市場調查報告書
商品編碼
1551233
2030年小分子原料藥藥市場預測:全球產量、治療領域與地區分析Small Molecule Active Pharmaceutical Ingredient Market Forecasts to 2030 - Global Analysis By Production, Therapeutic Area and By Geography |
根據 Stratistics MRC 的數據,2024 年全球小分子活性藥物原料藥(API) 市場規模為 1,695 億美元,預計在預測期內複合年成長率為 9.4%,到 2030 年將達到 2,906 億美元。
小分子原料藥(API)是指具有藥理活性並用於藥品配方的小分子化合物。這些化合物的分子量通常小於 900 道爾頓,其特徵是能夠與特定的生物標的相互作用並產生治療效果。小分子原料藥通常透過化學過程合成並透過口服、局部或其他途徑給藥。
根據藥物、化學及相關技術協會(DCAT)統計,2021年核准了50種新分子藥物(NME),其中36種是小分子藥物。
慢性病增加
糖尿病、心血管疾病和癌症等慢性疾病的增加極大地推動了小分子原料藥(API)市場的成長。慢性病需要長期管理和持續給藥,增加了對有效小分子原料藥的需求。與生技藥品相比,這些 API 提供有針對性且通常更易於管理的治療方法,這對於藥物開發至關重要。此外,它們具有穿透細胞和調節特定生物途徑的能力,這使得它們對於治療慢性疾病至關重要。
環境和安全問題
環境和安全問題極大地影響了小分子活性藥物原料藥(API) 的生產和開發。這些分子的合成往往涉及危險化學品和工藝,導致潛在的環境污染和安全風險。製造業產生的排放和廢棄物會污染土壤和排放,造成長期的生態學和健康風險。監管壓力要求採取嚴格措施來盡量減少這些影響,從而導致原料藥生產的成本和複雜性增加。然而,公司必須投資先進技術和實踐,以減少環境足跡並確保工人安全,這可能會成為經濟負擔。
學名藥需求增加
對學名藥的需求不斷成長,大大推動了小分子活性藥物原料藥(API) 市場的發展。當品牌藥物的專利到期時,學名藥製造商可以以較低的成本生產和銷售這些藥物的仿製品,從而使醫療保健更容易獲得。這些變化增加了對小分子原料藥藥的需求,小分子學名藥的基本成分。此外,小分子原料藥藥以其穩定性和完善的製造流程而聞名,對於具有成本效益的學名藥生產至關重要。
智慧財產權問題
智慧財產權 (IP) 問題對創新和市場進入造成障礙,嚴重阻礙了小分子原料藥的開發和生產。製藥公司在研發方面投入巨資,以發現和開發新的小分子原料藥,但專利糾紛和重疊權利要求等智慧財產權糾紛可能會阻礙進展。然而,專利叢林(即由重疊專利組成的網路)可能會使公司難以談判授權合約並推遲新 API 的推出。
COVID-19 大流行擾亂了全球供應鏈和製造流程,對小分子原料藥(API) 產業產生了重大影響。由於嚴格的封鎖、旅行限制和工廠關閉,原料藥的生產和分銷面臨嚴重的延誤和短缺。之所以出現短缺,是因為許多對各種治療和藥物至關重要的小分子活性藥物原料藥依賴少數主要製造地,主要位於亞洲。這種中斷不僅擾亂了基本藥物的生產,還導致成本增加和價格波動。
預計在預測期內外包業務將是最大的
在預測期內,外包業務預計將是最大的。小分子原料藥對於藥物製劑至關重要,需要精確開發以確保功效、安全性和成本效益。外包該領域使製藥公司能夠利用專業知識、先進技術和專業受託製造廠商(CDMO) 資源來增強這些分子。該過程包括改進合成方法、提高產量、改進精製技術以及最佳化整個製造流程。
預計心血管疾病領域在預測期內複合年成長率最高
預計心血管疾病領域在預測期內複合年成長率最高。小分子已成為心血管治療的基石,因為它們能夠與特定的生物標的相互作用並調節其活性以治療高血壓、心臟衰竭和冠狀動脈疾病等疾病。需要增強這些原料藥的化學性質以提高生物有效性度並減少副作用、提高藥物穩定性和溶解度以及開發先進的遞送系統以實現標靶作用。這個過程通常涉及最尖端科技的使用,例如基於結構的藥物設計和高通量篩檢。
預計期內,北美地區佔據市場最大佔有率。隨著人口結構轉向老化,該地區對治療慢性病和與老齡化相關的健康問題(如心血管疾病、糖尿病和神經系統疾病)的藥物的需求不斷增加。這種不斷成長的需求正在推動 API 市場的成長,製藥公司專注於市場開發和小分子的製造,以解決全部區域的這些健康問題。該地區對老齡化相關疾病有效治療的需求正在推動 API 研發的創新和投資,有助於提高藥物療效和安全性。
預計歐洲地區在預測期內將保持盈利成長。歐洲藥品管理局 (EMA) 和國家監管機構實施了嚴格的指導方針,促進嚴格的測試、記錄和生產實踐。這些法規創造了強大的創新和可靠性環境,確保原料藥在進入市場之前符合最高標準。此外,這個法律規範不僅可以保護公眾健康,還可以增強投資者信心並促進製藥公司進入市場。
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).