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市場調查報告書
商品編碼
1831858
2025 年至 2033 年製劑開發外包市場報告(按服務、劑型、應用、最終用戶和地區)Formulation Development Outsourcing Market Report by Service, Dosage Form, Application, End User, and Region 2025-2033 |
2024年,全球製劑開發外包市場規模達255億美元。展望未來, IMARC Group預計到2033年,市場規模將達到410億美元,2025-2033年期間的複合年成長率(CAGR)為5.4%。研發成本的不斷成長、對專業知識需求的不斷成長、藥物開發週期的加快、監管複雜性的日益增加以及製藥行業的蓬勃發展,是推動市場成長的主要因素。
研發成本上升
製藥公司面臨高昂的研發成本,這促使它們將配方開發外包以降低費用並更有效地分配資源。例如,根據產業報告,默克公司 2023 會計年度的營收達到 601 億美元,研發投資達到最高 305 億美元。該公司的研發投資在一年內實現了驚人的 126% 的成長,目前佔 2023 年總收入的 50.8%。同樣,2023 年強生 (J&J) 表現出強勁的財務成長,並成為營收方面領先的製藥公司。這家製藥巨頭在研發支出方面排名第三,投資約 151 億美元,創下公司歷史新高。製藥業的擴張正積極提升配方開發外包市場的收入。
對專業知識的需求日益成長
藥物製劑日益複雜,需要專業知識和先進技術,而許多製藥公司內部可能缺乏這些能力。例如,根據產業報告,印度製藥公司在學名藥(包括生物相似藥)等產品出口領域的全球影響力,預示著將進一步拓展國際市場,尤其是美國市場的戰略轉型。為此,美國食品藥物管理局(FDA)關於製劑開發的指南,對印度製藥公司實現這一目標至關重要。該製劑開發指南草案概述了開發藥物製劑(尤其是面向美國市場的製劑)的監管要求和最佳實踐。遵守這些指南不僅可以確保合規性,還能提高藥品的品質和療效。印度製藥業專家表示,對於著眼於全球擴張的印度製藥公司而言,此類指南提供了開發符合國際標準的高品質製劑的路線圖,從而增強其在全球市場的信譽和競爭力。外包合作夥伴提供開發複雜藥物製劑所需的技能和尖端技術,從而提高藥品的品質和療效,從而為製劑開發外包市場創造了積極的前景。
監理合規性不斷提高
嚴格的監管要求需要全面合規的配方流程,而擁有監管專業知識的外包合作夥伴可以有效地管理這些流程。例如,根據行業報告,印度製藥公司必須根據聯邦衛生部的通知,在2024年達到新的生產標準,儘管一些小型公司以債務負擔為由要求延期。根據修訂後的Schedule M指南,製藥公司必須將藥品召回事宜告知許可機構,並報告產品缺陷、變質或生產故障。此前,尚無關於藥品召回事宜告知許可機構的規定。預計這將進一步促進市場成長。
配方最佳化佔據大部分市場佔有率
市場對製劑最佳化的需求源自於對增強藥物療效、穩定性和生物利用度的需求。日益嚴格的監管審查要求製劑必須穩健合規性。此外,複雜和個人化藥物的興起也對精準的製劑技術提出了更高的要求。外包能夠提供專業知識和先進技術,從而實現高效的最佳化。此外,加快上市時間和降低開發成本的壓力進一步推動了製藥業對最佳化製劑的需求。例如,輝瑞公司於2024年7月宣布,已選定其首選的每日一次口服胰高血糖素樣肽-1 (GLP-1) 受體激動劑達格利隆 (Danuglipron) 的緩釋製劑。展望未來,輝瑞計劃在2024年下半年進行劑量最佳化研究,評估此優選緩釋製劑的多種劑量,為註冊授權研究提供資訊。
注射劑佔產業最大佔有率
市場對注射劑型的需求源於慢性疾病日益成長的盛行率以及對標靶和可控給藥的需求。注射劑型吸收迅速、生物利用度高,這對於重症監護和生物製劑至關重要。此外,主要透過注射給藥的生物製劑和生物相似藥的興起也推動了這一需求。外包提供了獲得專業製造能力和監管專業知識的機會,確保注射劑型的高品質和合規性。這反過來又提升了製劑開發外包市場的整體價值。
腫瘤學是領先的細分市場
腫瘤治療的複雜性和對專業知識的需求推動了腫瘤製劑開發外包的需求。標靶治療和個人化醫療的進步需要創新的製劑技術。高昂的研發成本和嚴格的監管要求也使得外包成為必要,以有效應對這些挑戰,從而推動了製劑開發外包需求的成長。此外,加速新型抗癌藥物上市速度的迫切性促使製藥公司尋求在腫瘤製劑開發方面擁有先進技術和經驗的外部合作夥伴。
製藥和生物製藥公司在市場上佔據明顯主導地位
製藥和生物製藥公司對製劑開發外包的需求源自於高昂的研發成本、對專業知識和先進技術的需求。外包有助於加快藥物開發進度並確保合規性。包括生物製劑和個人化藥物在內的新藥製劑的複雜性需要外部專業知識,這進一步促進了製劑開發外包市場的成長。此外,外包使公司能夠專注於核心競爭力,同時利用專業合作夥伴的創新解決方案來提高藥物的療效、穩定性和市場準備度。
北美引領市場,佔據最大的製劑開發外包市場佔有率
該報告還對所有主要區域市場進行了全面分析,包括北美(美國和加拿大);歐洲(德國、法國、英國、義大利、西班牙、俄羅斯等);亞太地區(中國、日本、印度、韓國、澳洲、印尼等);拉丁美洲(巴西、墨西哥等);以及中東和非洲。報告指出,北美是製劑開發外包最大的區域市場。
高昂的研發成本以及開發複雜藥物製劑所需的專業知識,推動著該地區市場的成長。該地區嚴格的監管環境要求遵守嚴格的標準,而外包合作夥伴可以有效地管理這些標準。此外,生物技術和個人化醫療的興起需要先進的製劑解決方案,這進一步推動了外包需求。根據該地區製劑開發外包市場的預測,加速藥物開發進度和縮短上市時間的壓力也促進了該市場的成長。例如,2024年5月, Coriolis Pharma(一家全球營運的研發和GMP藥品開發、研發和GMP分析以及無菌藥品生產支援服務提供者)宣布成立美國公司,使客戶能夠將本地服務的便利性與國際專業知識的優勢相結合。美國客戶將由位於美國的Coriolis商業組織提供服務,該組織由業務開發和客戶專案管理專業人員組成。
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.