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到 2030 年高活性药物成分 (HPAPI) 市场预测:按产品、製造商、药物类型、应用和地区分類的全球分析High Potency Active Pharmaceutical Ingredient (HPAPI) Market Forecasts to 2030 - Global Analysis By Product (Biologic, Biosimilar and Biotech), Manufacturer (Outsourced/ Contract and In-House (Captive)), Drug Type, Application and By Geography |
根据 Stratistics MRC 的数据,2024 年全球高活性药物成分 (HPAPI) 市场规模为 345.1 亿美元,预计在预测期内将以 11.7% 的复合年增长率增长,到 2030 年达到 670.2 亿美元。
高活性药物成分是一种在极低剂量下表现出生物活性的化合物。在人类基因组被描绘出来后,抗癌药物开始为每个患者製造,而不仅仅是针对特定的癌症。全球高活性活性原料药分为非专利药HPAPI和创新HPAPI。非专利HPAPI 含有与曾经受化学专利保护的药物相同的化学物质,而创新 HPAPI 则含有不同的化学分子。
据阿兹海默症协会称,美国约有 620 万名 65 岁及以上的人患有老年痴呆症失智症,预计到 2050 年这一数字将增至 1,270 万人。
癌症发生率增加
HPAPI是一种高效的药理活性成分。 HPAPI 的作用非常特异性,即使在较低的每日治疗剂量下也具有很大的功效。 HPAPI 具有针对精确疾病细胞的能力,因此可用于配製高活性药物。由于 HPAPI 的靶向释放特性,它在标靶治疗中得到了主要应用。在全球范围内,癌症发生率正在显着增加。癌症患者数量的增加对全球抗癌药物的销售产生了重大影响。
初始投资大
HPAPI 的细胞毒性带来了重大的处理挑战,并且需要大量投资来安装特殊的防护设施以防止员工接触。儘管 HPAPI 市场是一个新兴且不断成长的市场,但製药商在升级现有设施方面面临重大挑战,这些设施只能处理具有低或中等药理活性的原料药。契约製造需要大量投资建设专用为 HPAPI 生产而设计的新设施,与常规 GMP 生产设施分开。
新兴地区趋势
印度、中国和中东等新兴经济体为 HPAPI 市场的参与企业提供了高成长机会。其中许多地区人口众多、日益繁荣、寿命不断延长,因此预计未来几年市场将呈现高成长率。肌肉骨骼疾病、青光眼,尤其是癌症等疾病对全世界人民的健康状况有重大影响,其中新兴国家的成长率相对较高。
业界标准不断演进
该市场参与企业(尤其是提供 HPAPI 製造服务的 CMO)面临的主要挑战之一是行业标准、技术和法规的不断发展。想要进入这个市场的公司将需要采用这些新技术,这通常需要大量投资。例如,SAFC(美国)宣布,美国的 HPAPI 生产将采用更强大的分析技术,提高灵敏度和检测水平,以确定十亿分之一的潜在原料原料药残留,并且必须对设施进行升级。
COVID-19 大流行对高活性药物成分 (HPAPI) 市场产生了重大影响。对有效治疗方法和疫苗的需求激增,增加了包括 HPAPI 在内的製药业的投资和产能。供应链中断和关闭措施最初是一个挑战,导致延误和短缺。然而,这场危机加速了技术进步和监管核准,推动了 HPAPI 製造的创新和效率。
预计肿瘤学将成为预测期内最大的领域
由于癌症治疗中含有大量 HPAPI,肿瘤学领域占了最大的市场。癌症盛行率的上升是推动 HPAPI 需求的主要因素。此外,与荷尔蒙失调和青光眼等其他治疗应用相比,对癌症的需求不断增长以及标靶治疗的最新趋势是肿瘤学发展加快的关键因素。
预计合成材料领域在预测期内复合年增长率最高
合成 HPAPI 市场的成长速度很快,因为这些分子在非常低的剂量下就能非常有效地治疗各种疾病。此外,许多合成分子预计将在未来几年失去专利,从而促进市场成长。日本政府提倡使用学名药来降低整体医疗费用和患者的经济负担。
由于先进的製药基础设施、严格的监管标准以及大量的研发投资,预计北美将在高活性药物成分 (HPAPI) 市场中占据最大的市场占有率。该地区是大型製药公司和受託製造厂商(CMO) 的所在地,进一步推动了市场成长。此外,慢性病盛行率的增加和对标靶癌症治疗的需求增加了对 HPAPI 的需求,从而巩固了北美在市场上的主导地位。
老年人口增加、慢性病和文明病盛行率高、可支配收入增加、文明病和老龄化疾病盛行率、政府医疗改革措施、推广学名药的采用 亚太地区预计复合年增长率最高。该地区製药商的市场扩张得益于较低的人事费用和製造成本,这正在推动亚洲市场的成长。
According to Stratistics MRC, the Global High Potency Active Pharmaceutical Ingredient (HPAPI) Market is accounted for $34.51 billion in 2024 and is expected to reach $67.02 billion by 2030 growing at a CAGR of 11.7% during the forecast period. High potency active pharmaceutical ingredients are biologically active compounds that exhibit biological activity at extremely low dose levels. After the human genome was depicted, cancer drugs were produced not only for distinct cancer but also for different patients. The global high potency active ingredient is classified as Generic HPAPI and Innovative HPAPI. The generic HPAPI involve the same chemical agent as a drug that was once secured by chemical patent claims Whereas, Innovative HPAPI involves different chemical molecule.
According to the Alzheimer's Association, roughly 6.2 Million people in the United States over the age of 65 have Alzheimer's dementia, with the number expected to rise to 12.7 Million by 2050.
Increasing incidence of cancer
HPAPIs are extremely effective pharmacologically active ingredients. They are highly specific in their action and offer significant efficiency even at low daily therapeutic doses. HPAPIs have the ability to target precise disease cells and are, hence, used in formulations for highly potent drugs. Owing to their target release characteristics, HPAPIs find major applications in target therapies for cancer. Globally, there is a significant growth in the incidence of cancer. This growth in the number of cancer cases has a tremendous impact on the sales of cancer drugs across the globe.
Large initial investments
The cytotoxic nature of HPAPIs presents significant handling challenges and thus requires heavy investments for implementing specialized containment facilities that facilitate the safety of employees from exposure. Although the HPAPIs market is an emerging and growing market, pharmaceutical manufacturers face significant challenges in upgrading their existing facilities that are capable of handling only low- or medium-potency APIs. Contract manufacturers are required to heavily invest in building new facilities that are designed specifically for HPAPI manufacturing apart from the usual GMP production facilities.
Developments in emerging regions
Developing economies such as India, China, and the Middle East presents high growth opportunities for players in the HPAPIs market. In most of these geographies, the market is expected to show a high growth rate in the coming years owing to their huge population, increasing prosperity, and improving longevity. Diseases like musculoskeletal diseases, glaucoma, and specifically cancer have a significant impact on the health status of people worldwide, with comparatively higher growth rates in developing countries.
Continual evolution of industry standards
One of the major challenges faced by the players in this market, especially CMOs that offer HPAPI manufacturing services, is the continual evolution of industry standards, technologies, and regulations. Companies that are willing to enter this marker are required to adopt these newer technologies, which generally translates to huge investments. For instance, SAFC (US) had to upgrade its HPAPI manufacturing facility in the US to include more robust analytical technologies with improved sensitivity and detection levels that allow for the determination of potential API carryover at part-per-billion levels.
The COVID-19 pandemic significantly impacted the high-potency active pharmaceutical ingredient (HPAPI) market. The surge in demand for effective treatments and vaccines led to increased investment and production capacity in the pharmaceutical sector, including HPAPIs. Supply chain disruptions and lockdown measures initially posed challenges, causing delays and shortages. However, the crisis also accelerated technological advancements and regulatory approvals, fostering innovation and efficiency in HPAPI manufacturing.
The oncology segment is expected to be the largest during the forecast period
The oncology segment has the largest share of the market because of the greater amount of HPAPIs found in oncology drugs. The rising prevalence of cancer is a major factor driving up demand for HPAPI. And also, some of the factors like rising demand for cancer and initiate of recent target therapy are the main cause of the increase in the development of oncology as compared to other therapeutic applications such as hormonal disorder and glaucoma.
The synthetic segment is expected to have the highest CAGR during the forecast period
The synthetic HPAPI market is growing at a faster rate because, at very low doses, these molecules are very effective in the treatment of a variety of diseases. Many synthetic molecules are also predicted to lose their patents in the years ahead, boosting market growth. The Japanese government has been advocating for the utilize of generic medicines in lowering the overall healthcare costs and the economic burden placed on patients
North America is projected to hold the largest market share in the High Potency Active Pharmaceutical Ingredient (HPAPI) market due to its advanced pharmaceutical infrastructure, stringent regulatory standards, and significant investments in R&D. The presence of key pharmaceutical companies and contract manufacturing organizations (CMOs) in the region further drives market growth. Additionally, the increasing prevalence of chronic diseases and the demand for targeted cancer therapies boost the need for HPAPIs, reinforcing North America's leading position in the market.
Asia Pacific is projected to have the highest CAGR due to the growth in geriatric population, high prevalence of chronic and lifestyle diseases, increase in disposable income, prevalence of lifestyle- and age-related diseases, government efforts to reform healthcare and encourage the adoption of generics. The growing market for merchant manufacturers in this region is attributed to the low labour and manufacturing costs are driving the growth of the market in Asia.
Key players in the market
Some of the key players in High Potency Active Pharmaceutical Ingredient (HPAPI) market include Abbvie, Alkermes plc, Bristol-Myers Squibb, Cambrex Corporation, Corden Pharma International, Dr. Reddy's Laboratories, Eli Lilly and Company, F. Hoffmann-La Roche, Lonza Group, Merck KGaA, Novartis AG, Novasep, Pfizer, Sanofi, Sigma-Aldrich Co LLC, SK Biotek, Sun Pharmaceutical Industries Ltd, Teva Pharmaceutical Industries, Thermo Fisher Scientific Inc., Viatris Inc. and WuXi AppTec
In May 2024, Alkermes plc has completed the previously announced sale of its development and manufacturing facility in Athlone, Ireland to Novo Nordisk. In connection with the closing of the transaction, Alkermes will receive a one-time cash payment for the facility and certain related assets of approximately $91 million.
In April 2024, Bio-Techne Corporation announced a significant milestone in its commitment to providing cutting-edge solutions to its customers. Effective May 1, 2024, Bio-Techne will enter into a strategic distribution agreement with Thermo Fisher Scientific, a leading provider of laboratory products and services, in Europe. This partnership marks an important collaboration between two industry leaders in the fields of scientific research, diagnostics, and biotechnology.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.