Companion Diagnostics Market (Indication: Breast Cancer, Lung Cancer, Colorectal Cancer, Gastric Cancer, Melanoma, and Others) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2022-2030

The global Companion Diagnostics market gathered revenue around USD 6.9 billion in 2021 and market is set to grow USD 12.8 billion by the end of 2030 and is estimated to expand at a modest CAGR of 10.4% during the prediction period 2022 to 2030.

Growth Factors:

Technological advancements, higher prevalence of cancer across the globe, research & development activities, drug development, demand for personalized medicines, expansion of the pharmaceutical industry, key mergers & acquisitions, and impact of COVID-19 on companion diagnostics are projected to boost the growth of the global market during the forecast period. Rise in prevalence and incidence of various infectious diseases such as HIV would attract advanced companion diagnostics, which is likely to propel the global companion diagnostics market during the forecast period. Breast cancer affects one in eight women in their lifetime, and the number of breast cancer cases is rising consistently both in developing and developed countries. According to a research, breast cancer is considered the most prevalent cancer in the U.S. According to Breast Cancer Statistics, 287,851 breast cancer cases are expected to be diagnosed in women in 2022. This is likely to augment the global market.

Major risk factors for cancer are heredity, aging, obesity, high alcohol consumption, hormone replacement therapy, and cosmetic implants. Technological advancements leading to fast approval of companion diagnostic tests/assays are projected to drive the global market in the next few years. According to research, in 2021, around 44 CDx assays were approved by the FDA. Hence, regulatory approvals for CDx assays across countries is anticipated to propel the global market during the forecast period.

Companion Diagnostics Market: Overview

Companion diagnostics are biological tests or assays, which aid in predicting the clinical effectiveness or safety of the therapeutic intervention administered to diseased individuals. These diagnostic tests assist physicians in taking effective treatment decisions by elucidating the efficacy of a specific drug prescribed for a specific target population. For instance, Herceptin (trastuzumab), a monoclonal antibody treatment prescribed for treating breast cancer patients who contain one or more copies of the HER2 gene.

Companion diagnostics hold significant growth potential in the near future, owing to several tests in pipeline. The major advantage associated with the use of companion diagnostics is that it aids in predicting whether a patient will respond to a particular therapy and improves patient outcomes, thereby reducing the overall healthcare costs. Other advantages include the ruling out of generic therapies, thereby preventing side effects and resultant hospitalizations.

Report Scope of the Companion Diagnostics Market

COVID-19 Impact on Global Companion Diagnostics Market

The coronavirus pandemic has put intense pressure on the global healthcare system. With shortage of hospital beds, medical staff, and necessary protective equipment required for elective surgical processes, healthcare practitioners gave priority to critical patients suffering from severe health complications. Considering risk and safety of patients, non-emergency diagnostic and treatment procedures have been cancelled or postponed in the time of rapidly spreading coronavirus. This factor has negatively affected the global companion diagnostics market as cancer surgeries also been cancelled. Clinical trials in oncology have also been affected by the coronavirus. However, the market is booming after the significant efforts taken by governments, healthcare practitioners, and market stakeholders to recover from losses caused due to pandemic.

Increasing Prevalence of Chronic Disorders Fueling Market Growth

Rising incidences of HIV, thalassemia, colorectal cancer, melanoma, breast cancer, gastric cancer, and lung cancer is driving the demand for companion diagnostics procedures. There is a growing demand for companion diagnostic tests for early detection and screening of chronic diseases. These tests also help reduce the side effects of drugs, improve patient outcomes, provide high diagnostic accuracy and specificity, reduce pharmacotherapy variability, and identify the most effective targeted therapy options. They are also associated with higher drug development success. The global companion diagnostics market is booming due to the increasing demand for personalized medicines. Rising incidences of cancer and reduction in cost of developing drugs are also having a positive impact on the global companion diagnostics market. Companion diagnostics tests and procedures help bring about better decisions with respect to treatment.

Market Segmentation: Companion Diagnostics Market

• In terms of indication, the global companion diagnostics market has been classified into breast cancer, lung cancer, colorectal cancer, gastric cancer, melanoma, and others (HIV and thalassemia)
• The breast cancer segment accounted for the largest market share in 2021 and the trend is expected to continue during the forecast period. Rise in prevalence of breast cancer among middle-aged women across the globe and surge in awareness about the early diagnosis of breast cancer are likely to augment the segment in the next few years. Prostate, lung, and colorectal cancer are the most common cancers diagnosed in men and accounted for 42% of the cases. In women, breast, lung, and colorectal cancer account for more than 52% of the cancer cases.
• In 2021, around 4.1 million women were diagnosed with breast cancer, and 685,010 deaths were reported globally in the same year. Breast cancer is considered the most prevalent cancer across the globe. This drives the need of companion diagnostics. According to GLOBOCAN data, globally, new lung cancer accounted to 4.2 million of total cancer cases in 2021. Hence, increase in incidence of cancer across the globe is projected to drive the need of companion diagnostics during the forecast period.
• Each of the segments has been analyzed in detail for market trends, recent trends, and developments, drivers, restraints, opportunities, and useful insights. The companion diagnostics market report provides current and expected revenue (US$ Mn) for each of these segments from 2022 to 2030, considering 2021 as the base year. The compound annual growth rate (percentage CAGR) has been provided for each segment and market from 2022 to 2030 along with market size estimations.

North America to Lead Companion Diagnostics Market

North America is expected to account for a major market share of the global companion diagnostics market. Rising affordability of treatment and well-established healthcare infrastructure are driving the companion diagnostics market in the region. The increasing prevalence of chronic diseases all over the world demand companion diagnostics procedures. A large number of ongoing clinical trials, outsourcing services, research activities, and increasing healthcare investment by governments are some of the factors responsible for the growth of the companion diagnostics market in North America. Moreover, the significant presence of manufacturers is fueling the expansion of the North America companion diagnostics market. Asia Pacific and Latin America are other attractive companion diagnostics regions, where the market is poised to increase due to rising healthcare spending and improving healthcare facilities.

Regional Overview: Companion Diagnostics Market

North America accounted for the largest share of the global companion diagnostics market in 2020 and the trend is projected to continue during the forecast period. Technological advancements, increase in patient population, and rise in prevalence & incidence rate of cancer are anticipated to drive the market in the region during the forecast period. According to National Cancer statistics, 1,806,590 new cancer cases were diagnosed in the U.S. in 2020, and 606,520 people succumbed to the disease. This is expected to propel the need of companion diagnostics in North America.

The market in Asia Pacific is likely to grow at a rapid pace in the next few years, owing to rise in prevalence and incidence rates of cancer in several countries, outbreak of COVID-19 pandemic, and innovation & growth in advanced diagnostic products. Increase in cases of breast cancer is projected to drive the companion diagnostics market in the region. Surge in demand for personalized medicines is anticipated to propel the market in Asia Pacific. Untapped potential, several avenues of scientific research, positive economic growth, ever-increasing population, and positive regulatory scenario for healthcare in high growth countries attract leading global players to the region.

Some of the prominent players in the Companion Diagnostics Market include:

• Labcorp Drug Development
• Agilent Technologies
• Myriad Genetic Laboratories, Inc.
• Qiagen
• Roche Molecular Systems, Inc.
• Dako, Inc.
• Abbott
• Foundation Medicine, Inc.
• MolecularMD Corporation
• Ventana Medical Systems, Inc.
• Illumina, Inc.
• Life Technologies Corporation
• Invivoscribe Technologies, Inc.
• ARUP Laboratories, Inc.
• Leica Biosystems
• Biogenex Laboratories, Inc.
• bioMérieux, Inc.
• GE Healthcare
• Agendia N.V
• Exact Sciences Corp
• Genomic Health

Segments Covered in the Report

This research report offers market revenue, sales volume, production assessment and prognoses by classifying it on the basis of various aspects. Further, this research study investigates market size, production, consumption and its development trends at global, regional, and country level for the period of 2017 to 2030 and covers subsequent region in its scope:

• By Indication
• Breast Cancer
• Lung Cancer
• Colorectal Cancer
• Gastric Cancer
• Melanoma
• Others (HIV, Thalassemia)

By Geography

North America

• U.S.
• Canada

Europe

• Germany
• France
• United Kingdom
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Southeast Asia
• Rest of Asia Pacific

Latin America

• Brazil
• Rest of Latin America

Middle East & Africa (MEA)

• GCC
• North Africa
• South Africa
• Rest of Middle East & Africa

Key Points Covered in Companion Diagnostics Market Study:

• Growth of Companion Diagnostics in 2022
• Market Estimates and Forecasts (2017-2030)
•  Brand Share and Market Share Analysis
•  Key Drivers and Restraints Shaping Market Growth
•  Segment-wise, Country-wise, and Region-wise Analysis
•  Competition Mapping and Benchmarking
•  Recommendation on Key Winning Strategies
•  COVID-19 Impact on Demand for Companion Diagnostics and How to Navigate
•  Key Product Innovations and Regulatory Climate
•  Companion Diagnostics Consumption Analysis
•  Companion Diagnostics Production Analysis
•  Companion Diagnostics and Management