Lowest Price Guaranteed From USD 3,499
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.
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.
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:
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:
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.