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[pathologylab]

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[marketanalysisdata]

In Vitro Diagnostics (IVD) Industry Size, Trends, Value, Sales and Forecast 2030

The global in vitro diagnostics (IVD) market was valued at approximately USD 77.92 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 4.4% from 2024 to 2030. This growth can be attributed to several factors, including the increasing adoption of IVD technologies due to the rising prevalence of infectious and chronic diseases. The development and integration of automated IVD systems in laboratories and hospitals, which aim to deliver more efficient, accurate, and error-free diagnoses, are also expected to significantly drive market growth. Additionally, the continuous introduction of new IVD products by key industry players contributes to this positive trend. For instance, in November 2023, ARUP Laboratories obtained a CE mark under the EU-IVDR for the AAV5 DetectCDx, a companion diagnostic test that determines the eligibility of patients with severe hemophilia A for BioMarin's gene therapy, Roctavian.

Technological advancements in IVD systems, particularly improvements in accuracy, portability, and cost-effectiveness, are among the high-impact factors influencing this market. Innovations in highly accurate clinical laboratory tests are fostering global adoption of novel IVD diagnostics. For example, in June 2023, Japan's Ministry of Health, Labour, and Welfare granted marketing approval to Toray Industries, Inc. for its Toray APOA2-iTQ, a diagnostic tool used for pancreatic cancer detection. Similarly, in March 2023, Abbott received U.S. FDA clearance for its novel laboratory blood test for Traumatic Brain Injury (TBI). These developments highlight the increasing approval of IVD tests targeting life-threatening diseases, which is expected to create significant opportunities in untapped market segments.

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics (IVD) Market

Leading companies in the IVD market are adopting diverse strategies to strengthen their positions, often introducing new products and forming partnerships to attract more customers and meet evolving diagnostic needs. For instance, in March 2023, BD received 510(k) clearance from the U.S. FDA for its BD Vaginal Panel on the BD COR System, aimed at detecting infectious causes of vaginitis. In August 2023, the Precision Medicine Centre (PMC) partnered with the Regional Molecular Diagnostic Service (RMDS) to implement genomic technology for cancer diagnosis in Northern Ireland. These strategic collaborations and product launches are critical for companies seeking to leverage cutting-edge technologies in diagnostics.

Product Segmentation Insights:

In terms of products, the reagents segment accounted for the largest market share, representing 65.88% of total revenue in 2023. This segment is expected to maintain its dominance, growing at the fastest CAGR from 2024 to 2030. The growth of the reagents segment is driven by extensive research and development (R&D) efforts by key players aimed at developing novel reagents and test kits. For example, in February 2023, BD received market approval for its BD Onclarity HPV Assay, which is used with the ThinPrep Pap Test in the U.S. Ongoing R&D efforts focused on faster cancer detection and precision medicine are prompting companies to concentrate on specialized, profitable areas of the IVD market. In March 2023, QIAGEN formed a partnership with Servier to develop a companion diagnostic test for TIBSOVO, which is indicated for the treatment of acute myeloid leukemia, a type of blood cancer.

The growing demand for precision medicine is expected to further boost the overall demand for these novel reagents and consumables. The instruments segment held the second-largest share of the IVD market in 2023. Increasing approvals of novel IVD instruments are likely to contribute to the segment's growth. For instance, in April 2023, bioMérieux SA submitted a 510(k) application to the U.S. FDA for VITEK REVEAL, a rapid antimicrobial susceptibility testing (AST) system. Moreover, companies are aligning their instrument launches to meet the increasing demand for genetic tests globally. In March 2022, Thermo Fisher Scientific introduced the Ion Torrent Genexus Dx Integrated Sequencer for both research and diagnostic purposes, showcasing the alignment of technological advancements with the growing needs of genetic testing.

In conclusion, the global IVD market is poised for substantial growth, driven by the increasing incidence of infectious and chronic diseases, rising demand for precision medicine, and ongoing advancements in diagnostic technologies. Companies are continuously innovating, launching new products, and forming strategic partnerships to meet the evolving needs of healthcare providers and patients, which will further accelerate market expansion.

Order a free sample PDF of the In Vitro Diagnostics (IVD) Market Intelligence Study, published by Grand View Research.

[marketstudyreport]

In Vitro Diagnostics (IVD) Market Growth Analysis & Forecast Research Report, 2030

The global in vitro diagnostics (IVD) market was valued at approximately USD 77.92 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 4.4% from 2024 to 2030. This growth can be attributed to several factors, including the increasing adoption of IVD technologies due to the rising prevalence of infectious and chronic diseases. The development and integration of automated IVD systems in laboratories and hospitals, which aim to deliver more efficient, accurate, and error-free diagnoses, are also expected to significantly drive market growth. Additionally, the continuous introduction of new IVD products by key industry players contributes to this positive trend. For instance, in November 2023, ARUP Laboratories obtained a CE mark under the EU-IVDR for the AAV5 DetectCDx, a companion diagnostic test that determines the eligibility of patients with severe hemophilia A for BioMarin's gene therapy, Roctavian.

Technological advancements in IVD systems, particularly improvements in accuracy, portability, and cost-effectiveness, are among the high-impact factors influencing this market. Innovations in highly accurate clinical laboratory tests are fostering global adoption of novel IVD diagnostics. For example, in June 2023, Japan's Ministry of Health, Labour, and Welfare granted marketing approval to Toray Industries, Inc. for its Toray APOA2-iTQ, a diagnostic tool used for pancreatic cancer detection. Similarly, in March 2023, Abbott received U.S. FDA clearance for its novel laboratory blood test for Traumatic Brain Injury (TBI). These developments highlight the increasing approval of IVD tests targeting life-threatening diseases, which is expected to create significant opportunities in untapped market segments.

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics (IVD) Market

Leading companies in the IVD market are adopting diverse strategies to strengthen their positions, often introducing new products and forming partnerships to attract more customers and meet evolving diagnostic needs. For instance, in March 2023, BD received 510(k) clearance from the U.S. FDA for its BD Vaginal Panel on the BD COR System, aimed at detecting infectious causes of vaginitis. In August 2023, the Precision Medicine Centre (PMC) partnered with the Regional Molecular Diagnostic Service (RMDS) to implement genomic technology for cancer diagnosis in Northern Ireland. These strategic collaborations and product launches are critical for companies seeking to leverage cutting-edge technologies in diagnostics.

Product Segmentation Insights:

In terms of products, the reagents segment accounted for the largest market share, representing 65.88% of total revenue in 2023. This segment is expected to maintain its dominance, growing at the fastest CAGR from 2024 to 2030. The growth of the reagents segment is driven by extensive research and development (R&D) efforts by key players aimed at developing novel reagents and test kits. For example, in February 2023, BD received market approval for its BD Onclarity HPV Assay, which is used with the ThinPrep Pap Test in the U.S. Ongoing R&D efforts focused on faster cancer detection and precision medicine are prompting companies to concentrate on specialized, profitable areas of the IVD market. In March 2023, QIAGEN formed a partnership with Servier to develop a companion diagnostic test for TIBSOVO, which is indicated for the treatment of acute myeloid leukemia, a type of blood cancer.

The growing demand for precision medicine is expected to further boost the overall demand for these novel reagents and consumables. The instruments segment held the second-largest share of the IVD market in 2023. Increasing approvals of novel IVD instruments are likely to contribute to the segment's growth. For instance, in April 2023, bioMérieux SA submitted a 510(k) application to the U.S. FDA for VITEK REVEAL, a rapid antimicrobial susceptibility testing (AST) system. Moreover, companies are aligning their instrument launches to meet the increasing demand for genetic tests globally. In March 2022, Thermo Fisher Scientific introduced the Ion Torrent Genexus Dx Integrated Sequencer for both research and diagnostic purposes, showcasing the alignment of technological advancements with the growing needs of genetic testing.

In conclusion, the global IVD market is poised for substantial growth, driven by the increasing incidence of infectious and chronic diseases, rising demand for precision medicine, and ongoing advancements in diagnostic technologies. Companies are continuously innovating, launching new products, and forming strategic partnerships to meet the evolving needs of healthcare providers and patients, which will further accelerate market expansion.

Order a free sample PDF of the In Vitro Diagnostics (IVD) Market Intelligence Study, published by Grand View Research.

[ganeshg]

In Vitro Diagnostics Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2022-2032

The In Vitro Diagnostics Market is indeed competitive, with numerous significant competitors. The industry is currently dominated by a few big companies in terms of market share.

Mid-size to smaller businesses, on the other hand, are expanding their market presence by releasing new items at reduced prices, thanks to technical improvements and product innovations.

In vitro diagnostic companies include Thermo Fischer Scientific Inc., Abbott Laboratories, Siemens Healthcare GmbH, and F. Hoffmann-La Roche AG.

In addition, important players are active in strategic alliances with firms that complement their product lines, such as acquisitions, collaborations, and partnerships.

F. Hoffmann-La Roche Ltd. and GenMark Diagnostics, Inc. announced their formal merger agreement in March 2021. Roche is likely to benefit from this purchase by gaining access to GenMark's innovative technology for testing a wide spectrum of infections with a single patient sample.

Becton Dickinson and Company completed the acquisition of NAT Diagnostics in May 2020 to broaden its infectious disease point-of-care testing portfolio.

F. Hoffmann-La Roche Ltd stated in March 2021 that Cobas pure integrated solutions would be available in countries that accept the CE certification. This innovative compact analyzer integrates three technologies on a single platform to assist small to medium-sized laboratories in streamlining operations.

Siemens Healthineers AG, BD (Becton, Dickinson, and Company), Seegene Inc., DiaSorin S.p.A., and Quest Diagnostics Incorporated are among the other industry participants having a substantial presence in the worldwide market. To grow their market share, these businesses are anticipated to focus on launching new items.

Key Takeaways

·         Owing to the rising incidences of HIV/AIDS, hepatitis, and other infectious disorders, the infectious diseases segment has a high potential.

·         In 2020, the reagents & kits sector held the greatest share of the IVD market, accounting for 68.1 percent. The demand for reliable, specific, and speedier detection of chronic diseases and genetic disorders in the early stages, as well as access to a broader range of reagents, are projected to fuel the expansion of in-vitro diagnostics market.

·         Hospital laboratories will account for 47 percent of the IVD market in 2020, followed by clinical laboratories (23.8 percent) and point-of-care testing centers (13 percent).

·         The increasing adoption of diagnostic devices is boosting the market for in vitro diagnostics. Due to the growing use of in-vitro diagnostics medical devices, the instruments market is expected to rise at a 4.5 percent annual pace through 2027. IVD instruments' high precision and usefulness will drive up demand in the future years.

·         North America is likely to account for 39.8 percent of the all in-vitro diagnostics products in 2020, followed by Europe (28 percent), Asia Pacific (22.9 percent), Latin America (6.5 percent), and the Middle East and Africa (6.5 percent) (2.9 percent).

“Automation of clinical laboratory procedures, microfluids-based point of care diagnostic devices for laboratory testing, and an increasing number of reagent rental agreements are among the leading trends in the in-vitro diagnostics industry.”

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Competitive Landscape

The key players responsible for the major share of sales of in-vitro diagnostics include Roche Diagnostics, Siemens Healthineers, Danaher Corporation, Abbott, Thermo Fisher Scientific, Johnson & Johnson, Becton, Dickinson and Company, Bio-Rad Laboratories, Sysmex Corporation, bioMérieux, DiaSorin, and Ortho Clinical Diagnostics among many others.

·         Roche Diagnostics (Switzerland) introduced the cobas pulse system in January 2022, a blood glucose management system with mobile digital health features to improve patient care.

·         Abbott Laboratories (US) gained US FDA approval for the Freestyle libre 2 iOS application for use with compatible iPhones in September 2021.

·         Siemens Healthineers reaffirmed its long-standing hemostasis supply, distributorship, sales, and service agreement, including a multi-year extension with Sysmex Corporation, in March 2021. (Japan).

·         Sysmex Corporation (Japan) and Roche Diagnostics (Switzerland) formed a cooperation in January 2021 to combine their capabilities, to improve the in-vitro diagnostics products and services as well as significant sales and service networks.

[blueweave]

In Vitro Diagnostics(IVD) Market Robustly Expected to Reach USD 102.4 Billion in 2027

A study, recently conducted by the strategic consulting and market research firm, BlueWeave Consulting, revealed that the global In-Vitro Diagnostics(IVD) market reached USD 82.3 billion in 2020 and is further projected to reach USD 102.4 billion by 2027, growing at a CAGR of 3.2% during 2021-2027 (forecast period). The growth of the global IVD market has been positively impacted by the growing demand for POC IVD devices. The recently introduced IVD instruments/devices are highly effective and easy to use, which is boosting their adoption among healthcare professionals. Also, some over-the-counter diagnostics devices, such as glucose monitoring kits, available in the market are highly preferred by elderly people, which in turn is reducing the frequency of hospital admissions.

Technological advancements in IVD tools driving the market growth

The increasing application of immunoassay in the detection of infectious microbes, such as viruses, bacteria, and fungi, through detection of their toxins is expected to grow at a lucrative rate in the coming years. The greatest market share can also be attributed to the growing prevalence of chronic diseases, such as HIV, and the advent of instruments with higher precision.

Clinical chemistry is the practical application of biochemistry and is used for diagnostics and therapeutic purposes to analyze body fluids. Serum, plasma, and urine are the most frequently tested samples in pathology. It is anticipated that the growing use of licensed blood-gas analyzers to track respiratory conditions would drive the growth of the IVD market. For example, in March 2020, Siemens Healthineers AG earned U.S. FDA approval for the blood gas analyzer called Rapidpoint 500e, which obtained the CE-IVD mark in August 2019. Likewise, in March 2020, Abbott launched a molecular point-of-care test to detect novel coronavirus in as little as five minutes.

Report URL:  https://www.blueweaveconsulting.com/global-in-vitro-diagnostics-(ivd)-market

Growing prevalence of chronic and infectious diseases in geriatric population augmenting market growth

The growth of the IVD market would be positively influenced by the growing geriatric population in developed as well as emerging regions. With the exponential growth of the geriatric population globally, it is predicted that the incidence of age-related diseases will increase significantly. According to The Organization for Economic Cooperation and Development (OECD), the number of older people living in the US in 2019 was 54 million. Huge and increasing geriatric populations also exist in other developed economies around the world. For example, in Japan, followed by Germany, the ratio of the elderly population to the active population is the largest. Japan's total population is about 126 million, with older people accounting for more than 28 percent of the population.

Major growth in demand coming from hospital segment

 A Based on end-users, the market has been segmented into: hospitals, point-of-care testing, laboratories, and academic institutes. It is anticipated that the hospital segment would dominate the market during the forecast period. This is due to increasing hospital admissions, which call for diagnostic interpretation by doctors for further care. Most of the diagnostic centers collaborate with hospitals; thus, hospitals have their own diagnostic setup. Additionally, it is expected that the ongoing expansion of healthcare infrastructure would boost existing hospital facilities. The demand for hospital-based IVDtests is thus growing.

Home care refers to compassionate care provided by licensed healthcare practitioners at home, or patients' self-care. The majority share of the home care market is accounted for by self-care devices. It is more convenient as it minimizes hospital visits. With a higher CAGR over the forecast period, the home care segment is projected to see the highest growth due to the growing geriatric population and increasing demand for in vitro diagnostic devices for home care. Other end-users of IVDinclude laboratories, outpatient care facilities, colleges, and academic institutions, especially in emergency situations and research institutes. POC tests are also conducted by such healthcare facilities to track or diagnose diseases. Due to lower costs and faster results, high acceptance of these tests by the above-mentioned entities is expected to drive the growth of the market.

Reagent segment occupies the largest market share

The growth of this segment can be attributed to the growing demand for rapid, accurate, and sensitive devices.The increasing use of such devices in in-vitro diagnostics research, along with increased demand for self-testing, point-of-care products, and an increase in the number of reagent-related R&D initiatives are expected to support market development. Additionally, equipment and machines also referred to as analytical tools, help simplify the diagnostics process and bring reagents and samples together. Nowadays, commercial kits and robots are also used to help identify and measure infectious microorganisms, blood antigens and viral load in polymerase chain reaction (PCR) laboratories.

Global IVD Market: Regional Insights

Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. It is anticipated that North America will account for the largest revenue share in the market due to the local presence of major market players. Additionally, the need for better diagnostics devices is being propelled by increasing disease prevalence and increased customer awareness. The market is projected to witness the highest growth over the forecast period in the Asia-Pacific as it consists of several emerging economies. Increased awareness about healthcare and the growing need for early diagnosis among patients in the area, along with a high prevalence of chronic diseases are expected to fuel the market.

The leading players include Abbott, Danaher, Siemens Healthineers AG, Roche Diagnostics, Sysmex Corporation, QIAGEN, Quidel Corporation, Quest Diagnostics, Agilent Technologies, and Bio-Rad Laboratories.

Don’t miss the business opportunity of IVD market. Consult our analysts to gain crucial insights and facilitate your business growth.

The in-depth analysis of the report provides information about growth potential, upcoming trends, and statistics of global IVD market size & forecast. The report promises to provide recent technology trends of the global in-vitro diagnostic market and industry insights to help decision-makers make sound strategic decisions. Furthermore, the report also analyses the growth drivers, challenges, and competitive dynamics of the market.

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[factmrresearch1]

Lifescience Reagent Market Insights

Increasing prevalence of infectious disease, which requires early diagnosis is creating the opportunity for the biotechnology industry players to produce effective reagents to carry out various diagnostic tests. Moreover, launching of new diagnostic tests and assays is contributing to the lifescience reagents market share. For instance, in April 2019, Roche launched Ventana HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast and gastric cancer patients to determine the eligibility for the targeted drug trastuzumab (Herceptin). The new reagent is intended for in vitro diagnostic (IVD) use.

The global lifescience reagent market was valued at US$ 33,754.0 million in 2017, and is expected to witness a CAGR of 7.3% during the forecast period (2018–2026).

Figure 1. Global Lifescience Reagent Market value Analysis (US$ Mn) and Forecast and Absolute $ Opportunity

Source: Coherent Market Insights Analysis (2019)

Increasing number of product launches is expected to drive growth of global lifescience reagent market

Increasing product launches for reagents to assist different types of diagnostics tests and research purpose is expected to drive the global lifescience reagent market growth. For instance, in March 2019, Dolomite Bio, a provider of single cell technologies, launched a new scRNA-Seq reagent kit to expand the Nadia Instrument portfolio. The new scRNA-Seq reagent kit is designed to enable the generation of PCR­amplified cDNA libraries on the Nadia Instrument, allowing high throughput gene expression profiling of heterogeneous cell populations.

Moreover, in October 2016, Beckman Coulter’s lifescience division launched Clearllab LS Lymphoid Screen Reagent. It is CE-marked and 10-colour containing 12 antibody reagent combinations used for leukemia and lymphoma analysis. The new approach is designed to provide results with a faster turnaround time (TAT). ClearLLab has been specifically designed for identification of haematolymphoid cells on the Beckman Coulter’s Navios flow cytometer.

Increasing acquisitions among biotechnology industry players is contributing to the global lifescience reagent market during the forecast period. For instance, in February 2017, Anatrace (StoneCalibre’s portfolio company), acquired Molecular Dimensions Ltd. Molecular Dimensions Ltd is the U.K.-based supplier of modern screens, reagents, and other consumables and instrumentation for structural biology research. With this acquisition, Anatrace intended to establish its presence in Europe and expand its position in the structural biology product portfolio.

Global Lifescience Reagent Market- Regional Analysis

North America is expected to witness lucrative growth in global lifescience reagent market, owing to growing initiatives taken by market players to establish their product portfolio in North American countries. For instance, in May 2018, Grifols received the U.S. Food & Drug Administration (FDA) licensing approval to commercialize a range of antisera reagents designed for routine and complex immunohematology testing in the U.S.

Moreover, in 2016, LabX Media Group, Inc. acquired 1DegreeBio Inc., (www.1degreebio.com), the antibody and reagent search engine for lifesciences. With this acquisition, LabX Media Group introduced 1DegreeBio Inc. to its portfolio of established brands. The website ‘www.1degreebio.com’ includes a database of lifescience reagents and kits including quality validation data, citation history, as well as antibody reviews and community ratings.

Asia Pacific is also expected to drive the global lifescience reagent market growth, owing to presence of key players in this regions. For instance, in December 2015, Sekisui Chemical, a Japanese company, acquired Eidia, a subsidiary company of Eisai, to develop and market reagents, especially diagnostic reagents, for curbing cancer and rheumatism. Eisai was the manufacturer, importer, and marketer of chemical equipment, clinical diagnostic reagents, clinical analyzers, and laboratory reagents. Sekisui purchased the Eidia from Eisai for US$ 18 million.

Europe is expected to show significant lifescience reagent growth rate, owing to increasing number of approvals from the European Union for the diagnostics reagents and assays. For instance, in March 2017, HTG Molecular Diagnostics, Inc. received CE marking in the European Union for its HTG EdgeSeq ALKPlus Assay EU. The company is provider of instruments, reagents, and services for molecular profiling applications. HTG EdgeSeq ALKPlus Assay EU is an in vitro diagnostic assay used to measure and analyze mRNA ALK gene rearrangements in formalin-fixed, paraffin-embedded lung tumor specimens from patients previously diagnosed with non-small cell lung cancer (NSCLC).

Figure 2: Global Lifescience Reagent Market Value (US$ Mn), By Region

Source: Coherent Market Insights Analysis (2019)

Global Lifescience Reagent Market - Competitive Landscape

Key players operating in the global lifescience reagent market include F. Hoffmann-La Roche Ltd., Danaher Corporation, Abbott Laboratories, Merck KGaA, Bio-Rad Laboratories, GE Healthcare, Siemens Healthineers, Becton, Dickinson and Company, Agilent Technologies Inc., Perkin Elmer Inc., Waters Corporation, Ortho Clinical Diagnostics, bioMérieux SA, and Sysmex Corporation.

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[godollyfan]

Guidelines For The Validation And Batch Testing Of Covid-19 Diagnostic Kits

The Indian Council of Medical Research and Drugs Controller General of India have jointly come up with some of the guidelines for validating and batch testing of Covid-19 diagnostic kits. In a joint meeting, all the recommended guidelines were approved and this is a recommendatory and a dynamic document without any prejudice to the statutory provisions.

According to guidelines, US FDA approved RT-PCR kits, RNA extraction kits, as well as the viral transport medium, ELISA, CLIA Kits along with rapid antibody test and it will not require any ICMR validation. All the manufacturers, as well as the supplier of those kits, can apply for obtaining  approval from DCGI directly.

The first batch of CE-IVD that got approval and the non-US FDA got approval but the indigenous RT PCR kits will need the basic validation from 24 ICMR recognized validation centers before getting approval from DCGI. Then for post-marketing, extra two batches must be tested according to the medical device rules in a period of four months.

The firm is needed to deposit a batch testing certificate while conducting deliverance of the consignment. A validation center identified by ICMR will undertake random sample testing of a batch of kits because of quality assurance as per Medical Device Regulations in India. For sending the request to validate the kits of RT-PCR, Rapid antibody test, CLIA, RNA Extraction, VTM, the manufacturer or the supplier must send an email to Dr. GS Toteja who is the additional director general of ICMR and the national nodal officer for granting validations.

This request sent by the manufacturer or the supplier must be accompanied with all information like the name of the manufacturer, kit name, batch no, supplier, first-time validation by ICMR along with details of the validation along with the overall validation report, and any differences in the composition of the kit when compared with the first validation.

The request, after proper scrutinization will be forwarded to any of the ICMR recognized validation centers based on the workload as well as logistics issues when it is a first-time validation.

When the kit is scrutinized for obtaining second-time validation or any successive validation, the manufacturer or the supplier has to deposit a justification that has to be reviewed at ICMR, New Delhi. The decision taken will be provided to the manufacturer or the supplier within one week.

The request for re-validation will be taken into consideration when there is any kind of significant change in the kind of composition of the reagents present in the kit. When the kit is supplied to any of the validation centers with the required number of test reactions, methods as well as reagents, the overall validation report will be given to the manufacturer or the supplier in 15 days.

As of now, there are a total of 24 centers for validating and batch testing of the Covid 19 diagnostic kits that includes 9 ICMR institutes, 3 CSIR institutes, 5 departments of biotechnology institutes along with 7 other such institutes. Till now about 97 RT-PCR kits have been evaluated by the ICMR validation centers from which 40 kits were found to be satisfactory.

[meeraoperon]

CDSCO Application Process| Operon Strategist

CDSCO Application process of India’s Central Drugs Standard Control Organization (CDSCO) has published several notices since mid-March in response to the ongoing pandemic. These address new measures to expedite access to devices intended to prevent or treat COVID-19, to safeguard supply of other critical IVDs, and to reduce the exposure of CDSCO staff to the SARS-CoV-2 virus.

The CDSCO Application process involves the development of the online licensing system for multiple stakeholders like Industry applicants, CDSCO officials from HQ, Zones, Subzones, Port offices, Investigators, medical practitioners.

We provide regulatory consulting for medical devices manufacturing.

When it comes to CDSCO medical device license process, Operon strategist makes the lengthy process easy and smooth.

With the best technical team working for you, along with excellent assistance, timely responses and affordable fees structure.

The system will provide an online interface for Applicants to submit applications, upload supporting documents, respond to queries from CDSCO officials and track their CDSCO Application process status. It will also enable CDSCO officials to process the applications, generate note sheet, and raise queries and issue approvals / permissions online. The purpose of the document is to specify in detail the Processing of applications of medical devices by the regulatory authority (CDSCO and SFDA).

For medical devices registration in India, 21 devices categories have been listed as ‘Notified Medical Devices’ by the CDSCO. However, devices which require CDSCO Application process extend beyond the listed.

The CDSCO announced that it will prioritize COVID-19 IVD test kits for expedited approval. Manufacturers who already have approval for an IVD in another market are encouraged to contact the Drugs Controller General of India (DCGI) to discuss fast-track approval. Additionally, manufacturers pursuing the development of new IVDs may contact the DCGI directly to solicit guidance on the applicable regulatory pathway.

Priority applications are to be processed within seven days. As part of the expedited CDSCO Application process, data requirements (e.g., for clinical performance evaluations) may be condensed, deferred, or waived on a case-by-case basis.

CDSCO Application process

An application shall be made to the Licensing Authority in Form 40, either by the manufacturer himself, having a valid wholesale License, for sale or distribution of drugs or by his authorized agent in India either having a valid License to manufacture for sale of a drug or having a valid wholesale License for sale or distribution of drugs.

DETAILS TO BE CAPTURED IN FORM 40: The authorized signatory name, designation, department, along with the complete address of the Company.

i) Authorized Signatory: The person authorized preferably Director approved by the Board of Directors in case of company or by the proprietor in case of proprietorship firm. The application to accompany affidavit in respect of authorized person or the Power of Attorney in the name of the authorized person.

The Form shall detail the Foreign Manufacturer‘s contact person in the manufacturing site complete address, (i.e. address of the manufacturing premises), with corporate office address, along with the Telephone number, Fax number and E-mail address.

ii) The address of manufacturing premises shall be captured as below: Undertaking on the document contents by the responsible person at the manufacturing site (contact person in the manufacturing site) – In respect of import of more than one drug or class of drugs manufactured by the same manufacturer, provided that drug or the classes of drugs, are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit. – In respect of the drugs manufactured in two or more factories situated in different places, for the manufacturing of the same or different drugs the name and address of both the manufacturing site should be included e.g. if the tablets are manufactured at one location and packed at another location, Name and Address of both the locations indicating the activity of each location.

iii) The drug(s) name shall be captured as below: – The brand name shall be captured. – Different pack, pack size and/or different strengths of the same brand shall be captured. Importer‘s undertaking letter declaring for the information specified in Schedule D

And Schedule D (II), provided by the original manufacturer. The registration Fees amount (Challan number and date) shall be mentioned on Original TR 6 challan having complete name and address of the applicant and details of application to be enclosed.

iv) Fee structure for Import Registration under Form 40: – Fees and Form(s) and the undertakings as per Schedule D(I) (for registration of the manufacturing premises) and Schedule D(II) (for registration of the drugs): – Applicant shall make a payment of 1500 USD (or its equivalent to Indian Currency), as registration fee for the Manufacturing premises. – Applicant shall make an payment of 1000 USD (or its equivalent to Indian Currency), as registration fee for a single drug and additional fee of 1000 USD for each additional drug in case the manufacturing site remains the same. Fees shall be paid through a Challan

How to apply Cdsco?

To view Submitted Application, click on Menu Form Submission Submitted Applications. If application is approved by CDSCO, then it will be visible under Approved Applications tab. To view Approved Application, click on Menu Form Submission proved Applications.

Cdsco registration process

After submitting the Registration Form, Check Registered email for E-mail Verification. Submit ID proof, Undertaking, Address Proof Document in hard copy to CDSCO office. Registration will be approved by CDSCO only after evaluation of the submitted documents. Check your registered email id for all communications.

Manufacturers of medical devices, cosmetics, IVDs, are attracted to the Indian market due to the reliance of it on the imports. However the challenge is that the regulatory body in India is currently at its infancy and rules may be updated within short periods. The general timeline followed by the CDSCO for the various process of approval, trails, applications, can be found on CDSCO timelines.

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CDSCO Application process

Contact details –Phone no -  9325283428Mail  -

dm@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

   1.    

Medical Device Manufacturing

   2.    

CDSCO Registration

   3.    

FDA 510 k clearance

   4.    

Continuous Improvement Program

   5.    

Design Control Requirements

   6.    

QMS Certification Services

   7.    

Manufacturing Plant Layout Design

   8.    

Primary Packaging Consultant

   9.    

CE Marking Consultant

 10.

Combination Product

11.

Medical Device Design And Development

 12.

Clean Room Design Consultant

13.

ISO 13485 Certification

14.

ISO 15378 certification

15.

Medical Device Process Validation

16.

21 cfr part 820

17.

21 cfr part 210 and 211

18.

DMF submission

19.

CAPA Management

20.

TURNKEY PROJECT CONSULTANT

21.

Manufacturing Site Conceptualization

[pathologylab]

Glimpses from Medica 2024!

We are thrilled to share highlights from our impactful experience at the #Medica2024 Conference! This year's event was nothing short of remarkable—full of innovation, #collaboration, and inspiration.

Our team had the privilege of connecting with #global industry leaders and visionaries, gaining invaluable insights from expert keynote speakers shaping the future of #healthcare. At our booth, we showcased our latest breakthroughs: over 28 CE-IVD approved #NGS Clinical Panels, advanced point-of-care testing solutions, real-time #PCR kits, and cutting-edge nucleic acid extraction technologies. These innovations sparked engaging #conversations and inspired new ideas with #professionals.

A heartfelt thank you to everyone who visited us and contributed to our journey. Together, we're raising the standards of patient care and #medical #technology. We’re energized and ready to leverage these insights to make a meaningful impact in healthcare.

Stay tuned for more highlights and insights from Medica 2024!

#Medica2024 #HealthcareInnovation #TransformingHealthcare #ConferenceInsights #Networking #conference #globalindustry #ivd #clinicalpanels #kits #rtpcr #nucleicacid #newideas #products #g2m #genes2me

[kunalcmi]

METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) TESTING SYSTEMS MARKET ANALYSIS (2020-2027)

Methicillin Resistant Staphylococcus aureus (MRSA) is the most prevalent multi-drug resistant bacteria and a growing threat to health. The Centers for Disease Control and Prevention estimates that around 1 in 50 people in the U.S. carried MRSA in their noses as of August 2019. Furthermore, these individuals are four times more susceptible to infection. MRSA is commonly found in hospitals and healthcare facilities and it can cause severe health problems such as pneumonia, bloodstream infections, sepsis, and even death. The MRSA infection can be tested with the help of test kits, instruments, reagents and software. New DNA-based tests are fast, however they have proven to be cost-prohibitive for widespread use. Traditional methods rely on time-consuming culture techniques which require 48 hours to exclude MRSA and several days to confirm positives. However, these allow hospitals to affordably implement screening to help optimize patient outcomes and mitigate the risks associated with cross-contamination.

The Methicillin Resistant Staphylococcus Aureus (MRSA) Testing Systems market is estimated to be valued at US$ 105.08 million in 2020 and is expected to exhibit a CAGR of 10.5% during the forecast period (2020-2027).

Fig. 1 Methicillin Resistant Staphylococcus Aureus (MRSA) Testing Systems Market Share (%) Analysis, By Product, 2020

The increasing prevalence of methicillin resistant staphylococcus aureus infection as well as approvals for products developed by market players are expected to drive growth of the methicillin resistant Staphylococcus aureus (MRSA) testing systems market.

The growing prevalence of methicillin resistant Staphylococcus aureus infection worldwide is expected to drive growth of the methicillin resistant Staphylococcus aureus (MRSA) testing systems market. According to the U.S. Department of Health and Human Services report of March 2019, nearly 120,000 staphylococcus aureus bloodstream infections and 20,000 associated deaths occurred in the U.S. in 2017. After years of slow progress, the rate of decline of MRSA bloodstream infections has slowed, but bloodstream infections caused by methicillin-susceptible S. aureus in hospitals are increasing day by day in the community.

Moreover, products approvals by regulatory bodies are expected to accelerate the Methicillin Resistant Staphylococcus Aureus (MRSA) Testing Systems market growth in the near future. For instance, in October 2019, Luminex Corporation announced that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ARIES MRSA Assay. The assay is an integrated, real-time, polymerase chain reaction (PCR) based, qualitative, in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. The Luminex ARIES System is a real-time instrument designed to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into the modern laboratory.

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Methicillin Resistant Staphylococcus Aureus (MRSA) Testing Systems Market - Restraints

However, growth of the methicillin resistant staphylococcus aureus (MRSA) testing systems market may be hampered owing to the increasing product recalls of methicillin resistant staphylococcus aureus (MRSA) testing systems in the market. For instance, in August 2019, the U.S. FDA initiated a product recall on Becton Dickinson & Company’s BD Max MRSA test kit because the foil bags containing extraction tubes for BD MAX Reagent products may not be sealed properly which can lead to false representation of test results. An advisory has been released to all the users of BD Max instruments within testing facilities to ensure awareness and prevent false test results.

Methicillin Resistant Staphylococcus Aureus (MRSA) Testing Systems Market – Regional Analysis

North America accounted for the largest share in the methicillin resistant staphylococcus aureus (MRSA) testing systems market, in 2019 owing to the increasing number of mergers and acquisitions in the U.S. For instance, in April 2017, Avantor Performance Materials, LLC, announced the acquisition of Puritan Products, Inc., a supplier of cGMP buffers and solutions for Biopharma customers, and high-purity chemistries for Research and Electronic Materials customers. The acquisition of the Puritan Products brand expanded Avantor’s cGMP operations, improved supply chain security, and provided new teams experienced in high-purity materials manufacturing such as J.T.Baker, Macron Fine Chemicals, Puritan MRSA Transport Medium and Puritan brands of high-purity products and packaging for Avantor to become more agile and responsive to the needs of its customers.

Furthermore, major companies in the market are focusing on obtaining product approvals to gain commercial rights for the sale of their products in a particular country. This is expected to drive growth of the methicillin resistant staphylococcus aureus (MRSA) testing systems market in Europe. For instance, in January 2014, Roche announced the CE-IVD launch of the cobas MRSA/SA Test for the early, simultaneous detection of methicillin-resistant staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus aureus (SA) from nasal specimens. The cobas MRSA/SA test detects both organisms from a single specimen, providing accurate and reliable results for effective prevention and control of MRSA/SA infections. With an innovative design to include diverse geographical strain coverage, coupled with automation on the cobas 4800 System, the cobas MRSA/SA test can process specimens using a fast and advanced real-time polymerase chain reaction (PCR) amplification and detection available.

Fig.2 Methicillin Resistant Staphylococcus Aureus (MRSA) Testing Systems Market Value (US$ Mn) & Y-o-Y Growth (%), 2017-2027

Methicillin Resistant Staphylococcus Aureus (MRSA) Testing Systems Market - Competitive Landscape

Key players operating in the methicillin resistant Staphylococcus aureus (MRSA) testing systems market are F.Hoffmann-La Roche, Becton, Dickinson and Company, Hain Lifescience GmbH, BioMérieux, 3M Company, Bio-Rad Laboratories Inc., Abacus Diagnostica, Abbott Laboratories, Puritan Medical Products, Diatherix Eurofins, LLC, Arlington Scientific Inc., AdvanDx, Genspeed Biotech GmbH, Cepheid Inc., Luminex Corporation, and R-Biopharm AG.

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Source: https://www.coherentmarketinsights.com/market-insight/methicillin-resistant-staphylococcus-aureus-testing-systems-market-3803

[biotechtimes]

Govt HLL Lifecare Limited Biochemistry & Biotechnology QC Jobs

New Post has been published on https://biotechtimes.org/2019/10/10/govt-hll-lifecare-limited-biochemistry-biotechnology-qc-jobs/

Govt HLL Lifecare Limited Biochemistry & Biotechnology QC Jobs

Govt HLL Lifecare Limited Jobs

HLL Lifecare Limited, a Government of India Public Sector Enterprise is hiring for Manufacturing Chemist and Quality Control Chemist post. Govt HLL Lifecare Limited Jobs 2019. Govt Biochemistry & Biotechnology Jobs. Check out below mentioned details for more information:

Position  Name: Manufacturing Chemist

Location: Manesar, District- Gurgaon (Haryana) 

Qualification & Relevant Post Qualification Experience: Graduate in Science (Chemistry / Biochemistry) / Pharmacy from a recognized university with minimum 2 years or Diploma in Engineering (Biotechnology) / Pharmacy from a recognized institute with minimum 4 years experience in manufacturing or testing of Medical Devices (In-Vitro diagnostic kits).

Shall be approved as manufacturing chemist for In-vitro diagnostics and preference will be given to those are approved Manufacturing Chemist by Haryana State FDA.

Job Responsibility

Production planning & execution of orders in a time-bound manner.

Compliance with regulatory protocols, SOP for the manufacturing of IVDs.

Documentation as per ISO 13485 including Batch Manufacturing Records, Calibration, Validation Records.

Maintenance of manufacturing records complying with regulatory requirements.

Managing shop floor activities for manufacturing of IVDs,

Handling regulatory & statutory audits

Position  Name: Q.C. Chemist

Location: Manesar, District- Gurgaon (Haryana) 

Qualification & Relevant Post Qualification Experience: Graduate in Science (Chemistry/ Biochemistry) / Pharmacy with a minimum 2 years or Diploma in Engineering (Biotechnology) / Pharmacy from a recognized institute with a minimum 4 years experience in testing of Medical Devices (In-Vitro diagnostic kits).

Shall be approved as Q.C. chemist for In-vitro diagnostics and preference will be given to those are approved Q.C. Chemist by Haryana State FDA.

Job Responsibility

Plan and control QA/QC activities, quality supervision and in-process quality control (IPQC)

Compliance to SOP, STP, Specification of materials and finished products.

Method validation, Qualification and Calibration of Instruments

Quality testing of incoming materials and finished products and stability study.

Maintenance of QC records complying to regulatory requirements, ISO 13485, CE

Development of marketing support material including product design and development

Handling customer complaints including corrective and preventive action (CAPA), Handling Deviation, OOS

Maintaining licenses, ISO, CE mark certification; Handling regulatory & statutory audits.

Selection for the position of Manufacturing Chemist and Quality Control Chemist will be based on the qualification, experience and the marks scored in the written test. The duration for the written test is 30 minutes and the maximum mark is 50.

Age: Maximum 37 years as on 01.10.2019

Interested and eligible candidates may walk-in for selection test between 10.00 AM and 12.30 PM on 17/10/2019 at HLL Lifecare Limited B-14A, Sector-62, Noida-201301, Haryana.

(Candidates who register up to 12.30 PM only will be allowed to attend the selection test. Candidates are required to bring their original Mark sheets and Certificates for verification)

General Conditions

Upper age relaxation will be given to candidates belonging to SC/ST/OBC/PH, as per Government of India Rules in this regard.

Canvassing in any form will be a disqualification.

Candidates are requested to fill up the Application Blank attached herewith affixing their latest passport size photograph, which has to be produced at the time of verification of certificates.

The appointment will be on Fixed Tenure Contract basis

Candidates are required to bring all certificates in original along with attested copies to prove age, qualification, experience and latest salary certificate with break-up. SC/ST/OBC (non-creamy layer) candidates should produce their Community Certificate in original from the concerned Revenue Authorities. Failure to produce the above certificates in original will disqualify from appearing for the selection test.

The candidate shall mention their preferred place of posting in the application form. However proposed place of posting shown in the detail may vary as per the business requirement, management keeps the right for the final place of posting as deemed fit.

Only candidates with relevant QUALIFICATION and EXPERIENCE will be permitted to attend the written test.

Download Notification

[pharmanewstrands-blog]

Lifescience Reagent Market - Size, Share, Outlook, and Opportunity Analysis, 2018 – 2026

Lifescience Reagent Market Insights

Increasing prevalence of infectious disease, which requires early diagnosis is creating the opportunity for the biotechnology industry players to produce effective reagents to carry out various diagnostic tests. Moreover, launching of new diagnostic tests and assays is contributing to the lifescience reagents market share. For instance, in April 2019, Roche launched Ventana HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast and gastric cancer patients to determine the eligibility for the targeted drug trastuzumab (Herceptin). The new reagent is intended for in vitro diagnostic (IVD) use.

Request A Sample Copy: http://bit.ly/2xnY3EE

Increasing number of product launches is expected to drive growth of global lifescience reagent market

Increasing product launches for reagents to assist different types of diagnostics tests and research purpose is expected to drive the global lifescience reagent market growth. For instance, in March 2019, Dolomite Bio, a provider of single cell technologies, launched a new scRNA-Seq reagent kit to expand the Nadia Instrument portfolio. The new scRNA-Seq reagent kit is designed to enable the generation of PCRamplified cDNA libraries on the Nadia Instrument, allowing high throughput gene expression profiling of heterogeneous cell populations.

Increasing acquisitions among biotechnology industry players is contributing to the global lifescience reagent market during the forecast period. For instance, in February 2017, Anatrace (StoneCalibre’s portfolio company), acquired Molecular Dimensions Ltd. Molecular Dimensions Ltd is the U.K.-based supplier of modern screens, reagents, and other consumables and instrumentation for structural biology research. With this acquisition, Anatrace intended to establish its presence in Europe and expand its position in the structural biology product portfolio.

Global Lifescience Reagent Market- Regional Analysis

North America is expected to witness lucrative growth in global lifescience reagent market, owing to growing initiatives taken by market players to establish their product portfolio in North American countries. For instance, in May 2018, Grifols received the U.S. Food & Drug Administration (FDA) licensing approval to commercialize a range of antisera reagents designed for routine and complex immunohematology testing in the U.S.

Asia Pacific is also expected to drive the global lifescience reagent market growth, owing to presence of key players in this regions. For instance, in December 2015, Sekisui Chemical, a Japanese company, acquired Eidia, a subsidiary company of Eisai, to develop and market reagents, especially diagnostic reagents, for curbing cancer and rheumatism. Eisai was the manufacturer, importer, and marketer of chemical equipment, clinical diagnostic reagents, clinical analyzers, and laboratory reagents. Sekisui purchased the Eidia from Eisai for US$ 18 million.

Europe is expected to show significant lifescience reagent growth rate, owing to increasing number of approvals from the European Union for the diagnostics reagents and assays. For instance, in March 2017, HTG Molecular Diagnostics, Inc. received CE marking in the European Union for its HTG EdgeSeq ALKPlus Assay EU. The company is provider of instruments, reagents, and services for molecular profiling applications. HTG EdgeSeq ALKPlus Assay EU is an in vitro diagnostic assay used to measure and analyze mRNA ALK gene rearrangements in formalin-fixed, paraffin-embedded lung tumor specimens from patients previously diagnosed with non-small cell lung cancer (NSCLC).

Global Lifescience Reagent Market - Competitive Landscape

Key players operating in the global lifescience reagent market include F. Hoffmann-La Roche Ltd., Danaher Corporation, Abbott Laboratories, Merck KGaA, Bio-Rad Laboratories, GE Healthcare, Siemens Healthineers, Becton, Dickinson and Company, Agilent Technologies Inc., Perkin Elmer Inc., Waters Corporation, Ortho Clinical Diagnostics, bioMérieux SA, and Sysmex Corporation.

Click To Read More On Lifescience Reagent Market

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Coherent Market Insights

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[blueweave]

In Vitro Diagnostics(IVD) Market Size and Share is Expected to Reach USD 102.4 Billion in 2027 | BlueWeave

A study, recently conducted by the strategic consulting and market research firm, BlueWeave Consulting, revealed that the global In-Vitro Diagnostics(IVD) market reached USD 82.3 billion in 2020 and is further projected to reach USD 102.4 billion by 2027, growing at a CAGR of 3.2% during 2021-2027 (forecast period). The growth of the global IVD market has been positively impacted by the growing demand for POC IVD devices. The recently introduced IVD instruments/devices are highly effective and easy to use, which is boosting their adoption among healthcare professionals. Also, some over-the-counter diagnostics devices, such as glucose monitoring kits, available in the market are highly preferred by elderly people, which in turn is reducing the frequency of hospital admissions.

Technological advancements in IVD tools driving the market growth

The increasing application of immunoassay in the detection of infectious microbes, such as viruses, bacteria, and fungi, through detection of their toxins is expected to grow at a lucrative rate in the coming years. The greatest market share can also be attributed to the growing prevalence of chronic diseases, such as HIV, and the advent of instruments with higher precision.

Clinical chemistry is the practical application of biochemistry and is used for diagnostics and therapeutic purposes to analyze body fluids. Serum, plasma, and urine are the most frequently tested samples in pathology. It is anticipated that the growing use of licensed blood-gas analyzers to track respiratory conditions would drive the growth of the IVD market. For example, in March 2020, Siemens Healthineers AG earned U.S. FDA approval for the blood gas analyzer called Rapidpoint 500e, which obtained the CE-IVD mark in August 2019. Likewise, in March 2020, Abbott launched a molecular point-of-care test to detect novel coronavirus in as little as five minutes.

Request to Download Free Sample Report: https://www.blueweaveconsulting.com/global-in-vitro-diagnostics-(ivd)-market/report-sample 

Growing prevalence of chronic and infectious diseases in geriatric population augmenting market growth

The growth of the IVD market would be positively influenced by the growing geriatric population in developed as well as emerging regions. With the exponential growth of the geriatric population globally, it is predicted that the incidence of age-related diseases will increase significantly. According to The Organization for Economic Cooperation and Development (OECD), the number of older people living in the US in 2019 was 54 million. Huge and increasing geriatric populations also exist in other developed economies around the world. For example, in Japan, followed by Germany, the ratio of the elderly population to the active population is the largest. Japan's total population is about 126 million, with older people accounting for more than 28 percent of the population.

Major growth in demand coming from hospital segment

Based on end-users, the market has been segmented into: hospitals, point-of-care testing, laboratories, and academic institutes. It is anticipated that the hospital segment would dominate the market during the forecast period. This is due to increasing hospital admissions, which call for diagnostic interpretation by doctors for further care. Most of the diagnostic centers collaborate with hospitals; thus, hospitals have their own diagnostic setup. Additionally, it is expected that the ongoing expansion of healthcare infrastructure would boost existing hospital facilities. The demand for hospital-based IVDtests is thus growing.

Home care refers to compassionate care provided by licensed healthcare practitioners at home, or patients' self-care. The majority share of the home care market is accounted for by self-care devices. It is more convenient as it minimizes hospital visits. With a higher CAGR over the forecast period, the home care segment is projected to see the highest growth due to the growing geriatric population and increasing demand for in vitro diagnostic devices for home care. Other end-users of IVDinclude laboratories, outpatient care facilities, colleges, and academic institutions, especially in emergency situations and research institutes. POC tests are also conducted by such healthcare facilities to track or diagnose diseases. Due to lower costs and faster results, high acceptance of these tests by the above-mentioned entities is expected to drive the growth of the market.

Reagent segment occupies the largest market share

The growth of this segment can be attributed to the growing demand for rapid, accurate, and sensitive devices.The increasing use of such devices in in-vitro diagnostics research, along with increased demand for self-testing, point-of-care products, and an increase in the number of reagent-related R&D initiatives are expected to support market development. Additionally, equipment and machines also referred to as analytical tools, help simplify the diagnostics process and bring reagents and samples together. Nowadays, commercial kits and robots are also used to help identify and measure infectious microorganisms, blood antigens and viral load in polymerase chain reaction (PCR) laboratories.

Global IVD Market: Regional Insights

Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. It is anticipated that North America will account for the largest revenue share in the market due to the local presence of major market players. Additionally, the need for better diagnostics devices is being propelled by increasing disease prevalence and increased customer awareness. The market is projected to witness the highest growth over the forecast period in the Asia-Pacific as it consists of several emerging economies. Increased awareness about healthcare and the growing need for early diagnosis among patients in the area, along with a high prevalence of chronic diseases are expected to fuel the market.

The leading players include Abbott, Danaher, Siemens Healthineers AG, Roche Diagnostics, Sysmex Corporation, QIAGEN, Quidel Corporation, Quest Diagnostics, Agilent Technologies, and Bio-Rad Laboratories.

Don’t miss the business opportunity of IVD market. Consult our analysts to gain crucial insights and facilitate your business growth.

The in-depth analysis of the report provides information about growth potential, upcoming trends, and statistics of global IVD market size & forecast. The report promises to provide recent technology trends of the global in-vitro diagnostic market and industry insights to help decision-makers make sound strategic decisions. Furthermore, the report also analyses the growth drivers, challenges, and competitive dynamics of the market.

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[jesse-pinkman123]

Methicillin Resistant Staphylococcus Aureus (MRSA) Testing Systems Market -2027

Global Methicillin Resistant Staphylococcus Aureus (MRSA) Testing Systems Market, By Product (Instruments, Reagents & Kits), By Test Type (Immunodiagnostic Test and Molecular Diagnostic Test), By End User (Hospitals, Diagnostic Laboratories, and Academic and Research Institute), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa), is estimated to be valued at US$  211.3  million in 2020 and is expected to exhibit a CAGR of 10.5% during the forecast period (2020-2027), as highlighted in a new report published by Coherent Market Insights.

The increasing number of product approvals and launches, adoption of methicillin resistant staphylococcus aureus (MRSA) testing systems, and mergers and acquisitions by key players are the major factors that are expected to drive growth of the Methicillin Resistant Staphylococcus Aureus (MRSA) Testing Systems market during the forecast period.

Product approvals by regulatory bodies are expected drive growth of the methicillin resistant Staphylococcus aureus (MRSA) testing systems market during the forecast period. For instance, in December 2019, the US Food and Drug Administration (FDA) granted marketing approval for Roche Molecular Systems’ cobas vivoDx MRSA, a diagnostic test that detects colonisation of Methicillin-resistant Staphylococcus aureus (MRSA) bacteria. The cobas vivoDx MRSA test uses a new bacteriophage technology based on bioluminescence to detect MRSA from nasal swab samples in as less as 5 hours compared to 24-48 hours for conventional culture. The cobas vivoDx MRSA diagnostic test may allow healthcare professionals to evaluate patients for colonization with MRSA bacteria more quickly than traditional culture-based techniques.

* The sample copy includes: Report Summary, Table of Contents, Segmentation, Competitive Landscape, Report Structure, Methodology.

Request a sample copy of this report: https://www.coherentmarketinsights.com/insight/request-sample/3803

Key players are focused on development and launch of new methicillin resistant staphylococcus aureus (MRSA) testing systems in the market which is expected to contribute significantly to the methicillin resistant staphylococcus aureus (MRSA) testing systems market growth. For instance, in June 2019, Spindiag, a medtech startup company based in Germany, announced that it had expanded financing of its first Series A funding for MRSA testing systems. A proprietary microfluidic technology was first researched at the company’s main institute. Spindiag is developing a sustainable platform to diagnose infections and as a first product, a rapid test for multidrug-resistant bacteria. Furthermore, the additional money will enable industrializing the production and securing CE-IVD approval for the EU market of an MRSA (methicillin-resistant Staphylococcus aureus) rapid test is planned for launch in 2020. Spindiag intends to use US$ 4.3 million to execute its market entry in Europe in 2020.

The increasing awareness about methicillin resistant staphylococcus aureus (MRSA) infections and prevention efforts by hospitals, governments, and other organizations is expected to accelerate the methicillin resistant staphylococcus aureus (MRSA) testing systems market growth in the near future. The U.S. Department of Health and Human Services and Centers for Disease Control and Prevention are working with healthcare facilities to meet the goals in the 2013 National Action Plan to Prevent Healthcare-Associated Infections and reduce bloodstream infections caused by MRSA by 50% by 2020 using the 2015 baseline.

Browse 35 Market Data Tables and 29 Figures spread through 177 Pages and in-depth TOC on Global Methicillin Resistant Staphylococcus Aureus (MRSA) Testing Systems Market, By Product (Instruments, Reagents & Kits), By Test Type (Immunodiagnostic Test, and Molecular Diagnostic Test), By End User (Hospitals, Diagnostic Laboratories, and Academic and Research Institute), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Forecast to 2027"

Browse Research Report: https://www.coherentmarketinsights.com/market-insight/methicillin-resistant-staphylococcus-aureus-testing-systems-market-3803

Several market players are focused on acquisitions and mergers to expand their product portfolio and gain a maximum share in the market. For instance, in September 2017, Abbott Laboratories announced that they have completed the acquisition of Alere, Inc. for US$ 5.3 billion. With the acquisition of Alere, the company also obtained the subsidiary Arriva Medical, which is the largest mail-order diabetic supplier. This acquisition has established Abbott as the global leader in point of care testing in vitro diagnostics market and further strengthened the company's diagnostics presence.

Key Takeaways of the Methicillin Resistant Staphylococcus Aureus (MRSA) testing systems market:

The methicillin resistant staphylococcus aureus (MRSA) testing systems market is expected to exhibit a CAGR of xx% during the forecast period (2020-2027) owing to increasing product approvals and product launches.

Among product type, the instruments segment is expected to hold a major revenue share in 2027 owing to the increasing product approvals and launches. For instance, in March 2014, AdvanDx announced that it has submitted its new mecA XpressFISH test to the U.S. Food and Drug Administration for 510(k) clearance for the rapid detection of methicillin-resistant Staphylococcus aureus (MRSA) from S. aureus positive blood cultures. This assay will provide physicians with a new way to rapidly identify MRSA enabling them to implement appropriate treatment for patients with bloodstream infections.

Major players operating in the methicillin resistant Staphylococcus aureus (MRSA) testing systems market are F.Hoffmann-La Roche, Becton, Dickinson and Company, Hain Lifescience GmbH, BioMérieux, 3M Company, Bio-Rad Laboratories Inc., Abacus Diagnostica, Abbott Laboratories, Puritan Medical Products, Diatherix Eurofins, LLC, Arlington Scientific Inc., AdvanDx, Genspeed Biotech GmbH, Cepheid Inc., Luminex Corporation, and R-Biopharm AG.

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About Coherent Market Insights:            

Coherent Market Insights is a prominent market research and consulting firm offering action-ready syndicated research reports, custom market analysis, consulting services, and competitive analysis through various recommendations related to emerging market trends, technologies, and potential absolute dollar opportunity.

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With products, services and applications, valued at US$ 13,266.5 Mn in 2019, the Latin America Pharmaceutical Products CMO Market is forecast to reach a value of US$ 40,070.3 Mn by 2027 at a CAGR of 14.8% from 2020 to 2027.

Latin America Pharmaceutical Products CMO Market is estimated to reach US$ 40,070.3 Mn in terms of valuation, as increasing prevalence of chronic disorders, increasing research & development, and adoption of expansion strategies from major companies are the major factors behind the driving force of the exponential growth in the Pharma market.

The interest for conventional items is high in the pharmaceutical market in Latin America. Also, dominant part of pharmaceutical organizations are continuously redistributing fabricating exercises to contract producing associations (CMO). Insights: Latin America Pharmaceutical Products CMO Market is assessed to represent US$ 13,266.5 Mn as far as incentive before the finish of 2027. Latin America Pharmaceutical Products CMO Market: Drivers Expanding pervasiveness of ceaseless issues is relied upon to impel development of Latin America Pharmaceutical Products CMO Market over the estimate time frame. For example, as per Incidência de Câncer no Brasil, the evaluated number of new instances of disease was 600,000, barring instances of non-melanoma skin malignancy during 2018-2019 biennium, in Brazil. Besides, expanding inoculation drives are additionally expected to help in development of the market. For example, in March 2020, Brazil started its National Flu Vaccination Campaign in three stages against flu. The immunization is shown for anybody more than a half year old enough, aside from the individuals who have had unfavorably susceptible responses at past portions.

Statistics:

Brazil held dominant position in Latin America Pharmaceutical Products CMO Market in 2019, accounting for 38.6% share in terms of value, followed by Mexico and Argentina, respectively

Latin America Pharmaceutical Products CMO Market: Restraints

The pharmaceutical industry in Mexico does not operate through an established system of reimbursement and there is minimal reimbursement offered outside the hospital setting. Reimbursement is limited to generic drugs, based on health technology assessment and to the under privileged population. Such scenario is expected to hinder growth of Latin America Pharmaceutical Products CMO Market.

Weak or ambiguity in patent laws is also expected to limit growth of the market. Different countries in Latin America have adopted different approaches for intellectual property protection. Ambiguity also prevails regarding pricing of drugs. For instance, prices of public sector pharmaceutical drugs in Latin America varied than those sold through the private sector.

Latin America Pharmaceutical Products CMO Market: Opportunities

Growing medical tourism in Latin America is expected to offer lucrative growth opportunities for players in the market. For instance, according to Tourism of the Federal District, Mexico City, in 2018, Tijuana received 1.7 million patients and companions from the U.S. and Canada generating a revenue of US$ 600 million.

Moreover, integration of public and private healthcare sector in Latin America may lead to revival of a weak sector in the region, thereby aiding in growth of the market.  

Statistics:

Latin America Pharmaceutical Products CMO Market was valued at US$ 13,266.5 Mn in 2019 and is forecast to reach a value of US$ 40,070.3 Mn by 2027 at a CAGR of 14.8% between 2020 and 2027.

Market Trends/Key Takeaways

Major pharmaceutical companies are focused on approval and launch of COVID-19 test kits. For instance, in February 2020, Osang Healthcare received European certification (CE-IVD) for GeneFinder, a test kit for the new coronavirus, and the company has commercialized the product in Italy, Romania, Morocco, Brazil, and Russia.

The coronavirus pandemic has adversely impacted the healthcare system in Latin America. As of May 07, 2020, there have been 26,025 confirmed cases of COVID-19 with 2,507 deaths in Mexico as reported to the World Health Organization. The lockdown implemented in several countries in Latin America is expected to have mixed impact on the market.

Latin America Pharmaceutical Products CMO Market: Competitive Landscape

Major players operating in Latin America Pharmaceutical Products CMO Market include, BASF SE, Bayer AG, Boehringer Ingelheim GmbH, F. Hoffmann-La Roche Ltd., Merck & Co., Inc., Novartis AG, Pfizer, Inc., Pisa Farmacéutica, Fresenius SE & Co. KGaA, Takeda Pharmaceutical Company Limited, Ferring Pharmaceuticals, Inc., and Landsteiner Scientific.

Latin America Pharmaceutical Products CMO Market: Key Developments

Major players in the market are focused on adopting partnership strategies to enhance their market share. For instance, in March 2019, Pfizer, Inc. partnered with Unión Latinoamerica Contra el Cáncer de la Mujer - Latin American Union Against Cancer of Women, to launch the personal guide “Me and Metastatic Breast Cancer”.

Major players in the market are also focused on R&D of new products to expand their product portfolio. For instance, in December 2019, FerGene, a new gene therapy company formed as an alliance between Ferring Pharmaceuticals and Blackstone Life Sciences, announced positive results from a clinical trial that assessed the efficacy of nadofaragene firadenovec (rAd-IFN/Syn3), an investigational gene therapy, for the treatment of high-grade, Bacillus Calmette-Guérin  unresponsive non-muscle invasive bladder cancer.

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