市场调查报告书
商品编码
1551233
2030年小分子原料药药市场预测:全球产量、治疗领域与地区分析Small Molecule Active Pharmaceutical Ingredient Market Forecasts to 2030 - Global Analysis By Production, Therapeutic Area and By Geography |
根据 Stratistics MRC 的数据,2024 年全球小分子活性药物原料药(API) 市场规模为 1,695 亿美元,预计在预测期内复合年增长率为 9.4%,到 2030 年将达到 2,906 亿美元。
小分子原料药(API)是指具有药理活性并用于药品配方的小分子化合物。这些化合物的分子量通常小于 900 道尔顿,其特征是能够与特定的生物标的相互作用并产生治疗效果。小分子原料药通常透过化学过程合成并透过口服、局部或其他途径给药。
根据药物、化学及相关技术协会(DCAT)统计,2021年核准了50种新分子药物(NME),其中36种是小分子药物。
慢性病增加
糖尿病、心血管疾病和癌症等慢性疾病的增加极大地推动了小分子原料药(API)市场的成长。慢性病需要长期管理和持续给药,增加了对有效小分子原料药的需求。与生技药品相比,这些 API 提供有针对性且通常更易于管理的治疗方法,这对于药物开发至关重要。此外,它们具有穿透细胞和调节特定生物途径的能力,这使得它们对于治疗慢性疾病至关重要。
环境和安全问题
环境和安全问题极大地影响了小分子活性药物原料药(API) 的生产和开发。这些分子的合成往往涉及危险化学品和工艺,导致潜在的环境污染和安全风险。製造业产生的排放和废弃物会污染土壤和排放,造成长期的生态学和健康风险。监管压力要求采取严格措施来尽量减少这些影响,从而导致原料药生产的成本和复杂性增加。然而,公司必须投资先进技术和实践,以减少环境足迹并确保工人安全,这可能会成为经济负担。
学名药需求增加
对学名药的需求不断增长,大大推动了小分子活性药物原料药(API) 市场的发展。当品牌药物的专利到期时,学名药製造商可以以较低的成本生产和销售这些药物的仿製品,从而使医疗保健更容易获得。这些变化增加了对小分子原料药药的需求,小分子学名药的基本成分。此外,小分子原料药药以其稳定性和完善的製造流程而闻名,对于具有成本效益的学名药生产至关重要。
智慧财产权问题
智慧财产权 (IP) 问题对创新和市场进入造成障碍,严重阻碍了小分子原料药的开发和生产。製药公司在研发方面投入巨资,以发现和开发新的小分子原料药,但专利纠纷和重迭权利要求等智慧财产权纠纷可能会阻碍进展。然而,专利丛林(即由重迭专利组成的网路)可能会使公司难以谈判授权合约并推迟新 API 的推出。
COVID-19 大流行扰乱了全球供应链和製造流程,对小分子原料药(API) 产业产生了重大影响。由于严格的封锁、旅行限制和工厂关闭,原料药的生产和分销面临严重的延误和短缺。之所以出现短缺,是因为许多对各种治疗和药物至关重要的小分子活性药物原料药依赖少数主要製造地,主要位于亚洲。这种中断不仅扰乱了基本药物的生产,还导致成本增加和价格波动。
预计在预测期内外包业务将是最大的
在预测期内,外包业务预计将是最大的。小分子原料药对于药物製剂至关重要,需要精确开发以确保功效、安全性和成本效益。外包该领域使製药公司能够利用专业知识、先进技术和专业受託製造厂商(CDMO) 资源来增强这些分子。该过程包括改进合成方法、提高产量、改进精製技术以及优化整个製造流程。
预计心血管疾病领域在预测期内复合年增长率最高
预计心血管疾病领域在预测期内复合年增长率最高。小分子已成为心血管治疗的基石,因为它们能够与特定的生物标的相互作用并调节其活性以治疗高血压、心臟衰竭和冠状动脉疾病等疾病。需要增强这些原料药的化学性质以提高生物有效性度并减少副作用、提高药物稳定性和溶解度以及开发先进的递送系统以实现标靶作用。这个过程通常涉及最尖端科技的使用,例如基于结构的药物设计和高通量筛检。
预计期内,北美地区占据市场最大份额。随着人口结构转向老化,该地区对治疗慢性病和与老龄化相关的健康问题(如心血管疾病、糖尿病和神经系统疾病)的药物的需求不断增加。这种不断增长的需求正在推动 API 市场的成长,製药公司专注于市场开发和小分子的製造,以解决全部区域的这些健康问题。该地区对老龄化相关疾病有效治疗的需求正在推动 API 研发的创新和投资,有助于提高药物疗效和安全性。
预计欧洲地区在预测期内将保持盈利成长。欧洲药品管理局 (EMA) 和国家监管机构实施了严格的指导方针,促进严格的测试、记录和生产实践。这些法规创造了强大的创新和可靠性环境,确保原料药在进入市场之前符合最高标准。此外,这个法律规范不仅可以保护公众健康,还可以增强投资者信心并促进製药公司进入市场。
According to Stratistics MRC, the Global Small Molecule Active Pharmaceutical Ingredient (API) Market is accounted for $169.5 billion in 2024 and is expected to reach $290.6 billion by 2030 growing at a CAGR of 9.4% during the forecast period. A Small Molecule Active Pharmaceutical Ingredient (API) refers to a low molecular weight compound that is pharmacologically active and used in the formulation of medications. These compounds typically have a molecular weight less than 900 Daltons and are characterized by their ability to interact with specific biological targets to elicit a therapeutic effect. Small molecule APIs are often synthesized through chemical processes and can be administered orally, topically, or through other routes.
According to the Drug, Chemical & Associated Technologies Association (DCAT), in 2021, 50 New Molecular Entities (NME) were approved, of which 36 products were small molecule entities.
Rising prevalence of chronic diseases
The increasing prevalence of chronic diseases such as diabetes, cardiovascular conditions, and cancer is significantly driving the growth of the Small Molecule Active Pharmaceutical Ingredient (API) market. Chronic diseases require long-term management and consistent medication, leading to a heightened demand for effective small molecule drugs. These APIs, which are crucial in the development of pharmaceuticals, offer targeted and often more manageable treatments compared to biologics. Furthermore, their ability to penetrate cells and modulate specific biological pathways makes them indispensable for treating chronic conditions.
Environmental and safety concerns
Environmental and safety concerns significantly impact the production and development of Small Molecule Active Pharmaceutical Ingredients (APIs). The synthesis of these molecules often involves hazardous chemicals and processes, leading to potential environmental pollution and safety risks. Waste products and emissions from manufacturing can contaminate soil and water, posing long-term ecological and health hazards. Regulatory pressures require stringent measures to minimize these impacts, leading to increased costs and complexities in API production. However, companies must invest in advanced technologies and practices to reduce their environmental footprint and ensure worker safety, which can be financially burdensome.
Increasing demand for generic drugs
The rising demand for generic drugs is substantially boosting the market for Small Molecule Active Pharmaceutical Ingredients (APIs). As patents for branded pharmaceuticals expire, generic drug manufacturers can produce and market copies of these medications at lower costs, making healthcare more accessible. This shift drives up the need for small molecule APIs, which are the foundational ingredients in these generic drugs. Additionally, small molecule APIs, known for their stability and well-established production processes, are crucial for creating cost-effective generic medications.
Intellectual property issues
Intellectual property (IP) issues significantly hinder the development and production of Small Molecule Active Pharmaceutical Ingredients (APIs) by creating barriers to innovation and market access. Pharmaceutical companies invest heavily in research and development to discover and develop new small molecule APIs, but IP conflicts, such as patent disputes and overlapping claims, can stall progress. However, patent thickets dense webs of overlapping patents can make it challenging for companies to navigate licensing agreements and may delay the introduction of new APIs.
The COVID-19 pandemic significantly impacted the small molecule Active Pharmaceutical Ingredient (API) industry by disrupting global supply chains and manufacturing processes. With stringent lockdowns, travel restrictions, and factory shutdowns, the production and distribution of APIs faced severe delays and shortages. Many small molecule APIs, critical for various treatments and medications, experienced shortages due to the dependency on a few key manufacturing hubs, primarily in Asia. This disruption not only hindered the production of essential drugs but also led to increased costs and price volatility.
The Outsourced segment is expected to be the largest during the forecast period
Outsourced segment is expected to be the largest during the forecast period. Small molecule APIs, essential for pharmaceutical formulations, require precise development to ensure efficacy, safety, and cost-effectiveness. By outsourcing this segment, pharmaceutical companies can leverage the expertise, advanced technologies, and resources of specialized contract development and manufacturing organizations (CDMOs) to enhance these molecules. This process may include improving synthesis methods, increasing yield, refining purification techniques, or optimizing the overall production process.
The Cardiovascular Diseases segment is expected to have the highest CAGR during the forecast period
Cardiovascular Diseases segment is expected to have the highest CAGR during the forecast period. Small molecules are a cornerstone in cardiovascular therapy due to their ability to interact with specific biological targets, modulating their activity to manage diseases such as hypertension, heart failure, and coronary artery disease. Enhancing these APIs involves optimizing their chemical properties to increase bioavailability and reduce side effects, improving the drug's stability and solubility, and developing advanced delivery systems for targeted action. This process often includes the use of cutting-edge technologies like structure-based drug design and high-throughput screening.
North America region commanded the largest share of the market over the extrapolated period. As the demographic shifts towards an older population, there is an increased demand for pharmaceuticals to manage chronic diseases and age-related health issues, such as cardiovascular conditions, diabetes, and neurological disorders across the region. This rising demand is driving growth in the API market, as pharmaceutical companies intensify their focus on developing and manufacturing small molecules that can address these health concerns throughout the region. The regional need for effective treatments for age-related conditions fuels innovation and investment in API research and development, contributing to advancements in drug efficacy and safety.
Europe region is projected to hold profitable growth during the forecast period. European Medicines Agency (EMA) and national regulatory bodies enforce stringent guidelines that promote rigorous testing, documentation, and manufacturing practices. These regulations foster a robust environment for innovation and reliability, ensuring that APIs meet the highest standards before reaching the market. Furthermore, this regulatory framework not only protects public health but also boosts investor confidence and facilitates market access for pharmaceutical companies.
Key players in the market
Some of the key players in Small Molecule Active Pharmaceutical Ingredient (API) market include Aurobindo Pharma, Boehringer Ingelheim GmbH, Cambrex Corporation, Dr. Reddy's Laboratories Ltd, Gilead Sciences, Inc, GlaxoSmithKline PLC, Novartis AG, Pfizer Inc, Sanofi S.A, Sun Pharmaceutical Industries Ltd and Teva Pharmaceutical Industries Ltd.
In October 2023, Axplora announced the cGMP (current Good Manufacturing Practices) approval from Agenzia Italiana Del Farmaco (AIFA) for the expansion of the manufacturing capacities for HPAPIs and steroids in to meet the growing demand.
In March 2023, medicine developer CatSci announced a distribution agreement with small molecule developer AGC Pharma Chemicals (CDMO). For the development of new therapeutics, AGC says CatSci has the expertise to develop chemicals and analytical methods, crystallization and solids, pre-formulation, and high-potency active pharmaceutical ingredients (API), along with chemical manufacturing and control (CMC).