Extractables and Leachables Testing Services Market, 2028 - After Several Drug / Medical Device Recalls, Extractables and Leachables Testing has Now become a Pre-Requisite for Regulatory Approval

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Nov 06, 2018, 07:45 ET

DUBLIN, Nov. 6, 2018 /PRNewswire/ --

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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