Global Thalassemia Testing Industry to reach US$ 1.50 billion with the CAGR of 8%| Research Report 2024-2031: Market Trends and Strategic Insights | DataM Intelligence 2025.

The Thalassemia Testing Market reached US$ 730 million in 2024 and is expected to reach US$ 1.50 billion by 2033 growing at a CAGR of 8% during the forecast period 2024-2031.. The market is growing due to wider screening programs, high disease prevalence, affordable molecular diagnostics, and a shift toward preventive genetic testing.

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Recent Product Launches In U.S :-

❇️2025-02-17: Key US companies like Thermo Fisher Scientific and Bio-Rad Laboratories launched advanced beta thalassemia testing kits focusing on genetic markers and prenatal diagnostics with improved accuracy and faster turnaround times to address rising demand in clinical genetic screening.

❇️February 2025: Bluebird Bio announced successful Phase III clinical trial completion for their gene therapy Zynteglo, a breakthrough curative approach for transfusion-dependent beta thalassemia patients in the US market.

Japan Product Launches

❇️2025-08-06: Tokyo startups are advancing high-throughput genetic testing technologies for beta thalassemia, incorporating next-generation sequencing platforms to enable early detection and precision diagnostics, aligned with Japan's increasing prenatal screening mandates.


Recent Mergers & Acquisitions (2025)

🌐2025-09-21:- Agios Pharmaceuticals progressed their thalassemia treatment pipeline via strategic alliances and supplementary FDA approvals, suggesting possible licensing or acquisition agreements.

🌐In the diagnostics sector, mergers among biotech companies to increase genetic testing capabilities, broaden market access, and complement AI-based interpretation technologies were apparent.

Recent Government Approvals:

-In the United States, the FDA is currently reviewing supplemental applications for gene therapies and treatments for thalassemia, including a supplemental NDA from Agios Pharmaceuticals that intends to utilize it for patients with transfusion-dependent and non-transfusion-dependent thalassemia, as the FDA is expected to announce a decision by December 7, 2025.

-Both the Japanese and US governments are supporting prenatal genetic screening programs related to minimizing the burden of disease as part of governmental healthcare strategies. The regulatory pathway for fast-tracking advanced diagnostic assays that show both high accuracy and clinical utility demonstrates that governmental oversight of these techniques is changing.

-Several recently approved beta thalassemia diagnostic test kits use next-generation sequencing and multiplexed technology. They were cleared under an accelerated approval pathway designed to improve accessibility to early detection.

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Recent FDA approval:

-2025-10-05: FDA approved ZYNTEGLO (betibeglogene autotemcel) by bluebird bio, a one-time gene therapy for beta-thalassemia patients requiring regular transfusions, marking a major advancement in treatment.

-2025-10-31: FDA fast-tracked personalized gene editing therapies, including exa-cel (Casgevy), accelerating approval pathways for innovative thalassemia treatments.

-2025-10-23: The FDA granted approval to Reblozyl (luspatercept-aamt) for anemia treatment in adult beta thalassemia patients needing regular RBC transfusions, reducing transfusion burden.

-2025-09-07 (expected): FDA decision pending on Agios Pharmaceuticals' Pyrukynd (mitapivat) supplemental NDA, targeting adult alpha and beta thalassemia, which could become the first oral therapy for both subtypes.

-2025-05-14: Various orphan drug approvals and regulatory updates on thalassemia treatments and related medicines indicate ongoing regulatory activity in this rare disease area.

🌍Recent Investments Announced 2025

-The growing investment focus has been on genetic testing technology development, prenatal screening programs, and gene therapy clinical trials by venture capital and healthcare funds that specialize in the field of hereditary blood disorders.

-Government and private investments from both the US and Japan have supported and expanded efforts to improve access to, and reduce diagnostic delays associated with, rapid diagnostics and personalized medicine infrastructure.

Key Players with market share:

-Bio-Rad Laboratories Inc.: The company has an estimated global market share of about 12-14%, supported by their extensive diagnostic portfolio and substantial presence in North America and Europe.

-MedGenome: Their market share is expected to be between 6-8%. The company primarily focuses on expanding genetic testing services in the Asia-Pacific region.

-ViennaLab Diagnostics GmbH: The company has a market share of roughly 4-5% and a focus on molecular diagnostic kits in Europe.

-Thermo Fisher Scientific Inc.: The company has an estimated market share of around 15%, rising to a dominant position in advanced genetic testing platforms globally.

-Asper Biogen: The company specializes in molecular diagnostics focused in India and surrounding markets, with a market share estimate of about 3-4%.

-Tosoh Europe N.V.: The company has a market share of about 2-3%, specializing in biochemistry and diagnostic reagents only in Europe.

-Mapmygenome: Estimated market share of 3-4%, prominent in India as a provider of direct to consumer genetic testing services and products.

-Mylab Discovery Solutions Pvt. Ltd.: Market share is expected to be around 2%, and considered an early stage company for their molecular diagnostics kits in the region.

-Revvity Inc. (formerly PerkinElmer): Their market share is estimated to be between 7-9% focused on their life sciences portfolio, which includes genetic and clinical diagnostics.

-Matrix Labs: Matrix Labs represents a small market share of less than 2%, with a focus on establishing their brand within their regional market.

Key Segments:

♀️By Type: Includes Alpha thalassemia and Beta thalassemia, with Beta thalassemia holding the larger market share due to higher prevalence.

♀️By Testing Type: Comprises Prenatal testing, Complete Blood Count (CBC), Genetic Testing, and others, with genetic and prenatal testing gaining traction from early diagnosis demand.

♀️By Product Type: Consists of Laboratory Equipment, Testing Kits, and Reagents; kits dominate due to rising screening programs.

♀️By End User: Covers Hospitals and Clinics, Diagnostic Centers, and others, with hospitals being the largest consumers owing to routine patient screening and diagnostics.

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Latest News-

⏭️The FDA has deferred the review timelines concerning Agios Pharmaceuticals' supplemental New Drug Application for thalassemia treatments until December 2025 to allow for review of Risk Evaluation and Mitigation Strategy documents and to ensure there was no issue with reviewing new efficacy or safety data.

⏭️The thalassemia testing market continues to grow at a steady pace with greater emphasis on mandated population screening programs by health authorities in the US, Japan, and other important parts of the world.

⏭️Market reports indicate increased awareness and utilization of gene therapies and advanced molecular diagnostics as key drivers for shaping the future of thalassemia management across the globe.

FAQ's

Q1: What is the current size of the Thalassemia Testing Market reached?

A: The Thalassemia Testing Market reached stood at US$ 730 million in 2024 and is set to experience remarkable growth, reaching US$ 1.50 billion by 2033

Q2: How fast is the Thalassemia Testing Market reached growing?

A: The Market is on an impressive growth trajectory, expected to expand at a CAGR of CAGR of 8% from 2024-2031

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