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醫藥品原料藥

市場調查報告書

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1557329

全球醫藥 API 市場：2024-2029 年預測

Global Drug API Market - Forecasts from 2024 to 2029

出版日期: 2024年08月27日 | 出版商:

Knowledge Sourcing Intelligence | 英文 101 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

醫藥原料藥市場預計將從 2024 年的 2,450.53 億美元增至 2029 年的 3,096.42 億美元，複合年成長率為 6.23%。

API（活性藥物成分）是藥物中能產生所需效果的成分。例如，聯合治療具有治療不同症狀或功能的多種活性成分。為滿足市場需求持續成長而進行的開發新藥熱潮以及生物技術和合成藥物開發的後續創新預計將推動市場擴張。

API 通常由製藥公司內部生產。然而，近年來，許多公司將製造外包以降低成本。因此，這些藥物的法規發生了重大變化，包括更嚴格的標準和測試實務。然而，市場擴張可能會受到一些國家藥品價格監管、高製造成本和嚴格監管政策的阻礙。

全球原料藥市場按藥物合成類型、應用和地區進行細分。

醫藥原料藥市場促進因素：

生物製藥領域的有利投資和合作夥伴關係預計將支持 API 的全球成長

推動原料藥市場的主要因素是藥品生產研發活動的擴大、學名藥的重要性日益增加以及生物製藥消費的成長。例如，2024年5月，賽諾菲宣布對塞納河畔維特里、Le Trait工廠和里昂熱爾蘭投資超過10億歐元。該公司將建立生技藥品生產設施，以擴大單株抗體生產並改善基本藥物的整體生產。

同樣，2023 年 7 月，輝瑞和 Flagship Pioneering 合作開發了一系列新的創新藥物，以滿足患有高度複雜疾病的廣大患者群體未滿足的需求。透過此次合作，兩家公司將投資近 5,000 萬美元開發 10 個單一資產項目，利用 Flagship 由 40 家人類健康公司和生物技術平台組成的網路。

慢性病發病率的增加預計將增加藥物需求並推動 API 藥物市場向前發展。據世界衛生組織 (WHO) 稱，心血管疾病是世界上最主要的死亡原因，每年估計導致 1,790 萬人死亡。

隨著對抗疾病的創新藥物的需求激增，預計未來幾年 API 的整體使用量將會增加。

藥物原料藥經過嚴格的測試，以確保它們對患者的病情產生預期的效果而不造成傷害。因此，與健康相關的 API 非常適合影響身體功能的特定疾病的藥理活性、診斷、治療和預防。老年失智症症等複雜疾病會對運動技能產生負面影響，尤其是老年人。

據阿茲海默症協會稱，該疾病是美國第六大死因，主要影響 65 歲以上的人群，該年齡層的患者約有 560 萬人。據同一消息來源稱，到 2050 年，預計每 33 秒就會出現一例新病例。此類疾病的日益普及將增加對具有高度理想功能和最低功效的創新藥物的需求，從而為醫藥原料藥市場範圍提供光明的前景。

醫藥原料藥市場地域展望

北美未來將佔據重要市場佔有率

從地區來看，全球原料藥市場分為北美、南美、歐洲、中東和非洲以及亞太地區。由於疾病發病率上升和人口老化，預計北美地區將顯著成長。例如，根據美國疾病管制與預防中心的數據，美國每年約有 795,000 人受到中風影響，其中缺血性中風佔這些中風的 87%。

新興經濟體，特別是美國和加拿大，對開發新藥和原料藥技術的投資正在穩步成長。例如，禮來公司 (Eli Lilly and Company) 於 2024 年 5 月宣布，將額外投資 53 億美元在印第安納州建造製造工廠。這項投資將使 Mounjaro® 和 Zepbound® 注射的 API 製造能力成為可能，這些注射劑用於治療成人 2 型糖尿病和肥胖症。

由於醫療保健支出的增加和製藥公司的存在，預計亞太地區在預測期內將以該市場最快的速度發展。該地區受益於世界所依賴的低成本原料藥生產經濟體的存在，例如中國和印度。這進一步推動了亞太原料藥市場的成長。

此外，新藥和生物製藥的推出、收購、合作夥伴關係和地理擴張也是該產業策略營運的一部分。例如，Bortezomib是一種用於治療已接受過至少一種既往治療的多發性骨髓瘤或套細胞淋巴瘤成年患者的藥物。

The active pharmaceutical ingredient (API) is the component of medicine that generates the desired effects. Combination therapies, for example, have several active ingredients that treat different symptoms or function differently. The booming new drug development to cater to the ongoing increase in market demand, followed by innovations in biotech & synthetic drug development, is anticipated to drive market expansion.

APIs have generally been manufactured in-house by pharmaceutical businesses in their home nations. However, in recent years, many companies have outsourced manufacturing to save money. This has resulted in considerable changes in regulating these pharmaceuticals, including implementing more stringent criteria and inspections. However, the market's expansion will likely be hampered by negative medicine price control regimes in several countries, high manufacturing costs, and strict regulatory policies.

The global API market is segmented by drug synthesis type, application, and geography.

Global Drug API Market Drivers:

The favorable investment & collaboration in biological drugs is expected to boost the growth of API globally.

The key factors driving the API drug market are the expanding drug research and development activities for drug manufacturing, the increasing importance of generics, and the increasing consumption of biopharmaceuticals. For instance, in May 2024, Sanofi announced an investment of more than EUR1 billion in Vitry-sur-Seine, Le Trait site, and Lyon Gerland. The company will establish a biologics production facility that will expand its monoclonal antibody production, thereby improving the overall manufacturing of essential medicines.

Likewise, in July 2023, Pfizer Inc. and Flagship Pioneering Inc. partnered to develop a new pipeline of innovative medicines to address the unmet needs of a wide patient population suffering from highly complex diseases. As per the collaboration, both companies would invest nearly US$50 million to develop 10 single-asset programs that would leverage Flagship's network of 40 human health companies and biotech platforms.

The rising frequency of chronic diseases is predicted to boost medicine demand, which will drive the API drug market forward. Cardiovascular illnesses are the biggest cause of death worldwide, with an estimated 17.9 million people each year, according to the World Health Organization (WHO).

The booming demand for innovative drugs to fight diseases is expected to bolster overall API usage in the coming years.

Active Pharmaceutical Ingredients undergo rigorous testing to ensure they have the desired effect on the patient's condition without causing harm. Hence, health-related APIs are ideal for pharmacological activities, diagnosis, treatment, and prevention of certain diseases that affect the body's functioning. Complex diseases such as Alzheimer's, especially in the elderly population, negatively impact their motor skills.

According to the Alzheimer's Association, the disease is the sixth leading cause of death in the United States, and it primarily affects people over the age of 65, with approximately 5.6 million patients falling into this age bracket. As per the same source, by 2050, a new case of the disease is expected to occur every 33 seconds. The growing prevalence of such diseases will increase the demand for innovative drugs with highly desired functionality and minimal effects, thereby providing a positive outlook to the market scope of active pharmaceutical ingredients.

Global Drug API Market Geographical Outlook

North America is projected to constitute a considerable market share in the given time frame.

Region-wise, the global API drug market is segmented into North America, South America, Europe, the Middle East and Africa, and Asia Pacific. The North American region is poised for considerable growth, fuelled by increased disease rates and an aging population. For instance, according to the Centers for Disease Control and Prevention, approximately 795,000 people in the United States suffer from the effects of stroke each year, with ischemic stroke accounting for 87% of instances.

Major regional economies, mainly the United States and Canada, are experiencing positive growth in new drug development and investment in API medicinal technologies. For instance, in May 2024, Eli Lilly and Company announced an additional investment of US$5.3 billion for its Indiana manufacturing facility. This investment enables the company's API manufacturing capacity for Mounjaro(R) (tirzepatide) and Zepbound(R) (tirzepatide) injections that would be used for treating adults suffering from type 2 diabetes and obesity.

Due to rising healthcare expenditures and a high number of pharmaceutical businesses, Asia-Pacific is predicted to develop at the fastest rate in this market over the forecast period. The existence of economies like China and India, which the world relies on for low-cost API production, benefits the region. This further boosts the growth in the API market in Asia-Pacific.

Moreover, new pharmaceutical and biological product launches, acquisitions, collaborations, and geographic expansions are some of the industry's strategic operations. For instance, Bortezomib is a drug that is used to treat adult patients with multiple myeloma or mantle cell lymphoma who have had at least one previous treatment.

Global Drug API Key Market Developments

In May 2024, The United States Agency for International Development (USAID) launched a new project to provide US$5 million for sustainably producing, regulating, and exporting active pharmaceutical ingredients and other assured medical products to Kazakhstan and Uzbekistan. USAID's International Development Group-led Indo-Pacific Opportunity Program and the U.S. Pharmacopeia-led Promoting the Quality of Medicines Plus (PQM+) program will regulate the project.
In November 2023, Novo Nordisk announced plans to invest more than 42 billion Danish Krone to expand the company's active pharmaceutical ingredient production capacity at its Kalundborg facility. The investment would bolster the production scale of the product inclusive of GLP-1 products thereby enabling Novo to meet future demand.
In May 2023, the API Innovation Center announced a cooperation agreement to support the adoption of flexible pharmaceutical manufacturing technologies, improving the scale of critical drugs required in the United States. The agreement will further improve pharmaceutical companies' domestic API manufacturing.
In January 2023, Agilent Technologies announced an investment of US$275 million to double its therapeutic nucleic acid manufacturing capacity, which produces active pharmaceutical ingredients for drugs targeting cardiovascular, cancer, and other infectious diseases.

The Global Drug API market is segmented and analyzed as follows:

By Synthesis Type

Biotech Drugs
Synthetic Drugs

By Drug Type

Generic Drug
Branded Drug

By Application

Cardiology
Pulmonology
Oncology
Ophthalmology
Neurology
Orthopedic
Other Applications

By Geography

North America
United States
Canada
Mexico
South America
Brazil
Argentina
Others
Europe
Germany
France
United Kingdom
Spain
Others
Middle East and Africa
Saudi Arabia
Israel
Others
Asia Pacific
China
Japan
South Korea
India
Others

1. INTRODUCTION

1.1. Market Overview
1.2. Market Definition
1.3. Scope of the Study
1.4. Market Segmentation
1.5. Currency
1.6. Assumptions
1.7. Base and Forecast Years Timeline
1.8. Key Benefits for the Stakeholder

2. RESEARCH METHODOLOGY

2.1. Research Design
2.2. Research Processes

3. EXECUTIVE SUMMARY

3.1. Key Findings

4. MARKET DYNAMICS

4.1. Market Drivers
4.2. Market Restraints
4.3. Porter's Five Forces Analysis
- 4.3.1. Bargaining Power of Suppliers
- 4.3.2. Bargaining Power of Buyers
- 4.3.3. Threat of New Entrants
- 4.3.4. Threat of Substitutes
- 4.3.5. Competitive Rivalry in the Industry
4.4. Industry Value Chain Analysis
4.5. Analyst View

5. GLOBAL DRUG API MARKET BY SYNTHESIS TYPE

5.1. Introduction
5.2. Biotech Drugs
5.3. Synthetic Drugs

6. GLOBAL DRUG API MARKET BY DRUG TYPE

6.1. Introduction
6.2. Generic Drug
6.3. Branded Drug

7. GLOBAL DRUG API MARKET BY APPLICATION

7.1. Introduction
7.2. Cardiology
7.3. Pulmonology
7.4. Oncology
7.5. Ophthalmology
7.6. Neurology
7.7. Orthopedics
7.8. Other Applications

8. GLOBAL DRUG API MARKET BY GEOGRAPHY

8.1. Introduction
8.2. North America
- 8.2.1. United States
- 8.2.2. Canada
- 8.2.3. Mexico
8.3. South America
- 8.3.1. Brazil
- 8.3.2. Argentina
- 8.3.3. Others
8.4. Europe
- 8.4.1. Germany
- 8.4.2. France
- 8.4.3. United Kingdom
- 8.4.4. Spain
- 8.4.5. Others
8.5. Middle East and Africa
- 8.5.1. Saudi Arabia
- 8.5.2. Israel
- 8.5.3. Others
8.6. Asia Pacific
- 8.6.1. China
- 8.6.2. Japan
- 8.6.3. South Korea
- 8.6.4. India
- 8.6.5. Others