Canada Biosimilar Monoclonal Antibodies Market Analysis

Canada Biosimilar Monoclonal Antibodies Market Analysis


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Canada Biosimilar Monoclonal Antibodies Market is projected to grow from $xx Mn in 2022 to $xx Mn by 2030, registering a CAGR of xx% during the forecast period of 2022 - 2030. Market drivers for biosimilar monoclonal antibodies include rising demand for low-cost biologics, the increasing frequency of chronic diseases, and the need for more economical biologic therapeutics. Among the key global pharmaceutical companies in the Biosimilar Monoclonal Antibodies Market are Samsung Bioepis Co., Celltrion Inc., Biocon Ltd., Pfizer Inc., Amgen Inc., Novartis AG (Sandoz), Mylan N.V., Boehringer Ingelheim International GmbH, Fresenius Kabi AG, and Teva Pharmaceutical Industries Ltd.

ID: IN10CAPH246 CATEGORY: Pharmaceuticals GEOGRAPHY: Canada AUTHOR: Dr. Medha Sansanwal

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Canada Biosimilar Monoclonal Antibodies Market Analysis Summary

Canada Biosimilar Monoclonal Antibodies Market is valued at around $559.4 Mn in 2022 and is projected to reach $2621.9 Mn by 2030, exhibiting a CAGR of 21.3% during the forecast period 2023-2030.

Biosimilar monoclonal antibodies (mAbs) are biological drugs that are highly similar to an approved reference mAb product. Biosimilars are developed to be comparable in terms of safety, efficacy, and quality to the reference product while offering potential cost savings and increased access to treatment options. Monoclonal antibodies are protein-based therapeutics that are designed to target specific antigens involved in various diseases, such as cancer, autoimmune disorders, and inflammatory conditions. They are produced by genetically engineered cells and are known for their high specificity and targeted mechanism of action. The development of biosimilar mAbs involves a complex and rigorous process. Regulatory authorities, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established specific guidelines for the approval of biosimilars. Market drivers for biosimilar monoclonal antibodies include rising demand for low-cost biologics, the increasing frequency of chronic diseases, and the need for more economical biologic therapeutics. Samsung Bioepis Co., Celltrion Inc., Biocon Ltd., Pfizer Inc., Amgen Inc., Novartis AG (Sandoz), Mylan N.V., Boehringer Ingelheim International GmbH, Fresenius Kabi AG and Teva Pharmaceutical Industries Ltd. Are among the key global pharmaceutical companies in Biosimilar Monoclonal Antibodies Market.

Market Dynamics

Market Growth Drivers

  1. Cost Reductions: When compared to their originator counterparts, biosimilar monoclonal antibodies offer potential cost savings, making them an appealing option for healthcare systems, payers, and patients
  2. Increasing Biologics Demand: The demand for biosimilar monoclonal antibodies is being driven by the increasing frequency of chronic diseases and the need for effective biologic therapeutics
  3. Strong Biologics Pipeline: The robust pipeline of originator monoclonal antibodies provides biosimilar producers with a significant chance to explore new therapeutic areas

Market Restraints

  1. Complex Manufacturing Process: The creation of biosimilar monoclonal antibodies entails complex manufacturing processes that can provide difficulties in terms of retaining similarity to the originator and guaranteeing consistent quality
  2. Regulatory Obstacles: The primary barriers to biosimilars entering the US market are regulatory exclusivity, regulatory similarity, and interchangeability criteria, and patent exclusivity periods. Even when the core biological molecule patent (primary patent) has expired, the presence of current secondary patents further delays the emergence of affordable biosimilar copies. Secondary patents covered new formulations, manufacturing processes, therapeutic applications of existing active compounds, and innovative combinations of known active components
  3. Patent disputes and intellectual property rights issues can create impediments for biosimilar makers, thereby delaying market access and competitiveness
  4. Physician and patient acceptance: Education and acceptance of biosimilar monoclonal antibodies among physicians and patients may be a barrier, as there may be questions about efficacy, safety, and interchangeability with the originator drugs

Competitive Landscape

Key Players

  • Samsung Bioepis Co.
  • Celltrion Inc.
  • Biocon Ltd.
  • Pfizer Inc.
  • Amgen Inc.
  • Novartis AG (Sandoz)
  • Mylan N.V.
  • Boehringer Ingelheim International GmbH
  • Fresenius Kabi AG
  • Teva Pharmaceutical Industries Ltd

1. Executive Summary
1.1 Disease Overview
1.2 Global Scenario
1.3 Country Overview
1.4 Healthcare Scenario in Country
1.5 Patient Journey
1.6 Health Insurance Coverage in Country
1.7 Active Pharmaceutical Ingredient (API)
1.8 Recent Developments in the Country

2. Market Size and Forecasting
2.1 Epidemiology of Disease
2.2 Market Size (With Excel & Methodology)
2.3 Market Segmentation (Check all Segments in Segmentation Section)

3. Market Dynamics
3.1 Market Drivers
3.2 Market Restraints

4. Competitive Landscape
4.1 Major Market Share

4.2 Key Company Profile (Check all Companies in the Summary Section)

4.2.1 Company
4.2.1.1 Overview
4.2.1.2 Product Applications and Services
4.2.1.3 Recent Developments
4.2.1.4 Partnerships Ecosystem
4.2.1.5 Financials (Based on Availability)

5. Reimbursement Scenario
5.1 Reimbursement Regulation
5.2 Reimbursement Process for Diagnosis
5.3 Reimbursement Process for Treatment

6. Methodology and Scope

Canada Biosimilar Monoclonal Antibodies Market Segmentation

By Indication

  • Oncology
  • Autoimmune Diseases
  • Inflammatory Disorders
  • Others

By Distribution Channel

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
  • Specialized Clinics or Treatment Centres

By End-User

  • Hospitals
  • Clinics
  • Ambulatory Surgical Centres
  • Research Institutions

Insights10 will provide you with the reports within 10 key parameters which are:

  1. Market Overview
  2. Market Growth Drivers & Restraints
  3. Epidemiology of Disease Type
  4. Market Segmentation
  5. Market Share
  6. Competitive Landscape
  7. Key Company Profiles
  8. Healthcare Policies & Regulatory Framework
  9. Reimbursement Scenario
  10. Factors Driving Future Growth

Based on our many years of experience, we believe that these are the parameters that are critical to decision-making for business stakeholders. Our focused approach to developing reports focused on 10 key parameters, enabled us to arrive at the name “Insights10”.

 

Stage I: Market Data Collection

Primary Interviews: We have developed a network of experts, freelancers, and researchers across countries through which we engage with local experts to gather key data points and assumptions about each market. We also engage regularly with some of the best market research agencies such as Atheneum, GuidePoint, GLG, etc. to conduct surveys and interviews, and build intelligence. We have language translators as a part of our team, who between them can cover 30+ languages allowing us to extract better local insights.

Secondary Data Collection: We have developed strong expertise and experience in secondary data collection methods for developing unique data sets and research material. We gather data from multiple reliable sources to maintain a high level of accuracy and consistency. The market data is analyzed and forecasted using appropriate statistical and coherent models. The report offers an overall analysis of the market size, growth, and market share as well as a segment-level analysis of the specific market. Our report includes precise, to-the-point information related to the overall market, competition, growth drivers, challenges, regulatory updates, and competition.

Data Sources: We have access to multiple highly reliable free and subscription data sources. We have many years of experience to understand which sources are more dependable for what and which to prefer for the reliable and latest information. The key sources of information include the following, but are not limited to:

 

 

Stage II: Market Data Analysis and Statistical Model

Market Trends: We generally look at macro parameters and micro indicators. The macro parameters include changes in government policies, demand and supply of the market, government intervention programs, and major market share. The micro indicators are GDP growth, market size, market volume, etc. We also understand nuances specific to each country like the US, Canada, India, Germany, etc., and have worked across 60+ countries and hence not only understand global trends but how these differ by country, how payment models, market structure, cultural parameters, etc. differ in each country.

Market Sizing and Analysis: Our expert data analytics team has created various market forecast models by employing the top-down approach i.e. starting with the large overall market and segmenting different areas and the bottom-up approach i.e. starting with population and epidemiology and rolling up based on spend, etc., estimating the size of the market, and distributing among the geographic and/or product segments.

The top-down approach is mainly used for new product forecasting and the bottom-up approach is used for demand estimation of any product for different countries summed up to form the total market. We are able to round off insights and build stronger forecasts because we always do both these methods and triangulate the final numbers.

The study on the market covers the analysis of the leading geographies such as Asia-Pacific, Africa, Europe, Middle East, North America, and  Latin America for the period of 2022 to 2030. The qualitative analysis covers the industry landscape and trends, market opportunities, competitive landscape, and policy and regulatory scenario, and the quantitative analysis covers different market estimates and forecasts.

Data Triangulation & Validation:

Data triangulation of various sources and results of the research are carried out by benchmarking with reliable sources such as industry statistics, statistical databases, and company-level averages, etc.

We make sure to finalize the numbers in alignment with the market research. Firstly, our internal experts ensure thorough validation and checking to ensure accurate and precise analysis and then validation is also done using a multiple-data analysis model. Two-level validation is done and entails the finalization of the report scope and the way of representation pattern.

 

 

Stage III: Interpretation and Presentation

Analysis & Interpretation: The information gathered is then analyzed and synthesized. The second series of interviews are done if necessary to check and validate. The future opportunities are analyzed by understanding product commercialization and many other factors. It also comprises the analysis of data discrepancies observed across various data sources. Information procured from secondary and primary results is then, interpreted by considering the following parameters: (a partial list)

  • Establishing market drivers and trends
  • Analyzing the regulatory landscape to understand future growth
  • Market Segment based analysis to obtain revenue/volume
  • ​Analyzing current needs and determining penetration to estimate the market

Insights: Our reports deliver actionable insights backed with supporting facts and figures to assist you in achieving exemplary growth. Our in-depth analyses are interspersed with relevant insights and statistics to offer an executive-level view of a given market. The description helps in correlating many minor factors affecting the market and their impact on the different segments within the market.

Data curated from the analysis and interpretation are drawn to portray all in one consolidated report.

Presentation & Reporting: The market research report is presented in different forms such as charts by using a scientific approach for easy understanding. Historic, current, and future analysis is provided for each market in terms of both value and volume. The size of the market is interpreted in the US Dollar value and the respective unit, based on the product, for volume consumption.

The foreign exchange rates are calculated on the respective dates and for the respective regions covered in the study.

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This report addresses

  • Intelligent insights to take informed business decisions
  • Qualitative, acute and result oriented market analysis
  • Market size and forecasts from 2022 to 2030
  • Opportunities for expansion and in-depth market analysis
  • Segmentation and regional revenue forecasts
  • Analysis of the market share and competitive landscape
  • Strategic Recommendations to chart future course of action
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Last updated on: 27 February 2024
Updated by: Dr. Purav Gandhi

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