USD 117.8 billion
In-Vitro Diagnostics (IVD) Market Size, Share, Growth Analysis, By Product type(Instrument & Reagent, Software, Services), Technology(Immunoassays, Molecular diagnostics, Hematology, Microbiology, Others), Specimen, Test Type, Application, End User, and Region - Industry Forecast 2024-2031
Report ID:
SQSG35G2015 |
Region:
Global |
Published Date: June, 2024
Pages:
157
|Tables:
124
|Figures:
77
In-Vitro Diagnostics Market Insights
In-vitro Diagnostics (IVD) Market size was valued at USD 83.50 billion in 2022 and is poised to grow from USD 87.93 billion in 2023 to USD 132.90 billion by 2031, growing at a CAGR of 5.3% during the forecast period (2024-2031).
The growing opportunities in unexploited emerging markets with enhanced health infrastructure, rising unfulfilled medical needs, increasing prevalence of chronic diseases, and more demand for cutting-edge testing methodologies have been predicted to serve as the driving force behind the proliferation of the in vitro diagnostics market. The emergence of personalized medicine as an individualized treatment approach tailored to patient’s specific genetic, molecular, and clinical contexts is also a contributing factor that is shaping the IVD market. On the spectrum of IVDs, companion diagnostics, a unique subset, take an active part in assessing patients appropriate for therapies or those at risk of adverse drug reactions or toxicity. These individualized interventions not only increase the treatment efficacy but also contain the healthcare costs by avoiding wasteful treatments, thus emphasizing market expansion.
IVD industry operates in a regulated environment to confirm patient safety and accuracy of the test. Getting regulatory approvals for an innovative IVD test may be time-consuming and be resource intensive. The rigorous regulatory standards, imposed by the regulatory institutions like the FDA and similar bodies worldwide, might slow down the rapid entrance of new tests and technologies, which in turn may become an obstacle in the growth path of the IVD market. It is forecasted that the market will face growth due to the arrival of products that have improved versatility. For instance, Agilent Technologies introduced IVD-compliant instruments, kits, and reagents that follow the new European Union IVDR regulation and further and greater the demand for and usage of IVD devices. This growth is also supported by increased investment from leading industrial actors aimed at research and development projects to develop new products and explore new applications of IVD technologies.
US In-Vitro Diagnostics Market is poised to grow at a sustainable CAGR for the next forecast year.
Market Snapshot - 2024-2031
Global Market Size
Largest Segment
Reagents & Kits, Services
Fastest Growth
Reagents & Kits, Services
Growth Rate
3.3% CAGR
Global In Vitro Diagnostic (IVD) Market ($ Bn)
Country Share for Asia Pacific Region (%)
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In-Vitro Diagnostics Market Segmental Analysis
In Vitro Diagnostics Market is segmented by Product type, Specimen, testing type, Application, Technology, End User and region. Based on Product type, the market can be segmented into Instrument & Reagent (Instruments, Reagents [By Raw Material {Antigen-antibody, Enzyme & Substrate, Primers & Probe, Others}]), Software, Service. Based on technology, the market is segmented into Immunoassays (Enzyme-Linked Immunosorbent Assays (ELISA), Chemiluminescence immunoassays, Immunofluorescence assays, Rapid tests, Enzyme-Linked Immunospot Assays (ELISPOT), Western blotting, Other), Clinical chemistry (Basic Metabolic Panels, Liver Panels, Renal Profiles, Lipid Profiles, Thyroid Function Panels, Electrolyte Panels, Others), Molecular diagnostics (Polymerase chain reaction (PCR), Isothermal nucleic acid amplification technology (INAAT), DNA sequencing & next-generation sequencing (NGS), In situ hybridization (ISH), DNA microarrays, Other), Hematology, Microbiology, and Others. Based on specimen, the market is segmented into Blood, CSF, Urine, Blood Fluid, and Others. Based on test type, the market is segmented into Laboratory Tests and Point-Of-Care Tests. Based on application, the market is segmented into infectious diseases, Diabetics, Oncology, Nephrology, Cardiology, Autoimmune Diseases, Drug Monitoring & Testing, and Other. Based on the end user, the market is segmented into Hospitals & Clinics, Clinical Laboratories (Large Reference Laboratories, Small and Medium-Sized Laboratories), Blood Banks, Home Care Settings, Pharmaceutical & Biotechnology Companies, Academic Institutes, and other. Based on region, the market is segmented into North America, Europe, Asia Pacific, Middle East and Africa, and Latin America.
Analysis by Product type
In the in vitro diagnostics market size in 2023, the instrument & reagents segment held the largest share, and it is expected to be the leader throughout the forecast period as well. This long-term dominance is due to a variety of reasons including persistent demand for diagnostic solutions testing, on-going development of innovative and specialized reagents, and the increase in the number of patients needing accurate diagnostic procedures. For instance, in April 2023, bioMérieux SA submitted a 510(k) application to the US FDA to get a rapid AST (Antimicrobial Susceptibility Testing) system, VITEK REVEAL, approved. Organizations are cleverly launching equipment for screening purposes to be able to cope with the increasing demand for the worldwide genetic testing.
In 2023, the service segment holds the position as the second leading category. Services within this market encompass various activities, including consulting, maintenance, training, and quality assurance. The growth in the service segment is primarily driven by the increasing complexity and technological advancements in diagnostic instruments, which require specialized support and maintenance to ensure optimal performance and regulatory compliance. Additionally, the integration of advanced diagnostic systems in healthcare facilities necessitates professional services for proper implementation and user training. This trend is further supported by the growing demand for personalized medicine and precision diagnostics, which rely heavily on sophisticated instruments and the expertise provided by service professionals to maintain and operate these devices efficiently
Analysis by End User
The hospitals & clinics segment was the leading revenue earner in 2023, due to the ever-increasing number of hospitalizations needing prompt diagnostic help. Furthermore, the continuous advancement in healthcare infrastructure and the implementation of government-friendly initiatives are expected to increase the existing hospital capabilities and hence enhance demand for hospital-based IVD testing. The majority of IVD devices are purchased by hospitals and used in considerable quantities. Based on Skyquest in-depth analysis, in the United States, as of 2023, there are over 6,129 hospitals that trust the accuracy and speed of IVD technology. Furthermore, hospitals often act as referral centres, receiving patients from clinics and smaller healthcare facilities, which further boosts their diagnostic testing volume
However, the homecare setting segment is anticipated to experience an impressive growth from 2024 to 2031 mainly due to the growing older population and the increasing demand for home care IVD devices. In December, the American Hospital Association opposed the FDA from enforcing their regulations on hospitals' Laboratory Developed Tests (LDTs). The demand for the development of molecular diagnostic and immunoassay platforms that can be performed by the patients themselves is growing. For instance, in February 2023, the FDA granted Emergency Use Authorization (EUA) to the first OTC home diagnostic test that can discriminate between influenza A and B, as well as SARS-CoV-2 which is the virus responsible for COVID-19.
Global In Vitro Diagnostic (IVD) Market By Product Type ($ Bn)
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In-Vitro Diagnostics Market Regional Insights
In 2023, North America contributed to the major share of the in vitro diagnostics market, and it is considered to maintain its top position during the market forecast period. The region benefits from substantial healthcare infrastructure and the presence of leading market players who continuously innovate and introduce new diagnostic products. For instance, companies like Abbott, Roche, and Thermo Fisher Scientific are actively engaged in developing precise testing solutions, such as the QuantStudio digital PCR research tool and the Cobas 5800 system. Apart from this, the region also has witnessed technological upgrades in manufacturing sector for in vitro diagnostics which is another driving factor for this market.
The Asia-Pacific area is expected that to have the most rapidly growth rate in the in vitro diagnostics market over the forecast period. This growth can be explained by the increased demand arising from countries that have a large population and abundant purchasing power of the population. Also, the expanding tendency for the personalised medicine, and application of the innovative production methods to improve the manufacturing of the in vitro diagnostics products create a favourable environment for unstoppable development of this market in this region. For Instance, In October 2023 Fapon and Halodoc have united being a part of a strategic partnership to promote sales and services in vitro diagnostic products in Indonesia. Furthermore, the leading players have chosen partnerships with local partners to take their presence deeper into developing countries emerging in the Asia Pacific region.
Global In Vitro Diagnostic (IVD) Market By Geography
- Largest
- Fastest
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In-Vitro Diagnostics Market Dynamics
In-Vitro Diagnostics Market Driver
Rising Burden of Chronic Diseases to Augment Market Growth
- The growing pressure of chronic diseases, majorly discussed by organizations is a major issue that is being seen as a challenge to all the global healthcare systems. Non-Communicable Diseases (NCDs) including cardiovascular diseases, cancer, chronic respiratory diseases and diabetes are responsible for a significant proportion of the global morbidity and mortality. In-Vitro Diagnostics (IVD) contribute to the early diagnosis of such diseases while allowing healthcare professionals to immediately provide an adequate treatment. Through the prompt determination of disease, IVD technologies enables early treatment that in turn ensures positive patient outcomes as well as helps to lower the overall pressure on the healthcare system.
Government Regulations and Investments
- The government and the agencies are the main entities that encourage IVD’s adoption through awareness campaigns and thereby, expansion of the markets. To streamline the disease prioritization process based on their burden and prevalence, the World Health Organization (WHO) put out a model list of Essential In Vitro Diagnostics for primary healthcare facilities and clinical laboratories. The latter represents general IVDs and those which are related to or caused by diseases. In addition, the emergence of research efforts as well as governmental support is accelerating innovations in IVD products, and this is what further enables the market to experience growth.
Restraints
Regulatory and legal Frameworks
- There are some changes in the regulatory landscape of in vitro diagnostic industry, including test kits used for infectious diseases, but gradual tightening of the regulatory requirements in both the US and European countries. For instance, in the USA, federal law demands that manufacturers of devices file a 510(k) application for any major changes in the device's properties. This entails updates of software or the installation of new software on existing gadgets, as well as any other changes made on devices.
Unfavourable Reimbursement Situation
- The reimbursement framework imposes considerable difficulty, most notably to a few pathology tests that do not have Healthcare Common Procedure Coding System codes, thus they are usually paid using typical codes. In these cases, the Medicare Administrative Contractors (MACs) use regional jurisdictions to determine the payment rates. Besides all these, lack of money and fund shortage impedes the implementations of the modern diagnostic methodologies of clinical laboratories. These adjustments in payment mechanisms are viewed as likely to have a negative impact on the industry's in-vitro diagnostics (IVD) segment.
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In-Vitro Diagnostics Market Competitive Landscape
The global in vitro diagnostics (IVD) market presents a dynamic competitive landscape characterized by a diverse array of players ranging from established multinational corporations to innovative startups. Leading companies in the market include Abbott Laboratories, F. Hoffmann-La Roche Ltd, Siemens Healthineers, Thermo Fisher Scientific Inc., and Danaher Corporation. These companies are at the forefront of developing advanced diagnostic technologies and expanding their product portfolios to address a broad range of medical conditions. However, the market also sees vigorous competition from niche players specializing in specific diagnostic segments or cutting-edge technologies, fostering innovation and driving market growth.
In-Vitro Diagnostics Market Top Player's Company Profiles
- Roche Diagnostics (Switzerland)
- Danaher Corporation (U.S.)
- Abbott Laboratories (U.S.)
- Becton, Dickinson and Company (U.S.)
- Bio-Rad Laboratories, Inc. (U.S.)
- QIAGEN N.V. (Netherlands)
- Quidel Corporation (U.S.)
- Siemens Healthineers (Germany)
- Sysmex Corporation (Japan)
- Thermo Fisher Scientific, Inc (U.S.)
- bioMérieux SA (France)
- Agilent Technologies, Inc. (U.S.)
- DiaSorin S.p.A (Italy)
- Illumina, Inc. (U.S.)
- Hologic, Inc. (U.S.)
- Devyser PerkinElmer Inc. (U.S.)
- Chembio Diagnostics, Inc. (U.S.)
- Surmodics, Inc. (U.S.)
- Menarini Silicon Biosystems (Italy)
- SpeeDx Pty. Ltd. (Australia)
In-Vitro Diagnostics Market Recent Developments
- In January 2024, World Health Organization (WHO) and the Medicines Patent Pool (MPP) have announced a license agreement with SD Biosensor Inc., a global in-vitro diagnostic company. This agreement grants sublicensees the rights, know-how, and materials necessary to manufacture SD Biosensor’s rapid diagnostic testing (RDT) technology.
- In December 2023, Thermo Fisher introduced the Applied Biosystems MagMAX Dx Viral/Pathogen NA Isolation Kit and the Thermo Scientific KingFisher Apex Dx, an automated device for nucleic acid purification. These products are designed for the separation and purification of bacterial and viral pathogens from respiratory biological samples.
- In December 2023, ARUP Laboratories partnered with Medicover to enhance diagnostic and healthcare services across Europe. Additionally, ARUP Laboratories has collaborated with BioMarin Pharmaceutical Inc. to develop the AAV5 DetectCDx, a diagnostic tool designed to aid in selecting therapies for patients with severe hemophilia A.
In-Vitro Diagnostics Key Market Trends
- Shift towards Sustainable and Resilient Infrastructure: The increase in the burden of diseases has urged medical device companies to speed up the design of highly advanced diagnostic devices. In addition, hospitals and laboratories are mainly relying on point-of-care devices due to their capability to provide immediate and real-time data. Point-of-Care (PoC) testing is a diagnostic method which is performed close to the patient, with minimal blood volume needed, and which offers rapid test results crucial for clinical decision making, making the physician to initiate timely treatment without waiting for the central laboratory results. Therefore, the demand for these instruments will increase, which will lead to an increase in the need for the in vitro diagnostics devices. Moreover, an increase in the launch of new and advanced products are set to drive the industry development. For instance, In January 2023, FUJIFILM Sonosite, Inc. came up with the new Sonosite PX ultrasound system in India to replace the traditional system. The aim is to enhance clinician ergonomics and streamline efficiency.
In-Vitro Diagnostics Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Co-relates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
According to our analysis, the global in vitro diagnostics (IVD) market is experiencing robust growth driven by the escalating prevalence of chronic and infectious diseases, increasing demand for personalized medicine, and advancements in technology. The market encompasses a wide array of diagnostic tests and devices used for early disease detection, diagnosis, monitoring, and management, spanning various healthcare settings from hospitals and laboratories to point-of-care facilities. Factors such as the growing geriatric population, rising healthcare expenditure, and expanding access to healthcare services in emerging economies further contribute to market expansion. Additionally, ongoing developments in molecular diagnostics, immunoassays, and point-of-care testing are driving innovation and diversification within the IVD market, fostering competition among key players and fuelling continuous research and development efforts to address evolving healthcare needs globally.
| Report Metric | Details |
|---|---|
| Market size value in 2022 | USD 83.50 billion |
| Market size value in 2031 | USD 132.90 billion |
| Growth Rate | 5.3% |
| Base year | 2023 |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on In-Vitro Diagnostics Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on In-Vitro Diagnostics Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the In-Vitro Diagnostics Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the In-Vitro Diagnostics Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the In-Vitro Diagnostics Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the In-Vitro Diagnostics Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
In-Vitro Diagnostics Market Report Snapshots
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