Anakinra Market Report 2025

The anakinra market size has grown rapidly in recent years. It will grow from $4.89 billion in 2024 to $5.46 billion in 2025 at a compound annual growth rate (CAGR) of 11.8%. The growth in the historic period can be attributed to the increasing prevalence of rheumatoid arthritis, the approval of anakinra for treating rare autoinflammatory conditions like NOMID, rising awareness of biologics for managing chronic inflammatory conditions, and growing adoption of targeted therapies.

The anakinra market size is expected to see rapid growth in the next few years. It will grow to $8.6 billion in 2029 at a compound annual growth rate (CAGR) of 12%. The growth in the forecast period can be attributed to the expansion of indications for anakinra in conditions, increasing focus on personalized medicine, rising prevalence of rare autoinflammatory disorders, advancements in drug delivery systems, and growing healthcare access in emerging markets driving demand for biologics. Major trends in the forecast period include the development of biosimilars and next-generation IL-1 inhibitors, the adoption of home-based and self-administered treatment options, collaborations between biotech companies and academic institutions, and digital health solutions to support patient adherence.

The forecast of 12% growth over the next five years reflects a modest reduction of 0.4% from the previous estimate for this market. This reduction is primarily due to the impact of tariffs between the US and other countries. Tariff barriers are expected to hamper U.S. rheumatology practices by increasing the cost of IL-1 receptor antagonists like anakinra sourced from Austria and Sweden, thereby limiting autoinflammatory disease treatment options and elevating immunology drug expenses. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.

The increasing prevalence of autoimmune disorders is expected to drive the expansion of the anakinra market in the coming years. Autoimmune disorders occur when the immune system mistakenly attacks and damages healthy tissues and organs, perceiving them as foreign threats. The rising incidence of these disorders is influenced by genetic predisposition and environmental factors, including infections, pollution, and dietary changes. Anakinra is used to manage autoimmune conditions by inhibiting interleukin-1 (IL-1) activity, reducing inflammation in diseases such as rheumatoid arthritis, Still’s disease, and periodic fever syndromes. For example, in June 2024, a report from the Australian Institute of Health and Welfare, an Australian governmental organization, revealed that in 2021-22, there were 10,000 hospitalizations for rheumatoid arthritis, reflecting a 25% increase from the previous year’s 8,000 cases. This equates to a rate of 39 hospitalizations per 100,000 people. Consequently, the increasing incidence of autoimmune disorders is fueling the demand for anakinra.

Rising healthcare expenditure is also contributing to the growth of the anakinra market. Healthcare expenditure encompasses the total financial resources allocated to healthcare services and products, including hospital care, physician services, medications, medical devices, and public health initiatives. The increase in healthcare spending is driven by factors such as an aging population, medical advancements, a higher prevalence of chronic diseases, rising drug prices, increased healthcare utilization, administrative costs, and inflation. Greater healthcare expenditure supports anakinra by funding its development, ensuring accessibility, and maintaining its role as an effective biologic therapy for inflammatory conditions such as rheumatoid arthritis. It also facilitates the integration of anakinra into healthcare systems through insurance coverage and patient assistance programs. For instance, in May 2023, the Office for National Statistics, a UK-based government department, reported that UK healthcare expenditure reached approximately $352 billion (£283 billion) in 2022, reflecting a 0.7% increase in nominal terms compared to 2021. As a result, rising healthcare spending is driving the expansion of the anakinra market.

Leading companies in the anakinra market are actively seeking regulatory approvals to broaden its therapeutic applications. Regulatory approvals represent official authorizations from government agencies that allow a drug to be marketed and prescribed for specific medical conditions after rigorous evaluation of its safety, efficacy, and quality. For example, in November 2022, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for Kineret (anakinra) to treat hospitalized adults with COVID-19-related pneumonia requiring supplemental oxygen, with the goal of reducing the risk of severe respiratory failure. This authorization was based on data from the SAVE-MORE phase 3 study, which demonstrated that early treatment with Kineret improved patient outcomes. Kineret functions by blocking cytokines IL-1α and IL-1β, which play a role in the hyperinflammatory response seen in severe COVID-19 cases. While the FDA has not fully approved Kineret for this indication, it has been temporarily authorized for use during the public health emergency.

Major players in the anakinra market are Swedish Orphan Biovitrum AB, Boehringer Ingelheim, Amgen Inc.

North America was the largest region in the anakinra market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in Anakinra report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the Anakinra market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The Anakinra market consists of sales of diagnostic kits, supportive care products, combination therapies, and biosimilars. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the pharmaceutical sector. Companies are grappling with higher costs on imported active pharmaceutical ingredients (APIs), glass vials, and laboratory equipment - many of which have limited alternative sources. Generic drug manufacturers, already operating with minimal profit margins, are particularly affected, with some scaling back production of low-margin medications. Biotech firms are also experiencing delays in clinical trials due to shortages of specialized reagents linked to tariffs. In response, the industry is shifting API production to regions like India and Europe, building up inventory reserves, and advocating for tariff exemptions on essential medicines.

The anakinra market research report is one of a series of new reports that provides anakinra market statistics, including anakinra industry global market size, regional shares, competitors with an anakinra market share, detailed anakinra market segments, market trends and opportunities, and any further data you may need to thrive in the anakinra industry. This anakinra market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Anakinra is a biopharmaceutical medication that functions as a recombinant version of the human interleukin-1 receptor antagonist. It is primarily used to treat moderate-to-severe rheumatoid arthritis in patients who have not responded adequately to other disease-modifying antirheumatic drugs (DMARDs).

The main indications for anakinra include rheumatoid arthritis, cryopyrin-associated periodic syndromes, familial cold autoinflammatory syndrome, systemic juvenile idiopathic arthritis, adult-onset Still's disease, neonatal-onset multisystem inflammatory disease, and other inflammatory conditions. Rheumatoid arthritis is a chronic autoimmune disorder in which the immune system mistakenly attacks joint tissues, particularly the synovium. Anakinra is distributed through hospital pharmacies, retail pharmacies, online pharmacies, and wholesale pharmacies, serving various end users such as hospitals, clinics, and home care settings.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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