Biosimilars Market - Global Industry Insights, Trends, Outlook, and Opportunity Analysis, 2017–2025

Biosimilars are biological medical products which are the identical copies of the original products. Biosimilars are also termed as subsequent entry biologic or follow-on biologic. Biosimilars are expected to possess active properties, similar to that of officially approved original product at present. Biosimilars can be manufactured only when the patent for the original innovator product expires. Biologics or biosimilars are sensitive to changes in manufacturing process due to the higher molecular complexity. In 2010, The Food and Drug Administration (FDA) has gained the authority to approve biosimilars as a part of Patient Protection and Affordable Care Act. The approval process is based on thorough demonstration of similarity and comparability with the existing approved product. Biosimilars are generally derived from living cells of plants, animals, yeast, bacteria and viruses, through genetic engineering processes including controlled gene expression and recombinant DNA technology.

Patent expiry of blockbuster drugs and increasing government initiatives for biosimilars promotion drives the growth of biosimilars market

The key factors driving the growth of biosimilars market are the increasing demand due to their cost-effectiveness, rising geriatric population, growing pressure to curtail healthcare expenditure, increasing government support and initiatives to develop and promote biosimilars, strategic collaborations to enhance productivity and clinical trial activities for biosimilars. According to the American Health and Drug Benefits in 2013, the average biosimilars sale was more than U.S. $1 billion annually. For instance the global sales was projected to be around U.S. $7.19 billion for Remicade (infliximab) and U.S. $5.98 billion for Avastin (bevacizumab), leading to the higher approval by the doctors and patients of biosimilars globally. Also, the early phase of biosimilars market, easy entry, high growth opportunity, agreement for improved reimbursements with insurance companies are further driving the biosimilars market. The expiry and termination of numerous blockbuster pharmaceuticals drugs like Humira, Enbrel and Remicade in the next 5 to 10 years is the primary driver providing significant opportunity for new players to enter the market.

Diabetes medicine and oncology segments are expected to attain faster growth during the forecast period

The global biosimilars market is segmented on the basis of product type, manufacturing type, application, end user and geography.

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

  • Monoclonal Antibodies
  • Recombinant Hormones
  • Anti-Inflammatory Agents
  • Recombinant Growth Stimulators
  • Immunomodulators

On the basis of by manufacturing type, the global biosimilars market is segmented into:

  • In-house Manufacturing
  • Contract Manufacturing Organizations

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

  • Chronic & Autoimmune Diseases
  • Oncology
  • Blood Disorders
  • Growth Hormone Deficiency Diseases
  • Infectious Diseases
  • Others

Cost effective potential of biosimilars is the primary factor expected to boost the biosimilars market in Asia Pacific

Regional segmentation of the biosimilars market by Coherent Market Insights comprises North America, Europe, Asia-Pacific, Latin America and Middle East and Africa.  The first FDA approval biosimilar in 2015, Sandoz’s Zarxio has marked a promising hit of the biosimilars market across North America. According to the American Society of Health-System Pharmacists survey in 2013, about 99% of 214 surveyed pharmacy directors reported at least one oncologic drug shortage with the consequences of adopting the distribution of biosimilars to meet the rising demands.  Also, the demand for biosimilars is expected to gather momentum in North America owing to the rising prevalence of cancers, autoimmune diseases, kidney failures and growth hormone deficiency and increasing approval rates by FDA. The treatment for various diseases including diabetes, rheumatoid arthritis and types of cancers are anticipated to become affordable in developing countries like China and India, thus providing opportunities for major players in the Asia Pacific biosimilar market to expand during the forecast period. Additionally, the Asia-Pacific market is expected to witness higher growth owing to economic biopharmaceuticals or the low- cost of biosimilars, high adoption rate and consistent guidelines issued by the regulatory authority.

The increase in product extensions integrated with technological innovations is expected to intensify the competitive environment within manufacturers

Key players operating in the biosimilars market include Sandoz International GmbH, Apotex, Biocon, Zydus Cadila Healthcare, Celltrion and Pfizer. The leading manufacturers are focusing on outsourcing the production of biosimilar products with strategic collaborations to replace the existing expensive drugs. For instance, in August 2016, the FDA approval by Sandoz for the biosimilar Erelzi, used for treating multiple inflammatory diseases such as rheumatoid arthritis, plaque psoriasis, ankylosing spondylitis and juvenile idiopathic arthritis. The other prominent vendors include Hexal, Accord Healthcare, Harvest Moon Pharmaceuticals, Eli Lilly and Teva Pharmaceuticals.

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.

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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.
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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

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