바이오의약품 첨가제 시장 분석 및 예측(-2034년) : 유형, 제품, 용도, 형태, 재료 유형, 최종사용자, 프로세스, 기능성, 기술
Biopharmaceutical Excipients Market Analysis and Forecast to 2034: Type, Product, Application, Form, Material Type, End User, Process, Functionality, Technology
상품코드:1838818
리서치사:Global Insight Services
발행일:2025년 10월
페이지 정보:영문 327 Pages
라이선스 & 가격 (부가세 별도)
한글목차
바이오의약품 첨가제 시장은 2024년 37억 달러에서 2034년 62억 달러에 이르고, 약 5.3%의 연평균 복합 성장률(CAGR)을 보일 것으로 예측됩니다. 바이오의약품 첨가제 시장에는 안정성, 생체 이용률, 환자 순응도를 보조하기 위해 바이오의약품의 유효 성분과 함께 배합되는 물질이 포함됩니다. 이러한 부형제는 약물 전달 시스템에서 매우 중요하며, 의약품의 효능과 안전성을 향상시킵니다. 생물학적 제제 및 바이오시밀러가 증가함에 따라 엄격한 규제 기준을 충족하는 혁신적인 부형제에 대한 수요가 증가하고 있습니다. 이 시장을 주도하는 것은 의약품 제제화 기술의 발전과 새로운 치료 대상의 복잡화입니다.
바이오의약품 첨가제 시장은 제제기술과 약물전달기술의 발전에 힘입어 큰 폭의 성장세를 보이고 있습니다. 폴리머 부문에서는 셀룰로오스 유도체와 폴리에틸렌글리콜이 범용성과 의약품 유효성분과의 적합성을 바탕으로 1위를 차지하고 있습니다. 당류와 폴리올이 그 뒤를 잇고 있으며, 소르비톨과 만니톨은 안정화 특성으로 인기를 끌고 있습니다. 신규 부형제 수요는 생물학적 제제 및 복합제제의 개발로 인해 증가하고 있습니다. 인지질과 트리글리세리드를 포함한 지질 기반 부형제는 난용성 약물 전달을 지원하는 두 번째로 높은 성능의 부형제 부문으로 부상하고 있습니다. 환자 중심의 약물 제형에 대한 관심이 높아지면서 생체이용률과 방출 제어를 향상시키는 부형제의 사용이 증가하고 있습니다. 또한, 혁신적인 부형제 개발에 대한 규제 당국의 지원은 시장 개척을 촉진하고 있습니다. 개인 맞춤형 의료와 표적 약물 전달 시스템에서 부형제의 통합은 부형제가 치료 효과와 환자 결과를 향상시키는 데 중요한 역할을 할 수 있다는 것을 분명히 하고 있으며, 시장 기업에게 유리한 기회를 제공합니다.
바이오의약품 첨가제 시장은 혁신적인 가격 전략과 신제품 출시의 급증에 따라 시장 점유율이 좌우되는 역동적인 변화를 목격하고 있습니다. 이 분야는 전략적 제휴와 파트너십이 매우 중요한 경쟁 환경입니다. 이러한 환경은 약물 전달과 효능을 높이기 위해 고안된 새로운 부형제의 도입을 촉진합니다. 각 업체들이 패권을 다투는 가운데, 품질과 비용 효율성이 강조되면서 진화하는 산업 수요에 대응하는 고도의 솔루션 개발이 추진되고 있습니다. 바이오의약품 첨가제 시장 내 경쟁은 치열하며, 주요 기업들은 경쟁력을 유지하기 위해 끊임없이 서로를 벤치마킹하고 있습니다. 특히 북미와 유럽 등의 지역에서는 규제의 영향이 시장 역학을 형성하는 데 중요한 역할을 하고 있습니다. 이러한 규제는 안전성과 유효성을 보장하기 위한 것으로, 각 기업은 엄격한 기준을 준수하면서 기술 혁신을 하도록 장려하고 있습니다. 또한, 시장은 미충족 수요를 충족시키고 유리한 기회를 활용하기 위한 강력한 R&D 활동이 특징이며, 이를 통해 지속적인 성장과 확장을 촉진하고 있습니다.
주요 동향 및 촉진요인
바이오의약품 첨가제 시장은 생물학적 제제와 바이오시밀러 수요 증가로 성장하고 있습니다. 바이오의약품 산업이 확대되는 가운데, 부형제는 약물의 안정성과 전달을 강화하는 데 있어 매우 중요한 역할을 합니다. 의약품 제제 기술의 발전은 다기능 부형제에 초점을 맞춘 부형제 개발의 기술 혁신을 촉진하고 있습니다. 규제 기관은 부형제의 품질과 안전성을 점점 더 중요시하고 있으며, 이는 시장 역학을 형성하는 엄격한 지침으로 이어지고 있습니다. 개인 맞춤형 의료의 추세는 특정 치료 요구에 맞는 특수 부형제에 대한 수요를 더욱 증가시키고 있습니다. 또한, 전 세계적으로 만성질환 증가는 바이오의약품에 대한 수요를 증가시켜 부형제 수요를 증가시키고 있습니다. 친환경 및 생분해성 부형제에 대한 관심이 높아지면서 지속가능성이 중요한 고려사항으로 떠오르고 있습니다. 새로운 부형제 연구개발에 투자하는 기업들은 새로운 기회를 활용할 준비가 되어 있습니다. 부형제 제조 공정에 디지털 기술을 통합하여 효율성과 제품 품질을 향상시키고 시장 경쟁력을 제공합니다.
억제와 과제:
바이오 의약품 첨가제 시장은 몇 가지 중요한 시장 성장 억제요인과 문제에 직면해 있습니다. 주요 과제 중 하나는 엄격한 규제 상황입니다. 규제 상황은 엄격한 규정 준수 요구 사항을 부과하고 있으며, 개발 및 승인 프로세스를 지연시키고 있습니다. 이는 비용 증가와 시장 진입 기간 연장으로 이어집니다. 또 다른 제약은 신규 부형제 개발 및 제조와 관련된 높은 비용입니다. 이러한 경제적 부담은 중소기업 시장 진입을 막고, 기술 혁신과 경쟁을 제한할 수 있습니다. 또한, 부형제와 의약품의 상호작용이 복잡하기 때문에 대규모 조사와 시험이 필요하며, 비용이 더욱 증가합니다. 공급망의 혼란은 품절과 가격 상승으로 이어져 생산 일정에 영향을 미치기 때문에 큰 문제가 될 수 있습니다. 또한, 업계 전반에 걸쳐 표준화가 이루어지지 않아 보편적인 가이드라인과 관행의 개발이 복잡해졌습니다. 마지막으로, 기술 발전 속도가 빠르기 때문에 연구 개발에 대한 지속적인 투자가 필요하며, 이는 자원을 압박하고 중소기업이 시장 리더를 따라잡는 데 방해가 될 수 있습니다.
Biopharmaceutical Excipients Market is anticipated to expand from $3.7 billion in 2024 to $6.2 billion by 2034, growing at a CAGR of approximately 5.3%. The Biopharmaceutical Excipients Market encompasses substances formulated alongside active ingredients in biopharmaceutical products to aid in stability, bioavailability, and patient compliance. These excipients are crucial in drug delivery systems, enhancing the efficacy and safety of medications. With the rise in biologics and biosimilars, there is a growing demand for innovative excipients that meet stringent regulatory standards. This market is driven by advancements in drug formulation technologies and the increasing complexity of new therapeutic entities.
The Biopharmaceutical Excipients Market is poised for significant growth, driven by advancements in drug formulation and delivery technologies. The polymers segment is the top-performing category, with cellulose derivatives and polyethylene glycols leading due to their versatility and compatibility with active pharmaceutical ingredients. Sugars and polyols follow, with sorbitol and mannitol gaining traction for their stabilizing properties. The demand for novel excipients is rising, fueled by the development of biologics and complex drug formulations. Lipid-based excipients, including phospholipids and triglycerides, are emerging as the second highest-performing segment, supporting the delivery of poorly soluble drugs. The increasing focus on patient-centric drug formulations propels the use of excipients that enhance bioavailability and controlled release. Moreover, regulatory support for innovative excipient development is fostering market expansion. The integration of excipients in personalized medicine and targeted drug delivery systems underscores their critical role in enhancing therapeutic efficacy and patient outcomes, presenting lucrative opportunities for market players.
Pharmaceutical Companies, Biotechnology Firms, Contract Research Organizations, Academic Research Institutes
Process
Granulation, Direct Compression, Lyophilization, Spray Drying
Functionality
Film Forming, Emulsifying, Suspending, Plasticizing
Technology
Nanotechnology, Micronization, Coacervation
Market Snapshot:
The biopharmaceutical excipients market is witnessing a dynamic shift, with market share being influenced by innovative pricing strategies and a surge in new product launches. The sector is marked by a competitive landscape where strategic collaborations and partnerships are pivotal. This environment fosters the introduction of novel excipients designed to enhance drug delivery and efficacy. As companies vie for dominance, there is a notable emphasis on quality and cost-effectiveness, driving the development of advanced solutions that cater to evolving industry demands. Competition within the biopharmaceutical excipients market is intense, with key players continuously benchmarking against each other to maintain a competitive edge. Regulatory influences, particularly in regions like North America and Europe, play a significant role in shaping market dynamics. These regulations ensure safety and efficacy, prompting companies to innovate while adhering to stringent standards. The market is further characterized by robust research and development activities, aimed at addressing unmet needs and capitalizing on lucrative opportunities, thereby driving sustained growth and expansion.
Geographical Overview:
The biopharmaceutical excipients market is witnessing robust growth across various regions, each exhibiting unique trends. North America remains a dominant player, driven by advanced pharmaceutical research and substantial investments in drug formulation technologies. The region's strong regulatory framework and emphasis on innovative drug delivery systems further bolster market expansion. Europe follows suit, with significant investments in biopharmaceutical research and development. The region's focus on sustainable and green excipients enhances its market appeal. In the Asia Pacific, rapid industrialization and increasing healthcare expenditure drive market growth. Countries like China and India are emerging as key players, with their expanding pharmaceutical manufacturing capabilities and favorable government policies. Latin America and the Middle East & Africa present promising growth pockets. Latin America benefits from increasing investments in pharmaceutical infrastructure, while the Middle East & Africa are recognizing the potential of biopharmaceutical excipients in advancing healthcare solutions and fostering economic growth.
Key Trends and Drivers:
The biopharmaceutical excipients market is experiencing growth due to the rising demand for biologics and biosimilars. As the biopharmaceutical industry expands, excipients are crucial in enhancing drug stability and delivery. Advances in drug formulation technologies are driving innovation in excipient development, with a focus on multifunctional excipients. Regulatory agencies are increasingly emphasizing excipient quality and safety, leading to stringent guidelines that shape market dynamics. The trend toward personalized medicine is further propelling the demand for specialized excipients tailored to specific therapeutic needs. Additionally, the increase in chronic diseases globally is boosting the need for biopharmaceuticals, thereby driving excipient demand. Sustainability is becoming a key consideration, with a growing interest in eco-friendly and biodegradable excipients. Companies investing in research and development of novel excipients are poised to capitalize on emerging opportunities. The integration of digital technologies in excipient manufacturing processes is enhancing efficiency and product quality, offering a competitive edge in the market.
Restraints and Challenges:
The biopharmaceutical excipients market faces several significant restraints and challenges. One primary challenge is the stringent regulatory landscape, which imposes rigorous compliance requirements, slowing down the development and approval process. This can lead to increased costs and extended timelines for market entry. Another restraint is the high cost associated with the development and manufacturing of novel excipients. This financial burden can deter smaller companies from entering the market, limiting innovation and competition. Additionally, the complexity of excipient-drug interactions necessitates extensive research and testing, further inflating costs. Supply chain disruptions also pose a significant challenge, as they can lead to shortages and increased prices, affecting production schedules. Moreover, there is a lack of standardization across the industry, complicating the development of universal guidelines and practices. Lastly, the rapid pace of technological advancements requires continuous investment in research and development, which can strain resources and hinder smaller players from keeping up with market leaders.
Estimates and forecasts the overall market size across type, application, and region.
Provides detailed information and key takeaways on qualitative and quantitative trends, dynamics, business framework, competitive landscape, and company profiling.
Identifies factors influencing market growth and challenges, opportunities, drivers, and restraints.
Identifies factors that could limit company participation in international markets to help calibrate market share expectations and growth rates.
Evaluates key development strategies like acquisitions, product launches, mergers, collaborations, business expansions, agreements, partnerships, and R&D activities.
Analyzes smaller market segments strategically, focusing on their potential, growth patterns, and impact on the overall market.
Outlines the competitive landscape, assessing business and corporate strategies to monitor and dissect competitive advancements.
Our research scope provides comprehensive market data, insights, and analysis across a variety of critical areas. We cover Local Market Analysis, assessing consumer demographics, purchasing behaviors, and market size within specific regions to identify growth opportunities. Our Local Competition Review offers a detailed evaluation of competitors, including their strengths, weaknesses, and market positioning. We also conduct Local Regulatory Reviews to ensure businesses comply with relevant laws and regulations. Industry Analysis provides an in-depth look at market dynamics, key players, and trends. Additionally, we offer Cross-Segmental Analysis to identify synergies between different market segments, as well as Production-Consumption and Demand-Supply Analysis to optimize supply chain efficiency. Our Import-Export Analysis helps businesses navigate global trade environments by evaluating trade flows and policies. These insights empower clients to make informed strategic decisions, mitigate risks, and capitalize on market opportunities.
TABLE OF CONTENTS
1: Biopharmaceutical Excipients Market Overview
1.1 Objectives of the Study
1.2 Biopharmaceutical Excipients Market Definition and Scope of the Report
1.3 Report Limitations
1.4 Years & Currency Considered in the Study
1.5 Research Methodologies
1.5.1 Secondary Research
1.5.2 Primary Research
1.5.3 Market Size Estimation: Top-Down Approach
1.5.4 Market Size Estimation: Bottom-Up Approach
1.5.5 Data Triangulation and Validation
2: Executive Summary
2.1 Summary
2.2 Key Opinion Leaders
2.3 Key Highlights of the Market, by Type
2.4 Key Highlights of the Market, by Product
2.5 Key Highlights of the Market, by Application
2.6 Key Highlights of the Market, by Form
2.7 Key Highlights of the Market, by Material Type
2.8 Key Highlights of the Market, by End User
2.9 Key Highlights of the Market, by Process
2.10 Key Highlights of the Market, by Functionality
2.11 Key Highlights of the Market, by Technology
2.12 Key Highlights of the Market, by North America
2.13 Key Highlights of the Market, by Europe
2.14 Key Highlights of the Market, by Asia-Pacific
2.15 Key Highlights of the Market, by Latin America
2.16 Key Highlights of the Market, by Middle East
2.17 Key Highlights of the Market, by Africa
3: Premium Insights on the Market
3.1 Market Attractiveness Analysis, by Region
3.2 Market Attractiveness Analysis, by Type
3.3 Market Attractiveness Analysis, by Product
3.4 Market Attractiveness Analysis, by Application
3.5 Market Attractiveness Analysis, by Form
3.6 Market Attractiveness Analysis, by Material Type
3.7 Market Attractiveness Analysis, by End User
3.8 Market Attractiveness Analysis, by Process
3.9 Market Attractiveness Analysis, by Functionality
3.10 Market Attractiveness Analysis, by Technology
3.11 Market Attractiveness Analysis, by North America
3.12 Market Attractiveness Analysis, by Europe
3.13 Market Attractiveness Analysis, by Asia-Pacific
3.14 Market Attractiveness Analysis, by Latin America
3.15 Market Attractiveness Analysis, by Middle East
