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2024-2032 年按服务、剂型、应用、最终用户和地区分類的製剂开发外包市场报告Formulation Development Outsourcing Market Report by Service, Dosage Form, Application, End User, and Region 2024-2032 |
2023年,全球製剂开发IMARC Group市场规模达242亿美元。不断增加的研发(R&D)成本、不断增长的专业知识需求、加快的药物开发时间表、日益复杂的监管以及不断发展的製药行业是推动市场成长的一些主要因素。
研发 (R&D) 成本上升
製药公司面临高昂的研发成本,促使他们外包製剂开发以减少开支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 (R&D) 投资最高达到 305 亿美元。该公司的研发 (R&D) 投资在一年内实现了 126% 的惊人增长,目前占 2023 年总收入的 50.8%。收入而言,是领先的製药公司。这家製药巨头在研发支出方面排名第三,投资额约 151 亿美元,创纪录。製药业的扩张正在积极提高製剂开发外包市场的收入。
对专业知识的需求不断增加
药物配方日益复杂,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知识。例如,根据行业报告,印度製药公司在生物相似药等仿製药出口领域的全球影响力将表明其策略转向进一步扩张国际市场,特别是美国市场。为此,美国 FDA 关于製剂开发的指导成为印度製药公司实现这一目标的关键推动力。製剂开髮指南草案概述了开发药物製剂的监管要求和最佳实践,特别是针对美国市场的药物製剂。遵守这些指南不仅可以确保合规性,还可以提高药品的品质和功效。印度製药业专家表示,对于着眼全球扩张的印度製药公司来说,该指南为开发符合国际标准的高品质製剂提供了路线图,从而增强了其在全球舞台上的信誉和竞争力。外包合作伙伴提供必要的技能和尖端技术来开发复杂的药物配方,提高药品的品质和功效,从而创造积极的配方开发外包市场前景。
不断提高监管合规性
严格的监管要求需要全面且合规的配方流程,而具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 年达到新的製造标准,儘管小公司以债务负担为由要求推迟。根据修订后的 Schedule M 指南,製药公司必须向许可机构通报召回药品并报告产品缺陷、变质或生产缺陷。到目前为止,还没有向许可机构通报药品召回的规定。预计这将进一步促进市场成长。
IMARC Group提供了每个细分市场的主要趋势分析,以及 2024-2032 年全球、区域和国家层面的预测。我们的报告根据服务、剂型、应用和最终用户对市场进行了分类。
配方优化占大部分市场份额
该报告根据服务提供了详细的市场细分和分析。这包括製剂前服务(发现和临床前服务、分析服务)和製剂优化(第一阶段、第二阶段、第三阶段和第四阶段)。根据该报告,配方优化是最大的部分。
市场对配方优化的需求是由增强药物功效、稳定性和生物利用度的需求所驱动的。日益严格的监管审查需要稳健且合规的配方。此外,复杂和个人化药物的兴起需要精确的配方技术。外包提供了获得专业知识和先进技术的机会,从而实现高效优化。此外,加快上市时间和降低开发成本的压力进一步刺激了製药业对优化配方的需求。例如,2024 年 7 月,辉瑞宣布已选择其首选的每日一次改良释放製剂 danuglipron,这是一种口服胰高血糖素样胜肽 1 (GLP-1) 受体激动剂。展望未来,辉瑞计划在 2024 年下半年进行剂量优化研究,评估首选改良释放製剂的多个剂量,为註册支持研究提供资讯。
注射剂占产业最大份额
製剂开发外包市场报告还提供了基于剂型的详细市场区隔和分析。这包括注射剂、口服剂、外用剂等。报告称,注射剂占据最大的市场份额。
慢性病的日益普及以及对标靶和控制药物传递的需求推动了市场对注射剂型的需求。注射形式具有快速吸收和生物利用度,这对于重症监护和生物药物至关重要。此外,主要透过注射给药的生物製剂和生物相似药的成长也推动了这一需求。外包提供了专业製造能力和监管专业知识,确保高品质且合规的注射配方。这反过来又提高了製剂开发外包的整体市场价值。
肿瘤学代表了领先的细分市场
该报告根据应用程式提供了详细的市场细分和分析。这包括肿瘤学、遗传性疾病、神经病学、传染病、呼吸系统疾病、心血管疾病等。根据该报告,肿瘤学占最大的部分。
癌症治疗的复杂性和对专业知识的需求推动了肿瘤学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配方技术。高昂的研发 (R&D) 成本和严格的监管要求也需要外包来有效应对这些挑战,这推动了製剂开发外包需求。此外,加速新抗癌药物上市时间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表现出明显的主导地位
报告还提供了基于最终用户的详细市场细分和分析。这包括製药和生物製药公司以及政府和学术机构。报告显示,製药和生物製药公司占了最大的市场份额。
高昂的研发 (R&D) 成本、对专业知识和先进技术的需求推动了製药和生物製药公司对製剂开发外包的需求。外包有助于加快药物开发进度并确保合规性。新药配方(包括生物製剂和个人化药物)的复杂性需要外部专业知识,这进一步积极影响配方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功效、稳定性和市场准备度。
北美市场领先,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,其中包括北美(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。报告称,北美是製剂开发外包最大的区域市场。
高昂的研发(R&D)成本以及开发复杂药物配方对专业知识的需求正在推动该地区的市场成长。该地区严格的监管环境需要遵守严格的标准,外包合作伙伴可以有效管理这些标准。此外,生物技术和个人化医疗的兴起需要先进的配方解决方案,进一步推动了外包需求。根据对该地区製剂开发外包市场的预测,加速药物开发时间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 是一家全球营运服务提供商,致力于研发和GMP 药品开发、研发和GMP 分析以及无菌药品製造支持,宣布成立美国实体,使客户能够将以下便利结合起来:具有国际专业知识优势的本地服务。美国客户将由总部位于美国的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。
(请注意,这只是关键参与者的部分列表,报告中提供了完整列表。)
The global formulation development outsourcing market size reached US$ 24.2 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 40.4 Billion by 2032, exhibiting a growth rate (CAGR) of 5.6% during 2024-2032. 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.
IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2024-2032. Our report has categorized the market based on service, dosage form, application, and end user.
Formulation Optimization accounts for the majority of the market share
The report has provided a detailed breakup and analysis of the market based on the service. This includes pre-formulation services (discovery and preclinical services, analytical services) and formulation optimization (Phase I, Phase II, Phase III, and Phase IV). According to the report, formulation optimization represented the largest segment.
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
A detailed breakup and analysis of the market based on the dosage form have also been provided in the formulation development outsourcing market report. This includes injectable, oral, topical, and others. According to the report, injectable accounted for the largest market share.
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 report has provided a detailed breakup and analysis of the market based on the application. This includes oncology, genetic disorders, neurology, infectious diseases, respiratory, cardiovascular, and others. According to the report, oncology represented the largest 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
A detailed breakup and analysis of the market based on the end user have also been provided in the report. This includes pharmaceutical and biopharmaceutical companies and government and academic institutes. According to the report, pharmaceutical and biopharmaceutical companies accounted for the largest market share.
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.
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)