A biomarker is a biological gene or a molecule used to effectively examine the pathogenic procedures, pharmacological responses and biological procedures. The biomarker is either produced by a diseased organ such as a tumor or by the body in response to a disease. Biomarkers have immense scientific and clinical value in medicine. They are potentially useful across the entire spectrum of the disease process. Biomarkers can be used for risk assessment and screening before diagnosis. During diagnosis, they can determine staging and selection of the initial therapy. During treatment they can be used for monitoring therapy, selecting additional therapy if required or for monitoring recurrent diseases. With advancements in genomics, molecular pathology and proteomics, many candidate biomarkers have been generated over the years having potential clinical value.
Biomarkers play a crucial role in the drug development process. Due to the industry’s inability to predict failure of a drug in early stages of development, a lot of time and investment gets wasted when drugs fail at the latter stages of the development cycle. A biomarker can deliver information about the action of the drug, its safety and efficacy along with its metabolic profile. As biomarkers are capable of predicting drug efficacy much earlier than traditional clinical endpoints, they have accelerated the product development process for certain disease cases over the years. Moreover, as biomarkers can effectively identify such candidates which are likely to fail, they considerably reduce the drug development cost. Biomarkers have also proven valuable in increasing efficacy in cardiology. One such example is an inflammatory marker called C-reactive-protein (CRP). It is released by inflamed atherosclerotic plaques present in the arteries of a patient suffering from a coronary heart disease. Increase in levels of CRP is associated with a high risk of plaque rupturing, resulting in formation of a clot leading to a heart attack. Those biomarkers that are not related to specific disease are also significant, especially in the early stages of drug development. Target biomarkers or mechanistic biomarkers can be used in phase I trials to evaluate the pharmacological effect of the drug. Such biomarkers can effectively assess whether a drug interacts with its enzyme, protein target or receptor. They check whether the drug is distributed to the intended site where it needs to act. Such biomarkers can aid in critical decision making regarding drug development processes.
Some of the key factors driving the global biomarkers market are proven effectiveness of biomarkers in early identification of drug efficacy, increase in biomarkers’ diagnostic applications and technological advancements related to biomarker research. However, factors such as high initial capital investment involved in research and unfavorable reimbursement and regulatory policies can hamper the market growth to some extent.
The key players in the global biomarkers market focus on product development to develop new therapies or drugs in order to gain a competitive edge over other players. For instance, in May 2016, Roche obtained the FDA approval for the VENTANA PD-L1 (SP142) biomarker assay as a complementary diagnostic to determine PD-L1 status in patients suffering from metastatic urothelial cancer.
Some of the key players operating in the global biomarkers market are Roche Diagnostics Ltd., Agilent Technologies, Inc., Abbott, Johnson & Johnson Private Limited, GE Healthcare (owned by General Electric Company), Siemens Healthcare GmbH, Merck & Co., Inc. and Qiagen.
Biomarkers Market Segmentation
- Drug Development
- Personalized Medicine
- Other Applications
- Oncology Diseases
- Immunological Disease
- Neurological Disease
- Cardiovascular Disease
- Other Diseases
- Rest of Europe
- South Korea
- Rest of Asia-Pacific
- South Africa
- Saudi Arabia
- United Arab Emirates
We use both primary as well as secondary research for our market surveys, estimates and for developing forecast. Our research process commence by analyzing the problem which enable us to design the scope for our research study. Our research process is uniquely designed with enough flexibility to adjust according to changing nature of products and markets, while retaining core element to ensure reliability and accuracy in research findings. We understand both macro and micro-economic factors to evaluate and forecast different market segments.
Data is extensively collected through various secondary sources such as annual reports, investor presentations, SEC filings, and other corporate publications. We also refer trade magazines, technical journals, paid databases such as Factiva and Bloomberg, industry trade journals, scientific journals, and social media data to understand market dynamics and industry trends. Further, we also conduct primary research to understand market drivers, restraints, opportunities, challenges, and competitive scenario to build our analysis.
Data Collection Matrix
Data Collection Matrix
Primary Data Sources
- Distributors & Wholesalers
- Healthcare Providers
Secondary Data Sources
- Annual Reports/SEC Filings/ Investor Presentations/ Press Releases
- Government/Associations Publications
- Case Studies
- Reference Customers
Market Modeling and Forecasting
We use epidemiology and capital equipment-based models to forecast market size of different segments at country and regional level.
- Epidemiology-based Forecasting Model: This method uses epidemiology data gathered through various publications and from physicians to estimate population of patients, flow of treatment of individual disease and therapies. The data collected through this method includes statics on incidence of disease, population suffering from disease, and treatment population. This method is used to understand:
- Number of patients for particular device or medical procedure and
- Repeated use of particular device depending on health and condition of patient
- Capital-based Forecasting Model: This method of forecasting is based on number of replacements, installed-based and new sales of capital equipment used in various healthcare and diagnostic centers. These three parameters are calculated and forecast is developed. Installation base is calculated as average number of units per facility; while sales for particular year is calculated from number of new and replace units. Secondary data is collected through various supply chain intermediaries and opinion leaders to arrive at installation and sales rate. These techniques help our analysts in validating market and developed market estimates and forecast.
We do forecast on basis of several parameters such as market drivers, market opportunities, industry trends government regulations, raw materials supply and trade dynamics to ensure relevance of forecast with market scenario. With increasing need to granulized information, we used bottom-up methodology for forecasting where we evaluate each regional segment differently and combined all forecast to develop final market forecast.
We believe primary research is a very important tool in analyzing and forecasting different markets. In order to make sure accuracy of our findings, our team conducts primary interviews at every stage of research to gain deep insights into current business environment and future trends and key developments in market. This includes use of various methods such as telephonic interviews, focus groups, face to face interviews and questionnaires to validate our research from all aspects. We validate our data through primary research from key industry leaders such as CEO, product managers, marketing managers, suppliers, distributors, and consumers are frequently interviewed. These interviews provide valuable insights which help us to have better market understanding besides validating our estimates and forecast.
Quantitative Data (2017-2025)
- Market Dynamics (Drivers, Restraints, and Challenges)
- Industry Trend Analysis
- Market Opportunities
- Government Policies and Regulations, Patent Analysis, and Reimbursement Policies
- Porter’s Five Forces and PESTLE Analysis
- Key Developments and Competitive Landscape
- Market Assessment and Forecast
- Market Assessment and Forecast, By Product
- Market Assessment and Forecast, By Technology
- Market Assessment and Forecast, By Application
- Market Assessment and Forecast, By End User
- Market Assessment and Forecast, By Region/Country