市场调查报告书
商品编码
1451060
2024-2032 年按药物类型、製造商类型、合成类型、治疗应用和地区分類的活性药物成分市场报告Active Pharmaceutical Ingredients Market Report by Drug Type, Type of Manufacturer, Type of Synthesis, Therapeutic Application, and Region 2024-2032 |
2023年,全球活性药物成分(API)市场规模达到2,347亿美元。展望未来, IMARC Group预计到2032年市场规模将达到3,570亿美元,2024-2032年复合年增长率(CAGR)为4.6%。癌症、糖尿病、心血管和神经系统疾病等慢性病的盛行率不断上升,对生物相似药和仿製药的需求不断增加,以及对药物研发(R&D)活动的投资不断增加,是推动市场发展的一些关键因素。
活性药物成分(API)用于药物中以产生预期的治疗效果。它们是生物活性物质,可以直接解决疾病病理学并控制各种医疗状况的症状。它们通常透过一系列复杂的化学和生物过程合成,其纯度、效力和稳定性对其治疗效果至关重要。它们有助于对不同的医疗状况进行有针对性的治疗,使药品製造商能够开发针对疾病和患者群体的药物。它们以多种形式使用,如片剂、胶囊、软膏或註射剂,每种形式都有不同的生产要求。除此之外,它们还促进了药物输送系统的进步,使药物在体内更有效、更安全地分布。
受多种药物专利到期以及对具有成本效益的治疗方案日益关注的推动,仿製药市场的崛起是刺激 API 需求的关键因素之一。此外,各种领先的製药公司正在投资研发(R&D)活动,以发现和开发创新药物和治疗方法,这有利于市场成长。此外,由于原料药生产成本高、流程复杂,许多製药公司将原料药生产外包给第三方製造商,这正在加强市场成长。此外,药品研发和生产支持性监管政策的实施也提供了良好的市场前景。
慢性病盛行率上升
心臟病、癌症、糖尿病和呼吸系统疾病等慢性疾病目前影响全球很大一部分人口。根据世界卫生组织统计,慢性病造成的死亡人数约占全球死亡人数的 71%。随着受这些疾病影响的人数持续增加,对有效药物治疗的需求不断增加。依赖 API 发挥治疗作用的新型药物和改进的现有药物都受到追捧。因此,目前以慢性病高发生为特征的全球健康格局不断推动对高品质原料药的需求,并刺激市场成长。
生物技术和生物製药的进步
生物技术领域目前正在取得重大进展,导致製药业发生重大变革。生物製药通常源自生物体,现在比传统化学药物更有效、更安全地治疗多种疾病。透过生物技术过程合成的 API(称为生物技术 API)是这些生物製药的组成部分。随着技术的不断进步和生物製药的应用不断增加,对生技原料药的需求也随之激增。
专注于个人化医疗和标靶给药系统
目前正在强调个人化医疗,包括根据个人的基因组成、生活方式和环境量身定制治疗计划。这种方法正在将范式转向更针对患者的特定疗法。同样,标靶药物输送系统的进步旨在提高药物疗效、减少副作用并提高患者依从性。 API 在这两个领域都发挥着至关重要的作用,为各种组合和配方提供了可能性,以实现所需的治疗效果。随着这些领域不断发展并获得关注,它们不断推动 API 市场的成长。
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.