Biosimilars Market – Insights
Biosimilar products are suspected to continue to have a significant impact on the pharmaceutical industry. Many regulatory bodies have established clinical guidelines to support the development of biosimilars, laying down the requirements for demonstrating comparable pharmacokinetics, pharmacodynamics, safety and efficacy from Phase I on to controlled, randomized Phase III trials.
Although biosimilars are not required to undergo intense clinical trials for their approval, the data demonstrating their similarity to an original biologic in terms of clinical efficacy and safety is required. The adoption of biosimilars varies from country to country, which is invariably linked to regulatory and market access issues. The biosimilars market is expected to witness significant growth, owing to expiry and termination of existing drugs and presence of rich pipeline of biosimilar products especially those in Phase III stage.
The global biosimilars market size was valued at US$ 5.0 billion in 2017, and is expected to witness a CAGR of 35.2% over the forecast period (2018 – 2026).
Global Biosimilars Market Share (%) Analysis, By Product Type, 2017
Source: Coherent Market Insights Analysis (2019)
Increasing number of biosimilar approvals is expected to drive the growth of biosimilars market
Increase in number of approved biosimilars due to greater clarity in the U.S. Food and Drug Administration (FDA) review process other than manufacturing and development process are expected to drive biosimilars market growth. For instance, in July 2018, the U.S. FDA introduced a Biosimilars Action Plan to encourage the development of biosimilars. This approval process encourages applicants to resolve patent disputes before launch of biosimilars.
Moreover, the number of filed biosimilars applications has increased as manufacturers have become more comfortable with the complex regulatory and litigation schemes associated with filing a biosimilar application. For instance, since 2015, the U.S. FDA has approved 16 biosimilars and the number is expected to increase over the forecast period. Several other government agencies are also following similar trends for product approvals. For instance, in November 2017, Samsung Bioepis received two approval for its adalimumab biosimilar, Hadlima (SB5) and for its trastuzumab biosimilar, Samfenet (SB3), from the Korean Ministry of Food and Drug Safety (South Korea).
Biosimilars Market – Restraints
Stringent regulatory guidelines for development and manufacturing of biosimilars in the U.S. is expected to restrain growth of the global biosimilars market. For instance, the U.S. FDA rejected four biosimilar applications during 2018. In April 2018, the U.S. FDA rejected Pfizer’s candidate trastuzumab biosimilar and Sandoz’s candidate rituximab biosimilar in May 2018.
Moreover, several manufacturing challenges for biosimilars that primarily arise due to biologics being far more structurally complex and more difficult to characterize, produce, and reproduce than most small-molecule drugs are also expected to restrain the market growth. A small variations in the manufacturing process can potentially alter the medicine’s safety and efficacy.
Biosimilars Market - Regional Insights
On the basis of region, the global biosimilars market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. Europe is expected to be the most lucrative market for biosimilars over the forecast period. Increasing focus of regulatory bodies in development of novel biosimilars is expected to drive growth of the market in Europe. For instance, in July 2016, the European Medicines Agency (EMA) authorized the introduction and marketing of Thorinane and Inhixa, biosimilars of the Low Molecular Weight Heparin (LMWH), enoxaparin.
Asia Pacific biosimilars market size is expected to foresee a rapid growth, owing to significantly increasing number of biosimilar approvals. For instance, in 2017, Celltrion received approval from China Food and Drug Administration (CFDA) to start clinical trials for its infliximab biosimilar, Remsima (CT-P13), in China. This makes Celltrion the first foreign company to initiate clinical trials of an antibody biosimilar in China.
Global Biosimilars Market Value (US$ Bn) & Y-o-Y Growth (%), 2016-2026
Source: Coherent Market Insights Analysis (2019)
Biosimilars Market - Competitive Landscape
Key players operating in the global biosimilars market include, Novartis AG, Pfizer, Inc., Teva Pharmaceutical Industries Ltd., Celltrion Healthcare Co., Ltd., Biocon Limited, Amgen, Inc., Dr. Reddy's Laboratories, and Sanofi S.A.
Biosimilars are biopharmaceutical drugs that have active components and are similar to the drugs, which have been previously licensed. They are identical copies of the original product and can be manufactured only when the patent for the original innovator product expires. Biosimilars are majorly used in therapeutic applications for the treatment of various types of cancer and non-communicable diseases (asthma and arthritis).
Increasing prevalence of cancer is expected to boost growth of the biosimilars market. For instance, according to National Institute of Cancer Prevention and Research (NICPR), in 2018, 1,62,468 new cases and 87,090 deaths were reported due to breast cancer in India. Biosimilars are designed to be highly similar to originator biologic products, which represents an opportunity to increase access and reduce costs for patients and healthcare systems.
Increasing number of biosimilar approvals in clinical management of various diseases such as diabetes and hormonal imbalance is expected to drive growth of the biosimilars market. According to the Generics and Biosimilars Initiative (GABI) 2017 report, around 40 different biosimilars were approved in Europe, covering several different therapeutic classes: granulocyte colony-stimulating factors, and erythropoiesis-stimulating agents (ESAs), among others.
Moreover, increasing research and development in biosimilars, robust biosimilar pipeline portfolio, and support from healthcare regulatory bodies in fast lining biosimilar approvals are some of the major factors that are expected to drive growth of the market. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both provide guidance for the development of biosimilar drugs. However, stringent regulatory guidelines for development and manufacturing of biosimilars and fragile process of biosimilars production are expected to negatively impact growth of the global biosimilars market.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.
Table of Contents
*Browse 27 market data tables and 21 figures on "Biosimilars Market” - Global forecast to 2026”
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:
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.
Coherent Market Insights desk research is based on a principle set of research techniques:
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:
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.
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:
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.
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:
The primary research is conducted with the ecosystem players including, but not limited to:
Finding it difficult to find the research that would cater to your business demands? Give us a chance to help you. One of our Research Consultants will connect to provide a customized solution.
Talk to our research consultant to design an exclusive report as per your research needs.
We aim to fulfil client's research demands with tailored research solutions.
We aim to provide research studies in quickest turnaround time and in a much cost effective manner.
We cover each industry from supply and demand side with an aim to provide a most holistic research study.
We strive to provide most accurate and reliable research findings in our research reports.