Precision Medicine Market is expected to reach US$ 329.73 billion by 2033 | Major players - F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., AstraZeneca, Pfizer Inc.

Market Size and Growth:

The Precision Medicine Market Size reached US$ 98.87 billion in 2024 and is expected to reach US$ 329.73 billion by 2033, growing at a CAGR of 14.8% during the forecast period of 2025-2033. The Market is growing due to rising adoption of genomic sequencing and targeted therapies, along with increasing demand for personalized, effective treatments for complex diseases such as cancer. According to DataM Intelligence report.

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The Precision Medicine Market refers to the healthcare segment focused on delivering personalized treatment based on an individual's genetic profile, lifestyle, environment, and biomarker data. It integrates advanced diagnostics, targeted therapies, and data analytics to improve accuracy, predict disease risk, enhance treatment outcomes, and minimize adverse effects. This market supports customized medical solutions for more effective, patient-centric care.

United States: Recent Developments of Precision Medicine Market

✅ September 2025: Illumina announced a collaboration with pharmaceutical companies to develop KRAS companion diagnostics, enhancing personalized cancer treatments.​

✅ October 2025: North America solidified leadership in AI applications for precision medicine, with increased investments in AI-driven diagnostics and patient profiling.​

✅ November 2025: The U.S. market saw projections for significant growth to USD 153.45 billion by 2033, driven by advancements in targeted therapies and oncology applications.

Europe: Recent Developments of Precision Medicine Market

✅ September 2025: Validation studies for innovative precision medicine solutions began under the EP PerMed Fast Track Call, running through early 2026 to improve solution maturity.​

✅ October 2025: Europe advanced policy and approvals in precision medicine, including oncology and immunology therapies alongside diagnostic progress.​

✅ November 2025: The region experienced a surge in venture capital for AI-native precision-oncology startups, boosting gene sequencing and CRISPR editing technologies.

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FDA Approvals in 2025:

✅ IdyllaTM CDx MSI Test (Biocartis) - PMA granted (Aug 15, 2025). First PMA for the cartridge-based Idylla CDx MSI Test to identify MSI-high colorectal cancer patients eligible for PD-1 therapy; significant because it's a fully automated "sample-to-result" CDx.

✅ Guardant360® CDx approved as companion diagnostic for imlunestrant (Inluriyo / Lilly) - FDA approval tied to imlunestrant (Sept 25, 2025). The liquid-biopsy Guardant360 CDx was approved to identify ESR1-mutant breast cancer patients eligible for imlunestrant - another example of blood-based CGP tied to a targeted therapy.

✅ Revuforj® (revumenib, Syndax) - approval for NPM1-mutated AML (Oct 24, 2025). Revumenib, a menin inhibitor, received FDA approval for relapsed/refractory AML with a susceptible NPM1 mutation (adult and pediatric indication). This is a precision, biomarker-driven oncology approval.

✅ KomziftiTM (ziftomenib, Kura Oncology / Kyowa Kirin) - approval for NPM1-mutated AML (Nov 13, 2025). Another menin inhibitor approved for relapsed/refractory AML with a susceptible NPM1 mutation - further evidence of rapid approvals in biomarker-defined hematologic oncology in late 2025.

✅ Oncomine Dx Target Test (Thermo Fisher / Ion Torrent) - cleared/approved as CDx for sevabertinib (Hyrnuo / Bayer) - late Nov 2025 (news Nov 20-Dec 1, 2025 reporting). Thermo Fisher's NGS-based Oncomine Dx Target Test was approved/cleared as the companion diagnostic to identify HER2 (ERBB2) TKD-mutant NSCLC eligible for sevabertinib (Hyrnuo).

Major Mergers & Acquisitions in 2025:

✅ Gilead (Kite) → acquired Interius BioTherapeutics (~$350M) - announced Aug 2025 (deal reported Aug 21, 2025). Kite/Gilead bought Interius to strengthen in-vivo CAR-T / cell-therapy capabilities (relevance: accelerates cell-therapy platforms used in precision oncology).

✅ mdxHealth → acquired Exosome Diagnostics (assets from Bio-Techne) - agreement announced Aug 5, 2025. Acquisition consolidated exosome / cfDNA-based precision diagnostics (notable for prostate & urologic molecular assays).

✅ AbbVie → acquired bretisilocin program from Gilgamesh (deal announced Aug 25, 2025; close Oct 17, 2025) - up to ~$1.2B for the program. While psychiatry-focused, the deal highlights pharma M&A activity and program buys that shape precision pipelines and associated biomarker development.

✅ DoseMe (model-informed precision dosing) → acquired Firstline - Nov 3, 2025 (reported in healthcare M&A roundups). This is a precision-med related deal (clinical decision software / personalized dosing).

Regulatory / Policy Actions in 2025:

✅ FDA proposal / initiative to reclassify companion diagnostic (CDx) test systems - Nov 2025: FDA moved to reclassify certain nucleic-acid based CDx test systems (policy discussions & docket activity in November 2025). This is potentially material - it could change premarket pathways and regulatory burden for many CDx/NGS providers.

✅ Broader trend - accelerated approvals & CDx pairings in oncology and hematology (Aug-Nov 2025): FDA's Novel/Oncology approvals list and multiple oncology roundups show a cluster of biomarker-driven approvals (CDx + targeted drugs) in this period (examples above: revumenib, ziftomenib, imlunestrant + Guardant360, Idylla CDx, Oncomine CDx).

Major Players:

Key companies in the Precision Medicine market include:

F. Hoffmann-La Roche Ltd
Thermo Fisher Scientific Inc.
AstraZeneca
Pfizer Inc.
GSK plc
Biogen
Bristol-Myers Squibb Company
Abbott
Merck & Co., Inc.
BGI

Segments Covered in the Precision Medicine Market:

By Technology: Big Data Analytics, Bioinformatics, Gene Sequencing, Drug Discovery, Others.

By Application: Diagnostics, Therapeutics, Others.

Regional Analysis for Precision Medicine Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline:

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Precision Medicine market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Precision Medicine Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The global Precision Medicine market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Precision Medicine Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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Frequently asked questions:

➠ What is the global sales value, production value, consumption value, import and export of Precision Medicine market?

➠ Who are the global key manufacturers of the Precision Medicine Industry? How is their operating situation (capacity, production, sales, price, cost, gross, and revenue)?

➠ What are the Precision Medicine market opportunities and threats faced by the vendors in the global Precision Medicine Industry?

➠ Which application/end-user or product type may seek incremental growth prospects? What is the market share of each type and application?

➠ What focused approach and constraints are holding the Precision Medicine market?

➠ What are the different sales, marketing, and distribution channels in the global industry?

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