Companion Diagnostic Market

Rising preference for personalized medicine market growth

Personalized or targeted medicine is one of the upcoming trends in medical innovation. It is one of the most significant fields that creates the need for companion diagnostics products. The healthcare providers are focusing on using CDx to develop new drugs based on specific genetic biomarkers in major fields such as oncology, cardiac disease, inflammation, infectious diseases, central nervous system disorders, and many more to improve patient outcomes.

Moreover, the companion diagnostic tests are currently used to help identify specific genetic/somatic mutations in patient samples that are specified for targeted therapies for many different types of cancers. For instance, in July 2021, QIAGEN N.V. (Germany) partnered with Sysmex (Japan) to develop and market cancer companion diagnostics (CDx), leveraging the latter’s Plasma-Safe-SeqS technology for next-generation sequencing (NGS); this partnership aims to develop drug treatments for cancer and boost quick clinical use of ultra-sensitive liquid biopsy clinical diagnostics.

The Global Companion Diagnostics Market Industry is poised for remarkable growth, with projections indicating a market value of 36.8 USD Billion in 2024 and an anticipated increase to 308.0 USD Billion by 2035. This trajectory suggests a compound annual growth rate (CAGR) of 21.32% from 2025 to 2035, reflecting the increasing integration of companion diagnostics into clinical practice. The growth is driven by various factors, including advancements in technology, rising chronic disease prevalence, and regulatory support for personalized medicine. Such projections highlight the dynamic nature of the market and its potential to reshape healthcare delivery.

Investment in research and development is a critical driver of the Global Companion Diagnostics Market Industry. Pharmaceutical companies and biotechnology firms are allocating substantial resources to develop innovative companion diagnostics that can enhance treatment efficacy and patient outcomes. This trend is supported by collaborations between industry stakeholders and academic institutions, fostering an environment conducive to innovation. As a result, the market is poised for significant growth, with projections indicating a market value of 36.8 USD Billion in 2024. The emphasis on R&D is likely to yield breakthroughs that further advance the field of personalized medicine.

Technological advancements in genomics are significantly influencing the Global Companion Diagnostics Market Industry. Innovations such as next-generation sequencing and CRISPR gene editing are enabling more precise identification of biomarkers associated with various diseases. These technologies enhance the development of companion diagnostics, allowing for tailored treatment plans that improve patient outcomes. As a result, the market is expected to expand, with projections indicating a growth to 308.0 USD Billion by 2035. The integration of these advanced technologies into clinical practice is likely to drive demand for companion diagnostics, thereby reshaping the landscape of personalized medicine.

The demand for targeted therapies is a significant factor propelling the Global Companion Diagnostics Market Industry. As healthcare providers increasingly recognize the benefits of personalized treatment approaches, the need for companion diagnostics that can identify the most effective therapies for specific patient populations becomes paramount. This shift towards precision medicine is evident in the rising number of targeted therapies approved by regulatory agencies. The market's growth is underscored by the projected increase in value to 308.0 USD Billion by 2035, reflecting the ongoing transformation in treatment paradigms that prioritize individualized care.

The Global Companion Diagnostics Market Industry is experiencing growth driven by the increasing prevalence of chronic diseases such as cancer, diabetes, and cardiovascular disorders. As these conditions become more widespread, the demand for personalized medicine rises, necessitating the development of companion diagnostics that can identify suitable therapies for individual patients. For instance, the rise in cancer cases has led to a greater need for targeted therapies, which companion diagnostics can facilitate. This trend is reflected in the projected market value of 36.8 USD Billion in 2024, indicating a robust growth trajectory as healthcare systems adapt to these challenges.

Regulatory bodies are increasingly supporting the development of personalized medicine, which is a key driver for the Global Companion Diagnostics Market Industry. Initiatives aimed at streamlining the approval process for companion diagnostics encourage innovation and investment in this sector. For example, the FDA has established pathways that expedite the review of companion diagnostics alongside their corresponding therapies. This regulatory environment fosters collaboration between pharmaceutical companies and diagnostic developers, enhancing the market's growth potential. As the industry evolves, the supportive regulatory framework is likely to contribute to the anticipated CAGR of 21.32% from 2025 to 2035.

By Region, the study segments the market into North America, Europe, Asia-Pacific, and Rest of the World. North America companion diagnostics market accounted for the largest market share in 2021, The increasing number of healthcare organizations working on generated genomic databases to understand the human genome and growing research activities in this region using companion diagnosis kits are also driving the market growth.

Further, the major countries studied are: The US, Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 3: COMPANION DIAGNOSTICS MARKET SHARE (%) BY REGION

Source: Secondary Research, Primary Research, Market Research Future Database and Analyst Review

Europe companion diagnostics market accounts for the second-largest market share due to the growing preference for personalized medicine and increasing collaboration among companies, and increasing product approval by major players coupled with the various government initiatives to promote companion diagnostics are some of the prominent factors driving the growth of the market of companion diagnostics. Furthermore, the Germany market of companion diagnostics held the largest market share in 2021, and the France market of companion diagnostics was the fastest growing market in the Europe region.

The rapid growth of the Asia-Pacific regional market is due to the increasing prevalence of infectious diseases, rising of proteomics & genomics, the growing number of cancer patients, cardiovascular and neurological diseases, and growing research funding and rising investments by pharmaceutical biotechnological companies. According to the Alzheimer's Association report, countries such as India have more than four million people with some form of dementia and Alzheimer's, the most common type of dementia. Moreover, China market of companion diagnostics held the largest market share, and the India market of companion diagnostics was the fastest growing market in the Asia-Pacific region.

Major market players are spending a lot of money on R&D to increase their product lines, which will help the market of companion diagnostics grow even more. Market participants are also taking a range of strategic initiatives to grow their worldwide footprint, including new product launches, contractual agreements, mergers and acquisitions, increased investments, and collaboration with other organizations. Competitors in the companion diagnostics industry must offer cost-effective items to expand and survive in an increasingly competitive and rising market environment.

In addition, Thermo Fisher Scientific, Inc. (US) specializes in various biotechnology products such as analytical instruments, laboratory supply chain programs and e-commerce, laboratory equipment, lab services, and specialty diagnostics. The company helps its customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to the market, and increase the productivity of the laboratory. In December 2021, the company received approval for Oncomine Dx Target Test as a companion diagnostic (CDx) by the FDA that aims to assist healthcare experts in identifying non-small cell lung cancer patients whose tumors carry epidermal growth factor receptor (EGFR).

Hoffmann-La Roche Ltd (Switzerland) is one of the leading companies in the field of diagnostics and pharmaceuticals. The company develops and markets products for diagnosis and treatment of anemia, cancer, anticoagulation therapy, cardiovascular diseases, diabetes, central nervous system, chlamydia, dermatology, gonorrhea, gout, hepatitis B and C, hemostasis disorders, HIV/AIDS, HPV, infectious diseases, and autoimmune diseases. In August 2020, the company announced the approval of FoundationOne liquid CDx by the FDA. The product is applicable for pan tumor liquid biopsy tests. This launch aims to strengthen the company’s companion diagnostics product portfolio.