市場調查報告書
商品編碼
1451060
2024-2032 年按藥物類型、製造商類型、合成類型、治療應用和地區分類的活性藥物成分市場報告Active Pharmaceutical Ingredients Market Report by Drug Type, Type of Manufacturer, Type of Synthesis, Therapeutic Application, and Region 2024-2032 |
2023年,全球活性藥物成分(API)市場規模達到2,347億美元。展望未來, IMARC Group預計到2032年市場規模將達到3,570億美元,2024-2032年複合年成長率(CAGR)為4.6%。癌症、糖尿病、心血管和神經系統疾病等慢性病的盛行率不斷上升,對生物相似藥和學名藥的需求不斷增加,以及對藥物研發(R&D)活動的投資不斷增加,是推動市場發展的一些關鍵因素。
活性藥物成分(API)用於藥物中以產生預期的治療效果。它們是生物活性物質,可以直接解決疾病病理學並控制各種醫療狀況的症狀。它們通常透過一系列複雜的化學和生物過程合成,其純度、效力和穩定性對其治療效果至關重要。它們有助於對不同的醫療狀況進行有針對性的治療,使藥品製造商能夠開發針對疾病和患者群體的藥物。它們以多種形式使用,如片劑、膠囊、軟膏或注射劑,每種形式都有不同的生產要求。除此之外,它們還促進了藥物輸送系統的進步,使藥物在體內更有效、更安全地分佈。
受多種藥物專利到期以及對具有成本效益的治療方案日益關注的推動,學名藥市場的崛起是刺激 API 需求的關鍵因素之一。此外,各種領先的製藥公司正在投資研發(R&D)活動,以發現和開發創新藥物和治療方法,這有利於市場成長。此外,由於原料藥生產成本高、流程複雜,許多製藥公司將原料藥生產外包給第三方製造商,這正在加強市場成長。此外,藥品研發和生產支持性監管政策的實施也提供了良好的市場前景。
慢性病盛行率上升
心臟病、癌症、糖尿病和呼吸系統疾病等慢性疾病目前影響全球很大一部分人口。根據世界衛生組織統計,慢性病造成的死亡人數約佔全球死亡人數的 71%。隨著受這些疾病影響的人數持續增加,對有效藥物治療的需求不斷增加。依賴 API 發揮治療作用的新型藥物和改進的現有藥物都受到追捧。因此,目前以慢性病高發生為特徵的全球健康格局不斷推動對高品質原料藥的需求,並刺激市場成長。
生物技術和生物製藥的進步
生物技術領域目前正在取得重大進展,導致製藥業發生重大變革。生物製藥通常源自生物體,現在比傳統化學藥物更有效、更安全地治療多種疾病。透過生物技術過程合成的 API(稱為生物技術 API)是這些生物製藥的組成部分。隨著技術的不斷進步和生物製藥的應用不斷增加,對生技原料藥的需求也隨之激增。
專注於個人化醫療和標靶給藥系統
目前正在強調個人化醫療,包括根據個人的基因組成、生活方式和環境量身定做治療計劃。這種方法正在將範式轉向更針對患者的特定療法。同樣,標靶藥物輸送系統的進步旨在提高藥物療效、減少副作用並提高患者依從性。 API 在這兩個領域都發揮著至關重要的作用,為各種組合和配方提供了可能性,以實現所需的治療效果。隨著這些領域不斷發展並獲得關注,它們不斷推動 API 市場的成長。
The global active pharmaceutical ingredients (API) market size reached US$ 234.7 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 357.0 Billion by 2032, exhibiting a growth rate (CAGR) of 4.6% during 2024-2032. The growing prevalence of chronic diseases, such as cancer, diabetes, cardiovascular and neurological disorders, rising demand for biosimilars and generic drugs, and increasing investments in pharmaceutical research and development (R&D) activities represent some of the key factors driving the market.
Active pharmaceutical ingredients (APIs) are used in medications to produce the intended therapeutic effects. They are biologically active substances that directly address disease pathology and manage the symptoms of various medical conditions. They are typically synthesized through a range of complex chemical and biological processes, and their purity, potency, and stability are paramount to their therapeutic effectiveness. They facilitate targeted treatment of diverse medical conditions, enabling drug manufacturers to develop medication specific to diseases and patient groups. They are utilized in various forms like tablets, capsules, ointments, or injectables, each having distinct production requirements. Besides this, they facilitate advancements in drug delivery systems, allowing for more effective and safe distribution of medications in the body.
The rise of the generics market, driven by patent expiries of several drugs and the rising focus on cost-effective treatment options, represents one of the key factors catalyzing the demand for APIs. Moreover, various leading pharmaceutical companies are investing in research and development (R&D) activities to discover and develop innovative drugs and therapeutic methods, which is favoring market growth. Furthermore, due to the high costs and complex processes involved in API production, many pharmaceutical companies are outsourcing their API manufacturing to third-party manufacturers, which is strengthening the market growth. Additionally, the implementation of supportive regulatory policies for drug development and manufacturing is offering a favorable market outlook.
Rising prevalence of chronic diseases
Chronic diseases like heart disease, cancer, diabetes, and respiratory disorders are currently affecting a significant percentage of the global population. According to the World Health Organization, chronic diseases are responsible for an estimated 71% of all global deaths. As the number of people affected by these diseases continues to rise, there is an increasing demand for effective pharmaceutical treatments. Both new and improved existing medications, which depend on APIs for their therapeutic effects, are being sought after. Hence, the current global health landscape marked by a high prevalence of chronic diseases is continually driving the demand for high-quality APIs and is stimulating the market growth.
Advancements in biotechnology and biopharmaceuticals
The biotechnology sector is currently making significant strides, resulting in major transformations within the pharmaceutical industry. Biopharmaceuticals, often derived from living organisms, are now treating a wide array of diseases more effectively and safely than traditional chemical drugs. APIs synthesized through biotechnological processes, known as biotech APIs, are integral to these biopharmaceuticals. As technological advancements continue to unfold and the adoption of biopharmaceuticals increases, the demand for biotech APIs is concurrently experiencing a surge.
Focus on personalized medicine and targeted drug delivery systems
Personalized medicine, which includes tailoring treatment plans to the genetic makeup of an individual, lifestyle, and environment, is currently being emphasized. This approach is shifting the paradigm towards more patient-specific therapies. Similarly, advancements in targeted drug delivery systems aim to improve drug efficacy, reduce side effects, and enhance patient compliance. APIs play a crucial role in both these areas, offering possibilities for various combinations and formulations to achieve the desired therapeutic effects. As these areas continue to evolve and gain traction, they are constantly fueling the growth of the API market.
IMARC Group provides an analysis of the key trends in each segment of the global active pharmaceutical ingredients (API) market report, along with forecasts at the global, regional and country levels from 2024-2032. Our report has categorized the market based on drug type, type of manufacturer, type of synthesis and therapeutic application.
Innovative Active Pharmaceutical Ingredients (API)
Generic Active Pharmaceutical Ingredients (API)
Innovative active pharmaceutical ingredients (API) dominate the market
The report has provided a detailed breakup and analysis of the market based on the drug type. This includes innovative active pharmaceutical ingredients (API) and generic active pharmaceutical ingredients (API). According to the report, innovative active pharmaceutical ingredients (API) represented the largest segment.
With the constant pursuit of advancements in healthcare, there is a continuous demand for new and improved treatment options. Additionally, innovative APIs play a crucial role in the development of these cutting-edge drugs that target specific diseases and offer enhanced therapeutic benefits. Apart from this, innovative APIs are often protected by patents, providing exclusivity to pharmaceutical companies and enabling them to capitalize on their investments in research and development (R&D). This exclusivity creates a competitive advantage and drives growth of this segment. Furthermore, the increasing focus on personalized medicine and precision therapies further fuels the demand for innovative APIs as they are tailored to specific patient needs.
Captive Manufacturers
Merchant API Manufacturers
Innovative Merchant API Manufacturers
Generic Merchant API Manufacturers
Captive manufacturers hold the largest share in the market
A detailed breakup and analysis of the market based on the type of manufacturer has also been provided in the report. This includes captive manufacturers and merchant API manufacturers (innovative merchant API manufacturers and generic merchant API manufacturers). According to the report, captive manufacturers accounted for the largest market share.
Captive manufacturers produce APIs exclusively for their own internal use in the production of branded medications. They can ensure a secure and reliable supply chain, which is essential for the consistent manufacturing of their branded pharmaceutical products. Additionally, this approach provides them with greater flexibility in terms of developing and optimizing APIs to suit their specific product portfolio, resulting in enhanced therapeutic outcomes. Apart from this, captive manufacturers often have robust research and development (R&D) capabilities, allowing them to innovate and create new APIs that align with their strategic objectives.
Synthetic Active Pharmaceutical Ingredients (API)
Market Breakup by Type
Innovative Synthetic APIs
Generic Synthetic APIs
Biotech Active Pharmaceutical Ingredients (API)
Market Breakup by Type
Innovative Biotech APIs
Biosimilars
Market Breakup By Product
Monoclonal Antibodies
Vaccines
Cytokines
Fusion Proteins
Therapeutic Enzymes
Blood Factors
Market Breakup By Expression System
Mammalian Expression Systems
Microbial Expression Systems
Yeast Expression Systems
Transgenic Animal Systems
Others
Synthetic API accounted for the largest market share
A detailed breakup and analysis of the market based on the type of synthesis has also been provided in the report. This includes Synthetic Active Pharmaceutical Ingredients (API) [Market Breakup By Type {Innovative Synthetic APIs and Generic Synthetic APIs}]; and Biotech Active Pharmaceutical Ingredients (API) [Market Breakup By Type {Innovative Biotech APIs and Biosimilars}, Market Breakup By Product {Monoclonal Antibodies, Vaccines, Cytokines, Fusion Proteins, Therapeutic Enzymes, and Blood Factors}, and Market Breakup By Expression System {Mammalian Expression Systems, Microbial Expression Systems, Yeast Expression Systems, Transgenic Animal Systems and Others}]. According to the report, synthetic active pharmaceutical ingredients (API) accounted for the largest market share.
Synthetic APIs are those that are produced through chemical synthesis in the laboratory. The synthetic synthesis process allows for precise control over the molecular structure and composition of the API, ensuring consistency and purity of the final product. This reliability is essential for the development of safe and effective medications. Additionally, synthetic APIs offer a wide range of options in terms of chemical modifications and derivatizations, enabling pharmaceutical companies to optimize the therapeutic properties of the drug. Furthermore, synthetic synthesis methods often offer scalability, allowing for large-scale production to meet the market demand efficiently. Moreover, the scalability of synthetic synthesis methods is another advantage driving the demand for synthetic APIs. Chemical synthesis can often be easily scaled up to meet large-scale production requirements, ensuring a steady and reliable supply of APIs to meet market demands. This scalability is particularly important for medications with high demand or for treating widespread conditions.
Oncology
Cardiovascular and Respiratory
Diabetes
Central Nervous System Disorders
Neurological Disorders
Others
Oncology holds the largest market share
Based on the therapeutic application, the market has been segmented as oncology, cardiovascular & respiratory, diabetes, central nervous system disorders, neurological disorders, and others. According to the report, oncology accounted for the largest market share.
The rising incidence of cancer globally is catalyzing the demand for APIs in the oncology segment. This growing prevalence necessitates the development and availability of effective cancer therapies, which heavily rely on APIs for their therapeutic effects. Additionally, the evolving understanding of cancer biology and the emergence of targeted therapies is revolutionizing cancer treatment. Targeted therapies focus on specific molecular targets involved in cancer development and progression. Apart from this, the substantial investment in oncology research and development (R&D) by pharmaceutical companies and the healthcare industry is propelling market growth. Furthermore, the regulatory environment and drug approval processes are becoming more streamlined and expedited for oncology therapies. This is encouraging pharmaceutical companies to invest in the development of oncology APIs and bring new cancer treatments to the market more efficiently.
North America
United States
Canada
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Asia Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Latin America
Middle East and Africa
North America exhibits a clear dominance, accounting for the largest active pharmaceutical ingredients (API) 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; and the Middle East and Africa. According to the report, North America accounted for the largest market share.
North America has a well-established and advanced pharmaceutical industry with significant investments in research and development (R&D). This enables the region to lead in the development and production of high-quality APIs. Additionally, North America possesses a robust regulatory framework that ensures adherence to stringent quality standards and safety regulations. This encourages domestic and international buyers regarding the reliability and credibility of APIs originating from the region. Furthermore, the presence of major pharmaceutical companies and API manufacturers in North America is creating a positive market outlook. These companies have extensive capabilities in API production, supply chain management, and distribution networks, solidifying their market position.
Leading companies are currently prioritizing various strategies to strengthen their market presence. They are actively investing in R&D to explore innovative APIs, particularly in the field of biotechnology and precision medicine. To meet the increasing demand, these companies are continuously expanding their production capacities and adopting advanced manufacturing processes. They are also entering strategic collaborations and partnerships to optimize their supply chain and enhance their global footprint. Furthermore, they are progressively addressing environmental concerns by promoting sustainable practices in their operations. In the face of evolving health challenges, these companies are persistently adapting to cater to the changing needs of the global patient population, making a significant impact on the health sector.
Pfizer, Inc.
Novartis International AG
Sanofi
Boehringer Ingelheim
Bristol-Myers Squibb
Teva Pharmaceutical Industries Ltd.
ELI Lilly and Company
GlaxoSmithKline
Merck & Co., Inc.
Abbvie Inc
In June 2023, Pfizer Inc. invested $25 million in a biopharma company Caribou Biosciences to support the development of an immune-cloaked allogeneic CAR-T cell therapy.
In May 2023, Novartis International AG purchased cystinosis gene therapy from AVROBIO Novartis and has acquired an investigational gene therapy program for the treatment of cystinosis, a rare genetic disease, from AVROBIO for $87.5 million. The purchase is aimed at extending Novartis' cash runway and aligns with their platform strategy in Gene & Cell Therapy.
In December 2022, Merck & Co., Inc. collaborated with Antengene to test Keytruda, ATG-037 Combo for solid tumors in phase 1 trial. This collaboration aims to explore the potential benefits of combining targeted therapies and immune-oncology drugs to improve treatment outcomes.