New York, Oct. 30, 2023 (GLOBE NEWSWIRE) -- The biomarkers market, valued at USD 58.6 billion in 2022, is projected to witness a CAGR of 14.3% from 2023 to 2032. It is expected to reach USD 215.7 billion by 2032.
The diagnostic landscape is increasingly emphasizing early and precise detection, particularly for diseases in their nascent stages like cancer. In response, diagnostic biomarkers, offering minimally or non-invasive solutions, have emerged to meet these demands, though not without their unique challenges. They seamlessly integrate with cutting-edge imaging and data management technologies, ensuring precise imaging of oncology tumors while minimizing radiation exposure during procedures like CT and MRI scans.
Technological progress in biomarker-based diagnostics, leveraging omics, proteomics, and metabolomics, has significantly propelled industry growth. Applications span risk assessment, molecular diagnostics, and DNA fingerprinting, among others. Additionally, biomarkers play a pivotal role in drug validation, testing, sample preparation, and assay development, streamlining the intricate process of discovering and developing novel drugs.
Recent strides in technology enable non-invasive testing, expediting drug development and early diagnosis. Notable collaborations, like Altoida's partnership with the Digital Medicine Society in March 2022, highlight the drive towards precision neuro-biomarker platforms. Industry leaders are spearheading initiatives to bolster the commercialization of biomarker-based products. For instance, Amgen, Inc.'s Biomarker Assist program, launched in April 2021, offers financial support for metastatic NSCLC patients seeking access to biomarker testing, including the KRAS Single Gene Test and the NGS Affordability Programs.
Despite substantial progress in data sharing and analytical infrastructure, its full potential remains underutilized, and a universally standardized regulatory framework is yet to be established globally. Nonetheless, the significance of biomarkers is rapidly ascending, especially in the diagnosis of critical ailments like cancer and cardiovascular diseases. They play a pivotal role in early diagnosis, significantly influencing the development of effective treatments and overall advancements in the field of medicine. Addressing reimbursement hurdles through regulatory interventions is expected to catalyze growth in the commercial-level diagnostic market.
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Key Takeaways
- Drug Discovery and Development dominates the segment, accounting for over 32.6% of the market's revenue share.
- The diagnostics segment is anticipated to witness the fastest expansion in the coming years, particularly in early-stage disease detection.
- The cancer segment commands the largest portion of the global biomarkers market, driven by early detection and management facilitated by cancer biomarkers.
- North America dominates the biomarkers market, holding a significant 39.0% share, driven by factors like high cancer rates and advanced healthcare infrastructure.
- Europe shows promise for growth due to esteemed research institutions and collaborations.
- The Asia-Pacific region anticipates a remarkable 16.20% CAGR, fueled by rising cardiovascular disease cases and government R&D investments.
Driving Factors
The rate of cancer is rising worldwide.
The rising global cancer rates, attributed to factors like increased smoking, unhealthy diets, and sedentary lifestyles, are expected to result in a greater cancer burden. Biomarkers, revealing diverse health and disease characteristics, are pivotal in comprehending the intricate development of cancer, which involves multiple molecular pathway events. Given cancer's complex nature, a single marker falls short, with each type of cancer presenting a distinct molecular profile.
The discovery of novel biomarkers opens new avenues for developing therapeutic approaches to address cancer dysregulation. Consequently, the increasing prevalence of cancer is set to drive biomarker research and facilitate the expansion of the global market.
Increasing Biomarker Diagnostic Uses to Promote Industry Growth
The increasing investment in biomarker research and development, coupled with strategic partnerships and product launches, is expected to drive demand for biomarkers in the coming years. Notable collaborations, such as the one between Personalis, Inc. and Merck KGaA, are focused on discovering novel biomarkers associated with cancer therapy response and resistance mechanisms, utilizing Personalis' advanced cancer immunogenomics platform, ImmunoID NeXT.
Similar partnerships are poised to introduce cutting-edge products. Additionally, innovations like Owlstone Medical Ltd.'s ReCIVA Breath Sampler and CASPER Portable Air Supply, alongside Olink Proteomics' ONCOLOGY III panel, are pushing the boundaries of biomarker exploration. The FDA's approval of Keytruda for specific genetic biomarkers underscores the growing significance of biomarkers in cancer treatment. With a surge in cancer and cardiovascular diseases and increased investment from major market players, the demand for biomarkers is set for substantial growth.
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Restraining Factors
Strict Regulation Practices
Incorporating biomarker-based diagnostics into clinical practice frequently requires adherence to rigorous regulatory procedures. The specific pathway depends on the intended use of the biomarker, be it for diagnostic, prognostic, or predictive applications. While different countries have their own regulatory agencies, in the United States, the Food and Drug Administration (FDA) is tasked with overseeing the approval process.
Growth Opportunities
Advancing personalized medicine
Biomarkers play a pivotal role in customizing remedies based on an individual’s precise genetic make-up and disordered traits. With continuous development in genomics and proteomics research, the identification of unique biomarkers for focused healing procedures is about to proliferate. It’s best to improve treatment efficacy, but it also reduces facet consequences, leading to an upsurge in demand for biomarker-pushed diagnostics.
Rapid uptake of biomarkers in clinical trials
The fast integration of biomarkers into scientific trials is reshaping the landscape of medical studies. Biomarkers serve as worthwhile gear in the improvement of the latest drugs, offering important insights into disorder biology, treatment responsiveness, and patient categorization. Pharmaceutical agencies are increasingly relying on biomarkers to expedite drug development, reduce expenses, and increase the probability of successful scientific trials. A growing call for biomarkers helping in drug improvement, clinical trial strategizing, and discovery is expected, supplying a sizeable opportunity for market growth.
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Report Scope
| Report Attribute | Details |
| Market Value (2022) | US$ 58.6 Billion |
| Market Size (2032) | US$ 215.7 Billion |
| CAGR (from 2023 to 2032) | 14.3% from 2023 to 2032 |
| Europe Revenue Share | 39.0% |
| Historic Period | 2016 to 2022 |
| Base Year | 2022 |
| Forecast Year | 2023 to 2032 |
Regional Analysis
North America leads the global biomarkers market with a substantial 39.0% share, driven by factors like high cancer rates, proactive government initiatives, advanced healthcare infrastructure, and increased use of biomarkers in personalized treatment. This dominance is expected to continue due to ongoing investments and heightened awareness, particularly in the U.S. and Canada. Europe is poised for substantial market growth, ascribed to esteemed research institutions, collaborations, improved access to biomarker testing, and growing interest from universities and solution providers in countries like the U.K., France, Germany, and Italy.
The Asia-Pacific region is projected to experience a remarkable compound annual growth rate (CAGR) of 16.20%, fueled by rising cardiovascular disease cases in China and India, increased government R&D investments, and advances in biopharmaceuticals. The aging populations also contribute to this growth, with substantial expansion anticipated from 2023 to 2032 due to heightened global cancer concerns and a surge in research activities.
The country-specific report section offers detailed insights into individual markets, including domestic regulatory changes influencing current and future trends. Various analytical tools like value chain analysis, technical trend assessment, Porter's five forces, and case studies are utilized to project market scenarios. Additionally, global brand presence and accessibility, competition from local players, considerations of domestic tariffs, and trade routes are all factored into the comprehensive forecast analysis of country-specific data.
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Segment Analysis
The biomarkers market is driven by substantial investments in research and development, resulting in tailored treatments and improved predictability of drug effectiveness. This sector accounts for over 32.6% of the market's revenue share. Notable advances, like Halozyme, Inc.'s personalized therapy for EGFR mutations in non-small cell lung cancer, exemplify this trend.
In the diagnostics segment, there's projected swift growth due to its advantages in early-stage disease detection, particularly for COVID-19. The expansion of hospital capacities and increasing disposable income further drive this demand.
The cancer biomarkers sector within the indication type is thriving, fueled by early management and detection enabled by cancer biomarkers. This sector is set to receive an additional boost from a robust product pipeline courtesy of major manufacturers in the field. The growing elderly population and a surge in cancer cases are further propelling the demand for biomarkers.
In terms of end user type, the market is categorized into pharmaceutical and biotechnology companies, diagnostics and research facilities, specialty clinics, hospitals, and other entities. The diagnostics and research laboratories sector is poised for growth, with substantial financial commitments and support from both the governmental and private sectors driving biomarker development. Empire Genomics, LLC, for instance, provides significant grants to aid researchers and clinicians in creating and validating novel biomarkers in oncology.
Segments Covered in the Report
By Application
- Risk Assessment
- Development of Molecular Diagnostics
- Disease Diagnosis
- Drug discovery and development
- Drug Formulation
- Forensic Application
- Others (DNA fingerprinting and others)
By Indication
- Cancer
- Infectious Diseases
- Immune Disorders
- Neurological Disorders
- Cardiovascular Disorders
- Other disease indications
By End User
- Pharmaceutical and biotechnology companies
- Diagnostics and Research Laboratories
- Hospitals
- Specialty Clinics
- Others
By Geography
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East and Africa
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Competitive Landscape Analysis
Key competitors in the biomarkers market are evaluated based on diverse factors, including company overview, financial performance, revenue generation, market potential, R&D investments, global presence, production capabilities, strengths and weaknesses, product portfolio, and application dominance. Dominant players like Abbott Laboratories Inc., Johnson & Johnson, Roche Diagnostics, Bio-Rad Laboratories, Epigenomics AG, and Qiagen collectively hold the majority market share.
The market's growth trajectory is intrinsically linked with technological advancements and R&D investments. Currently, a significant portion of resources in pharmaceutical companies are allocated towards research and development, with governments also providing substantial funding to drive technological progress. This collaborative effort between the private and public sectors is instrumental in shaping the future of the biomarker market.
Top Key Player in the Biomakers Market
- Abbott
- Qiagen
- Hoffmann-La Roche Ltd.
- Thermo Fisher Scientific, Inc.
- Siemens Healthcare Private Limited
- Agilent Technologies, Inc.
- Bio-Rad Laboratories, Inc.
- Johnson & Johnson Services, Inc.
- Epigenomics AG
- Bruker
- Quest Diagnostics Incorporated
- General Electric Company
- Becton, Dickinson, and Company
- Cisbio Bioassays
Recent Developments
- In October 2023, the Indian Institute of Technology (IIT), Madras, inaugurated a cutting-edge Center of Excellence focused on Cancer Genomics and Molecular Therapeutics, dedicated to advancing biomarkers for early detection of pancreatic cancer.
- In October 2023, PDS Biotech revealed encouraging preliminary results from a biomarker study involving a specific cohort of advanced HPV-positive head and neck cancer patients, indicating potential positive outcomes.
- In October 2023, Pfizer obtained FDA approval for its combination therapy comprising encorafenib (BRAFTOVI) and binimetinib (MEKTOVI) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) carrying a BRAF V600E mutation. This achievement was underpinned by promising data from the Phase 2 PHAROS clinical trial (NCT03915951), encompassing both treatment-naïve and previously treated patients with this mutation.
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