Driven by regulatory mandate, the extractables and leachables testing services market is anticipated
By: Roots Anlaysis
Ishita Nanda, the principal analyst, stated, "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. Presently, over 100 companies offer services for extractables and leachables testing, and such offerings have grown to become an important segment of the overall pharmaceutical industry."
The report presents opinions on several key aspects of the market. Among other elements, it includes:
1. 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.
2. 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. Approximately 50% of the companies are based in the US. Examples of key players in this region include 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 Eurofins, First Source Laboratories, GVK Biosciences, Intertek, LGC, Reading Scientific Services, Sartorius, Schott and WuXi AppTec.
3. Comprehensive profiles of service providers, featuring 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.
4. A detailed analysis of the acquisitions that have taken place in this domain, featuring an ownership change matrix and a detailed financial evaluation of the deals (in terms of company revenues and deal multiples). 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 known) 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.
5. 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. Majority of the service providers claim to operate in compliance to guidelines issued by the FDA. Nearly 50 service providers have based their working protocols in accordance to 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.
6. Detailed forecast highlighting the likely evolution of the market in different regions, including North America, Europe, Asia-Pacific and the rest of the world. In addition, the study includes likely distribution of the opportunity across the types of products being tested (pharmaceutical products, container closure systems, medical devices and combination products). 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%.
The report features inputs from a number of eminent industry stakeholders. Nanda remarked, "Most of the experts we spoke to mentioned that extractables and leachables testing is one of the relatively faster growing fields in the pharmaceutical industry and is primarily being driven by companies that are making new devices, new drugs, or new packaging systems." The report features detailed transcripts of discussions held with the following experts:
1. Cheryl Johnson (Commercial Development Manager of Biotechnology, Alcami)
2. Mike Ludlow (Technical Study Manager Drug Development Services, LGC)
3. Mourad Rahi (Director of Analytical Services, American Preclinical Services)
4. Roger Pearson (President of Analytical Services, Aspen Research)
The research covers detailed profiles and assesses product portfolios of several companies, including (illustrative list, may not be comprehensive)
3. EKG Labs
4. High Street Capital
6. Quantex Laboratories
7. Stringencies International
8. VR Analytical
11. Smithers Rapra
12. Vitas Analytical Services
13. Nextar Chempharma Solutions
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