HLA Typing for Transplant Market by Product & Service, Technology, Transplant Type, Application, End-User

Description

List of Tables

[195 Pages Report] The HLA Typing for Transplant Market size was estimated at USD 998.31 million in 2023 and expected to reach USD 1,086.39 million in 2024, at a CAGR 9.09% to reach USD 1,836.58 million by 2030.

Human leukocyte antigen (HLA) typing is a vital process in medicine transplant that involves identifying specific proteins on the surface of cells, known as HLA antigens. The HLA typing for the transplant is used to identify, match, and monitor compatibility between donors and recipients for organ, tissue, or stem cell transplantation. This process is crucial to ensure a successful transplant by reducing the risk of graft rejection and improving overall patient outcomes. Moreover, the rising demand for organ transplants is due to an increase in chronic diseases such as kidney failure, liver cirrhosis, heart failure, diabetes mellitus, and hematological disorders. Precision medicine advancements can lead to personalized approaches based on individual genetic makeup for improved compatibility between donors and recipients. However, there is a need for more trained professionals performing these tests and ethical concerns surrounding organ transplantation consent policies, which restrict the growth of the Human leukocyte antigen (HLA) processes. Furthermore, technological advancements in HLA typing methods such as Next-Generation Sequencing (NGS), PCR-based techniques, and Sanger sequencing contribute to improved accuracy and a faster donor-recipient matching process. Government support through awareness campaigns promoting organ donation and investments in healthcare infrastructure further drive market expansion.

KEY MARKET STATISTICS
Base Year [2023]	USD 998.31 million
Estimated Year [2024]	USD 1,086.39 million
Forecast Year [2030]	USD 1,836.58 million
CAGR (%)	9.09%

Technology: Adoption of molecular assay technologies due to their high specificity and reproducibility

Molecular assay technologies are increasingly adopted due to their high resolution, specificity, and reproducibility. Sequence-based typing (SBT) techniques involve sequencing exon regions of HLA genes to determine the alleles present in a donor or patient sample. This method provides the highest resolution possible, allowing for precise matching between donors and recipients. In addition, Polymerase chain reaction (PCR) techniques rely on the amplification of target HLA gene regions followed by probe hybridization or restriction fragment length polymorphism (RFLP) analysis to identify specific alleles. Non-molecular assay technologies involve serological and cellular methods for HLA typing. They are primarily used when low-resolution typing is sufficient or where molecular methods may not be accessible due to cost or resource constraints. Serological techniques involve testing serum samples for the presence of specific HLA antigens using antisera obtained from previously typed individuals. Cellular assays assess the compatibility between donor and recipient immune cells by measuring their ability to respond to each other in-vitro.

Product & Service: Preference for software and services to facilitate data interpretation and managing laboratory workflow

Instruments play a crucial role in the HLA typing process as they provide accurate and efficient results for transplant compatibility testing. This includes sequencers, PCR-based instruments, and other laboratory equipment. Reagents and consumables are essential components of the HLA typing process as they ensure reproducibility, sensitivity, specificity, and reliability of test results. This constitutes DNA amplification reagents, DNA sequencing reagents (NGS-based), kits for probe hybridization assays, microarrays/solid-phase assays, and quality control materials & standards used in laboratories. Software and services are integral to the HLA typing process as they facilitate data interpretation, reporting of results, and laboratory workflow management. The software for data analysis, database management systems, and quality assurance programs for proficiency testing are used.

Transplant Type: Increasing use of stem cell transplantation therapy for leukemia, lymphoma, myeloma, and immune system diseases

Organ transplantation involves replacing a damaged or non-functional organ with a healthy one from a donor. HLA typing is essential in this process to minimize the risk of graft rejection due to immune system response, Stem cell transplantation is a therapy for various blood-related disorders such as leukemia, lymphoma, myeloma, and immune system diseases. It involves transplanting healthy hematopoietic stem cells into a patient to replace damaged or dysfunctional cells. HLA typing in stem cell transplantation is vital for ensuring the compatibility of donor and recipient cells, reducing the risk of graft-versus-host disease (GVHD). Tissue transplantation involves grafting healthy donor tissues such as corneas, bone marrow, blood vessels, and skin onto a recipient to restore the function of organs or improve the quality of patient's lives.

Application: Use of HLA typing in diagnostic applications for organ transplantation

HLA typing is preferred for diagnostic applications to ensure compatibility between donors and recipients for organ transplantation, hematopoietic stem cell transplantation, and transfusion medicine. It helps identify suitable matches to reduce the risk of graft rejection and improve patient outcomes. HLA typing is widely used in research applications for population genetics, disease association studies, vaccine development, pharmacogenomics research, and precision medicine initiatives. In addition, it provides efficient tools to generate robust data supporting advancements in medical science.

End-User: High penetration in independent reference laboratories for high-throughput capabilities and scalability

Hospitals and transplant centers form the core end-user segment for HLA typing for transplant purposes. These facilities perform tissue typing to determine compatibility between donors and recipients, ensuring successful organ or bone marrow transplants. HLA causes rapid turnaround time, high accuracy, and cost-effective solutions in HLA typing services. Independent reference laboratories provide specialized diagnostic testing services such as HLA typing to hospitals and transplant centers commercially. They are preferred due to high-throughput capabilities, scalability, and technological advancements that enhance efficiency. Research laboratories and academic institutes conduct scientific studies on transplantation biology using advanced techniques such as Next-Generation Sequencing (NGS), PCR-based methods, or Sanger sequencing for HLA typing. This segment primarily seeks innovative technologies, user-friendly platforms, and extensive support services to facilitate the seamless adoption of new methodologies.

Regional Insights

The Human leukocyte antigen (HLA) typing for transplant market is experiencing significant growth worldwide due to technological advancements and the availability of numerous organ transplant procedures. In the United States and Canada, demand for HLA typing is increasing due to growing organ transplantation needs. The National Institutes of Health (NIH) in the U.S. has funded numerous research initiatives to improve HLA typing techniques. Moreover, the Americas human leukocyte antigen (HLA) typing market is expected to grow at a higher rate due to increasing awareness about organ transplantation among both physicians and patients, along with technological advancements leading to more accurate HLA typing results. Europe has witnessed a steady increase in demand for HLA typing services owing to factors such as an aging population that increases the prevalence of chronic diseases requiring organ transplantation. Additionally, favorable reimbursement policies have supported patients undergoing transplant procedures in Europe. Organizations such as the Saudi Society for Organ Transplantation (SSOT) are working to increase awareness and collaborations between nations, such as the Gulf Cooperation Council (GCC) Organ Transplant Program. China, Japan, and India are witnessing an increased demand for HLA typing due to a high prevalence of genetic disorders and growing organ transplantation needs. China's National Natural Science Foundation has funded research on novel HLA typing techniques. Moreover, Japan's Ministry of Health, Labor, and Welfare supports projects such as the Japan Society for Transplantation and Cellular Therapy (JSTCT). In India, government initiatives, such as the 'National Organ and Tissue Transplant Organization (NOTTO) contribute to market growth by increasing public awareness about organ donation.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the HLA Typing for Transplant Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the HLA Typing for Transplant Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Key Company Profiles

The report delves into recent significant developments in the HLA Typing for Transplant Market, highlighting leading vendors and their innovative profiles. These include Agilent Technologies, Inc., BAG Diagnostics GmbH, Becton, Dickinson, and Company, BGI Genomics Co.,Ltd., Bio-Rad Laboratories, Inc., Bio-Techne Corporation, CapitalBio Technology Co., Ltd., CareDx, Inc., CeGaT GmbH, Chugai Pharmaceutical Co., Ltd., Creative Biolabs, Inc., DiaSorin S.p.A., Eurofins Scientific SE, F. Hoffman-La Roche AG, Fujirebio, Inc. by H.U. Group Holdings, Inc., Garuda Therapeutics, GenDx by Eurobio Scientific Group, HEALIOS K.K., Hologic, Inc., Illumina, Inc., Immatics N.V., Immucor, Inc. by Werfen, S.A., ImmunOs Therapeutics AG, Invectys Inc., Laboratory Corporation of America Holdings, Lonza Group Ltd., Merck KGaA, NeoGenomics Laboratories, Inc., OraSure Technologies, Inc., Oxford Nanopore Technologies PLC, Pure MHC, LLC, Pure Protein, LLC, QIAGEN N.V., STEMCELL Technologies Inc., T-Cure Bioscience Inc., Takara Bio Inc., TBG Diagnostics Ltd., TCR2 Therapeutics by Adaptimmune Therapeutics PLC, and Thermo Fisher Scientific, Inc..

Market Segmentation & Coverage

This research report categorizes the HLA Typing for Transplant Market to forecast the revenues and analyze trends in each of the following sub-markets:

Product & Service
- Instruments
- Reagents & Consumables
- Software & Services

Technology
- Molecular Assay Technologies
  - PCR-Based Molecular Assays
    - Real-Time PCR
    - Sequence-Specific Oligonucleotide-PCR
    - Sequence-Specific Primer-PCR

Sequencing-Based Molecular Assays
- Next-Generation Sequencing
- Sanger Sequencing

Non-Molecular Assay Technologies

Transplant Type
- Organ Transplantation
- Stem Cell Transplantation
- Tissue Transplantation

Application
- Diagnostic Applications
  - Antibody Screening
  - Chimerism Monitoring

Research Applications

End-User
- Clinical Laboratories & Research Institution
- Hospitals & Transplant Centers
- Independent Reference Laboratories

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the HLA Typing for Transplant Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the HLA Typing for Transplant Market?

3. What are the technology trends and regulatory frameworks in the HLA Typing for Transplant Market?

4. What is the market share of the leading vendors in the HLA Typing for Transplant Market?

5. Which modes and strategic moves are suitable for entering the HLA Typing for Transplant Market?

Product Code: MRR-3D2FD205B873

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Rising incidence of bone marrow, organ, and blood transplant processes
  - 5.1.1.2. Adoption of HLA typing in personalized medicine for reduced graft rejections
- 5.1.2. Restraints
  - 5.1.2.1. Lack of reimbursement and inadequate insurance policies
- 5.1.3. Opportunities
  - 5.1.3.1. Technological advancements in the field of transplant diagnostics and HLA-typing methods
  - 5.1.3.2. Preference for immunosuppressive therapies to complement HLA typing
- 5.1.4. Challenges
  - 5.1.4.1. Concerns regarding the inaccuracy of HLA typing
5.2. Market Segmentation Analysis
- 5.2.1. Technology: Adoption of molecular assay technologies due to their high specificity and reproducibility
- 5.2.2. Product & Service: Preference for software and services to facilitate data interpretation and managing laboratory workflow
- 5.2.3. Transplant Type: Increasing use of stem cell transplantation therapy for leukemia, lymphoma, myeloma, and immune system diseases
- 5.2.4. Application: Use of HLA typing in diagnostic applications for organ transplantation
- 5.2.5. End-User: High penetration in independent reference laboratories for high-throughput capabilities and scalability
5.3. Market Trend Analysis
- 5.3.1. Advanced Healthcare R&D and presence of established market vendors facilitate the expansion of HLA typing in Americas
- 5.3.2. Dynamically expanding HLA typing for transplant market in the APAC, with emphasis on advanced technology adoption for offering improved healthcare infrastructure for transplantation
- 5.3.3. Rising need for transplant procedures and government support for commercializing quality HLA typing to create a favorable market landscape in EMEA
5.4. Cumulative Impact of High Inflation
5.5. Porter's Five Forces Analysis
- 5.5.1. Threat of New Entrants
- 5.5.2. Threat of Substitutes
- 5.5.3. Bargaining Power of Customers
- 5.5.4. Bargaining Power of Suppliers
- 5.5.5. Industry Rivalry
5.6. Value Chain & Critical Path Analysis
5.7. Regulatory Framework Analysis

6. HLA Typing for Transplant Market, by Product & Service

6.1. Introduction
6.2. Instruments
6.3. Reagents & Consumables
6.4. Software & Services

7. HLA Typing for Transplant Market, by Technology

7.1. Introduction
7.2. Molecular Assay Technologies
7.3. Non-Molecular Assay Technologies

8. HLA Typing for Transplant Market, by Transplant Type

8.1. Introduction
8.2. Organ Transplantation
8.3. Stem Cell Transplantation
8.4. Tissue Transplantation

9. HLA Typing for Transplant Market, by Application

9.1. Introduction
9.2. Diagnostic Applications
9.3. Research Applications

10. HLA Typing for Transplant Market, by End-User

10.1. Introduction
10.2. Clinical Laboratories & Research Institution
10.3. Hospitals & Transplant Centers
10.4. Independent Reference Laboratories

11. Americas HLA Typing for Transplant Market

11.1. Introduction
11.2. Argentina
11.3. Brazil
11.4. Canada
11.5. Mexico
11.6. United States

12. Asia-Pacific HLA Typing for Transplant Market

12.1. Introduction
12.2. Australia
12.3. China
12.4. India
12.5. Indonesia
12.6. Japan
12.7. Malaysia
12.8. Philippines
12.9. Singapore
12.10. South Korea
12.11. Taiwan
12.12. Thailand
12.13. Vietnam

13. Europe, Middle East & Africa HLA Typing for Transplant Market

13.1. Introduction
13.2. Denmark
13.3. Egypt
13.4. Finland
13.5. France
13.6. Germany
13.7. Israel
13.8. Italy
13.9. Netherlands
13.10. Nigeria
13.11. Norway
13.12. Poland
13.13. Qatar
13.14. Russia
13.15. Saudi Arabia
13.16. South Africa
13.17. Spain
13.18. Sweden
13.19. Switzerland
13.20. Turkey
13.21. United Arab Emirates
13.22. United Kingdom

14. Competitive Landscape

14.1. Market Share Analysis, 2023
14.2. FPNV Positioning Matrix, 2023
14.3. Competitive Scenario Analysis
- 14.3.1. GenDx launches NGS-Turbo: revolutionizing high-resolution HLA typing with Oxford Nanopore Technologies sequencing devices
- 14.3.2. Omixon Launches NanoTYPE MONO and MONOall RUO, a Singleplex Human Leukocyte Antigen Amplification kit compatible with Oxford Nanopore's MinION Platform
- 14.3.3. JURA Bio Announces Partnership With Replay Product Company Syena to Advance T Cell Receptor NK Therapies in Cancer
- 14.3.4. Ossium Health and Be The Match Unveil Partnership to Increase Bone Marrow Transplant Accessibility and Treatment Efficiency
- 14.3.5. BriaCell receives NCI grant for cancer platform development
- 14.3.6. Tempus Announces Companion Diagnostic Collaboration with TScan Therapeutics
- 14.3.7. Metropolis Healthcare unveils NextGen HLA test for organ transplantation
- 14.3.8. CD Genomics Longseq Division Unveils Human Leukocyte Antigen (HLA) Typing Service
- 14.3.9. Garuda Therapeutics Secures USD 62 Million Series B Financing to Advance Off-the-Shelf Blood Stem Cell Technology Platform
- 14.3.10. FDA Grants De Novo Classification to HLA Typing Test for Use as a Companion Diagnostic with a T Cell Receptor Therapy for Metastatic or Unresectable Uveal Melanoma
- 14.3.11. Eurobio Scientific acquires GenDx for USD 132.3 million
- 14.3.12. Be The Match BioTherapies, Atara Biotherapeutics Ink Multi-Year Partnership Extension

15. Competitive Portfolio

15.1. Key Company Profiles
15.2. Key Product Portfolio