NEW YORK, Dec. 26, 2017 — The global in vitro diagnostics (IVD) market should reach $102.4 billion by 2022 from $74.1 billion in 2017 at a compound annual growth rate (CAGR) of 6.7%, from 2017 to 2022.
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• North American IVD market is expected to grow from $31.1 billion in 2017 to $36.9 billion in 2022 at a CAGR of 3.4% for the period 2017-2022.
• Asia-Pacific IVD market is expected to grow from $18.5 billion in 2017 to $34.8 billion in 2022 at a CAGR of 13.5% for the period 2017-2022.
Chapter 1: Introduction
Study Goals and Objectives
This report offers a comprehensive analysis of the global in-vitro diagnostic market, along with an indepth study of the various in vitro diagnostics (IVD). Segments include clinical chemistry, immunoassays, point-of-care diagnostics, molecular diagnostics, hematology, microbiology and tissue diagnostics. The regional markets covered are North America, Europe, Asia-Pacific and LAAM (Latin America/Africa/Middle East).
This report provides a complete review and analysis of the current trends in the IVD markets, along with industry growth drivers and restraints. Revenues are broken down by regions, segments, products and end users, and sales figures have been estimated for the five-year period from 2017 through 2022 in constant U.S. dollars.
In addition, it provides an examination and description of select products, current and emerging technologies, and company profiles. Applications for IVD are also discussed, with an emphasis on the use of these types of tests in various disease sectors. Further, the report offers a view on IVD patents, regulatory aspects and emerging developments in the IVD market across the globe.
Reasons for Doing This Study
In vitro diagnostic tests performed on biological samples, such as blood, urine, saliva, spinal fluid, and DNA, are a key component of healthcare delivery. The information provided by IVD tests enable medical care providers to manage several diseases through timely prevention, diagnosis and decision making, and by administering patient-specific treatment modalities.
Due to recent rapid technological advances and automation, the range and complexity of diagnostic tests have overwhelmingly increased; this has made lab tests much easier to use and less error-prone, with more precise and timelier results, thus transforming medical practice.
As a result of these rapid innovations, disease detection has been made possible before the appearance of symptoms, along with the prediction of beneficial and adverse treatment outcomes.
These developments have in turn enabled personalized treatment through the emergence of point-of-care (POC) tests and home-based testing in the form of blood glucose meters for diabetics, pregnancy tests and cholesterol tests. These tests facilitate more rapid decision-making, especially for the management of major chronic diseases such as diabetes, hypertension or cardiovascular conditions.
Instead of a patient having to wait for test results and schedule his or her next visit, test values for key biochemical parameters, such as, for example, glycated hemoglobin (HbA1c) or lipid profiles, are generated the same day, allowing a doctor to make treatment decisions during the same visit. In addition, new tests have become less invasive, easier to perform and more patient-friendly. Likewise, for critical care, POC tests enable doctors to make lifesaving decisions within minutes, as opposed to waiting for hours for test data that was once available only from a central lab.
Today, more than 4,000 different diagnostic tests have become available, and as more IVD tests become compatible with POC environments, health care providers may take advantage of the benefits of these evolving IVDs for effective treatment of life-threatening illnesses through the optimization of healthcare delivery.
IVDs have already tremendously impacted cancer diagnosis and treatment globally by gaining deeper insights into genetic pathways of the disease enabled by human genome sequencing. As a result, identifying faulty genes, personalized risk predictions and tailored therapies have now become possible.
However, despite IVDs being at the top of global market attractiveness index, big challenges need to be addressed. The regional and country-wise differences in regulatory aspects, market approvals and entry bottlenecks, affordability issues, reimbursement inadequacies, logistics and healthcare infrastructure may hold the market back.
Due to these factors, IVD companies need to look at each country's market landscape and IVD requirements, and then tailor their entries, launches and marketing strategies to gain a strong foothold. This BCC Research report, In Vitro Diagnostics: Technologies and Global Markets, will thereby provide a detailed analysis of these aspects and other key factors governing the growth of IVD industry, and provide strategic insights and recommendations for those looking to expand their markets.
Intended Readership The intended audience includes all the stakeholders of the IVD marke Since this study provides business and technical information of a timely nature, it will prove valuable to a variety of readers, including industry executives, managers and planners, purchasers, industry analysts and investors. The projections, forecasts and trend analyses found in this report provide readers with the necessary data and information for careful decision-making and products that will best meet the needs of the IVD segment.
Scope of Report
The scope of this study is global. BCC Research analyzes each market and its applications, regulatory environment, technologies involved, market projections and market shares. The emerging markets discussed include countries such as India, China, Korea, Taiwan, Africa, Australia, Brazil, and Russia, among others.
The report also examines the IVD market drivers as well as restraints and challenges affecting its growth. Further, the report also highlights the emerging products and technologies and associated start-ups that are likely to accelerate the growth of the IVD industry through their best practices in the research and development of IVDs. Excluded from this study is diagnostic testing such as imaging, veterinary diagnostics and their associated products.
This study will provide information on these areas:
• Structure and current market size of the IVD market as outlined with forecasts through 2022.
• Impact of chronic diseases, growing and aging populations.
• Current technology and product suppliers and key innovations.
• A look at the IVD industry and trends affecting the market.
• Markets by each segment (immunochemistry, molecular diagnostics, POC tests, clinical microbiology, hematology and tissue diagnostics) provide a global overview showing market data for the U.S., Europe, Asia-Pacific and Latin America, Africa and the Middle East (LAAM) regions.
• Emerging opportunities and potential investment opportunity areas for IVD.
• Technology patent trends relating to IVD.
• Profiles for more than 20 companies in the industry with significant contributions and market shares.
Information for this report was derived from a variety of primary and secondary research sources including industry analysts, annual reports and Securities and Exchange Commission (SEC) reports, the United Network for Organ Sharing (UNOS), the Organ Procurement and Transplantation Network (OPTN), the Scientific Registry of Transplant Recipients (SRTR), the Center for Medicare and Medicaid Services (CMS), the National Institutes of Health (NIH), the Centers for Disease Control (CDC), other government agencies and journal articles. Secondary sources include literature searches, product literature and press releases. When precise information was not available, a consensus was made using reasonable assumptions and estimates based on historical data. Data were collected through interviews and correspondence with IVD industry experts. Projections were based on estimates and information based on historical revenue trends in subsegments, validations through primary research, mergers and acquisitions, and market trends.
In this report, the geographic regions considered for market analysis include, and only include:
• North America
• Latin America, Africa and the Middle East ( LAAM)
In Vitro Diagnostics, by Segment
Chapter 2: Summary and Highlights
In vitro diagnostics (IVD) are of utmost importance in the global healthcare industry and are the highest revenue segment of the medical devices market valued in the multi-billion-dollar range.
IVD includes analyzers, reagents, disposable and reusable products, and accessory software products used by both clinical and research laboratories around the world. IVDs range from simple self-use tests to state-ofthe-art genomic tests performed in laboratories, and can be used in the diagnosis of infectious and chronic diseases, as well as for preventive care and drug therapy monitoring.
IVDs are of significant value to the general public as they are deemed not only as indispensable tools of medical diagnoses but also as decision-making aids for disease prevention and timely treatment to enhance well-being and keep health care costs under check. In addition, the IVDs are also one of the vital aids that address the needs of the governments, payers, and patients by delivering optimal, individualized and affordable treatments.
These factors and rapid technological developments should drive the growth of the IVD market in the next five years. The market is also expected to be driven by the aging demographics of the developed world, the rising demand and improving healthcare infrastructure in the developing world, and most importantly is being driven by the shift from curative to preventive healthcare for both infectious and chronic diseases such as diabetes.
Further, two emerging segments of IVDs: companion diagnostics and next-generation sequencing techniques, are expected to contribute to the market growth of IVDs through the decade.
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