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市場調查報告書
商品編碼
1471327
小分子原料藥市場:按類型、產品、應用分類 - 2024-2030 年全球預測Small-Molecule APIs Market by Type (Biological, Synthetic), Production (Contract Manufacturing, In-House Manufacturing), Application - Global Forecast 2024-2030 |
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預計2023年小分子原料藥市場規模為1,843.2億美元,預估2024年將達1,973.5億美元,2030年將達3,011.9億美元,複合年成長率為7.26%。
小分子活性藥物成分是低分子量的有機化合物,通常小於 900 道爾頓。這些分子是藥物中的活性成分,在給予患者時負責引發預期的治療效果。小分子原料藥由於尺寸小、結構簡單,可以輕鬆地跨細胞膜擴散,這使得它們在靶向細胞內位點時特別有效。癌症、心血管疾病和感染疾病等慢性疾病的增加促進了市場的成長。藥物開發週期的加速和全球學名藥的普及正在推動小分子原料藥的使用。然而,與藥物開發相關的高成本和嚴格的監管標準限制了市場的成長。此外,接觸活性藥物成分對健康的影響正在阻礙市場成長。然而,將生產外包到具有成本效益的地點、開發複雜的合成方法以及在藥物發現中利用人工智慧等策略可能會改變這個充滿機會的行業的遊戲規則。由於學名藥的迅速普及和受託製造的擴張,有進一步的成長機會。
主要市場統計 | |
---|---|
基準年[2023] | 1843.2億美元 |
預測年份 [2024] | 1973.5億美元 |
預測年份 [2030] | 3011.9億美元 |
複合年成長率(%) | 7.26% |
減少類型副作用增加對生物主題的傾向
生物來源小分子原料藥來自或含有生物成分。這些 API 通常透過生物技術方法生產,例如重組 DNA 技術、受控基因表現、抗體技術和發酵製程。與合成原料藥相比,生物原料藥通常在結構上更加複雜,並且可以提供獨特的治療優勢,例如更高的特異性和更少的副作用。合成小分子原料藥是透過各種化學合成過程化學製造的。由於相對容易製造、擴充性以及藥物開發中化學合成的豐富歷史,該領域在小分子原料藥市場佔據主導地位。與生物原料藥相比,合成原料原料藥的生產量更大,成本更低。合成原料原料藥涵蓋廣泛的學名藥和非處方藥,對於治療許多疾病至關重要。
增加內部製造以確保生產品質標準
契約製造組織(CMO)在小分子原料藥市場中發揮著至關重要的作用。 CMO 為出於各種原因希望委託製造的製藥公司提供製造服務,這些原因包括節省成本、缺乏內部設備或需要專業知識。契約製造具有更大的靈活性,有助於管理與小分子原料藥製造相關的複雜問題,例如法規遵循和品管。內部生產是指製藥公司持有自己的低分子原料藥生產設施。該細分市場包括擁有廣泛資源和基礎設施的大型製藥公司,能夠支持從原料藥合成到最終產品配方的整個藥品製造流程。內部製造可以更好地控制製造過程,有可能增加製造和研發的整合,並在智慧財產權保護和供應鏈管理方面提供策略優勢。
應用:腫瘤學領域的不斷進步將提高小分子原料藥的利用率。
用於治療CVD的小分子藥物包括抗高血壓藥物、抗凝血藥物和降膽固醇藥物。全球心臟病、高血壓和中風的高盛行率推動了對這些原料藥的需求,因此需要強大的心血管治療產品線。由於全球 1 型和 2 型糖尿病盛行率不斷增加,與糖尿病相關的原料藥正在擴大。胰島素增敏劑、磺醯尿素和 SGLT2 抑制劑等小型分子藥物對於控制血糖值和預防糖尿病相關併發症至關重要。免疫性疾病包括自體免疫疾病、過敏等多種疾病。用於治療這些疾病的小分子原料藥包括免疫抑制劑、發炎劑和抗組織胺藥物。腫瘤學是小分子原料藥市場最重要且發展最快的領域之一。對有效癌症治療的迫切需求推動了對腫瘤原料藥的需求。小分子化療、激酶抑制劑和荷爾蒙療法是癌症治療方法中使用的原料藥。
區域洞察
美洲地區的特點是強大的製藥業、先進的醫療基礎設施以及對研發的高度重視。領先的製藥公司和尖端生物技術公司的存在促進了對小分子原料藥的高需求。美國食品藥物管理局(FDA) 的嚴格監管確保了高品質標準,使美國地區成為原料藥生產的一個有吸引力的地點。歐洲是小分子原料藥的主要市場,並擁有成熟的製藥業。歐洲國家以其對藥品創新和生產的重大貢獻而聞名。歐洲藥品管理局(EMA)在監管原料藥的品質和安全方面發揮重要作用,創造了高度監管的市場環境。此外,歐洲的戰略貿易協定和對學名藥的強烈關注正在推動該地區對小分子原料藥的需求。在中東和非洲地區,文明病的盛行率不斷上升以及政府改善醫療保健系統的舉措是刺激市場成長的因素。在中國、日本和印度等新興國家的推動下,亞太地區小分子 API 市場正在快速成長。由於較低的生產成本、熟練的勞動力以及醫療基礎設施投資的增加,這些國家正在成為原料藥製造的全球中心。該地區人口眾多,慢性病盛行,也導致藥品和原料藥的需求增加。
FPNV定位矩陣
FPNV定位矩陣對於評估小分子原料藥市場至關重要。我們檢視與業務策略和產品滿意度相關的關鍵指標,以對供應商進行全面評估。這種深入的分析使用戶能夠根據自己的要求做出明智的決策。根據評估,供應商被分為四個成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市場佔有率分析
市場佔有率分析是一種綜合工具,可以對小分子原料藥市場供應商的現狀進行深入而深入的研究。全面比較和分析供應商在整體收益、基本客群和其他關鍵指標方面的貢獻,以便更好地了解公司的績效及其在爭奪市場佔有率時面臨的挑戰。此外,該分析還提供了對該行業競爭特徵的寶貴見解,包括在研究基準年觀察到的累積、分散主導地位和合併特徵等因素。詳細程度的提高使供應商能夠做出更明智的決策並制定有效的策略,從而在市場上獲得競爭優勢。
1. 市場滲透率:提供有關主要企業所服務的市場的全面資訊。
2. 市場開拓:我們深入研究利潤豐厚的新興市場,並分析其在成熟細分市場的滲透率。
3. 市場多元化:提供有關新產品發布、開拓地區、最新發展和投資的詳細資訊。
4.競爭力評估與資訊:對主要企業的市場佔有率、策略、產品、認證、監管狀況、專利狀況、製造能力等進行全面評估。
5. 產品開發與創新:提供對未來技術、研發活動和突破性產品開發的見解。
1.小分子原料藥市場規模及預測是多少?
2.小分子原料藥市場預測期間需要考慮投資的產品、細分市場、應用和領域有哪些?
3.小分子原料藥市場的技術趨勢與法規結構是什麼?
4.小分子原料藥市場主要廠商的市場佔有率是多少?
5.進入小分子原料藥市場合適的型態與策略手段是什麼?
[185 Pages Report] The Small-Molecule APIs Market size was estimated at USD 184.32 billion in 2023 and expected to reach USD 197.35 billion in 2024, at a CAGR 7.26% to reach USD 301.19 billion by 2030.
Small-molecule Active Pharmaceutical Ingredients are organic compounds with a low molecular weight, typically below 900 daltons. These molecules are the active components in pharmaceuticals that are responsible for eliciting the intended therapeutic effect when administered to patients. Small-molecule APIs can easily diffuse across cell membranes because of their small size and simple structure, making them particularly effective in targeting intracellular sites. Growing chronic disease prevalence, including cancer, cardiovascular, and infectious diseases, contributes to the market growth. Accelerated drug development cycles and rising adoption of generic drugs across the globe boost the utilization of small-molecule API. However, high costs and stringent regulatory standards associated with drug development limit the growth of the market. In addition, the health effects of exposure to active pharmaceutical ingredients create hindrances to market growth. However, strategies such as outsourcing production to cost-effective locations, developing sophisticated synthesis methods, and leveraging AI in drug discovery can be potential game-changers for an industry ripe with opportunity. Further growth opportunities exist due to the burgeoning generic drugs popularity and expanding contract manufacturing sectors.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 184.32 billion |
Estimated Year [2024] | USD 197.35 billion |
Forecast Year [2030] | USD 301.19 billion |
CAGR (%) | 7.26% |
Type: Growing inclination towards biological based small-molecule APIs due to its reduced side effects
Biological small-molecule APIs are derived from living organisms or contain components of living organisms. These APIs are typically produced through biotechnological methods, including recombinant DNA technology, controlled gene expression, antibody technologies, and fermentation processes. Biological APIs are often more complex in structure compared to their synthetic counterparts and may offer unique therapeutic benefits, such as high specificity and reduced side effects. Synthetic small-molecule APIs are chemically manufactured through various chemical synthesis processes. This segment dominates the small-molecule APIs market due to the relative ease of production, scalability, and the extensive history of chemical synthesis in drug development. Synthetic APIs can be produced in large quantities and at a lower cost compared to biological APIs. They encompass a wide range of drugs, including generics and over-the-counter medications, and are critical in treating a multitude of conditions.
Production: Increasing in-house small-molecule APIs manufacturing to ensure quality standards
Contract manufacturing organizations (CMOs) play a pivotal role in the small-molecule APIs market. They offer their manufacturing services to pharmaceutical companies that prefer to outsource production for various reasons, such as cost reduction, lack of in-house facilities, or the need for specialized expertise. Contract manufacturing allows for greater flexibility and can help companies manage the complexities associated with the production of small-molecule APIs, including regulatory compliance and quality control. In-house manufacturing refers to pharmaceutical companies that maintain their own production facilities for small-molecule APIs. This segment includes large pharmaceutical companies with extensive resources and infrastructure that can support the entire drug manufacturing process, from API synthesis to final product formulation. In-house manufacturing allows for greater control over the production process, potentially leading to better integration of manufacturing and R&D efforts, and can provide a strategic advantage in terms of protecting intellectual property and supply chain management.
Application: Ongoing advancements in oncology enhances the utilization of small-molecule APIs
Small-molecule drugs used in the treatment of CVDs include antihypertensives, anticoagulants, and cholesterol-lowering drugs, among others. The demand for these APIs is driven by the high global prevalence of heart disease, hypertension, and stroke, necessitating a robust pipeline of cardiovascular medications. Diabetes-related APIs are expanding due to the increasing incidence of Type 1 and Type 2 diabetes worldwide. Small-molecule drugs such as insulin sensitizers, sulfonylureas, and SGLT2 inhibitors are essential in managing blood glucose levels and preventing complications associated with diabetes. Immunological disorders encompass a wide range of conditions, including autoimmune diseases and allergies. Small-molecule APIs used in the treatment of these disorders include immunosuppressants, anti-inflammatory drugs, and antihistamines. Oncology is one of the most critical and rapidly evolving segments in the small-molecule APIs market. The demand for oncology APIs is driven by the urgent need for effective cancer treatments. Small-molecule chemotherapeutic agents, kinase inhibitors, and hormone therapies are among the APIs used in cancer treatment regimens.
Regional Insights
The American region is characterized by a robust pharmaceutical industry, advanced healthcare infrastructure, and a strong focus on research and development. The presence of major pharmaceutical companies, along with cutting-edge biotechnology firms, contributes to the high demand for small-molecule APIs. Stringent regulations by the U.S. Food and Drug Administration (FDA) ensure high-quality standards, making American regions an attractive location for API manufacturing. Europe stands as a key market for small-molecule APIs, with a well-established pharmaceutical sector. European countries are known for their significant contributions to pharmaceutical innovation and production. The European Medicines Agency (EMA) plays a crucial role in regulating API quality and safety, fostering a highly regulated market environment. Additionally, Europe's strategic trade agreements and a strong emphasis on generic drugs bolster the demand for small-molecule APIs in the region. The increasing incidence of lifestyle-related diseases and government initiatives to improve healthcare systems are factors that could stimulate market growth across the Middle East and Africa. The APAC region is witnessing rapid growth in the small-molecule API market, driven by emerging economies such as China, Japan, and India. These countries are becoming global hubs for API manufacturing due to lower production costs, skilled labor, and increasing investments in healthcare infrastructure. The region's large population base and growing prevalence of chronic diseases also contribute to the rising demand for pharmaceuticals and APIs.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Small-Molecule APIs Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Small-Molecule APIs Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Small-Molecule APIs Market, highlighting leading vendors and their innovative profiles. These include AbbVie Inc., Agilent Technologies, Inc., Alacrita Holdings Limited, Albemarle Corporation, Aspen Group, Astrazeneca PLC, Aurobindo Pharma Limited, Bachem Holding AG, Bio-Rad Laboratories, Inc., Boehringer Ingelheim GmbH, Bristol-Myers Squibb, Cambrex Corporation by Permira funds, Carlyle Group, Charles River Laboratories International, Inc., Deciphera Pharmaceuticals, Inc., Dr. Reddy's Laboratories Ltd., F. Hoffmann-La Roche Ltd,, Gilead Sciences, Inc, GlaxoSmithKline PLC, Koninklijke DSM N.V., Lonza Group AG, Merck KGaA, Pfizer, Inc., and Teva Pharmaceutical Industries Ltd..
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Small-Molecule APIs Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Small-Molecule APIs Market?
3. What are the technology trends and regulatory frameworks in the Small-Molecule APIs Market?
4. What is the market share of the leading vendors in the Small-Molecule APIs Market?
5. Which modes and strategic moves are suitable for entering the Small-Molecule APIs Market?