For my occasional series of blogs examining various facets of the companion diagnostics market, I asked some of the major IVD manufacturers to share their thoughts and opinions on the current opportunities and challenges in companion diagnostics. The following is presented in a panel discussion format. The panel participants are Trevor Hawkins, Senior Vice President, Strategy, Innovation, and Business Development at Siemens Healthcare Diagnostics; George Maliekal, Senior Director, Business Development and Companion Diagnostics at Abbott Diagnostics; and Helene Peyro-Saint-Paul, Personalized Healthcare/Oncology Portfolio Team Lead at Qiagen GmbH.

What are the growth opportunities in companion diagnostics for IVD manufacturers?
Abbott: Personalized medicine is transforming the way medicine is practiced, and in recent years, the approach has emerged as a viable treatment approach for cancer. Currently, oncology is a major driver of personalized medicine. In 2013, cancer represented nearly 70% of the field of personalized medicine. The bedrock of personalized medicine is molecular diagnostics, and in fact, a reported 6,000 clinical studies are incorporating biomarkers, 40% of which are in oncology. Companion diagnostics tests are important tools to improving patient outcomes and helping doctors identify patients who are more likely to respond positively to treatments. By 2020, companion diagnostics are expected to account for 14% of the total global IVD market, more than four times its 3% share in 2010.

Qiagen: Personalized healthcare is a very dynamic market segment with significant opportunities for continuous and rapid growth. Spurred by the development of novel biomarkers, personalized treatment approaches continue to rapidly gain ground in oncology and are beginning to make inroads into other therapeutic areas, such as autoimmune disorders or diseases of the central nervous system. The sustained interest in personalized healthcare is also reflected in the number of new collaborations and contracts we were able to add to our pipeline in 2013, and the double-digit growth of corresponding product sales. Overall, we don’t expect the underlying market conditions to change anytime soon, and we view the personalized healthcare franchise as an important driver for our midterm growth.

Siemens: Pharmaceutical companies now recognize companion diagnostics as a necessity in the drug development process, particularly for hard-to-treat chronic diseases, such as cancer. The application of companion diagnostics in the drug development process has the potential to result in more targeted personalized medicine for patients, thus improving outcomes. Case-in-point, currently many oncology therapies have been reported to have a companion diagnostic component. The growing need of pharmaceuticals for companion diagnostics may result in the development of new biomarkers or even new applications for existing tests on the market. Also, I anticipate there will be clinical trial testing opportunities throughout the therapeutic development process and patient testing opportunities in the commercialization phases.

What business challenges do IVD manufacturers encounter in developing, marketing, and selling companion diagnostics?
Qiagen: The model for developing and validating companion diagnostics in collaboration with pharmaceutical companies is well established and works. The two areas in the business model that are still in flux, however, are regulations and reimbursement. One challenge is the highly diverse regulatory landscape in the U.S., Europe, and Asia. The coexistence of laboratory-developed tests with limited regulatory oversight also poses a challenge for marketing of approved companion diagnostics. The adoption of approved companion diagnostics can and should be supported by a value-based regulatory approach that differentiates between analytically validated, clinically validated, and officially approved companion diagnostics on one hand, and lab-developed tests on the other. This situation is reflected in discussions actively going on in the U.S., while things are a bit behind in Europe.

Siemens: To work effectively with pharmaceutical companies, IVD manufacturers must have companion diagnostics as a key element of their business strategies that drives organizational behaviors and structures. Generally, companion diagnostics development, marketing, and selling processes are different to the equivalent processes for pharmaceutical therapies. Also, both therapeutics and IVDs are highly regulated throughout the world. A major driver of these differences may be attributed to the variances in the regulatory environment needs for companion diagnostic tests compared to therapies. To address these challenges, IVD manufacturers must set expectations upfront and educate their pharmaceutical partners on the IVD test requirements for development and selling. This is a critical initial alignment activity, followed by coordination once a development plan is implemented.

Abbott: Personalized medicine is still a relatively new area for medicine, and the development of companion diagnostics is still in its infancy. As the climate continues to evolve with regards to personalized medicine, so does the opportunity for the adoption of companion diagnostics in clinical practice. The future success and widespread acceptance of personalized medicine approaches depend on an even closer collaboration between pharmaceutical and IVD companies when it comes to the adoption of these new technologies by physicians. One of the areas that will help with the ongoing adoption of personalized medicine in clinical practice is communication. A key factor in the use of these new tools is the ability to bring laboratorians and treating physicians together to understand both the availability and clinical usefulness of a new tool, especially one that requires a change in clinical practice. Historically, pharmaceutical companies have focused on communicating with the prescribing physicians, and IVD companies focused on their partnerships with laboratories and pathologists. As medical practice advances, we see opportunities for increased educational events, cosponsored by both pharmaceutical and IVD companies, to help the labs and physicians better understand innovations in personalized medicine.

What technology challenges do IVD manufacturers encounter in developing companion diagnostics?
Siemens: Clearly, IVD manufacturers need access to the appropriate technology platform to deliver the companion diagnostic for clinical trials and eventually patient testing. Biomarker companion diagnostic applications will drive technology choices, and it is likely pharmaceutical partners will also have their own preferences. The ideal technology must be reliable and reproducible for even initial clinical trial applications. In the event the therapy is commercialized, requiring the companion diagnostic for patient testing, the technology must meet regulatory requirements for global market access. Therefore, established technology platforms may be the preferred solution for companion diagnostic applications.

Qiagen: The main challenges in developing companion diagnostics relate to the access to high quality specimens with correlated clinical annotations, the decreasing volume of available tumor tissue, the need for increased assay sensitivity, and the rapid emergence of new biomarkers and new medical data. The scarcity of sample material poses a particular challenge in oncology, where pathologists and clinicians are more and more interested in early detection of cancer and treatment monitoring, for instance in lung and colorectal cancers. In addition, you also need to deal with intra-tumor and intercellular heterogeneity. This has a direct influence on the assay technology, which needs to be sensitive yet robust enough to produce meaningful results. Finally, our understanding of many mutations and their effect on clinical outcomes grows virtually every day, which has an effect on the design of a given companion diagnostic and its lifespan following market entry. Finally, an additional technology challenge for IVD manufacturers is to offer molecular laboratories a full range of instruments and technologies allowing each lab to implement the best technical options matching its workflow and reimbursement context.

How do IVD manufacturers overcome these technology challenges?
Qiagen: To overcome the challenges related to tissue access, we are engaging in the development and implementation of noninvasive liquid biopsies such as plasma or urine, and tapping into free circulating nucleic acids or exosomes, which potentially opens up the way for new IVD applications in cancer and other diseases. We believe the increase in the number of biomarkers and a better understanding of tumor biology will ultimately drive the personalized healthcare market toward a stronger use of sequencing technologies paired with advanced bioinformatics solutions able to process and interpret vast amounts of highly complex biological data.

Siemens: When an IVD manufacturer does not have the technology of choice, partnering with a third party or laboratory may be an option to realize the companion diagnostics opportunity.

What are the future business prospects in the companion diagnostics market?
Abbott: The landscape and behaviors that will allow personalized medicine to flourish are continuing to take shape, and they require both short and long-term vision. We believe companion diagnostics will increasingly change how IVD and pharmaceutical companies collaborate during discovery to develop tests in combination with the drugs they are used with, rather than separately. While we have a lot of work ahead of us, it is an exciting time to be in this field. Research investment, new models for collaboration, and evolving regulatory and policy approaches are allowing new technologies and potential treatment breakthroughs to emerge. By leveraging clinically validated companion diagnostics, personalized medicine can increase the percentage of patients who benefit from treatment, lower the rate of serious adverse events, and improve outcomes.

Qiagen: We see a strong underlying momentum in the market for personalized healthcare in oncology. Currently, we’re looking at multimodal or multiplex approaches both on tissue samples and liquid biopsies. We also see very interesting developments in the field of autoimmune diseases and neurology. Overall, we believe the personalized healthcare franchise will remain an important growth driver for our future growth.

Siemens: Today, the companion diagnostics market is relatively small but growing. With the recent widespread adoption of these tests by pharmaceutical companies, we believe companion diagnostics will be key to driving future clinical and market development of new-to-market biomarkers for widespread use and adoption in patient testing.