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  4. > Growth Drivers for Biomarkers in Healthcare : Managing Success in the Biomarker Industry - Challenges and Opportunities

Key Findings

•The global biomarkers market was estimated at $ x billion in 2014 and is expected to reach $ x billion in 2020, growing at a robust CAGR of x % (2014–2020).
•North America is the highest revenue-generating region with $ x billion revenue in 2014, accounting for x % of the total global biomarkers market.
•Genomics is the highest revenue-generating segment with a revenue of $ x billion in 2014, accounting for x % of the total global biomarkers market. The segment is expected to grow at a CAGR of x % (2014–2020).
•The Asia-Pacific region will experience the highest growth rate in the forecast period, outpacing other regions, with a CAGR of x % (2014–2020).
•Currently, the adoption of genomics- and proteomics-based biomarkers is the highest, with a number of novel lipidomics and immunomics markers coming to the fore.
•Developments in the ‘omics’ platforms, such as glycomics, lipidomics, and immunomics, are paving way for the discovery of potentially useful biomarkers that can be used for early diagnosis, prognosis, and drug development.
•Complex diseases with unmet needs are the major areas for biomarker development. Traumatic brain injury (TBI), cardiovascular diseases (CVDs), and autoimmune diseases are some of the areas witnessing quality R&D* of novel biomarker-based tests.
•With the advent of personalised medicine and more patient-based care, there has been an increased activity in the partnerships between pharmaceutical companies and in-vitro diagnostic (IVD) companies.
•A majority of genetic tests are yet to be recognised by the reimbursement system. Once the value of biomarker assays is established, the reimbursement policies linked to them are likely to change.
•Oncology is an area with the highest number of initiatives and funding for biomarker research—a key opportunity for companies and organisations working in this space.
•Quick translation of biomarker-based diagnostics is being made possible with biomarker qualification strategies and the establishment of biomarker validation companies that focus on cancer and CVD biomarkers.

Biomarker in R&D
A majority of pharmaceutical companies are hesitant in using biomarkers in R&D, mainly due to the belief that it could narrow down the commercial aspect of a drug.
Biomarkers will become an integral part of R&D processes. Pharmaceutical companies have started realising the importance of personalised medicine in serving even small addressable segments with commercial benefits.

Patient treatment and diagnostic model
It is ‘one-drug-one-diagnostic’ model.
It will move towards ‘one-patient-multibiomarker-and-multifactorial’ diagnostic model. This will provide a holistic approach to patients and physicians in choosing optimal treatment options.

‘Omics’ technologies
Analysis of nucleic acids using biomarkers is the most developed clinical application. Oncology applications and genomic analysis are the most common among them.
Genomics is expected to dominate. As Genomics technologies become more common, prices of genomic biomarkers and whole-gene sequencing are expected to fall. However, other ‘omics’ technologies in drug discovery, such as transcriptomics, epigenomics, proteomics, metabolomics, and lipidomics, are expected to grow.

New Market Opportunities

Standardisation of validation protocols for biomarkers is not well established; biomarkers often face commercial and regulatory problems.
Collecting adequate samples for data analysis can be achieved by:
•Companies need to start sharing data and information to validate biomarkers extensively.
•Sample integrity by clinical development companies will ensure high quality of sample.
•Application of advanced technologies such as Big Data can be instrumental in better understanding and validation of biomarkers.

Strategies for the use of biomarkers in clinical trials are unclear.
•Deciding the use and role of a potential biomarker at an early stage of clinical trial can impact the success of a biomarker.
•Adaptive trial design and Bayesian statistical approaches with computational modelling and simulation using biomarkers will help in getting efficient and timely clinical trial results.

There is a need for a collaborative model that will enable companies to self-finance the demonstration of clinical utility and bring products to market on time.
•Collaboration with pharmaceutical companies will help diagnostic companies in the linkage between companion tests and specific drugs, which may facilitate regulatory approval and uptake in clinical settings.
•Incorporation of single biomarkers into simple molecular and non-molecular tests; the use of existing technology platforms by well-established diagnostic companies may enable the provision of low-cost tests.

Key Innovations and Companies to Watch

Google: Launched a massive scientific study to detect illness biomarkers
•The company has started a huge project to establish the genetic and molecular profile of a perfectly healthy human body.
•The project will help researchers and physicians to detect specific biomarkers buried in the information and use these biomarkers to detect diseases at a very early stage.
•Google aims to use its computational power to find these biomarkers.

Qiagen: Launched a cancer biomarker analysis project with Eli Lilly
•Qiagen and Lilly have entered into a contract to co-develop companion diagnostics that can handle simultaneous analysis of DNA and RNA biomarkers for various types of cancer.
•Qiagen will leverage its FDA-approved proprietary technology known as Modaplex analysis platform. The platform is capable of handling multiple samples and biomarkers in a single test.
•Eli Lilly’s aim is to broaden its personalised healthcare portfolio.

Biocartis: Launched its flagship molecular diagnostics platform Idylla
•Idylla is a fully automated, real-time PCR-based molecular system.
•It is capable of rapidly detecting biomarkers in cancer samples with a high sensitivity when compared to other standard diagnostic assays and sequencing.
•The company is working on developing specialised assays that will allow clinicians to detect more that 30 biomarkers per sample.

Quanterix: Announced the Simoa Accelerator launch
•Quaterix announced the launch of Simoa Accelerator in December 2014.
•It is an innovation centre for biomarker research and custom assay development.
•Simoa Accelerator will help scientists and clinicians to explore biomarkers with greater precision and sensitivity.
•This will help in the development of improved diagnostic tests and management of diseases such as cancer and neurological disorders.

Protagen AG: Developed its proprietary platform, SeroTag
•Protagen AG has developed its innovative proprietary platform, SeroTag, which can be used for biomarker discovery.
•This helps in the identification of autoantibody signatures in blood, which will help in the development of IVD, patient stratification, and therapy selection.
•Protagen has signed agreements with Qiagen to develop novel protein-based companion diagnostics for autoimmune therapies.

Indivumed GmbH: Developed a unique protein biomarker discovery strategy
•Indivumed GmbH has developed a unique strategy for protein biomarker discovery.
•It is a combination of cellular specificity and selectivity of laser-capture microdissection (LCM) and the sensitivity of liquid chromatography coupled with mass spectrometry (LC-MALDI MS).
•Indivumed holds an advantage in terms of availability of a highly characterised bio-bank that offers the possibility of selecting tissues for biomarker discovery.

BioSystems: Is developing an innovative series of antibody microarrays
•BioSystems is involved in protein biomarker R&D as well as biomarker discovery through an innovative process called Monoclonal Antibody Proteomics.
•The company is developing an innovative series of antibody microarrays, PlasmaScan and QuantiPlasma, in collaboration with Arrayit Corporation and Randox Laboratories.
•These microarrays will serve as powerful discovery tools for blood-based diagnostics by facilitating the discovery of blood-based biomarkers.

Thermo Fisher Scientific: Launched Thermo Scientific Dionex GlycanPac AXH-1 HPLC
•Glycans are being researched as potential biomarkers. In February 2013, Thermo Fisher Scientific introduced the Thermo Scientific Dionex GlycanPac AXH-1 HPLC column for the separation of glycans based on charge, size, and polarity.
•The new workflow in metabolomics research can enhance glycan analysis.
•The company renewed its long-term, royalty-bearing agreement with Roche for improved detection of sepsis using a Procalcitonin (PCT) biomarker.

Roche: Is developing a Lampalizumab biomarker for geographic atrophy (GA)
•Roche is developing a Lampalizumab biomarker for geographic atrophy (GA), an advanced form of dry age-related macular degeneration. It is in phase II clinical trial stage.
•The company is also developing a prognostic marker for Alzheimer’s, and a biomarker is under evaluation for Schizophrenia.
•In July 2013, Roche renewed its partnership with Thermo Fisher Scientific for improved detection of sepsis using a PCT biomarker.

Table Of Contents

Growth Drivers for Biomarkers in Healthcare : Managing Success in the Biomarker Industry - Challenges and Opportunities
Executive Summary 3
Market Overview 14
Total Biomarkers Market -
• Drivers and Restraints 25
• Forecast and Trends 33
Biomarkers Industry Trends and Recent Developments 41
Conclusions and Recommendations 53
Appendix 59
• List of Exhibits 63
The Frost and Sullivan Story 66

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