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活性药物成分的全球市场预测(~2030):按药物类型、製造商类型、API 类型、应用、最终用户和地区进行分析Active Pharmaceutical Ingredients Market Forecasts to 2030 - Global Analysis By Drug Type, Manufacturer Type, API Type, Application, End User and by Geography |
2023年全球活性药物成分市场规模为1,637.5亿美元,预估预测期间内复合年增长率为10.2%,至2030年达到3,231.9亿美元。药物中提供所需治疗效果的基本成分称为活性药物成分 (API)。
这些化学物质在用于药物配方之前经过严格的测试并获得政府核准。 API 有多种工艺,例如发酵、自然资源分离和合成。 API 效力、稳定性和纯度对于确保最终药品的安全性和有效性至关重要。
根据世界卫生组织 (WHO) 的说法,获得基本药物,包括活性药物成分 (API) 是一项基本人权,对于实现可达到的最高健康标准至关重要。
处方药的需求不断增长
随着品牌药的专利到期,学名药公司有机会以更便宜的替代品进入市场。学名药为患者和医疗保健系统节省了大量成本,推动了它们的普及。美国简化新药认证申请 (ANDA) 等监管核准途径允许学名药进入市场。此外,随着医疗保健支付者和提供者实施学名药替代政策,负担得起的学名药的可用性将鼓励它们的使用。
价格下降和成本限制
由于製药业(尤其是学名药领域)的激烈竞争,原料药製造商经常面临利润压力和价格下降。由于买家和卖家之间的价格竞争、行业整合以及政府控制医疗保健成本的计划,价格呈下降趋势。此外,为了在价格压力下保持获利,原料药製造商必须不断改善业务、提高效率并考虑降低成本的方法。
个性化医疗的成长
API 製造商可以从个人化医疗策略中受益匪浅,这些策略的重点是根据每个患者的独特需求量身定制护理。基因组序列测定、生物标记识别和资料分析的进步使得开发更有效且副作用更少的标靶治疗成为可能。此外,个人化医疗应用可以采用标靶治疗治疗、基因编辑技术和伴同性诊断作为 API。 API 製造商可以与製药、诊断和医疗机构合作开发和生产客製化医疗产品。
激烈的竞争和价格压力
原料药製造业无论在国内或国际上都存在着激烈的竞争。製造商之间争夺市场占有率的竞争正在压缩利润并降低价格。这种压力在主要由价格竞争驱动的非专利药市场尤其严重。此外,人事费用和生产成本较低的地区存在低成本製造商,这加剧了竞争,使企业难以持续成长和保持获利。
COVID-19 大流行对药品供应链造成了重大干扰,对 API 市场产生了重大影响。封锁措施、旅行限制和劳动力短缺扰乱了製造业务,导致生产延误和供应链瓶颈。对类固醇、抗生素和抗病毒药物等重要药物的需求正在增加。这给供应链带来了压力,导致成品药和关键原料药严重短缺。此外,製药业者还面临疫情带来的不确定性,原物料保障、产品运输、业务永续营运都面临困难。
品牌和处方新药市场预计将在预测期内成为最大的市场
在活性药物成分(API)市场中,品牌和处方新药领域预计将占最大份额。品牌处方药通常需要独特且专有的 API,导致对新型化合物和复杂合成程序的高需求。这些药物市场价值和市场份额高的原因之一是它们在上市前通常要经过漫长的临床试验、监管核准程序和研发。此外,製药公司正在大力投资开发新治疗方法,以填补医疗领域的空白,并使自己与竞争对手区分开来。
肿瘤学领域预计在预测期内复合年增长率最高
活性药物成分(API)市场预计将在肿瘤学领域拥有最高的复合年增长率。由于全球癌症发生率不断上升以及新癌症治疗方法的不断开发,肿瘤学领域对 API 的需求量很大。用于治疗固体癌和骨髓恶性肿瘤的原料药属于肿瘤学类别。此外,由于分子生物学、标靶治疗和免疫治疗的进步,依赖特定 API 的新型癌症治疗方法正在开发中。
活性药物成分(API)市场预计将占据北美地区的最大份额。许多因素促成了该地区的主导地位,包括强大的製药业、大量的研发投资、先进的製造基础设施以及严格的监管要求。此外,由于拥有顶级製药公司、受託製造厂商(CMO) 和 API 製造商,北美成为市场领导者。该地区大量患者、高额医疗支出和有利的报销政策进一步推动了对处方药中使用的原料药的需求。
医药原料药 (API) 市场预计将在欧洲拥有最高的复合年增长率。强大的法律规范、先进的製造能力和完善的製药工业是推动欧洲原料药市场成长的一些因素。该地区受益于强大的研发生态系统,可培养创造力并促进依赖专门 API 的尖端药物治疗的创建。此外,欧洲对负担得起且可及的医疗保健的重视以及对学名药不断增长的需求也推动了 API 市场的成长。
According to Stratistics MRC, the Global Active Pharmaceutical Ingredients Market is accounted for $163.75 billion in 2023 and is expected to reach $323.19 billion by 2030 growing at a CAGR of 10.2% during the forecast period. The essential elements of pharmaceuticals that result in the desired therapeutic effect are known as active pharmaceutical ingredients, or APIs. These chemicals go through rigorous testing and are approved by the government before being used in pharmaceutical formulations. APIs can come from a range of processes, such as fermentation, natural resource isolation, or synthetic processes. Their potency, stability, and purity are essential for guaranteeing the final drug product's safety and effectiveness.
According to the World Health Organization (WHO), access to essential medicines, including Active Pharmaceutical Ingredients (APIs), is a fundamental human right, essential for achieving the highest attainable standard of health.
Growing need for prescription drugs
Generic pharmaceutical companies are seeing an opening to enter the market with less expensive alternatives as a result of branded drug patents expiring. The substantial cost savings that generic medications provide to patients and healthcare systems encourage their widespread use. Generic versions of previously patented drugs are being allowed to enter the market thanks to regulatory pathways for approval, such as the US Abbreviated New Drug Applications (ANDAs). Furthermore, when affordable generic substitutes are available, the use of them is encouraged by generic drug substitution policies put in place by healthcare payers and providers.
Price decline and cost constraints
API manufacturers frequently face margin pressure and price erosion as a result of the fierce competition in the pharmaceutical industry, especially in the generic drug segment. Prices are trending lower as a result of price competition between buyers and sellers, industry consolidation, and government programs to control healthcare costs. Additionally, in order to stay profitable in the face of price pressure, API manufacturers need to constantly improve their operations, increase efficiency, and look into ways to cut costs.
Growth of customized health care
API producers can greatly benefit from personalized medicine strategies, which center on adjusting medical care to the unique needs of each patient. The development of more effective and less side-effect-prone targeted therapies is made possible by developments in genomic sequencing, biomarker identification, and data analytics. Furthermore, personalized medicine applications may employ targeted therapeutics, gene editing technologies, and companion diagnostics as APIs. To create and produce customized medical products, API manufacturers can work with pharmaceutical, diagnostic, and healthcare organizations.
Strong rivalry and pricing pressure
There is fierce competition in the API manufacturing sector, both nationally and internationally. As a result of competition among manufacturers for market share, margins are compressed and prices are eroded. In the generic API market, where businesses mainly compete on price, this pressure is especially intense. Moreover, the existence of low-cost manufacturers in areas with cheaper labor and production costs heightens competition, making it difficult for businesses to continue growing and remaining profitable.
The COVID-19 pandemic has caused significant disruptions in the pharmaceutical supply chain and has had a significant effect on the API market. Production delays and supply chain bottlenecks have resulted from disruptions in manufacturing operations caused by lockdown measures, travel restrictions, and workforce shortages. The demand for vital drugs, like steroids, antibiotics, and antivirals, has increased. This has put pressure on supply chains and made shortages of finished dosage forms and vital APIs worse. Additionally, pharmaceutical companies have encountered difficulties in locating raw materials, shipping products, and preserving business continuity in the face of uncertainties brought on by pandemics.
The Branded or Innovative Prescription Drugs segment is expected to be the largest during the forecast period
In the Active Pharmaceutical Ingredients (API) market, the branded or innovative prescription drug segment is projected to hold the largest share. Novel compounds and intricate synthesis procedures are in high demand since branded prescription medications frequently need unique and proprietary APIs. One reason for these medications' higher market value and share is that they usually go through lengthy clinical trials, regulatory approval procedures, and research and development before going on sale. Furthermore, to fill gaps in the medical field and set themselves apart from competitors, pharmaceutical companies heavily invest in the development of novel therapies.
The Oncology segment is expected to have the highest CAGR during the forecast period
It is projected that the market for active pharmaceutical ingredients (APIs) will have the highest CAGR in the oncology segment. Due to the rising global incidence of cancer and the ongoing development of novel cancer therapies, oncology APIs are in high demand. The APIs utilized in the treatment of solid tumors and hematologic malignancies fall under the category of oncology. Moreover, novel cancer treatments that rely on specific APIs have been developed as a result of advancements in molecular biology, targeted therapies, and immunotherapy.
It is projected that the market for active pharmaceutical ingredients (APIs) will hold the largest share in the North American region. Many factors contribute to this region's dominance, such as a strong pharmaceutical industry, large investments in R&D, sophisticated manufacturing infrastructure, and strict regulatory requirements. Additionally, North America is the market leader due in part to the existence of top pharmaceutical companies, contract manufacturing organizations (CMOs), and API manufacturers. Demand for APIs used in prescription medications is further driven by the region's large patient population, high healthcare expenditures, and advantageous reimbursement policies.
It is anticipated that the market for active pharmaceutical ingredients (APIs) will grow at the highest CAGR in Europe. A robust regulatory framework, sophisticated manufacturing capabilities, and a well-established pharmaceutical industry are some of the factors propelling the growth of the API market in Europe. The area gains from a strong ecosystem for research and development, which promotes creativity and the creation of cutting-edge medication treatments that depend on specialized APIs. Furthermore, the emphasis Europe has placed on affordable and accessible healthcare, along with the growing need for generic drugs, all support the growth of the API market.
Key players in the market
Some of the key players in Active Pharmaceutical Ingredients market include BASF SE, Dr. Reddy's Laboratories Ltd, Cambrex Corporation, Abbott, Cipla Inc., GlaxoSmithKline plc, Amgen Inc., Merck & Co., Inc., AbbVie, Inc., Mylan N.V., Bausch Health Companies Inc., Eli Lilly and Company, Biocon Ltd., Johnson & Johnson Private Limited, AstraZeneca, Takeda Pharmaceutical Company Limited, Novartis AG, Teva Pharmaceutical Industries Ltd., Sun Pharmaceutical Industries Ltd and Pfizer, Inc.
In April 2024, BASF signed a 25-year power purchase agreement (PPA) with China Energy Engineering Group Guangdong Electric Power Design Institute Co., Ltd. (GEDI) to purchase renewable electricity for its Zhanjiang Verbund site. The PPA is a further step in the renewable energy partnership between BASF and GEDI following the Letter of Intent (LOI).
In March 2024, Dr. Reddy's Laboratories said that it has entered into a license agreement with Pharmazz Inc. to commercialise the first-in-class innovative drug Centhaquine in India. Pharmazz is a U.S. based biopharmaceutical company developing and commercializing drug products to treat critically ill patients.
In September 2023, Abbott has entered a definitive agreement for the acquisition of Bigfoot Biomedical, which develops smart insulin management systems for individuals with diabetes. Together, the companies have worked on connected diabetes solutions since 2017.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.