Visiongain has published a new report entitled Companion Diagnostics (CDx) Market Report 2024-2034: Forecasts by Product & Services (Assays, Kits & Reagents, Software & Services), by Technology (Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), In Situ Hybridization (ISH), Immunohistochemistry (IHC), Other)), by Indication (Cancer, Infectious Diseases, Cardiovascular Diseases, Neurological Diseases, Other), by End-users (Pharmaceutical & Biopharmaceutical Companies, Reference Laboratories, Contract Research Organizations (CROs), Other) AND Regional and Leading National Market Analysis PLUS Analysis of Leading Companies AND COVID-19 Impact and Recovery Pattern Analysis.

The companion diagnostics (CDx) market is estimated at US$6,574.6 million in 2024 and is projected to grow at a CAGR of 11.0% during the forecast period 2024-2034.

Increasing Public Awareness of Personalised Medicine

The increased acceptance of personalised medicine is also fueling the expansion of the CDx market. Patients increasingly demand CDx testing to verify that they receive the most suitable care as they become more aware of the benefits of personalised treatment options. Furthermore, healthcare practitioners are rapidly recognising the importance of CDx tests in improving patient outcomes and implementing them into their clinical practice.

The following are some of the elements that are influencing the increased public awareness of personalised medicine:

• The rising incidence of chronic illnesses: Illnesses, including diabetes, cancer, and heart disease, are becoming more widespread. Since these illnesses are frequently complicated, individualised treatment plans are necessary.
• The creation of novel targeted therapies: The introduction of novel targeted therapies has allowed for the more efficient treatment of numerous illnesses. Nevertheless, patients with certain genetic or molecular defects are sometimes the only ones for whom these medicines work. Identification of these patients requires CDx testing.
• The growing accessibility and affordability: Genetic testing is becoming more widely available. This simplifies the process for patients and physicians to obtain genetic information, which may be utilised to customise treatment plans.

Thus, personalised medicine refers to treating patients that consider their unique genetic makeup, lifestyle, and environment. Because they enable physicians to choose the best course of action for each patient at each stage of the process, CDx tests are a crucial component of personalised medicine.

Also, the following data and methods are intended to raise public awareness of personalised medicine:

• According to a GenomeWeb survey from 2023, barely 30% of Americans are familiar with personalised medicine.
• A different PLOS ONE research from 2023 found that just 28% of Koreans knew what personalised medicine was.
• Eighty percent of Americans expressed interest in learning more about personalised medicine, according to a 2022 study by the Personalised Medicine Coalition.
• Despite their lack of knowledge, 77% of Koreans polled for the 2023 PLOS ONE study agreed that the national health examination should incorporate pharmacogenomic testing, a crucial part of personalised treatment.
• According to a National Human Genome Research Institute research from 2023, 90% of Americans think knowing their genetic information will help them receive better medical care.

How has COVID-19 had a positive impact on the Companion Diagnostics (CDx) Market?

The market for companion diagnostics (CDx) has been affected by the COVID-19 pandemic in various ways. Due to the fact that CDx tests are necessary to determine whether patients can benefit from specific targeted medicines, the pandemic has, on the one hand, raised demand for them. For instance, patients with lung cancer who qualify for EGFR inhibitor treatment are found via CDx tests. However, the pandemic has also caused supply chain disruptions for CDx testing, resulting in fewer patients undergoing elective procedures, which has decreased demand for CDx tests.

The COVID-19 pandemic has affected the CDx market in the following specific ways:

• Demand for CDx tests has increased: There are several reasons why the pandemic has raised demand for CDx tests. To start with, more cancer patients are receiving targeted therapy for their condition. Secondly, the pandemic has resulted in a scarcity of medical personnel and hospital beds, which has complicated elective surgery performance. Because targeted therapies can be used to treat patients who are not candidates for surgery, there has been a spike in the usage of CDx testing to determine which patients are eligible for them.
• Disruption of the CDx test supply chain: The pandemic has caused difficulties in obtaining the components and raw materials required to create CDx tests, which has disrupted the supply chain. This has resulted in a lack of CDx testing in many regions of the world.
• Reduction in the number of patients having elective operations: Hospitals have prioritised treating COVID-19 patients, which has reduced the number of people having elective procedures due to the pandemic. Since CDx tests are frequently performed before and after elective procedures, this has decreased demand for them.

In general, the long-term effects of the COVID-19 pandemic are anticipated to be favourable for the CDx market. In the upcoming years, the need for CDx testing is anticipated to increase due to the acceleration of the pandemic's adoption of precision medicine. Furthermore, creating novel CDx technologies, including next-generation sequencing (NGS), is anticipated to expand the market.

How will this Report Benefit you?

Visiongain’s 307-page report provides 100 tables and 170 charts/graphs. Our new study is suitable for anyone requiring commercial, in-depth analyses for the companion diagnostics (CDx) market, along with detailed segment analysis in the market. Our new study will help you evaluate the overall global and regional market for companion diagnostics. Get financial analysis of the overall market and different segments, including product & services, technology, indication, end-user, and company size and capture higher market share. We believe that there are strong opportunities in this fast-growing companion diagnostics (CDx) market. See how to use the existing and upcoming opportunities in this market to gain revenue benefits in the near future. Moreover, the report will help you to improve your strategic decision-making, allowing you to frame growth strategies, reinforce the analysis of other market players, and maximise the productivity of the company.

What are the Current Market Drivers?

Rising Importance of Personalized Medicine

Personalised medicine is emerging as a dominant force in the paradigm shift occurring in the healthcare industry. With its personalised treatment plans based on each patient's own genetic and molecular composition, this method promises higher effectiveness and fewer adverse effects. In this case, companion diagnostics (or CDx) are essential for both promoting market expansion and directing treatment choices.

Certain biomarkers that indicate a patient's reaction to a particular medicine are identified by CDx tests. This enables medical professionals to recommend treatments with a greater chance of success and refrain from giving out potentially hazardous or ineffective medications. This focused strategy drastically lowers the amount of trial-and-error therapy, which helps healthcare systems save money in the long run by facilitating quicker diagnoses and better patient outcomes. Numerous noteworthy advancements in personalised medicine occurred in 2023. As an example, the FDA recently approved **dostalimanab**, the first cancer treatment that is based on a patient's genetic composition rather than the origin of the tumour. Furthermore, a great deal of progress has been made in creating customised treatments for difficult conditions like Parkinson's and Alzheimer's.

In addition, The US Food and medical Administration (FDA) authorised 12 new personalised medications in 2023, marking the seventh consecutive year in which at least 25% of new medical approvals were personalised. This is a considerable increase from a decade ago, when personalised medicines accounted for less than 10% of new therapeutics.

The CDx market is being driven by the emergence of personalised medicine in multiple ways:

• Growing need for tailored therapies: As more medications with particular genetic targets are created by pharmaceutical companies, there is a greater need for companion diagnostics to find the right individuals. Targeted medicines and CDx have a synergistic relationship that promotes market expansion for both industries.
• Increase in available cancer treatments: Personalised medicine has completely changed cancer care, and CDx is a key component in determining whether patients may benefit from particular therapies like immunotherapy or targeted medications. As a result, cancer patients now have more therapy options and higher survival rates, which is driving the CDx market even higher.
• Growing public awareness of genetic testing: There is a growing body of knowledge regarding the potential applications of genetic testing for both personalised medicine and disease prevention. Growth in the CDx test industry is aided by the greater pool of potential users that results from this enhanced understanding.

Creating New CDx Tests for Novel Targeted Medicines

Creating novel CDx tests for upcoming targeted medicines is a critical area of research and development. New CDx tests are required to identify patients who are most likely benefit from newly emerging targeted medicines. This can assist to speed up the development of new medicines and get them to patients faster.

In addition, developing novel CDx tests is critical for the sustained expansion of the targeted treatments business. In 2022, there were over 200 CDx assays in development for various kinds of cancer. Also, as of October 2023, there are over 150 FDA-approved CDx tests, with many more under development. These tests are being created employing a range of technologies, including next-generation sequencing (NGS), immunohistochemistry (IHC), and fluorescence in situ hybridization (FISH).

Following are some particular instances of newly authorised CDx testing for innovative targeted medications in 2022:

• Roche's Cobas EGFR Mutation Test v2: This test helps determine whether patients with non-small cell lung cancer (NSCLC) will benefit from treatment with EGFR-targeted treatments by identifying EGFR mutations in those patients.
• The Oncomine Dx Target Test from Thermo Fisher Scientific is an NGS-based test that examines 23 genes and mutations in colorectal cancer, NSCLC, melanoma, and other tumour types.
• Therascreen EGFR RGQ PCR Kit from Qiagen: Patients with NSCLC and breast cancer can use this test to identify EGFR mutations, which can help with treatment selection.

Thus, creating new CDx tests is a difficult and time-consuming task. However, the potential benefits are substantial, as CDx testing can improve patient outcomes while lowering healthcare costs.

Where are the Market Opportunities?

Favourable Government Policies

Companion diagnostics, improved statistics, and supportive government policy could greatly accelerate healthcare innovation.

Positive Policies of the Government:

• More money for research and development: Tax breaks, grants, and subsidies from the government can incentivise the purchase of cutting-edge medical devices and treatments.
• Simplified regulatory procedures: New technologies may be approved and made available more quickly when regulatory processes are faster and more effective.
• Encouraging cooperation between the public and private sectors can facilitate the exchange of knowledge and hasten the creation of personalised medicine solutions.

Government Initiative Examples:

• US FDA: The US Food and Drug Administration (FDA) has established a framework for approving and co-developing CDx and medicinal products. The Centre for Devices and Radiological Health (CDRH) of the FDA has launched several programmes, such as the In Vitro Diagnostic (IVD) Regulatory Review Improvement Initiative and the Companion Diagnostic Pilot Programme, to aid in creating and approving companion diagnostics.
• EU IVDR: The In Vitro Diagnostic Regulation (IVDR) of the European Union establishes strict guidelines for creating, producing, and distributing CDx. Companion diagnostics are covered by a new rule on in vitro diagnostic medical devices (IVDR) that the European Commission enacted. The IVDR is intended to support innovation and competition while guaranteeing the safety and efficacy of IVDs.
• China NMPA: Special rules for CDx approval and clinical trial conduct have been put in place by the China National Medical Products Administration (NMPA). The China-US Joint Laboratory for Precision Medicine and the National Key R&D Programme for Precision Medicine are two of the many programmes the Chinese government has started to aid in the growth of the companion diagnostic business.
• India CDx Guidelines: A draft set of guidelines for the creation and endorsement of CDx has been made public by the Indian government. The Department of Biotechnology (DBT) was founded by the Indian government to further biotechnology-related research and development, including companion diagnostics.

Expansion into New Geographic Markets

• Asia Pacific: Because of its vast and expanding population, rising healthcare costs, and growing awareness of personalised treatment, this region offers enormous potential for the companion diagnostics industry. China, India, Japan, and South Korea are important markets in this area.
• Latin America: Driven by factors such as an expanding middle class, rising healthcare expenditures, and increasing government attempts to improve healthcare infrastructure, this area also presents potential growth opportunities for the companion diagnostics (CDx) market.
• Middle East and Africa: Although this region's market for companion diagnostics is currently smaller, it is anticipated to grow significantly in the upcoming years due to rising disposable income, interest in personalised medicine, and growing government spending on healthcare.

Several top businesses are aggressively entering emerging regions with their companion diagnostics services. Here are a few instances:

• Roche Diagnostics: Roche is a prominent player in developing markets, specialising in diagnosing cancer and infectious disorders. Additionally, the company is engaging in joint ventures with regional healthcare providers to increase access to its companion diagnostics.
• Abbott Diagnostics: Abbott provides a wide range of companion diagnostics for various diseases and has a lengthy history of doing business in developing markets. In order to provide access to diagnostic testing in rural places, the company is also investing in mobile health solutions.
• Siemens Healthineers: With an emphasis on cancer and cardiovascular diagnostics, Siemens Healthineers is growing the range of companion diagnostics it offers in developing countries. Additionally, in order to enhance connectivity and data management in these areas, the company is investing in digital health solutions.
• Thermo Fisher Scientific: This top supplier of laboratory consumables and equipment is also growing its companion diagnostics business in emerging regions. The company's main goal is to offer these markets options that are both accessible and reasonably priced.

In the upcoming years, expanding geographic markets are anticipated to be major contributors to the growth of the companion diagnostics (CDx) market. Prominent corporations are proactively broadening their product offers in these domains; nonetheless, they encounter many obstacles, such as regulatory barriers, restricted reimbursement, and inadequate infrastructure. There are substantial prospects for businesses that can effectively navigate these constraints and break into these industries despite these challenges.

Competitive Landscape

The major players operating in the companion diagnostics (CDx) market are Abbott, Agilent Technologies, Inc., Almac Group, bioMerieux, Danaher Corporation, F. Hoffmann-La Roche Ltd, Guardant Health, Illumina, Myriad Genetics, Inc,, QIAGEN, Sysmex Corporation, and Thermo Fisher Scientific Inc. These major players operating in this market have adopted various strategies comprising M&A, investment in R&D, collaborations, partnerships, regional business expansion, and new product launches.

Recent Developments

• In October 2023, Almac announced a Master Collaboration Agreement (MCA) with AstraZeneca to develop and commercialise multiple CDx products. This partnership will leverage Almac's expertise in CDx development and commercialisation with AstraZeneca's drug development pipeline.
• In February 2023, Roche and Janssen announced an expanded collaboration to develop and commercialize a wider range of companion diagnostics. This includes tests based on tissue, blood, next-generation sequencing, and digital pathology. This collaboration is expected to accelerate the development of personalized medicine solutions.

Notes for Editors

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