How Precision Medicine is Reshaping Healthcare: A Market Perspective
The global precision diagnostics and medicine market, valued at US$132.46 billion in 2023, is forecasted to grow at a robust CAGR of 11.1%, reaching US$145.53 billion in 2024 and an impressive US$246.66 billion by 2029. Factors such as the increasing integration of advanced technologies such as Artificial intelligence and machine learning, supported by the rising collaborations between pharmaceutical and diagnostic companies to develop advanced precision medicine solutions, are propelling the market's growth. Additionally, the rising demand for direct-to-consumer testing owing to the growing awareness amongst patients for early and accurate diagnosis and therapy is also supporting the growth in this market. The expanding application of precision medicines to other therapeutic areas and the rising integration of wearable devices to improve precision healthcare offer growth opportunities to players in this market. However, the high cost of precision medicine solutions and the challenges associated with the integration and management of big data in precision healthcare are expected to restrain the growth of this market to a certain extent.
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The precision diagnostics market is competitive. Key market players include F. Hoffmann-La Roche Ltd (Switzerland), Agilent Technologies, Inc. (US), Thermo Fisher Scientific Inc. (US), Myriad Genetics, Inc. (US), Guardant Health (US), Natera, Inc. (US), Abbott (US), Illumina, Inc. (US), Danaher (US), Exact Sciences Corporation (US), Novartis AG (Switzerland), Bristol-Myers Squibb Company (US), Gilead Sciences, Inc. (US), AstraZeneca (UK), AbbVie Inc. (US), Eli Lilly and Company. (US), Pfizer Inc. (US), and GSK plc. (UK). These companies have adopted various strategies such as the development of advanced diagnostics products and therapies, partnerships, contracts, expansions, and acquisitions to strengthen their position in the precision medicine market. The organic and inorganic strategies have helped the market players expand globally by offering advanced precision medicine products. However, the high R&D investments and complications related to regulatory approvals for precision healthcare products act as a barrier for new entrants in the market. Moreover, the precision medicine market is consolidated and includes key players such as Merck & Co., Inc. (US), F. Hoffmann-La Roche Ltd (Switzerland), Novartis AG (Switzerland), Bristol-Myers Squibb Company (US), Gilead Sciences, Inc. (US), AstraZeneca (UK), AbbVie Inc. (US), Lilly (US), Pfizer Inc. (US), GSK plc. (UK), Sanofi (France), Johnson & Johnson Services, Inc. (US), Vertex Pharmaceuticals Incorporated (US), Daiichi Sankyo Company, Limited (Japan), Amgen Inc. (US), Merck KGaA (Germany), Neurocrine Biosciences, Inc. (US), Takeda Pharmaceutical Company Limited. (Japan), Alnylam Pharmaceuticals, Inc. (US), Teva Pharmaceutical Industries Ltd. (Israel), Sarepta Therapeutics, Inc. (US), Regeneron Pharmaceuticals Inc. (US), Immunocore Holdings plc. (UK), BioMarin. (US), and Novo Nordisk A/S (Denmark).
F. Hoffmann-La Roche Ltd (Switzerland)is one of the key players in the precision medicine market offering a wide range of precision medicine products, including FDA-approved precision therapeutic products such as Itovebi (inavolisib), Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), and Gavreto (pralsetinib) among others and FDA-approved precision diagnostics products such as VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, and FoundationOne CDx among others. The company has a significant global footprint due to its robust sales and distribution network. Additionally, multiple production sites at various geographic locations give the company an edge over other players in the precision medicine market.
Gilead Sciences, Inc. (US) is a leading biopharmaceutical company focused on developing and delivering innovative therapies in precision medicine. The company operates in over 35 countries through subsidiaries such as Gilead Biopharmaceutics Ireland Corporation and Gilead Holdings LLC (UK). Gilead’s key precision therapies include SUNLENCA (lenacapavir) an HIV-1 capsid protein inhibitor for drug-resistant HIV, TRODELVY for metastatic triple-negative breast cancer and urothelial cancer, and TECARTUS, a T-cell therapy for relapsed or refractory mantle cell lymphoma and acute lymphoblastic leukemia among others. Gilead further strengthens its precision medicine portfolio through strategic collaborations, including partnerships with Genesis Therapeutics to leverage AI platforms for optimized small-molecule therapies and with Merus for developing tri-specific antibodies targeting tumor-associated antigens.
Agilent Technologies, Inc. (US) is a global leader in life sciences, diagnostics, and applied chemical markets, offering instruments, software, services, and consumables. The Diagnostics & Genomics segment focuses on precision diagnostics, providing companion diagnostics (CDX) solutions and advanced testing products. Key products include MAGE-A4 IHC 1F9 BhamRx (SK032) for detecting MAGE-A4 expression and PD-L1 IHC 22C3 PharmaDx for identifying gastric or gastroesophageal junction (GEJ) adenocarcinoma patients eligible for KEYTRUDA (pembrolizumab) among others. Agilent launched the Biopharma CDX Services Lab (BCSL), supporting companion diagnostics development from assay creation to FDA approval. The company collaborated with Incyte to develop CDX solutions for hematology and oncology and with Akoya Biosciences to create multiplex IHC and immunofluorescence-based diagnostic tools for tissue biomarker analysis.
Guardant Health (US) is a precision oncology company specializing in advanced blood and tissue tests to improve cancer detection, monitoring, and treatment selection. Key products of the company include the Guardant360 liquid biopsy test, Guardant Reveal and Guardant360 Response for early-stage cancer, and GuardantINFINITY for advanced cancer research. Guardant also introduced the Shield test for early colorectal cancer detection and is expanding into lung and multi-cancer screening. These tests aim to provide a reliable alternative to tissue testing, detecting genomic alterations with equal or improved accuracy. Guardant Health received EU In Vitro Diagnostic Regulation (IVDR) certification for the Guardant360 CDX test, enabling tumor mutation profiling in all solid cancers and as a companion diagnostic for targeted therapies in advanced NSCLC and breast cancer. Strategic collaborations entered by the company include partnership with Hikma Pharmaceuticals for commercializing Guardant's biopsy tests in the MENA region, a research collaboration with the Parker Institute for Cancer Immunotherapy to study cancer biomarkers and immunotherapy responses, and a partnership with AnHeart Therapeutics to develop the Guardant360 CDX and TissueNext assays as companion diagnostics for talescitinib, an investigational ROS1 inhibitor for ROS1-positive NSCLC.
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North America was the dominant region on the precision diagnostics market in 2023.
The North American precision diagnostics market emerged as the largest market for precision diagnostics in 2023, which is expected to remain the same during the forecast period. The large share of this regional market is supported by the presence of major diagnostics companies in the region that are actively focusing on developing novel precision diagnostics solutions for various disease areas. The presence of prominent academic and research institutions has also supported the large share of this market. Moreover, the rising prevalence of chronic disorders, such as cancer and autoimmune diseases, and increased investments and funding in precision medicine research in the region further boost the market of precision diagnostics in the region.
Recent Developments of Precision Diagnostics and Medicine Market:
- In November 2024, Roche received CE Mark for its VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, to identify epithelial ovarian cancer (EOC) patients eligible for ELAHERE (mirvetuximab soravtansine), for FRα-positive platinum-resistant ovarian cancer.
- In September 2024, Foundation Medicine entered into a collaboration with Syndax Pharmaceuticals to develop a companion diagnostic for identifying acute myeloid leukemia (AML) patients with the NPM1 mutation.