profiles of service providers, featuringbrief overview of the company, details on its extractables and leachables testing services portfolio,information on the location of their headquarters, year of establishment, recent developments and a detailed future outlook. In addition, each profile features a peer group-based benchmark comparison matrix, wherein the companies that have been profiled were compared on the basis of several different parameters, such as the number of products tested, number of techniques used, extent of regulatory compliance and the company’s experience.
  • A detailed analysis of the acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired from 2013-2018, along with the geographical distribution of this activity. The analysis features an ownership change matrix and presents a detailed financial evaluation of the aforementioned deals (in terms of company revenues and deal multiples).
  • An elaborate discussion of the various guidelines laid down by major regulatory bodies across different countries and the risk-based approach to extractables and leachables testing. The section also highlights the various regulatory considerations for specific products, such as single use systems, biopharmaceuticals, parenteral and ophthalmic drug products (PODPs) and electronic nicotine delivery systems.
  • An analysis on packaging trends for drugs approved in the last five years (beginning 2014). In this section, we have analyzed the various container closure systems used based on parameters such as year of approval of the drug, type of molecule, dosage forms and the packaging material(s) used.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on a proprietary forecast model, we have provided insights on the likely evolution of the market in different regions, including North America, Europe, Asia-Pacific and the rest of the world. In addition, we have provided the likely distribution of the opportunity across the type of service provider companies (small-sized, mid-sized and large companies) and types of products being tested (pharmaceutical products, container closure systems, medical devices and combination products). The opinions and insights presented in this study were influenced by inputs solicited via a comprehensive survey and discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with the following industry stakeholders:

  • Cheryl Johnson (Commercial Development Manager of Biotechnology, Alcami)
  • Mike Ludlow (Technical Study Manager Drug Development Services, LGC)
  • Mourad Rahi (Director of Analytical Services, American Preclinical Services)
  • Roger Pearson (President of Analytical Services, Aspen Research)

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

Contents

Chapter 2  provides an executive summary of the insights captured in our research. It offers a high-level view on the current state of the extractables and leachables market and its likely evolution in the mid-long term.

Chapter 3  provides a general introduction to extractables and leachables, highlighting the significance of testing for such chemical contaminants along with details on the different stages of the investigation process. In addition, the chapter describes the various techniques used in the detection of different organic and inorganic impurities. It also features a discussion on the regulatory guidelines for extractables and leachables testing and the challenges faced by service providers engaged in this domain.

Chapter 4  includes a comprehensive market landscape analysis of companies offering services for extractables and leachables testing. The chapter presents detailed analyses based on the geographical location, company size, types of pharmaceutical products tested (parenteral, ophthalmic, topical, nasal, and  others), types of container closures and devices tested (container closure components, single use systems, medical devices, combination products, electronic nicotine delivery systems, and others)and types of techniques used (spectroscopic techniques, chromatographic techniques, and others) ) and different regulatory guidelines that they adhere to. In addition, it presents a bubble analysis, summarizing the regulatory initiatives of key players in this domain.

Chapter 5  provides a comparative landscape of contemporary service providers based on various parameters, such as number of products tested, number of techniques used, extent of regulatory compliance and the experience of the company. Based on the aforementioned analysis, the chapter highlights the most active players within North America, Europe and Asia-Pacific, presented in the form of 2X2 matrix.

Chapter 6  presentsdetailed profiles of some of the active players engaged in providing extractables and leachables testing services to biopharmaceutical companies across different geographies. Each profile includes a brief overview of the company, details on its extractables and leachables testing services portfolio, year of establishment, recent developments, and a comprehensive future outlook. In addition, each profile features a peer group-based benchmark comparison matrix for the profiled players.

Chapter 7  presents a detailed analysis of the acquisitions that have taken place within this industry, providing information on both the acquiring and the acquired companies (location of headquarters and ownership (public / private)), along with the year of acquisition, acquisition cost ( if available ), and the financial status of the acquired company at the time of the acquisition. It also features a detailed ownership change matrix depicting the distribution of acquisitions across private firms and public firms. It also includes an analysis of the financials of these deals (revenues of the acquired firms at the time of acquisition and their respective deal multiples).

Chapter 8  features a detailed discussion on the regulatory guidelines issued by different authorities, such as the EMA, Health Canada and US FDA. In addition, the chapter presents details on the risk-based approach to extractables and leachables testing, toxicological assessments, and regulatory considerations for specific products.

Chapter 9  presentsa comprehensive market forecast analysis, highlighting the future potential of the extractables and leachables testing services domain till the year 2028. It also features the likely distribution of the upcoming opportunity across [A] key geographies, (North America, Europe, Asia Pacific and the rest of the world), [B] size of the service provider (small-sized, mid-sized and large companies), and [C] types of products tested (pharmaceutical products, container closure systems, medical devices and combination products).        

Chapter 10  features packaging trends for drugs approved in the last five years (beginning 2014). In this section, we have analyzed the various container closure systems used based on parameters such as year of approval of the drug, type of molecule, dosage forms and the packaging material(s) used.

Chapter 11  is a summary of the overall report. In this chapter, we have provided a list of the key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 12  is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the details of interviews held with ( in alphabetical order of person name ) Cheryl Johnson (Commercial Development Manager of Biotechnology, Alcami), Mike Ludlow (Technical Study Manager Drug Development Services,LGC), Mourad Rahi (Director of Analytical Services,American Preclinical Services) and Roger Pearson (President of Analytical Services,Aspen Research).

Chapter 13  is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 14  is an appendix, which contains the list of companies and organizations mentioned in the report.

Table of Contents

1 PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2 EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Significance of Testing for Extractables and Leachables
3.2.1. Extractables Testing
3.2.2. Leachables Testing
 
3.3. Stages of Extractables and Leachables Testing
3.3.1. Sample Assessment
3.3.2. Vigorous Extraction of Sample Material
3.3.3. Analysis of Extracts
3.3.4. Assessment of Extractables Data
3.3.5. Conducting a Leachables Study
 
3.4. Identification of Extractables and Leachables
3.4.1. Detection of Organic Impurities
3.4.2. Detection of Inorganic Impurities
3.4.3. Quality Considerations in an Extractables and Leachables Study
 
3.5. Regulatory Guidelines for Extractables and Leachables Testing
3.6. Challenges Associated with Extractables and Leachables Testing
 
4. MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Extractables and Leachables Testing: List of Service Providers
4.2.1. Distribution by Year of Establishment
4.2.2. Distribution by Company Size
4.2.3. Distribution by Geographical Location
4.2.4 Distribution by Type of Products
4.2.4 Distribution by Type of Techniques
 
4.3. Extractables and Leachables Testing Service Providers: Regulatory Compliance
4.3.1. Key Players: Compliance to Existing Regulatory Standards
 
5. COMPANY COMPETITIVENESS ANALYSIS
5.1. Chapter Overview
5.2. Assumptions and Key Evaluable Parameters
5.3. Company Competitive Analysis: Final Output
5.3.1. Key Players: North America
5.3.2. Key Players: Europe
5.3.3. Key Players: Asia Pacific
 
6. LEADING PLAYERS
6.1. Chapter Overview
6.2. Key Players in North America
6.2.1. Agilent
6.2.1.1. Company Overview
6.2.1.2. Extractables and Leachables Testing Services Portfolio
6.2.1.3. Recent Developments and Future Outlook
6.2.1.4. Peer Group-based Benchmarking Analysis
 
6.2.2. AMRI (Whitehouse Laboratories)
6.2.2.1. Company Overview
6.2.2.2. Extractables and Leachables Testing Services Portfolio
6.2.2.3. Recent Developments and Future Outlook
6.2.2.4. Peer Group-based Benchmarking Analysis
 
6.2.3. EKG Labs
6.2.3.1. Company Overview
6.2.3.2. Extractables and Leachables Testing Services Portfolio
6.2.3.3. Recent Developments and Future Outlook
6.2.3.4. Peer Group-based Benchmarking Analysis
 
6.2.4. High Street Capital (Avomeen)
6.2.4.1. Company Overview
6.2.4.2. Extractables and Leachables Testing Services Portfolio
6.2.4.3. Recent Developments and Future Outlook
6.2.4.4. Peer Group-based Benchmarking Analysis
 
6.2.5. PPD
6.2.5.1. Company Overview
6.2.5.2. Extractables and Leachables Testing Services Portfolio
6.2.5.3. Recent Developments and Future Outlook
6.2.5.4. Peer Group-based Benchmarking Analysis
 
6.2.6. Quantex Laboratories
6.2.6.1. Company Overview
6.2.6.2. Extractables and Leachables Testing Services Portfolio
6.2.6.3. Recent Developments and Future Outlook
6.2.6.4. Peer Group-based Benchmarking Analysis
 
6.2.7. Stringencies International (Nelson Labs)
6.2.7.1. Company Overview
6.2.7.2. Extractables and Leachables Testing Services Portfolio
6.2.7.3. Recent Developments and Future Outlook
6.2.7.4. Peer Group-based Benchmarking Analysis
 
6.2.8. VR Analytical
6.2.8.1. Company Overview
6.2.8.2. Extractables and Leachables Testing Services Portfolio
6.2.8.3. Recent Developments and Future Outlook
6.2.8.4. Peer Group-based Benchmarking Analysis
 
6.3. Key Players in Europe
6.3.1. Eurofins (EAG Laboratories)
6.3.1.1. Company Overview
6.3.1.2. Extractables and Leachables Testing Services Portfolio
6.3.1.3. Recent Developments and Future Outlook
6.3.1.4. Peer Group-based Benchmarking Analysis
 
6.3.2. SGS (Polymer Solutions)
6.3.2.1. Company Overview
6.3.2.2. Extractables and Leachables Testing Services Portfolio
6.3.2.3. Recent Developments and Future Outlook
6.3.2.4. Peer Group-based Benchmarking Analysis
 
6.3.3. Smithers Rapra
6.3.3.1. Company Overview
6.3.3.2. Extractables and Leachables Testing Services Portfolio
6.3.3.3. Recent Developments and Future Outlook
6.3.3.4. Peer Group-based Benchmarking Analysis
 
6.3.4. Vitas Analytical Services
6.3.4.1. Company Overview
6.3.4.2. Extractables and Leachables Testing Services Portfolio
6.3.4.3. Recent Developments and Future Outlook
6.3.4.4. Peer Group-based Benchmarking Analysis
 
6.4. Key Players in Asia Pacific
6.4.1. Nextar Chempharma Solutions
6.4.1.1. Company Overview
6.4.1.2. Extractables and Leachables Testing Services Portfolio
6.4.1.3. Recent Developments and Future Outlook
6.4.1.4. Peer Group-based Benchmarking Analysis
 
6.4.2. Vimta
6.4.2.1. Company Overview
6.4.2.2. Extractables and Leachables Testing Services Portfolio
6.4.2.3. Recent Developments and Future Outlook
6.4.2.4. Peer Group-based Benchmarking Analysis
 
7. RECENT ACQUISITIONS
7.1. Chapter Overview
7.2. Extractables and Leachables Testing Service Providers: List of Acquisitions
7.2.1. Analysis by Year
7.2.2. Analysis by Experience and Size of the Acquired Company
7.2.3. Analysis by Geographical Activity
7.2.4. Ownership Change Matrix
7.3. Key Acquisitions: Deal Multiples
 
8. REGULATORY LANDSCAPE FOR EXTRACTABLES AND LEACHABLES
8.1. Chapter Overview
8.2. Safety Concerns Related to Extractables and Leachables in Final Drug Products
8.3. Guidelines Issued by Different Regulatory Authorities / Organizations
8.3.1. United States Food and Drug Administration (USFDA)
8.3.2. European Medicines Agency (EMA)
8.3.3. Health Canada
8.3.4. Product Quality Research Institute (PQRI)
8.3.5. Biophorum Operations Group (BPOG)
 
8.4. Risk-Based Approach to Extractables and Leachables Testing
8.5. Toxicological Assessments
8.6. Regulatory Considerations for Different Products
8.6.1. Single Use Systems
8.6.2. Biopharmaceuticals
8.6.3. Parenteral and Ophthalmic Drug Products
8.6.4. Electronic Nicotine Delivery Systems
 
9. MARKET FORECAST
9.1. Chapter Overview
9.2. Forecast Methodology
9.3. Extractables and Leachables Testing Services Market, 2018-2028
9.4. Extractables and Leachables Testing Services Market: Distribution by Geography, 2018-2028
9.4.1. Extractables and Leachables Testing Services Market: North America, 2018-2028
9.4.2. Extractables and Leachables Testing Services Market: Europe, 2018-2028
9.4.3. Extractables and Leachables Testing Services Market: Asia Pacific, 2018-2028
9.4.4. Extractables and Leachables Testing Services Market: Rest of the World, 2018-2028
 
9.5. Extractables and Leachables Testing Services Market: Distribution by Type of Products, 2018-2028
9.5.1. Extractables and Leachables Testing Services: Market for Pharmaceutical Products, 2018-2028
9.5.2 Extractables and Leachables Testing Services: Market for Medical Devices and Container Closure Systems, 2018-2028
 
10. ANALYSIS OF PRIMARY PACKAGING USED FOR RECENTLY APPROVED PRODUCTS
10.1. Chapter Overview
10.2. List of Recently Approved Drugs
10.2.1. Analysis by Approval Year
10.2.2. Analysis by Type of Primary Packaging Container
10.2.3. Analysis by Type of Primary Packaging Container and Molecule Type
10.2.4. Analysis by Type of Primary Packaging Container and Dosage Form
10.3. Concluding Remarks
 
11. CONCLUSION
11.1 After Several Drug / Medical Device Recalls Owing to Contamination, Extractables and Leachables Testing has Now become a Pre-Requisite for Regulatory Approval
11.2 Several Players with Extractables and Leachables Testing Capabilities have Emerged across the Globe; North America and Europe are the Key Hubs for such Services
11.3 Analytical Testing Techniques are Available for a Wide Range of Drug Formulations, Container Closure Systems and Medical Devices
11.4 Nearly 30 Acquisitions Took Place Between 2013-2018; This Clearly Indicates The Rising Interest Amongst Private And Public Entities in Strengthening Their Foothold in this Evolving Domain
11.5 Driven by Regulatory Mandate, the Extractables and Leachables Testing Services Market is Expected to Grow at a Steady Pace over the Coming Decade
 
12. INTERVIEW TRANSCRIPTS
12.1 Chapter Overview
12.2 Cheryl Johnson (Commercial Development Manager of Biotechnology, Alcami)
12.3 Mike Ludlow (Senior Study Manager, LGC)
12.4 Mourad Rahi (Director, Analytical Services, American Preclinical Services)
12.5 Roger Pearson (President, Analytical Services, Aspen Research)
 
13. APPENDIX 1: TABULATED DATA
 
14. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

List of Figures

Figure 3.1 Correlation between Extractables and Leachables
Figure 3.2 Extractables and Leachables Testing: Types of Products Tested
Figure 3.3 Extractables and Leachables Testing: Steps Involved
Figure 3.4 Instrumentation used for Detecting Unknown Organic Compounds
Figure 3.5 Techniques used for Detecting Unknown Inorganic Compounds
Figure 3.6 Role of Regulatory Authorities in Extractables and Leachables Testing
Figure 3.7 Industry & Regulatory Guidance for Extractables and Leachables Evaluation
Figure 4.1 Extractables and Leachables Testing Service Providers: Distribution by Year of Establishment
Figure 4.2 Extractables and Leachables Testing Service Providers: Distribution of by Size 
Figure 4.3 Extractables and Leachables Testing Service Providers: Distribution by Geographical Location and Scale of Operation
Figure 4.4 Extractables and Leachables Testing Service Providers: Regional Market Landscape 
Figure 4.5 Extractables and Leachables Testing Service Providers: Distribution by Type of Products
Figure 4.6 Extractables and Leachables Testing Service Providers: Distribution by Type of Pharmaceutical Products Tested
Figure 4.7 Extractables and Leachables Testing: Distribution by Type of Container Closure Systems and Medical Devices Tested
Figure 4.8 Extractables and Leachables Testing Service Providers: Distribution by Type of Techniques
Figure 4.9 Key Players: Compliance to Existing Regulatory Standards
Figure 5.1 Company Competitiveness Analysis: North America
Figure 5.2 Company Competitiveness Analysis: Europe
Figure 5.3 Company Competitiveness Analysis: Asia Pacific
Figure 6.1 Agilent: Peer Group-based Benchmarking Analysis
Figure 6.2 AMRI: Peer Group-based Benchmarking Analysis
Figure 6.3 EKG Labs: Peer Group-based Benchmarking Analysis
Figure 6.4 High Street Capital: Peer Group-based Benchmarking Analysis
Figure 6.5 PPD: Peer Group-based Benchmarking Analysis
Figure 6.6 Quantex Laboratory: Peer Group-based Benchmarking Analysis
Figure 6.7 Sterigenics International: Peer Group-based Benchmarking Analysis
Figure 6.8 VR Analytical: Peer Group-based Benchmarking Analysis
Figure 6.9 Eurofins: Peer Group-based Benchmarking Analysis
Figure 6.10 SGS: Peer Group-based Benchmarking Analysis
Figure 6.11 Smithers Rapra: Peer Group-based Benchmarking Analysis
Figure 6.12 Vitas: Peer Group-based Benchmarking Analysis
Figure 6.13 Nextar Chempharma Solutions: Peer Group-based Benchmarking Analysis
Figure 6.14 Vimta: Peer Group-based Benchmarking Analysis
Figure 7.1 Acquisitions: Year-Wise Trend (2013-2018)
Figure 7.2 Acquisitions: Experience and Size of the Acquired Company
Figure 7.3 Extractables and Leachables Acquisitions: Geographical Activity
Figure 7.4 Extractables and Leachables Acquisitions: Intercontinental and Intracontinental Distribution 
Figure 7.5 Extractables and Leachables Acquisitions: Ownership Change Matrix
Figure 8.1 USFDA’s Considerations for Leachables Testing 
Figure 8.2 Special Considerations for Extractables and Leachables Testing in Parenteral Products
Figure 8.3 Risk-Based Approach to Extractables and Leachables Testing
Figure 8.4 Decision Tree for Disposable Manufacturing
Figure 9.1 Extractables and Leachables Testing Services Market, 2018-2028 (USD Million)
Figure 9.2 Extractables and Leachables Testing Services Market, 2018-2028: Distribution by Geography (USD Million)
Figure 9.3 Extractables and Leachables Testing Services Market: North America, 2018-2028 (USD Million)
Figure 9.4 Extractables and Leachables Testing Services Market: Europe, 2018-2028 (USD Million)
Figure 9.5 Extractables and Leachables Testing Services Market: Asia Pacific, 2018-2028 (USD Million)
Figure 9.6 Extractables and Leachables Testing Services Market: Rest of the World, 2018-2028 (USD Million)
Figure 9.7 Extractables and Leachables Testing Services: Market for Pharmaceutical Products, 2018-2028 (USD Million)
Figure 9.8 Extractables and Leachables Testing Services: Market for Container / Closures and Packaging Material, 2018-2028 (USD Million)
Figure 10.1 List of Approved Drugs (2014-2018): Analysis by Approval Year
Figure 10.2 List of Approved Drugs (2014-2018): Analysis by Type of Primary Packaging Container 
Figure 10.3 List of Approved Drugs (2014-2018): Analysis by Type of Primary Packaging Container and Type of Molecule 
Figure 10.4 List of Approved Drugs (2014-2018): Analysis by Type of Primary Packaging    Container and Dosage Form
Figure 10.5 List of Approved Drugs (2014-2018): Summary by Primary Packaging Containers

List of Tables

Table 3.1 Physical and Chemical Indicators for Leachable Impurities
Table 3.2 Pharmaceutical Products / Components: Leachable Impurities Risk 
Table 3.3 Volatile Organic Impurities: Threshold Levels (USP 467)
Table 4.1 Extractables and Leachables Testing Service Providers: List of Industry Players
Table 6.1 Extractables and Leachables Testing Service Providers: List of Companies Profiled
Table 6.2 Agilent: Extractables and Leachables Testing Services Portfolio
Table 6.3 Agilent: Recent Developments and Future Outlook
Table 6.4 AMRI (Whitehouse Laboratories): Extractables and Leachables Testing Services Portfolio
Table 6.5 AMRI (Whitehouse Laboratories): Recent Developments and Future Outlook
Table 6.6 EKG Labs: Extractables and Leachables Testing Services Portfolio
Table 6.7 EKG Labs: Recent Developments and Future Outlook
Table 6.8 High Street Capital (Avomeen): Extractables and Leachables Testing Services Portfolio
Table 6.9 High Street Capital (Avomeen): Recent Developments and Future Outlook
Table 6.10 PPD: Extractables and Leachables Testing Services Portfolio
Table 6.11 PPD: Recent Developments and Future Outlook
Table 6.12 Quantex Laboratories: Extractables and Leachables Testing Services Portfolio
Table 6.13 Quantex Laboratories: Recent Developments and Future Outlook
Table 6.14 Sterigenics International (Nelson Labs): Extractables and Leachables Testing Services Portfolio
Table 6.15 Sterigenics International (Nelson Labs): Recent Developments and Future Outlook 
Table 6.16 VR Analytical: Extractables and Leachables Testing Services Portfolio
Table 6.17 VR Analytical: Recent Developments and Future Outlook 
Table 6.18 Eurofins (EAG Laboratories): Extractables and Leachables Testing Services Portfolio
Table 6.19 Eurofins (EAG Laboratories): Recent Developments and Future Outlook
Table 6.20 SGS (Polymer Solutions): Extractables and Leachables Testing Services Portfolio
Table 6.21 SGS (Polymer Solutions): Recent Developments and Future Outlook
Table 6.22 Smithers Rapra: Extractables and Leachables Testing Services Portfolio
Table 6.23 Smithers Rapra: Recent Developments and Future Outlook
Table 6.24 Vitas: Extractables and Leachables Testing Services Portfolio
Table 6.25 Vitas: Recent Developments and Future Outlook
Table 6.26 Nextar Chempharma Solutions: Extractables and Leachables Testing Services Portfolio
Table 6.27 Nextar Chempharma Solutions: Recent Developments and Future Outlook
Table 6.29 Vimta: Extractables and Leachables Testing Services Portfolio
Table 6.30 Vimta: Recent Developments and Future Outlook
Table 7.1 Extractables and Leachables Service Providers: List of Acquisitions
Table 7.2 Acquisitions: Deal Multiples
Table 8.1 Safety Concerns for Leachables in Pharmaceutical Products
Table 8.2 USFDA: Threshold Levels for Leachables Testing
Table 8.3 PQRI: Safety Classification of Extractables and Leachables 
Table 10.1 Recently Approved Drugs (2014-2018): List of Primary Packaging Containers Used 
Table 13.1 Extractables and Leachables Testing Service Providers: Distribution by Year of Establishment
Table 13.2 Extractables and Leachables Testing Service Providers: Distribution of by Size (Employee Count)
Table 13.3 Extractables and Leachables Testing Service Providers: Distribution by Geographical Location and Scale of Operation
Table 13.4 Extractables and Leachables Testing Service Providers: Regional Market landscape 
Table 13.5 Extractables and Leachables Testing Service Providers: Distribution by Type of Products
Table 13.6 Extractables and Leachables Testing Service Providers: Distribution by Type of Pharmaceutical Products Tested
Table 13.7 Extractables and Leachables Testing: Distribution by Type of Container Closure Systems and Medical Devices Tested
Table 13.8 Extractables and Leachables Testing Service Providers: Distribution by Type of Techniques
Table 13.9 Acquisitions: Year-Wise Trend
Table 13.10 Acquisitions: Geographical Activity
Table 13.11 Acquisitions: Distribution by International and Local Acquisitions
Table 13.12 Extractables and Leachables Acquisitions: Ownership Change Matrix
Table 13.13 Extractables and Leachables Testing Services Market, 2018-2028 (USD Million), Base Case
Table 13.14 Extractables and Leachables Testing Services Market, 2018-2028 (USD Million), Conservative Case
Table 13.15 Extractables and Leachables Testing Services Market, 2018-2028 (USD Million), Optimistic Case
Table 13.16 Extractables and Leachables Testing Services Market, 2018-2028: Distribution by Geography (USD Million)
Table 13.17 Extractables and Leachables Testing Services Market: North America, 2018-2028 (USD Million)
Table 13.18 Extractables and Leachables Testing Services Market: Europe, 2018-2028 (USD Million)
Table 13.19 Extractables and Leachables Testing Services Market: Asia Pacific, 2018-2028 (USD Million)
Table 13.20 Extractables and Leachables Testing Services Market: Rest of the World, 2018-2028 (USD Million)
Table 13.21 Extractables and Leachables Testing Services: Market for Pharmaceutical Products, 2018-2028 (USD Million)
Table 13.22 Extractables and Leachables Testing Services: Market for Container / Closures and Packaging Material, 2018-2028 (USD Million)
Table 13.23 List of Approved Drugs (2014-2018): Analysis by Approval Year
Table 13.24 List of Approved Drugs (2014-2018): Analysis by Type of Primary Packaging Container
Table 13.25 List of Approved Drugs (2014-2018): Analysis by Type of Primary Packaging Container and Type of Molecule
Table 13.26 List of Approved Drugs (2014-2018): Analysis by Type of Primary Packaging    Container and Dosage Form
Table 13.27 List of Approved Drugs (2014-2018): Summary by Primary Packaging Containers
 

List of Companies

The following companies and organizations have been mentioned in the report:AbbVie

  1. AbbVie
  2. ABC Laboratories 
  3. ACADIA Pharmaceuticals
  4. Achaogen
  5. Acrux
  6. Actelion Pharmaceuticals
  7. Advanced Accelerator Applications
  8. AdvantaPure
  9. Aerie Pharmaceuticals
  10. Agilent Technologies 
  11. Agios Pharmaceuticals
  12. AkaRx
  13. Akron Rubber Development Laboratory 
  14. Alcami
  15. Alcon 
  16. ALcontrol Laboratories
  17. Alera Labs
  18. Alexion Pharmaceuticals
  19. Alkermes
  20. Allergan
  21. Alliance Medical Acquisitionco 
  22. American Preclinical Services
  23. Amgen
  24. Ampersand Capital Partners 
  25. AnaCipher
  26. Anacor Pharmaceuticals
  27. Analytica Chemie
  28. Argis Pharmaceutical Research and Development 
  29. ARIAD Pharmaceuticals
  30. Array BioPharma
  31. Astellas Pharma
  32. AstraZeneca
  33. Avista Pharma Solutions 
  34. Avomeen 
  35. Azierta
  36. Bausch & Lomb
  37. Bayer HealthCare Pharmaceuticals 
  38. Bibra Toxicology Advice & Consulting  
  39. BioCryst Pharmaceuticals
  40. Biogen
  41. BioMarin Pharmaceutical
  42. BioScreen Testing Services
  43. Bloodworks Northwest 
  44. Blue Earth Diagnostics 
  45. Boehringer Ingelheim
  46. Boston Analytical
  47. Boston Scientific 
  48. Bracco Diagnostics
  49. Bristol-Myers Squibb
  50. Bureau Veritas
  51. Cambrex
  52. Cambridge Polymer Group
  53. Capsugel
  54. Catalent Pharma Solutions
  55. Celgene
  56. Chelsea Therapeutics
  57. Chemic Laboratories
  58. Chemical Solutions
  59. ChemPartner
  60. Chiesi USA
  61. ChRi Laboratories
  62. Cinven
  63. Cleveland Cord Blood Center
  64. ClinImmune Labs 
  65. Clovis Oncology
  66. Concept Life Sciences
  67. Confarma
  68. Covance
  69. Crawford Scientific
  70. Crenza Pharmaceuticals
  71. Criterion Scientific
  72. Cubist Pharmaceuticals
  73. Daiichi Sankyo
  74. Danaher 
  75. Datwyler 
  76. Duke University School of Medicine
  77. Durata Therapeutics
  78. DYNAMICRO LABS
  79. EAG Laboratories
  80. Eisai
  81. EKG Labs
  82. Element Materials Technology 
  83. Eli Lilly
  84. Elusys Therapeutics
  85. EMD Serono
  86. Encompass Pharmaceutical Services
  87. EOS Scientific
  88. Eurofins Scientific
  89. Eutech Scientific Services 
  90. Excite Pharma Services
  91. Exova
  92. ExtLe Solutions
  93. Fan Testing Laboratory  
  94. Ferrer
  95. Fibrocell Technologies
  96. FirstSource Laboratory Solutions 
  97. Fresenius Kabi
  98. Gateway Analytical
  99. GBA Pharma 
  100. GE Healthcare Life Sciences
  101. Genentech
  102. Gilead Sciences
  103. GlaxoSmithKline 
  104. GRAM Laboratories 
  105. Greenwich Biosciences
  106. GVK BIO 
  107. GVS Cibatech
  108. Hall Analytical Laboratories 
  109. Halo Pharma 
  110. HDH Pharma
  111. Helsinn Healthcare 
  112. High Street Capital
  113. Impact Analytical
  114. Indoco Remedies
  115. InnoGen Pharmaceuticals
  116. Insud Pharma ChemTrace
  117. Intercept Pharmaceuticals
  118. Intertek 
  119. Ironwood Pharmaceuticals
  120. iuvo BioScience
  121. Janssen
  122. Janssen Biotech
  123. Jazz Pharmaceuticals
  124. Jordi Labs
  125. KAI Pharmaceuticals
  126. Kite Pharma
  127. Kymos Pharma Services 
  128. KYTHERA Biopharmaceuticals 
  129. La Jolla Pharmaceutical Company
  130. LabCorp
  131. Lexicon Pharmaceuticals
  132. LGC
  133. LifeSouth Community Blood Centers
  134. Limerston Capital 
  135. Lonza
  136. Lucideon
  137. Lunaria
  138. Lupin Pharmaceuticals
  139. Madison Dearborn Partners 
  140. Mass Spec Lab
  141. Maxxam Analytics
  142. Medibrane
  143. Medical Engineering Technologies
  144. Medicines Development for Global Health
  145. Melinta Therapeutics
  146. Merck
  147. Mérieux NutriSciences 
  148. Microbac Laboratories
  149. Millennium Pharmaceuticals
  150. Mitsubishi Tanabe Pharma
  151. mKnal Global Solutions
  152. NAMSA
  153. National Institute for Bioprocessing Research and Training 
  154. National Science Foundation 
  155. NeoGenomics Laboratories 
  156. Neurocrine Biosciences
  157. New York Blood Center
  158. Next Breath
  159. Nextar Chempharma Solutions
  160. Nitto Avecia Pharma Services 
  161. Novartis
  162. Novo Nordisk
  163. NPS Pharmaceuticals
  164. Organogenesis
  165. Organon International
  166. Otsuka Pharmaceutical
  167. Pace Analytical Life Sciences 
  168. Pacific BioLabs
  169. Paladin Labs 
  170. Pall 
  171. Pfizer
  172. Pharmaceutical Product Development 
  173. Pharmalytica Services
  174. Pharmaprogress
  175. Pine Lake Laboratories
  176. Piramal Pharma Solutions
  177. Polymer Solutions 
  178. Portola Pharmaceuticals
  179. Primera Analytical Solutions
  180. PTC Therapeutics
  181. Puma Biotechnology
  182. Quadriga Capital 
  183. Quality Chemical Laboratories
  184. Quantex Laboratories
  185. Radius Health
  186. Reading Scientific Services 
  187. Recipharm
  188. Regeneron Pharmaceuticals
  189. Relypsa
  190. Rempex Pharmaceuticals
  191. Retrophin
  192. Rigel Pharmaceuticals
  193. Roche
  194. Sanofi
  195. Sanofi Genzyme 
  196. Sarepta Therapeutics
  197. Sartorius
  198. SCHOTT
  199. SCIENT ANALYTICS
  200. SG Laboratory 
  201. SGS
  202. Shionogi
  203. Shire 
  204. SIGA Technologies
  205. Sigma-Aldrich 
  206. Sipra Labs 
  207. Smithers Rapra
  208. Solvias
  209. Spark Therapeutics
  210. Spectris 
  211. Spectrum Pharmaceuticals
  212. Sprout Pharmaceuticals
  213. SSM Health Cardinal Glennon Children's Hospital 
  214. Sterigenics 
  215. Strongbridge Biopharma
  216. Sun Pharmaceutical Industries
  217. Synergy Bioscience
  218. Synergy Pharmaceuticals
  219. SYNLAB International 
  220. Taiho Pharmaceutical 
  221. TaiMed Biologics
  222. Takeda Pharmaceuticals
  223. Tentamus Group 
  224. Terumo Medical 
  225. TESARO
  226. Teva Pharmaceutical Industries
  227. Teva Respiratory
  228. THE FORCE
  229. The Medicines Company
  230. Thermo Fisher Scientific
  231. Toxicology Knowledge Team 
  232. Toxikon 
  233. Tun Abdul Razak Research Centre
  234. TÜV SÜD 
  235. Ultragenyx Pharmaceutical
  236. Union Chimique Belge
  237. United Therapeutics
  238. US WorldMeds
  239. Valeant Pharmaceuticals Luxembourg
  240. Valeant Pharmaceuticals North America
  241. VANDA Pharmaceuticals
  242. Vanta Bioscience 
  243. Vela Labs
  244. Vericel
  245. Vertex Pharmaceuticals
  246. Vimta Labs 
  247. Vitas 
  248. VR Analytical
  249. VxP Pharma
  250. Wellstat Therapeutics
  251. West Pharmaceutical Services 
  252. Whitehouse Laboratories
  253. Wolfe Laboratories
  254. WuXi AppTec
  255. Wyeth
     

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