리툭시맙(Rituximab) 바이오시밀러 시장 보고서(2026년)
Rituximab Biosimilars Global Market Report 2026
상품코드 : 1957759
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

리툽시맙 바이오시밀러 시장 규모는 최근 급성장하고 있습니다. 2025년 34억 2,000만 달러에서 2026년에는 38억 4,000만 달러에 이르고, CAGR 12.5%의 성장이 전망되고 있습니다. 지난 수년간의 성장에는 리툭시맙의 고비용, 비호지킨림프종 발병률 증가, 만성 림프구성 백혈병 발병률 증가, 자가면역질환 관리에 대한 인식 개선, 첨단 바이오의약품에 대한 접근성 제한 등이 주요 요인으로 작용한 것으로 보입니다.

리툭시맙 바이오시밀러 시장 규모는 향후 몇 년간 급성장이 전망됩니다. 2030년에는 62억 6,000만 달러에 이르고, CAGR은 13.0%를 나타낼 전망입니다. 예측 기간 동안의 성장 요인으로는 신규 바이오시밀러 출시, 피하 투여 옵션 확대, 신흥 시장에서의 채택 증가, 바이오시밀러에 대한 정부 및 보험 지원 강화, 병원 및 전문 약국 프로그램과의 통합 등을 꼽을 수 있습니다. 예측 기간 동안 주요 동향으로는 종양학 및 자가면역질환에서 리툭시맙 바이오시밀러의 채택 확대, 피하주사 및 프리필드 전달 시스템의 보급, 비용 효율적인 단일클론항체 대체품의 선호도 증가, 표적 치료에서 항체 약물 복합체(ADC)의 사용 증가, 병원 및 소매 약국 유통 채널의 강화 등이 있습니다. 병원 및 소매 약국 유통 채널 강화 등을 들 수 있습니다.

비호지킨림프종(NHL)의 발병률 증가는 향후 몇 년간 리툭시맙 바이오시밀러 시장의 성장을 견인할 것으로 예측됩니다. 비호지킨림프종은 면역체계에서 중요한 역할을 하는 백혈구, 특히 림프구에 기원하는 암의 일종입니다. 비호지킨림프종의 유병률 증가는 특히 고령화 인구의 발병률 증가와 더불어 생활습관 및 환경적 요인의 영향에 기인하는 것으로 알려져 있습니다. 리툭시맙 바이오시밀러는 CD20 양성 B세포를 효과적으로 표적화하여 제거함으로써 종양 부하를 줄이고 면역체계 조절을 개선하여 비호지킨림프종(NHL) 환자들에게 보다 저렴하고 접근하기 쉬운 치료 옵션을 제공합니다. 이를 통해 전체 치료 결과와 삶의 질이 향상될 것으로 기대됩니다. 예를 들어, 미국암협회(미국 암 지원 단체)에 따르면 2024년 1월 기준 약 80,620명(남성 44,590명, 여성 36,030명)이 비호지킨림프종 진단을 받고 약 20,140명(남성 11,780명, 여성 8,360명)이 사망할 것으로 예상하고 있습니다. 사망할 것으로 예측됩니다. 또한, 평생 동안 이 암에 걸릴 위험은 남성의 경우 약 42명 중 1명, 여성의 경우 약 52명 중 1명으로 추정되고 있습니다. 따라서 비호지킨림프종 유병률 증가는 리툭시맙 바이오시밀러 시장의 성장에 기여하고 있습니다.

향후 몇 년 동안 자가면역질환의 유병률 증가는 리툭시맙 바이오시밀러 시장의 성장을 뒷받침할 것으로 예측됩니다. 자가면역질환은 면역체계가 건강한 조직을 이물질로 오인하여 공격하는 상태를 말합니다. 리툭시맙 바이오시밀러는 특정 B세포를 표적으로 하여 염증과 자가면역반응을 억제하여 자가면역질환 관리에 활용됩니다. 예를 들어, 호주의 비영리단체인 'Arthritis Australia'에 따르면, 2024년 2월 기준 2025년에는 약 56만 2,378명의 호주인이 류마티스 관절염(RA)을 앓고 있는 것으로 추산되며, 이는 같은 해 전체 관절염 환자의 14%에 해당합니다. 2040년까지 이 수치는 33% 증가하여 748,721명에 달할 것으로 예상되며, 2025년에 비해 2040년에는 18만 6,343명의 호주인이 추가로 RA를 앓게 될 것으로 예측됩니다. 따라서 자가면역질환의 유병률 증가가 리툭시맙 바이오시밀러 시장의 성장을 가속하고 있습니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 공급망 분석

제4장 세계 시장 동향과 전략

제5장 최종 이용 산업 시장 분석

제6장 시장 : 금리, 인플레이션, 지정학, 무역 전쟁과 관세의 영향, 관세 전쟁과 무역 보호주의의 공급망에 대한 영향, 코로나 팬데믹이 시장에 미치는 영향을 포함한 거시경제 시나리오

제7장 세계 전략 분석 프레임워크, 현재 시장 규모, 시장 비교 및 성장률 분석

제8장 TAM(Total Addressable Market) 규모

제9장 시장 세분화

제10장 지역별/국가별 분석

제11장 아시아태평양 시장

제12장 중국 시장

제13장 인도 시장

제14장 일본 시장

제15장 호주 시장

제16장 인도네시아 시장

제17장 한국 시장

제18장 대만 시장

제19장 동남아시아 시장

제20장 서유럽 시장

제21장 영국 시장

제22장 독일 시장

제23장 프랑스 시장

제24장 이탈리아 시장

제25장 스페인 시장

제26장 동유럽 시장

제27장 러시아 시장

제28장 북미 시장

제29장 미국 시장

제30장 캐나다 시장

제31장 남미 시장

제32장 브라질 시장

제33장 중동 시장

제34장 아프리카 시장

제35장 시장 규제 상황과 투자환경

제36장 경쟁 구도와 기업 개요

제37장 기타 주요 기업 및 혁신 기업

제38장 세계 시장 경쟁 벤치마킹과 대시보드

제39장 주요 인수합병(M&A)

제40장 시장 잠재력이 높은 국가, 부문, 전략

제41장 부록

LSH
영문 목차

영문목차

Rituximab biosimilar is a chimeric monoclonal antibody designed to target the B cell-specific protein CD20 within the immune system. By eliminating B cells, it is effective in managing conditions characterized by excessive, overactive, or abnormal B cell activity.

Rituximab biosimilars are primarily administered through subcutaneous, intravenous, and molecular routes. Intravenous treatment involves the direct delivery of fluids, medications, or nutrients into a patient's vein. These biosimilars are used in the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and other indications, and are distributed via hospital pharmacies, online pharmacies, retail pharmacies, and other direct distribution channels.

Tariffs have impacted the rituximab biosimilars market by increasing the cost of imported biologics, raw materials, and infusion devices, affecting production and supply chain efficiency. Segments like intravenous infusion solutions and monoclonal antibodies are most affected, particularly in North America and Europe, which rely on imports for manufacturing and hospital use. Despite higher costs, tariffs have encouraged local production, accelerated biosimilar development, and promoted adoption of cost-effective treatment alternatives.

The rituximab biosimilars market research report is one of a series of new reports from The Business Research Company that provides rituximab biosimilars market statistics, including rituximab biosimilars industry global market size, regional shares, competitors with a rituximab biosimilars market share, detailed rituximab biosimilars market segments, market trends and opportunities, and any further data you may need to thrive in the rituximab biosimilars industry. This rituximab biosimilars 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.

The rituximab biosimilars market size has grown rapidly in recent years. It will grow from $3.42 billion in 2025 to $3.84 billion in 2026 at a compound annual growth rate (CAGR) of 12.5%. The growth in the historic period can be attributed to high cost of originator rituximab, increasing prevalence of non-hodgkin's lymphoma, growing incidence of chronic lymphocytic leukemia, rising awareness of autoimmune disease management, limited access to advanced biologics.

The rituximab biosimilars market size is expected to see rapid growth in the next few years. It will grow to $6.26 billion in 2030 at a compound annual growth rate (CAGR) of 13.0%. The growth in the forecast period can be attributed to launch of new biosimilar formulations, expansion of subcutaneous delivery options, increasing adoption in emerging markets, rising government and insurance support for biosimilars, integration with hospital and specialty pharmacy programs. Major trends in the forecast period include rising adoption of rituximab biosimilars for oncology and autoimmune diseases, expansion of subcutaneous administration and pre-filled delivery systems, growing preference for cost-effective monoclonal antibody alternatives, increasing use of antibody-drug conjugates (adcs) in targeted therapy, enhanced hospital and retail pharmacy distribution channels.

The increasing prevalence of non-Hodgkin's lymphoma (NHL) is anticipated to drive the expansion of the rituximab biosimilars market in the coming years. Non-Hodgkin's lymphoma is a form of cancer that originates in white blood cells, particularly lymphocytes, which play a key role in the immune system. The growing prevalence of non-Hodgkin's lymphoma is attributed to rising incidence rates, especially among aging populations, as well as lifestyle and environmental influences. Rituximab biosimilars effectively target and eliminate CD20-positive B cells, aiding in lowering tumor burden, improving immune system regulation, and offering a more affordable and accessible treatment option for patients with non-Hodgkin's lymphoma (NHL), thereby improving overall therapeutic results and quality of life. For example, in January 2024, according to the American Cancer Society, a US-based cancer advocacy organization, around 80,620 individuals (44,590 men and 36,030 women) were projected to be diagnosed with non-Hodgkin lymphoma, with approximately 20,140 deaths (11,780 men and 8,360 women), and the lifetime risk of developing this cancer was estimated at about 1 in 42 for men and 1 in 52 for women. Consequently, the growing prevalence of non-Hodgkin's lymphoma is contributing to the growth of the rituximab biosimilars market.

The increasing prevalence of autoimmune diseases is expected to support the growth of the rituximab biosimilars market in the years ahead. Autoimmune diseases are conditions in which the immune system mistakenly attacks healthy tissues, identifying them as foreign. Rituximab biosimilars are utilized in the management of autoimmune diseases by targeting specific B cells, thereby reducing inflammation and autoimmune activity. For example, in February 2024, according to Arthritis Australia, an Australia-based non-profit organization, an estimated 562,378 Australians were projected to be living with rheumatoid arthritis (RA) in 2025, representing 14% of all arthritis cases that year. By 2040, this figure is expected to increase by 33% to 748,721 individuals, reflecting an additional 186,343 Australians living with RA in 2040 compared to 2025. Therefore, the rising prevalence of autoimmune diseases is fueling the growth of the rituximab biosimilars market.

Leading companies operating in the rituximab biosimilars market are concentrating on the development of innovative products through strategic collaborations to improve accessibility and deliver more cost-effective treatment options for patients with a range of immunological and oncological disorders. Partnerships with established organizations enable companies to speed up commercialization, utilize shared expertise in regulatory approvals and distribution, and efficiently introduce biosimilars to the market, thereby enhancing patient access and market reach. For instance, in July 2023, Dr. Reddy's Laboratories partnered with Fresenius Kabi to commercialize its proposed rituximab biosimilar in the United States. This partnership is intended to introduce a biosimilar version of rituximab to the market, offering a more affordable and accessible treatment option for patients. The introduction of a biosimilar rituximab in the US has the potential to expand access to this critical therapy for patients with conditions such as rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis, and microscopic polyangiitis.

Major companies operating in the rituximab biosimilars market are Novartis AG, Pfizer, BIOCAD, Shanghai Henlius Biotech Inc., Innovent Biologics Inc., Cadila Pharmaceuticals, Hetero Drugs Limited, Dr. Reddy's Laboratories, Shanghai Fosun Pharmaceutical (Group) Co. Ltd., Reliance Life Sciences India, Zenotech Laboratories, Celltrion, Biocad, MABION S.A., Amgen, Teva Pharmaceuticals, Celltrion Healthcare, Coherus BioSciences, Aryogen Biopharma, TR-Pharm, Hikma Pharmaceuticals plc.

North America was the largest region in the rituximab biosimilars market in 2025. Middle East is expected to be the fastest-growing region in the rituximab biosimilars market report during the forecast period. The regions covered in the rituximab biosimilars market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the rituximab biosimilars market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The rituximab biosimilar market consists of sales of mabthera, truxima, ruxience, or rixathon. 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.

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.

Rituximab Biosimilars Market Global Report 2026 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses rituximab biosimilars market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for rituximab biosimilars ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The rituximab biosimilars market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

Scope

Added Benefits available all on all list-price licence purchases, to be claimed at time of purchase. Customisations within report scope and limited to 20% of content and consultant support time limited to 8 hours.

Table of Contents

1. Executive Summary

2. Rituximab Biosimilars Market Characteristics

3. Rituximab Biosimilars Market Supply Chain Analysis

4. Global Rituximab Biosimilars Market Trends And Strategies

5. Rituximab Biosimilars Market Analysis Of End Use Industries

6. Rituximab Biosimilars Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, Supply Chain Impact from Tariff War & Trade Protectionism, And Covid And Recovery On The Market

7. Global Rituximab Biosimilars Strategic Analysis Framework, Current Market Size, Market Comparisons And Growth Rate Analysis

8. Global Rituximab Biosimilars Total Addressable Market (TAM) Analysis for the Market

9. Rituximab Biosimilars Market Segmentation

10. Rituximab Biosimilars Market Regional And Country Analysis

11. Asia-Pacific Rituximab Biosimilars Market

12. China Rituximab Biosimilars Market

13. India Rituximab Biosimilars Market

14. Japan Rituximab Biosimilars Market

15. Australia Rituximab Biosimilars Market

16. Indonesia Rituximab Biosimilars Market

17. South Korea Rituximab Biosimilars Market

18. Taiwan Rituximab Biosimilars Market

19. South East Asia Rituximab Biosimilars Market

20. Western Europe Rituximab Biosimilars Market

21. UK Rituximab Biosimilars Market

22. Germany Rituximab Biosimilars Market

23. France Rituximab Biosimilars Market

24. Italy Rituximab Biosimilars Market

25. Spain Rituximab Biosimilars Market

26. Eastern Europe Rituximab Biosimilars Market

27. Russia Rituximab Biosimilars Market

28. North America Rituximab Biosimilars Market

29. USA Rituximab Biosimilars Market

30. Canada Rituximab Biosimilars Market

31. South America Rituximab Biosimilars Market

32. Brazil Rituximab Biosimilars Market

33. Middle East Rituximab Biosimilars Market

34. Africa Rituximab Biosimilars Market

35. Rituximab Biosimilars Market Regulatory and Investment Landscape

36. Rituximab Biosimilars Market Competitive Landscape And Company Profiles

37. Rituximab Biosimilars Market Other Major And Innovative Companies

38. Global Rituximab Biosimilars Market Competitive Benchmarking And Dashboard

39. Key Mergers And Acquisitions In The Rituximab Biosimilars Market

40. Rituximab Biosimilars Market High Potential Countries, Segments and Strategies

41. Appendix

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