Canada Biosimilars Market Analysis

Canada Biosimilars Market Analysis


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Canada's biosimilar market size was valued at $1.53 Bn in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of 22.2% from 2022 to 2030 and will reach $7.63 Bn in 2030. The market is segmented by product type and indication type. This market will grow as there is a shortage of qualified radiologists and imaging technologists in some areas, leading to longer wait times and delays in diagnosis and treatment. The key market players are Sonic Healthcare Limited Amgen, Biocon, Celltrion Healthcare, Dr. Reddy's Laboratories, and others.

ID: IN10CAPH027 CATEGORY: Pharmaceuticals GEOGRAPHY: Canada AUTHOR: Chandani Patel

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Canada Biosimilars Market Executive Summary

Canada's biosimilars market size was valued at $1.53 Bn in 2022 and is estimated to expand at a CAGR of 22.2% from 2022-30 and will reach $7.63 Bn in 2030. The use of biosimilars in Canada varies by province, as each province is responsible for making decisions about the funding and use of drugs in their jurisdiction.

In April 2020, the Ontario government introduced a biosimilar switching program, which requires patients who are currently using a reference biologic drug to switch to a biosimilar product. The program applies to several biological drugs used to treat conditions such as rheumatoid arthritis and inflammatory bowel disease. British Columbia has implemented a biosimilar initiative, which encourages the use of biosimilar drugs as a way to reduce healthcare costs. The initiative includes a biosimilar switching program, as well as incentives for prescribers to choose biosimilars over reference products.

Biosimilars have the potential to offer significant cost savings to the healthcare system, while also increasing patient access to important treatments. As the use of biosimilars continues to grow in Canada, they are expected to play an increasingly important role in the country's healthcare system. Hence the market will grow during the forecast period.

canada biosimilar market analysis

Market Dynamics

Market Growth Drivers

Biosimilars provide a less expensive option to costly biologic medications, which can aid in lowering healthcare costs for patients and payers. Furthermore, as the patents on the reference biologic products expire, producers of biosimilars will have the chance to enter the market and provide less expensive substitutes.

Moreover, the Canadian government has implemented policies and measures to encourage the use of biosimilars, including switching programs for biosimilars and increased financing for biosimilar R&D.

Market Restraints

Biosimilar development and approval can be a complex and lengthy process, with manufacturers facing regulatory and legal challenges. Also, physician and Patient Education: There can be some resistance to the use of biosimilars among healthcare providers and patients who may be unfamiliar with these products.

Additionally, maybe market barriers that prevent biosimilars from gaining a significant share of the market, such as exclusivity agreements between reference product manufacturers and payers.

Competitive Landscape

Key Players

  • Apotex Inc. (CAN)
  • Pfizer Canada ULC (CAN)
  • Sandoz Canada Inc. (CAN)
  • Teva Canada Limited (CAN)
  • Sanofi-Aventis Canada Inc. (CAN)
  • JAMP Pharma Corporation (CAN)
  • Mylan Pharmaceuticals ULC (CAN)
  • Fresenius Kabi Canada Ltd. (CAN)
  • Celltrion Healthcare Co. Ltd. (CAN)
  • Biogen Canada Inc. (CAN)

Healthcare Policies and Regulatory Landscape

Health Canada, the government agency in charge of protecting the security and effectiveness of medicines and medical devices in the nation, is in charge of regulating biosimilars in Canada. A regulatory framework for the licensing of biosimilars has been created by Health Canada, and it involves a detailed assessment procedure to assess how similar the biosimilar is to the reference biologic product.

Similar to other nations, Canada has regulatory criteria for biosimilars, including the necessity to show consistency with the reference product in terms of quality, safety, and effectiveness. Pre-clinical testing is the first phase in the approval procedure, which is followed by human clinical trials. The Canadian Agency for Drugs and Technologies in Health (CADTH) is in charge of making recommendations on how medications and medical equipment should be used and paid for in Canada. In order to examine the clinical and financial advantages of novel medications, including biosimilars, CADTH performs Health Technology Assessments (HTAs) and provides suggestions on how to utilize and support them.

On the basis of the recommendations of CADTH and other considerations including local priorities and finances, the Canadian provinces and territories are in charge of making the ultimate choices about the funding and usage of medications, including biosimilars. In an effort to lower healthcare costs and improve patient access to treatment alternatives, certain provinces have developed policies to promote the use of biosimilars, such as biosimilar switching programs.

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 Biosimilars Market Segmentation

By Product

The monoclonal antibodies, insulin, granulocyte colony-stimulating factor, erythropoietin, recombinant human growth hormone, etanercept, follitropin, teriparatide, interferons, enoxaparin sodium, glucagon, and calcitonin are among the product categories that make up the biosimilars market. Monoclonal antibodies held a sizable portion of the market in 2020. The market is being driven by elements including the widespread use of monoclonal antibodies in the treatment of autoimmune diseases, cancer, and osteoporosis, as well as the affordability of such treatments.

  • Monoclonal Antibodies
    • Infliximab
    • Trastuzumab
    • Rituximab
    • Adalimumab
    • Other monoclonal antibodies (bevacizumab, cetuximab, ranibizumab, denosumab, and eculizumab)
  • Insulin
  • Granulocyte Colony-Stimulating Factor
  • Erythropoietin
  • Recombinant Human Growth Hormone
  • Etanercept
  • Follitropin
  • Teriparatide
  • Interferons
  • Enoxaparin Sodium
  • Glucagon
  • Calcitonin

By Indication

The biosimilars market is divided into oncology, autoimmune and inflammatory diseases, chronic illnesses, blood disorders, growth hormone insufficiency, infectious diseases, and other indications based on the indication (infertility, hypoglycemia, myocardial infarction, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases). The market's largest sector in 2020 will be oncology. This market is expanding as a result of elements like the reduced cost of biosimilars compared to novel biologics and the increased incidence and prevalence of cancer.

  • Oncology
  • Inflammatory & Autoimmune Disorders
  • Chronic Diseases
  • Blood Disorders
  • Growth Hormone Deficiency
  • Infectious Diseases
  • Other Indications (infertility, hypoglycemia, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases)

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”.

 

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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

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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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Last updated on: 05 December 2023
Updated by: Keta Vora

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