Dublin, Nov. 05, 2018 (GLOBE NEWSWIRE) -- The "Extractables and Leachables Testing Services Market, 2018-2028" report has been added to ResearchAndMarkets.com's offering.

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)

Key Topics Covered:

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
6.2.2. AMRI (Whitehouse Laboratories)
6.2.3. EKG Labs
6.2.4. High Street Capital (Avomeen)
6.2.5. PPD
6.2.6. Quantex Laboratories
6.2.7. Stringencies International (Nelson Labs)
6.2.8. VR Analytical
6.3. Key Players in Europe
6.3.1. Eurofins (EAG Laboratories)
6.3.2. SGS (Polymer Solutions)
6.3.3. Smithers Rapra
6.3.4. Vitas Analytical Services
6.4. Key Players in Asia Pacific
6.4.1. Nextar Chempharma Solutions
6.4.2. Vimta

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
9.5. 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

• 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
• Mrieux 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
• TV SD
• 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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