France Biosimilars Market Research Report, 2030

In France, biosimilars play an important role in reducing health costs while maintaining quality of care. This economic concern is even more important given the current context (economic crisis, budgetary pressure, aging population, therapeutic innovation, etc.), that biologics and their biosimilars mainly target chronic conditions such as cancer, chronic inflammatory diseases, or autoimmune diseases. The France Biosimilars market will grow with the increased incidence of chronic illnesses, rising healthcare expenses, and the demand for affordable biologic medicine substitutes. With substantial growth potential in the upcoming years, biosimilars are becoming a major portion of the French pharmaceutical business. With several initiatives in place to stimulate the use of biosimilars, France has been one of the leading European nations in this area. The desire to offer more inexpensive alternatives to biologic medications, which can be prohibitively expensive for many patients and healthcare systems, is what essentially drives the French biosimilar business. When compared to their reference goods, biosimilars are less expensive, and the French government has taken a number of steps to encourage the adoption of these medicines. The "Plan de Développement des Médicaments Génériques et Biosimilaires" (Generic and Biosimilar Drug Development Plan), which was introduced in 2015, is one of the major projects. By fostering the development of these medications and encouraging healthcare professionals to utilize them, this initiative seeks to enhance the availability of biosimilars in France. According to the research report, “France Biosimilars Market Research Report, 2030” published by Actual Market Research, the France Biosimilars market is projected to grow with 17.62% CAGR by 2025-30. France is a strong supporter of biosimilars, which it states as having the same effectiveness, quality and safety as the reference biological. In France, it is the use of biosimilar medicinal products that generates the most savings and as a result, in order to accelerate their use, various incentives were introduced. The Article 51 test progamme in the hospital setting, in particular, has been recognized as a “success” by the strategic council for health innovation. Addendum 9 to the national contract between private physicians and health insurance also produced visible and encouraging results in the community setting. However, the adoption of biosimilars in these different countries, like the measures deployed in France, depends on incentives that are often based on the sharing of value between prescribers and health authorities, and makes it possible to generate savings for health systems. The increased incidence of chronic illnesses, rising healthcare expenses, and the demand for affordable biologic medicine substitutes are some of the drivers driving the French biosimilar industry. Because they are significantly less expensive than their reference products, biosimilars are becoming more and more well-liked by payers and healthcare providers. Additionally, the French government has taken steps to encourage the use of biosimilars, including establishing a national platform to track their usage and providing financial incentives to hospitals that employ them. The biosimilar market in France is anticipated to increase as a result of these measures.

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The National Agency for the Safety of Medicines and Health Products (ANSM) oversees biosimilar regulation in France. For the approval of biosimilars, the ANSM adheres to the standards established by the European Medicines Agency (EMA). The National Union of Health Insurance Funds (UNCAM) and the Transparency Commission are in charge of managing biosimilar reimbursement in France. The Transparency Commission assesses the clinical and financial viability of new medications, including biosimilars, to determine whether the French national health insurance system should pay for them. The increasing utilization of biosimilars in healthcare has prompted the French National Agency for Medicines and Health Products Safety (ANSM) to establish a new Temporary Scientific Committee (TSC). This committee is tasked with defining the conditions under which biologics can be substituted for biosimilars by pharmacists. The move comes as part of broader efforts to optimize the use of biosimilars, aligning with the objectives outlined in the Social Security Financing Act (LFSS) for 2024. The creation of the TSC represents a significant step towards enhancing patient access to cost-effective alternatives while ensuring the safety and efficacy of biosimilar substitution. By the end of 2024, the committee aims to evaluate all currently reimbursed biologics and biosimilars, developing a comprehensive framework that includes clear conditions for substitution. This framework will provide guidance to healthcare professionals and pharmacists, facilitating the integration of biosimilars into treatment plans. Moreover, the establishment of clear guidelines for biosimilar substitution is expected to benefit companies invested in biosimilar development. As the prescription of biosimilars continues to grow, these companies may experience increased revenue streams. The TSC aims to lead this growth by providing comprehensive guidance and reducing barriers to prescribing biosimilars. France has also experimented with financial incentives to reward the prescribing of biosimilars. These incentive structures include shared savings for centers that acquire medicines at lower costs, as well as biosimilar prescribing targets. The 2025 Social Security Financing Law (LFSS) aims to achieve over €1 billion in savings from drug price reductions, up from €850 million in 2024. Biosimilars play a crucial role in this strategy, offering comparable efficacy and safety to originator biologics at reduced costs. The implementation of favorable reimbursement policies and the expansion of production facilities further support the growth of the biosimilars market in France. The therapeutic areas driving biosimilar adoption in France include oncology, rheumatology, and immunology, where biologic treatments are prevalent and costly. The introduction of biosimilars for drugs like ustekinumab has shifted the autoimmune disease market, providing more affordable treatment options . Additionally, the launch of biosimilars for medications such as eculizumab and ranibizumab has expanded the market, offering alternatives for conditions like paroxysmal nocturnal hemoglobinuria and age-related macular degeneration. Insulin biosimilars are experiencing steady growth in France's biosimilars industry, driven by a combination of economic, demographic, and healthcare policy factors. The country's universal healthcare system, which covers 100% of diabetes-related treatments under the Affections de Longue Durée (ALD) scheme, creates a favorable environment for the adoption of cost-effective therapies like biosimilar insulins. With approximately one in ten French citizens living with diabetes, the demand for insulin therapies is substantial and growing. Biosimilar insulins offer a more affordable alternative to originator biologics, aligning with France's emphasis on cost containment and accessibility in healthcare. The shift toward biosimilars is further supported by regional dynamics, with Northern France emerging as a hub for insulin production and distribution, benefiting from a concentration of pharmaceutical companies and robust healthcare infrastructure . Technological advancements in insulin delivery, such as the increasing adoption of insulin pens and continuous glucose monitoring systems, are enhancing patient adherence and outcomes, thereby supporting the integration of biosimilars into diabetes management . Moreover, the expiration of patents for several insulin products has opened the market to biosimilar manufacturers, fostering competition and potentially leading to price reductions.

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Nikita Jabrela

Business Development Manager

The biosimilars market for blood disorders in France is experiencing steady growth, propelled by a combination of demographic trends, healthcare policies, and the need for cost-effective treatments. Blood disorders such as anemia, thrombocytopenia, and various hematologic malignancies are prevalent in the region, necessitating effective and affordable therapeutic options. Biosimilars, including erythropoietin and filgrastim, offer comparable efficacy to originator biologics at reduced costs, making them attractive alternatives for both healthcare providers and patients. The expiration of patents for several key biologic drugs has opened the market to biosimilar manufacturers, fostering competition and driving down prices. France's national healthcare system, with its emphasis on cost containment and accessibility, has implemented favorable reimbursement policies to encourage the adoption of biosimilars. Additionally, educational initiatives aimed at healthcare professionals have increased awareness and confidence in prescribing biosimilars for blood disorders. In-house manufacturing is experiencing steady growth within France's biosimilars industry, driven by the strategic advantages it offers in quality control, cost efficiency, and operational agility. Pharmaceutical companies in France are increasingly investing in internal production capabilities to maintain stringent oversight over the complex processes involved in biosimilar development. This approach ensures consistent quality and compliance with regulatory standards, which is crucial given the intricate nature of biologic drugs. By producing biosimilars in-house, companies can swiftly adapt to market demands and regulatory changes, reducing dependency on third-party manufacturers and mitigating potential supply chain disruptions. Moreover, internal manufacturing allows for better protection of proprietary technologies and intellectual property, providing a competitive edge in a market where innovation and differentiation are key. The French government's supportive policies, aimed at promoting biosimilar adoption to alleviate healthcare costs, further incentivize companies to enhance their manufacturing capabilities domestically. Considered in this report • Historic Year: 2019 • Base year: 2024 • Estimated year: 2025 • Forecast year: 2030

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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 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.