Global Clinical Diagnostics Market Analysis

Global Clinical Diagnostics Market Analysis


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The global clinical diagnostic market was valued at $68.92 Bn in 2022 and is estimated to expand at a CAGR of 6% from 2022-30 and will reach $109.85 Bn in 2030. One of the main reasons propelling the growth of this market is an increase in chronic disease and the aging population. The market is segmented by type, drug, and distribution channel. Some key players in this market are Abbott, BD, bioMérieux SA, Bio-Rad Laboratories, Danaher Corporation, Siemens AG, Hologic, Qiagen NV, Quest Diagnostics, F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific, Sysmex, Sonic Healthcare Ltd, Exact Sciences Corporation, NeoGenomics, Inc., BioReference Laboratories, Laboratory Corporation of America Holdings, DiaSorin, PerkinElmer, FUJIFILM Corporation, and others.

ID: IN10GLHS003 CATEGORY: Healthcare Services GEOGRAPHY: Global AUTHOR: Nandini Shah

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Global Clinical Diagnostic Market Executive Summary

The Global Clinical Diagnostic market was valued at $68.92 Bn in 2022 and is estimated to expand at a CAGR of 6% from 2022-30 and will reach $109.85 Bn in 2030. The process of determining a disease, ailment, or damage based on a patient's signs and symptoms, as well as the patient's health history and physical exam. Following a clinical diagnosis, further testing such as blood tests, imaging studies, and biopsies may be performed.

Because of the COVID-19 pandemic, there has been a rise in lab testing, which has caused demand to expand even faster in order to keep up with the suspected cases of COVID-19. According to the Atlantic Monthly Group, COVID-19 tests have increased dramatically worldwide, rising from 760,441 in September 2020 to 964,792 by October 2020. Hence, the increasing number of tests due to the steady increase in patients and government financing were the elements responsible for driving the overall market growth tremendously. Furthermore, due to the advent of a mutant strain of the COVID-19 virus, the need for clinical diagnostics is predicted to stay steady during the post-pandemic period, leading to the growth of the market over 5 years.

global clinical diagnostics market analysis

Market Dynamics

Market Growth Drivers

The rising incidence of chronic and infectious diseases, such as cancer, diabetes, cardiovascular diseases, and infectious diseases, is a major driver of the clinical diagnostics market. Globally 3 in 1 suffer from Chronic disease. Chronic disease/ Noncommunicable diseases (NCDs) kill 41 Mn people per year, accounting for 74% of all deaths worldwide. Every year, 17 Mn people die from an NCD before the age of 70, with low- and middle-income nations accounting for 86% of these premature fatalities. 77% of NCD fatalities occur in low- and middle-income countries. Cardiovascular diseases kill the most individuals each year (17.9 Mn), followed by cancer (9.3 Mn), chronic respiratory disorders (4.1 Mn), and diabetes (2.0 Mn including kidney disease deaths caused by diabetes). The need for accurate and timely diagnosis of these diseases is increasing, leading to a higher demand for clinical diagnostic tests and equipment.

The development of advanced diagnostic technologies, such as next-generation sequencing, digital pathology, and point-of-care testing, is driving the growth of the clinical diagnostics market. These technologies enable faster and more accurate diagnoses, leading to better patient outcomes. Personalized medicine, which involves the use of diagnostic tests to tailor treatment to individual patients, is becoming increasingly important in the healthcare industry. This trend is driving the demand for clinical diagnostic products that can provide more precise and personalized diagnoses. Point-of-care testing, which involves conducting diagnostic tests at the patient's bedside or in the physician's office, is becoming more popular due to its convenience and efficiency. This trend is driving the demand for clinical diagnostic products that can be used in point-of-care settings. Governments around the world are implementing favorable policies and initiatives to improve healthcare infrastructure and increase access to healthcare services. This is driving the growth of the clinical diagnostics market by increasing the demand for diagnostic tests and equipment. The global aging population is increasing, leading to a higher incidence of age-related diseases, such as cancer and Alzheimer's disease. This is driving the demand for clinical diagnostic products that can diagnose and monitor these diseases.

Market Restraints

Diagnostic tests can be expensive, particularly advanced tests and imaging procedures. This can limit access to these tests for some patients, particularly those in low-income countries or those without adequate health insurance coverage. The interpretation of diagnostic test results requires specialized knowledge and skills, which can be in short supply in some regions. This can limit the availability and quality of diagnostic services. Clinical diagnostic products are subject to stringent regulatory requirements, particularly in developed countries. Meeting these requirements can be time-consuming and expensive, which can limit the ability of small and medium-sized companies to enter the market. The reimbursement for diagnostic tests can be limited in some countries, particularly for advanced tests and procedures. This can limit the demand for these tests and affect the financial viability of diagnostic companies. The lack of standardization in diagnostic tests can lead to variability in test results, making it difficult to compare results across laboratories or establish consistent treatment protocols. The clinical diagnostics market is subject to the threat of counterfeit products, which can pose a risk to patient safety and the reputation of legitimate diagnostic companies.

Competitive Landscape

Key Players

  • Abbott
  • BioMérieux
  • Bio-Rad Laboratories
  • Danaher Corporation
  • Siemens
  • Hologic
  • Qiagen NV
  • Quest Diagnostics
  • F. Hoffmann-La Roche
  • Thermo Fisher Scientific
  • Sysmex
  • Sonic Healthcare
  • Exact Sciences Corporation
  • NeoGenomics
  • BioReference Laboratories
  • Laboratory Corporation of America Holdings
  • DiaSorin
  • PerkinElmer
  • FUJIFILM Corporation

Healthcare Policies and Regulatory Landscape

In the United States, the Food and Drug Administration (FDA) regulates diagnostic tests under the Clinical Laboratory Improvement Amendments (CLIA) program. The FDA also regulates in vitro diagnostic (IVD) tests under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA has established a classification system for IVD tests based on their level of risk to patients, with Class I tests being considered low risk and Class III tests being considered high risk.

In Europe, diagnostic tests are regulated under the European Union (EU) In Vitro Diagnostic Regulation (IVDR), which went into effect in May 2022. The IVDR establishes a new regulatory framework for IVD tests in the EU, with a focus on ensuring the safety and performance of tests and improving patient access to innovative tests. Under the IVDR, IVD tests are classified based on their level of risk, similar to the FDA's classification system.

Other countries and regions have their own regulatory frameworks for diagnostic tests. For example, in Japan, diagnostic tests are regulated by the Ministry of Health, Labour and Welfare (MHLW) under the Pharmaceutical Affairs Law (PAL). In China, diagnostic tests are regulated by the China Food and Drug Administration (CFDA) under the Medical Device Regulations.

Latest News and Updates

  1. 17 Feb 2023, BioEcho has received two patents for their unique EchoLUTION technology, which transforms traditional nucleic acid extraction techniques
  2. 6 Sep 2022, the Azerbaijan Thalassemia Center and BGI performed a virtual signing ceremony to conclude a Cooperation Agreement in September. With genetic technologies, the collaboration hopes to improve thalassemia screening in Azerbaijan
  3. In March 2020, Thermo Fisher Scientific completed its acquisition of Qiagen, a leading provider of sample and assay technologies for molecular diagnostics. The acquisition was valued at $11.5 Bn and is expected to strengthen Thermo Fisher's position in the clinical diagnostics market

Reimbursement Scenario

The reimbursement scenario for clinical diagnostic tests varies by country and region. In general, government and private insurers determine the reimbursement rates for diagnostic tests. The rates may vary depending on factors such as the type of test, the complexity of the test, and the setting in which the test is performed.

In many countries, government-run healthcare systems, such as the National Health Service (NHS) in the UK, provide reimbursement for diagnostic tests. In these systems, diagnostic tests are typically provided free of charge to patients. Private insurers also provide reimbursement for diagnostic tests, often with some out-of-pocket cost to the patient.

In the United States, reimbursement for diagnostic tests is typically provided by private insurance companies or by Medicare, the government-run insurance program for people over 65 and certain people with disabilities. Reimbursement rates are determined through a complex process that considers factors such as the cost of the test, the clinical utility of the test, and the potential impact of the test on patient outcomes.

Reimbursement rates for diagnostic tests can vary widely depending on the country and the type of test. Some tests may be reimbursed at a higher rate than others, particularly if they are considered to be medically necessary or if they are used to diagnose a rare or serious condition.

1. Executive Summary
1.1 Service Overview
1.2 Global Scenario
1.3 Country Overview
1.4 Healthcare Scenario in Country
1.5 Healthcare Services Market in Country
1.6 Recent Developments in the Country

2. Market Size and Forecasting
2.1 Market Size (With Excel and Methodology)
2.2 Market Segmentation (Check all Segments in Segmentation Section)

3. Market Dynamics
3.1 Market Drivers
3.2 Market Restraints

4. Competitive Landscape
4.1 Major Market Share

4.2 Key Company Profile (Check all Companies in the Summary Section)

4.2.1 Company
4.2.1.1 Overview
4.2.1.2 Product Applications and Services
4.2.1.3 Recent Developments
4.2.1.4 Partnerships Ecosystem
4.2.1.5 Financials (Based on Availability)

5. Reimbursement Scenario
5.1 Reimbursement Regulation
5.2 Reimbursement Process for Services
5.3 Reimbursement Process for Treatment

6. Methodology and Scope

Clinical Diagnostics Market Segmentation

By Test

  • Lab Test
  • Imaging Test
  • Other Tests

By Product

  • Instruments
  • Reagents
  • Other Products

By End User (Revenue, USD Bn)

  • Hospital Laboratory
  • Diagnostic Laboratory
  • Point-of-care Testing
  • Other End Users

By Geography

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

Insights10 will provide you with the reports within 10 key parameters which are:

  1. Market Overview
  2. Market Growth Drivers & Restraints
  3. Epidemiology of Disease Type
  4. Market Segmentation
  5. Market Share
  6. Competitive Landscape
  7. Key Company Profiles
  8. Healthcare Policies & Regulatory Framework
  9. Reimbursement Scenario
  10. Factors Driving Future Growth

Based on our many years of experience, we believe that these are the parameters that are critical to decision-making for business stakeholders. Our focused approach to developing reports focused on 10 key parameters, enabled us to arrive at the name “Insights10”.

 

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The top-down approach is mainly used for new product forecasting and the bottom-up approach is used for demand estimation of any product for different countries summed up to form the total market. We are able to round off insights and build stronger forecasts because we always do both these methods and triangulate the final numbers.

The study on the market covers the analysis of the leading geographies such as Asia-Pacific, Africa, Europe, Middle East, North America, and  Latin America for the period of 2022 to 2030. The qualitative analysis covers the industry landscape and trends, market opportunities, competitive landscape, and policy and regulatory scenario, and the quantitative analysis covers different market estimates and forecasts.

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We make sure to finalize the numbers in alignment with the market research. Firstly, our internal experts ensure thorough validation and checking to ensure accurate and precise analysis and then validation is also done using a multiple-data analysis model. Two-level validation is done and entails the finalization of the report scope and the way of representation pattern.

 

 

Stage III: Interpretation and Presentation

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  • Establishing market drivers and trends
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Last updated on: 11 December 2023
Updated by: Vidhi Upadhyay

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