Global Biomarker Clinical Phase Outsourcing Services Market 2023-2030

Global Biomarker Clinical Phase Outsourcing Services Market 2023-2030

Global Biomarker Clinical Phase Outsourcing Services Market Size, Share & Trends Analysis Report by Type (Predictive Biomarkers, Prognostic Biomarkers, Safety Biomarkers, and Surrogate Endpoints), by Therapeutic Area (Oncology, Cardiology, Neurology, and Autoimmune Diseases), and by End-Use (Pharmaceutical Companies and Biotechnology Companies), Forecast Period (2023-2030)

The global biomarker clinical phase outsourcing services market is anticipated to grow at a CAGR of 21.3% during the forecast period (2023-2030). Significant factors including the increasing number of drug development processes, and the rising prevalence of chronic diseases such as cancer, cardiovascular diseases, and neurological disorders has led to an increased focus on biomarkers for early detection, disease monitoring, and treatment response assessment. World Health Organization (WHO) estimated 17.9 million lives every year. Furthermore, according to the American Cancer Society, in 2020, there were an estimated 18.1 million new cancer cases and 9.9 million cancer deaths globally. It is projected that the burden of cancer would increase in coming years as a result of factors including the rising rates of smoking, poor eating habits, and inactivity. Biomarkers indicate a variety of health or disease characteristics.

Segmental Outlook

The global biomarker clinical phase outsourcing services market is segmented on the type, therapeutic area, and end-user. Based on the type, the market is sub-segmented into predictive biomarkers, prognostic biomarkers, safety biomarkers, and surrogate endpoints. Based on the therapeutic area, the market is sub-segmented into oncology, cardiology, neurology, and autoimmune diseases. Further, based on end-user, the market is bifurcated into pharmaceutical companies and biotechnology companies. Among the type, the surrogate endpoints sub-segment is anticipated to hold a considerable share of the market. Surrogate endpoints are a small subset of well-characterized biomarkers with well-evaluated clinical relevance. The segmental growth is attributed to the increasing investment by contract researchers in developing surrogate endpoints for the diagnosis and monitoring of several chronic ailments.

Cardiology Sub-Segment is Anticipated to Hold a Considerable Share of the Global Biomarker Clinical Phase Outsourcing Services Market

Among the therapeutic area, the cardiology sub-segment is expected to hold a considerable share of the global biomarker clinical phase outsourcing services market. The segmental growth is attributed to the increasing prevalence of coronary artery disease, heart failure, valvular heart disease, coupled with the rising demand for coronary artery clinical trials and technical advancement. The British Heart Foundation (BHF) data published in January 2023 reported that in 2021, the most common cardiovascular conditions includes coronary (ischemic) heart disease (global prevalence estimated at 200 million in 2019), peripheral arterial (vascular) disease (110 million), stroke (100 million) and atrial fibrillation (60 million). Additionally, the report revealed that the prevalence of heart and circulatory diseases was 48 million, 100 million, 98 million, 48 million and 340 million in North America, Europe, Africa and the Middle East, Latin America, and Asia & Australia.

Regional Outlook

Global biomarker clinical phase outsourcing services market is further segmented based on geography including North America (the US, and Canada), Europe (UK, Italy, Spain, Germany, France, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, and Rest of Asia), and the Rest of the World (the Middle East & Africa, and Latin America). Among these, the Asia-Pacific region is anticipated to hold a prominent share of the market around the globe, owing to the increasing prevalence of cancers, increasing number of Western pharmaceutical companies outsourcing their manufacturing activities in emerging economies such as India, and China are driving the biomarker clinical phase outsourcing services market in the Asia Pacific.

The North America Region is Expected to Grow at a Significant CAGR in the Global Biomarker Clinical Phase Outsourcing Services Market

Among all the regions, North America is anticipated to grow at a considerable CAGR over the forecast period. The market growth is attributed to the increasing number of cardiovascular disorders across the North America is estimated to positively impact the clinical trials market growth in upcoming years. According to the American Heart Association (AHA), CVDs remains as the leading cause of death in the US, accounted for 928,741 deaths in the year 2020. American Cancer Society, estimated in 2023, over 1.9 million new cancer cases are expected to be diagnosed in the US. Approximately 609,820 deaths from cancer are expected in the US in 2023, which is about 1,670 deaths per day. Additionally, owing to the presence of established contract research organizations specializing in biomarker clinical phase outsourcing services, such as global clinical trials, Caidya, ICON plc, and several others. Owing to the introduction of several innovative, ground-breaking technologies in clinical research and the provision of state-of-the-art infrastructure, numerous clinical trials for heart disorders are being performed across the region. As per Clinicaltrials.gov, as of September 2023, around 5,068 enduring biomarker clinical phase outsourcing services are registered in the US.

Market Players Outlook

The major companies serving the global biomarker clinical phase outsourcing services market include Celerion, Fujirebio Europe NV, ICON plc, and Parexel International Corp., among others. The market players are considerably contributing to the market growth by the adoption of various strategies including mergers and acquisitions, partnerships, collaborations, funding, and new product launches, to stay competitive in the market. For instance, in March 2023, healthcare technology firm Koneksa Health Inc., expanded collaboration with life sciences consulting firm SSI Strategy to scale evidence-based digital biomarker adoption in clinical trials. The digital biomarker solutions of Koneksa include a platform which allows research sponsors and clinical sites to impeccably aggregate data, in real-time, from patient diaries, devices, ePROs, and clinical assessments, to deliver a complete view of a person’s health.

The Report Covers

Market value data analysis of 2022 and forecast to 2030.

Annualized market revenues ($ million) for each market segment.

Country-wise analysis of major geographical regions.

Key companies operating in the global biomarker clinical phase outsourcing services market. Based on the availability of data, information related to new product launches, and relevant news is also available in the report.

Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.

Analysis of market-entry and market expansion strategies.

Competitive strategies by identifying ‘who-stands-where’ in the market.