Product Code: BIO263A
The global market for AI in clinical and molecular diagnostics is expected to grow from $2.6 billion in 2024 and is projected to reach $8.9 billion by the end of 2029, at a compound annual growth rate (CAGR) of 27.6% during the forecast period of 2024 to 2029.
The global market for companion diagnostics is estimated to increase from $7.6 billion in 2023 and is projected to reach $15.4 billion by 2028, at a CAGR of 15.2% from 2023 through 2028.
The global market for drugs and diagnostics for hematological disorders is expected to grow from $131.2 billion in 2024 and is projected to reach $189.3 billion by the end of 2029, at a CAGR of 7.6% during the forecast period of 2024 to 2029.
Research Review Scope
The diagnostics industry has grown despite the challenging economic conditions in recent years. The industry draws much attention and scrutiny from the public and government and is currently undergoing many changes due to increased focus on regulations. These changes can be seen across many countries. The U.S., the largest diagnostics market, is leading the trend with changes intended to make healthcare more affordable. Opportunities for the diagnostics industry are manifold with the appearance of new markets located mainly in emerging economies with varying needs.
Increasing healthcare expenditures and the growth of emerging economies have increased the demand for technologically better diagnostic devices, kits, reagents, and other accessories. Additionally, the introduction of more stringent regulations, specifically in the developed markets of the U.S. and Europe, has forced diagnostics manufacturers to launch advanced products that include new materials, a focus on in-depth indications, and the ability to produce additional new data.
Some of the major driving factors in the market are increasing prevelance of chronic and infectious diseases, technological advancements in the diagnostics, increasing investments in AI in diagnostics market, increased applications in non-oncology areas, growing adotion of personalized medicine, and other driving factors.
Furthermore, technically sophisticated diagnostics are needed for clinical research, as the market is highly competitive, and companies must continuously reinvent their product portfolios to enter new markets and place themselves as significant players in the healthcare system. There is a shift toward a value-based healthcare market where price and purchase decisions are based on outcomes. This has further resulted in increased scrutiny of the technology of devices, and consequently, the degree of competition has risen. Some of the major players in the diagnostics market include Abbott, Medtronic, F. Hoffmann-La Roche Ltd., Siemens Healthineers AG, GE Healthcare, Koninklijke Philips N.V., Agilent Technologies Inc., QIAGEN, Danaher Corp., Sysmex, Thermo Fisher Scientific, Inc., BD, and others.
The diagnostics industry is a multi-billion-dollar market whose outlook is supposed to rise in the coming years. Hospital care is growing, and the diagnostics industry is being looked at to provide low-cost technology for home healthcare. Now, the industry seeks healthcare diagnostic devices, kits, and reagents that individuals with unskilled healthcare experience can use. The need for modern technology, equipment, and devices can be leveraged through diagnostic equipment as manufacturers seek to create better-quality healthcare solutions.
Today's market is worthy of close investigation as it deals with the fallout from COVID-19 and how the global diagnostics market is after the post-COVID-19 pandemic. The global pandemic has impacted the diagnostics industry both positively and negatively.
The above reasons are compelling enough to analyze and research the diagnostics market, as the market has tremendous growth potential.
It includes highlights from these reports published in 2024:
- BIO261A AI in Clinical and Molecular Diagnostics Market
- BIO077F Companion Diagnostics: Technologies and Global Markets
- PHM116C Drugs and Diagnostics for Hematological Disorders Global Markets
- BIO233B In Vitro Diagnostics (IVD) Quality Controls: Global Market
- HLC043H Point of Care Diagnostics: Technologies and Global Markets
- BIO157C Polymerase Chain Reaction (PCR) for Point of Care (POC) Diagnostics
- PHM227B Rare Disease Diagnostics: Technologies and Global Markets
After you survey the excerpts in this Research Review, we encourage you to follow up on these topics by checking out the full market research reports associated with each topic. BCC Research looks forward to serving your market intelligence needs in the future.
Table of Contents
Chapter 1 Foreword
Chapter 2 AI in Clinical and Molecular Diagnostics Market(BIO261A)
- AI in Clinical and Molecular Diagnostics
- Market Outlook
- Scope of Report
- Market Summary
- Market Overview of AI in Clinical and Molecular Diagnostics
- AI in Healthcare
- AI in Clinical Diagnostics
- AI in Molecular Diagnostics
- Market Dynamics of AI in Clinical and Molecular Diagnostics
- Market Drivers
- Investment in the AI Health Sector
- Increasing Prevalence of Chronic and Infectious Diseases
- Technological Advances
- Demand for Personalized Medicine
- Market Restraints
- Practitioners Reluctant to Adopt AI-based Technologies
- Data Security
- Regulatory Challenges
- Market Opportunities
- Software with AI
- Untapped Opportunities in Developing Markets
- Regulatory Structure
- Emerging Technologies and Developments
- Machine Learning Algorithms
- Deep Learning
- Generative AI
- Natural Language Processing (NLP)
- Genomic AI
- Cloud-Based Solutions
- Market Segmentation Analysis
- AI in Clinical and Molecular Diagnostics: Global Markets
- Molecular Diagnostics
- Clinical Diagnostics
- Market Analysis of AI in Clinical and Molecular Diagnostics by Component
- Software
- Services
- Hardware
- Geographic Breakdown
- Market Analysis 0f AI in Clinical and Molecular Diagnostics by Region
- North America
- Europe
- Asia-Pacific
- Rest of the World
Chapter 3 Companion Diagnostics: Technologies and Markets ( BIO077F)
- Companion Diagnostics
- Market Outlook
- Scope of Report
- Market Summary
- Highlights of the Market for Companion Diagnostics (CDx)
- Market Introduction
- Regulatory Landscape
- Companion Diagnostics Regulations in the U.S.
- Companion Diagnostics Regulations Outside the U.S.
- LDT-CDx Regulation
- Market Dynamics of Companion Diagnostics
- Market Drivers
- Rising Incidence of Cancer
- Growing Adoption of Personalized Medicine
- Expanded Application in Non-Oncology Areas
- Optimization of Drug Development Costs
- Market Restraints
- High Development Cost of CDx
- Reimbursement Challenges
- Market Opportunities
- Advances in NGS Technologies
- Market Challenges
- Inefficiencies in Clinical Testing Landscape
- Lack of Skilled Labor
- Emerging Technologies and Developments
- Multiplex Testing
- Next-Generation Sequencing (NGS)
- Digital PCR
- Liquid Biopsy
- Artificial Intelligence
- Market Segmentation Analysis
- Global Market for Companion Diagnostics by Product and Service
- Market Share and Forecast
- Instruments
- Consumables
- Services
- Global Market for Companion Diagnostics by Type of Test
- Market Share and Forecast
- LDT-CDx
- Commercial CDx
- Global Market for Companion Diagnostics by Technology
- Market Share and Forecast
- Polymerase Chain Reaction
- Immunohistochemistry
- Next-Generation Sequencing
- In Situ Hybridization
- Genotyping
- Immunoassays
- Exosomes
- Others
- Services
- Global Market for Companion Diagnostics by Application
- Market Share and Forecast
- Cancer
- Market for the Application of CDx in Cancer by Type
- Neurologic Disorders
- Cardiovascular Disease
- Infectious Diseases
- Other Diseases
- Market Breakdown of Companion Diagnostics by End User
- Market Share and Forecast
- Clinical Laboratories
- Pharmaceutical Companies
- Contract Research Organizations (CROs)
- Other End Users
- Geographic Breakdown
- Global Market for Companion Diagnostics by Region
- North America
- The U.S.
- Canada
- Europe
- Germany
- The U.K.
- France
- Italy
- Rest of Europe
- Asia-Pacific
- China
- Japan
- India
- Rest of Asia-Pacific
- Rest of the World
Chapter 4 Drugs and Diagnostics for Hematological Disorders: Global Markets (PHM116C)
- Drugs and Diagnostics for Hematological Disorders
- Market Outlook
- Scope of Report
- Market Summary
- Market Overview of Drugs and Diagnostics for Hematological Disorders
- PESTEL Analysis
- Political
- Economic
- Social
- Technological
- Environmental
- Legal
- Porter's Five Forces Analysis
- Bargaining Power of Buyers
- Bargaining Power of Suppliers
- Potential of New Entrants
- Threat of Substitutes
- Competition in the Industry
- Supply Chain and Logistics for Hematological Instruments
- Market Dynamics of Drugs and Diagnostics for Hematological Disorders
- Market Drivers
- Incidence of Blood Disorders
- Rising Use of Automation
- Diagnosis of Hematology Disorders
- Increasing Government and Private Funding for Treatment
- Market Restraints
- High Cost of Instruments
- High Cost of Treatment
- Reimbursement Challenges for Physicians
- Market Opportunities
- Rising Health Awareness
- Emerging Economies
- Emerging Technologies and Developments
- AI-Assisted Diagnosis
- Next-Generation Sequencing (NGS)
- Microfluidics and Lab-on-a-Chip Devices
- Gene Therapies
- Immunotherapies
- Market Segmentation Analysis
- Segmentation by Market
- Hematological Disorders Diagnostics Market
- Hematological Disorders Diagnostic Market, By Product Type
- Hematological Disorders Diagnostic Market, By End User
- Hematology Drug Market
- Hematology Drug Market, By Drug Type
- Geographic Breakdown
- North America
- Europe
- Asia-Pacific
- Rest of the World
Chapter 5 In Vitro Diagnostics (IVD) Quality Controls: Global Market( BIO233B)
- In Vitro Diagnostics (IVD) Quality Controls
- Market Outlook
- Scope of Report
- Market Summary
- Market and Technology Background
- Overview
- Classification of In Vitro Diagnostics Elements
- Importance of In Vitro Diagnostics Quality Control
- Regulations
- Regulation of IVD products in Different countries
- Market Dynamics of In Vitro Diagnostics (IVD) Quality Controls
- Market Drivers
- Rise in the Aging Population and Dependency on Frequent Diagnosis Procedures
- Rising Demand for Third-Party Quality Control Products
- Rising Incidence of Chronic Disease Cases
- Strengthening Clinical Laboratories
- Improving the Quality of Point-of-Care Testing
- Market Restraints
- Challenges for Quality Control Product Packaging
- Increases in Shipping Costs or Service Issues
- Improper Operation and Maintenance of Laboratory Equipment and Consumables
- Market Opportunities
- Rise in Home Care Testing Devices
- Demand for Point-of-Care (POC) Testing Units
- Emerging Technologies and Developments
- Artificial Intelligence
- Prioritizing Old IVD Techniques
- Automating In-Vitro Diagnostic Devices
- Emerging Trends in In Vitro Diagnostics
- FDA Approval
- Rise in Demand for Personalized Medicine
- Market Segmentation Analysis
- Market Breakdown of In Vitro Diagnostics (IVD) Quality Controls by Test Type
- Immunodiagnostics
- Clinical Chemistry
- Hematology
- Molecular Diagnostics
- Microbiology
- Other Test Types
- Market Breakdown of In Vitro Diagnostics (IVD) Quality Controls by Type of Manufacturer
- Third-party Controls
- ODM Controls
- Market Breakdown of In Vitro Diagnostics (IVD) Quality Controls by Products and Services
- Quality Control Products
- Data Management Solutions
- Quality Assurance Services
- Market Breakdown of In Vitro Diagnostics (IVD) Quality Controls by End User
- Diagnostic Laboratories
- Hospitals and Clinics
- Point-of-Care Centers
- Research Institutions
- Other End Users
- Geographic Breakdown
- Market Analysis of In Vitro Diagnostics (IVD) Quality Controls by Region
- North America
- Market Size and Forecast
- U.S.
- Canada
- Mexico
- Europe
- Market Size and Forecast
- Germany
- France
- U.K.
- Italy
- Spain
- Rest of Europe
- Asia-Pacific
- Market Size and Forecast
- Japan
- China
- India
- Australia and New Zealand
- Rest of Asia-Pacific
- Rest of the World
- Market Size and Forecast
- Brazil
- GCC Countries
- Rest of the World Countries
Chapter 6 Point-of-Care Diagnostics: Technologies and Global Markets ( HLC043H)
- Point-of-Care Diagnostics
- Market Outlook
- Scope of Report
- Market Summary
- Market Overview of Point-of-Care Diagnostics
- Novel Approaches for POC
- Significance of CLIA in the United States
- Regulatory Guidelines
- Good Manufacturing Practice
- The FDA's Role in POC Testing
- Conclusion
- Market Dynamics of Point-of-Care Diagnostics
- Market Drivers
- High Incidences of Infectious Diseases
- Growing Prevalence of Chronic Diseases
- Increasing Demand for Self-Testing
- Aging Population
- Market Restraints
- Challenges Faced by POC Manufacturers Due to Pricing Pressure
- Technical Complexity
- Lack of Specialized Training
- Market Challenges
- Challenges in Deploying Point-of-Care (POC) Diagnostics in Remote Settings
- Environmental and Contamination Challenges in Point-of-Care Diagnostics
- Market Opportunities
- Increasing R&D Budget
- Excellent Market Potential for POCT with AI and ML Integration
- Emerging Economies
- Emerging and Upcoming Technologies in the Market
- AI in Point-of-Care Diagnostics
- CRISPR-Cas Systems
- 3D Rapid Prototyping
- Quantum Dots
- RFID (Radio-Frequency Identification) and NFC (Near Field Communication)
- Smartphone-Based Medical Imaging
- Nanomaterials in POC Devices for Pathogen Detection
- Microfluidics-Based Sensing Technologies
- Cloud-Integrated AI
- D3 Array-UTI
- EVIK DxSpheres: A Solid Assay Solution
- UNIQO 160 Automated IIFT System
- Market Segmentation Analysis
- Market Breakdown of Point-of-Care Diagnostics by Test Type
- Drug and Alcohol Screening
- Blood Gas Electrolyte and Metabolite (BGEM)
- Cardiac Markers
- Cholesterol Testing/Monitoring
- Glucose Testing and Monitoring
- Infectious Disease Testing
- Pregnancy and Fertility Testing
- Hemoglobin and Hemostasis
- Tumor Marker
- Urinalysis/Urine Chemistry
- Others
- Market Breakdown of Point-of-Care Diagnostics Market by Product
- Hardware
- Software
- Market Breakdown of Point-of-Care Diagnostics Market by End User
- Hospitals and Critical Care Settings
- Home Care Settings
- Geographic Breakdown
- Market Breakdown of Point-of-Care Diagnostics Market by Region
- North America
- Europe
- Asia-Pacific
- Rest of the World (RoW)
Chapter 7 Polymerase Chain Reaction (PCR) for Point-of-Care (POC) Diagnostics (BIO157C)
- Polymerase Chain Reaction (PCR) for Point-of-Care (POC) Diagnostics
- Market Outlook
- Scope of Report
- Market Summary
- Market Overview of Polymerase Chain Reaction (PCR) for Point-of-Care (POC) Diagnostics
- Polymerase Chain Reaction Technology
- Point of Care PCR Systems and Assays
- Market Dynamics of Polymerase Chain Reaction (PCR) for Point-of-Care (POC) Diagnostics
- Market Drivers
- Increasing Incidence of Infectious Diseases
- Decentralization of Testing
- Increasing Adoption of Point-of-Care Testing and Expansion
- Multiplexing Testing
- Response to the Pandemics
- Market Opportunities
- Integration of PCR POC Technology in Primary Care and Low-Income Countries
- Market Restraints
- High Initial Cost
- Market Competition
- Market Challenges
- Operational Challenges
- Supply Shortages
- Emerging Technologies and Developments
- Instrument-Free PCR Tests
- Five-Minute Point-of-Care Testing
- Smartphone Enabled PCR System
- Global Market for PCR POC Diagnostics
- Market Breakdown of Polymerase Chain Reaction (PCR) for Point-of-Care (POC) Diagnostics by Product Type
- Market Breakdown of Polymerase Chain Reaction (PCR) for Point-of-Care (POC) Diagnostics by Analyte
- PCR POC Analyzers by Analyte
- PCR POC Consumables by Analyte
- Market Breakdown of Polymerase Chain Reaction (PCR) for Point-of-Care (POC) Diagnostics by Application
- Infectious Diseases
- STIs
- Geographic Breakdown
- Market Breakdown of Polymerase Chain Reaction (PCR) for Point-of-Care (POC) Diagnostics by Region
- North America
- Latin America
- Europe
- Asia-Pacific
- Rest of the World
Chapter 8 Rare Disease Diagnostics: Technologies and Global Markets (PHM227B)
- Rare Disease Diagnostics
- Market Outlook
- Scope of Report
- Market Summary
- Market Overview of Rare Disease Diagnostics
- Diagnostic Odyssey
- What Is Genomic Testing?
- Rare Disease Clinical Assays Development and Marketing
- Rare Disease Treatment
- Bioinformatic Resources for Rare Disease Research and Genetic Information
- Large-Scale Initiatives and Consortia
- Population Sequencing Programs
- Market Dynamics of Rare Disease Diagnostics
- Market Drivers
- Significant Unmet Need in Rare Disease Diagnostics
- Orphan Drug Act
- Advances In Gene Therapy
- Rare Disease Initiatives
- Advances in Genomic Technologies and Analytical Tools
- Decreasing Cost of Next-Generation Sequencing (NGS)
- Market Driving Forces and Their Impact on Market Growth
- Market Restraints
- Lack of Commercially Available IVDs for Rare Disease Diagnosis
- Stringent Regulatory Landscape
- Ethical and Legal Concerns
- Shortage of Genetic and Rare Disease Specialists
- Emerging Technologies and Developments
- Shift Towards a Multi-omics Approach
- Artificial Intelligence (AI) and Machine Learning
- Collaboration Between Rare Disease Diagnostics and Pharma Companies
- Market Segmentation Analysis
- Market Breakdown of Rare Disease Diagnostics by Analysis Platform
- Next-Generation Sequencing (NGS)
- Polymerase Chain Reaction (PCR)
- Sanger Sequencing
- Microarrays
- Karyotyping and Fluorescent in Situ Hybridization (FISH)
- Biochemical Testing
- Market Breakdown of Rare Disease Diagnostics by Analysis Target Type
- Single Genes
- Multiple Genes
- Whole Exome
- Whole Genome
- Other Genomic Variants
- Protein and Other Biochemical Markers
- Market Breakdown of Rare Disease Diagnostics by Disease Class
- Rare Cancers
- Neurological Diseases
- Metabolic and Endocrine Disorders
- Hematology
- Respiratory
- Immune System and Inflammation-Related Disorders
- Dermatology
- Musculoskeletal
- Others
- Market Breakdown of Rare Disease Diagnostics by Test Purpose
- Diagnosis
- Screening and Early Detection
- Therapy Guidance
- Monitoring
- Geographic Breakdown
- Market Breakdown of Rare Disease Diagnostics by Region
- North America
- Europe
- Asia-Pacific
- Rest of the World
Chapter 9 Appendix
- Methodology
- Analyst's Credentials