Alere, Inc.

DUBLIN--( BUSINESS WIRE )--The "In Vitro Diagnostics (IVD) Quality Controls: Global Market" report has been added to ResearchAndMarkets.com's offering. The global market for In Vitro diagnostics quality controls is expected to grow from $1.5 billion in 2024 and is projected to reach $2.1 billion by the end of 2029, at a compound annual growth rate (CAGR) of 7.8% during the forecast period of 2024 to 2029. This report provides details about the market for in vitro diagnostics quality controls used in checking the in vitro diagnostic devices present in labs, clinics and hospitals. This report will also highlight the current and future market potentiality of in vitro diagnostics quality controls, with a detailed analysis of the competitive environment between companies. Drivers, restraints, opportunities, prevalence or incidence of chronic diseases, and a regulatory scenario assessment will be covered in the current report. The report includes market projections for 2029 and market shares for key players. Based on test type, the market is segmented into immunodiagnostics, clinical chemistry, hematology and hemostasis, molecular diagnostics, microbiology, and others. Based on products and services, the market is categorized into quality control products, data management solutions and quality assurance services. Based on type of manufacturer, the market is segmented into third-party controls and OEM controls. Based on end users, the market is segmented into hospitals, diagnostic laboratories and academic institutions. By geographical region, the market has been segmented into North America, Europe, Asia-Pacific, and Rest of the World. Detailed analyses of major countries such as the U.S., Germany, the U.K., Italy, France, Spain, Japan, China, India, Brazil, Mexico, and GCC countries are covered within the regional segments. For market estimates, data will be provided for 2023 as the base year, with estimates for 2024 and forecast value for 2029. Report Includes 40 data tables and 40 additional tables An overview of the global market for in vitro diagnostics (IVD) quality controls Analysis of global market trends, featuring revenue data for 2021-2023, estimated figures for 2024, and projected CAGRs through 2029 Evaluation of the current market's size and revenue growth prospects, along with a market share analysis by test type, manufacturer, product/services, end user and region Discussion of market drivers and restraints and other dynamics Assessment of the regulatory landscape, including product recalls Analysis of the key companies' market shares, recent M&A activity, acquisitions, joint ventures, partnerships, and patents Company profiles including Abbott, bioMerieux, F. Hoffmann-La Roche Ltd., Siemens Healthineers, and Thermo Fisher Scientific Inc. Company Profiles Abbott BD Biomerieux Bio-Rad Laboratories Inc. Bio-Techne Danaher Corp. F. Hoffmann-La Roche Ltd. Microbiologics Quidelortho Corp. Siemens Heathnieers Ag Sysmex Corp. Thermo Fisher Scientific Inc. Key Topics Covered: Chapter 1 Executive Summary Market Outlook Scope of Report Market Summary Chapter 2 Market and Technology Background Introduction Overview Classification of In Vitro Diagnostics Elements Importance of In Vitro Diagnostics Quality Control Regulations Regulation of IVD products in Different countries Chapter 3 Market Dynamics Market Drivers Rise in the Aging Population and Dependency on Frequent Diagnosis Procedures Rising Demand for Third-Party Quality Control Products Rising Incidence of Chronic Disease Cases Strengthening Clinical Laboratories Improving the Quality of Point-of-Care Testing Market Restraints Challenges for Quality Control Product Packaging Increases in Shipping Costs or Service Issues Improper Operation and Maintenance of Laboratory Equipment and Consumables Market Opportunities Rise in Home Care Testing Devices Demand for Point-of-Care (POC) Testing Units Chapter 4 Emerging Technologies and Developments Artificial Intelligence Prioritizing Old IVD Techniques Automating In-Vitro Diagnostic Devices Emerging Trends in In Vitro Diagnostics FDA Approval Rise in Demand for Personalized Medicine Chapter 5 Market Segmentation Analysis Segmentation Breakdown Market Breakdown by Test Type Immunodiagnostics Clinical Chemistry Hematology Molecular Diagnostics Microbiology Other Test Types Market Breakdown by Type of Manufacturer Third-party Controls ODM Controls Market Breakdown by Products and Services Quality Control Products Data Management Solutions Quality Assurance Services Market Breakdown by End User Diagnostic Laboratories Hospitals and Clinics Point-of-Care Centers Research Institutions Other End Users Geographic Breakdown Market Analysis by Region North America Market Size and Forecast U.S. Canada Mexico Europe Market Size and Forecast Germany France U.K. Italy Spain Rest of Europe Asia-Pacific Market Size and Forecast Japan China India Australia and New Zealand Rest of Asia-Pacific Rest of the World Market Size and Forecast Brazil GCC Countries Rest of the World Countries Chapter 6 Competitive Intelligence Introduction Global Analysis of Company Market Ranking Agreements, Collaborations and Partnerships In Vitro Diagnostics Developments and Startups, 2021-2023 Chapter 7 Sustainability Importance of ESG in the In Vitro Diagnostics Industry ESG Practices in the In Vitro Diagnostics Industry Environmental Performance Social Performance Governance Performance Case Studies Publisher Viewpoint Chapter 8 Appendix For more information about this report visit https://www.researchandmarkets.com/r/qp1yas About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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After the blow of an FDA rejection, Lykos Therapeutics is facing another hit. Psychopharmacology has pulled three articles about midstage clinical trial data assessing Lykos Therapeutics’ investigational MDMA candidate for treating post-traumatic stress disorder (PTSD). The journal cited “unethical conduct” at a research site as the reason for the retraction.The article removals are related to protocol violations at a study site that was involved in phase 2 trials assessing midomafetamine, an MDMA capsule designed to be delivered alongside psychological intervention that was just denied FDA approval on Friday. The studies included in the retracted articles were not the same studies that underpinned Lykos’ request for FDA approval.Authors with their names attached to the papers have subsequently confirmed they were aware of the protocol violations when the articles were submitted for publication but didn’t say anything about it to Psychopharmacology nor exclude the data coming from the site, according to the retraction notices.One of the authors is Lykos CEO Amy Emerson, while several other authors are associated with Lykos’ parent company Multidisciplinary Association for Psychedelic Studies (MAPS) or a MAPS subsidiary dubbed MAPS Public Benefit Corporation. “Lykos has been made aware that three articles that had been previously published including pooled data from a 2015 phase 2 study have been retracted by Psychopharmacology,” a company spokesperson told Fierce Biotech in an emailed statement. “Lykos disagrees with this retraction and believes the identified issues should have been addressed through corrections. Lykos has filed an official complaint with the Committee on Publication Ethics (COPE) to review the process through which the journal came to this decision.”MAPS fully funded the trials and the company’s subsidiary organized the trials, as stated in the funding declarations. However, Psychopharmacology says the authors didn’t fully declare a potential competing interest, a claim Lykos denies.“The journal also raised an issue regarding disclosure around conflict of interest, however, the authors did appropriately disclose contributions, funding sources and affiliations,” the biotech spokesperson said.Lykos went on to say that the articles “remain scientifically sound” and present important contributions to the field of potential PTSD treatments. “The journal’s retraction decision cites concern with the inclusion of data from the 2015 MP4 phase 2 study where there was a previously known, widely reported case of unethical therapist conduct,” according to the Lykos spokesperson.That therapist has been accused of practicing without a license and of sexually assaulting a MAPS trial participant, according to Stat. “Originally, the publication authors chose to retain these data for sake of completeness, but that should have been disclosed to the journal and was not,” the Lykos spokesperson continued. “The ethical violations at issue were reported to the FDA, Health Canada and the Institutional Review Board (IRB)/Independent Ethics Committee (IEC), and a public statement was issued in May 2019. However, we did not disclose the violations to the journal itself, an additional step we should have taken and regret not doing.”The MDMA-focused biotech initially requested a correction to the journal, the Lykos spokesperson said, adding that the authors removed the data from the four participants treated at the site. Afterward, the updated analyses remained consistent with the original publications.The Journal of Traumatic Stress has decided that a correction is the proper response for another article that included data from the same study, the spokesperson added.Allison Feduccia, Ph.D., an author of all three papers and affiliate of MAPS Public Benefit Corporation, said she agreed with the retraction but disagreed with the wording of the notice, according to the retraction.Meanwhile, several other authors including MAPS founder Rick Doblin, Ph.D., disagree with the retraction. Lykos' CEO didn’t respond to the publisher about the retraction, according to Psychopharmacology.  The retractions closely follow the FDA rejection of Lykos’ midomafetamine at the end of last week. In its complete response letter to Lykos, the drug agency said it couldn't approve the treatment based on the data submitted, according to the company. The regulator has requested that Lykos run another phase 3 trial to further weigh the efficacy and safety of MDMA-assisted therapy for PTSD.For its part, Lykos said it plans to request a meeting to ask the FDA to reconsider the decision.

A day after the Food and Drug Administration rejected MDMA as a therapy aid for post-traumatic stress disorder, a scientific journal retracted three papers about the treatment, citing “unethical conduct.“Editors at Psychopharmacology said they were informed by researchers associated with the studies of protocol violations at a testing site in Canada. This is the same site where, years prior, an unlicensed therapist was accused of sexually assaulting a participant during a mid-stage clinical trial of MDMA-assisted therapy, which the California-based biotechnology company Lykos Therapeutics has been developing.According to the journal, the authors have confirmed they were aware of the ethical violations at the time the papers were submitted but didnt disclose that information or remove data generated by the Canada site from their analysis.The journal also claims the authors failed to declare a potential competing interest. At least two from each of the articles had affiliations with either the Multidisciplinary Association for Psychedelic Studies known, in short, as MAPS or the MAPS Public Benefit Corp., which was the precursor to Lykos. The founder of MAPS, Rick Doblin, and the CEO of Lykos, Amy Emerson, are listed as authors on two of the papers.In a statement, Lykos noted how the violations at the Canada site were reported to the FDA, Canadas drug review agency and an independent group meant to monitor and uphold ethical standards in clinical research. The publication authors included data from the site for sake of completeness, but that should have been disclosed to the journal and was not. Lykos said it regrets not taking that additional step.At the journals request, the authors removed data from four participants at the Canada site. The updated results were consistent with the original publications, according to Lykos.As for the conflicts of interest, the company maintains that the authors appropriately disclosed contributions, funding sources and affiliations.Lykos said it disagrees with the retractions and believes the more appropriate way to address the journals concerns would be to issue corrections to the original papers. The company has filed a complaint with a third party to review the way the journal came to its decision.The data included in the three papers are not what Lykos used in its approval application. One looked at pooled results from six mid-stage studies to assess the long-term effects of MDMA-assisted psychotherapy for PTSD. The second used those same pooled data to inform the design and rationale for a late-stage program. The third examined how patient responses to MDMA-assisted psychotherapy are affected by a class of psychiatric medications known as reuptake inhibitors.Lykos approval application, meanwhile, hinged on results from a pair of Phase 3 studies that found MDMA, when administered alongside talk therapy, led to significant reductions in the severity of PTSD symptoms.Such positive results are rare in psychiatric drug development, which, among other challenges, has almost none of biological markers that scientists need to build better treatments. In PTSD alone, its been more than two decades since a new medicine received FDA approval.That drought put pressure on the FDA to clear Lykos application. But agency staff have expressed doubts over the strength of the results and the way Lykos gathered and analyzed them.According to the company, the FDA ultimately concluded that approval couldnt be granted based on the data submitted. The regulator has requested another Phase 3 trial be run to further evaluate the safety and efficacy of MDMA. Lykos, though, plans to ask the agency to reconsider its decision. '