HLA Typing Market by Technology (PCR (SSO, SSP, Real Time), Sequencing (NGS, Sanger)), Product (Instrument, Reagent, Software), Application (Chimerism, Antibody Screening), End User (Hospital, Diagnolab, Academia) & Region - Global Forecast to 2028
Updated on : May 10, 2023
The global HLA typing market in terms of revenue was estimated to be worth $1.4 billion in 2022 and is poised to reach $2.1 billion by 2028, growing at a CAGR of 6.5% from 2022 to 2028. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. The growing geriatric population will boost the growth of the market, as elderly individuals are frequently referred for organ transplant procedures due to age or chronic ailment-related organ failure. Diseases such as tuberculosis, end-stage renal disease (ESRD), and liver cirrhosis are more common among seniors and may make it necessary for individuals to undergo organ or tissue transplants.
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Global HLA Typing Market
e- Estimated; p- Projected
HLA typing market: Market Dynamics
Driver: Rising technological advancements in HLA typing
HLA-typing procedures have transitioned from serology-based to genome-based diagnostic techniques due to the advent of PCR-based genome sequencing and its integration with microfluidics, biomedical instrumentation, and robotics. Ongoing technological advancements in HLA typing have resulted in higher sample throughput, increased device sensitivity, early detection of incompatibility, and improved procedural efficacy compared to serological techniques. Such advantages have increased the demand for HLA typing products among key end users such as research laboratories, hospitals, transplant centers, and diagnostic laboratories.
A key development in HLA diagnostics is the introduction of molecular diagnostic techniques such as Sanger sequencing, PCR, HLA-based genotyping, and NGS, which enable the identification of specific alleles and point mutations of HLA genes. Moreover, incorporating nanofabrication and microfluidic technology in PCR procedures is a key factor driving the adoption of PCR and NGS techniques. When combined with bioinformatics tools, NGS approaches provide deep sequencing of complete HLA genes to generate insights on immune disorders in which HLA associations have been implicated. These include rheumatological conditions, coeliac disease, and complex disorders such as type-1 diabetes and systemic lupus erythematosus.
Additionally, several market players have now developed and commercialized PCR and NGS-based HLA typing reagents capable of detecting many genetic changes or identifying specific HLA alleles. For instance, recent developments in line with PCR and NGS-based HLA typing reagents include:
- In 2021, BD introduced the MX instrument, a fully automated instrument that helps in molecular diagnostics. This instrument is included in the new BD COR system.
- In 2021, Bio-Rad Laboratories launched the CFX Opus 96 Dx System and CFX Opus 384Dx Systems. These systems are used in quantitative PCR and have uniform thermal performance.
- In 2022, F. Hoffman LA Roche launched its next-generation PCR. These PCR systems are used for sequencing samples and help reduce human error.
Several prominent players in the life sciences market are involved in developing and commercializing innovative HLA typing reagents, software, and instruments. These players include Abbott Laboratories, Inc., Bio-Rad Laboratories, Inc., and F. Hoffmann-La Roche Ltd. With the growing focus of market players on launching technologically advanced PCR, NGS, and Sanger sequencing-based diagnostics, the market is expected to witness significant growth.
Opportunity: Rising adoption of cross-matching and chimerism testing procedures
Cross-matching is an important procedure during donor-recipient screening that can eliminate the clinical risk of immune rejection or pathogenic or other disorders in recipients. Surgeons usually perform transplantation procedures after ascertaining the results of cross-matching with the help of HLA typing during the pre-transplantation period.
Chimerism testing permits the detection and timely treatment of graft rejection or future relapse. Chimerism testing is also witnessing increasing demand as it analyzes genomic polymorphisms (STR loci) in prospective donors. Chimerism testing uses PCR-based STR/CE systems, including HLA typing. These procedures offer clinical advantages in terms of higher accuracy in patients with graft failure and leukopenia.
Challenge: Limited number of organ donations and long waiting lists for transplantations
There is a significant gap between the number of organs donated annually and the number of organ donations required. The number of patients waiting for organ transplants continuously increases across major countries worldwide. For example, there was a 37.2% increase in waiting list patients for organ transplants in the US, which increased from 83,731 to 113,000 from 2003–July 2019 (Source: US Department of Health and Human Services, 2018). As of December 2021, the European Union had 150,000 patients on the organ donation waiting list (Source: Council of Europe, 2021).
The limited number of organs donated annually worldwide is primarily due to strict government laws that limit medical reimbursements for living organ donors and a lack of public awareness about organ donation, especially in developing countries. This is further aggravated by the lower proportion of organ donations through deceased donors, mainly due to socio-ethical concerns.
Restraint: High cost of HLA typing products
HLA typing is conducted through specialized molecular diagnostic platforms with advanced technologies such as nanofabrication, microfluidics, device automation, and robotics. These advanced technologies are integrated with conventional PCR/NGS instruments to achieve the desired process outcomes, reduce cycle times, and increase sample throughput.
However, such innovative instruments require significant capital investments and extensive scientific validation for market commercialization. Most NGS or PCR-based assay manufacturers offer their instruments at premium prices. Thus, healthcare providers offer NGS and PCR-based diagnostic assays at high procedural costs. For instance, Illumina’s Trusight HLA V2, an amplicon based NGS HLA typing kit, costs around USD 5,000 for 11 HLA genes of 24 samples; this amounts to USD 208 per sample. This is further loaded with additional sequencing costs of around USD 5 (0.3 M, pair-end 100 bp on Illumina X10 platform) per sample.
By technology, the molecular assay technologies segment accounted for the largest share of the HLA typing market during the forecast period.
The molecular assay technologies segment accounted for the largest share of 86.5% in 2022. This segment is projected to reach USD 1,913.3 million by 2028 from USD 1,360 million in 2023, at a CAGR of 6.9% during the forecast period.
By Product & Services, the Reagents & Consumables segment holds the largest share of the HLA typing market.
The reagents & consumables segment accounted for the largest share of 71.8% of the market in 2022. This segment is also projected to register the highest CAGR during the forecast period.
By Application, the diagnostic applications segment accounted for the largest share of the HLA typing market during the forecast period.
The diagnostic applications segment accounted for the largest share of 95.6% of the global market in 2022.
By End User, the commercial service providers segment of HLA typing market is expected to grow at the fastest rate during the forecast period.
The commercial service providers segment accounted for the largest share of 60.2% of the market in 2022. This segment is also projected to register the highest CAGR of 7.0%, reaching USD 1,295.7 million in 2028 from an estimated value of USD 917.1 million in 2023.
North America is expected to be the largest region in the global HLA typing market during the forecast period.
North America accounted for the largest share of 45.0% of the global market.
The large share of the North American market is attributed to the high adoption of advanced diagnostic technologies, the increasing prevalence of target diseases, and technological advancements.
Europe accounted for the second-largest share of 29.5% of the global market in 2021.
The Asia Pacific market is estimated to grow at the highest CAGR of 7.5% during the forecast period.
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Prominent players in the market include Bio-Rad Laboratories, Inc. (US), F. Hoffmann-La Roche Ltd. (Switzerland), QIAGEN N.V. (Netherlands), Thermo Fisher Scientific Inc. (US), and bioMérieux S.A. (France). Other players in the market are Immucor, Inc. (US), among others.
HLA Typing Market Report Scope
|
Report Metric |
Details |
|
Market Revenue in 2022 |
$1.4 billion |
|
Projected Revenue by 2028 |
$2.1 billion |
|
Revenue Rate |
Poised to grow at a CAGR of 6.5% |
|
Market Driver |
Rising technological advancements in HLA typing |
|
Market Opportunity |
Rising adoption of cross-matching and chimerism testing procedures |
This study categorizes the global HLA typing market to forecast revenue and analyze trends in each of the following submarkets:
By Technology
-
Molecular Assay Technologies
-
PCR-based Molecular Assays
- Sequence-specific Primer-PCR
- Sequence-specific Oligonucleotide-PCR
- Other PCR-based Molecular Assays
-
Sequencing-based Molecular Assays
- Sanger Sequencing
- Next-generation Sequencing
- Pyrosequencing
-
PCR-based Molecular Assays
- Non-molecular Assay Technologies
By Product & Service
- Reagents & Consumables
- Instruments
- Software & Services
By Application
- Diagnostic Applications
- Research Applications
- Donor-recipient cross-matching
- Infectious disease testing
- Cancer diagnosis & prevention
- Transfusion therapy
- Other diagnostic applications
By End User
- Commercial service providers
- Hospitals & surgical centers
- Research laboratories & academic institutes
By Region
-
North America
- US
- Canada
-
Europe
- Germany
- France
- UK
- Italy
- Spain
- Rest of Europe
-
Asia Pacific
- Japan
- China
- India
- Australia
- South Korea
- Rest of Asia Pacific
-
Latin America
- Brazil
- Mexico
- Rest of Latin America
- Middle East & Africa
Recent Developments
- In March 2023, BioRad received The company received AOAC International and AFNOR approval for its iQ-Check kits, which are used with the CFX Opus Deepwell Real-time PCR System
- In August 2022 Roche developed a new digital Light cycler system that helps determine a patient’s cancer.
- In May 2022, CareDx received CE marking for its AlloSeq HCT chimerism testing kit and AlloSeq HCT software. These AlloSeq are used in patients who have received Hematopoietic cell transplantation.
Frequently Asked Questions (FAQ):
What is the projected market revenue value of the HLA typing market?
The HLA typing market boasts a total revenue value of $2.1 billion by 2028.
What is the estimated growth rate (CAGR) of the HLA typing market?
The global HLA typing market has an estimated compound annual growth rate (CAGR) of 6.5% and a revenue size in the region of $1.4 billion in 2022.
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This study involved the extensive use of both primary and secondary sources. The research process involved the study of various factors affecting the industry to identify the segmentation types, industry trends, key players, competitive landscape, key market dynamics, and key player strategies.
Secondary Research
The secondary research process involves the widespread use of secondary sources, directories, databases (such as Bloomberg Businessweek, Factiva, and D&B Hoovers), white papers, annual reports, company house documents, investor presentations, and SEC filings of companies. Secondary research was used to identify and collect information useful for the extensive, technical, market-oriented, and commercial study of the microcatheter market. It was also used to obtain important information about the key players and market classification & segmentation according to industry trends to the bottom-most level, and key developments related to market and technology perspectives. A database of the key industry leaders was also prepared using secondary research.
Primary Research
In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include industry experts such as CEOs, vice presidents, marketing and sales directors, technology & innovation directors, and related key executives from various key companies and organizations in the medical aesthetic market. The primary sources from the demand side include medical OEMs, Oncologists, CDMOs and service providers, among others. Primary research was conducted to validate the market segmentation, identify key players in the market, and gather insights on key industry trends & key market dynamics.
A breakdown of the primary respondents is provided below:
*Others include sales managers, marketing managers, business development managers, product managers, distributors, and suppliers.
Note: Companies are classified into tiers based on their total revenue. As of 2021, Tier 1 = >USD 1,000 million, Tier 2 = USD 500–1,000 million, and Tier 3 = <USD 500 million.
To know about the assumptions considered for the study, download the pdf brochure
Market Estimation Methodology
In this report, the HLA Typing Market size was arrived at by using the revenue share analysis of leading players. For this purpose, key players in the market were identified, and their revenues from the HLA Typing business were determined through various insights gathered during the primary and secondary research phases. Secondary research included the study of the annual and financial reports of the top market players. In contrast, primary research included extensive interviews with key opinion leaders, such as CEOs, directors, and key marketing executives.
To calculate the global market value, segmental revenues were calculated based on the revenue mapping of major solution/service providers. This process involved the following steps:
- Generating a list of major global players operating in the Market
- Mapping annual revenues generated by major global players from the product segment (or nearest reported business unit/product category)
- Revenue mapping of major players to cover major share of the global market share, as of 2021.
- Extrapolating the global value of the Market
Approaches
Bottom-up Approach
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- For estimating the size of the HLA Typing Market, the country-level market revenues were obtained from secondary sources and through extensive primary interviews.
- Country-level markets for the US and Canada were added to arrive at the market size for North America. Similarly, country-level markets for other countries were added to arrive at the market size of Europe and Asia Pacific.
- The total market derived through the bottom-up approach was again validated through secondary sources and primary sources.
Top-down approach
- The overall market size derived from the bottom-up approach was used in the top-down procedure to estimate the size of the subsegment.
- Percentage splits were applied to the total market size (splits were obtained from secondary and primary research) to obtain the market size for each subsegment.
- The top-down approach was used to reach the regional and country-level market size for these subsegments.
Data Triangulation
After arriving at the overall market size from the market size estimation process explained above, the HLA Typing Market was split into segments and subsegments. Data triangulation and market breakdown procedures were employed to complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments. The data was triangulated by studying various factors and trends from both the demand and supply sides. Additionally, the market was validated using both top-down and bottom-up approaches.
Market definition
HLA Typing procedures are used to determine donor-recipient compatibility to avoid immune rejection in a recipient. These procedures are adopted for donor-recipient cross-matching, subject profiling, genotyping, and other related diagnostic tests. Advanced genomic techniques (such as PCR and NGS) are increasingly being used during HLA Typing procedures, apart from serological and other conventional techniques for immune-compatibility testing.
Key stakeholders
- HLA Typing product manufacturing companies.
- Healthcare service providers (Including hospitals, transplant centers and blood transfusion centers)
- Blood, tissue, and stem cell banks
- Government Organizations
- Independent association and regulatory authorities
- R&D companies
- Independent reference laboratories
- Diagnostic Laboratories
- Clinical Research organizations
Objectives of the Study
- To define, describe, and forecast the HLA Typing Market based on Technology, Product & Service, Application, End User & Region.
- To provide detailed information regarding the major factors influencing the growth potential of the Market (drivers, restraints, opportunities, challenges, and trends)
- To analyze the micro markets with respect to individual growth trends, prospects, and contributions to the Market
- To analyze key growth opportunities in the Market for key stakeholders and provide details of the competitive landscape for market leaders.
- To forecast the size of market segments and/or subsegments with respect to five major regions, namely, North America (US and Canada), Europe (Germany, France, the UK, Italy, Spain, and the RoE), Asia Pacific (Japan, China, India, Thailand, Indonesia and the RoAPAC), Latin America (Brazil, Mexico, and RoLATAM), and the Middle East & Africa
- To profile the key players in the Market and comprehensively analyze their market shares and core competencies.
- To track and analyze the competitive developments undertaken in the Market, such as product launches, agreements, expansions, and mergers & acquisitions.
Available Customizations
With the given market data, MarketsandMarkets offers customizations as per the company’s specific needs. The following customization options are available for the present HLA Typing Market.
Product Analysis
- Product matrix, which gives a detailed comparison of the product portfolios of the top five companies.
Company Information
- Detailed analysis and profiling of additional market players (up to 5)
Geographic Analysis
- Further breakdown of the Rest of Europe Market into Russia, Belgium, the Netherlands, Switzerland, Austria, Finland, Sweden, Poland, and Portugal among other
- Further breakdown of the Rest of the Asia Pacific Market into Singapore, Taiwan, New Zealand, Philippines, Malaysia, and other APAC countries
- Further breakdown of the Latin American Market into Colombia, Chile, Argentina, and Peru, among other
Generating Response ...
Growth opportunities and latent adjacency in HLA Typing Market