Companion Diagnostics - Market Insights, Competitive Landscape, and Market Forecast - 2030

The global companion diagnostics market was valued at USD 5.91 billion in 2023, growing at a CAGR of 12.32% during the forecast period from 2024 to 2030, to reach USD 11.89 billion by 2030. The increase in the market for companion diagnostics is predominantly owing to an exponential rise in cancer cases across the globe. Additionally, the rise in awareness regarding precision medicine among the patient population as well as the growing focus of the manufacturers concerning the development of precision medicine has bolstered the demand for companion diagnostics. Furthermore, an increase in research and development for developing companion diagnostics for non-cancer disorders, and growing approvals and launches of various companion diagnostic products in the market, among others are some of the key factors anticipated to augment the global market for companion diagnostics during the forecast period (2024-2030).

Companion Diagnostics Market Dynamics:

The market for companion diagnostics is projected to witness considerable growth due to the increase in preference for precision medicine or personalized medicine among cancer patients. This is because precision medicine has the potential to offer an improved medication selection and targeted therapy for cancer patients thereby reducing adverse effects. Moreover, personalized medicine increases patient compliance by making the treatment regimen for cancer more cost-effective. Companion diagnostics are predictive biomarker assays that play a significant role in the development of precision medicine which leverages genetic and genomic data to improve health outcomes. Thus, a growing preference for personalized medicine is likely to increase the market for companion diagnostics.

Furthermore, government, as well as organizations' initiatives to raise awareness regarding precision medicine and biomarker testing for cancer are likely to increase the adoption of precision medicine which in return is expected to raise the demand for companion diagnostics thus, fuelling the market. For instance, in November 2022, LUNGevity Foundation, a leading lung cancer-focused nonprofit organization, launched a year-long #KnowYourBiomarker social media initiative as part of the No One Missed campaign aimed at driving awareness of comprehensive biomarker testing in non-small cell lung cancer (NSCLC).

Additionally, a shift in the focus of key manufacturers on developing companion diagnostics for various non-cancer disorders such as Alzheimer’s disorders, Huntington’s disease, and others are also expected to increase the adoption of companion diagnostic tools to aid in the management and treatment of such diseases and improve patient outcomes. For instance, in November 2019, Asuragen, a biotechne brand partnered with Wave Life Sciences to develop companion diagnostics for Huntington’s Disease.

Thus, all the above factors are expected to augment the global companion diagnostics market in the forthcoming years.

However, the high cost of companion diagnostics coupled with limited reimbursement in many countries and complex regulations for the approval of these devices are expected to impede the market growth for companion diagnostics.

Also, owing to the outbreak of the COVID-19 pandemic, the companion diagnostics market witnessed slow growth. This is due to the implementation of lockdown, and restrictions on demand & supply chain. Moreover, during the pandemic the healthcare system guidelines across the globe temporarily focused all their efforts on the management of COVID-19 patient, due to which the number of cancer screening were reduced. For instance, as per the data provided by the National Cancer Institute 2022, besides the challenges associated with the lockdown restrictions due to the COVID-19 pandemic, it was observed that in March 2020 alone, COVID-19 forced the postponement of more than 800 appointments for lung cancer screening. However, owing to the approval and administration of numerous COVID-19 vaccines across the globe, there was a significant improvement in the resumption of activities across various domains including healthcare services, thereby paving the way for a sound period of recovery for the companion diagnostics market.

Companion Diagnostics Market Segment Analysis:

Companion Diagnostics Market By Type (Product [Assays, Kits & Reagents and Instruments], Services), By Technology (Immunohistochemistry (IHC), Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), Others), By Indication (Lung Cancer, Breast Cancer, Colorectal Cancer, Others), By End-User (Hospitals, Diagnostic Labs, Others), and By Geography (North America, Europe, Asia-Pacific, and Rest of the World).

In the product type segment of the companion diagnostics market, the assays, kits & reagents subsegment is expected to hold a significant market share in the year 2023. The rise in collaboration among the companies focused on developing diagnostic products and giant pharmaceutical companies for developing companion diagnostics kits to improve cancer treatment and management is expected to augment the market for these product types. For instance, on August 05, 2022, Shanghai Henlius Biotech, Inc. entered into a Collaboration with Promega to Develop the Companion Diagnostic Kit for Henlius' Serplulimab MSI-H Solid Tumours Indication.

Furthermore, the rise in the focus on developing and launching companion diagnostic assays with advanced sequencing techniques and those which require non-invasive samples could also increase the demand for this segment. For instance, in August 2020, the US Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology (Guardant360 CDx assay) to identify patients with specific types of mutations of the epidermal growth factor receptor (EGFR) gene in a deadly form of metastatic non-small cell lung cancer (NSCLC).

Additionally, companies raising funds to develop companion diagnostic products and strengthen their portfolio to expand the market access are further projected to contribute to the segmental growth of the companion diagnostics market. For instance, in May 2018, Cergentis, a Dutch biotech company, secured a > €1.2 million grant from the European Commission’s Horizon 2020 program for the development of cancer companion diagnostics. The company planned to use the funds obtained to optimize and validate the TLA technology for the analysis of (FFPE) tumor biopsies.

Hence, the interplay of all the above-mentioned factors is projected to boost the companion diagnostics market in the upcoming years.

North America is expected to dominate the overall Companion Diagnostics Market:

Among all the regions, North America is expected to hold a major share in the overall Companion Diagnostics market in the year 2023 and will retain its market position during the forecast period. This is due to the rising prevalence and incidence of various cancers in the region. For instance, as per the 2020 data revealed by the GLOBOCAN, the new cancer cases reported in the US, Canada, and Mexico were 2,281,658; 2,74,364; and 1,95,499, respectively.

Moreover, favorable reimbursement policies, approval & launches of various companion diagnostic products in the region, various business expansion activities underwent by the companies present in the region, and others are some of the factors responsible for the companion diagnostics market.

For instance, in 2018, the Centers for Medicare & Medicaid Services (CMS) finalizes coverage of Next Generation Sequencing tests, ensuring enhanced access for cancer patients. The CMS believed when these tests are used as a companion diagnostic to identify patients with certain genetic mutations may benefit from the US Food and Drug Administration (FDA)-approved treatments.

Also, in April 2019, Agilent received an expanded FDA Approval for its companion diagnostic in NSCLC.

Hence, all the above-stated factors are projected to propel the regional market growth of companion diagnostics during the forecast period.

Companion Diagnostics Market Key Players:

Some of the key market players operating in the Companion Diagnostics market include Agilent Technologies, Inc., F. Hoffmann-La Roche Ltd, Myriad Genetics, Inc., Abbott Laboratories., QIAGEN, BIOMÉRIEUX, Guardant Health Inc., Illumina, Inc., Pillar Biosciences, Inc., Leica Biosystems, Thermo Fisher Scientific Inc., Almac Group, NeoGenomics Laboratories., Invitae Corporation, 3D Medicines Corporation, ASURAGEN, INC. (Biotechne), Invivoscribe, Inc., Amoy Diagnostics Co., Ltd., Laboratory Corporation of America® Holdings., SAGA Diagnostics, and others.

Recent Developmental Activities in the Companion Diagnostics Market:

• In March 2022, Myriad Genetics received FDA approval of BRACAnalysis® CDx as a companion diagnostic for Lynparza® in early breast cancer.
• In October 2022, Agilent was granted the FDA approval for its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) as a companion diagnostics in identifying patients with early breast cancer (EBC) at high risk of disease recurrence, for whom adjuvant treatment with Verzenio® (abemaciclib) in combination with endocrine therapy is being considered.
• In August 2022, Roche received FDA approval for the first companion diagnostic to identify dMMR solid tumor patients eligible for anti-PD-1 immunotherapy.

Key Takeaways from the Companion Diagnostics Market Report Study

• Market size analysis for current market size (2023), and market forecast for 6 years (2024-2030)
• The effect of the COVID-19 pandemic on this market is significant. To capture and analyze suitable indicators, our experts are closely watching the Companion Diagnostics market.
• Top key product/services/technology developments, mergers, acquisitions, partnerships, and joint ventures happened in the last 3 years
• Key companies dominating the Global Companion Diagnostics Market.
• Various opportunities available for the other competitor in the Companion Diagnostics Market space.
• What are the top-performing segments in 2023? How these segments will perform in 2030.
• Which are the top-performing regions and countries in the current market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for Companion Diagnostics market growth in the coming future?

Target Audience who can be benefited from the Companion Diagnostics Market Report Study

• Companion Diagnostics providers
• Research organizations and consulting companies
• Companion Diagnostics-related organization, association, forum, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and Traders in Companion Diagnostics
• Various End-users want to know more about the Companion Diagnostics Market and the latest technological developments in the Companion Diagnostics market.

Frequently Asked Questions for the Companion Diagnostics Market:

1. What are Companion Diagnostics?

A companion diagnostic is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product.

2. What is the market for Global Companion Diagnostics?

The global companion diagnostics market was valued at USD 5.91 billion in 2023, growing at a CAGR of 12.32% during the forecast period from 2024 to 2030, to reach USD 11.89 billion by 2030.

3. What are the drivers for Global Companion Diagnostics?

The major factors driving the demand for Companion Diagnostics are the exponential rise in cancer cases across the globe. Additionally, the rise in awareness regarding precision medicine among the patient population as well as the growing focus of the manufacturers concerning the development of precision medicine has bolstered the demand for companion diagnostics. Furthermore, an increase in research and development for developing companion diagnostics for non-cancer disorders, and growing approvals and launches of various companion diagnostic products in the market, among others are some of the key factors anticipated to augment the global market for companion diagnostics during the forecast period (2024-2030).

4. Who are the key players operating in Global Companion Diagnostics?

Some of the key market players operating in the Companion Diagnostics market include Agilent Technologies, Inc., F. Hoffmann-La Roche Ltd, Myriad Genetics, Inc., Abbott Laboratories., QIAGEN, BIOMÉRIEUX, Guardant Health Inc., Illumina, Inc., Pillar Biosciences, Inc., Leica Biosystems, Thermo Fisher Scientific Inc., Almac Group, NeoGenomics Laboratories., Invitae Corporation, 3D Medicines Corporation, ASURAGEN, INC. (Biotechne), Invivoscribe, Inc., Amoy Diagnostics Co., Ltd., Laboratory Corporation of America® Holdings., SAGA Diagnostics, and others.

5. Which region has the highest share in the Companion Diagnostics market?

Among all the regions, North America is expected to hold a major share in the overall Companion Diagnostics market in the year 2023 and will retain its market position during the forecast period. This is due to the rising prevalence and incidence of various cancers in the region. Moreover, favorable reimbursement policies, approval & launches of various companion diagnostic products in the region, various business expansion activities underwent by the companies present in the region, and others are some of the factors responsible for the companion diagnostics market.


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