Canada Biosimilars Market Research Report, 2030

Potential savings from biosimilars are a subject of keen interest internationally, with a particular relevance for Canadians. Given the high use and cost of biologics in Canada, the increased use of biosimilars offers a significant opportunity for cost savings for Canadian payers. Unlike small molecule medicines, which experience a relatively quick market adjustment after generic entry, most originator biologics in Canada continue to dominate the market after the introduction of a biosimilar. This, in turn, limits the savings for Canadian payers and their potential ability to fund new therapies that enter the market with increasingly high prices. Recent policy changes to promote biosimilar switching are expected to result in significant cost reductions for relevant classes of biologics in Canada, helping to offset the pressure from new higher-cost medicines in coming years. As the historic savings from generic price reductions and substitutions begin to wane, savings from biosimilars could play in increasing role in offsetting rising drug costs. Given that these switching initiatives are implemented at the jurisdiction level and by payer, Canada offers a unique model to observe the impacts of variations in approach and timing of biosimilar uptake across jurisdictions. Canada’s healthcare system has made significant strides in integrating biosimilars into the treatment landscape. The rigorous regulatory framework established by Health Canada, a federal department responsible for helping Canadians maintain and improve their health, ensures that biosimilars meet stringent standards of efficacy, safety and quality (chemistry, manufacturing and controls). This has paved the way for many biosimilars to be approved and made available to Canadian patients, including Biocon Biologics products in the therapeutic areas of oncology, diabetes and immunology. According to the research report, “Canada Biosimilars Market Research Report, 2030” published by Actual Market Research, the Canada Biosimilars market is projected to reach USD 5.80 Billion market size by 2030.The majority of provinces and territories in Canada have implemented biosimilar switching policies, encouraging the transition from originator biologics to biosimilars, further driving cost savings and health system sustainability and accessibility to treatments. Biocon Biologics and industry partners such as Biosimilars Canada continue to advocate for more predictable switching policies to support effective commercialization and access to treatments for patients and doctors. To-date, the majority of regional governments have implemented switch initiatives for various specific products, with Canada’s largest province, Ontario, recently completing its first initiative with its deadline ending in January 2024. The government notes that funding oncology biosimilars for people starting treatment has led to substantial savings for the healthcare system. In fiscal years 2020/2021, 2021/2022 and 2022/2023, Ontario saved an estimated $53 million, $44 million and $53 million, respectively***. These savings from biosimilars can help increase patient access and lessen the financial burden on the Canadian health care system. As of March 2024, Health Canada has approved 56 biosimilars corresponding to 18 innovator reference products, marking a substantial increase in available biosimilar options for Canadian patients. All ten Canadian provinces have implemented policies to encourage the use of biosimilars, including transitioning patients from originator biologics to biosimilar versions. These initiatives aim to optimize healthcare spending while maintaining high standards of patient care. For instance, Manitoba announced its transition to cost-saving biosimilar medicines in August 2024, joining other provinces in this nationwide effort. Such policies have been instrumental in increasing biosimilar uptake across various therapeutic areas.

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Through expanded access, education and awareness, policy development and collaboration, there is an exciting future for biosimilars in Canada. One of the main goals is to broaden the availability of biosimilars across all provinces and territories, ensuring that more patients can benefit from these treatments. Enhancing education efforts among healthcare providers and patients about the benefits and safety of biosimilars is crucial, as it will help in increasing acceptance and confidence in using biosimilars. In Canada, the regulatory body for the approval of biologicals is the Biologics and Genetic Therapies Directorate (BGTD) of the Health Products and Food Branch (HPFB) of Health Canada. The BGTD regulates biologicals (products derived from living sources) and radiopharmaceuticals for human use in Canada, whether manufactured in Canada or elsewhere. Some of the products regulated by the BGTD include blood and blood products, haemostatic agents, bacterial and viral vaccines, hormones, enzymes, cytokines, monoclonal antibodies, allergenic extracts, gene and cell therapies, tissues and organs. Health Canada, which is Canada’s federal department responsible for health, develops and enforces regulations under Canadian governmental legislation. The agency applies the Food and Drug Regulations under the authority of the Food and Drugs Act to ensure that the pharmaceutical drugs offered for sale in Canada are safe, effective and of high quality. 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. 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. Erythropoietin (EPO) is experiencing high compound annual growth rate (CAGR) in the Canadian biosimilars industry due to a confluence of clinical necessity, cost pressures, and expanding healthcare access initiatives across the country. Erythropoietin, a biologic used primarily to treat anemia associated with chronic kidney disease, chemotherapy, and certain chronic conditions, has long been a staple in therapeutic regimens where red blood cell production is impaired. With the original biologics like Epogen and Aranesp carrying high price tags, especially for long-term treatment, the emergence of biosimilar versions has opened the door for significant cost savings within provincial health budgets. Canada’s single-payer healthcare system makes it particularly sensitive to drug pricing, and erythropoietin biosimilars provide an attractive opportunity to alleviate financial burdens without compromising on clinical outcomes. Provincial governments have actively supported the transition to biosimilars through policy changes and formulary updates, encouraging healthcare providers to switch from originator products to biosimilars. Furthermore, the prevalence of chronic kidney disease and the increasing use of chemotherapy due to an aging population have fueled demand for erythropoiesis-stimulating agents. Coupled with rising patient acceptance and clinician familiarity with biosimilar EPO products, the market has been primed for rapid growth. The strong regulatory oversight by Health Canada, which ensures that biosimilar erythropoietin meets stringent safety, efficacy, and quality standards, has also played a crucial role in bolstering confidence and adoption. Additionally, as biosimilar manufacturers improve their supply chain capabilities and expand their reach within hospital networks and dialysis centers, the accessibility and availability of erythropoietin biosimilars are improving. Oncology is leading the biosimilars industry in Canada due to its high therapeutic demand, the substantial cost burden of cancer treatment, and the strategic alignment of biosimilar policies across provinces that target oncology as a priority area for cost containment and improved patient access. Cancer is one of the leading causes of death in Canada, with tens of thousands of new cases diagnosed annually, placing immense pressure on the healthcare system to deliver effective treatment at scale. Many frontline biologics used in oncology such as trastuzumab (Herceptin), bevacizumab (Avastin), and rituximab (Rituxan) have lost patent protection in recent years, creating a significant opening for biosimilar competition. These biologics are critical in treating prevalent cancers like breast cancer, colorectal cancer, non-Hodgkin’s lymphoma, and lung cancer, and they are often used in combination therapies or for extended treatment durations, making them some of the most expensive medications on the formulary. The introduction of biosimilars in oncology has offered Canadian provinces a valuable lever to reduce treatment costs without compromising efficacy or safety, especially as Health Canada’s stringent regulatory requirements ensure biosimilars meet rigorous clinical standards. Moreover, oncology specialists and hospital systems have increasingly embraced biosimilars, thanks to growing clinical data and real-world evidence that support their interchangeability and safety profiles. This shift has been reinforced by provincial mandates encouraging or requiring the transition to biosimilars for eligible cancer treatments, which accelerates their integration into public drug plans. Additionally, the oncology setting characterized by defined treatment protocols and centralized delivery in cancer centers enables more straightforward implementation of biosimilar substitution compared to other therapeutic areas.

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Nikita Jabrela

Business Development Manager

Contract Research and Manufacturing Services (CRAMS) are witnessing strong growth in the Canadian biosimilars industry due to the increasing demand for specialized expertise, cost-effective development, and accelerated time-to-market for complex biologic products. Biosimilars, by nature, are highly intricate to develop and manufacture, requiring advanced analytical tools, cell line development, bioprocess optimization, and stringent quality control capabilities that not all biopharmaceutical companies possess in-house. As a result, many firms are turning to CRAMS providers to outsource critical phases of the biosimilar lifecycle, from early-stage research and clinical trial management to large-scale commercial manufacturing. Canada’s CRAMS ecosystem is particularly attractive due to its robust regulatory environment aligned with global standards, skilled scientific workforce, competitive operational costs compared to the U.S. and Western Europe, and government incentives supporting biopharmaceutical innovation. These advantages make Canadian contract service providers a preferred choice for both domestic biosimilar developers and international firms seeking North American market entry. Furthermore, the increasing number of biosimilars being approved by Health Canada coupled with provincial mandates promoting their use has triggered a need for agile, scalable manufacturing solutions to meet rising demand across oncology, autoimmune, and nephrology therapies. CRAMS companies in Canada are capitalizing on this by investing in state-of-the-art facilities and bioprocess technologies that ensure regulatory compliance and high product consistency. Additionally, the growing complexity of biosimilar clinical trials, especially those requiring comparative efficacy and immunogenicity studies, has further fueled reliance on contract research organizations (CROs) that can manage sophisticated trial designs and patient recruitment strategies. As the biosimilars market matures and competition intensifies, pharmaceutical companies are seeking to reduce development costs and risks, making CRAMS not just a cost-saving option but a strategic enabler of innovation and market responsiveness. Considered in this report • Historic Year: 2019 • Base year: 2024 • Estimated year: 2025 • Forecast year: 2030 Aspects covered in this report • Biosimilars Market with its value and forecast along with its segments • Various drivers and challenges • On-going trends and developments • Top profiled companies • Strategic recommendation

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By Product • Monoclonal Antibodies • Insulin • Erythropoietin • Others (Includes recombinant glycosylated and non-glycosylated proteins) By Application • Oncology • Chronic & Autoimmune Disorders • Blood Disorders • Growth Hormonal Deficiency • Infectious Disease • Others (Filgrastim/Pegfilgrastim, Teriparatide, Somatropin, Etanercept) By Manufacturer • In-house • Contract Research and Manufacturing Services The approach of the report: This report consists of a combined approach of primary as well as secondary research. Initially, secondary research was used to get an understanding of the market and listing out the companies that are present in the market. The secondary research consists of third-party sources such as press releases, annual report of companies, analyzing the government generated reports and databases. After gathering the data from secondary sources primary research was conducted by making telephonic interviews with the leading players about how the market is functioning and then conducted trade calls with dealers and distributors of the market. Post this we have started doing primary calls to consumers by equally segmenting consumers in regional aspects, tier aspects, age group, and gender. Once we have primary data with us we have started verifying the details obtained from secondary sources. Intended audience This report can be useful to industry consultants, manufacturers, suppliers, associations & organizations related to this industry, government bodies and other stakeholders to align their market-centric strategies. In addition to marketing & presentations, it will also increase competitive knowledge about the industry.