![]() |
市场调查报告书
商品编码
1831858
2025 年至 2033 年製剂开发外包市场报告(按服务、剂型、应用、最终用户和地区)Formulation Development Outsourcing Market Report by Service, Dosage Form, Application, End User, and Region 2025-2033 |
2024年,全球製剂开发外包市场规模达255亿美元。展望未来, IMARC Group预计到2033年,市场规模将达到410亿美元,2025-2033年期间的复合年增长率(CAGR)为5.4%。研发成本的不断增长、对专业知识需求的不断增长、药物开发週期的加快、监管复杂性的日益增加以及製药行业的蓬勃发展,是推动市场成长的主要因素。
研发成本上升
製药公司面临高昂的研发成本,这促使它们将配方开发外包以降低费用并更有效地分配资源。例如,根据产业报告,默克公司 2023 财年的营收达到 601 亿美元,研发投资达到最高 305 亿美元。该公司的研发投资在一年内实现了惊人的 126% 的成长,目前占 2023 年总收入的 50.8%。同样,2023 年强生 (J&J) 表现出强劲的财务成长,并成为营收方面领先的製药公司。这家製药巨头在研发支出方面排名第三,投资约 151 亿美元,创下公司历史新高。製药业的扩张正积极提升配方开发外包市场的收入。
对专业知识的需求日益增长
药物製剂日益复杂,需要专业知识和先进技术,而许多製药公司内部可能缺乏这些能力。例如,根据产业报告,印度製药公司在仿製药(包括生物相似药)等产品出口领域的全球影响力,预示着将进一步拓展国际市场,尤其是美国市场的战略转型。为此,美国食品药物管理局(FDA)关于製剂开发的指南,对印度製药公司实现这一目标至关重要。该製剂开髮指南草案概述了开发药物製剂(尤其是面向美国市场的製剂)的监管要求和最佳实践。遵守这些指南不仅可以确保合规性,还能提高药品的品质和疗效。印度製药业专家表示,对于着眼于全球扩张的印度製药公司而言,此类指南提供了开发符合国际标准的高品质製剂的路线图,从而增强其在全球市场的信誉和竞争力。外包合作伙伴提供开发复杂药物製剂所需的技能和尖端技术,从而提高药品的品质和疗效,从而为製剂开发外包市场创造了积极的前景。
监理合规性不断提高
严格的监管要求需要全面合规的配方流程,而拥有监管专业知识的外包合作伙伴可以有效地管理这些流程。例如,根据行业报告,印度製药公司必须根据联邦卫生部的通知,在2024年达到新的生产标准,儘管一些小型公司以债务负担为由要求延期。根据修订后的Schedule M指南,製药公司必须将药品召回事宜告知许可机构,并报告产品缺陷、变质或生产故障。此前,尚无关于药品召回事宜告知许可机构的规定。预计这将进一步促进市场成长。
配方优化占据大部分市场份额
市场对製剂优化的需求源自于对增强药物疗效、稳定性和生物利用度的需求。日益严格的监管审查要求製剂必须稳健合规性。此外,复杂和个人化药物的兴起也对精准的製剂技术提出了更高的要求。外包能够提供专业知识和先进技术,从而实现高效的最佳化。此外,加快上市时间和降低开发成本的压力进一步推动了製药业对优化製剂的需求。例如,辉瑞公司于2024年7月宣布,已选定其首选的每日一次口服胰高血糖素样肽-1 (GLP-1) 受体激动剂达格利隆 (Danuglipron) 的缓释製剂。展望未来,辉瑞计划在2024年下半年进行剂量优化研究,评估此优选缓释製剂的多种剂量,为註册授权研究提供资讯。
注射剂占产业最大份额
市场对注射剂型的需求源于慢性疾病日益增长的盛行率以及对标靶和可控给药的需求。注射剂型吸收迅速、生物利用度高,这对于重症监护和生物製剂至关重要。此外,主要透过注射给药的生物製剂和生物相似药的兴起也推动了这一需求。外包提供了获得专业製造能力和监管专业知识的机会,确保注射剂型的高品质和合规性。这反过来又提升了製剂开发外包市场的整体价值。
肿瘤学是领先的细分市场
肿瘤治疗的复杂性和对专业知识的需求推动了肿瘤製剂开发外包的需求。标靶治疗和个人化医疗的进步需要创新的製剂技术。高昂的研发成本和严格的监管要求也使得外包成为必要,以有效应对这些挑战,从而推动了製剂开发外包需求的成长。此外,加速新型抗癌药物上市速度的迫切性促使製药公司寻求在肿瘤製剂开发方面拥有先进技术和经验的外部合作伙伴。
製药和生物製药公司在市场上占据明显主导地位
製药和生物製药公司对製剂开发外包的需求源自于高昂的研发成本、对专业知识和先进技术的需求。外包有助于加快药物开发进度并确保合规性。包括生物製剂和个人化药物在内的新药製剂的复杂性需要外部专业知识,这进一步促进了製剂开发外包市场的成长。此外,外包使公司能够专注于核心竞争力,同时利用专业合作伙伴的创新解决方案来提高药物的疗效、稳定性和市场准备度。
北美引领市场,占据最大的製剂开发外包市场份额
该报告还对所有主要区域市场进行了全面分析,包括北美(美国和加拿大);欧洲(德国、法国、英国、义大利、西班牙、俄罗斯等);亚太地区(中国、日本、印度、韩国、澳洲、印尼等);拉丁美洲(巴西、墨西哥等);以及中东和非洲。报告指出,北美是製剂开发外包最大的区域市场。
高昂的研发成本以及开发复杂药物製剂所需的专业知识,推动着该地区市场的成长。该地区严格的监管环境要求遵守严格的标准,而外包合作伙伴可以有效地管理这些标准。此外,生物技术和个人化医疗的兴起需要先进的製剂解决方案,这进一步推动了外包需求。根据该地区製剂开发外包市场的预测,加速药物开发进度和缩短上市时间的压力也促进了该市场的成长。例如,2024年5月, Coriolis Pharma(一家全球营运的研发和GMP药品开发、研发和GMP分析以及无菌药品生产支援服务提供者)宣布成立美国公司,使客户能够将本地服务的便利性与国际专业知识的优势相结合。美国客户将由位于美国的Coriolis商业组织提供服务,该组织由业务开发和客户专案管理专业人员组成。
The global formulation development outsourcing market size reached USD 25.5 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 41.0 Billion by 2033, exhibiting a growth rate (CAGR) of 5.4% during 2025-2033. The increasing research and development (R&D) costs, the rising need for specialized expertise, accelerated drug development timelines, growing regulatory complexities, and the growing pharmaceutical sector are some of the major factors propelling the growth of the market.
Rising Research and Development (R&D) Costs
Pharmaceutical companies face high costs in research and development (R&D), prompting them to outsource formulation development to reduce expenses and allocate resources more efficiently. For instance, according to industry reports, Merck & Co's revenues reached $60.1bn in FY 2023, with research and development (R&D) investments peaking at $30.5bn. Displaying a staggering 126% growth over the course of one year, the company's research and development (R&D) investments now represent 50.8% of its total revenue for 2023. Similarly, in 2023 Johnson & Johnson (J&J) displayed strong financial growth and was the leading pharmaceutical company in terms of revenues. The pharma giant ranked third in terms of R&D expenditure, investing approximately $15.1bna record-breaking figure for the company. The pharmaceutical industry's expansion is positively enhancing the formulation development outsourcing market revenue.
Increasing Need for Specialized Expertise
The growing complexity of drug formulations requires specialized expertise and advanced technologies, which many pharmaceutical companies may lack internally. For instance, according to industry reports, Indian pharma's global presence in generic medicine exports among others like biosimilars will indicate a strategic shift toward further expansion in the international markets, particularly the US. To this end, the guidance from the US FDA on formulation development serves as a crucial enabler for Indian pharma companies in this pursuit. The draft guidance on formulation development outlines the regulatory requirements and best practices for developing drug formulations, especially those intended for the US market. Adhering to these guidelines not only ensures compliance but also enhances the quality and efficacy of pharmaceutical products. According to Indian pharma industry experts, for Indian pharmaceutical firms eyeing global expansion, such guidance provides a roadmap for developing high-quality formulations that meet international standards, thereby bolstering their credibility and competitiveness in the global arena. Outsourcing partners offer the necessary skills and cutting-edge technologies to develop sophisticated drug formulations that enhance the quality and efficacy of pharmaceutical products, thereby creating a positive formulation development outsourcing market outlook.
Growing Regulatory Compliance
Stringent regulatory requirements necessitate comprehensive and compliant formulation processes, which outsourcing partners with regulatory expertise can effectively manage. For instance, according to industry reports, Indian pharmaceutical companies must meet new manufacturing standards in 2024, as per a Union Health Ministry notification, although small companies have asked for a delay, citing their debt load. Under the revised Schedule M guidelines, pharmaceutical companies will have to inform the licensing authority about recalling a drug and report product defects, deterioration, or faulty production. Till now there was no provision for informing the licensing authority about drug recall. This is further expected to facilitate the market growth.
Formulation Optimization accounts for the majority of the market share
The demand for formulation optimization in the market is driven by the need for enhanced drug efficacy, stability, and bioavailability. Increasing regulatory scrutiny necessitates robust and compliant formulations. Additionally, the rise of complex and personalized medicines requires precise formulation techniques. Outsourcing provides access to specialized expertise and advanced technologies, enabling efficient optimization. Moreover, the pressure to accelerate time-to-market and reduce development costs further fuels the demand for optimized formulations in the pharmaceutical industry. For instance, in July 2024, Pfizer announced that it had selected its preferred once-daily modified-release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist. Looking ahead, Pfizer plans to conduct dose optimization studies in the second half of 2024, evaluating multiple doses of the preferred modified release formulation to inform the registration enabling studies.
Injectable holds the largest share of the industry
The demand for injectable dosage forms in the market is driven by the growing prevalence of chronic diseases and the need for targeted and controlled drug delivery. Injectable forms offer rapid absorption and bioavailability, essential for critical care and biologic drugs. Additionally, the rise in biologics and biosimilars, which are predominantly administered via injection, fuels this demand. Outsourcing provides access to specialized manufacturing capabilities and regulatory expertise, ensuring high-quality and compliant injectable formulations. This, in turn, is enhancing the overall formulation development outsourcing market value.
Oncology represents the leading market segment
The demand for formulation development outsourcing in oncology is driven by the complexity of cancer treatments and the need for specialized expertise. Advancements in targeted therapies and personalized medicine require innovative formulation techniques. High research and development (R&D) costs and stringent regulatory requirements also necessitate outsourcing to manage these challenges efficiently which is driving the formulation development outsourcing demand. Additionally, the urgency to accelerate time-to-market for new cancer drugs pushes pharmaceutical companies to seek external partners with advanced technologies and experience in oncology formulation development.
Pharmaceutical and biopharmaceutical companies exhibits a clear dominance in the market
The demand for formulation development outsourcing in pharmaceutical and biopharmaceutical companies is driven by high research and development (R&D) costs, the need for specialized expertise, and advanced technologies. Outsourcing helps accelerate drug development timelines and ensures regulatory compliance. The complexity of new drug formulations, including biologics and personalized medicines, necessitates external expertise which is further influencing formulation development outsourcing market growth positively. Additionally, outsourcing allows companies to focus on core competencies while leveraging innovative solutions from specialized partners to enhance drug efficacy, stability, and market readiness.
North America leads the market, accounting for the largest formulation development outsourcing market share
The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represents the largest regional market for formulation development outsourcing.
The high research and development (R&D) costs and the need for specialized expertise to develop complex drug formulations are driving the market growth in the region. The region's stringent regulatory environment necessitates compliance with rigorous standards, which outsourcing partners can manage efficiently. Additionally, the rise of biotechnology and personalized medicine requires advanced formulation solutions, further boosting the demand for outsourcing. According to the formulation development outsourcing market forecast across the region, the pressure to accelerate drug development timelines and reduce time-to-market also contributes to the growth of this market. For instance, in May 2024, Coriolis Pharma, a globally operating service provider for R&D and GMP drug product development, R&D and GMP analytics, and sterile drug product manufacturing support, announced the launch of a U.S. entity that allows customers to combine the convenience of a local service with the advantages of international expertise. U.S. customers will be served by the U.S.-based Coriolis commercial organization, which consists of business development and client project management professionals.