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Companion Diagnostics Market (2nd Edition), 2014-2024

  • June 2014
  • 233 pages
  • Roots Analysis Private Ltd.
Report ID: 2160163


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With an influx of new technologies and increasing awareness about personalized medicine, the pharmaceutical industry has steadily started to adopt a more customized drug development model. The concept of companion diagnostics holds huge potential for pharma companies as well as medical community. This new approach to medication is expected to transform healthcare by improving treatment outcomes, eliminating adverse reactions and reducing cost and time barriers associated with the conventional methods of medication.

In fact, targeted drugs have been fast to overshadow traditional drugs, which favour the concept of one-size-fits-all. Several targeted drugs are being developed in association with a companion diagnostic test and have reached blockbuster status despite targeting a limited audience. Both large and small biopharmaceutical companies are now actively developing drug-diagnostic combination products. The success of Herceptin and Glivec has proved that the benefits of use of companion diagnostics far outweigh the challenge of a limited target population. There are ample opportunities for growth in this niche market for both pharmaceutical and diagnostic companies.

The journey of a biomarker to a companion diagnostic is a long one, with the regulatory authorities favouring the co-development and approval of companion drug and diagnostic. Although complex, the pipeline for companion diagnostics is rich. In the future, the launch and success of drugs will also be governed by the successful development of a commercial companion diagnostic test. The 2014-2024 period is likely to see launch of many new companion diagnostics, transforming the promise into reality.


The ‘Companion Diagnostics Market, 2014-2024’ report provides an extensive study of the growing market of companion diagnostics. The report differentiates personalized medicine diagnostics and companion diagnostics; we have separately defined these two closely associated markets. The research covers various aspects, such as, advantages of personalized medicine over traditional medicine and the need for companion diagnostics. In addition to evaluating the marketed and pipeline companion diagnostic tests, we have also provided our views on the current state of the companion drugs market.

One of the key objectives of this report is to understand the future evolution of the companion diagnostics market. Our proprietary ‘Companion Diagnostics Market Forecasting Model’ allows us to predict the likely growth of companion diagnostics tests across various parameters. The model, built over a ten year horizon, offers valuable insights on the following:
- Global market evolution, both in terms of volume (number of tests) and the associated sales value (USD billion)
- Regional variation, specifically in the US and European (Germany, Italy, France, Spain and the UK) markets
- Likely adoption of marketed / pipeline tests for specific biomarkers (e.g. EGFR, KRAS, ALK, HER2 and BRAF) till 2024
- Likely adoption of various marketed / pipeline tests for specific indications (e.g. metastatic non-small cell lung cancer, metastatic colorectal cancer, breast cancer and melanoma) till 2024

We have discussed, in detail, the key drivers behind the regional and global growth. The regional evaluation extends to other markets such as Japan, China and Australia. This provides a greater clarity in the differing approaches various regions have towards personalized medicine and companion diagnostics.

The research, analysis and insights presented in this report include the sales of all companion diagnostic tests that are essential before prescription of any companion drug. All actual figures have been sourced and analyzed from publicly available information. The figures mentioned in this report are in USD, unless otherwise specified.


1. The global companion diagnostics market is likely to grow at an annualized rate of 22.9% over the next ten years; by 2024, over 10 million tests are expected to be conducted annually across various indications.
2. In 2013, 18.5% of the new molecular entities (NMEs) were approved with a pharmacogenomic biomarker by the FDA.
3. The sales of marketed companion drugs generated estimated revenues of more than USD 26 billion in 2013, with six drugs achieving blockbuster status.
4. The pipeline for companion diagnostics is rich with most products being developed with the collaborative effort of pharmaceutical and diagnostics companies; we have identified over 75 drugs which are being co-developed with predictive biomarkers.
5. Partnership seems to be the most preferred model for development; since January 2011, there have been more than 90 collaborations between pharmaceutical and diagnostic companies.
6. Pharmaceutical companies have displayed keen interest in companion diagnostic start-ups such as Epic Sciences and Nodality. Specifically, Epic Sciences has inked deals with at least six pharmaceutical companies (including Genentech, Celgene and Pfizer) for development of companion diagnostics for cancer drugs.


Most of the data presented in this report has been gathered by secondary research. We have also conducted interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will shape up across different regions and drug segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Other analysts’ opinion reports

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.


Chapter 2 provides an executive summary of the insights captured in our research. The summary offers a high level view on the likely evolution of companion diagnostics market.

Chapter 3 provides a general introduction on personalized medicine. We have also explained, in detail, companion diagnostics and their development from pharmacogenomics biomarkers.

Chapter 4 analyzes the global companion drugs market, including the FDA and EMA approved companion drugs. The chapter provides details on leading companion drugs and indications. It also highlights leading pharmaceutical companies active in this market, along with case studies of some well-known companion drugs.

Chapter 5 analyzes the global companion diagnostics market, identifying the currently marketed diagnostics and those in the pipeline. In this chapter, we have included our estimates on how the overall market is going to evolve globally over the next ten years. We adopted a bottom-up approach to forecast details on the number of tests and associated sales value for different biomarker and indication combinations.

Chapter 6 provides a detailed analysis on the regional market for companion diagnostics. The major markets covered include the US and Europe (Germany, France, Italy, Spain and the UK). We have also included details on companion diagnostic testing in Japan, China and Australia. The chapter highlights policies that govern the approval and reimbursement of in vitro diagnostics (in particular companion diagnostics) and investments made in the field of personalized medicine. In addition, we have identified the companion diagnostics approved in these countries, including the historical data on number of tests conducted in some of the regions. For the US and EU5 markets, we have provided our regional market forecast over the next ten years, both in terms of volume and value (by type of biomarker and by type of indication).

Chapter 7 includes profiles of the key companies in the companion diagnostics market. Each company profile includes information such as financial performance, geographical presence, marketed / pipeline products (including companion drugs and diagnostics) and recent developments.

Chapter 8 analyzes the theranostics market as a whole with detailed discussion on the role of various stakeholders in the market. We have also covered the recent partnerships that have taken place in the theranostics market to develop drug-diagnostic combinations.

Chapter 9 focuses on the key drivers of companion diagnostics, expanding on the advantages they hold for the delivery of healthcare. We have included a discussion on the tools and technologies promoting their use. The chapter also provides a SWOT analysis capturing the key elements likely to influence future growth.

Chapter 10 is a collection of transcripts of interviews conducted during the course of this study.

Chapter 11 summarizes the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.

Chapters 12 and 13 are appendices. These provide tabulated data for all the figures provided in the report and a list of companies / organizations mentioned in the report.

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