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Phase-Xs | Biologics & Biosimilars | Coherent Market Insights

Diabetes is a group of metabolic disease characterized by high blood sugar level due to inadequate secretion of insulin. Common symptoms of diabetes include increased hunger, tiredness, weight loss, and excessive thirst and urination. The prevalence of diabetes is increasing, in turn, boosting demand for insulin biosimilar. For instance, according the World Health Organization (WHO) report in 2014, globally around 422 million adults were living with diabetes and 1.5 million people died due to the disease in 2012. Insulin biosimilar has the ability to increase access to treatment of diabetes mellitus among the patients while reducing treatment costs.

Biosimilar is a medicine developed on the original biological reference product. The production process of biopharmaceuticals vary from one manufacturer to another, thus every biosimilar product is unique from the other. Biosimilar manufactures use different culture conditions, master cell lines, purification techniques, and raw materials. This in turn, helps meet the rising prevalence of diabetes due to inadequate healthcare services, rising prevalence of obesity, For instance, According to 2013 American Society For Metabolic And Bariatric Surgery report, obesity was a major independent risk factor for developing the disease, and more than 90% of type 2 diabetics population are overweight or obese due to growing adoption of unhealthy lifestyle. Insulin is distributed and manufactured by small number of multinational companies in emerging economies, beyond the established biosimilar manufactures, and a handful of small players are developing insulin manufacturing capacities based on modern biotechnological methods in turn, boosting growth of the insulin biosimilars market size.

Insulin Biosimilars Market – Dynamics

Increasing number of manufacturers are developing biosimilar insulin to provide clinical aid that are similar to current insulin analogs at the more affordable price. Moreover, the patents of several insulin manufacturing companies are soon expected to lose patent protection, For instance, LEVEMIR an Insulin detemir by Novo Nordisk is going to lose its patent rights in year 2019, which is influencing numerous pharmaceutical key manufacturers to develop alternatives to patents, referred as biosimilar. The low cost of biosimilar insulin for diabetes treatment and effectiveness is helping treat patients suffering from diabetes mellitus. Companies are also focusing on developing medical devices that allows for less painful and safe delivery of the biosimilar insulin treatment, which in turn, is boosting market growth. Government agencies are focusing on the endorsement of insulin biosimilar by funding research and development. Furthermore, rising geriatric population across the globe and increasing demand for rapid-acting insulin analogues is boosting growth of the insulin biosimilar market. For instance, according to a consensus report published in 2012 American Diabetes Association, showed over 25% of the U.S. population aged ≥65 years suffered from diabetes.

However, critical regulatory requirements for approval of insulin biosimilar products besides strong opposition from branded manufactures regarding patent rights, high cost of production, manufacturing complexities, and various safety concerns associated with changes in drug formulations pose as factors hampering growth of the insulin biosimilars market.

Insulin Biosimilars Market – Regional Insights

On the basis of region, the global insulin biosimilars market is segmented into North America, Europe, Latin America, Asia Pacific, Middle East, and Africa. North America leads the global insulin biosimilar market, owing to rising geriatric population and high prevalence of diabetes-related disorders in the region. Moreover, government support for diabetes-free states is accelerating growth of the insulin biosimilar market in North America. For instance, Centers for Disease Control and Prevention (CDC) runs a National Diabetes Prevention Program in various U.S states.

The market in Europe accounts for the second-leading share in the global market, mainly due to increasing number of primary approvals for biosimilar insulin. For example, European Commission (EC) approved Mylan and Biocon’s biosimilar insulin—Glargine—for treating diabetes on March 27, 2018. Asia Pacific market is expected to gain significant traction over the forecast period due to increasing government support, improving healthcare conditions and growing diabetes incidence in the region. For instance, 2011 World Health Organization report shows that diabetes deaths will double between 20011 and 2030. 

Insulin Biosimilars Market – Competitive Insights

The key players operating in the global insulin biosimilars market includes Boehringer Ingelheim, Pfizer Inc., Biocon, Merck & Co., Mylan N.V., Eli Lilly & Co., Wockhardt Limited, NOVO Nordisk A/S, Sanofi S.A., Ypsomed AG and others Key players are engaged in developing new technologies and collaborations in order to retain dominant position in the market. For instance on 2018 Sandoz, a Norartis division and Asia’s premier biopharmaceutical company, Biocon announced exclusive global collaboration for next generation biosimilars.

Insulin Biosimilars Market - Taxonomy

On the basis of biosimilar type, the global insulin biosimilars market is segmented into:

  • Rapid Acting Biosimilars
  • Long Acting Biosimilars
  • Premixed Biosimilars

On the basis of disease indication type, the global insulin biosimilars market is segmented into:

  • Type 1 Diabetes
  • Type 2 Diabetes

On the basis of geography, the global insulin biosimilars market is segmented into:

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East
  • Africa

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.

Data Triangulation Methodology | Coherent Market Insights

Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

Market Analysis | Coherent Market Insights

Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users