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한글목차
휴미라 바이오시밀러 시장 규모는 향후 몇 년 동안 빠르게 성장하여 2029년까지 12.6%의 CAGR로 59억 6,000만 달러에 달할 것으로 예상됩니다. 향후 바이오시밀러 개발 기술 발전, 의료비 절감 노력 강화, 오리지널 바이오의약품의 특허 만료, 시장 진입 및 상환 정책 개선, 종양학 및 자가면역질환에 대한 바이오시밀러 채택 증가 등이 예측 기간 동안 성장을 견인할 것으로 보입니다. 이 기간 동안 예상되는 주요 동향으로는 바이오시밀러의 추가 승인 증가, 제조 기술 발전, 연구개발 활동 확대, 바이오시밀러 신약 개발 및 승인, 제형 혁신 등이 있습니다.
자가면역질환의 유병률 증가는 휴미라 바이오시밀러 시장의 성장을 촉진할 것으로 예상됩니다. 자가면역질환은 면역체계가 건강한 세포, 조직, 장기를 잘못 공격하여 발생합니다. 이러한 사례의 증가는 면역 체계의 기능을 방해하고 자가 면역 반응의 위험을 증가시키는 환경 오염과 관련성이 높아지고 있습니다. 휴미라 바이오시밀러는 자가면역질환에서 염증을 유발하는 단백질인 종양괴사인자(TNF)를 억제하여 자가면역질환의 증상을 완화하고 건강한 조직 손상을 예방할 수 있습니다. 예방할 수 있습니다. 예를 들어, 2024년 6월 호주 보건 복지 연구소는 2022년에 약 51만 4,000명의 호주인(인구의 2.0%)이 류마티스 관절염을 앓고 있을 것으로 추정된다고 보고했습니다. 이에 따라 자가면역질환의 유병률이 증가하면서 휴미라 바이오시밀러에 대한 수요가 증가하고 있습니다.
휴미라 바이오시밀러 시장의 주요 업체들은 자가면역질환의 치료 접근성을 개선하기 위해 비용 효율적인 TNF 차단제 개발에 주력하고 있으며, TNF 차단제는 TNF의 작용을 억제하여 염증과 질병 증상을 감소시키는 생물학적 제제입니다. 예를 들어, 2023년 7월 미국 제약사 오가논(Organon)은 한국 바이오기업 삼성바이오에피스와 손잡고 휴미라 바이오시밀러 HADLIMA를 출시했으며, HADLIMA는 구연산염을 함유하지 않은 고농도 제제(100mg/mL)와 구연산염을 함유한 저농도 제제(100mg/mL)를 출시했습니다. 구연산염을 포함한 저농도 제제(50mg/mL)가 있어 휴미라와 동일한 선택이 가능합니다. 휴미라는 오리지널 의약품의 정가 대비 약 85% 낮은 가격으로 제공되며, 환자 지원 프로그램을 통해 지원받을 수 있습니다. 이번 휴미라의 출시는 전 세계적인 합의에 따른 것으로, 미국 내 자가면역 치료제의 가격 및 접근성을 크게 향상시킬 수 있는 계기가 될 것으로 기대됩니다.
목차
제1장 주요 요약
제2장 시장 특징
제3장 시장 동향과 전략
제4장 시장 - 금리, 인플레이션, 지정학, 무역 전쟁과 관세, 그리고 코로나와 회복이 시장에 미치는 영향을 포함한 거시경제 시나리오
제5장 세계의 성장 분석과 전략 분석 프레임워크
세계의 휴미라 바이오시밀러 PESTEL 분석(정치, 사회, 기술, 환경, 법적 요인, 촉진요인과 억제요인)
최종 이용 산업 분석
세계의 휴미라 바이오시밀러 시장 : 성장률 분석
세계의 휴미라 바이오시밀러 시장 실적 : 규모와 성장, 2019-2024년
세계의 휴미라 바이오시밀러 시장 예측 : 규모와 성장, 2024-2029년, 2034년
세계의 휴미라 바이오시밀러 전체 시장(TAM)
제6장 시장 세분화
세계의 휴미라 바이오시밀러 시장 : 제품 유형별, 실적과 예측, 2019-2024년, 2024-2029년, 2034년
아달리무맙 바이오시밀러
기타 유형
세계의 휴미라 바이오시밀러 시장 : 유통 채널별, 실적과 예측, 2019-2024년, 2024-2029년, 2034년
병원 약국
소매 약국
온라인 약국
기타 유통 채널
세계의 휴미라 바이오시밀러 시장 : 용도별, 실적과 예측, 2019-2024년, 2024-2029년, 2034년
류마티스 관절염
건선
크론병
궤양성 대장염
강직성 척추염
기타 용도
세계의 휴미라 바이오시밀러 시장, 아달리무맙 바이오시밀러 종류별 하위 세분화, 실적과 예측, 2019-2024년, 2024-2029년, 2034년
완전 인간 단클론항체
프래그먼트 결정화 영역(Fc영역)을 개변한 바이오시밀러
고농도 제제
구연산 프리 처방
세계의 휴미라 바이오시밀러 시장, 기타 유형 하위 세분화, 유형별, 실적과 예측, 2019-2024년, 2024-2029년, 2034년
기타 종양괴사인자(TNF) 억제제 바이오시밀러
호환성 있는 바이오시밀러
페그화 바이오시밀러
아달리무맙 이외 단클론항체 바이오시밀러
제7장 지역별·국가별 분석
세계의 휴미라 바이오시밀러 시장 : 지역별, 실적과 예측, 2019-2024년, 2024-2029년, 2034년
세계의 휴미라 바이오시밀러 시장 : 국가별, 실적과 예측, 2019-2024년, 2024-2029년, 2034년
제8장 아시아태평양 시장
제9장 중국 시장
제10장 인도 시장
제11장 일본 시장
제12장 호주 시장
제13장 인도네시아 시장
제14장 한국 시장
제15장 서유럽 시장
제16장 영국 시장
제17장 독일 시장
제18장 프랑스 시장
제19장 이탈리아 시장
제20장 스페인 시장
제21장 동유럽 시장
제22장 러시아 시장
제23장 북미 시장
제24장 미국 시장
제25장 캐나다 시장
제26장 남미 시장
제27장 브라질 시장
제28장 중동 시장
제29장 아프리카 시장
제30장 경쟁 구도와 기업 개요
휴미라 바이오시밀러 시장 : 경쟁 구도
휴미라 바이오시밀러 시장 : 기업 개요
Pfizer Inc. Overview, Products and Services, Strategy and Financial Analysis
Merck & Co. Inc. Overview, Products and Services, Strategy and Financial Analysis
AbbVie Inc. Overview, Products and Services, Strategy and Financial Analysis
LG Chem Ltd. Overview, Products and Services, Strategy and Financial Analysis
Amgen Inc. Overview, Products and Services, Strategy and Financial Analysis
제31장 기타 주요 기업과 혁신적 기업
Teva Pharmaceutical Industries Ltd.
Boehringer Ingelheim GmbH
Mylan N.V.
Sandoz Group AG
Fresenius Kabi AG
Celltrion Inc.
Biocon Limited
Torrent Pharmaceuticals
Samsung Bioepis Co. Ltd.
Alvotech
Coherus BioSciences Inc.
Zydus Cadila
Hetero Drugs Ltd.
Fujifilm Kyowa Kirin Biologics
Synermore Biologics
제32장 세계의 시장 경쟁 벤치마킹과 대시보드
제33장 주요 인수합병
제34장 최근의 시장 동향
제35장 시장 잠재력이 높은 국가, 부문, 전략
휴미라 바이오시밀러 시장 2029년 : 새로운 기회를 제공하는 국가
휴미라 바이오시밀러 시장 2029년 : 새로운 기회를 제공하는 부문
휴미라 바이오시밀러 시장 2029년 : 성장 전략
시장 동향에 기반한 전략
경쟁 전략
제36장 부록
ksm
영문 목차
영문목차
A Humira biosimilar is a biologic drug developed to closely replicate Humira in the treatment of autoimmune disorders. It mirrors the original in terms of safety, effectiveness, and quality but is generally more affordable. By offering a cost-effective alternative, these biosimilars improve patient access to treatment while helping to reduce overall healthcare expenses.
The primary product types of Humira biosimilars include adalimumab biosimilars and others. Adalimumab biosimilars are biologic medications that closely resemble the reference anti-TNF drug Humira, offering equivalent safety, effectiveness, and quality in the treatment of autoimmune conditions. These biosimilars are distributed through various channels such as hospital pharmacies, retail pharmacies, online pharmacies, and others, and are used for a range of conditions including rheumatoid arthritis, psoriasis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, and more.
The humira biosimilars market research report is one of a series of new reports from The Business Research Company that provides humira biosimilars market statistics, including the humira biosimilars industry global market size, regional shares, competitors with the humira biosimilars market share, detailed humira biosimilars market segments, market trends, opportunities, and any further data you may need to thrive in the humira biosimilars industry. This humira biosimilars market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.
The humira biosimilar market size has grown rapidly in recent years. It will grow from $3.28 billion in 2024 to $3.70 billion in 2025 at a compound annual growth rate (CAGR) of 13.0%. The growth observed during the historic period can be attributed to the increasing demand for cost-effective alternatives, rising approval of biosimilars by regulatory bodies, the growing prevalence of autoimmune diseases, expanding healthcare access in emerging markets, and the high cost of original biologic drugs.
The humira biosimilar market size is expected to see rapid growth in the next few years. It will grow to $5.96 billion in 2029 at a compound annual growth rate (CAGR) of 12.6%. Looking ahead, growth in the forecast period is expected to be driven by advancements in biosimilar development technologies, increasing efforts to contain healthcare costs, the expiration of patents for original biologics, improvements in market access and reimbursement policies, and the rising adoption of biosimilars in oncology and autoimmune diseases. Key trends expected during this period include the increasing approval of additional biosimilars, advancements in manufacturing technologies, expanding research and development activities, the development and approval of new biosimilar drugs, and innovations in drug formulations.
The growing prevalence of autoimmune diseases is expected to drive the expansion of the Humira biosimilar market. Autoimmune diseases arise when the immune system mistakenly attacks healthy cells, tissues, or organs. This rise in cases is increasingly linked to environmental pollution, which can disrupt immune system function and elevate the risk of autoimmune reactions. Humira biosimilars function by blocking tumor necrosis factor (TNF), a protein responsible for causing inflammation in autoimmune conditions. By inhibiting TNF, these biosimilars help reduce the immune system's overactivity, relieve symptoms, and prevent damage to healthy tissue. For instance, in June 2024, the Australian Institute of Health and Welfare reported that an estimated 514,000 Australians (2.0% of the population) were living with rheumatoid arthritis in 2022, including 2.5% of females and 1.6% of males. As a result, the rising incidence of autoimmune diseases is boosting demand for Humira biosimilars.
Key players in the Humira biosimilar market are focused on advancing cost-effective TNF-blocking therapies to improve treatment accessibility for autoimmune diseases. TNF blockers are biologic medications that inhibit the action of TNF, reducing inflammation and disease symptoms. For example, in July 2023, Organon & Co., a U.S.-based pharmaceutical company, partnered with Samsung Bioepis, a South Korea-based biotech firm, to launch HADLIMA, a Humira biosimilar. HADLIMA is available in both citrate-free high-concentration (100 mg/mL) and citrate-containing low-concentration (50 mg/mL) formulations, mirroring the original Humira options. It is offered at a price approximately 85% lower than the originator's list price and is supported by patient assistance programs. This launch, permitted by a global settlement, significantly enhances affordability and access to autoimmune treatments in the U.S.
In February 2024, Alvotech, a Luxembourg-based biotech company, partnered with Teva Pharmaceuticals to introduce SIMLANDI, the first high-concentration, citrate-free interchangeable Humira biosimilar in the U.S. The collaboration aims to expand access to affordable adalimumab therapy, stimulate biosimilar market competition, and improve treatment outcomes for patients with chronic autoimmune diseases. Teva Pharmaceuticals is a U.S.-based pharmaceutical company.
Major players in the humira biosimilar market are Pfizer Inc., Merck & Co. Inc., AbbVie Inc., LG Chem Ltd., Amgen Inc., Teva Pharmaceutical Industries Ltd., Boehringer Ingelheim GmbH, Mylan N.V., Sandoz Group AG, Fresenius Kabi AG, Celltrion Inc., Biocon Limited, Torrent Pharmaceuticals, Samsung Bioepis Co. Ltd., Alvotech, Coherus BioSciences Inc., Zydus Cadila, Hetero Drugs Ltd., Fujifilm Kyowa Kirin Biologics, Synermore Biologics, and CVS Health.
North America was the largest region in the humira biosimilar market in 2024. The regions covered in humira biosimilar report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the humira biosimilar market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The humira biosimilar market consists of sales of prefilled syringes, autoinjector (AI) pens, and vials. 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 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.
Humira Biosimilar Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on humira biosimilar 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.
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Where is the largest and fastest growing market for humira biosimilar ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward? The humira biosimilar 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, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The market characteristics section of the report defines and explains the market.
The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
The forecasts are made after considering the major factors currently impacting the market. These include:
The forecasts are made after considering the major factors currently impacting the market. These include the Russia-Ukraine war, rising inflation, higher interest rates, and the legacy of the COVID-19 pandemic.
Market segmentations break down the market into sub markets.
The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth. It covers the growth trajectory of COVID-19 for all regions, key developed countries and major emerging markets.
The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
The trends and strategies section analyses the shape of the market as it emerges from the crisis and suggests how companies can grow as the market recovers.
Scope
Markets Covered:1) By Product Type: Adalimumab Biosimilars; Other Types
2) By Distribution Channel: Hospital Pharmacies; Retail Pharmacies; Online Pharmacies; Other Distribution Channels
3) By Application: Rheumatoid Arthritis; Psoriasis; Crohn's Disease; Ulcerative Colitis; Ankylosing Spondylitis; Other Applications
Subsegments:
1) By Adalimumab Biosimilars: Fully Human Monoclonal Antibodies; Fragment Crystallizable (Fc) Region Modified Biosimilars; High-Concentration Formulations; Citrate-Free Formulations
2) By Other Types: Biosimilars Of Other Tumor Necrosis Factor (TNF) Inhibitors; Interchangeable Biosimilars; Pegylated Biosimilars; Non-Adalimumab Monoclonal Antibody Biosimilars
Companies Mentioned: Pfizer Inc.; Merck & Co. Inc.; AbbVie Inc.; LG Chem Ltd.; Amgen Inc.
Regions: Asia-Pacific; Western Europe; Eastern Europe; North America; South America; Middle East; Africa
Time series: Five years historic and ten years forecast.
Data: Ratios of market size and growth to related markets, GDP proportions, expenditure per capita,
Data segmentations: country and regional historic and forecast data, market share of competitors, market segments.
Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.
Delivery Format: PDF, Word and Excel Data Dashboard.
Table of Contents
1. Executive Summary
2. Humira Biosimilar Market Characteristics
3. Humira Biosimilar Market Trends And Strategies
4. Humira Biosimilar Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market
5. Global Humira Biosimilar Growth Analysis And Strategic Analysis Framework
5.1. Global Humira Biosimilar PESTEL Analysis (Political, Social, Technological, Environmental and Legal Factors, Drivers and Restraints)
5.2. Analysis Of End Use Industries
5.3. Global Humira Biosimilar Market Growth Rate Analysis
5.4. Global Humira Biosimilar Historic Market Size and Growth, 2019 - 2024, Value ($ Billion)
5.5. Global Humira Biosimilar Forecast Market Size and Growth, 2024 - 2029, 2034F, Value ($ Billion)
5.6. Global Humira Biosimilar Total Addressable Market (TAM)
6. Humira Biosimilar Market Segmentation
6.1. Global Humira Biosimilar Market, Segmentation By Product Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Adalimumab Biosimilars
Other Types
6.2. Global Humira Biosimilar Market, Segmentation By Distribution Channel, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Hospital Pharmacies
Retail Pharmacies
Online Pharmacies
Other Distribution Channels
6.3. Global Humira Biosimilar Market, Segmentation By Application, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Rheumatoid Arthritis
Psoriasis
Crohn's Disease
Ulcerative Colitis
Ankylosing Spondylitis
Other Applications
6.4. Global Humira Biosimilar Market, Sub-Segmentation Of Adalimumab Biosimilars, By Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Fully Human Monoclonal Antibodies
Fragment Crystallizable (Fc) Region Modified Biosimilars
High-Concentration Formulations
Citrate-Free Formulations
6.5. Global Humira Biosimilar Market, Sub-Segmentation Of Other Types, By Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Biosimilars of Other Tumor Necrosis Factor (TNF) Inhibitors
Interchangeable Biosimilars
Pegylated Biosimilars
Non-Adalimumab Monoclonal Antibody Biosimilars
7. Humira Biosimilar Market Regional And Country Analysis
7.1. Global Humira Biosimilar Market, Split By Region, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
7.2. Global Humira Biosimilar Market, Split By Country, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
