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Extractables and Leachables Testing Services Market, 2018-2028

  • ID: 4662805
  • Report
  • 200 Pages
  • Roots Analysis
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Extractables And Leachables Testing Services Market to Grow at an Annualized Rate Of ~10% Between 2018 and 2028

FEATURED COMPANIES

  • AbbVie
  • Boston Analytical
  • EMD Serono
  • Kite Pharma
  • Pharmaprogress
  • Sterigenics
  • MORE

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. Extractable is the term used to refer to a compound that is 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 from 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.

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, featuring a brief 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 of 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.

Note: Product cover images may vary from those shown
2 of 4

FEATURED COMPANIES

  • AbbVie
  • Boston Analytical
  • EMD Serono
  • Kite Pharma
  • Pharmaprogress
  • Sterigenics
  • MORE

1. Preface
 
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

Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • AbbVie
  • Boston Analytical
  • EMD Serono
  • Kite Pharma
  • Pharmaprogress
  • Sterigenics
  • MORE

Example Highlights

  • During our research, we identified over 100 players offering a wide range of extractables and until testing services for a variety of pharmaceutical products (such as parenteral formulations, ophthalmic formulations, inhalation drugs, oral solutions and topical or transdermal products), medical devices (such as single use systems, combination products, implants and electronic nicotine delivery systems) and container closure systems. Some players claim to offer services for the majority of the products listed above. Examples of such players include (in alphabetical order) American Preclinical Services, Bibra Toxicology Advice & Consulting, Sterigenics, Pine Lake Laboratories, Smithers Rapra and Vimta. It is also worth mentioning that the market is highly fragmented, featuring the presence of several large companies (33%), mid-sized companies (26%) and small-sized companies (41%).
  • Approximately 50% of the companies offering extractables and leachables testing services are based in North America, primarily in the US. Examples of key players in this region include (in alphabetical order, no specific selection criteria) Aspen, Alcami, EKG Labs, Merck, NSF and VR Analytical. On the other hand, close to 35% of such companies are based in Europe, while the remaining are located in the Asia Pacific and the rest of the world. Examples of service providers based in the Europe and Asia Pacific include (in alphabetical order, no specific selection criteria) Eurofins, First Source Laboratories, GVK Biosciences, Intertek, LGC, Reading Scientific Services, Sartorius, Schott and WuXi AppTec.
  • Companies engaged in this domain use a diverse range of analytical techniques, such as GC-MS, LC-MS, ICP, HPLC, FT-IR and NMR, for the detection of a wide range of potential impurities in pharmaceutical products and / or primary packaging. Over 30% of the companies we identified offer the necessary expertise for a relatively broader suite of analytical techniques. Examples include (in alphabetical order, no specific selection criteria) ARDL, Avecia Pharma, BioScreen Testing Services, Mérieux NutriSciences Italia, Quantex Laboratories, Recipharm, and VITAS Analytical Services.
  • Nearly 30 acquisitions have taken place among stakeholders in this domain during the period 2013-2018. An evaluation of the financial terms of these deals revealed that over 40% of the companies (for which the acquisition cost was revealed) were acquired for relatively higher deal multiples as compared to their stated revenues at the time of their acquisition. Examples of companies acquired after 2016 include (in alphabetical order) Concept Life Sciences, Crawford Scientific, EAG Laboratories, Halo Pharmaceutical, and Toxikon Europe.
  • Majority of the service providers claim to operate in compliance to guidelines issued by the FDA. In addition, we were able to confirm that nearly 50 service providers have based their working protocols in accordance with US Pharmacopeia guidelines. Similar guidelines (specific to analytical testing) have also been laid down by other regulatory authorities across the globe; examples include ICH, EMEA, MHRA, PQRI, BPOG and ISO.
  • We expect the extractables and leachables testing services market to grow at an annualized rate of ~10% in the period between 2018 and 2028. It is important to mention that small and mid-sized service providers with expertise in analytical testing services, including extractables and leachables testing, are estimated to currently capture nearly 30% of the overall market share; by 2028, this share is likely to grow up to 40%.
  • In terms of the geographical activity, North America (primarily US) and Europe currently capture the largest share (close to 60%) in the extractable and leachables services market. This is followed by Asia Pacific and the rest of the world, which currently capture around 40% of the overall market share. This trend is not likely to change significantly in the future.

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

The secondary sources of information include:

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

Chapter Outlines

  • 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 the number of products tested, the number of techniques used, the 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 presents detailed 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 presents a 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.
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  • AbbVie
  • ABC Laboratories
  • ACADIA Pharmaceuticals
  • Achaogen
  • Acrux
  • Actelion Pharmaceuticals
  • Advanced Accelerator Applications
  • AdvantaPure
  • Aerie Pharmaceuticals
  • Agilent Technologies
  • Agios Pharmaceuticals
  • AkaRx
  • Akron Rubber Development Laboratory
  • Alcami
  • Alcon
  • ALcontrol Laboratories
  • Alera Labs
  • Alexion Pharmaceuticals
  • Alkermes
  • Allergan
  • Alliance Medical Acquisitionco
  • American Preclinical Services
  • Amgen
  • Ampersand Capital Partners
  • AnaCipher
  • Anacor Pharmaceuticals
  • Analytica Chemie
  • Argis Pharmaceutical Research and Development
  • ARIAD Pharmaceuticals
  • Array BioPharma
  • Astellas Pharma
  • AstraZeneca
  • Avista Pharma Solutions
  • Avomeen
  • Azierta
  • Bausch & Lomb
  • Bayer HealthCare Pharmaceuticals
  • Bibra Toxicology Advice & Consulting
  • BioCryst Pharmaceuticals
  • Biogen
  • BioMarin Pharmaceutical
  • BioScreen Testing Services
  • Bloodworks Northwest
  • Blue Earth Diagnostics
  • Boehringer Ingelheim
  • Boston Analytical
  • Boston Scientific
  • Bracco Diagnostics
  • Bristol-Myers Squibb
  • Bureau Veritas
  • Cambrex
  • Cambridge Polymer Group
  • Capsugel
  • Catalent Pharma Solutions
  • Celgene
  • Chelsea Therapeutics
  • Chemic Laboratories
  • Chemical Solutions
  • ChemPartner
  • Chiesi USA
  • ChRi Laboratories
  • Cinven
  • Cleveland Cord Blood Center
  • ClinImmune Labs
  • Clovis Oncology
  • Concept Life Sciences
  • Confarma
  • Covance
  • Crawford Scientific
  • Crenza Pharmaceuticals
  • Criterion Scientific
  • Cubist Pharmaceuticals
  • Daiichi Sankyo
  • Danaher
  • Datwyler
  • Duke University School of Medicine
  • Durata Therapeutics
  • DYNAMICRO LABS
  • EAG Laboratories
  • Eisai
  • EKG Labs
  • Element Materials Technology
  • Eli Lilly
  • Elusys Therapeutics
  • EMD Serono
  • Encompass Pharmaceutical Services
  • EOS Scientific
  • Eurofins Scientific
  • Eutech Scientific Services
  • Excite Pharma Services
  • Exova
  • ExtLe Solutions
  • Fan Testing Laboratory
  • Ferrer
  • Fibrocell Technologies
  • FirstSource Laboratory Solutions
  • Fresenius Kabi
  • Gateway Analytical
  • GBA Pharma
  • GE Healthcare Life Sciences
  • Genentech
  • Gilead Sciences
  • GlaxoSmithKline
  • GRAM Laboratories
  • Greenwich Biosciences
  • GVK BIO
  • GVS Cibatech
  • Hall Analytical Laboratories
  • Halo Pharma
  • HDH Pharma
  • Helsinn Healthcare
  • High Street Capital
  • Impact Analytical
  • Indoco Remedies
  • InnoGen Pharmaceuticals
  • Insud Pharma ChemTrace
  • Intercept Pharmaceuticals
  • Intertek
  • Ironwood Pharmaceuticals
  • iuvo BioScience
  • Janssen
  • Janssen Biotech
  • Jazz Pharmaceuticals
  • Jordi Labs
  • KAI Pharmaceuticals
  • Kite Pharma
  • Kymos Pharma Services
  • KYTHERA Biopharmaceuticals
  • La Jolla Pharmaceutical Company
  • LabCorp
  • Lexicon Pharmaceuticals
  • LGC
  • LifeSouth Community Blood Centers
  • Limerston Capital
  • Lonza
  • Lucideon
  • Lunaria
  • Lupin Pharmaceuticals
  • Madison Dearborn Partners
  • Mass Spec Lab
  • Maxxam Analytics
  • Medibrane
  • Medical Engineering Technologies
  • Medicines Development for Global Health
  • Melinta Therapeutics
  • Merck
  • Microbac Laboratories
  • Millennium Pharmaceuticals
  • Mitsubishi Tanabe Pharma
  • mKnal Global Solutions
  • Mérieux NutriSciences
  • NAMSA
  • National Institute for Bioprocessing Research and Training
  • National Science Foundation
  • NeoGenomics Laboratories
  • Neurocrine Biosciences
  • New York Blood Center
  • Next Breath
  • Nextar Chempharma Solutions
  • Nitto Avecia Pharma Services
  • Novartis
  • Novo Nordisk
  • NPS Pharmaceuticals
  • Organogenesis
  • Organon International
  • Otsuka Pharmaceutical
  • Pace Analytical Life Sciences
  • Pacific BioLabs
  • Paladin Labs
  • Pall
  • Pfizer
  • Pharmaceutical Product Development
  • Pharmalytica Services
  • Pharmaprogress
  • Pine Lake Laboratories
  • Piramal Pharma Solutions
  • Polymer Solutions
  • Portola Pharmaceuticals
  • Primera Analytical Solutions
  • PTC Therapeutics
  • Puma Biotechnology
  • Quadriga Capital
  • Quality Chemical Laboratories
  • Quantex Laboratories
  • Radius Health
  • Reading Scientific Services
  • Recipharm
  • Regeneron Pharmaceuticals
  • Relypsa
  • Rempex Pharmaceuticals
  • Retrophin
  • Rigel Pharmaceuticals
  • Roche
  • Sanofi
  • Sanofi Genzyme
  • Sarepta Therapeutics
  • Sartorius
  • SCHOTT
  • SCIENT ANALYTICS
  • SG Laboratory
  • SGS
  • Shionogi
  • Shire
  • SIGA Technologies
  • Sigma-Aldrich
  • Sipra Labs
  • Smithers Rapra
  • Solvias
  • Spark Therapeutics
  • Spectris
  • Spectrum Pharmaceuticals
  • Sprout Pharmaceuticals
  • SSM Health Cardinal Glennon Children's Hospital
  • Sterigenics
  • Strongbridge Biopharma
  • Sun Pharmaceutical Industries
  • Synergy Bioscience
  • Synergy Pharmaceuticals
  • SYNLAB International
  • Taiho Pharmaceutical
  • TaiMed Biologics
  • Takeda Pharmaceuticals
  • Tentamus Group
  • Terumo Medical
  • TESARO
  • Teva Pharmaceutical Industries
  • Teva Respiratory
  • THE FORCE
  • The Medicines Company
  • Thermo Fisher Scientific
  • Toxicology Knowledge Team
  • Toxikon
  • Tun Abdul Razak Research Centre
  • TÜV SÜD
  • Ultragenyx Pharmaceutical
  • Union Chimique Belge
  • United Therapeutics
  • US WorldMeds
  • Valeant Pharmaceuticals Luxembourg
  • Valeant Pharmaceuticals North America
  • VANDA Pharmaceuticals
  • Vanta Bioscience
  • Vela Labs
  • Vericel
  • Vertex Pharmaceuticals
  • Vimta Labs
  • Vitas
  • VR Analytical
  • VxP Pharma
  • Wellstat Therapeutics
  • West Pharmaceutical Services
  • Whitehouse Laboratories
  • Wolfe Laboratories
  • WuXi AppTec
  • Wyeth
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