Precision Diagnostics Market Size, Share & COVID-19 Impact Analysis, By Type (Genetic Tests, Esoteric Tests, and Others), By Application (Oncology, Cardiovascular, Immunology, and Others), By End User (Hospitals, Clinical Laboratories, and Homecare), and Regional Forecast, 2021-2028

The global precision diagnostics market size was USD 54.05 billion in 2020. The market is projected to grow from USD 60.35 billion in 2021 to USD 138.85 billion in 2028 at a CAGR of 12.6% over 2021-2028. The global impact of COVID-19 has been unprecedented and staggering, with the market witnessing a positive demand shock across all regions amid the pandemic. Based on our analysis, the precision diagnostics market analysis exhibited a stellar growth of 23.3% in 2020 as compared to the average year-on-year growth during 2017-2019. The sudden rise in CAGR is attributable to this market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.  

Precision diagnostics is a method of disease diagnosis with a precise and & timely explanation of a patient's health problem. It is majorly used for diabetes and cancer treatment and includes the use of genetic tests, esoteric tests, and others (direct-to-consumer tests). The increased prevalence of cancer and rise in neurological disorders are anticipated to boost the demand for precision medicine, thereby driving the industry growth. For example, according to National Cancer Institute, it is projected that the number of new cancer cases will rise by 29.5 million and cancer-related deaths to 16.4 million per year by 2040.

Strong Demand for Diagnostics during COVID-19 Pandemic has Affirmative Impact on Market Growth

COVID-19 pandemic has created an intense focus on diagnostics, emphasizing the significance of precision and timely diagnosis to increase the quality of care and reduce healthcare and community-related costs. It has become a stimulus for change and starts at the beginning of the patient pathway, with precision diagnosis, the compass for effective treatment. According to Worldometer, in May 2021, the U.S. recorded the highest COVID-19 cases globally, accounting for about 96.2% in the North American region. Therefore, it has increased the demand for precision diagnostic for effective treatment procedures and rise in R&D activities for the development of disease diagnostics such as genetic tests and point-of-care tests. Countries are battling to slow down the spread of the diseases by executing necessary measures and increasing sample testing. Therefore, the pandemic has given impetus for companies to accelerate the adoption of effective diagnostic procedures.

LATEST TRENDS

Growing Adoption of Precision Diagnostic to Propel Market Growth

Diagnostic testing is the backbone of the coronavirus disease 2019 response, supporting containment efforts to diminish the outbreak. Numerous pharmaceutical and biotechnology companies have registered their preclinical and clinical studies for testing novel therapies against toxic viruses. Plasma therapy, immunotherapy trials are presently in the pipeline. This trend is likely to accelerate the potentiality of the coronavirus detection market during the forecast period.

Additionally, increased focus on digital diagnostics is propelling the precision diagnostics market growth. For example, in January 2021, Roche announced the launch of its digital pathology algorithms for precision patient diagnosis for breast cancer to help establish the best treatment strategy for each patient.

DRIVING FACTORS

Increased Demand for Personalized Medicine to Augment Market Growth

Personalized therapy is available to patients with an understanding of the molecular basis of diseases. It has become famous over recent years when genetic testing and genome sequencing are two of the essential tools used to comprehend the molecular basis of disease. European countries are screened for many genetic disorders, as early detection of these diseases can prevent the onset of symptoms or reduce the severity of the disease.

Additionally, a sudden increase in pandemic cases has escalated the demand for COVID-19 diagnostic procedures and products, leading to increased demand for disease diagnostics. According to the World Health Organization (WHO), in May 2021, 163,312,429 people worldwide were affected by COVID-19. Such instant daily rise in cases has surged the adoption of advanced diagnostic solutions to provide early treatment to patients.

Increased Applications in Oncology and Other Rare Disorders to Propel Market Growth

The rising prevalence of cancer and growing incidence of neurological diseases are estimated to increase the demand for precision medicine and drive the growth of the global market. For example, in 2019, as per Neurological Alliance, there were about 14.7 million neurological cases, with at least 1 in 6 people living with one or more neurological conditions. For example, according to WHO, Alzheimer's disease is the most conventional form of dementia, contributing nearly 60–70% of cases as of September 2020.

Many organizations collaborate to develop medicines targeted to treat a particular group of patients according to their specific requirements, consequently increasing the number of clinical trials, thus leading to an increase in disease diagnostics. For instance, in June 2021, Personal Genome Diagnostics Inc. Massachusetts General Hospital announced a strategic collaboration to advance the development of effective treatment services.

RESTRAINING FACTORS

High-Capital Investment Required for Research & Development of Precision Medicine and Diagnostic Kits to Limit Market Growth

Despite immense potential in various areas of modern healthcare, high R&D costs could slow down developments in the field of precision diagnostics, thereby hindering the market growth. Accurate diagnosis remains one of the major priorities for healthcare providers. Still, quick turnaround time for results, rising demand for test kits, and inefficiency of the tests themselves are affecting the market development.

Besides these factors, a strict regulatory scenario in most countries for the development of new test kits acts as a major growth restraining factor. As COVID-19 cases continue to rise across the world, the need for safer and more improved kits to deliver accurate diagnosis and treatment has caused disorder in the market. Manufacturers need to comply with strict healthcare standards to launch new test kits. In the U.S., for example, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are some of the regulatory bodies that have enforced new guidelines and restructured previous ones.

SEGMENTATION

By Type Analysis

Increased Awareness of Early Diagnosis of Genetic Diseases to Propel Genetic Tests Segment

Based on type, the market is segmented into genetic tests, esoteric tests, and others (direct to consumer tests). The genetic tests segment dominated the market in 2020 due to the increased awareness of the early diagnosis of diseases. This test looks for mutations or variants in the DNA and is helpful in many areas of medicine. For example, genetic testing can diagnose a genetic condition, such as Fragile X syndrome or Huntington's disease, and information about the risk of developing cancer.

By Application Analysis

Adoption of Precision Diagnostics for Cancer Treatment to Boost Oncology Segment Growth

Based on application, the market is categorized into oncology, cardiovascular, immunology, neurology, and others. The oncology segment will dominate the market in 2020, and is expected to emerge as the fastest-growing segment during the projected timeframe. Precision medicine has promptly changed the oncology diagnostic and treatment spectrum in recent times. Many organizations conducting precision medicine are focused on cancer for many reasons. Cancer is a genome disease, and tumors can be worked on to comprehend genetic changes with an individual’s specific cancer. Therefore, these play a vital role in improving patient outcomes by timely and accurately analyzing the disease.

By End User Analysis

Increased Adoption by Clinics Laboratories to Foster Segmental Growth

The clinical laboratories segment emerged as the dominant segment in the market in 2020. In the era of precision diagnostics, disruptive innovations are increasing as they disrupt an existing market and create a new one by providing different set of values, including the increasing cost of healthcare and the need for better accessibility of diagnostic care. Eventually, combining molecular results and other diagnostic parameters (e.g., genomic data) will lead to better diagnostic procedures and segmental growth. In comparison to hospitals and home care, clinical laboratories are provided with highly innovative technology that could offer beneficial growth opportunities for this segment.

REGIONAL INSIGHTS

North America is slated to capture the global market share during 2021-2028. In 2020, the regional market size amounted to USD 20.84 billion. This dominance is attributable to rising collaborations between government and private organizations. A well-established healthcare infrastructure will also promote the regional expansion. Neuberg Diagnostics Private Limited, a key player in this region, aims to expand its domestic and international presence by establishing new incubation centers across the country and in Europe to access novel technologies and solutions in the field of personalized medicine. In July 2021, the company also established a new pathology lab in Telangana, India. Similar initiatives from other market players in the region will strengthen the regional outlook significantly in the forthcoming years.

Europe is anticipated to be the second largest market for precision diagnostics in the forthcoming years. The regional growth is influenced by the growing number of COVID-19 infections and the subsequent rise in new technology adoption. Highlighting an instance, in July 2021, Xyall BV, a leading MedTech company in the molecular pathology space, introduced the Tissector High Throughput (HT) system for more improved diagnostics. The technology is the world’s first molecular diagnostics lab that leverages its unique, automated tissue dissection technology.

Meanwhile, the market in Asia Pacific will expand at the fastest CAGR over the projected period, led by the rising occurrence of chronic and lifestyle diseases and the increasing development of drugs for rare diseases. The regional growth will also be powered by continuous advances in next-gen sequencing and companion diagnostics in the genomics spaces.

Latin America and the Middle East & Africa regions will witness slower growth due to the lower awareness about modern diagnostic technologies. The lack of supportive reimbursement policies in various low-income countries could also be a major factor slowing down the market development in these regions.

KEY INDUSTRY PLAYERS

Mergers & Acquisitions with Other Participants to Help Companies Grow

The global market is a fragmented market with several players. Companies such as Koninklijke Philips N.V, GE healthcare, and other healthcare companies, are endlessly attempting to reach the maximum customers to expand their products and services and increase the adoption of diagnostic solutions. Moreover, mergers and partnerships among key players are also attributable to the development of the market. For instance, in October 2020, Diaceutics PLC announced the launch of DXRX, the diagnostic network designed to increase the end-to-end development and commercialization of precision medicine diagnostics by decreasing time to peak biomarker test adoption for cancer testing.

LIST OF KEY COMPANIES PROFILED:

• Quest Diagnostics (New Jersey, U.S.)


• QIAGEN (Hilden, Germany)


• Swiss Precision Diagnostics (Geneva, Switzerland)


• Koninklijke Philips N.V (Amsterdam, Netherlands)


• Lantheus Medical Imaging, Inc. (Massachusetts, U.S.)


• Bluebird Bio, Inc (Massachusetts, U.S.)

KEY INDUSTRY DEVELOPMENTS:

• June 2021 - Trivitron Healthcare, a medical devices company, announced two new innovation-driven products for HbA1c and Hb variant detection. These products will be used for monitoring diabetes, hemoglobin variants, and thalassemia. The new product includes NANO H5 & NANO H110, high-performance liquid chromatography analyzers, and is fully automated. The company will reach the new height of precision within a projected timeframe in the diagnostics market.


• October 2020 - Diaceutics PLC announced the launch of DXRX – The Diagnostic Network designed to increase the end-to-end development of precision medicine diagnostics by decreasing the time to peak biomarker test adoption for cancer testing from years to months.

REPORT COVERAGE

The global precision diagnostics market report provides a detailed analysis of the market and focuses on key aspects, such as leading companies, type, application, and end users. Besides this, the report offers insights into the market trends and highlights key industry developments. In addition, the report encompasses significant factors contributing to the market growth in recent years.

Report Scope & Segmentation