Extractable and Leachable Testing Market

Extractable and Leachable Testing Market Overview

The extractable and leachable testing market is estimated to be worth $1 billion in 2028, growing at CAGR of 9.9 % during the forecast period. 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.

Key Companies in Extractable and Leachable Testing Market 

Examples of key companies engaged in extractable and leachable testing market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Agilent, AMRI (Whitehouse Laboratories), EKG Labs, High Street Capital (Avomeen), PPD, Quantex Laboratories, Stringencies International (Nelson Labs), VR Analytical, Eurofins (EAG Laboratories), SGS (Polymer Solutions), Smithers Rapra, Vitas Analytical Services, Nextar Chempharma Solutions and Vimta. This market report includes an easily searchable excel database of all the companies providing extractable and leachable testing services, worldwide.

Scope of the Report

The ‘Extractable and Leachable Testing Market, 2018-2028’ market report provides an extensive study on the current market landscape, market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunities of the extractable and leachable testing market. The market research report features an in-depth analysis, highlighting the diverse capabilities of stakeholders engaged in extractable and leachable testing market.

Amongst various elements, the market research 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 extractable and leachable testing market, 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.

The key objective of extractable and leachable testing market report is to provide a detailed market analysis in order to estimate the existing market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunity for extractable and leachable testing market during the forecast period. 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 market report were influenced by inputs solicited via a comprehensive survey and discussions conducted with several key players in extractable and leachable testing market. The market research 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 market research report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What are extractables and leachables?

Answer: 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.

Question 2: How big is the extractables and leachables testing market?

Answer: The extractable and leachable testing market size is estimated to be worth $1 billion in 2028.

Question 3: What is the projected market growth of the extractable and leachable testing market?

Answer: The extractable and leachable testing industry is expected to grow at compounded annual growth rate (CAGR) of 9.9% during the forecast period 2018 - 2030.

Question 4: Who are the leading companies in the extractables and leachables testing market?

Answer: Agilent, AMRI (Whitehouse Laboratories), EKG Labs, High Street Capital (Avomeen), PPD, Quantex Laboratories, Stringencies International (Nelson Labs), VR Analytical, Eurofins (EAG Laboratories), SGS (Polymer Solutions), Smithers Rapra, Vitas Analytical Services, Nextar Chempharma Solutions and Vimta.

Question 5: Which type of packaging is mostly used for solid drug formulations?

Answer: Close to 95% of the pharmaceutical product manufacturers use blister packaging for solid drug formulations.

Question 6: Players engaged in the extractables and leachables testing market mostly provide services for which type of drug?

Answer: Majority (45%) of the players engaged in the extractable and leachable testing industru provide services for parenteral drugs.