Molecular Diagnostics Market Size, Share & Trends by Product & Services (Kits, Instruments, Software), Test Type (Lab, PoC), Sample (Blood, Urine), Technology (PCR, NGS, ISH, INAAT), Application (Infectious (Hepatitis, HIV, HAI, TB, HPV), Oncology) - Global Forecast to 2029
“DNA sequencing & next-generation sequencing (NGS) segment accounted for the highest growth rate in the molecular diagnostics market, by technology, during the forecast period.”
Based on technology, the molecular diagnostics market is bifurcated into polymerase chain reaction (PCR), isothermal nucleic acid amplification technology, in situ hybridization, DNA sequencing & next-generation sequencing (NGS), DNA microarrays, and other technologies. The DNA sequencing & NGS segment in the molecular diagnostics market is experiencing substantial growth. This technology has been rapidly improving, with faster, more accurate, and more affordable ways to sequence DNA. Advancements like high-speed sequencers and better methods for processing DNA samples and data analysis are making these technologies easier to use and more effective.
“Diagnostic laboratories segment is expected to have the fastest growth rate in the molecular diagnostics market, by end user, during the forecast period.”
The molecular diagnostics market is segmented into diagnostic laboratories, hospitals & clinics, and other end users, based on end user. Diagnostic laboratories segment is expected to account for the highest CAGR during the forecast period. This growth can be attributed to factors like the increasing volume of tests for infectious diseases and cancer that necessitates efficient and accurate solutions, increasing investments in healthcare infrastructure, and the presence of the specialized expertise required for complex molecular testing that are prompting healthcare providers to outsource these procedures to diagnostic laboratories.
“Asia Pacific: The fastest-growing region in molecular diagnostics market.”
The worldwide market for molecular diagnostics is categorized into North America, Europe, Asia Pacific, Latin America, the Middle East & Africa, and GCC countries. Notably, the Asia Pacific region is anticipated to experience the most substantial growth in the forecast period. The Asia Pacific region, a hub for medical tourism, is rapidly emerging as a leader in the market for medical procedures and devices. Furthermore, healthcare spending in Asia Pacific is on the rise, indicating a growing demand for advanced medical services. This demand is being met by the rapid expansion of medical infrastructure, particularly in countries like India and China, where the number of hospitals and diagnostic laboratories is experiencing significant growth. Additionally, countries like India, China, and Japan are making substantial investments in research dedicated to developing innovative diagnostic procedures. This confluence of factors is propelling the molecular diagnostics market within the Asia Pacific region.
The break-up of the profile of primary participants in the molecular diagnostics market:
- By Company Type: Tier 1 - 40%, Tier 2 - 30%, and Tier 3 – 30%
- By Designation: C-level - 27%, D-level - 18%, and Others - 55%
- By Region: North America - 51%, Europe - 21%, Asia Pacific - 18%, Latin America – 6%, and Middle East & Africa- 4%
Research Coverage:
This research report categorizes the molecular diagnostics market by product & service (reagents & kits, instruments, and services), by test type (lab tests and PoC tests), by sample type (blood, serum & plasma, urine, and other sample types, by technology (polymerase chain reaction (PCR), isothermal nucleic acid amplification technology, in situ hybridization, DNA sequencing & next-generation sequencing (NGS), DNA microarrays, and other technologies, by application (infectious disease diagnostics (hepatitis [hepatitis B, hepatitis C & other hepatitis diseases], HIV, CT/NG, HAI, HPV, tuberculosis, influenza, and other infectious diseases), oncology testing (breast cancer, colorectal cancer, lung cancer, prostate cancer, and other cancers), genetic testing and other applications), by end user (hospitals& clinics, diagnostic laboratories, and other end users), and region (North America, Europe, Asia Pacific, Latin America, the Middle East & Africa, and GCC countries). The scope of the report covers detailed information regarding the major factors, such as drivers, restraints, opportunities, and challenges influencing the growth of the molecular diagnostics market. A detailed analysis of the key industry players has been done to provide insights into their business overview, solutions, key strategies, acquisitions, and agreements. New product & service launches, and recent developments associated with the molecular diagnostics market. Competitive analysis of upcoming startups in the molecular diagnostics market ecosystem is covered in this report.
Reasons to buy this report:
The report will help the market leaders/new entrants in this market with information on the closest approximations of the revenue numbers for the overall molecular diagnostics market and the subsegments. This report will help stakeholders understand the competitive landscape and gain more insights to position their businesses better and plan suitable go-to-market strategies. The report also helps stakeholders understand the pulse of the market and provides them with information on key market drivers, restraints, opportunities, and challenges.
The report provides insights on the following pointers:
- Analysis of key drivers (Increasing prevalence of infectious diseases and cancer globally, rising focus on R&D and growing funding in molecular diagnostics by healthcare-based companies, growing awareness regarding early disease diagnosis in developing countries, rising technological advancements in molecular diagnostics in recent years, and increasing use of PoC diagnostic tests in homecare settings and hospitals), opportunities (Growing significance of companion diagnostics in drug development process and increasing growth opportunities for molecular diagnostics companies in emerging economies), restraints (Unfavorable reimbursement scenario for diagnostic companies and high cost of molecular diagnostic instruments), and challenges (Changing regulatory landscape for IVD and molecular diagnostics in US and European Union, operational barriers and shortage of skills across major markets, and introduction of alternative technologies for disease detection and diagnosis) influencing the growth of the molecular diagnostics market.
- Product Development/Innovation: Detailed insights on upcoming technologies, research & development activities, and new product launches in the molecular diagnostics market.
- Market Development: Comprehensive information about lucrative markets – the report analyses the molecular diagnostics market across varied regions.
- Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the molecular diagnostics market.
- Competitive Assessment: In-depth assessment of market shares, growth strategies, product offerings of leading players like Danaher (US), F. Hoffmann-La Roche Ltd (Switzerland), Illumina, Inc. (US), bioMйrieux (France), and Hologic, Inc. (US).
1.1 STUDY OBJECTIVES
1.2 MARKET DEFINITION
1.2.1 INCLUSIONS AND EXCLUSIONS
1.3 STUDY SCOPE
1.3.1 MARKETS COVERED
1.3.2 YEARS CONSIDERED
1.4 CURRENCY CONSIDERED
1.5 LIMITATIONS
1.6 STAKEHOLDERS
1.7 SUMMARY OF CHANGES
2 RESEARCH METHODOLOGY
2.1 RESEARCH DATA
2.2 RESEARCH APPROACH
2.2.1 SECONDARY DATA
2.2.1.1 Key data from secondary sources
2.2.2 PRIMARY DATA
2.2.2.1 Primary interview participants
2.2.2.2 Key data from primary sources
2.2.2.3 Key industry insights
2.2.2.4 Breakdown of primary interviews
2.3 MARKET SIZE ESTIMATION
2.3.1 BOTTOM-UP APPROACH
2.3.1.1 Approach 1: Company revenue estimation approach
2.3.1.2 Approach 2: Presentation of companies and primary interviews
2.3.1.3 Approach 3: Estimation of total molecular-based test for HIV in US
2.3.1.4 Growth forecast
2.3.1.5 CAGR projections
2.3.2 TOP-DOWN APPROACH
2.4 MARKET BREAKDOWN AND DATA TRIANGULATION
2.5 MARKET SHARE ANALYSIS
2.6 RESEARCH ASSUMPTIONS
2.6.1 PARAMETRIC ASSUMPTIONS
2.6.2 GROWTH RATE ASSUMPTIONS
2.7 RISK ASSESSMENT
3 EXECUTIVE SUMMARY
4 PREMIUM INSIGHTS
4.1 MOLECULAR DIAGNOSTICS MARKET OVERVIEW
4.2 MOLECULAR DIAGNOSTICS MARKET, BY PRODUCT & SERVICE, 2024 VS. 2029
4.3 MOLECULAR DIAGNOSTICS MARKET, BY TEST TYPE, 2024 VS. 2029
4.4 MOLECULAR DIAGNOSTICS MARKET, BY SAMPLE TYPE, 2024 VS. 2029
4.5 MOLECULAR DIAGNOSTICS MARKET, BY TECHNOLOGY, 2024 VS. 2029
4.6 MOLECULAR DIAGNOSTICS MARKET, BY APPLICATION, 2024 VS. 2029
4.7 MOLECULAR DIAGNOSTICS MARKET, BY END USER, 2024 VS. 2029
4.8 MOLECULAR DIAGNOSTICS MARKET: GEOGRAPHIC GROWTH OPPORTUNITIES
5 MARKET OVERVIEW
5.1 INTRODUCTION
5.2 MARKET DYNAMICS
5.2.1 DRIVERS
5.2.1.1 Increasing prevalence of infectious diseases and cancer
5.2.1.2 Growing R&D funding
5.2.1.3 Surge in technological advancements
5.2.1.4 Rising use of point-of-care diagnostic tests
5.2.2 RESTRAINTS
5.2.2.1 Inadequate reimbursements
5.2.2.2 High cost of molecular diagnostic instruments
5.2.3 OPPORTUNITIES
5.2.3.1 Growing significance of companion diagnostics
5.2.3.2 Increasing growth opportunities in emerging economies
5.2.4 CHALLENGES
5.2.4.1 Changing regulatory landscape
5.2.4.2 Operational barriers and labor shortage
5.2.4.3 Introduction of alternative technologies
5.3 PRICING ANALYSIS
5.3.1 INDICATIVE PRICING ANALYSIS
5.3.2 AVERAGE SELLING PRICE, BY REGION
5.4 PATENT ANALYSIS
5.5 VALUE CHAIN ANALYSIS
5.6 SUPPLY CHAIN ANALYSIS
5.7 TRADE ANALYSIS
5.8 ECOSYSTEM ANALYSIS
5.8.1 MOLECULAR DIAGNOSTICS MARKET: ROLE OF COMPANIES IN ECOSYSTEM
5.9 PORTER’S FIVE FORCES ANALYSIS
5.9.1 THREAT OF NEW ENTRANTS
5.9.2 THREAT OF SUBSTITUTES
5.9.3 BARGAINING POWER OF BUYERS
5.9.4 BARGAINING POWER OF SUPPLIERS
5.9.5 INTENSITY OF COMPETITIVE RIVALRY
5.10 REGULATORY LANDSCAPE
5.10.1 REGULATORY BODIES, GOVERNMENT AGENCIES,
AND OTHER ORGANIZATIONS
5.10.2 NORTH AMERICA
5.10.2.1 US
5.10.2.2 Canada
5.10.3 EUROPE
5.10.4 ASIA PACIFIC
5.10.4.1 China
5.10.4.2 Japan
5.10.4.3 India
5.10.5 LATIN AMERICA
5.10.5.1 Brazil
5.10.5.2 Mexico
5.10.6 MIDDLE EAST
5.10.7 AFRICA
5.11 TECHNOLOGY ANALYSIS
5.11.1 KEY TECHNOLOGY
5.11.1.1 Polymerase chain reaction
5.11.2 COMPLEMENTARY TECHNOLOGY
5.11.2.1 Microarrays
5.11.3 ADJACENT TECHNOLOGY
5.11.3.1 Next-generation sequencing
5.12 KEY CONFERENCES AND EVENTS, 2024–2025
5.13 TRENDS/DISRUPTIONS IMPACTING CUSTOMERS’ BUSINESSES
5.14 KEY STAKEHOLDERS AND BUYING CRITERIA
5.14.1 KEY STAKEHOLDERS IN BUYING PROCESS
5.14.2 BUYING CRITERIA
5.15 INVESTMENT AND FUNDING SCENARIO
5.16 CASE STUDY ANALYSIS
5.17 IMPACT OF ARTIFICIAL INTELLIGENCE ON MOLECULAR DIAGNOSTICS MARKET
6 MOLECULAR DIAGNOSTICS MARKET, BY PRODUCT & SERVICE
6.1 INTRODUCTION
6.2 REAGENTS & KITS
6.2.1 INCREASING AWARENESS ABOUT EARLY DISEASE DETECTION AND PREVENTIVE HEALTHCARE TO PROPEL MARKET
6.3 INSTRUMENTS
6.3.1 RISING NEED FOR FASTER AND MORE ACCURATE TEST RESULTS
TO BOOST MARKET
6.4 SERVICES & SOFTWARE
6.4.1 GROWING UPTAKE OF ADVANCED INSTRUMENTS TO DRIVE MARKET
7 MOLECULAR DIAGNOSTICS MARKET, BY TEST TYPE
7.1 INTRODUCTION
7.1.1 KEY INDUSTRY INSIGHTS
7.2 LAB TESTS
7.2.1 INCREASING NEED FOR AUTOMATION AND EFFICIENT DISEASE
TESTING TO DRIVE MARKET
7.3 POC TESTS
7.3.1 GROWING INVESTMENTS FROM PUBLIC HEALTH AGENCIES AND GOVERNMENT TO BOOST MARKET
8 MOLECULAR DIAGNOSTICS MARKET, BY SAMPLE TYPE
8.1 INTRODUCTION
8.2 BLOOD, SERUM, AND PLASMA
8.2.1 INCREASING UTILIZATION IN GENETIC TESTING, INFECTIOUS DISEASE DIAGNOSIS, AND CANCER DIAGNOSTICS TO PROPEL MARKET
8.3 URINE
8.3.1 NEED FOR NON-INVASIVE AND EASY SAMPLE COLLECTION
TECHNIQUE TO FUEL MARKET
8.4 OTHER SAMPLE TYPES
9 MOLECULAR DIAGNOSTICS MARKET, BY TECHNOLOGY
9.1 INTRODUCTION
9.2 KEY INDUSTRY INSIGHTS
9.3 POLYMERASE CHAIN REACTION
9.3.1 RISING USE IN PROTEOMICS AND GENOMICS TO AID GROWTH
9.4 ISOTHERMAL NUCLEIC ACID AMPLIFICATION TECHNOLOGY
9.4.1 NEED TO DEVELOP ANTIRETROVIRAL DRUGS AND PROMPT DIAGNOSIS TO STIMULATE GROWTH
9.5 DNA SEQUENCING & NEXT-GENERATION SEQUENCING
9.5.1 GROWING SHIFT TOWARD MOLECULAR-TARGETED DRUGS AND THERAPIES TO DRIVE MARKET
9.6 IN SITU HYBRIDIZATION
9.6.1 RISING APPLICATIONS IN DIAGNOSING CHROMOSOMAL ABNORMALITIES, GENE MAPPING, AND INFERTILITY TREATMENT TO BOOST MARKET
9.7 DNA MICROARRAYS
9.7.1 SURGE IN ADVANCEMENTS IN DESIGN, DENSITY, AND DETECTION TECHNIQUES TO FUEL MARKET
9.8 OTHER TECHNOLOGIES
10 MOLECULAR DIAGNOSTICS MARKET, BY APPLICATION
10.1 INTRODUCTION
10.2 INFECTIOUS DISEASE DIAGNOSTICS
10.2.1 HEPATITIS
10.2.1.1 Hepatitis B
10.2.1.1.1 Need for ongoing management and monitoring of
virus to drive market
10.2.1.2 Hepatitis C
10.2.1.2.1 Favorable government initiatives to support growth
10.2.1.3 Other hepatitis diseases
10.2.2 HIV
10.2.2.1 Increasing blood transfusions and blood donations to propel market
10.2.3 CT/NG
10.2.3.1 Growing development of novel assays to boost market
10.2.4 HAI
10.2.4.1 Booming geriatric population to aid growth
10.2.5 HPV
10.2.5.1 Rising cases of cervical cancer to augment growth
10.2.6 TUBERCULOSIS
10.2.6.1 Rising focus on reducing tuberculosis deaths to fuel market
10.2.7 INFLUENZA
10.2.7.1 Growing strains and subtypes to drive market
10.2.8 OTHER INFECTIOUS DISEASES
10.3 ONCOLOGY TESTING
10.3.1 BREAST CANCER
10.3.1.1 Increasing need to improve survival rates to support growth
10.3.2 COLORECTAL CANCER
10.3.2.1 Rising demand for biomarkers to fuel market
10.3.3 LUNG CANCER
10.3.3.1 Increasing use of predictive biomarkers to drive market
10.3.4 PROSTATE CANCER
10.3.4.1 Surge in advancements in genomic technologies to aid growth
10.3.5 OTHER CANCER TYPES
10.4 GENETIC TESTING
10.4.1 GROWING IMPORTANCE IN DIAGNOSING AND MANAGING RARE GENETIC DISEASES TO PROPEL MARKET
10.5 OTHER APPLICATIONS
11 MOLECULAR DIAGNOSTICS MARKET, BY END USER
11.1 INTRODUCTION
11.2 DIAGNOSTIC LABORATORIES
11.2.1 INCREASED OUTSOURCING OF LABORATORY DIAGNOSES FOR
COST REDUCTION TO AID GROWTH
11.3 HOSPITALS & CLINICS
11.3.1 GROWING FOCUS ON HEALTHCARE SYSTEMS TO STIMULATE GROWTH
11.4 OTHER END USERS
12 MOLECULAR DIAGNOSTICS MARKET, BY REGION
12.1 INTRODUCTION
12.2 NORTH AMERICA
12.2.1 US
12.2.1.1 Presence of advanced healthcare infrastructure and high healthcare expenditures to drive market
12.2.2 CANADA
12.2.2.1 Growing focus on genomic research to fuel market
12.3 EUROPE
12.3.1 GERMANY
12.3.1.1 Robust healthcare spending and increasing per capita disposable income to propel market
12.3.2 UK
12.3.2.1 Increasing number of accredited clinical laboratories and hospital laboratories to fuel market
12.3.3 FRANCE
12.3.3.1 Rising R&D expenditure for product launches and development of new technologies to augment market
12.3.4 ITALY
12.3.4.1 Growing demographic shift toward elderly population to
support market
12.3.5 SPAIN
12.3.5.1 Surge in demand for genetic and prenatal testing to aid growth
12.3.6 RUSSIA
12.3.6.1 Increasing access to quality healthcare to boost market
12.3.7 SWITZERLAND
12.3.7.1 Rising healthcare spending for new medications and therapies to drive market
12.3.8 REST OF EUROPE
12.4 ASIA PACIFIC
12.4.1 CHINA
12.4.1.1 Rapid economic growth to drive market
12.4.2 JAPAN
12.4.2.1 Universal healthcare reimbursement policy to support market
12.4.3 INDIA
12.4.3.1 Increasing penetration of medical insurance, hospital setups, and foreign direct investments to fuel market
12.4.4 AUSTRALIA
12.4.4.1 Rising technological advancements and automation to
stimulate growth
12.4.5 SOUTH KOREA
12.4.5.1 Favorable government initiatives for promoting medical tourism to support growth
12.4.6 REST OF ASIA PACIFIC
12.5 LATIN AMERICA
12.5.1 BRAZIL
12.5.1.1 Need for accurate and detailed disease profiling to drive market
12.5.2 MEXICO
12.5.2.1 Booming medical tourism industry to aid growth
12.5.3 REST OF LATIN AMERICA
12.6 MIDDLE EAST & AFRICA
12.6.1 GROWING INVESTMENTS IN HEALTHCARE PROJECTS TO PROPEL MARKET
12.7 GCC COUNTRIES
12.7.1 RISING FOCUS ON ADVANCED HEALTH INFRASTRUCTURE TO DRIVE MARKET
13 COMPETITIVE LANDSCAPE
13.1 INTRODUCTION
13.2 KEY PLAYER STRATEGY/RIGHT TO WIN
13.2.1 OVERVIEW OF STRATEGIES ADOPTED BY PLAYERS IN MOLECULAR DIAGNOSTICS MARKET
13.3 REVENUE ANALYSIS
13.4 MARKET SHARE ANALYSIS
13.4.1 MOLECULAR DIAGNOSTICS MARKET RANKING ANALYSIS, BY TECHNOLOGY
13.4.1.1 Polymerase chain reaction
13.4.1.2 DNA sequencing and next-generation sequencing
13.4.1.3 Isothermal nucleic acid amplification technology
13.4.1.4 In situ hybridization
13.4.2 MOLECULAR DIAGNOSTICS MARKET RANKING ANALYSIS, BY APPLICATION
13.4.2.1 Infectious disease diagnostics
13.5 COMPANY EVALUATION MATRIX: KEY PLAYERS, 2023
13.5.1 STARS
13.5.2 EMERGING LEADERS
13.5.3 PERVASIVE PLAYERS
13.5.4 PARTICIPANTS
13.5.5 COMPANY FOOTPRINT, KEY PLAYERS, 2023
13.5.5.1 Company footprint
13.5.5.2 Product footprint
13.5.5.3 Application footprint
13.5.5.4 Region footprint
13.6 COMPANY EVALUATION MATRIX: STARTUPS/SMES, 2023
13.6.1 PROGRESSIVE COMPANIES
13.6.2 RESPONSIVE COMPANIES
13.6.3 DYNAMIC COMPANIES
13.6.4 STARTING BLOCKS
13.6.5 COMPETITIVE BENCHMARKING: STARTUPS/SMES, 2023
13.7 COMPANY VALUATION AND FINANCIAL METRICS
13.7.1 FINANCIAL METRICS
13.7.2 COMPANY VALUATION
13.8 BRAND/PRODUCT COMPARISON
13.8.1 DANAHER
13.8.2 F. HOFFMANN-LA ROCHE LTD.
13.8.3 ABBOTT
13.9 COMPETITIVE SCENARIO
13.9.1 PRODUCT LAUNCHES
13.9.2 DEALS
14 COMPANY PROFILES
14.1 KEY PLAYERS
14.1.1 DANAHER
14.1.1.1 Business overview
14.1.1.2 Products offered
14.1.1.3 Recent developments
14.1.1.3.1 Product launches and approvals
14.1.1.3.2 Deals
14.1.1.3.3 Expansions
14.1.1.4 MnM view
14.1.1.4.1 Right to win
14.1.1.4.2 Strategic choices
14.1.1.4.3 Weaknesses and competitive threats
14.1.2 F. HOFFMANN-LA ROCHE LTD.
14.1.2.1 Business overview
14.1.2.2 Products offered
14.1.2.3 Recent developments
14.1.2.3.1 Product launches and approvals
14.1.2.3.2 Deals
14.1.2.4 MnM view
14.1.2.4.1 Right to win
14.1.2.4.2 Strategic choices
14.1.2.4.3 Weaknesses and competitive threats
14.1.3 ILLUMINA, INC.
14.1.3.1 Business overview
14.1.3.2 Products offered
14.1.3.3 Recent developments
14.1.3.3.1 Product launches and approvals
14.1.3.3.2 Deals
14.1.3.3.3 Expansions
14.1.3.4 MnM view
14.1.3.4.1 Right to win
14.1.3.4.2 Strategic choices
14.1.3.4.3 Weaknesses and competitive threats
14.1.4 HOLOGIC, INC.
14.1.4.1 Business overview
14.1.4.2 Products offered
14.1.4.3 Recent developments
14.1.4.3.1 Product launches and approvals
14.1.4.3.2 Deals
14.1.4.4 MnM view
14.1.4.4.1 Right to win
14.1.4.4.2 Strategic choices
14.1.4.4.3 Weaknesses and competitive threats
14.1.5 BIOMЙRIEUX
14.1.5.1 Business overview
14.1.5.2 Products offered
14.1.5.3 Recent developments
14.1.5.3.1 Product launches and approvals
14.1.5.3.2 Deals
14.1.5.4 MnM view
14.1.5.4.1 Right to win
14.1.5.4.2 Strategic choices
14.1.5.4.3 Weaknesses and competitive threats
14.1.6 ABBOTT
14.1.6.1 Business overview
14.1.6.2 Products offered
14.1.6.3 Recent developments
14.1.6.3.1 Product launches and approvals
14.1.7 THERMO FISHER SCIENTIFIC INC.
14.1.7.1 Business overview
14.1.7.2 Products offered
14.1.7.3 Recent developments
14.1.7.3.1 Product launches and approvals
14.1.7.3.2 Deals
14.1.8 QIAGEN
14.1.8.1 Business overview
14.1.8.2 Products offered
14.1.8.3 Recent developments
14.1.8.3.1 Product launches and approvals
14.1.8.3.2 Deals
14.1.8.3.3 Expansions
14.1.9 REVVITY
14.1.9.1 Business overview
14.1.9.2 Products offered
14.1.10 MYRIAD GENETICS, INC.
14.1.10.1 Business overview
14.1.10.2 Products offered
14.1.10.3 Recent developments
14.1.10.3.1 Product launches and approvals
14.1.11 SIEMENS HEALTHINEERS AG
14.1.11.1 Business overview
14.1.11.2 Products offered
14.1.11.3 Recent developments
14.1.11.3.1 Product launches and approvals
14.1.11.3.2 Deals
14.1.11.3.3 Expansions
14.2 OTHER PLAYERS
14.2.1 BECTON, DICKINSON AND COMPANY
14.2.2 GRIFOLS, S.A.
14.2.3 QUIDELORTHO CORPORATION
14.2.4 DIASORIN S.P.A.
14.2.5 EXACT SCIENCES CORPORATION
14.2.6 GENETIC SIGNATURES
14.2.7 AGILENT TECHNOLOGIES, INC.
14.2.8 MDXHEALTH
14.2.9 BIOCARTIS
14.2.10 TBG DIAGNOSTICS LIMITED
14.2.11 HTG MOLECULAR DIAGNOSTICS, INC.
14.2.12 VELA DIAGNOSTICS
14.2.13 AMOY DIAGNOSTICS CO., LTD.
14.2.14 ELITECHGROUP
14.2.15 MOLBIO DIAGNOSTICS PVT. LTD.
14.2.16 GENEOMBIO TECHNOLOGIES
14.2.17 SAVYON DIAGNOSTICS
14.2.18 UNIOGEN OY
15 APPENDIX
15.1 DISCUSSION GUIDE
15.2 KNOWLEDGESTORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL
15.3 CUSTOMIZATION OPTIONS
15.4 RELATED REPORTS
15.5 AUTHOR DETAILS
Molecular diagnostic tests are the tests that access the biological makeup at genetic level to identify the predisposition of an individual to a particular disease and to diagnose it.
The global molecular diagnostics market size, in terms of value, is expected to grow from $XX billion in 2013 to $XX billion by 2018, at a CAGR of XX% from 2013 to 2018.
This market is driven by the increasing prevalence of chronic diseases, augmented awareness and acceptance of personalized medicine and companion diagnostics, advancements in molecular techniques, inherited disease testing, and prenatal testing. However, persistent reimbursement issues and delay in approvals of molecular diagnostic tests are expected to curb the growth of this market.
Market dynamics
The molecular diagnostics market progresses with the advancement in the technology. New tests and new instruments to perform these advanced molecular diagnostic tests, automated analysis along with the rise in chronic infections, increasing investments in R&D, growing geriatric population, increasing demand for personalized medicines, and rising R&D activities for biomarker identification are the major influencing factors for the growth of the molecular diagnostics market.
As awareness and interest among patients for personalized medicine increases, the use of molecular diagnostics and genetic testing is bound to grow in the near future. In a recent survey conducted by the United Health Center for Health Reform & Modernization, more than XX% respondents agreed that genetic testing allows physicians to offer personalized treatment. Personalized medicine also involves pharmacogenomic tests, also considered as molecular diagnostic tests. They ensure maximum efficacy and safety, and are used in association with a drug. This field of personalized medicine is called companion diagnostics. As these tests increase in number, the molecular diagnostics market will also grow. Industry experts comment that in the coming decade, there will only be a handful of drugs without associated diagnostic tests.
New genes and biomarkers are continuously being identified and clinically validated, increasing the number of different molecular diagnostic tests available. The biomarker discovery and identification market has been showcasing a high double-digit CAGR of XX% since the recent past, and will continue to display the same over the next five years, thus highlighting the potential for growth in molecular tests.
Market share analysis
Novartis, with its Vaccines and Diagnostics division that was established after the acquisition of Chiron, followed at the number two position with a XX% share in the global market. Chiron offers Novartis access to its blood testing business in molecular diagnostics. Novartis has gained this position with its Procleix portfolio of systems, assays, and software. The company is also actively following a strategy of developing partnerships and signing agreements globally to expand its reach in the MDx market. The company, along with Gen-Probe with which it has collaborated to develop and market molecular technologies, has captured about two-thirds of the global blood screening MDx market. Novartis also signed an agreement with Grifols in early 2011 and Cepheid in 2010 to market their molecular diagnostics products in the U.S.Gen-Probe (now a part of Hologic) closely followed Novartis occupying a XX% share with its market leadership in CT/NG assays. It also has a significant presence in virology assays for diagnosis of HPV, HCV, and HIV.
Qiagen accounted for a share about XX% of the global MDx market with its leadership in HPV testing with a share of about XX%. Abbott occupied XX% of the MDx market with its PCR portfolio for a gamut of infectious disease testing and oncology. BD and Cepheid followed with a share of about XX%. Cepheid is the world leader in MRSA testing accounting for a share of more than XX% with its Xpert product line.
Molecular diagnostic laboratories and tests
The number of laboratories performing molecular diagnostics tests in 2013 in U.S. was XX and is estimated to reach XX in 2018 with a CAGR of XX%. In Europe, XX laboratories were performing molecular diagnostics tests in 2013. These laboratories are expected to reach XX in 2018 with CAGR of XX%.
Global molecular diagnostics market, by application
The infectious diseases application is leading the global molecular diagnostics market. It commanded the largest share of XX% of the market in 2013, valued at $XX million and is expected to reach $XX million by 2018, at a CAGR of XX% from 2013 to 2018. The growth is due to the development of advanced new assays and technologies, unprecedented occurrence of infections, and rising awareness for the need to control widespread infectious diseases.
Infectious diseases
The CT/NG tests market size, in terms of value, is estimated to grow from $XX million in 2013 to $XX million by 2018, at a CAGR of XX%. The markets for MRSA and HPV testing are estimated to grow at higher CAGRs of XX% and XX%, respectively from 2013 to 2018. This growth is attributed to the increasing test volumes of MRSA and HPV due to extensive screening programs in the U.S.
Global molecular diagnostics market, by technology
Molecular diagnostic tests are widely preferred for the detection of various pathogenic mutations in DNA/RNA samples in order to facilitate, diagnose, provide a prognosis, and monitor an individual’s response to therapy. These instruments leverage multiple technologies to identify genetic variations. The major molecular diagnostic technologies studied in this report include polymerase chain reaction (PCR), isothermal nucleic acid amplification technology (INAAT), microarray, hybridization, DNA sequencing, and next-generation sequencing (NGS). The other technologies associated with molecular diagnostics (MDx), but not as significant as the ones mentioned above, are electrophoresis, flow cytometry, and mass spectrometry.
PCR accounted for the largest share of XX% of the global MDx market in 2013, followed by INAAT (XX%) and hybridization (XX%). In the coming years, the MDx market will be driven by the microarray technology segment, which is poised to grow at a CAGR of XX% from 2013 to 2018.
Global molecular diagnostics market, by product type
The reagents segment accounted for the largest share of the molecular diagnostics market size, in terms of value, in 2013. This segment is expected to reach $XX million by 2018, at a CAGR of XX% from 2013 to 2018. As reagents are consumables, the growth in this market is attributed to the increase in the volumes of molecular diagnostic tests. The molecular diagnostics instruments market size is estimated to grow at a CAGR of XX% from 2013 to 2018.
Instruments
The instruments market accounted for a XX% share of the molecular diagnostics market in 2013. This market is vast, consisting of different technologies such as polymerase chain reaction, DNA sequencing, hybridization, electrophoresis, mass spectrometry, flow cytometry, and so on. The instruments used as platforms for molecular diagnostic test include amplifiers, thermal cyclers, DNA sequencers, DNA analyzers, and electrophoresis instruments, among others.
The instruments market is growing at a steady pace due to the continuous requirement for biotechnology instruments in laboratories, pharmaceutical, and biotechnology companies. The molecular diagnostic instrument market size, in terms of value, is poised to grow from $XX million in 2013 to $XX million by 2018, at a CAGR of XX% from 2013 to 2018. Automated and advanced instruments with high-throughput capacities, increase in number of biotechnology firms across the world, advances in life science research and technology innovations with human genome mapping, and emergence of omics technologies have enabled industry growth.
Geographic analysis
In this report, the molecular diagnostics market is divided into four major geographies, namely, North America, Europe, Asia, and the Rest of the World (RoW). The global molecular diagnostics market was valued at $XX million in 2013; North America was the largest market with a share of XX%, followed by Europe. In the next five years, the Asian region is estimated to register the highest CAGR of XX%, primarily due to the increasing investments by major players.
New product launch
Driven by research and innovation in the molecular diagnostics market, new product launch accounted for XX% all the strategies adopted by players to achieve growth in this market. Product launch proved to be very efficient in enhancing the company’s growth. This strategy mainly helped in increasing the customer base and application areas. Major players such as Becton, Dickinson and Company (U.S.), QIAGEN (Germany) and Roche (Switzerland) implemented this strategy successfully.
