모노클로널 항체 치료제 시장 : 세계 산업 규모, 점유율, 동향, 기회, 예측 - 제품 유형별, 용도별, 생산원별, 최종사용자별, 지역별, 경쟁(2021-2031년)
Monoclonal Antibody Therapeutics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product Type, By Application, By Production Source, By End User, By Region & Competition, 2021-2031F
상품코드:1953499
리서치사:TechSci Research
발행일:2026년 01월
페이지 정보:영문 180 Pages
라이선스 & 가격 (부가세 별도)
ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
한글목차
세계의 모노클로널 항체 치료제 시장은 2025년 2,472억 1,000만 달러에서 2031년까지 4,256억 7,000만 달러로 확대하며, CAGR 9.48%로 추이할 것으로 예측되고 있습니다. 이 치료제는 표적 세포를 공격하는 면역체계의 기능을 회복, 강화, 모방하는 대체 항체 역할을 하도록 실험실에서 설계된 분자로 구성되어 있습니다. 이러한 시장 성장은 주로 암과 자가면역질환을 포함한 만성질환의 발병률 증가로 인해 표적화된 의료 개입에 대한 수요가 증가하고, 고령화되는 세계 인구가 특정 생물학적 치료를 통해 노화 관련 질환을 효과적으로 관리하고자 하는 욕구가 높아진 것이 주요 요인으로 작용하고 있습니다.
시장 개요
예측 기간
2027-2031
시장 규모 : 2025년
2,472억 1,000만 달러
시장 규모 : 2031년
4,256억 7,000만 달러
CAGR : 2026-2031년
9.48%
가장 빠르게 성장하는 부문
인간화
최대 시장
북미
그러나 시장은 개발 및 제조에 따른 높은 비용과 관련된 심각한 장벽에 직면해 있으며, 이는 환자의 광범위한 접근을 제한하고 의료 예산에 부담을 줄 수 있습니다. 이러한 재정적 과제는 승인 절차의 기간을 연장시키는 엄격한 규제 기준에 의해 더욱 복잡해지고 있습니다. 이러한 과제를 극복하기 위한 업계의 지속적인 노력을 강조하는 형태로, 항체학회는 미국 식품의약국(FDA)이 2024년 15개의 치료용 항체 분자를 승인했다고 보고하여, 규제 복잡성을 극복하고 환자들에게 새로운 치료법을 제공하기 위한 지속적인 노력을 보여주고 있습니다.
시장 성장 촉진요인
세계 모노클로널 항체 치료제 시장의 주요 촉진요인은 질병 병태생리에 대한 임상적 이해도가 높아짐에 따라 맞춤형 의료와 표적치료제 채택이 확대되고 있다는 점입니다. 특히 종양학 및 면역학 분야에서 주요 체크포인트 억제제의 성공에서 알 수 있듯이, 의료 서비스 프로바이더는 특정 항원에 대해 정밀한 작용기전을 가진 생물제제를 점점 더 선호하고 있습니다. 미충족 수요를 충족시키기 위한 고효능 블록버스터에 대한 의존도는 머크가 2024년 2월에 발표한 보고서에서도 확인할 수 있습니다. 보고서에 따르면 키트루다의 세계 연간 매출액은 2023년 19% 증가하여 250억 달러에 달할 것으로 예상했습니다.
동시에 차세대 항체약물접합체(ADC) 개발을 가속화하기 위한 전략적 라이선스 계약과 제휴로 경쟁 구도가 재편되고 있습니다. 주요 제약사들은 길어지는 신약개발 단계를 피하고 귀중한 파이프라인 자산을 확보하기 위해 인수를 적극적으로 추진하고 있으며, 이러한 추세는 2023년 12월 화이자가 약 430억 달러(한화 약 4300억 원)에 시젠을 인수하여 종양학 자원을 두 배로 늘린 사례에서 잘 드러납니다. 두 배로 늘린 사례에서 두드러지게 나타나고 있습니다. 이 기세는 이듬해에도 이어져, 2024년 2월 보도자료를 통해 총 101억 달러에 ImmunoGen 인수를 완료했다고 발표하며 ADC 역량 확대에 대한 강한 의지를 강조했습니다.
시장이 해결해야 할 과제
세계 모노클로널 항체 치료제 시장의 성장은 이러한 복잡한 생물학적 의약품의 개발 및 제조에 따른 막대한 자금 비용으로 인해 크게 제약받고 있습니다. 화학적으로 합성된 저분자 화합물과 달리 모노클로널 항체는 살아있는 세포를 이용한 복잡한 제조 공정에 의존하며, 엄격한 환경 관리, 고가의 정제 시스템, 엄격한 품질 보증이 필요합니다. 이러한 복잡성은 막대한 설비투자를 필요로 하고, 진입장벽을 높게 설정하여 중소 바이오텍 기업의 진입을 막고 시장 지배력을 집중시킵니다. 결과적으로 가격 하락을 유도하는 경쟁의 다양성을 제한하는 결과를 초래합니다.
이러한 높은 운영비용은 최종 치료 제품의 고가화를 초래하여 시장 침투를 심각하게 저해하고 환자 접근성을 제한합니다. 의료제도와 민간 보험사는 비용 절감을 위해 엄격한 상환 기준을 적용하는 경우가 많으며, 이로 인해 많은 적격 환자가 필요한 치료를 받지 못하는 상황이 발생하고 있습니다. 유럽제약협회(EFPIA)에 따르면 유럽 제약업계는 2024년 유럽에서 약 550억 유로를 연구개발에 투자할 것으로 예상하고 있으며, 이는 혁신에 많은 자본이 필요하다는 것을 강조하고 있습니다. 이러한 재정적 압박으로 인해 제조업체는 투자 회수를 위해 높은 가격을 유지해야 하며, 이는 비용에 민감한 시장에서 채택률과 판매량 성장을 직접적으로 저해하고 있습니다.
시장 동향
항체공학 및 신약개발에 인공지능을 통합함으로써 기존 스크리닝 기술을 능가하는 최적화된 특성을 가진 생물제제의 데노보 설계를 가능하게 함으로써 개발 모델을 근본적으로 변화시키고 있습니다. 제약사들은 단백질 구조 및 결합 친화도 예측에 생성형 AI 모델을 적극 활용하여 복잡한 다특이성 항체의 개발 기간 단축 및 성공률 향상을 꾀하고 있습니다. 이러한 추세는 Xaira Therapeutics와 같은 AI 네이티브 바이오테크 기업에 대한 대규모 투자로 두드러집니다. 2024년 4월 Fierce Biotech 기사에 따르면 이 회사는 10억 달러 이상의 자금을 조달하여 통합 AI 기반 의약품 개발 플랫폼을 구축하기 시작했습니다.
이와 동시에 시장은 신경퇴행성 질환 영역으로의 전략적 확장을 추진하고 있으며, 기존 면역학 및 종양학 영역이 차지하고 있던 우위에 도전하고 있습니다. 최근 알츠하이머병 치료에서 질병 변형 치료제의 승인은 모노클로널 항체가 아밀로이드 베타 플라크를 제거하고 인지 기능 저하를 지연시키는 효능을 입증하여 이 분야에 결정적인 전환을 가져왔습니다. 이러한 잠재력은 매출 데이터에서도 나타나기 시작했으며, 바이오젠은 2024년 10월 레켄비의 3분기 전 세계 시장 매출이 약 6,700만 달러에 달했다고 보고했습니다. 이는 이러한 혁신적인 신경질환 치료에 대한 환자들의 높은 수용성과 인프라가 잘 갖추어져 있음을 보여줍니다.
목차
제1장 개요
제2장 조사 방법
제3장 개요
제4장 고객의 소리
제5장 세계의 모노클로널 항체 치료제 시장 전망
제6장 북미의 모노클로널 항체 치료제 시장 전망
제7장 유럽의 모노클로널 항체 치료제 시장 전망
제8장 아시아태평양의 모노클로널 항체 치료제 시장 전망
제9장 중동 및 아프리카의 모노클로널 항체 치료제 시장 전망
제10장 남미의 모노클로널 항체 치료제 시장 전망
제11장 시장 역학
제12장 시장 동향과 발전
제13장 세계의 모노클로널 항체 치료제 시장 : SWOT 분석
제14장 Porter's Five Forces 분석
제15장 경쟁 구도
제16장 전략적 제안
제17장 조사회사 소개·면책사항
KSA
영문 목차
영문목차
The Global Monoclonal Antibody Therapeutics Market is projected to expand from USD 247.21 Billion in 2025 to USD 425.67 Billion by 2031, reflecting a compound annual growth rate of 9.48%. These therapeutics consist of molecules engineered in laboratories to function as substitute antibodies that can restore, enhance, or mimic the immune system's ability to attack target cells. This market growth is principally driven by the rising incidence of chronic diseases, including cancer and autoimmune disorders, which create a strong need for targeted medical interventions, alongside a growing global geriatric population that demands effective management of age-related illnesses through specific biologic treatments.
Market Overview
Forecast Period
2027-2031
Market Size 2025
USD 247.21 Billion
Market Size 2031
USD 425.67 Billion
CAGR 2026-2031
9.48%
Fastest Growing Segment
Humanized
Largest Market
North America
However, the market encounters substantial obstacles related to the high costs inherent in development and manufacturing, which can restrict widespread patient access and impose strain on healthcare budgets. These financial hurdles are further complicated by stringent regulatory standards that extend the duration of the approval process. Highlighting the industry's continued dedication to overcoming these challenges, The Antibody Society reported that the US FDA approved 15 therapeutic antibody-based molecules in 2024, signaling sustained efforts to navigate regulatory complexities and bring new treatments to patients.
Market Driver
A primary catalyst for the global monoclonal antibody therapeutics market is the rising adoption of personalized medicine and targeted therapies, driven by a deeper clinical understanding of disease pathology. Healthcare providers are increasingly prioritizing biologics that deliver precise mechanisms against specific antigens, particularly within the fields of oncology and immunology, as evidenced by the success of leading checkpoint inhibitors. This reliance on high-efficacy blockbusters to meet critical unmet needs is illustrated by Merck & Co.'s report in February 2024, which noted that worldwide sales of Keytruda rose by 19 percent to reach $25.0 billion for the full year 2023.
Concurrently, the competitive landscape is being reshaped by strategic licensing agreements and collaborations aimed at accelerating the development of next-generation antibody-drug conjugates (ADCs). Major pharmaceutical companies are actively pursuing acquisitions to bypass lengthy discovery phases and secure valuable pipeline assets, a trend exemplified by Pfizer Inc.'s announcement in December 2023 that it completed the acquisition of Seagen for an enterprise value of approximately $43 billion to double its oncology resources. This momentum continued into the following year, as noted in a February 2024 press release from AbbVie Inc., which confirmed the finalization of its acquisition of ImmunoGen for a total equity value of roughly $10.1 billion, underscoring the intense focus on expanding ADC capabilities.
Market Challenge
The growth of the Global Monoclonal Antibody Therapeutics Market is heavily constrained by the immense financial costs involved in developing and manufacturing these complex biologic drugs. In contrast to chemically synthesized small molecules, monoclonal antibodies depend on intricate production methods using living cells, requiring strict environmental controls, costly purification systems, and rigorous quality assurance. This complexity necessitates significant capital expenditure, establishing high entry barriers that deter smaller biotechnology firms and consolidate market power, effectively limiting the competitive diversity required to foster price reductions.
These steep operational costs result in high prices for final therapeutic products, which severely limits market penetration and restricts patient access. Healthcare systems and private payers frequently impose stringent reimbursement criteria to control expenses, leaving many eligible patients without necessary treatments. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), the research-based pharmaceutical industry invested an estimated €55,000 million in R&D in Europe in 2024, highlighting the substantial capital required for innovation; such financial pressure compels manufacturers to sustain high prices to recover investments, which directly impedes adoption rates and volume growth in cost-sensitive markets.
Market Trends
The integration of artificial intelligence into antibody engineering and discovery is fundamentally transforming the development model by allowing for the de novo design of biologics with optimized traits, surpassing traditional screening techniques. Pharmaceutical entities are increasingly utilizing generative AI models to forecast protein structures and binding affinities, thereby shortening development timelines and enhancing success rates for complex multispecific antibodies. This trend is highlighted by significant investment in AI-native biotech firms, such as Xaira Therapeutics, which, according to a Fierce Biotech article from April 2024, launched with over $1 billion in committed capital to establish an integrated AI-driven drug development platform.
In parallel, the market is undergoing a strategic expansion into neurodegenerative disorders, challenging the historical dominance of immunology and oncology indications. Recent regulatory approvals for disease-modifying Alzheimer's therapies have validated the effectiveness of monoclonal antibodies in removing amyloid-beta plaques and slowing cognitive decline, creating a pivotal shift in the sector. This potential is beginning to reflect in revenue data, as Biogen Inc. reported in October 2024 that global in-market sales of Leqembi reached approximately $67 million for the third quarter, indicating strong patient uptake and infrastructure readiness for these innovative neurologic treatments.
Key Market Players
F. Hoffmann-La Roche Ltd.
Novartis AG
Merck & Co. Inc.
Pfizer Inc.
Eli Lilly and Co.
Sanofi S.A
AstraZeneca inc.
Bayer AG
Regeneron Pharmaceuticals Inc.
GSK Plc.
Report Scope
In this report, the Global Monoclonal Antibody Therapeutics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Monoclonal Antibody Therapeutics Market, By Product Type
Naked
Fusion Protein
Antibody Fragment
Conjugate
Multi-specific
Monoclonal Antibody Therapeutics Market, By Application
Cancer
Autoimmune Diseases
Infectious Diseases
Others
Monoclonal Antibody Therapeutics Market, By Production Source
Human
Humanized
Chimeric
Others
Monoclonal Antibody Therapeutics Market, By End User
Hospital
Specialty Centers
Research Institutes
Monoclonal Antibody Therapeutics Market, By Region
North America
United States
Canada
Mexico
Europe
France
United Kingdom
Italy
Germany
Spain
Asia Pacific
China
India
Japan
Australia
South Korea
South America
Brazil
Argentina
Colombia
Middle East & Africa
South Africa
Saudi Arabia
UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the Global Monoclonal Antibody Therapeutics Market.
Available Customizations:
Global Monoclonal Antibody Therapeutics Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:
Company Information
Detailed analysis and profiling of additional market players (up to five).
Table of Contents
1. Product Overview
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. Research Methodology
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. Executive Summary
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends
4. Voice of Customer
5. Global Monoclonal Antibody Therapeutics Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Product Type (Naked, Fusion Protein, Antibody Fragment, Conjugate, Multi-specific)
5.2.2. By Application (Cancer, Autoimmune Diseases, Infectious Diseases, Others)
5.2.3. By Production Source (Human, Humanized, Chimeric, Others)
5.2.4. By End User (Hospital, Specialty Centers, Research Institutes)
5.2.5. By Region
5.2.6. By Company (2025)
5.3. Market Map
6. North America Monoclonal Antibody Therapeutics Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Product Type
6.2.2. By Application
6.2.3. By Production Source
6.2.4. By End User
6.2.5. By Country
6.3. North America: Country Analysis
6.3.1. United States Monoclonal Antibody Therapeutics Market Outlook
6.3.1.1. Market Size & Forecast
6.3.1.1.1. By Value
6.3.1.2. Market Share & Forecast
6.3.1.2.1. By Product Type
6.3.1.2.2. By Application
6.3.1.2.3. By Production Source
6.3.1.2.4. By End User
6.3.2. Canada Monoclonal Antibody Therapeutics Market Outlook
6.3.2.1. Market Size & Forecast
6.3.2.1.1. By Value
6.3.2.2. Market Share & Forecast
6.3.2.2.1. By Product Type
6.3.2.2.2. By Application
6.3.2.2.3. By Production Source
6.3.2.2.4. By End User
6.3.3. Mexico Monoclonal Antibody Therapeutics Market Outlook
6.3.3.1. Market Size & Forecast
6.3.3.1.1. By Value
6.3.3.2. Market Share & Forecast
6.3.3.2.1. By Product Type
6.3.3.2.2. By Application
6.3.3.2.3. By Production Source
6.3.3.2.4. By End User
7. Europe Monoclonal Antibody Therapeutics Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Product Type
7.2.2. By Application
7.2.3. By Production Source
7.2.4. By End User
7.2.5. By Country
7.3. Europe: Country Analysis
7.3.1. Germany Monoclonal Antibody Therapeutics Market Outlook
7.3.1.1. Market Size & Forecast
7.3.1.1.1. By Value
7.3.1.2. Market Share & Forecast
7.3.1.2.1. By Product Type
7.3.1.2.2. By Application
7.3.1.2.3. By Production Source
7.3.1.2.4. By End User
7.3.2. France Monoclonal Antibody Therapeutics Market Outlook
7.3.2.1. Market Size & Forecast
7.3.2.1.1. By Value
7.3.2.2. Market Share & Forecast
7.3.2.2.1. By Product Type
7.3.2.2.2. By Application
7.3.2.2.3. By Production Source
7.3.2.2.4. By End User
7.3.3. United Kingdom Monoclonal Antibody Therapeutics Market Outlook
7.3.3.1. Market Size & Forecast
7.3.3.1.1. By Value
7.3.3.2. Market Share & Forecast
7.3.3.2.1. By Product Type
7.3.3.2.2. By Application
7.3.3.2.3. By Production Source
7.3.3.2.4. By End User
7.3.4. Italy Monoclonal Antibody Therapeutics Market Outlook
7.3.4.1. Market Size & Forecast
7.3.4.1.1. By Value
7.3.4.2. Market Share & Forecast
7.3.4.2.1. By Product Type
7.3.4.2.2. By Application
7.3.4.2.3. By Production Source
7.3.4.2.4. By End User
7.3.5. Spain Monoclonal Antibody Therapeutics Market Outlook
7.3.5.1. Market Size & Forecast
7.3.5.1.1. By Value
7.3.5.2. Market Share & Forecast
7.3.5.2.1. By Product Type
7.3.5.2.2. By Application
7.3.5.2.3. By Production Source
7.3.5.2.4. By End User
8. Asia Pacific Monoclonal Antibody Therapeutics Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Product Type
8.2.2. By Application
8.2.3. By Production Source
8.2.4. By End User
8.2.5. By Country
8.3. Asia Pacific: Country Analysis
8.3.1. China Monoclonal Antibody Therapeutics Market Outlook
8.3.1.1. Market Size & Forecast
8.3.1.1.1. By Value
8.3.1.2. Market Share & Forecast
8.3.1.2.1. By Product Type
8.3.1.2.2. By Application
8.3.1.2.3. By Production Source
8.3.1.2.4. By End User
8.3.2. India Monoclonal Antibody Therapeutics Market Outlook
8.3.2.1. Market Size & Forecast
8.3.2.1.1. By Value
8.3.2.2. Market Share & Forecast
8.3.2.2.1. By Product Type
8.3.2.2.2. By Application
8.3.2.2.3. By Production Source
8.3.2.2.4. By End User
8.3.3. Japan Monoclonal Antibody Therapeutics Market Outlook
8.3.3.1. Market Size & Forecast
8.3.3.1.1. By Value
8.3.3.2. Market Share & Forecast
8.3.3.2.1. By Product Type
8.3.3.2.2. By Application
8.3.3.2.3. By Production Source
8.3.3.2.4. By End User
8.3.4. South Korea Monoclonal Antibody Therapeutics Market Outlook
8.3.4.1. Market Size & Forecast
8.3.4.1.1. By Value
8.3.4.2. Market Share & Forecast
8.3.4.2.1. By Product Type
8.3.4.2.2. By Application
8.3.4.2.3. By Production Source
8.3.4.2.4. By End User
8.3.5. Australia Monoclonal Antibody Therapeutics Market Outlook
8.3.5.1. Market Size & Forecast
8.3.5.1.1. By Value
8.3.5.2. Market Share & Forecast
8.3.5.2.1. By Product Type
8.3.5.2.2. By Application
8.3.5.2.3. By Production Source
8.3.5.2.4. By End User
9. Middle East & Africa Monoclonal Antibody Therapeutics Market Outlook
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Product Type
9.2.2. By Application
9.2.3. By Production Source
9.2.4. By End User
9.2.5. By Country
9.3. Middle East & Africa: Country Analysis
9.3.1. Saudi Arabia Monoclonal Antibody Therapeutics Market Outlook
9.3.1.1. Market Size & Forecast
9.3.1.1.1. By Value
9.3.1.2. Market Share & Forecast
9.3.1.2.1. By Product Type
9.3.1.2.2. By Application
9.3.1.2.3. By Production Source
9.3.1.2.4. By End User
9.3.2. UAE Monoclonal Antibody Therapeutics Market Outlook
9.3.2.1. Market Size & Forecast
9.3.2.1.1. By Value
9.3.2.2. Market Share & Forecast
9.3.2.2.1. By Product Type
9.3.2.2.2. By Application
9.3.2.2.3. By Production Source
9.3.2.2.4. By End User
9.3.3. South Africa Monoclonal Antibody Therapeutics Market Outlook
9.3.3.1. Market Size & Forecast
9.3.3.1.1. By Value
9.3.3.2. Market Share & Forecast
9.3.3.2.1. By Product Type
9.3.3.2.2. By Application
9.3.3.2.3. By Production Source
9.3.3.2.4. By End User
10. South America Monoclonal Antibody Therapeutics Market Outlook
10.1. Market Size & Forecast
10.1.1. By Value
10.2. Market Share & Forecast
10.2.1. By Product Type
10.2.2. By Application
10.2.3. By Production Source
10.2.4. By End User
10.2.5. By Country
10.3. South America: Country Analysis
10.3.1. Brazil Monoclonal Antibody Therapeutics Market Outlook
10.3.1.1. Market Size & Forecast
10.3.1.1.1. By Value
10.3.1.2. Market Share & Forecast
10.3.1.2.1. By Product Type
10.3.1.2.2. By Application
10.3.1.2.3. By Production Source
10.3.1.2.4. By End User
10.3.2. Colombia Monoclonal Antibody Therapeutics Market Outlook
10.3.2.1. Market Size & Forecast
10.3.2.1.1. By Value
10.3.2.2. Market Share & Forecast
10.3.2.2.1. By Product Type
10.3.2.2.2. By Application
10.3.2.2.3. By Production Source
10.3.2.2.4. By End User
10.3.3. Argentina Monoclonal Antibody Therapeutics Market Outlook
10.3.3.1. Market Size & Forecast
10.3.3.1.1. By Value
10.3.3.2. Market Share & Forecast
10.3.3.2.1. By Product Type
10.3.3.2.2. By Application
10.3.3.2.3. By Production Source
10.3.3.2.4. By End User
11. Market Dynamics
11.1. Drivers
11.2. Challenges
12. Market Trends & Developments
12.1. Merger & Acquisition (If Any)
12.2. Product Launches (If Any)
12.3. Recent Developments
13. Global Monoclonal Antibody Therapeutics Market: SWOT Analysis
