Minimal Residual Disease Testing Market - By Technology (Flow-cytometry, Polymerase Chain Reaction (PCR), Next Generation Sequencing (NGS)), By Application (Lymphoma, Leukemia, Solid Tumors), By End-use, & Forecast, 2023 – 2032

Minimal Residual Disease Testing Market Size

Minimal Residual Disease Testing Market size was valued at around USD 2.45 billion in 2022 and is estimated to reach over USD 4.1 billion by 2032.
 

Advancements in minimal residual disease testing technologies result in an improvement in cancer treatment procedures. Additionally, these minimal residual disease tests are specially designed to measure the effectiveness of treatment, help doctors confirm & monitor remissions, and possibly identify an early return of cancer. As per the Leukemia & Lymphoma Society, the most widely used tests to evaluate minimal residual disease are flow cytometry, polymerase chain reaction (PCR), and next-generation sequencing (NGS) among others.
 

The minimal residual disease testing market from digital technology is also providing application prospects for personalized minimal residual disease diagnosis through quantifying nucleic acids precisely. These advantages pertaining to minimal residual disease testing are attributable to ongoing R&D activities and significant technological advancements. As a result, the recent technological advancements are set to increase the demand for minimal residual disease testing. Minimal residual disease (MRD) is a term used to describe the small number of cancer cells in the body after cancer treatment.
 

However, the stringent regulatory framework related to minimal residual disease testing may hamper the market growth. The U.S. FDA has rigid regulatory compliances and complex approval procedures that may obstruct the market gains. The majority of minimal residual tests need a premarket notification, or 510(k) process prior to their commercialization in the market. Such stringent product regulations may lead to penalties and loss of market access in a global marketplace.
 

COVID-19 Impact

The recent outbreak of COVID-19 had negatively impacted the minimal residual disease testing market revenue. The lucrative demand for COVID-19 testing had substantially impacted other disease testing services. During the initial period, the incidence, as well as the mortality rate of COVID-19, was highest, and people tended to avoid any other treatment or diagnosis procedures at facilities. The risk of infection during cancer diagnostic test at point-of-care facilities had resulted in procedure deferral.
 

In addition, the high rate of COVID-19 incidence across the globe had driven the need for expansion of existing testing facilities. These factors had shifted focus on increasing COVID-19 testing-related services leading to the decline in the point-of-care testing of other diseases including cancer testing, thus impeding the related product sales during the period. However, the cancer patients were at a higher risk of COVID-19 infection-related complications. A considerable portion of cancer patients was diagnosed with severe COVID-19 that had continued the need for disease testing to a certain limit.

Minimal Residual Disease Testing Market Trends

The increasing prevalence of cancer is anticipated to proliferate market growth in the coming years. The growing geriatric population suffering from cancer has accelerated the progress for diagnostic procedures that has further propelled the market expansion positively. Cancer including blood cancer, lymphoma, and solid tumors among others promote substantial disease burden. These ailments inflict health care costs and affect the health-associated quality of life.
 

According to the Leukemia and Lymphoma Society, in 2022, around 1.24 million blood cancer cases occurred across the globe that include a variety of chronic medical conditions. In addition, solid tumors represent around 90% of adult human cancers that leads to a large number of patients opting for minimal residual disease testing for diagnosis.
 

Furthermore, several government organizations across the globe have implemented strict regulations and recommendations to continuously monitor the treatment efficacy of patients suffering from cancer. Likewise, hospitals and clinics have focused more on continuous testing during treatment procedures. The surge in the prevalence & morbidity associated with cancer is amongst the key variables that are set to prove beneficial for the market.
 

Minimal residual disease testing market players and governments are collaboratively emphasizing on providing highly sensitive & specific diagnosis during treatment procedures that have resulted in aligning the minimal residual disease testing as an essential tool in healthcare facilities. As a result, the rise in in-patient hospitalization for various diagnosis and treatments is projected to fuel the minimal residual disease testing adoption.
 

Minimal Residual Disease Testing Market Analysis

Based on technology, the minimal residual disease testing market is segmented as flow-cytometry, polymerase chain reaction (PCR), next generation sequencing (NGS), and others. The polymerase chain reaction (PCR) held the considerable market share in 2022 and was valued at over USD 606 million. The significant segment progression is primarily attributed to novel technological advancement and an increase in the awareness of benefits related to the use of digital PCR (dPCR). This highly sensitive digital polymerase chain reaction allows absolute quantification through accurate molecular detection.
 

In the coming years, the popularity of minimal residual disease PCR test will produce even greater amounts of data in real-time through the integration of big data and artificial intelligence that will effectively reduce the mortality associated with cancer. Thus, the novel advancements, the emergence of integrative technologies that promote precision & reduce turn-around time, and associated benefits are projected to accelerate the market evolution.
 

Based on application, the minimal residual disease testing market is segmented as lymphoma, leukemia, solid tumors, and others. The lymphoma segment held a dominant market share in 2022 and was valued at around USD  891 million. The increasing prevalence of lymphoma is anticipated to drive the market in the forecast years. As per the American Cancer Society, in 2021, around 90,300 people were diagnosed with lymphoma in the U.S. This disease burden is expected to reach higher with each passing year. The common symptoms of having lymphoma include swelling of lymph nodes in neck, in armpits or groin.
 

Moreover, immune system disorders comprising HIV/AIDS, autoimmune disorders comprising rheumatoid arthritis, and other factors are significantly contributing to the surging incidence of blood cancer disorders. The next-generation minimal residual disease testing model will be highly sensitive & specific, incorporating novel technologies to show how well the patient has responded to treatment.
 

Based on end-use, the minimal residual disease testing market is segmented as hospitals, specialty clinics, diagnostic centers, and others. The hospitals segment is projected to reach more than USD 1.9 billion by 2032. This high market share is owing to the rising prevalence of cancer requiring minimal residual disease testing, soaring use of novel cancer tests in hospital settings, and the subsequent number of hospital admissions among others. The availability of a broad spectrum of kits for performing these tests with proven accuracy is set to drive product preference in hospitals. Growing admissions with cancer ailments and growing disease screening initiatives along with the accessibility to board-certified healthcare professionals are some other variables that are augmenting the segment enlargement positively.
 

Also, the rising disease burden in developed economies with enhanced healthcare infrastructure is projected to stimulate the diagnosis & treatment rate at hospitals. As a result, accessibility to an effective diagnosis coupled with the rising prevalence of cancer diseases and associated conditions will boost the patient visits to hospitals.
 

North America minimal residual disease testing market is anticipated to expand at a considerable pace to reach around USD 1.8 billion by 2032. The growing prevalence of cancer and the growing adoption of advanced cancer diagnostic test are some of the major factors that are driving the market growth in the country. For instance, as per the American Cancer Society, in 2022, around 1,918,030 new cancer cases and 609,360 cancer deaths were reported in the U.S.
 

Moreover, the rising patient influx associated with several chronic blood cancer disorders including leukemia, lymphoma, and myeloma among others is leading to increased product demand across several states in the U.S. According to the American Cancer Society, in 2021, 61,000 leukemia cases were reported in the U.S. As a result, minimal residual disease testing is widely adopted for residual disease & recurrence monitoring in patients with early-stage cancer by hospitals & specialty clinics in the country.
 

Minimal Residual Disease Testing Market Share

Some of the major minimal residual disease testing market players operating in the minimal residual disease testing industry are

• Adaptive Biotechnologies
• Amgen Inc.
• AstraZeneca
• Bio-Techne
• Bristol-Myers Squibb Company
• Exact Sciences Corporation 

Minimal Residual Disease Testing Industry News:

• In December 2022, Adaptive Biotechnologies announced the launch of clonoSEQ to assess minimal residual disease (MRD) in patients with diffuse large b-cell lymphoma (DLBCL) using circulating tumor DNA (ctDNA). This strategic move assisted the company in bolstering its product portfolio and offered a competitive edge.
   
• In February 2021,Guardant announced the launch of Reveal™ Liquid Biopsy Test for residual disease and recurrence monitoring in patients with early-stage colorectal cancer. This test improves the management of early-stage colorectal cancer (CRC) patients by detecting circulating tumor DNA (ctDNA) in blood after surgery to identify patients with residual disease. This product launch promoted the company’s existing portfolio of minimal residual disease testing.
   

Minimal residual disease testing market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD (million) and volume (Units) from 2018 to 2032 for the following segments:

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By Technology, 2018 - 2032 (USD Million & Units)

• Flow-cytometry
• Polymerase Chain Reaction (PCR)
• Next Generation Sequencing (NGS)
• Others

By Application, 2018 - 2032 (USD Million)

• Lymphoma
• Leukemia
• Solid Tumors
• Others

By End-use, 2018 - 2032 (USD Million)

• Hospitals
• Specialty Clinics
• Diagnostic Centers
• Others

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada 
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Poland
  • Sweden
• The Netherlands
  • Asia Pacific
  • Japan
  • China
  • India
  • Australia
• South Korea
  • Thailand
  • Indonesia
  • Philippines
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Colombia
  • Chile
  • Peru
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Israel
  • Turkey
  • Iran