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市場調查報告書
商品編碼
1561426
2024-2032 年按服務、劑型、應用、最終用戶和地區分類的製劑開發外包市場報告Formulation Development Outsourcing Market Report by Service, Dosage Form, Application, End User, and Region 2024-2032 |
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2023年，全球製劑開發IMARC Group市場規模達242億美元。不斷增加的研發（R&D）成本、不斷成長的專業知識需求、加快的藥物開發時間表、日益複雜的監管以及不斷發展的製藥行業是推動市場成長的一些主要因素。
製劑開發外包市場分析：
- 主要市場促進因素：不斷上升的研發（R＆D）成本和對專業知識不斷成長的需求是市場的主要促進因素。製藥公司擴大進行外包，以減少開支並獲得先進技術，從而提高藥物開發效率。
- 主要市場趨勢：廣泛採用人工智慧（AI）和機器學習（ML）等先進技術來最佳化藥物配方代表了市場的主要趨勢。市場也經歷了製藥公司與外包提供者之間的策略夥伴關係和長期合作的轉變。
- 地理趨勢：根據製劑開發外包市場概況，北美佔市場最大區域。高昂的研發（R＆D）成本、對專業知識不斷成長的需求、嚴格的監管要求以及對加速藥物開發的日益關注正在推動該地區市場的成長。
- 競爭格局：製劑開發外包產業的一些主要市場參與者包括 Aizant Drug Research Solutions Private Limited、Catalent Inc.、Charles River Laboratories、Dr. Reddy's Laboratories Ltd.、Emergent BioSolutions Inc.、Intertek Group plc、Irisys LLC（ Recro Pharma )、Laboratory Corporation of America Holdings、Lonza Group AG、Piramal Pharma Solutions、Quotient Sciences、Syngene International Limited (Biocon Limited) 和Thermo Fisher Scientific Inc. 等。
- 挑戰與機會：市場面臨各種挑戰，包括監管合規複雜性、智慧財產權問題以及嚴格品質控制的需要。然而，市場也面臨一些機遇，例如對先進藥物配方的需求不斷增加、個人化醫療的成長以及人工智慧（AI）和機器學習（ML）等技術進步。
製劑開發外包市場趨勢：
研發 (R&D) 成本上升
製藥公司面臨高昂的研發成本，促使他們外包製劑開發以減少開支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 (R&D) 投資最高達到 305 億美元。該公司的研發 (R&D) 投資在一年內實現了 126% 的驚人成長，目前佔 2023 年總收入的 50.8%。收入而言，是領先的製藥公司。這家製藥巨頭在研發支出方面排名第三，投資額約 151 億美元，創紀錄。製藥業的擴張正在積極提高製劑開發外包市場的收入。
對專業知識的需求不斷增加
藥物配方日益複雜，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知識。例如，根據行業報告，印度製藥公司在生物相似藥等學名藥出口領域的全球影響力將表明其策略轉向進一步擴張國際市場，特別是美國市場。為此，美國 FDA 關於製劑開發的指導成為印度製藥公司實現這一目標的關鍵推動力。製劑開發指南草案概述了開發藥物製劑的監管要求和最佳實踐，特別是針對美國市場的藥物製劑。遵守這些指南不僅可以確保合規性，還可以提高藥品的品質和功效。印度製藥業專家表示，對於著眼全球擴張的印度製藥公司來說，該指南為開發符合國際標準的高品質製劑提供了路線圖，從而增強了其在全球舞台上的信譽和競爭力。外包合作夥伴提供必要的技能和尖端技術來開發複雜的藥物配方，提高藥品的品質和功效，從而創造積極的配方開發外包市場前景。
不斷提高監管合規性
嚴格的監管要求需要全面且合規的配方流程，而具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 年達到新的製造標準，儘管小公司以債務負擔為由要求推遲。根據修訂後的 Schedule M 指南，製藥公司必須向許可機構通報召回藥品並報告產品缺陷、變質或生產缺陷。到目前為止，還沒有向許可機構通報藥品召回的規定。預計這將進一步促進市場成長。
製劑開發外包市場區隔：
IMARC Group提供了每個細分市場的主要趨勢分析，以及 2024-2032 年全球、區域和國家層面的預測。我們的報告根據服務、劑型、應用和最終用戶對市場進行了分類。
按服務分類：
- 製劑前服務
- 發現和臨床前服務
- 分析服務
- 配方最佳化
- 第一階段
- 第二階段
- 第三階段
- 第四階段
配方最佳化佔大部分市場佔有率
該報告根據服務提供了詳細的市場細分和分析。這包括製劑前服務（發現和臨床前服務、分析服務）和製劑最佳化（第一階段、第二階段、第三階段和第四階段）。根據該報告，配方最佳化是最大的部分。
市場對配方最佳化的需求是由增強藥物功效、穩定性和生物利用度的需求所驅動的。日益嚴格的監管審查需要穩健且合規的配方。此外，複雜和個人化藥物的興起需要精確的配方技術。外包提供了獲得專業知識和先進技術的機會，從而實現高效最佳化。此外，加快上市時間和降低開發成本的壓力進一步刺激了製藥業對最佳化配方的需求。例如，2024 年 7 月，輝瑞宣布已選擇其首選的每日一次改良釋放製劑 danuglipron，這是一種口服胰高血糖素樣胜肽 1 (GLP-1) 受體激動劑。展望未來，輝瑞計劃在 2024 年下半年進行劑量最佳化研究，評估首選改良釋放製劑的多個劑量，為註冊支持研究提供資訊。
按劑型分類：
- 可注射
- 口服
- 專題
- 其他
注射劑佔產業最大佔有率
製劑開發外包市場報告還提供了基於劑型的詳細市場區隔和分析。這包括注射劑、口服劑、外用劑等。報告稱，注射劑佔據最大的市場佔有率。
慢性病的日益普及以及對標靶和控制藥物傳遞的需求推動了市場對注射劑型的需求。注射形式具有快速吸收和生物利用度，這對於重症監護和生物藥物至關重要。此外，主要透過注射給藥的生物製劑和生物相似藥的成長也推動了這一需求。外包提供了專業製造能力和監管專業知識，確保高品質且合規的注射配方。這反過來又提高了製劑開發外包的整體市場價值。
按應用分類：
- 腫瘤學
- 遺傳性疾病
- 神經病學
- 傳染病
- 呼吸系統
- 心血管
- 其他
腫瘤學代表了領先的細分市場
該報告根據應用程式提供了詳細的市場細分和分析。這包括腫瘤學、遺傳性疾病、神經病學、傳染病、呼吸系統疾病、心血管疾病等。根據該報告，腫瘤學佔最大的部分。
癌症治療的複雜性和對專業知識的需求推動了腫瘤學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配方技術。高昂的研發 (R&D) 成本和嚴格的監管要求也需要外包來有效應對這些挑戰，這推動了製劑開發外包需求。此外，加速新抗癌藥物上市時間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。
按最終用戶分類：
- 製藥和生物製藥公司
- 政府和學術機構
製藥和生物製藥公司在市場上表現出明顯的主導地位
報告還提供了基於最終用戶的詳細市場細分和分析。這包括製藥和生物製藥公司以及政府和學術機構。報告顯示，製藥和生物製藥公司佔了最大的市場佔有率。
高昂的研發 (R&D) 成本、對專業知識和先進技術的需求推動了製藥和生物製藥公司對製劑開發外包的需求。外包有助於加快藥物開發進度並確保合規性。新藥配方（包括生物製劑和個人化藥物）的複雜性需要外部專業知識，這進一步積極影響配方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功效、穩定性和市場準備度。
按地區分類：
- 北美洲
- 美國
- 加拿大
- 亞太
- 中國
- 日本
- 印度
- 韓國
- 澳洲
- 印尼
- 其他
- 歐洲
- 德國
- 法國
- 英國
- 義大利
- 西班牙
- 俄羅斯
- 其他
- 拉丁美洲
- 巴西
- 墨西哥
- 其他
- 中東和非洲
北美市場領先，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，其中包括北美（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。報告稱，北美是製劑開發外包最大的區域市場。
高昂的研發（R＆D）成本以及開發複雜藥物配方對專業知識的需求正在推動該地區的市場成長。該地區嚴格的監管環境需要遵守嚴格的標準，外包合作夥伴可以有效管理這些標準。此外，生物技術和個人化醫療的興起需要先進的配方解決方案，進一步推動了外包需求。根據對該地區製劑開發外包市場的預測，加速藥物開發時間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 是一家全球營運服務提供商，致力於研發和GMP 藥品開發、研發和GMP 分析以及無菌藥品製造支持，宣布成立美國實體，使客戶能夠將以下便利結合起來：具有國際專業知識優勢的本地服務。美國客戶將由總部位於美國的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。
（請注意，這只是關鍵參與者的部分列表，報告中提供了完整列表。）
- 製劑開發外包市場競爭非常激烈，有許多參與者提供專業服務。這些製劑開發外包公司包括 Catalent、Lonza 和 Charles River Laboratories，它們以其豐富的專業知識和先進技術而聞名。新興公司和利基供應商也透過提供量身定做的解決方案和創新方法來競爭。例如，2024 年 4 月，Charles River Laboratories 啟動了替代方法推廣計畫 (AMAP)，該計畫旨在開發替代方法以減少動物測試並推動藥物發現和開發的新標準。該公司過去四年的初始投資為2億美元，五年目標是追加投資3億美元。這項投資涵蓋了一系列技術創新、合作夥伴關係和減少動物測試使用的宣傳工作。
製劑開發外包市場新聞：
- 2023 年 2 月，藥物開發和製造加速器 Quotient Sciences 宣布已完成其位於英國諾丁漢工廠的口服劑早期配方開發能力的擴展。擴展的服務建立在該中心現有的製劑能力的基礎上，並透過該公司的旗艦平台轉化製藥提高了支援完全整合的藥物開發專案的能力。
- 2024年5月，CDMO AGC Biologics和CMO BioConnection同意合作，利用AGC Biologics的開發和製造專業知識以及專業的無菌技術，為原料藥和藥品提供端到端的生物製藥開發和製造能力。 。
- 2023 年 10 月，製藥、生技和營養保健品市場的全球製造合作夥伴 Lonza 宣布擴大與主要生物製藥合作夥伴的合作，以進行 ADC 的商業規模填充。
本報告回答的關鍵問題：
- 迄今為止，全球製劑開發外包市場表現如何，未來幾年將如何表現？
- 全球製劑開發外包市場的促進因素、限制因素和機會是什麼？
- 每個促進因素、限制因素和機會對全球製劑開發外包市場有何影響？
- 主要區域市場有哪些？
- 哪些國家代表了最具吸引力的製劑開發外包市場？
- 基於服務的市場區隔是什麼？
- 製劑開發外包市場哪項服務最具吸引力？
- 根據劑型，市場的詳細情形如何？
- 製劑開發外包市場中哪種劑型最具吸引力？
- 基於應用的市場區隔是什麼？
- 製劑開發外包市場最具吸引力的應用是什麼？
- 基於最終用戶的市場區隔是什麼？
- 製劑開發外包市場中哪一個對最終用戶最具吸引力？
- 市場競爭結構如何？
- 全球製劑開發外包市場的主要參與者/公司有哪些？
本報告回答的關鍵問題：
- 迄今為止，全球製劑開發外包市場表現如何，未來幾年將如何表現？
- 全球製劑開發外包市場的促進因素、限制因素和機會是什麼？
- 每個促進因素、限制因素和機會對全球製劑開發外包市場有何影響？
- 主要區域市場有哪些？
- 哪些國家代表了最具吸引力的製劑開發外包市場？
- 基於服務的市場區隔是什麼？
- 製劑開發外包市場哪項服務最具吸引力？
- 根據劑型，市場的詳細情形如何？
- 製劑開發外包市場中哪種劑型最具吸引力？
- 基於應用的市場區隔是什麼？
- 製劑開發外包市場最具吸引力的應用是什麼？
- 基於最終用戶的市場區隔是什麼？
- 製劑開發外包市場中哪一個對最終用戶最具吸引力？
- 市場競爭結構如何？
- 全球製劑開發外包市場的主要參與者/公司有哪些？
目錄
第1章：前言
第 2 章：範圍與方法
- 研究目的
- 利害關係人
- 數據來源
- 主要來源
- 二手資料
- 市場預測
- 自下而上的方法
- 自上而下的方法
- 預測方法
第 3 章：執行摘要
第 4 章：簡介
- 概述
- 主要行業趨勢
第 5 章：全球製劑開發外包市場
- 市場概況
- 市場表現
- COVID-19 的影響
- 市場預測
第 6 章：市場區隔：按服務
- 製劑前服務
- 市場趨勢
- 關鍵環節
- 發現和臨床前服務
- 分析服務
- 市場預測
- 配方最佳化
- 市場趨勢
- 關鍵環節
- 第一階段
- 第二階段
- 第三階段
- 第四階段
- 市場預測
第 7 章：市場區隔：按劑型
- 可注射
- 市場趨勢
- 市場預測
- 口服
- 市場趨勢
- 市場預測
- 專題
- 市場趨勢
- 市場預測
- 其他
- 市場趨勢
- 市場預測
第 8 章：市場區隔：按應用
- 腫瘤學
- 市場趨勢
- 市場預測
- 遺傳性疾病
- 市場趨勢
- 市場預測
- 神經病學
- 市場趨勢
- 市場預測
- 傳染病
- 市場趨勢
- 市場預測
- 呼吸系統
- 市場趨勢
- 市場預測
- 心血管
- 市場趨勢
- 市場預測
- 其他
- 市場趨勢
- 市場預測
第 9 章：市場區隔：按最終用戶
- 製藥和生物製藥公司
- 市場趨勢
- 市場預測
- 政府和學術機構
- 市場趨勢
- 市場預測
第 10 章：市場區隔：按地區
- 北美洲
- 美國
- 加拿大
- 亞太
- 中國
- 日本
- 印度
- 韓國
- 澳洲
- 印尼
- 其他
- 歐洲
- 德國
- 法國
- 英國
- 義大利
- 西班牙
- 俄羅斯
- 其他
- 拉丁美洲
- 巴西
- 墨西哥
- 其他
- 中東和非洲
- 市場趨勢
- 市場細分：按國家/地區
- 市場預測
第 11 章：SWOT 分析
- 概述
- 優勢
- 弱點
- 機會
- 威脅
第 12 章：價值鏈分析
第 13 章：波特五力分析
- 概述
- 買家的議價能力
- 供應商的議價能力
- 競爭程度
- 新進入者的威脅
- 替代品的威脅
第 14 章：價格分析
第15章：競爭格局
- 市場結構
- 關鍵參與者
- 關鍵參與者簡介
- Aizant Drug Research Solutions Private Limited
- Catalent Inc.
- Charles River Laboratories
- Dr. Reddy's Laboratories Ltd.
- Emergent BioSolutions Inc.
- Intertek Group plc
- Irisys LLC (Recro Pharma)
- Laboratory Corporation of America Holdings
- Lonza Group AG
- Piramal Pharma Solutions
- Quotient Sciences
- Syngene International Limited (Biocon Limited)
- Thermo Fisher Scientific Inc.
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.
Formulation Development Outsourcing Market Analysis:
- Major Market Drivers: The rising research and development (R&D) costs and the growing need for specialized expertise represent the major drivers of the market. Pharmaceutical companies increasingly outsource to reduce expenses and access advanced technologies that enhance drug development efficiency.
- Key Market Trends: The widespread adoption of advanced technologies such as artificial intelligence (AI) and machine learning (ML) to optimize drug formulations represents the key trend of the market. The market also experiences a shift toward strategic partnerships and long-term collaborations between pharmaceutical companies and outsourcing providers.
- Geographical Trends: According to the formulation development outsourcing market overview, North America accounts for the largest region in the market. The high research and development (R&D) costs, the rising need for specialized expertise, strict regulatory requirements, and the increasing focus on accelerating drug development are driving the growth of the market across the region.
- Competitive Landscape: Some of the major market players in the formulation development outsourcing industry include Aizant Drug Research Solutions Private Limited, Catalent Inc., Charles River Laboratories, Dr. Reddy's Laboratories Ltd., Emergent BioSolutions Inc., Intertek Group plc, Irisys LLC (Recro Pharma), Laboratory Corporation of America Holdings, Lonza Group AG, Piramal Pharma Solutions, Quotient Sciences, Syngene International Limited (Biocon Limited), and Thermo Fisher Scientific Inc., among many others.
- Challenges and Opportunities: The market faces various challenges including regulatory compliance complexities, intellectual property concerns, and the need for stringent quality control. However, the market also faces several opportunities such as the increasing demand for advanced drug formulations, the growth of personalized medicine, and technological advancements like artificial intelligence (AI) and machine learning (ML).
Formulation Development Outsourcing Market Trends:
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 Development Outsourcing Market Segmentation:
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.
Breakup by Service:
- Pre-formulation Services
- Discovery and Preclinical Services
- Analytical Services
- Formulation Optimization
- Phase I
- Phase II
- Phase III
- Phase IV
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.
Breakup by Dosage Form:
- Injectable
- Oral
- Topical
- Others
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.
Breakup by Application:
- Oncology
- Genetic Disorders
- Neurology
- Infectious Diseases
- Respiratory
- Cardiovascular
- Others
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.
Breakup by End User:
- Pharmaceutical and Biopharmaceutical Companies
- Government and Academic Institutes
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.
Breakup by Region:
- North America
- United States
- Canada
- Asia-Pacific
- China
- Japan
- India
- South Korea
- Australia
- Indonesia
- Others
- Europe
- Germany
- France
- United Kingdom
- Italy
- Spain
- Russia
- Others
- Latin America
- Brazil
- Mexico
- Others
- Middle East and Africa
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.
Competitive Landscape:
- The market research report has also provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the major market players in the formulation development outsourcing industry include Aizant Drug Research Solutions Private Limited, Catalent Inc., Charles River Laboratories, Dr. Reddy's Laboratories Ltd., Emergent BioSolutions Inc., Intertek Group plc, Irisys LLC (Recro Pharma), Laboratory Corporation of America Holdings, Lonza Group AG, Piramal Pharma Solutions, Quotient Sciences, Syngene International Limited (Biocon Limited) and Thermo Fisher Scientific Inc.
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)
- The market for formulation development outsourcing is highly competitive, with numerous players offering specialized services. These formulation development outsourcing companies include Catalent, Lonza, and Charles River Laboratories, known for their extensive expertise and advanced technologies. Emerging firms and niche providers also compete by offering tailored solutions and innovative approaches. For instance, in April 2024, Charles River Laboratories launched its Alternative Methods Advancement Project (AMAP), an initiative to develop alternatives to reduce animal testing and to drive a new standard for drug discovery and development. The company's initial investment was $200 million over the past four years and its five-year goal is to invest an additional $300 million. This investment spans a portfolio of technology innovations, partnerships, and advocacy efforts to reduce the use of animal testing.
Formulation Development Outsourcing Market News:
- In February 2023, Quotient Sciences, the drug development and manufacturing accelerator, announced that it had completed an expansion of its early-phase formulation development capabilities for oral dosage forms at its Nottingham, UK, facility. The expanded services build upon the site's existing formulation capabilities and increase capacity to support fully integrated drug development programs through the company's flagship platform, Translational Pharmaceutics.
- In May 2024, AGC Biologics, a CDMO, and BioConnection, a CMO, agreed to partner to provide end-to-end biopharmaceutical development and manufacturing capabilities for drug substance and drug products using the development and manufacturing expertise of AGC Biologics and the specialized aseptic filling capabilities of BioConnection.
- In October 2023, Lonza, a global manufacturing partner to the pharmaceutical, biotech, and nutraceutical markets, announced the extension of a collaboration with a major biopharmaceutical partner for the commercial-scale filling of ADCs.
Key Questions Answered in This Report:
- How has the global formulation development outsourcing market performed so far, and how will it perform in the coming years?
- What are the drivers, restraints, and opportunities in the global formulation development outsourcing market?
- What is the impact of each driver, restraint, and opportunity on the global formulation development outsourcing market?
- What are the key regional markets?
- Which countries represent the most attractive formulation development outsourcing market?
- What is the breakup of the market based on the service?
- Which is the most attractive service in the formulation development outsourcing market?
- What is the breakup of the market based on the dosage form?
- Which is the most attractive dosage form in the formulation development outsourcing market?
- What is the breakup of the market based on the application?
- Which is the most attractive application in the formulation development outsourcing market?
- What is the breakup of the market based on the end user?
- Which is the most attractive end user in the formulation development outsourcing market?
- What is the competitive structure of the market?
- Who are the key players/companies in the global formulation development outsourcing market?
Table of Contents
1 Preface
2 Scope and Methodology
- 2.1 Objectives of the Study
- 2.2 Stakeholders
- 2.3 Data Sources
- 2.3.1 Primary Sources
- 2.3.2 Secondary Sources
- 2.4 Market Estimation
- 2.4.1 Bottom-Up Approach
- 2.4.2 Top-Down Approach
- 2.5 Forecasting Methodology
3 Executive Summary
4 Introduction
- 4.1 Overview
- 4.2 Key Industry Trends
5 Global Formulation Development Outsourcing Market
- 5.1 Market Overview
- 5.2 Market Performance
- 5.3 Impact of COVID-19
- 5.4 Market Forecast
6 Market Breakup by Service
- 6.1 Pre-formulation Services
- 6.1.1 Market Trends
- 6.1.2 Key Segments
- 6.1.2.1 Discovery and Preclinical Services
- 6.1.2.2 Analytical Services
- 6.1.3 Market Forecast
- 6.2 Formulation Optimization
- 6.2.1 Market Trends
- 6.2.2 Key Segments
- 6.2.2.1 Phase I
- 6.2.2.2 Phase II
- 6.2.2.3 Phase III
- 6.2.2.4 Phase IV
- 6.2.3 Market Forecast
7 Market Breakup by Dosage Form
- 7.1 Injectable
- 7.1.1 Market Trends
- 7.1.2 Market Forecast
- 7.2 Oral
- 7.2.1 Market Trends
- 7.2.2 Market Forecast
- 7.3 Topical
- 7.3.1 Market Trends
- 7.3.2 Market Forecast
- 7.4 Others
- 7.4.1 Market Trends
- 7.4.2 Market Forecast
8 Market Breakup by Application
- 8.1 Oncology
- 8.1.1 Market Trends
- 8.1.2 Market Forecast
- 8.2 Genetic Disorders
- 8.2.1 Market Trends
- 8.2.2 Market Forecast
- 8.3 Neurology
- 8.3.1 Market Trends
- 8.3.2 Market Forecast
- 8.4 Infectious Diseases
- 8.4.1 Market Trends
- 8.4.2 Market Forecast
- 8.5 Respiratory
- 8.5.1 Market Trends
- 8.5.2 Market Forecast
- 8.6 Cardiovascular
- 8.6.1 Market Trends
- 8.6.2 Market Forecast
- 8.7 Others
- 8.7.1 Market Trends
- 8.7.2 Market Forecast
9 Market Breakup by End User
- 9.1 Pharmaceutical and Biopharmaceutical Companies
- 9.1.1 Market Trends
- 9.1.2 Market Forecast
- 9.2 Government and Academic Institutes
- 9.2.1 Market Trends
- 9.2.2 Market Forecast
10 Market Breakup by Region
- 10.1 North America
- 10.1.1 United States
- 10.1.1.1 Market Trends
- 10.1.1.2 Market Forecast
- 10.1.2 Canada
- 10.1.2.1 Market Trends
- 10.1.2.2 Market Forecast
- 10.1.1 United States
- 10.2 Asia-Pacific
- 10.2.1 China
- 10.2.1.1 Market Trends
- 10.2.1.2 Market Forecast
- 10.2.2 Japan
- 10.2.2.1 Market Trends
- 10.2.2.2 Market Forecast
- 10.2.3 India
- 10.2.3.1 Market Trends
- 10.2.3.2 Market Forecast
- 10.2.4 South Korea
- 10.2.4.1 Market Trends
- 10.2.4.2 Market Forecast
- 10.2.5 Australia
- 10.2.5.1 Market Trends
- 10.2.5.2 Market Forecast
- 10.2.6 Indonesia
- 10.2.6.1 Market Trends
- 10.2.6.2 Market Forecast
- 10.2.7 Others
- 10.2.7.1 Market Trends
- 10.2.7.2 Market Forecast
- 10.2.1 China
- 10.3 Europe
- 10.3.1 Germany
- 10.3.1.1 Market Trends
- 10.3.1.2 Market Forecast
- 10.3.2 France
- 10.3.2.1 Market Trends
- 10.3.2.2 Market Forecast
- 10.3.3 United Kingdom
- 10.3.3.1 Market Trends
- 10.3.3.2 Market Forecast
- 10.3.4 Italy
- 10.3.4.1 Market Trends
- 10.3.4.2 Market Forecast
- 10.3.5 Spain
- 10.3.5.1 Market Trends
- 10.3.5.2 Market Forecast
- 10.3.6 Russia
- 10.3.6.1 Market Trends
- 10.3.6.2 Market Forecast
- 10.3.7 Others
- 10.3.7.1 Market Trends
- 10.3.7.2 Market Forecast
- 10.3.1 Germany
- 10.4 Latin America
- 10.4.1 Brazil
- 10.4.1.1 Market Trends
- 10.4.1.2 Market Forecast
- 10.4.2 Mexico
- 10.4.2.1 Market Trends
- 10.4.2.2 Market Forecast
- 10.4.3 Others
- 10.4.3.1 Market Trends
- 10.4.3.2 Market Forecast
- 10.4.1 Brazil
- 10.5 Middle East and Africa
- 10.5.1 Market Trends
- 10.5.2 Market Breakup by Country
- 10.5.3 Market Forecast
11 SWOT Analysis
- 11.1 Overview
- 11.2 Strengths
- 11.3 Weaknesses
- 11.4 Opportunities
- 11.5 Threats
12 Value Chain Analysis
13 Porters Five Forces Analysis
- 13.1 Overview
- 13.2 Bargaining Power of Buyers
- 13.3 Bargaining Power of Suppliers
- 13.4 Degree of Competition
- 13.5 Threat of New Entrants
- 13.6 Threat of Substitutes
14 Price Analysis
15 Competitive Landscape
- 15.1 Market Structure
- 15.2 Key Players
- 15.3 Profiles of Key Players
- 15.3.1 Aizant Drug Research Solutions Private Limited
- 15.3.1.1 Company Overview
- 15.3.1.2 Product Portfolio
- 15.3.2 Catalent Inc.
- 15.3.2.1 Company Overview
- 15.3.2.2 Product Portfolio
- 15.3.2.3 Financials
- 15.3.2.4 SWOT Analysis
- 15.3.3 Charles River Laboratories
- 15.3.3.1 Company Overview
- 15.3.3.2 Product Portfolio
- 15.3.3.3 Financials
- 15.3.3.4 SWOT Analysis
- 15.3.4 Dr. Reddy's Laboratories Ltd.
- 15.3.4.1 Company Overview
- 15.3.4.2 Product Portfolio
- 15.3.4.3 Financials
- 15.3.4.4 SWOT Analysis
- 15.3.5 Emergent BioSolutions Inc.
- 15.3.5.1 Company Overview
- 15.3.5.2 Product Portfolio
- 15.3.5.3 Financials
- 15.3.5.4 SWOT Analysis
- 15.3.6 Intertek Group plc
- 15.3.6.1 Company Overview
- 15.3.6.2 Product Portfolio
- 15.3.6.3 Financials
- 15.3.6.4 SWOT Analysis
- 15.3.7 Irisys LLC (Recro Pharma)
- 15.3.7.1 Company Overview
- 15.3.7.2 Product Portfolio
- 15.3.8 Laboratory Corporation of America Holdings
- 15.3.8.1 Company Overview
- 15.3.8.2 Product Portfolio
- 15.3.8.3 Financials
- 15.3.8.4 SWOT Analysis
- 15.3.9 Lonza Group AG
- 15.3.9.1 Company Overview
- 15.3.9.2 Product Portfolio
- 15.3.9.3 Financials
- 15.3.9.4 SWOT Analysis
- 15.3.10 Piramal Pharma Solutions
- 15.3.10.1 Company Overview
- 15.3.10.2 Product Portfolio
- 15.3.10.3 Financials
- 15.3.11 Quotient Sciences
- 15.3.11.1 Company Overview
- 15.3.11.2 Product Portfolio
- 15.3.12 Syngene International Limited (Biocon Limited)
- 15.3.12.1 Company Overview
- 15.3.12.2 Product Portfolio
- 15.3.12.3 Financials
- 15.3.13 Thermo Fisher Scientific Inc.
- 15.3.13.1 Company Overview
- 15.3.13.2 Product Portfolio
- 15.3.13.3 Financials
- 15.3.13.4 SWOT Analysis
- 15.3.1 Aizant Drug Research Solutions Private Limited
List of Figures
- Figure 1: Global: Formulation Development Outsourcing Market: Major Drivers and Challenges
- Figure 2: Global: Formulation Development Outsourcing Market: Sales Value (in Billion US$), 2018-2023
- Figure 3: Global: Formulation Development Outsourcing Market Forecast: Sales Value (in Billion US$), 2024-2032
- Figure 4: Global: Formulation Development Outsourcing Market: Breakup by Service (in %), 2023
- Figure 5: Global: Formulation Development Outsourcing Market: Breakup by Dosage Form (in %), 2023
- Figure 6: Global: Formulation Development Outsourcing Market: Breakup by Application (in %), 2023
- Figure 7: Global: Formulation Development Outsourcing Market: Breakup by End User (in %), 2023
- Figure 8: Global: Formulation Development Outsourcing Market: Breakup by Region (in %), 2023
- Figure 9: Global: Formulation Development Outsourcing (Pre-formulation Services) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 10: Global: Formulation Development Outsourcing (Pre-formulation Services) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 11: Global: Formulation Development Outsourcing (Formulation Optimization) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 12: Global: Formulation Development Outsourcing (Formulation Optimization) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 13: Global: Formulation Development Outsourcing (Injectable) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 14: Global: Formulation Development Outsourcing (Injectable) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 15: Global: Formulation Development Outsourcing (Oral) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 16: Global: Formulation Development Outsourcing (Oral) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 17: Global: Formulation Development Outsourcing (Topical) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 18: Global: Formulation Development Outsourcing (Topical) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 19: Global: Formulation Development Outsourcing (Other Dosage Forms) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 20: Global: Formulation Development Outsourcing (Other Dosage Forms) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 21: Global: Formulation Development Outsourcing (Oncology) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 22: Global: Formulation Development Outsourcing (Oncology) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 23: Global: Formulation Development Outsourcing (Genetic Disorders) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 24: Global: Formulation Development Outsourcing (Genetic Disorders) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 25: Global: Formulation Development Outsourcing (Neurology) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 26: Global: Formulation Development Outsourcing (Neurology) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 27: Global: Formulation Development Outsourcing (Infectious Diseases) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 28: Global: Formulation Development Outsourcing (Infectious Diseases) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 29: Global: Formulation Development Outsourcing (Respiratory) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 30: Global: Formulation Development Outsourcing (Respiratory) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 31: Global: Formulation Development Outsourcing (Cardiovascular) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 32: Global: Formulation Development Outsourcing (Cardiovascular) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 33: Global: Formulation Development Outsourcing (Other Applications) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 34: Global: Formulation Development Outsourcing (Other Applications) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 35: Global: Formulation Development Outsourcing (Pharmaceutical and Biopharmaceutical Companies) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 36: Global: Formulation Development Outsourcing (Pharmaceutical and Biopharmaceutical Companies) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 37: Global: Formulation Development Outsourcing (Government and Academic Institutes) Market: Sales Value (in Million US$), 2018 & 2023
- Figure 38: Global: Formulation Development Outsourcing (Government and Academic Institutes) Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 39: North America: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 40: North America: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 41: United States: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 42: United States: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 43: Canada: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 44: Canada: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 45: Asia-Pacific: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 46: Asia-Pacific: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 47: China: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 48: China: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 49: Japan: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 50: Japan: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 51: India: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 52: India: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 53: South Korea: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 54: South Korea: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 55: Australia: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 56: Australia: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 57: Indonesia: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 58: Indonesia: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 59: Others: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 60: Others: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 61: Europe: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 62: Europe: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 63: Germany: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 64: Germany: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 65: France: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 66: France: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 67: United Kingdom: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 68: United Kingdom: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 69: Italy: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 70: Italy: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 71: Spain: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 72: Spain: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 73: Russia: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 74: Russia: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 75: Others: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 76: Others: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 77: Latin America: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 78: Latin America: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 79: Brazil: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 80: Brazil: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 81: Mexico: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 82: Mexico: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 83: Others: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 84: Others: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 85: Middle East and Africa: Formulation Development Outsourcing Market: Sales Value (in Million US$), 2018 & 2023
- Figure 86: Middle East and Africa: Formulation Development Outsourcing Market: Breakup by Country (in %), 2023
- Figure 87: Middle East and Africa: Formulation Development Outsourcing Market Forecast: Sales Value (in Million US$), 2024-2032
- Figure 88: Global: Formulation Development Outsourcing Industry: SWOT Analysis
- Figure 89: Global: Formulation Development Outsourcing Industry: Value Chain Analysis
- Figure 90: Global: Formulation Development Outsourcing Industry: Porter's Five Forces Analysis
List of Tables
- Table 1: Global: Formulation Development Outsourcing Market: Key Industry Highlights, 2023 and 2032
- Table 2: Global: Formulation Development Outsourcing Market Forecast: Breakup by Service (in Million US$), 2024-2032
- Table 3: Global: Formulation Development Outsourcing Market Forecast: Breakup by Dosage Form (in Million US$), 2024-2032
- Table 4: Global: Formulation Development Outsourcing Market Forecast: Breakup by Application (in Million US$), 2024-2032
- Table 5: Global: Formulation Development Outsourcing Market Forecast: Breakup by End User (in Million US$), 2024-2032
- Table 6: Global: Formulation Development Outsourcing Market Forecast: Breakup by Region (in Million US$), 2024-2032
- Table 7: Global: Formulation Development Outsourcing Market: Competitive Structure
- Table 8: Global: Formulation Development Outsourcing Market: Key Players
