Complement Inhibitors Market Report 2025

The complement inhibitors market size has grown exponentially in recent years. It will grow from $16.41 billion in 2024 to $21.26 billion in 2025 at a compound annual growth rate (CAGR) of 29.6%. The growth in the historic period can be attributed to increasing prevalence of complement-mediated diseases, growing awareness of rare diseases, emergence of biologics as effective therapies, rising healthcare expenditure, increasing focus on personalized medicine, availability of orphan drug incentives, regulatory support for rare disease treatments and collaborations between pharmaceutical companies and research institutions.

The complement inhibitors market size is expected to see exponential growth in the next few years. It will grow to $60.28 billion in 2029 at a compound annual growth rate (CAGR) of 29.8%. The growth in the forecast period can be attributed to rising incidence of autoimmune and inflammatory diseases, growth in biologics and biosimilar markets, increasing number of clinical trials, development of longer-acting complement inhibitors, expansion of healthcare infrastructure in emerging markets, increasing adoption of targeted therapies, growing geriatric population and enhanced patient access to biologic treatments. Major trends in the forecast period include artificial intelligence in drug discovery, advanced biomarker identification techniques, machine learning for patient response prediction, long-acting drug formulations, next-generation sequencing for complement system analysis, high-throughput screening platforms, organ-on-a-chip models for complement inhibition testing, 3D bioprinting for complement inhibitor development and real-time monitoring tools for treatment efficacy.

The forecast of 29.8% growth over the next five years reflects a modest reduction of 0.5% from the previous estimate for this market. This reduction is primarily due to the impact of tariffs between the US and other countries. Trade tensions could hinder U.S. rare disease treatment by inflating prices of C5 complement inhibitors manufactured in Denmark and the Netherlands, resulting in compromised PNH management and higher hematology specialty drug expenditures. 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 focus on personalized medicine is expected to drive the growth of the complement inhibitors market in the coming years. Personalized medicine involves tailoring treatments to individual patients based on their genetic, environmental, and lifestyle factors to optimize outcomes and improve care. The rising adoption of personalized medicine is fueled by advancements in genomics, the growing availability of biomarker-based diagnostics, improved data analytics technologies, and a growing demand for more targeted and effective therapies. Complement inhibitors align with personalized medicine by targeting specific components of the complement system based on a patient's unique disease profile, genetic makeup, and complement activity levels. For instance, in February 2024, the Personalized Medicine Coalition (PMC), a US-based nonprofit organization, reported that the U.S. Food and Drug Administration (FDA) approved 26 new personalized medicines in 2023, a notable increase from 12 approvals in 2022. As a result, the expanding focus on personalized medicine is fueling the growth of the complement inhibitors market.

Leading companies in the complement inhibitors market are increasingly developing monoclonal antibodies to effectively regulate the complement system in various autoimmune and inflammatory diseases. Monoclonal antibodies are lab-engineered proteins designed to specifically target and bind to antigens, aiding in the treatment of conditions such as cancer, autoimmune disorders, and infections. For example, in August 2024, F. Hoffmann-La Roche AG, a Switzerland-based pharmaceutical company, received approval from the European Commission for PiaSky (crovalimab), a monoclonal antibody designed for adults and adolescents with paroxysmal nocturnal hemoglobinuria (PNH) who are either new to or previously treated with C5 inhibitors. PiaSky (crovalimab) targets complement protein C5 to prevent its cleavage, thereby inhibiting the formation of the membrane attack complex (MAC) and reducing terminal complement-mediated intravascular hemolysis. This mechanism helps improve hemoglobin levels, decrease the need for blood transfusions, and alleviate symptoms such as fatigue and anemia, ultimately enhancing patients' quality of life.

In September 2023, Magenta Therapeutics Inc., a US-based clinical-stage biotechnology company, merged with Dianthus Therapeutics Inc. for an undisclosed amount. This merger enables the combined company to focus on advancing Dianthus’ pipeline of next-generation complement inhibitors, including DNTH103, which is currently in a Phase I clinical trial. Dianthus Therapeutics Inc. is a US-based clinical-stage biotechnology company specializing in developing next-generation antibody complement therapeutics for severe autoimmune diseases.

Major players in the complement inhibitors market are F. Hoffmann-La Roche AG, Bayer AG, Sanofi S.A., AstraZeneca plc, Novartis AG, Amgen Inc., Regeneron Pharmaceuticals Inc., Astellas Pharma Inc., CSL Behring, UCB S.A., Takeda Pharmaceutical Company Limited, Alnylam Pharmaceuticals Inc., Innovent Biologics Inc., BioCryst Pharmaceuticals Inc., Pharming Group N.V., Apellis Pharmaceuticals Inc., Omeros Corporation, Akari Therapeutics Plc, InflaRx N.V., Kira Pharmaceuticals.

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

The complement inhibitors market consists of sales of small molecule inhibitors, recombinant proteins and biologics designed to regulate the complement system and treat complement-mediated diseases. 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 complement inhibitors market research report is one of a series of new reports that provides complement inhibitors market statistics, including complement inhibitors industry global market size, regional shares, competitors with a complement inhibitors market share, detailed complement inhibitors market segments, market trends and opportunities, and any further data you may need to thrive in the complement inhibitors industry. This complement inhibitors 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.

Complement inhibitors are therapeutic agents designed to regulate or block the complement system, a crucial part of the immune response involved in inflammation, pathogen elimination, and cell lysis. These inhibitors target specific complement components, such as complement component 3 (C3) or complement component 5 (C5), to prevent overactivation and reduce tissue damage in conditions such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

The key product types in the complement inhibitors market include complement component 3 (C3) inhibitors, complement component 5 (C5) inhibitors, and complement factor D inhibitors. C3 inhibitors are therapeutic agents that block the activation of C3, a central protein in the complement cascade. The mechanisms of action for complement inhibitors involve alternative pathway inhibitors, classical pathway inhibitors, and lectin pathway inhibitors. These therapies are used to treat conditions such as aHUS, generalized myasthenia gravis (GMG), and PNH. Administration routes include intravenous (IV) and subcutaneous (SC) methods, serving a broad patient demographic, including adults, geriatrics, and pediatrics.

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 and 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.

This product will be delivered within 1-3 business days.